U.S. patent application number 17/249473 was filed with the patent office on 2021-06-24 for devices, treatments and methods to restore tissue elastic recoil.
This patent application is currently assigned to Free Flow Medical, Inc.. The applicant listed for this patent is Free Flow Medical, Inc.. Invention is credited to Ryan Braxtan, Michael W. Lau, Mark L. Mathis, Kevin Mitz.
Application Number | 20210186512 17/249473 |
Document ID | / |
Family ID | 1000005434568 |
Filed Date | 2021-06-24 |
United States Patent
Application |
20210186512 |
Kind Code |
A1 |
Mathis; Mark L. ; et
al. |
June 24, 2021 |
DEVICES, TREATMENTS AND METHODS TO RESTORE TISSUE ELASTIC
RECOIL
Abstract
Pulmonary treatment devices, systems and methods of use are
provided which take into account the vast tissue damage of advanced
COPD sufferers and provide treatments designed specifically to
treat the particularly compromised lung tissues that are present in
these patients. These treatments reduce trapped air volume, tension
lung tissue and enhance lung elastic recoil. A variety of
embodiments are provided, including pulmonary treatment devices
that move portions of lung tissue around a rotational axis into a
torqued configuration, anchoring such tissue in place for improved
breathing mechanics.
Inventors: |
Mathis; Mark L.; (Fremont,
CA) ; Lau; Michael W.; (Menlo Park, CA) ;
Mitz; Kevin; (Campbell, CA) ; Braxtan; Ryan;
(Newark, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Free Flow Medical, Inc. |
Fremont |
CA |
US |
|
|
Assignee: |
Free Flow Medical, Inc.
Fremont
CA
|
Family ID: |
1000005434568 |
Appl. No.: |
17/249473 |
Filed: |
March 2, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16444849 |
Jun 18, 2019 |
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17249473 |
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PCT/US18/67160 |
Dec 21, 2018 |
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16444849 |
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62609761 |
Dec 22, 2017 |
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62651573 |
Apr 2, 2018 |
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62714411 |
Aug 3, 2018 |
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62720004 |
Aug 20, 2018 |
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62749005 |
Oct 22, 2018 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/12104 20130101;
A61B 17/12036 20130101; A61B 2017/1205 20130101; A61B 17/12136
20130101; A61F 2/88 20130101; A61B 2017/00809 20130101; A61B
1/00085 20130101; A61B 2017/00867 20130101; A61B 2017/00539
20130101; A61B 17/1214 20130101; A61F 2/04 20130101; A61B 1/267
20130101; A61M 16/00 20130101; A61F 2/02 20130101; A61F 2/95
20130101; A61B 17/0057 20130101; A61F 2/848 20130101; A61B
2017/00615 20130101; A61B 1/01 20130101; A61B 2017/00557
20130101 |
International
Class: |
A61B 17/12 20060101
A61B017/12; A61B 17/00 20060101 A61B017/00; A61B 1/01 20060101
A61B001/01; A61M 16/00 20060101 A61M016/00; A61B 1/267 20060101
A61B001/267; A61F 2/95 20060101 A61F002/95; A61F 2/04 20060101
A61F002/04; A61B 1/00 20060101 A61B001/00; A61F 2/02 20060101
A61F002/02; A61F 2/88 20060101 A61F002/88 |
Claims
1. A device for treating a lung comprising: a tissue engaging end
configured to engage loose damaged tissue; and a stabilizing end
configured to engage a lung passageway proximal to the loose
damaged tissue so as to seat in the lung passageway wherein a
portion of the device is configured to deform so as to store
energy, wherein the device is configured to re-tension a portion of
the lung by pulling the tissue engaging end proximally toward the
stabilizing end in the lung passageway and at least partially
maintaining such pulling by recoil force provided by deformation of
the portion configured to deform.
2. A device as in claim 1, wherein the portion configured to deform
is configured to be elongated to store elastic recoil strain
energy.
3. A device as in claim 2, wherein the portion configured to deform
has a potential longitudinal elongation in a range of 10-200
mm.
4. A device as in claim 3, wherein the portion configured to deform
has a length in a range of 5-75 mm in resting free space.
5. A device as in claim 2, wherein the stored elastic recoil strain
energy is configured to reduce a distance between an engaged first
location of loose damaged tissue and a second location within the
lung passageway to increase tension in locations in the lung that
are not between the first location and the second location.
6. A device as in claim 1, wherein the device has a potential
longitudinal elongation of between 0.25 and 10 inches beyond its
resting length. [this is for the device overall, not the
midsection]
7. A device as in claim 6, wherein the device has a potential
longitudinal elongation of between 2-4 inches beyond its resting
length.
8. A device as in claim 1, wherein the tissue engaging end
comprises a plurality of loops.
9. A device as in claim 8, wherein the plurality of loops allows
grabbing of loose damaged tissue and wherein pulling the tissue
engaging end proximally binds the tissue and traps tissue between
the loops to cause tissue traction.
10. A device as in claim 8, wherein the plurality of loops are
disposed in more than one plane.
11. A device as in claim 8, wherein the plurality of loops comprise
at least two loops disposed within the same plane.
12. A device as in claim 8, wherein device comprises a longitudinal
axis extending from the tissue engaging end to the stabilizing end,
and wherein the plurality of loops comprise at least two loops
extending radially outwardly from the longitudinal axis and curving
back around toward the longitudinal axis.
13. A device as in claim 12, wherein at least one of the at least
two loops forms an additional loop.
14. A device as in claim 1, wherein the portion configured to
deform comprises at least one loop.
15. A device as in claim 14, wherein the at least one loop
comprises a coiled midsection.
16. A device as in claim 1, wherein the portion configured to
deform comprises an extendible midsection.
17. A device as in claim 1, wherein the stabilizing end comprises
at least one loop.
18. A device as in claim 19, wherein the at least one loop includes
at least one loop which curves at least partially around a
longitudinal axis, wherein the longitudinal axis extends from the
stabilizing end to the tissue engaging end.
19. A device as in claim 1, wherein the device is formed from a
single continuous shaft.
20. A device as in claim 19, wherein the shaft is comprised of a
shape-memory alloy.
21. A device as in claim 1, wherein the tissue engaging end is
configured to be deployed independently of the stabilizing end.
22. A device as in claim 1, wherein the tissue gathering element
has a shape configured to engage the loose damaged tissue by
rotating the tissue gathering element around a rotational axis and
wherein the tissue gathering element has a stiffness configured to
move the loose damaged tissue around the rotational axis into a
torqued configuration.
23. A device as in claim 22, further comprising an attachment
element configured to attach to a torqueing tool so as to rotate
the tissue gathering element around the rotational axis.
24. A device as in claim 1, further comprising an attachment
element configured to couple with a delivery device so that the
device is able to remain attached to the delivery device after the
stabilizing end is deployed.
25. A device as in claim 1, wherein the lung passageway includes a
bifurcation and wherein device comprises a longitudinal axis
extending from the tissue gathering end to the stabilizing end,
wherein the stabilizing end comprises an anchoring element
configured to bow outwardly away from the longitudinal axis so as
to enter a portion of the bifurcation.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/444,849 (Attorney Docket No. 52086-703.302)
filed Jun. 18, 2019, which is a continuation of PCT Application No.
PCT/US18/67160, filed Dec. 21, 2018, (Attorney Docket No.
52086-703601), which claims priority to Provisional No. 62/609,761,
filed Dec. 22, 2017, (Attorney Docket No. 52086-703.101);
Provisional No. 62/651,573, filed Apr. 2, 2018, (Attorney Docket
No. 52086-703.102); Provisional No. 62/714,411, filed Aug. 3, 2018,
(Attorney Docket No. 52086-703.103); Provisional No. 62/720,004,
filed Aug. 20, 2018, (Attorney Docket No. 52086-703.104); and
62/749,005, filed Oct. 22, 2018, (Attorney Docket No.
52086-703.105), the entire contents of which are incorporated
herein by reference.
BACKGROUND OF THE INVENTION
[0002] Chronic obstructive pulmonary disease (COPD) is a common
progressive, debilitating lung disease that is often fatal. COPD
patients are diagnosed with either emphysema, chronic bronchitis or
more commonly, a combination of both. The symptoms of COPD include
a persistent cough, particularly one that produces excessive of
mucus, shortness of breath (especially during exercise), a wheezing
sound while breathing, a barrel-chest deformity, and tightness in
the chest muscles due to expansion of the chest with the
barrel-chest deformation. Late stages of COPD manifest in symptoms
that relate more closely to slow persistent suffocation as the
disease eventually nearly totally obstructs any outflow of gas from
the lungs. Such symptoms may start as a minor impediment to daily
life, but they often lead to difficulty in talking or basic
breathing. COPD reduces oxygen and carbon dioxide gas exchange
which leads to circulatory problems, such as low oxygen levels in
the blood, brain and heart muscles. This negatively affects mental
alertness and contributes to a very rapid heartbeat, due to
increased strain on the heart.
[0003] According to the National Institutes of Health, COPD is the
third leading cause of death in the United States. The American
Lung Association reports that more than 11 million people in the
United States have been diagnosed with COPD. However, about 24
million more people may have the disease and not know it. Globally,
COPD affects approximately 65 million people.
[0004] COPD can occur in people suffering from an inherited genetic
condition called Alpha-1 Antitrypsin Deficiency (A1AT Deficiency)
and from breathing air in environmental conditions such as air
pollution, contaminated air, in work environments that are not
ideal etc. However, COPD most commonly occurs in people who are
over age 40 and who have a history of smoking. Cigarette smoke is
composed of over 4000 different chemicals, many of which are toxic.
Both smoke that the smoker inhales (through the filter) and the
smoke from the burning end are toxic. There are three main
components that are hazardous to health: tar, nicotine and carbon
monoxide. Tar settles in the lungs and stimulates a series of
changes that lead to obstructive lung disease and lung cancer.
Nicotine is an addictive element in cigarettes and also stimulates
the nervous system to reduce arteriole diameter and release
adrenaline, increasing heart rate and blood pressure. Nicotine also
causes increased stickiness of blood platelets, which increases the
risk of blood clotting. Carbon monoxide combines irreversibly with
hemoglobin so that oxygen cannot bind effectively. This causes a
strain on the heart muscle because it must pump more to provide the
same amount of oxygen.
[0005] Tobacco smoke and secondhand smoke travel down through the
windpipe and into the bronchial tubes. The toxic smoke then moves
into the bronchioles, which contain the small clusters of air sacs
known as alveoli. Within the alveoli are the capillaries. In a
healthy person, oxygen moves through the alveoli and into the
capillaries and bloodstream during inhalation, allowing oxygen rich
blood to be distributed to the rest of the body via the arterial
system. Simultaneously, carbon dioxide is transported from blood
along venous pathways to the capillaries and into the alveoli so it
can be removed from the body during exhalation. This process is
known as gas exchange. The elasticity of healthy air sacs enables
this exchange to occur during lung volume change with breathing
cycles. However, the inhalation of smoke ultimately destroys this
elasticity and lung tissue itself.
[0006] The effect of tobacco smoke on lung elastin is extremely
complicated, affecting many facets of connective tissue metabolism.
Inhalation of cigarette smoke causes an accumulation in the
respiratory bronchi of alveolar macrophages, which appear to be
filled with pigments and are metabolically and morphologically
activated. The activated macrophage has the ability to secrete
chemo attractants and secretagogues for neutrophils, as well as
secrete a metalloprotease capable of digesting elastin and
.alpha..sub.1 antiprotease. The end result is a clustering of large
numbers of neutrophils and macrophages, poised to release
considerable amounts of elastolytic enzymes at the site where the
earliest signs of centrilobular emphysema are detected. This is
seen, in X-ray images of the lung as small pockets of dissolved
tissue known as blebs. In addition to this, the alveolar
macrophages, as well as cigarette smoke, are rich sources of
oxidizing agents. One potential action of these oxidants would be
to oxidize the methionine residue found at the active site of
.alpha..sub.1 proteinase inhibitor. This has been shown by
selective chemical oxidation to yield a relatively ineffective
inhibitor that associates with elastase some 2000 times more slowly
than the native protein. This results in oxidant damage to lung
cells and cellular components such as lipids, cofactors, and
nucleic acids. Endogenous antioxidant systems within the lung, such
as ceruloplasmin, vitamin C, or methionine sulphoxide-peptide
reductase, are adversely affected by cigarette smoke, lowering the
lung's defense against oxidants. The elastin maturation process is
impaired by cigarette smoke.
[0007] Such damage affects the walls between the alveolar sacs. As
the air sacs weaken, their walls break open or "melt", creating one
large air sac instead of many smaller ones. The total surface area
of the air sacs is reduced, and this reduces that amount of gas
that can be exchanged across the walls of the air sacs. These
gasses are transported across the thin air sac membrane surfaces
using a diffusion process. By reducing the majority of air sacs,
the total surface area of the sacs is limited causing gas exchange
to be reduced. This makes it more difficult for the capillaries to
absorb enough oxygen and for the body to expel carbon dioxide,
making it progressively harder to breathe. In addition, the air
sacs lose their elasticity making it harder to recoil and expel
air. The walls of the airways thicken and become swollen while
making more mucus than normal which can clog the airways that lead
to the air sacs. The thickening and mucus plugging are the chronic
bronchitis component of COPD. All of these factors contribute to
the symptoms of COPD.
[0008] Another common COPD symptom is air trapping which causes
breathing disfunction as well as lobar and lung hyperinflation. The
reduced volume reached by the lungs after exhalation is determined
by the balance of forces between the inward elastic recoil
pressure, or inward pulling tension of the lung tissue that lifts
the diaphragm and the outward recoil pressure or outward pulling of
the chest wall. The lung is suspended in an expanded state due to
negative pressure or vacuum between the chest wall and the exterior
lining of the lung. This vacuum keeps the lung expanded and pinned
to the chest wall. Because the lungs are held in a generally
expanded state, interior lung tissue (parenchyma) is stressed in
tension (creating lung elastic resistance to stretching, commonly
referred to as lung elastic recoil). This tension, throughout the
lung, pulls radially outward on the airways to hold these airways
open and the tension helps to allow air to be squeezed out of the
lungs during the expiration breathing cycle. During expiration, the
diaphragm muscle is relaxed, and the lung's internal elastic recoil
lifts the diaphragm and lung floor up which reduces the lung volume
and squeezes air out of the lung. During inspiration, the diaphragm
muscle contracts to pull the diaphragm down which increase lung
volume which draws air back into the lungs. Static hyperinflation
occurs when the lungs exert less recoil pressure to counter the
recoil pressure of the chest wall due to the destruction of
elastin. This results in an equilibrium of recoil forces at a
higher resting volume than normal. In other words, there is less
recoil so the diaphragm cannot be lifted as far and the lungs
ability to expel air is reduced. This creates a chronic increase in
lung volume, also known as increased total lung capacity (TLC).
Dynamic hyperinflation occurs when air is trapped within the lungs
after each breath due to a disequilibrium between the volumes
inhaled and exhaled. This most commonly occurs during exercise and
inspiration is more efficient than expiration. With each breath,
hyperinflation is increased. The ability to fully exhale depends on
the degree of airflow limitation and the time available for
exhalation. Both types of air trapping causes 1) lung gas
congestion, preventing new oxygen from being inspired, 2)
retainment of CO.sub.2 in the lung and blood stream (hypoxemia) and
3) crushing of better functioning lobes making them incapable of
inspiration or expiration. The last phenomenon occurs because the
trapping often occurs in places with the most lung tissue
destruction (regions with the greatest reduction of recoil). As
more air is trapped in this area and the lobe hyperinflates, it
expands into regions where tissue is better preserved and still
performing well but the added pressure of the inflated tissue
restricts air flow in and out of the healthier region.
[0009] Ultimately, enzymes destroy and eliminate airways and
alveoli tissue. Large holes are formed in alveoli beds forming
pulmonary blebs and bullae. Pulmonary blebs are small subpleural
thin walled air pockets, not larger than 1-2 cm in diameter. Their
walls are less than 1 mm thick. If they rupture, they allow air to
escape into the pleural space between the lung and chest wall,
which is normally holding the lungs expanded and pinned to the
chest wall with vacuum, resulting in a spontaneous pneumothorax or
collapse of the lung. Pulmonary bullae, like blebs, are cystic air
spaces or pockets that have an imperceptible wall (less than 1 mm).
The difference between blebs and bullae is generally considered to
be their size, with the cross-over being around 2 cm in diameter.
Blebs may, over time, coalesce to form bullae.
[0010] Smoking cessation continues to be an important therapeutic
intervention for COPD. Approaches to management by stage include
the following: [0011] Stage I (mild obstruction): Short-acting
bronchodilator as needed; [0012] Stage II (moderate obstruction):
Short-acting bronchodilator as needed; long-acting
bronchodilator(s); cardiopulmonary rehabilitation; [0013] Stage III
(severe obstruction): Short-acting bronchodilator as needed;
long-acting bronchodilator(s); cardiopulmonary rehabilitation;
inhaled glucocorticoids if repeated exacerbations; [0014] Stage IV
(very severe obstruction or moderate obstruction with evidence of
chronic respiratory failure): Short-acting bronchodilator as
needed; long-acting bronchodilator(s); cardiopulmonary
rehabilitation; inhaled glucocorticoids if repeated exacerbation;
long-term oxygen therapy (if criteria met); interventions such as
lung transplantation, lung volume reduction surgery (LVRS), or
implantable therapeutic devices.
[0015] Lung volume reduction surgery (LVRS) is a surgical procedure
to remove diseased, emphysematous lung tissue. The surgery removes
up to 1/3 of the lung to attempt to remove non-gas exchanging
portions of lung. This is intended to remove sections of
non-performing tissue that can no longer exchange gas to and from
the blood stream. It is also intended to remove blood vessels that
would otherwise shunt under oxygenated blood with high levels of
CO2 (vessels traveling through portions of the lung where gas
cannot be exchanged) back to the heart and blood circulatory
system. However, this surgery presents patients with high risk of
surgery related morbidity and mortality. Patients who already have
distressed breathing due to the disease are further stressed with
severe orthopedic trauma due to a sternotomy, which presents
difficulty in reviving these patients from general anesthesia. LVRS
related mortality and morbidity is a common result as was published
in the National Emphysema Treatment Trial (NETT) report. NETT was a
multicenter, randomized, controlled clinical trial, comparing the
efficacy of lung volume reduction surgery (LVRS) plus medical
management with rehabilitation to medical management with
rehabilitation in 1,218 patients with severe emphysema.
[0016] LVRS is performed with a long simple excision to remove a
large portion of lung volume. Thus, it is not discriminative in the
tissue that is removed. LVRS also removes portions of remaining
intact lung that would otherwise exchange gas. This reduces lung
capacity that patients need to exchange gas. LVRS is also not
effective for homogenous disease, which is the type that most COPD
patients suffer from. In homogenous disease, the disease is spread
evenly in all lobes without a discrete target lung volume that can
be sacrificed to enhance lung elastic recoil. Homogenous patients
need therapy because they suffer from an insufficient lung capacity
to exchange gas. Removing more lung tissue only reduces their
capacity. Therefore, the surgery actually degrades these patient's
ability to breathe.
[0017] A variety of implantable therapeutic devices have been
developed to assist in treating COPD sufferers. One such device is
an endobronchial valve. An endobronchial valve is minimally
invasive alternative to lung volume reduction surgery (LVRS).
Endobronchial valves were designed to replicate the effects of that
procedure without requiring incisions by allowing the most diseased
lobe of a lung to be pneumatically blocked off so air can be
evacuated to cause the treatment lobe to collapse. An endobronchial
valve is a small, one-way valve that is typically implanted such
that when a patient exhales, air is able to flow through the valve
and out of the lobe, but when the patient inhales, the valve closes
and blocks air from entering that lobe. Thus, a set of implanted
endobronchial valves can help a lobe to empty itself of air. This
has been shown to be beneficial in the treatment of a very small
population of patients suffering from heterogenous emphysema,
however such endobronchial valves suffer from some of the same
limitations as LVRS. Endobronchial valves that succeed to collapse
lobes in homogenous patients reduce their already insufficient lung
capacity. Homogeneous disease is the type that most COPD patients
suffer from. Thus, the valves may actually degrade these patient's
ability to breathe. Another limitation with the valves is the fact
that approximately 80% of patients present with additional flow
paths that lead into the lobe in addition to the major airway tree
that is typically shown in anatomy texts. The valves are designed
to block flow in airways but in the majority of patients, total
blockage or perfect pneumatic isolation can never be achieved and
the lobe never collapses. Many times, the alternate flow paths are
created by enzyme destruction due to the disease itself. This is
particularly true in heterogenous patients where tissue damage is
concentrated.
[0018] A similar type of therapy involves an endoscopic volume
reduction using lung sealant. The lung sealant foam is instilled
into the peripheral airways and alveoli where it polymerizes and
functions as tissue glue on the lungs inner surfaces in order to
seal the target region to cause durable irreversible absorption
atelectasis or collapse of the lung tissue. Such treatment by a
biological sealant produces an irreversible change in emphysematous
tissue. The biological sealant is delivered to the alveolar
compartment as separate liquid components via a dual lumen catheter
passed through the instrument channel of a flexible bronchoscope. A
common side effect is a systemic flu-like inflammatory reaction
after the foam sealant application accompanied by transient fever,
cough, bronchospasm, chest pain, leukocytosis, malaise, and
elevated C-reactive protein levels. This side effect is sometimes
self-limited and resolves within 24-96 h spontaneously. Other
times, the inflammation can cause long term morbidity and even
mortality. Other serious pulmonary side effects within 6 months
after the procedure include repetitive COPD exacerbations,
pneumonia, bronchitis, and hemoptysis. Over a period of several
weeks, the treated lung region will start to shrink, reducing lung
volume by atelectasis. However, such treatment again ultimately
suffers from some of the same limitations as LVRS. In particular,
lung sealants destroy lung tissue and reduce lung capacity so they
are not effective for homogenous disease, which is the type that
most COPD patients suffer from. Thus, these techniques actually
degrade these patient's ability to breathe.
[0019] Endobronchial coils are another type of therapeutic device
developed to assist in treating COPD sufferers and act as a
minimally invasive alternative to lung volume reduction surgery
(LVRS). Endobronchial coils are nitinol devices implanted
bronchoscopically under fluoroscopic guidance. The coils are
straightened so they can be passed through a bronchoscope and into
airways for deployment and then they are pushed out of the catheter
and allowed to recover to a programmed shape that bends the airway
they are deployed into. The device bends the airway to compress
adjacent tissue to cause a small lung volume reduction effect. As
multiple coils revert to their original double-loop shape within
the airways, targeted pockets of lung tissue are compressed between
features of the coil to replicate the effects of the LVRS in a
minimally invasive treatment. Multiple coils implanted throughout a
lobe attempt to achieve mechanical volume reduction. However, such
bending and folding of the airways increases resistance to gas flow
which blocks the airways from flowing efficiently to exchange gas.
The bending also compresses tissue by permanently freezing motion
in portions of the lung volume and preventing those portions from
efficiently contributing to exchanging gas. Thus, there is limited
inspiration and expiration in those regions which reduces the
patient's capacity to breathe. In addition, the coil design and
dimensions provide a very small contact area which produces high
pressure and compressive stress on the lung tissue. This
potentially allows for a kind of "cheese wire" cutting effect that
limits the effective time that a treatment remains effective, even
if initial results are positive. The coils are strong enough to
bend thick collagenous airways with substantial walls that would
not be easily abraded or subject to device related tissue erosion
or migration. However, due to the nature of the disease and the
enzymatic destruction in COPD patients, substantial, thick walled
airways are nearly absent beyond the 4th airway generation in
patients with the requisite degree of disease that would require
this type of intervention. The typical disease related tissue
destruction leaves only fragile segments of thin tissue in areas in
contact with the coils and this can only accelerate the "cheese
wire" effect which may reduce the potential for treatment success
substantially. In addition, blood vessels run parallel to most lung
airways and they are of comparable size with respect to the airway.
It is inadvisable to bend central airways (2nd-4th generation) as a
blood vessel could easily be pinched closed or ruptured. Since the
patient's entire cardiac pumping capacity is routed through the
lungs and these vessels, the use of such coils on these airways
would present the patient with extreme risk.
[0020] Devices such as the endobronchial coils and endobronchial
valves that are mechanical structures suffer from fatigue related
failure due to the high number of breathing cycles that these
products endure and the nature of the flexure that lung airways
present on these devices. In order to clear mucus, airways compress
flat during coughing to reduce the cross-sectional area of the
airway which increases the velocity of expelled gas and this
increases the effectiveness of a cough event in clearing unwanted
materials from the lung. In many cases, device failure occurs where
metallic or stiff biocompatible materials are placed in the lungs
where coughing presents the devices with repeated high force
flexure and airway collapse. Another cause for device failure is
tissue irritation and granular buildup of airway wall tissue and
the formation of bacterial colonies that are commonly found on
implanted polymers in the lung. Most devices that have been
previously proposed to treat COPD in the past have included one or
more design flaws to cause granulation tissue formations or
bacterial colonization's which are nearly impossible to remove or
otherwise treat.
[0021] Thus, additional treatment options are desired, particularly
for treatment of homogenous COPD where LVRS is particularly
ineffective and potentially harmful. Such treatment options should
avoid blocking off, rendering non-functioning or removing segments
of the lung in the manner of LVRS. In addition, such treatment
options should avoid deleterious compression of tissue. Compression
of lung tissue can compress and block blood vessels leading to
tissue necrosis and cell death, which in turn causes chronic air
leaks and eventual lung collapse due to breaching of the vacuum
seal between the lungs and chest wall. Such treatment options
should also be suitable for patients with late stage COPD. These
patients typically do not have any anatomically normal airways past
the 4.sup.th generation where the anatomy is comprised of extremely
weak, destroyed alveoli tissue which continues to degrade. The
ideal solution will be a device that treats COPD that is
manufactured with a minimum number of joints or features that may
present sharp edges, sharp and traumatic ends against soft tissues
and that is made using materials and using methods that minimizes
the potential for bacterial colonization and the formation of
granulation tissue in airways. At least some of these objectives
will be met by the present invention.
SUMMARY OF THE INVENTION
[0022] The present invention generally relates to medical systems,
devices and methods, and more particularly relates to treatment of
patients suffering from COPD. Likewise, the present invention
relates to the following numbered clauses:
[0023] 1. A pulmonary treatment device for treating a lung
comprising:
[0024] a tissue gathering element having a shape configured to
engage a portion of lung tissue within the lung by rotating the
tissue gathering element around a rotational axis and wherein the
tissue gathering element has a stiffness configured to move the
portion of lung tissue around the rotational axis into a torqued
configuration; and
[0025] an anchoring element configured to resist movement of the
engaged portion of the lung from the torqued configuration once
deployed.
[0026] 2. A device as in claim 1, wherein the pulmonary treatment
device has a longitudinal axis, and wherein the rotational axis is
concentric with the longitudinal axis.
[0027] 3. A device as in claim 2, wherein the anchoring element
comprises at least one turn of a coil which is concentric with the
longitudinal axis.
[0028] 4. A device as in claim 2 or 3, wherein the anchoring
element comprises a shaft which forms an angle with the
longitudinal axis.
[0029] 5. A device as in any of the above claims, wherein the shape
of the tissue gathering element includes at least one loop.
[0030] 6. A device as in claim 5, wherein the at least one loop
comprises a single loop.
[0031] 7. A device as in claim 5, wherein the at least one loop
comprises a pair of loops.
[0032] 8. A device as in claim 7, wherein the pair of loops extend
in opposite directions.
[0033] 9. A device as in claim 7, wherein the pair of loops extend
radially outwardly from a longitudinal axis along the pulmonary
treatment device at an angle from each other that is less than 180
degrees.
[0034] 10. A device as in any of claims 5-9, wherein at least one
of the at least one loop extends radially outwardly from a
longitudinal axis along the pulmonary treatment device and curves
at least partially back toward the longitudinal axis.
[0035] 11. A device as in claim 10, wherein the at least one of the
at least one loop comprises a half loop.
[0036] 12. A device as in claim 10, wherein the at least one of the
at least one loop extends radially outwardly from a longitudinal
axis along the pulmonary treatment device and curves back toward
the longitudinal axis crossing the longitudinal axis.
[0037] 13. A device as in any of claims 5-12, where each of the at
least one loops has a diameter in the range of 10 mm to 50 mm.
[0038] 14. A device as in any of the above claims, wherein the
tissue gathering element has a width in a range of 0.25 to 3
inches.
[0039] 15. A device as in any of the above claims, wherein the
tissue gathering element is comprised of a wire ribbon having a
width in the range of 0.040 and 0.100 inches.
[0040] 16. A device as in claim 15, wherein the wire ribbon is
twisted along its length at at least one location so as to rotate
at least one portion of a flat surface of the wire ribbon toward an
edge of the wire ribbon.
[0041] 17. A device as in claim 16, wherein the wire ribbon is
twisted along its length at multiple locations so as to rotate a
series of portions of the flat surface of the wire ribbon toward
the edge of the wire ribbon.
[0042] 18. A device as in any of the above claims, wherein the
tissue gathering element and the anchoring element are formed
together from a single continuous shaft.
[0043] 19. A device as in any of the above claims, wherein the
tissue gathering element and/or the anchoring element are comprised
of a wire.
[0044] 20. A device as in claim 19, wherein the wire is comprised
of a metal, stainless steel, steel containing chromium, steel
containing cobalt, steel containing chrome, a metal alloy with
nickel and/or titanium, a biocompatible metal, nitinol or a
shape-memory alloy.
[0045] 21. A device as in any of the above claims, wherein the
tissue gathering element and/or the anchoring element comprise a
jacket configured increase surface area for engagement.
[0046] 22. A device as in any of the above claims, further
comprising an attachment feature configured for attachment with a
tool.
[0047] 23. A device as in claim 22, wherein the tool comprises a
torqueing tool.
[0048] 24. A device as in claim 22, wherein the tool comprises a
deployment element.
[0049] 25. A device as in any of claims 22-24, wherein the
attachment feature comprises a loop.
[0050] 26. A device as in any of claims 22-24, wherein the
attachment feature comprises a hole, opening or slot.
[0051] 27. A device as in any of claims 22-24, wherein the
attachment feature comprises an attachment element configured to
hold the tissue gathering element and the anchoring element
together while forming a desired shape for attachment.
[0052] 28. A device as in claim 27, wherein the desired shape is
configured for torqueing.
[0053] 29. A device as in any of the above claims, further
comprising an extendable midsection.
[0054] 30. A device as in claim 29, wherein the extendable
midsection has a shape of an elastic spring or coil.
[0055] 31. A device as in any of claims 29-30, wherein the
extendable midsection has a length in the range of 5-75 mm in
resting free space.
[0056] 32. A device as in any of claims 29-31, wherein the
extendable midsection has a potential longitudinal elongation in
the range of 10-200 mm.
[0057] 33. A device as in any of the above claims, wherein the
anchoring element is configured to apply radial force against a
wall of an airway lumen.
[0058] 34. A device as in any of the above claims, wherein the
anchoring element is configured to extend into a secondary airway
lumen adjacent to a primary airway lumen through which the tissue
gathering element has entered.
[0059] 35. A device as in any of the above claims, wherein the
anchoring element comprises at least one loop.
[0060] 36. A device as in any of the above claims, wherein the
anchoring element comprises a stent.
[0061] 37. A device as in any of the above claims, wherein the
torqued configuration reduces an ability of the lung to trap
air.
[0062] 38. A device as in any of the above claims, wherein the
torqued configuration increases tension within the lung.
[0063] 39. A pulmonary treatment device having a longitudinal axis
for treating a portion of a lung comprising:
[0064] a tissue gathering element disposed near a first end of the
pulmonary treatment device, wherein the tissue gathering element
has a shape configured to engage lung tissue within the lung during
rotation of the tissue gathering element around the longitudinal
axis so that the engaged lung tissue moves around the longitudinal
axis into a torqued configuration; and
[0065] an anchoring element disposed near a second end of the
pulmonary treatment device, wherein the anchoring element resists
movement of the engaged lung tissue from the torqued configuration
once deployed.
[0066] 40. A pulmonary treatment device positionable at least
partially within a lung passageway of a lung leading to compromised
tissue, the device comprising:
[0067] a tissue gathering element disposed near a first end of the
pulmonary treatment device, wherein the tissue gathering element is
configured so that rotation of the pulmonary treatment device
engages the tissue gathering element with a portion of the
compromised tissue so as to move the portion of the compromised
tissue into a torqued configuration; and
[0068] an anchoring element disposed near a second end of the
pulmonary treatment device, wherein the anchoring element is
configured to be deployed within the lung passageway so as to
resist movement of the engaged compromised tissue from the torqued
configuration while maintaining patency of the lung passageway.
[0069] 41. A device as in claim 40, wherein the compromised tissue
comprises pulmonary blebs or bullae.
[0070] 42. A device as in claim 40, wherein the compromised tissue
comprises loose parenchyma.
[0071] 43. A device as in any of claims 40-42, wherein the lung
passageway comprises a fourth-generation airway.
[0072] 44. A device as in any of claims 40-43, wherein the tissue
gathering element comprises at least one loop.
[0073] 45. A device as in claim 44, wherein the at least one loop
comprises a single loop.
[0074] 46. A device as in claim 44, wherein at least one of the at
least one loop extends radially outwardly from a longitudinal axis
along the pulmonary treatment device and curves at least partially
back toward the longitudinal axis.
[0075] 47. A device as in any of claims 40-46, wherein the tissue
gathering element is comprised of a wire ribbon having a width in
the range of 0.040 and 0.100 inches.
[0076] 48. A device as in any of claims 40-47, wherein the tissue
gathering element includes a tip configured to pass through the
compromised tissue.
[0077] 49. A device as in any of claims 40-48, wherein the tissue
gathering element and the anchoring element are formed together
from a single continuous shaft.
[0078] 50. A device as in any of claims 40-49, wherein the tissue
gathering element and/or the anchoring element comprise a jacket
configured increase surface area for engagement.
[0079] 51. A device as in any of claims 40-50, further comprising
an attachment feature configured for attachment with a tool.
[0080] 52. A device as in claim 51, wherein the tool comprises a
torqueing tool.
[0081] 53. A device as in any of claims 40-52, further comprising
an extendable midsection.
[0082] 54. A device as in claim 53, wherein the extendable
midsection has a shape of an elastic spring or coil.
[0083] 55. A device as in any of claims 40-54, wherein the
anchoring element is configured to apply radial force against a
wall of the lung passageway.
[0084] 56. A device as in any of claims 40-55, wherein the
anchoring element comprises at least one loop.
[0085] 57. A device as in any of claims 40-55, wherein the
anchoring element comprises a stent.
[0086] 58. A device as in any of claims 40-57, wherein the torqued
configuration reduces an ability of the lung to trap air.
[0087] 59. A device as in any of claims 40-58, wherein the torqued
configuration increases tension within the lung.
[0088] 60. A system for treating a portion of a lung
comprising:
[0089] a pulmonary treatment device comprising a tissue gathering
element and an anchoring element, wherein the tissue gathering
element is configured to receive torqueing force which rotates the
tissue gathering element so as to engage tissue within the portion
of the lung and move the tissue into a torqued configuration, and
wherein the anchoring element is configured to resist rotation of
the tissue gathering element once deployed; and
[0090] a torqueing tool configured to engage the pulmonary
treatment device so as to impart the torqueing force to the tissue
gathering element.
[0091] 61. A system as in claim 60, wherein the pulmonary treatment
device comprises an attachment feature configured for releasably
joining with the torqueing tool.
[0092] 62. A system as in claim 61, wherein the attachment feature
comprises a loop, hole, opening or slot.
[0093] 63. A system as in claim 62, wherein the torqueing tool has
a protrusion configured to pass through the loop, hole, opening or
slot so as to releasably join the torqueing tool to the attachment
feature.
[0094] 64. A system as in any of claims 61-63, further comprising a
hitch wire configured to maintain joining of the torqueing tool
with the attachment feature while in an engaged position.
[0095] 65. A system as in claim 64, wherein the hitch wire is
configured to be moved to a disengaged position which releases
joining of the torqueing tool to the attachment feature.
[0096] 66. A system as in claim 65, wherein the torqueing tool is
comprised of a shape memory material and wherein the torqueing tool
is configured to return toward a pre-set shape upon release by the
hitch wire which withdraws the torqueing tool from the attachment
feature.
[0097] 67. A system as in any of claims 60-66, further comprising a
tether configured to attach to the pulmonary treatment device,
wherein the tether is configured to move at least a portion of the
pulmonary treatment device along a longitudinal axis around which
the tissue gathering element is configured to rotate.
[0098] 68. A system as in claim 67, wherein the tether is
configured to move to at least a portion of the pulmonary treatment
device along the longitudinal axis in a proximal direction.
[0099] 69. A system as in any of claims 67-68, wherein the tether
comprises a suture, a metallic wire, a monofilament or
multifilament fiber, a braid, a polymer fiber, a ceramic, a glass
fiber, a Kevlar.RTM. fiber, a carbon fiber, a nylon fiber, a
polyurethane fiber, a polypropylene fiber or any combination of
these.
[0100] 70. A system as in any of claims 67-69, wherein the
pulmonary treatment device includes an additional attachment
feature configured for attachment to the tether.
[0101] 71. A system as in claim 70, wherein the additional
attachment feature comprises a loop, opening, hole or slot.
[0102] 72. A system as in any of claims 60-71, further comprising a
catheter having a lumen at least partially therethrough, and
wherein the pulmonary treatment device is transitionable to a
collapsed configuration so as to pass through the lumen of the
catheter.
[0103] 73. A system as in claim 72, wherein the pulmonary treatment
device has a longitudinal axis alignable with a longitudinal axis
of the lumen when in the collapsed configuration and wherein the
pulmonary treatment device is transitionable from the collapsed
configuration to an expanded configuration upon release from the
lumen.
[0104] 74. A system as in claim 73, wherein the pulmonary treatment
device is configured so that transition from the collapsed
configuration to the expanded configuration includes bending of at
least a portion of the tissue gathering element radially outwardly
away from the longitudinal axis of the pulmonary treatment
device.
[0105] 75. A system as in claim 74, wherein the tissue gathering
element comprises at least one loop extending radially outwardly
away from the longitudinal axis of the pulmonary treatment device
and curving back toward the longitudinal axis of the pulmonary
treatment device.
[0106] 76. A system as in claim 73, wherein the anchoring element
comprises a coil and wherein the pulmonary treatment device is
configured so that transition from the collapsed configuration to
the expanded configuration includes expansion of the coil.
[0107] 77. A system as in claim 73, wherein the anchoring element
comprises a shaft and wherein the pulmonary treatment device is
configured so that transition from the collapsed configuration to
the expanded configuration includes bowing of the shaft angularly
outward from the longitudinal axis of the pulmonary treatment
device.
[0108] 78. A system as in any of claims 72-77, wherein the catheter
is sized and configured to enter a fourth-generation airway.
[0109] 79. A system as in any of claims 72-78, wherein the catheter
includes at least one leverage element disposed near its proximal
end, wherein the catheter is configured so that torqueing force
applied to the at least one leverage element is transmitted to a
distal end of the catheter.
[0110] 80. A system as in any of claims 72-79, wherein the catheter
includes at least one leverage element disposed near its proximal
end, wherein the catheter is configured so that longitudinal force
applied to the at least one leverage element moves the catheter
longitudinally along its length.
[0111] 81. A system as in any of claims 72-80, further comprising a
delivery device having a working channel through which the catheter
is configured to pass.
[0112] 82. A system as in claim 81, wherein the delivery device
includes a mechanism for visualization within the lung.
[0113] 83. A system as in claim 81, wherein the delivery device
comprises a bronchoscope.
[0114] 84. A system as in claim 83, wherein the bronchoscope
comprises an insertion cord having an outer diameter in the range
of 2 mm and 3 mm.
[0115] 85. A system for treating a lung comprising:
[0116] a delivery device comprising an elongate shaft configured to
extend through a lung passageway to a portion of the lung, wherein
the elongate shaft has a lumen extending at least partially
therethrough;
[0117] a pulmonary treatment device comprising a tissue gathering
element having a first configuration shaped to pass through the
lumen of the elongate shaft along a longitudinal axis and a second
configuration wherein at least a portion of the tissue gathering
element extends radially outwardly from the longitudinal axis and
is configured to gather loose tissue within the portion of the
lung.
[0118] 86. A system as in claim 85, wherein the loose tissue
comprises blebs and/or bullae.
[0119] 87. A system as in any of claims 85-86, wherein the at least
a portion of the tissue gathering element extending radially
outwardly from the longitudinal axis has a loop shape extending at
least partially around the longitudinal axis.
[0120] 88. A system as in claim 87, wherein the loop shape
comprises a single loop concentric with the longitudinal axis.
[0121] 89. A system as in claim 87, wherein the loop shape
comprises a plurality of loops extending around the longitudinal
axis.
[0122] 90. A system as in claim 87, wherein the at least a portion
of the tissue gathering element extending radially outwardly from
the longitudinal axis has a loop shape extending at least partially
around a parallel axis which is parallel to the longitudinal
axis.
[0123] 91. A system as in claim 90, wherein the parallel axis is
offset from the longitudinal axis by 3-30 mm.
[0124] 92. A system as in any of claims 85-91, wherein the
pulmonary treatment device is configured to penetrate the loose
tissue.
[0125] 93. A system as in any of claims 85-92, wherein the
pulmonary treatment device comprises an anchoring element
configured to anchor the pulmonary treatment device within the lung
passageway.
[0126] 94. A system as in claim 93, wherein the anchoring element
comprises at least one turn of a coil.
[0127] 95. A system as in claim 94, wherein the at least one turn
of a coil is sized and configured to expand within an ostium.
[0128] 96. A system as in any of claims 93-95, wherein the
pulmonary treatment device comprises an extendable midsection
between the tissue gathering element and the anchoring element.
[0129] 97. A system as in claim 96, wherein the extendable
midsection comprises a coil.
[0130] 98. A system as in any of claims 96-97, wherein the tissue
gathering element, the extendable midsection and the anchoring
element are formed together from a single continuous shaft.
[0131] 99. A system as in any of claims 93-98, wherein the tissue
gathering element and/or the anchoring element comprise a jacket
configured to increase surface area.
[0132] 100. A system as in any of claims 85-99, further comprising
a deployment element configured to extend through the elongate
shaft of the delivery device and to attach to the pulmonary
treatment device.
[0133] 101. A system as in claim 100, wherein the deployment
element comprises a tether, wherein the tether comprises a suture,
a metallic wire, a monofilament or multifilament fiber, a braid, a
polymer fiber, a ceramic, a glass fiber, a Kevlar.RTM. fiber, a
carbon fiber, a nylon fiber, a polyurethane fiber, a polypropylene
fiber or any combination of these.
[0134] 102. A system as in any of claims 100-101, wherein the
deployment element has at attachment mechanism configured to attach
to an attachment feature on the pulmonary treatment device.
[0135] 103. A system as in any of claims 100-102, wherein the
deployment element is configured to move the pulmonary treatment
device within the lumen of the elongate shaft of the delivery
device.
[0136] 104. A system as in claim 103, wherein the pulmonary
treatment device comprises an anchoring element configured to
anchor the pulmonary treatment device within the lung passageway,
and wherein the deployment element is configured to move the
pulmonary treatment device within the lumen so that the tissue
gathering element deploys while the anchoring element resides
within the delivery device.
[0137] 105. A system as in claim 104, wherein the deployment
element is configured to lock position in relation to the delivery
device so that retraction of the delivery device pulls the loose
tissue gathered by the tissue gathering element.
[0138] 106. A system as in claim 105, wherein the pulmonary
treatment device comprises an extendible midsection configured to
extend during retraction of the delivery device.
[0139] 107. A system as in any of claims 85-106, wherein the
delivery device comprises a bronchoscope.
[0140] 108. A system as in claim 107, wherein the bronchoscope
comprises an insertion cord having an outer diameter in the range
of 2 mm and 3 mm.
[0141] 109. A system as in any of claims 85-108, wherein the tissue
gathering element is configured to gather the loose tissue by
rotation of the tissue gathering element around the longitudinal
axis so as to move the loose tissue into a torqued
configuration.
[0142] 110. A system as in claim 109, wherein the pulmonary
treatment device further comprises an anchoring element configured
to resist movement of the loose tissue from the torqued
configuration once deployed.
[0143] 111. A system as in claim 110, wherein the anchoring element
comprises at least one turn of a coil which is concentric with the
longitudinal axis.
[0144] 112. A system as in any of claims 110-111, wherein the
anchoring element comprises a shaft which forms an angle with the
longitudinal axis.
[0145] 113. A system as in any of claims 110-112, wherein the shape
of the tissue gathering element includes at least one loop.
[0146] 114. A system as in any of claims 100-113, further
comprising a torqueing tool having an attachment feature configured
for attachment with the pulmonary treatment device.
[0147] 115. A system as in any of claims 85-114, wherein the
torqued configuration reduces an ability of the lung to trap
air.
[0148] 116. A system as in any of claims 85-115, wherein the
torqued configuration increases tension within the lung.
[0149] 117. A method of treating a lung comprising:
[0150] inserting a tissue gathering element of a pulmonary
treatment device into the lung so that the tissue gathering element
engages lung tissue;
[0151] rotating the tissue gathering element of the pulmonary
treatment device so that a portion of the lung tissue is moved
around a rotational axis into a torqued configuration; and
[0152] anchoring the pulmonary treatment device so as to assist in
maintaining the torqued configuration.
[0153] 118. A method as in claim 117, wherein the lung tissue
comprises loose parenchyma.
[0154] 119. A method as in claim 118, wherein the loose parenchyma
comprises blebs or bullae.
[0155] 120. A method as in any of claims 117-119, wherein the
torqued configuration reduces lung volume of the lung.
[0156] 121. A method as in any of claims 117-120, wherein the
tissue gathering element comprises at least one curved shaft and
wherein inserting the tissue gathering element comprises extending
the at least one curved shaft radially outwardly from a
longitudinal axis along the pulmonary treatment device.
[0157] 122. A method as in claim 121, wherein inserting the tissue
gathering element comprises extending at least one of the at least
one curved shaft radially outwardly so as to form a loop shape
extending at least partially around an axis perpendicular to the
longitudinal axis.
[0158] 123. A method as in claim 122, wherein inserting the tissue
gathering element comprises extending at least one of the at least
one curved shaft radially outwardly so as to form the loop shape
extending at least partially around the axis perpendicular to the
longitudinal axis and crossing the longitudinal axis.
[0159] 124. A method as in any of claims 121-123, wherein inserting
the tissue gathering element comprises extending at least one of
the at least one curved shaft radially outwardly so as to form a
loop shape extending at least partially around the longitudinal
axis.
[0160] 125. A method as in any of claims 121-124, wherein inserting
the tissue gathering element comprises extending at least one of
the at least one curved shaft radially outwardly so as to form a
loop shape extending at least partially around an axis parallel to
the longitudinal axis.
[0161] 126. A method as in any of claims 117-125, wherein the
pulmonary treatment device comprises an anchoring element and
wherein anchoring the pulmonary treatment device comprises
deploying the anchoring element.
[0162] 127. A method as in claim 126, wherein anchoring the
pulmonary treatment device comprises deploying the anchoring
element within an airway.
[0163] 128. A method as in claim 127, wherein the anchoring element
comprises at least one turn of a coil and anchoring the pulmonary
treatment device comprises deploying the anchoring element so that
the coil expands and applies force to a wall within the airway.
[0164] 129. A method as in claim 128, wherein rotating the tissue
gathering element comprises rotating the tissue gathering element
in a direction opposite to the at least one turn of the coil.
[0165] 130. A method as in any of claims 127-129, wherein the
anchoring element comprises at least one shaft which bows angularly
away from the longitudinal axis, and wherein anchoring the
pulmonary treatment device comprises positioning at least one of
the at least one shaft into the airway.
[0166] 131. A method as in claim 130, wherein inserting the tissue
gathering element of the pulmonary treatment device comprises
passing the tissue gathering element through a first airway, and
wherein anchoring the pulmonary treatment device comprises
positioning at least one of the at least one shaft into a second
airway.
[0167] 132. A method as in any of claims 117-131, wherein inserting
comprises passing the tissue gathering element at least partially
through a lumen of a delivery device.
[0168] 133. A method as in claim 132, wherein the delivery device
comprises a bronchoscope.
[0169] 134. A method as in claim 132, wherein the delivery device
comprises a catheter.
[0170] 135. A method as in claim 134, further comprising advancing
the catheter through a bronchoscope.
[0171] 136. A method as in any of claims 117-135, wherein a
torqueing tool is releasably attached to the pulmonary treatment
device and wherein rotating the tissue gathering element comprises
rotating the tissue gathering element with the use of the torqueing
tool.
[0172] 137. A method as in claim 136, wherein the torqueing tool is
releasably attached to the pulmonary treatment device by the
insertion of a protrusion of the torqueing tool into a loop,
opening, hole or slot on the pulmonary treatment device, further
comprising releasing the torqueing tool by withdrawal of the
protrusion.
[0173] 138. A method as in claim 137, wherein releasing the
torqueing tool by withdrawal of the protrusion comprises
manipulating a hitch wire so as to allow the protrusion to withdraw
from the torqueing tool.
[0174] 139. A method as in any of claims 117-138, wherein a
deployment element is releasably attached to the pulmonary
treatment device, and wherein inserting the tissue gathering
element comprises advancing the tissue gathering element through a
delivery device with the use of the deployment element.
[0175] 140. A method as in claim 139, further comprising deploying
the tissue gathering element while maintaining an anchoring element
within the delivery device.
[0176] 141. A method as in claim 140, further comprising retracting
the deployment element so as to apply longitudinal force to the
portion of the lung tissue.
[0177] 142. A method as in claim 140, wherein anchoring the
pulmonary treatment device comprises deploying the anchoring
element after deploying the tissue gathering element.
[0178] 143. A method as in claim any of claims 117-142, further
comprising inserting another pulmonary treatment device into the
lung and joining the pulmonary treatment device with the another
pulmonary treatment device.
[0179] 144. A system for performing lung volume reduction on a lung
comprising:
[0180] a delivery device comprising an elongate shaft; and
[0181] a pulmonary treatment device comprising a tissue gathering
element and an anchoring element, wherein the tissue gathering
element is configured to re-tension a slacked airway within the
lung and so as to generate a reduced volume of the lung, and
wherein the anchoring element is configured to hold the tissue
gathering element in a manner that assists in maintaining the
reduced volume of the lung.
[0182] 145. A system as in claim 144, wherein at least a portion of
the pulmonary treatment device is mountable upon an exterior of the
elongate shaft of the delivery device.
[0183] 146. A system as in claim 145, wherein the anchoring element
is mountable upon the exterior of the elongate shaft of the
delivery device.
[0184] 147. A system as in claim 145, further comprising a catheter
advanceable at least partially through a lumen of the delivery
device so as to extend beyond a distal end of the delivery
device.
[0185] 148. A system as in claim 147, wherein the tissue gathering
element is mountable upon an exterior of the catheter.
[0186] 149. A system as in claim 148, further comprising a
guidewire positionable within a lumen in the catheter so as to
extend beyond a distal end of the catheter.
[0187] 150. A system as in claim 149, wherein tissue gathering
element further includes a guide element positionable around the
guidewire in a manner which centers the pulmonary treatment device
upon the delivery device.
[0188] 151. A system as in claim 148, wherein the pulmonary
treatment device comprises an extendable midsection, wherein
advancement of the catheter extends the extendable midsection
within the slacked airway.
[0189] 152. A system as claim 151, wherein the tissue gathering
element is configured to deploy radially outwardly upon retraction
of the catheter from the tissue gathering element so as to create a
hold on the slacked airway.
[0190] 153. A system as in claim 152, wherein the extendable
midsection is configured apply force upon the tissue gathering
element in the direction of the anchoring element upon removal of
the delivery device which re-tensions the slacked airway.
[0191] 154. A system as in any of claims 144-153, wherein the
delivery device comprises a bronchoscope.
[0192] 155. A system as in claim 154, wherein the bronchoscope has
an insertion cord sized and configured to be insertable into a
fourth-generation airway.
[0193] 156. A pulmonary treatment device comprising:
[0194] an elongate shaft coiled into a helical shape around a
longitudinal axis to form a tissue gathering end, an extendable
midsection and a stabilizing end,
[0195] wherein the tissue gathering end includes at least one loop
which curves at least partially around the longitudinal axis and is
configured to engage loose damaged alveolar sac tissue,
[0196] wherein the stabilizing end includes at least one loop which
curves at least partially around the longitudinal axis and is
configured to engage a lung passageway proximal to the loose
damaged alveolar sac tissue, and
[0197] wherein the extendable midsection is configured to extend
along the longitudinal axis while the tissue gathering end engages
the loose damaged alveolar sac tissue so that the loose damaged
alveolar sac tissue is pulled toward the lung passageway and the
stabilizing end seats in the lung passageway in a manner that
maintains the loose damaged alveolar sac tissue in a pulled
position.
[0198] 157. A pulmonary treatment device comprising:
[0199] An elongate shaft having a longitudinal axis, wherein the
elongate shaft curves around a transverse axis with respect to the
longitudinal axis to form a tissue gathering end, and wherein the
elongate shaft curves around a different transverse axis with
respect to the longitudinal axis to form an anchoring end, and
wherein the elongate shaft forms an extendable midsection between
the tissue gathering end and the anchoring end,
[0200] wherein the tissue gathering end includes at least one loop
which curves at least partially around the transverse axis and is
configured to engage loose damaged alveolar sac tissue,
[0201] wherein the anchoring end is configured to engage a lung
passageway proximal to the loose damaged alveolar sac tissue,
and
[0202] wherein the extendable midsection is configured to extend
along the longitudinal axis while the tissue gathering end engages
the loose damaged alveolar sac tissue so that the loose damaged
alveolar sac tissue is rotated about the longitudinal axis and
pulled along the longitudinal axis and the anchoring end seats in
the lung passageway in a manner that maintains the loose damaged
alveolar sac tissue in a pulled condition.
[0203] 158. A device for treating a lung comprising:
[0204] a tissue engaging end configured to engage loose damaged
alveolar sac tissue; and
[0205] a stabilizing end configured to engage a lung passageway
proximal to the loose damaged alveolar sac tissue,
[0206] wherein the device is configured to re-tension a portion of
the lung by pulling the tissue engaging end toward the stabilizing
end seated in the lung passageway and maintaining such pulling by
recoil force.
[0207] 159. A device for treating a lung comprising:
[0208] a tissue gathering end configured to engage loose damaged
alveolar sac tissue; and
[0209] an anchoring end configured to engage a lung passageway
proximal to the loose damaged alveolar sac tissue,
[0210] wherein the device is configured to re-tension a portion of
the lung by rotating the tissue gathering end and pulling it toward
the anchoring end seated in a lung passageway and maintaining such
rotating and pulling by recoil force.
[0211] 160. A method for treating a lung comprising:
[0212] deploying a tissue engaging end of a pulmonary treatment
device into loose damaged alveolar sac tissue distal to a lung
passageway;
[0213] pulling the tissue engaging end toward the lung passageway
so that a portion of the lung associated with the loose damaged
alveolar sac tissue is re-tensioned; and
[0214] seating a stabilizing end of the pulmonary treatment device
into the lung passageway so as to maintain re-tensioning of the
portion of the lung.
[0215] 161. A method for treating a lung comprising:
[0216] deploying a tissue gathering end of a pulmonary treatment
device into loose damaged alveolar sac tissue distal to a lung
passageway;
[0217] rotating the tissue gathering end so that a portion of the
lung associated with the loose damaged alveolar sac tissue is
re-tensioned; and
[0218] seating an anchoring end of the pulmonary treatment device
into a lung passageway so as to maintain re-tensioning of the
portion of the lung.
[0219] 162. A system for treating a lung comprising:
[0220] a delivery device having a proximal end, a distal end and
lumen therethrough, wherein the distal end is configured to be
advanced through a tracheobronchial tree of the lung to an area of
loose damaged alveolar sac tissue;
[0221] a pulmonary treatment device advanceable through the lumen
of the delivery device, wherein the pulmonary treatment device
includes a tissue gathering end and a stabilizing end; and
[0222] a deployment element removably attached to the pulmonary
treatment device and insertable into the lumen of the delivery
device,
[0223] wherein together the delivery device and deployment
element
[0224] 1) deploy the tissue gathering end into the area of loose
damaged alveolar sac tissue while maintaining attachment of the
pulmonary treatment device to the deployment element,
[0225] 2) pull the deployed tissue gathering end so as to
re-tension the area of loose damaged alveolar sac tissue, and
[0226] 3) deploy the stabilizing end within a lung passageway so as
to maintain the re-tension of the area of loose damaged alveolar
sac tissue.
[0227] 163. A method for treating a lung of a patient, the method
comprising:
[0228] introducing an elongate body of an implant system axially
into a lung passageway system of the lung so that a proximal
portion of the elongate body is disposed within a first region of
the lung passageway system and so that a distal implant portion of
the elongate body is disposed within a second region of the lung
passageway system; and
[0229] tensioning a lung tissue volume of the lung by rotating the
elongate body.
[0230] A system for treating a lung comprising:
[0231] a delivery device having a proximal end, a distal end and
lumen therethrough, wherein the distal end is configured to be
advanced through a tracheobronchial tree of the lung to an area of
loose damaged alveolar sac tissue;
[0232] a pulmonary treatment device advanceable through the lumen
of the delivery device, wherein the pulmonary treatment device
includes a tissue gathering end and an anchoring end;
[0233] a deployment element removably attached to the pulmonary
treatment device and insertable into the lumen of the delivery
device,
[0234] wherein together the delivery device and deployment
element
[0235] 1) deploy the tissue gathering end into the area of loose
damaged alveolar sac tissue while maintaining attachment of the
pulmonary treatment device to the deployment element,
[0236] 2) rotate the deployed tissue gathering end so as to
re-tension the area of loose damaged alveolar sac tissue, and
[0237] 3) deploy the anchoring end within a lung passageway so as
to maintain the re-tension of the area of loose damaged alveolar
sac tissue.
[0238] In addition, the present invention relates to the following
aspects:
[0239] In an aspect of the present invention, the pulmonary
treatment devices, methods and systems contained herein treat COPD
and COPD symptoms by tensioning lung tissue in patients who have
been diagnosed with emphysema whereas lung tissue destruction has
been determined to present between zero and 70% volume of destroyed
tissue, preferably at least 30% destruction, determined by
calculating the percent of destroyed low density lung volume tissue
that presents in CT images with a Hounsfield unit score at or
higher than 850 (HU) Hounsfield units.
[0240] In another aspect of the present invention, the pulmonary
treatment devices, methods and systems contained herein treat COPD
and COPD symptoms by tensioning lung tissue in patients who have
been diagnosed with emphysema whereas the patient has also been
determined to be trapping air sufficiently so that retained
residual volume is determined to be between 100% and 400% of normal
but most preferably residual volume is determined to be in excess
of 175% of normal for the patients gender, age and height.
[0241] In another aspect of the present invention, the pulmonary
treatment devices, methods and systems contained herein treat COPD
and COPD symptoms by tensioning lung tissue in patients who have
been diagnosed with emphysema whereas the treatment may be
performed in each of the four major lobes of the lungs, in a single
or separate procedures, if the volume of damaged lung tissue in
each lobe, defined as the volume of low density tissue greater that
850 (HU), falls within a range of zero to 70% but preferably is in
excess of 30% in each lobe.
[0242] In another aspect of the present invention, the pulmonary
treatment devices, methods and systems contained herein treat COPD
and COPD symptoms by compressing lung tissue as the tissue is
wrapped around an implant device that has been fixed to lung tissue
and torqued to be rotated so lung tissue is drawn to the device and
then anchored to another portion of lung tissue, to prevent the
implant from counter-rotating which would allow lung tissue to be
unwound from the implant.
[0243] In another aspect of the present invention, the pulmonary
treatment devices, methods, systems and structures that may be
considered implant systems contained herein treat COPD and COPD
symptoms by tensioning lung tissue and reducing lung volume to make
at least one of the following measurable physiologic changes to
improve breathing in COPD patients:
[0244] 1) Lift the diaphragm with respect to a reference rib
location
[0245] 2) Measure diaphragm lift with respect to a reference rib
location while the patient maintains expiration, as a result of
treatment
[0246] 3) Elevate the base of at least one lung towards the
patient's upper chest
[0247] 4) Reduce coughing
[0248] 5) Reduce mucus production
[0249] 6) Reduce coughing caused by trapped air and mucus
[0250] 7) Reduce glottis closure sensitivity
[0251] 8) Increase the patient's ability to clear mucus from the
lungs
[0252] 9) Increase arterial blood oxygen levels in the blood
stream
[0253] 10) Increase arterial blood oxygen percent in the blood
stream
[0254] 11) Decrease arterial CO2 levels in the blood stream
[0255] 12) Decrease arterial CO.sub.2 percentage in the blood
stream
[0256] 13) Increase mobility as measured by the currently standard
6-minute walk test
[0257] 14) Increase the number of meters a patient can walk in 6
minutes
[0258] 15) Increase lung airway caliber as measured using high
resolution CT
[0259] 16) Increase airway diameter
[0260] 17) Increase lung emptying volume during expiration
[0261] 18) Increase airway lumen diameter
[0262] 19) Provide radial outward support to airways
[0263] 20) Assist reduction of lung volume during exhalation
[0264] 21) Reduce the volume of at least one lung
[0265] 22) Reduce the volume of a lobe
[0266] 23) Reduce the volume of both lungs
[0267] 24) Reduce the volume of a lung pair
[0268] 25) Reduce TLC of a lung pair
[0269] 26) Perform tissue compression
[0270] 27) Compress tissue in a lobe
[0271] 28) Remove slack in the lung tissue
[0272] 29) Restore lung tissue elastic recoil back to a physiologic
performance between 2 and 200 cm*H2O of pressure to expand the
lung
[0273] 30) Increase lung elastic recoil
[0274] 31) Decrease lung compliance
[0275] 32) Change the shape of the pressure volume curve generated
by measuring patient breathing
[0276] 33) Increase the area within a pressure vs. volume curve
describing a patient's breathing
[0277] 34) Displace fissures as seen using CT image post processed
images comparing inspiration and expiration data
[0278] 35) Delay airway closure during expiration, by using post
processed CT image data to compare pre-treatment versus post
treatment airway volumes of a similar region in the lung
[0279] 36) Cause a volume of the lung to be reduced
[0280] 37) Reduce airway resistance
[0281] 38) Reduce the volume of one or more lungs in a patient
[0282] 39) Reduce inspiratory effort using pulse transit time or
respiratory inductance plethysmography methods
[0283] 40) Reduce dynamic hyperinflation as measured by CT or
6-minute walk testing or plethysmography
[0284] 41) Reduce end-expiratory lung volume
[0285] 42) Reduce functional residual capacity
[0286] 43) Reduce the incidence of respiratory failure
[0287] 44) Increase time between COPD exacerbation events
[0288] 45) Increase time that airways stay open during
expiration
[0289] 46) Increase the forced expiratory volume in the first
second (FEV1)
[0290] 47) Increase the forced vital capacity volume (FVC)
[0291] 48) Increase the ratio FEV1/FVC
[0292] 49) Reduce dysthymia
[0293] 50) Reduce pressure on the heart
[0294] 51) Reduce pressure on coronary arteries
[0295] 52) Reduce blood hypertension
[0296] 53) Reduce hypertension in the lungs
[0297] 54) Reduce hypertension in blood vessels that supply the
heart muscle
[0298] 55) Reduce systolic and/or diastolic blood pressure
[0299] 56) Reduce heart rate
[0300] 57) Reduce systolic blood pressure
[0301] 58) Increase the heart's ejection fraction
[0302] 59) Reduce pulmonary artery pressure
[0303] 60) Reduce lung tissue density (from 800 to 810-1000 HU,
that's Hounsfield units)
[0304] 61) Make lung tissue density more uniform (adjust the
difference between lobes of average lobar density between 1-200
Hounsfield Units)
[0305] 62) Increase forced expiratory volume during expiration
[0306] 63) Reduce residual volume that is left in the lung during
or after expiration (RV)
[0307] 64) Reduce the volume of gas that is trapped in the lung
during or after expiration
[0308] 65) Reduce the volume of gas that is trapped in a lobe
during or after expiration
[0309] 66) Increase tidal expiratory volume change during tidal
breathing at rest
[0310] 67) Increase the inspiratory reserve volume during tidal
breathing at rest
[0311] 68) Decrease the patient's breathing rate
[0312] 69) Decrease the patient's heart rate
[0313] 70) Increase the patient's cardiac blood ejection
fraction
[0314] 71) Decrease the patient's total lung capacity
[0315] 72) Decrease lung compliance
[0316] 73) Decrease compliance in lobes or regions of lung
tissue
[0317] 74) Increase lung tissue compliance uniformity between upper
versus lower lobes
[0318] 75) Increase lung tissue compliance uniformity between lung
lobes in a patient
[0319] 76) Increase lung tissue compliance uniformity between lobar
segments
[0320] 77) Decrease inspiratory effort
[0321] 78) Decrease the total lung capacity (TLC)
[0322] 79) Reduce the RV/TLC ratio
[0323] 80) Increase the volume of airways in a lobe during
inspiration
[0324] 81) Increase the volume of airways in a lobe during
expiration
[0325] 82) Reduce the difference in volume of lung airways in a
lobe during breathing
[0326] 83) Increase the total blood volume in a patient's lung or
lobe by performing a treatment
[0327] 84) Reduce regional blood volume in severely compromised
lung tissue to reduce the volume of reduced oxygenated blood being
mixed with normal blood in emphysema patients
[0328] 85) Increase the change in lobar volume between an
inspiration and expiration breathing cycle
[0329] 86) Reduce the volume of trapped air in a lobe after
expiration
[0330] 87) Reduce expiratory volume of lungs after treatment
[0331] 88) Increase volume of one or more lobes during
inspiration
[0332] 89) Increase the volume within distal airways in one or more
lobes
[0333] 90) Increase the volume within central airways in one or
more lobes
[0334] 91) Reduce impedance of central airways in one or more
lobes
[0335] 92) Reduce impedance in one or both lungs
[0336] 93) Reduce resistance to flow in one or more lobes
[0337] 94) Reduce resistance to flow in one or more lungs
[0338] 95) Increase blood vessel density in one or more lobes
[0339] 96) Increase the number of blood vessels per liter of lobar
volume
[0340] 97) Increase the volume of airway wall in one or more
lobes
[0341] 98) Increase the volume of airway wall in central airways of
one or more lobes
[0342] 99) Decrease the percentage of damaged tissue per liter of
lung volume in one or more lobes
[0343] 100) Hold airways open longer to increase the rate of
aerosol transport in one or more lobes
[0344] 101) Hold airways open longer to increase regional
concentration of aerosol delivered drugs in one or more lobes
[0345] 102) Measure one or more fissures that have moved more than
2 mm to indicate lobar volume has changed
[0346] 103) Measure one or more fissures that have moved with
respect to a chest wall rib more than 2 mm to indicate lung volume
has changed
[0347] 104) Reduce the percentage of low attenuation lung tissue in
one lobe or more
[0348] 105) Reduce the volume of low attenuation lung tissue in one
lobe or more
[0349] 106) Reduce the percentage of low-density tissue that is 950
HU or higher in one lobe or more
[0350] 107) Reduce the volume of low-density tissue that is 950 HU
or higher in one lobe or more.
[0351] In another aspect of the present invention, a pulmonary
treatment device is provided comprising: a distal end that
efficiently attaches to lung tissue that has been degraded by
enzymatic destruction.
[0352] In another aspect of the present invention, a pulmonary
treatment device is provided comprising: a pulmonary treatment
device with proximal a distal end that anchors to an airway in the
lung.
[0353] In another aspect of the present invention, a pulmonary
treatment device is provided comprising: a pulmonary treatment
device with a distal end that attaches to tissue primarily
comprised of alveoli.
[0354] In another aspect of the present invention, a pulmonary
treatment device is provided comprising: a treatment device, method
or system that tensions lung tissue, parenchyma, alveoli, tissue
with enzyme damage, distended, slackened or stretched tissue.
[0355] In another aspect of the present invention, a pulmonary
treatment device is provided comprising: a pulmonary treatment
device that is produced from round wire shaft material that
presents minimal sharp edges to soft tissues in the lung, that
would otherwise cause the formulation of granulation tissue
[0356] In another aspect of the present invention, a COPD treatment
device is provided comprising: a lung treatment device that is
produced from round wire shaft material with a distal end and a
proximal end, whereas at least the distal or proximal end is formed
to make a blunt atraumatic end without the benefit of recasting
material.
[0357] In another aspect of the present invention, a COPD treatment
device is provided comprising: a lung treatment device that is
produced from round wire shaft material with a distal end, a
proximal end and a midsection whereas the distal end is connected
to the midsection and the proximal end is connected to the
midsection without the benefit of a connection to join
components.
[0358] In another aspect of the present invention, a COPD treatment
device is provided comprising: a lung treatment device that is
produced and coated with an anti-bacterial coating such as silver
or some other material that bacteria is repelled from.
[0359] In one aspect of the present invention, a pulmonary
treatment device is provided comprising: an elongate shaft coiled
into a helical shape around a longitudinal axis to form a tissue
gathering end, an extendable midsection and a stabilizing end,
wherein the tissue gathering end includes at least one loop which
curves at least partially around the longitudinal axis and is
configured to engage loose damaged alveolar sac tissue, wherein the
stabilizing end includes at least one loop which curves at least
partially around the longitudinal axis and is configured to engage
a lung passageway proximal to the loose damaged alveolar sac
tissue, and wherein the extendable midsection is configured to
extend along the longitudinal axis while the tissue gathering end
engages the loose damaged alveolar sac tissue so that the loose
damaged alveolar sac tissue is pulled toward the lung passageway
and the stabilizing end seats in the lung passageway in a manner
that maintains the loose damaged alveolar sac tissue in a pulled
position.
[0360] In another aspect of the present invention, a device is
provided for treating a lung comprising: a tissue engaging end
configured to engage loose damaged alveolar sac tissue; and a
stabilizing end configured to engage a lung passageway proximal to
the loose damaged alveolar sac tissue, wherein the device is
configured to re-tension a portion of the lung by pulling the
tissue engaging end toward the stabilizing end seated in the lung
passageway and maintaining such pulling by recoil force.
[0361] In another aspect of the present invention, a lung treatment
device is provided for treating a lung; comprising a tissue
gathering distal end, a stabilizing proximal end and an elastic
midsection whereas at least a portion of the device is configured
to be positioned around the exterior of a bronchoscope in a
configuration that is suitable for advancement into the lung. The
device is configured so that at least a portion of the tissue
gathering end or a portion of the mid-section or a portion of the
stabilizing end is configured to circle at least partially around
the longitudinal axis of the bronchoscope during advancement into
the lung and is configured to displace lung tissue, wherein the
extendable midsection is configured to be lengthened while the
tissue gathering end is anchored to lung tissue in a way that
allows lung tissue to be pulled toward the midsection of the device
and the stabilizing end seats in lung tissue in a manner so lung
tissue at the proximal end of the treatment device is pulled
towards the midsection of the treatment device, after the
bronchoscope is removed from the lung.
[0362] In another aspect of the present invention, a lung treatment
device is provided for treating a lung comprising: a tissue
gathering end configured to be fixed to lung tissue; a stabilizing
proximal end configured to be fixed to lung tissue that is proximal
to the tissue the tissue gathering end is fixed to, wherein the
device is configured to re-tension a portion of the lung by pulling
the tissue gathering end towards the stabilizing end seated in the
lung.
[0363] In another aspect of the present invention, a lung treatment
device is provided for treating a lung comprising: a tissue
gathering end configured to be fixed to lung tissue; a stabilizing
proximal end configured to be fixed to lung tissue that is proximal
to the tissue the tissue gathering end is fixed to, wherein the
device is configured to re-tension a portion of the lung by pulling
the tissue that the tissue gathering end is fixed to toward the
tissue that the stabilizing end is fixed to in the lung.
[0364] In another aspect of the present invention, a pulmonary
treatment device is provided for treating a lung comprising: a
tissue gathering end configured to be fixed to lung tissue; a
stabilizing proximal end configured to be fixed to lung tissue that
is proximal to the tissue the tissue gathering end is fixed to,
wherein the device is configured to re-tension a portion of the
lung by pulling the tissue that the tissue engaging end is fixed to
toward the tissue that the stabilizing end is fixed to in the lung
while the midsection of the lung treatment device is configured to
maintain a patent lumen through the lung treatment device.
[0365] In another aspect of the present invention, a lung treatment
device is provided for treating a lung comprising: a tissue
gathering end configured to be fixed to lung tissue; a stabilizing
proximal end configured to be fixed to lung tissue that is proximal
to the tissue the tissue gathering end is fixed to, wherein the
device is configured to be advanced into the lung and then
stretched to a longer configuration before fixing the tissue
gathering end to tissue and before fixing the proximal stabilizing
end to tissue to more effectively re-tension a portion of the lung
by pulling the tissue engaging end towards the stabilizing end
which is fixed to tissue in the lung.
[0366] In another aspect of the present invention, a pulmonary
treatment device is provided comprising: an elongate shaft coiled
into a helical shape around a longitudinal axis to form a tissue
gathering end, an extendable midsection and a stabilizing end,
wherein the tissue gathering end includes at least one loop that is
configured to engage loose damaged alveolar sac tissue or the wall
of an airway, wherein the stabilizing end includes at least one
loop which curves at least partially around the longitudinal axis
and is configured to engage a lung passageway proximal to the loose
damaged alveolar sac tissue, and wherein the extendable midsection
is configured to extend along the longitudinal axis while the
tissue gathering end engages the loose damaged alveolar sac tissue
so that the loose damaged alveolar sac tissue is pulled toward the
lung passageway and the stabilizing end seats in the lung
passageway in a manner that maintains the loose damaged alveolar
sac tissue in a pulled position.
[0367] In another aspect of the present invention, a pulmonary
treatment device is provided comprising: an implant made from
polymer or metal that behaves in at least a partially elastic manor
that is shaped to form a tissue gathering anchor end, an extendable
midsection and a stabilizing end, wherein the tissue gathering end
can be advanced distally to cause the extendable midsection to be
extended with increased length and strained elastically after which
the tissue gathering end may be deployed to be fixed or anchored to
the wall of the airway, wherein the stabilizing end includes at
least one loop which curves at least partially around the
longitudinal axis and is configured to engage a lung passageway
proximal to the midsection, and wherein the extendable midsection
is configured to provide elastic recoil force that tensions lung
tissue and provides lumen patency maintaining support to stent the
airway and prevent airway collapse while the tissue gathering end
and the proximal stabilizing ends are pulled towards each
other.
[0368] In another aspect of the present invention, a pulmonary
treatment device is provided that reduces the length of airway
segments to enhance lung elastic recoil.
[0369] In another aspect of the present invention, a pulmonary
treatment device is provided that is configured to be mounted to
the outside of a bronchoscope while it is delivered to a location
in the lung.
[0370] In another aspect of the present invention, a pulmonary
treatment device is provided that configured to be advanced into
the lung in a length unconstrained configuration. This allows the
system to be flexible while being delivered along a tortuous path.
Most of these devices are delivered to the upper lobes and that
typically requires the scope and device to go through at least one
small radius bend in the lungs.
[0371] In another aspect of the present invention, a pulmonary
treatment device is provided that can be advanced into the lung in
a condition that is unstressed to allow the delivery system to be
flexible while the device is being delivered along a tortuous
path.
[0372] In another aspect of the present invention, a pulmonary
treatment device is provided for treating a lung that has not been
stressed to lengthen or shorten the device length so as to allow
the delivery system to be as flexible as possible while being
delivered along a tortuous path.
[0373] In another aspect of the present invention, a pulmonary
treatment device is provided that is configured so that the length
can be lengthened or shorted before deploying the device into the
lung to stress lung tissue.
[0374] In another aspect of the present invention, a pulmonary
treatment device is provided that can be advanced along a tortuous
path to a treatment location in the lung and configured in a
flexible unstressed condition that allows the length to be
unconstrained but configured to be elongated at the treatment
location before being deployed to distort lung tissue.
[0375] In another aspect of the present invention, a pulmonary
treatment device is provided that can be advanced along a tortuous
path to a treatment location in the lung, configured in a flexible
unstressed condition, but configured to be strained to a longer
configuration to store strain energy that may be applied to lung
tissue after deployment of the treatment device.
[0376] In another aspect of the present invention, a pulmonary
treatment device is provided that can be advanced into the lung and
the device length can be adjusted to change length after a portion
of the device is placed in contact with lung tissue.
[0377] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal anchor, a proximal
anchor and spring coil midsection.
[0378] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a central lumen and a
constrained distal anchor feature that is unconstrained by
retracting a delivery device component from the central lumen of
the treatment device.
[0379] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a central longitudinal
axis, a distal end, a proximal end and a lumen running coaxial
along the central longitudinal axis that is configured to be guided
by a guidewire that is advanced through the lumen along the central
longitudinal axis.
[0380] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a central longitudinal
axis, a distal end, a proximal end and a lumen running coaxial
along the central longitudinal axis that is configured to be guided
by a bronchoscope that is advanced through the lumen along the
central longitudinal axis.
[0381] In another aspect of the present invention, a pulmonary
treatment device is provided comprising distal and proximal anchors
and a midsection that can be elongated to store fully elastic
strain energy in the midsection.
[0382] In another aspect of the present invention, a pulmonary
treatment device is provided comprising distal and proximal anchors
and a midsection that can be elongated to store fully elastic
strain energy in the treatment device before the device is coupled
to lung tissue.
[0383] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a tissue gathering distal
end, a stabilizing proximal end and a midsection that can be
elongated to store fully elastic strain energy.
[0384] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a tissue gathering distal
end, a stabilizing proximal end and a midsection that can be
elongated to store fully elastic strain energy before the device is
coupled to lung tissue so the device causes length compression of
the lung tissue.
[0385] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a tissue gathering distal
end, a stabilizing proximal end and a midsection that can be
elongated to store fully elastic strain energy after the
stabilizing proximal end is seated in lung tissue.
[0386] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal end, a proximal
end and a midsection that can be elongated to store fully elastic
strain energy that can be deployed in a lung to restore tension in
lung tissue.
[0387] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal end, a proximal
end and a midsection that can be elongated to store fully elastic
strain energy that can be deployed in a lung to restore lung
elastic recoil in the lung.
[0388] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a proximal end, a distal
end and a midsection configured such that the midsection is
cylindrical and the proximal end is flared.
[0389] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a proximal end, a distal
end and a midsection configured such that the midsection is tapered
so the diameter varies along the length of the midsection of the
device.
[0390] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a proximal end, a distal
end and a midsection configured such that the distal end comprises
a spring element that can be constrained by the exterior surfaces
of a bronchoscope.
[0391] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a proximal end, a distal
end and a midsection configured such that the device comprises a
spring element that can be expanded to a larger diameter by a
balloon.
[0392] In another aspect of the present invention, a pulmonary
treatment device is provided that is configured to be mounted
around the outside of a bronchoscope while it is delivered to a
location in the lung to increase tension in lung tissue.
[0393] In another aspect of the present invention, a pulmonary
treatment device is provided having a distal anchor, a proximal
anchor and a midsection that can be elongated to store elastic
strain energy to tension lung tissue.
[0394] In another aspect of the present invention, a pulmonary
treatment device is provided that can be advanced into the lung in
a condition that is unstressed to allow the system to be flexible
while being delivered along a tortuous path, configured with a
distal anchor, a proximal anchor and a midsection that is made from
single wire shaft.
[0395] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal anchor, a proximal
anchor and a midsection that is made from continuous wire
shaft.
[0396] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal anchor, a proximal
anchor and a midsection that is made from single element with no
connections to join features of the device.
[0397] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal anchor, a proximal
anchor and a midsection; the treatment device is configured in a
way that may be elongated to store elastic strain energy to tension
lung tissue comprising at least one weldment to connect features of
the device.
[0398] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal anchor, a proximal
anchor and a midsection; the treatment device is configured in a
way that may be elongated to store elastic strain energy to tension
lung tissue comprising at least one crimped sleeve to connect
features of the device.
[0399] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal anchor, a proximal
anchor and a midsection; the treatment device is configured in a
way that may be elongated to store elastic strain energy to tension
lung tissue comprising at least one glue bonded joint to connect
features of the device.
[0400] In another aspect of the present invention, a pulmonary
treatment device is provided that is made from a continuous wire
shaft whereas the wire shaft ends are terminated to be blunt
atraumatic tips.
[0401] In another aspect of the present invention, a pulmonary
treatment device is provided that is made from a continuous wire
shaft whereas at least one wire shaft end is recast to be shaped
into a blunt atraumatic blunt end.
[0402] In another aspect of the present invention, a pulmonary
treatment device is provided that is made from a continuous wire
shaft that may be delivered while at least partially encircling a
bronchoscope and at least one wire shaft end is recast to be shaped
into a ball shaped tip.
[0403] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal end, a proximal
end and a midsection; the treatment device is made from one or more
wire shaft components and at least one proximal end or one distal
end or both ends are recast to be shaped into ball shaped blunt
tip.
[0404] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal end, a proximal
end and a midsection; the treatment device is configured to be
delivered at least partially mounted to the outside of a
bronchoscope and at least one proximal end or one distal end or
both ends are recast to be shaped into ball shaped blunt tips.
[0405] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal anchor, a proximal
anchor and a midsection; the treatment device is configured in a
way that may be elongated to store elastic strain energy to tension
lung tissue whereas the distal end has been melted to form a blunt
ball end.
[0406] In another aspect of the present invention, a pulmonary
treatment device is provided that is configured in a way that may
be elongated to store elastic strain energy to tension lung tissue
whereas the distal end has been melted to form a blunt ball
end.
[0407] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal anchor, a proximal
anchor and a midsection; the treatment device is configured in a
way that may be elongated to store elastic strain energy to tension
lung tissue whereas the distal end has been melted to form a blunt
end.
[0408] In another aspect of the present invention, a pulmonary
treatment device is provided that is configured in a way that may
be elongated to store elastic strain energy to tension lung tissue
whereas the distal end has been melted to form a blunt end.
[0409] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal anchor, a proximal
anchor and a midsection; the treatment device is configured in a
way that may be elongated to store elastic strain energy to tension
lung tissue whereas the distal end has had material joined to it to
form an atraumatic end.
[0410] In another aspect of the present invention, a pulmonary
treatment device is provided that is configured in a way that may
be elongated to store elastic strain energy to tension lung tissue
whereas the distal end has had material joined to it to form an
atraumatic end.
[0411] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal anchor, a proximal
anchor and a midsection; the device being configured so it can be
advanced into the lung in a delivery configuration that has not
been stressed to lengthen or shorten the device length and the
device is configured in such a way that the device may be elongated
to store elastic strain energy and anchored to lung tissue such
that lung tissue is tensioned in a delivered treatment
configuration.
[0412] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal anchor, a proximal
anchor and a midsection that may be delivered to a treatment site
in a delivery configuration and made to perform work on lung tissue
in a treatment configuration. In the delivery configuration, the
device may be advanced into the lung free from stress that would
otherwise lengthen or shorten the device; in the treatment
configuration the device may be elongated to store elastic strain
energy to beneficially tension lung tissue.
[0413] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal anchor, a proximal
anchor and a midsection; the device being configured so it can be
elongated to store elastic strain energy whereby the distal anchor
is anchored to a location in a lung, the proximal anchor is
anchored in a proximal location in the lung that is distant from
the location of the distal anchor and the elastic strain energy is
allowed to reduce the distance between the distal anchor and the
proximal anchor to bring the distal and proximal anchors closer
together in the lung.
[0414] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal anchor, a proximal
anchor and a midsection that may be delivered to a treatment site
in a delivery configuration and made to perform work on lung tissue
in a treatment configuration. In the delivery configuration, the
device may be elongated to store elastic strain energy; in the
treatment configuration the device may use the elastic strain
energy to shorten the device to beneficially tension lung
tissue.
[0415] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal anchor, a proximal
anchor and a midsection that may be delivered to a treatment site
in a delivery configuration and made to perform work on lung tissue
in a treatment configuration. In the delivery configuration, the
device may be mounted around the exterior of a bronchoscope; in the
treatment configuration the device may benefit by the use of
pneumatic pressure to shorten the device to beneficially tension
lung tissue. Shortening may be accomplished by pneumatically
expanding the device diameter, using a balloon, while allowing
device foreshortening to shorten the device to cause lung tissue
tensioning.
[0416] In another aspect of the present invention, a pulmonary
treatment device is provided comprising a distal anchor, a proximal
anchor and a midsection that may be delivered to a treatment site
in a delivery configuration and made to perform work on lung tissue
in a treatment configuration. In the delivery configuration, the
device may be mounted around the exterior of a bronchoscope; in the
treatment configuration the device may benefit by the use of
hydraulic pressure to shorten the device to beneficially tension
lung tissue.
[0417] In another aspect of the present invention, a pulmonary
treatment device is provided that can be advanced along a tortuous
path to a treatment location in the lung, configured in a flexible
unstressed condition that allows the length to be unchanged from
its unstressed state, but configured to be elongated at the
treatment location before being deployed to distort lung
tissue.
[0418] In another aspect of the present invention, a pulmonary
treatment device is provided that can be advanced along a tortuous
path to a treatment location in the lung, configured in a flexible
condition whereas the length is unchanged from its unstressed
state, but configured to be elongated at the treatment location
before being deployed to distort lung tissue.
[0419] In another aspect of the present invention, a pulmonary
treatment device is provided that can be advanced along a tortuous
path to a treatment location in the lung, configured in a flexible
condition whereas the length is unchanged from its unstressed state
but configured to shorten in an unassisted way, after being
deployed in tissue, to beneficially tension lung tissue.
[0420] In another aspect of the present invention, a pulmonary
treatment device is provided that can be advanced along a tortuous
path to a treatment location in the lung, configured in a flexible
condition configured to shorten in an unassisted way, after being
deployed in tissue, to beneficially tension lung tissue.
[0421] In another aspect of the present invention, a pulmonary
treatment device is provided, configured with a distal end, a
proximal end and a midsection that can be advanced along a tortuous
path to a treatment location in the lung, configured to shorten in
an unassisted way, after being deployed in tissue, to beneficially
tension lung tissue.
[0422] In another aspect of the present invention, a pulmonary
treatment device is provided, configured with a distal end, a
proximal end and a midsection that can be advanced along a tortuous
path to a treatment location in the lung, configured to shorten in
an unassisted way, after being elongated to store elastic strain
energy, to beneficially tension lung tissue.
[0423] In another aspect of the present invention, a pulmonary
treatment device is provided, configured with a distal anchor, a
proximal anchor and a midsection that can be advanced along a
tortuous path to a treatment location in the lung, configured to
shorten in an unassisted way, after being elongated to store
elastic strain energy, to beneficially tension lung tissue.
[0424] In another aspect of the present invention, a pulmonary
treatment device is provided, configured with a distal anchor that
anchors a first location in a lung, a proximal anchor that anchors
a second location in a lung that is distant to the first location
and a midsection, connected to the proximal and distal anchors; the
device is configured so it can be advanced along a tortuous path to
a treatment location in the lung, the midsection is configured to
be lengthened before the proximal and distal anchors are deployed
to beneficially tension lung tissue.
[0425] In another aspect of the present invention, a pulmonary
treatment device is provided, configured with a distal anchor that
anchors a first location in a lung, a proximal anchor that anchors
a second location in a lung that is distant to the first location
and a midsection, connected to the proximal and distal anchors; the
device is configured so it can be advanced along a tortuous path to
a treatment location in the lung, the midsection is configured to
shorten after the proximal and distal anchors are deployed, to
beneficially tension lung tissue.
[0426] In another aspect of the present invention, a pulmonary
treatment device is provided, configured with a distal anchor that
anchors a first location in a lung, a proximal anchor that anchors
a second location in a lung that is distant to the first location
and a midsection, connected to the proximal and distal anchors; the
device is configured to be mounted at least partially around the
outside of a bronchoscope so it can be advanced along a tortuous
path to a treatment location in the lung, the midsection is
configured to shorten after the proximal and distal anchors are
deployed, to beneficially tension lung tissue.
[0427] In another aspect of the present invention, a pulmonary
treatment device is provided, configured with a distal anchor that
anchors a first location in a lung, a proximal anchor that anchors
a second location in a lung that is distant to the first location
and a midsection, connected to the proximal and distal anchors; the
device is configured to be mounted at least partially around the
outside of a bronchoscope so it can be advanced along a tortuous
path to a treatment location in the lung, the midsection is
configured to shorten after the proximal and distal anchors are
deployed, to beneficially tension lung tissue.
[0428] In another aspect of the present invention, a pulmonary
treatment device is provided, configured with a distal anchor that
anchors a first location in a lung, a proximal anchor that anchors
a second location in a lung that is distant to the first location
and a midsection, connected to the proximal and distal anchors; the
device is configured to be mounted at least partially around the
outside of a bronchoscope so it can be advanced along a tortuous
path to a treatment location in the lung, the midsection is
configured to be shortened after the proximal and distal anchors
are deployed, to beneficially tension lung tissue.
[0429] In another aspect of the present invention, a pulmonary
treatment device is provided that acts in a stent-like manner to
maintain lung airway patency and straighten the airway path between
its proximal and distal ends.
[0430] In another aspect of the present invention, a pulmonary
treatment device is provided that acts in a stent-like manner that
supports the airway to open the airway lumen and also to act as a
tensioning device along the longitudinal axis of the airway.
[0431] In another aspect of the present invention, a pulmonary
treatment device is provided that is advanceable into the lung in a
non-strained state.
[0432] In another aspect of the present invention, a pulmonary
treatment device is provided that is advanceable into the lung
while maintaining an unstretched length.
[0433] In another aspect of the present invention, a pulmonary
treatment device is provided that at least partially encircles the
bronchoscope used to deliver the pulmonary treatment device.
[0434] In another aspect of the present invention, a pulmonary
treatment device is provided with a distal anchor feature,
configured to beneficially use a bronchoscope shaft to hold the
distal anchor from being deployed while the device is being
advanced into the lung.
[0435] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to encircle the
bronchoscope so the scope shaft strength is used to beneficially
modify the treatment device dimensions.
[0436] In another aspect of the present invention, a pulmonary
treatment device is provided that may be lengthened by advancing
the bronchoscope.
[0437] In another aspect of the present invention, a pulmonary
treatment device is provided that may be elongated by advancing the
bronchoscope.
[0438] In another aspect of the present invention, a pulmonary
treatment device is provided that may be elongated by retracting
the bronchoscope.
[0439] In another aspect of the present invention, a pulmonary
treatment device is provided that may be elongated by retracting a
bronchoscope guide sleeve.
[0440] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to deploy the proximal end
to engage tissue first before being lengthened to enhance lung
elastic recoil.
[0441] In another aspect of the present invention, a pulmonary
treatment device is provided that may be advanced into the lung in
a state whereby the device has not been strained to be lengthened
or shortened from a zero-strain length, whereby the device length
may be increased, using delivery system components at the treatment
site before any portion of the device is released from the delivery
system.
[0442] In another aspect of the present invention, a pulmonary
treatment device is provided that can be pulled and lengthened
after partial deployment.
[0443] In another aspect of the present invention, a pulmonary
treatment device is provided that can be pulled and lengthened
after deploying its distal end.
[0444] In another aspect of the present invention, a pulmonary
treatment device is provided that may be tensioned along the
longitudinal direction but the device length is maintained after
deploying the distal end.
[0445] In another aspect of the present invention, a pulmonary
treatment device is provided that can be longitudinally tensioned
to pull distal end and adjacent lung tissue more proximally after
deploying the distal end.
[0446] In another aspect of the present invention, a pulmonary
treatment device is provided with flared ends for treating
emphysema (end diameter is larger than midsection).
[0447] In another aspect of the present invention, a pulmonary
treatment device is provided that acts in a stent-like manner with
flared ends for treating emphysema (end diameter is larger than
central body).
[0448] In another aspect of the present invention, a pulmonary
treatment device is provided that tensions lung tissue that can be
deployed in every anatomical lumen in lung that is either
anatomical or made by disease or created by a device as shown as
RB1 through LB10 on conventional airway charts.
[0449] In another aspect of the present invention, a pulmonary
treatment device is provided that acts in a stent-like manner that
is delivered by advancing a bronchoscope.
[0450] In another aspect of the present invention, a pulmonary
treatment device is provided that stents lung tissue that is
delivered by advancing a catheter (without the use of a scope).
[0451] In another aspect of the present invention, a pulmonary
treatment device is provided to stent lung tissue wherein the
device is delivered by guiding a bronchoscope in position using a
guidewire.
[0452] In another aspect of the present invention, a pulmonary
treatment device is provided to stent lung tissue wherein the
device is delivered by guiding a catheter in position using a
guidewire.
[0453] In another aspect of the present invention, a pulmonary
treatment device is provided that straightens airways.
[0454] In another aspect of the present invention, a pulmonary
treatment device is provided that straightens 2 or more airways at
the same time.
[0455] In another aspect of the present invention, a pulmonary
treatment device is provided that straightens 2 or more airways
while laterally urging them closer together.
[0456] In another aspect of the present invention, a pulmonary
treatment device is provided that urges 2 or more airways together
to cause lung tissue tension.
[0457] In another aspect of the present invention, a pulmonary
treatment device is provided that urges 2 or more airways together
to cause any one of the beneficial changes listed above as items
(1) through (107) above.
[0458] In another aspect of the present invention, a pulmonary
treatment device is provided that straightens an airway while
shortening the length of the airway.
[0459] In another aspect of the present invention, a pulmonary
treatment device is provided that displaces lung tissue closer to
the trachea.
[0460] In another aspect of the present invention, a pulmonary
treatment device is provided that pulls tissue farther from the
pleura.
[0461] In another aspect of the present invention, a pulmonary
treatment device is provided that shifts lung tissue closer to the
heart.
[0462] In another aspect of the present invention, a pulmonary
treatment device is provided that urges 2 or more airways together
to displaces lung tissue closer to the trachea. In another aspect
of the present invention, a pulmonary treatment device is provided
that urges 2 or more airways together to pull tissue farther from
the pleura.
[0463] In another aspect of the present invention, a pulmonary
treatment device is provided that urges 2 or more airways together
to shift lung tissue closer to the heart.
[0464] In another aspect of the present invention, a pulmonary
treatment device is provided that shortens an airway length while
tensioning tissue that is distal to its distal end.
[0465] In another aspect of the present invention, a pulmonary
treatment device is provided that is tensioned while supporting
airway patency.
[0466] In another aspect of the present invention, a pulmonary
treatment device is provided that is tensioned while supporting
airway patency between its ends.
[0467] In another aspect of the present invention, a pulmonary
treatment device is provided that stents lung tissue to provide
support to keep airways open while also providing tension in the
longitudinal axis of the airway.
[0468] In another aspect of the present invention, a pulmonary
treatment device is provided that is resilient enough to change
dimension during breathing.
[0469] In another aspect of the present invention, a pulmonary
treatment device is provided, comprising a curvilinear shape that
maintains a fixed length as measured down the curvilinear path
before and after deployment, that tensions lung tissue.
[0470] In another aspect of the present invention, a pulmonary
treatment device is provided that straightens an airway while
allowing gas to flow through in at least one direction.
[0471] In another aspect of the present invention, a pulmonary
treatment device is provided that deploys into an airway while the
device also straightens the gas flow path through the airway where
the pulmonary treatment device is deployed.
[0472] In another aspect of the present invention, a pulmonary
treatment device is provided, comprising a distal end designed to
couple to low density lung tissue that is known to be greater than
800 HU in density.
[0473] In another aspect of the present invention, a pulmonary
treatment device is provided, comprising an optimized design with
high tissue contact area to reduce lung tissue stress,
[0474] In another aspect of the present invention, a pulmonary
treatment device is provided that tensions lung tissue distal to
the pulmonary treatment device and shortens the length of the
airway the pulmonary treatment device occupies.
[0475] In another aspect of the present invention, a pulmonary
treatment device is provided that tensions lung tissue distal to
the pulmonary treatment device and shortens the length of the
airway the pulmonary treatment device occupies and supports the
airway wall to maintain airway patency.
[0476] In another aspect of the present invention, a pulmonary
treatment device is provided that tensions lung tissue distal to
the pulmonary treatment device whereas the device length is
increased as tension is applied to the device.
[0477] In another aspect of the present invention, a pulmonary
treatment device is provided, comprising an anchor that tensions
lung tissue whereas the device length is increased as the proximal
end of the device is moved closer to the trachea.
[0478] In another aspect of the present invention, a pulmonary
treatment device is provided, comprising an anchor that tensions
lung tissue whereas the device length is increased as a portion of
the device is moved closer to the trachea.
[0479] In another aspect of the present invention, a pulmonary
treatment device is provided that tensions lung tissue
longitudinally along the axis the device occupies while also
supporting the airway wall to maintain airway patency.
[0480] In another aspect of the present invention, a pulmonary
treatment device is provided that tensions lung tissue and reduces
elastic recoil adjacent the airway that the pulmonary treatment
device occupies.
[0481] In another aspect of the present invention, a pulmonary
treatment device is provided that tensions lung tissue distal or
proximal to the pulmonary treatment device and supports the airway
wall to maintain airway patency.
[0482] In another aspect of the present invention, a pulmonary
treatment device is provided that straightens at least a portion of
airway wall.
[0483] In another aspect of the present invention, a tensioning
pulmonary treatment device is provided, comprising at least one end
that forms a circular shape.
[0484] In another aspect of the present invention, a tensioning
pulmonary treatment device is provided, comprising at least one end
that forms a helical shape.
[0485] In another aspect of the present invention, a tensioning
pulmonary treatment device is provided, comprising at least one end
that penetrates lung tissue.
[0486] In another aspect of the present invention, a tensioning
pulmonary treatment device is provided, comprising at least one end
that deploys in a shape that contacts itself.
[0487] In another aspect of the present invention, a tensioning
pulmonary treatment device is provided, comprising at least one end
that does not compress tissue.
[0488] In another aspect of the present invention, a tensioning
pulmonary treatment device is provided, comprising a design which
is axisymmetric.
[0489] In another aspect of the present invention, a tensioning
pulmonary treatment device is provided that changes the lung volume
sufficiently to move the heart laterally.
[0490] In another aspect of the present invention, a pulmonary
treatment device is provided that stents lung tissue to hold at
least a portion of an airway lumen open while providing
longitudinal tension.
[0491] In another aspect of the present invention, a pulmonary
treatment device is provided, comprising a proximal or distal end
that straightens as tension is applied to the device during
deployment.
[0492] In another aspect of the present invention, a lung tissue
tensioning pulmonary treatment device is provided that does not
compress tissue.
[0493] In another aspect of the present invention, a lung tissue
tensioning pulmonary treatment device is provided that selectively
tensions tissue regions.
[0494] In another aspect of the present invention, a lung tissue
tensioning pulmonary treatment device is provided that increases
tension in lung tissue to a uniform magnitude.
[0495] In another aspect of the present invention, a pulmonary
treatment device is provided that tensions lung tissue in a portion
of a lung while relieving tension in another portion of the same
lung.
[0496] In another aspect of the present invention, a pulmonary
treatment device is provided that is delivered in a delivery
configuration and deployed in a deployed configuration, comprising
a proximal end; a distal end and a midsection which is connected to
the proximal end and the distal end; configured to a delivery
length in a delivery configuration and a deployed length that is
longer than the delivery length.
[0497] In another aspect of the present invention, a pulmonary
treatment device is provided that tensions lung tissue in a way
that is compliant during breathing.
[0498] In another aspect of the present invention, a pulmonary
treatment device is provided that tensions lung tissue and
elongates during the inspiration portion of the breathing
cycle.
[0499] In another aspect of the present invention, a pulmonary
treatment device is provided that tensions lung tissue and
contracts to a shorter length during the expiration portion of the
breathing cycle.
[0500] In another aspect of the present invention, a COPD treatment
device is provided that lengthens during the inspiration portion of
the breathing cycle.
[0501] In another aspect of the present invention, a COPD treatment
device is provided that shortens during the exhalation portion of
the breathing cycle.
[0502] In another aspect of the present invention, a COPD treatment
device is provided that acts as a stent device, comprising: a
tubular shaped member having first and second open end and a lumen
running therethrough, said member is sized for placement within a
lung airway, said member is comprised of a shape memory material
that exhibits a shape recovery transition temperature in a
temperature range below normal body temperature such that after
placement within the lung, having a temperature at or near normal
body temperature, said member expands radially and contracts
longitudinally so at least a portion of said member becomes firmly
anchored to lung tissue.
[0503] In another aspect of the present invention, a COPD treatment
device is provided that acts as a stent device, comprising: a
tubular shaped member having first and second open end and a lumen
running therethrough, said member is sized for placement within a
lung airway, said member is comprised of a shape memory material
that exhibits a shape recovery transition temperature in a
temperature range below normal body temperature such that after
placement within the lung, having a temperature at or near normal
body temperature, said member expands radially and contracts
longitudinally so at least a portion of said member straightens the
lung airway.
[0504] In another aspect of the present invention, a COPD treatment
device is provided comprising a helically wound coil spring,
wherein the spring has a tubular shaped member having first and
second open end and a lumen running therethrough, said member sized
for placement within a lung airway, said member comprised of a
shape memory material that exhibits a shape recovery transition
temperature in a temperature range below normal body temperature
such that after placement within the lung, having a temperature at
or near normal body temperature, said member expands radially and
contracts longitudinally so at least a portion of said member
straightens the lung airway.
[0505] In another aspect of the present invention, a COPD treatment
device is provided that acts as a stent device, comprising: a
tubular shaped member having first and second open end and a lumen
running therethrough, said member is sized for placement within a
lung airway, said member is comprised of a shape memory material
that exhibits a shape recovery transition temperature in a
temperature range below normal body temperature such that after
placement within the lung, having a temperature at or near normal
body temperature, said member expands radially and contracts
longitudinally so at least a portion of said member tensions the
lung tissue.
[0506] In another aspect of the present invention, a COPD treatment
device is provided that acts as a helically wound coil spring,
comprising: a tubular shaped member having first and second open
end and a lumen running therethrough, said member is sized for
placement within a lung airway, said member is comprised of a shape
memory material that exhibits a shape recovery transition
temperature in a temperature range below normal body temperature
such that after placement within the lung, having a temperature at
or near normal body temperature, said member expands radially and
contracts longitudinally so at least a portion of said member
tensions lung tissue.
[0507] In another aspect of the present invention, a COPD treatment
device is provided that acts as a stent device, comprising: a
tubular shaped member having first and second open end and a lumen
running therethrough, said member is sized for placement within a
lung airway, said member is comprised of a nitinol material that
exhibits a shape recovery transition temperature in a temperature
range below normal body temperature such that after placement
within the lung, having a temperature at or near normal body
temperature, said member expands radially and contracts
longitudinally so at least a portion of said member tensions the
lung tissue.
[0508] In another aspect of the present invention, a COPD treatment
device is provided that acts as a helically wound coil spring,
comprising: a tubular shaped member having first and second open
end and a lumen running therethrough, said member is sized for
placement within a lung airway, said member is comprised of nitinol
material that exhibits a shape recovery transition temperature in a
temperature range below normal body temperature such that after
placement within the lung, having a temperature at or near normal
body temperature, said member expands radially and contracts
longitudinally so at least a portion of said member tensions lung
tissue.
[0509] In another aspect of the present invention, a COPD treatment
device is provided that acts as a stent device, comprising a
proximal end, a distal end and a midsection that joins the ends and
a lumen running therethrough, said member is sized for placement
within a lung airway, said member is comprised of a nitinol
material that exhibits a shape recovery transition temperature in a
temperature range below normal body temperature such that after
placement within the lung, having a temperature at or near normal
body temperature, said member contracts longitudinally so at least
a portion of said member tensions the lung tissue.
[0510] In another aspect of the present invention, a COPD treatment
device is provided that acts as a stent device, comprising a
proximal end, a distal end and a midsection that joins the ends and
a lumen running therethrough, said member is sized for placement
within a lung airway, said member is comprised of a nitinol
material that exhibits a shape recovery transition temperature in a
temperature range below normal body temperature such that after
placement within the lung, having a temperature at or near normal
body temperature, said member contracts longitudinally so at least
a portion of said member tensions the lung tissue; whereas the
distal end is configured to anchor to loose lung tissue.
[0511] In another aspect of the present invention, a COPD treatment
device is provided comprising a helically wound coil spring,
comprising: a tubular shaped member having first and second open
end and a lumen running therethrough, said member is sized for
placement within a lung airway, said member is comprised of nitinol
material that exhibits a shape recovery transition temperature in a
temperature range below normal body temperature such that after
placement within the lung, having a temperature at or near normal
body temperature, said member contracts longitudinally so at least
a portion of said member tensions lung tissue.
[0512] In another aspect of the present invention, a COPD treatment
device is provided comprising a helically wound coil spring,
comprising: a tubular shaped member having first and second open
end and a lumen running therethrough, said member is sized for
placement within a lung airway, said member is comprised of nitinol
material that exhibits a shape recovery transition temperature in a
temperature range below normal body temperature such that after
placement within the lung, having a temperature at or near normal
body temperature, said member contracts longitudinally so at least
a portion of said member tensions lung tissue; whereas the distal
end is configured to anchor in loose lung tissue.
[0513] In another aspect of the present invention, a COPD treatment
device is provided comprising a helically wound coil spring,
comprising: a tubular shaped member having first and second open
end and a lumen running therethrough, said member is sized for
placement within a lung airway, said member is comprised of nitinol
material that exhibits a shape recovery transition temperature in a
temperature range below normal body temperature such that after
placement within the lung, having a temperature at or near normal
body temperature, said member contracts longitudinally so at least
a portion of said member tensions lung tissue; whereas the proximal
end is configured to anchor in reinforced lung tissue.
[0514] In another aspect of the present invention, a COPD treatment
device is provided comprising a first coil shaped end and second
coil shaped end and a lumen running therethrough, said device is
sized for placement within a lung airway, said device is comprised
of nitinol material that exhibits a shape recovery transition
temperature in a temperature range below normal body temperature
such that after placement within the lung, having a temperature at
or near normal body temperature, said device contracts
longitudinally so at least a portion of said device tensions lung
tissue.
[0515] In another aspect of the present invention, a COPD treatment
device is provided that straightens the airway comprising a single
helical component with an arc length that is not changed during
deployment.
[0516] In another aspect of the present invention, a COPD treatment
device is provided that does not cause lung volume reduction.
[0517] In another aspect of the present invention, a COPD treatment
device is provided that causes minimal lung volume reduction.
[0518] In another aspect of the present invention, a COPD treatment
device is provided that does not cause lung volume compression.
[0519] In another aspect of the present invention, a COPD treatment
device is provided that causes minimal lung volume compression.
[0520] In another aspect of the present invention, a COPD treatment
device is provided that does not cause lung tissue compression.
[0521] In another aspect of the present invention, a COPD treatment
device is provided that causes minimal lung tissue compression.
[0522] In another aspect of the present invention, a COPD treatment
device is provided comprising: a resilient stent device for
straightening lung airways comprising a wire formed into a
plurality of bends to generally form a helical shape having a
longitudinal axis that is lengthened before being decoupled from a
delivery system to apply longitudinal tension to lung tissue in a
patient when said stent device is disposed within said airway.
[0523] In another aspect of the present invention, a COPD treatment
device is provided comprising: a medical device for straightening a
lung airway, comprising: a tissue gathering end, a stabilizing end,
and a tether extending between the tissue gathering end and
stabilizing end, the device configured so that the distance between
the ends measured along the tether is fixed and maintained after
being released from a delivery device but the distance between the
ends can be lengthened by moving the delivery device before
releasing the medical device from the delivery device.
[0524] In another aspect of the present invention, a COPD treatment
device is provided that tensions lung tissue and a tension
indicator feature.
[0525] In another aspect of the present invention, a COPD treatment
device is provided that tensions lung tissue and a displacement
indicator feature.
[0526] In another aspect of the present invention, a COPD treatment
device is provided that straightens airways in the lung that
includes a tension indicator feature.
[0527] In another aspect of the present invention, a COPD treatment
device is provided that straightens airways in the lung and
includes a displacement indicator feature.
[0528] In another aspect of the present invention, a COPD treatment
device is provided that straightens airways in the lung when
tension is applied to the lung tissue.
[0529] In another aspect of the present invention, a COPD treatment
device is provided that dilates airways in the lung when the device
is used to apply tension to lung tissue.
[0530] In another aspect of the present invention, a COPD treatment
device is provided comprising: a medical device for straightening a
lung airway, comprising: a tissue gathering end, a stabilizing end,
and a tether extending between the tissue gathering end and
stabilizing end, whereas the tether is shaped to form a coil and
the coil is straightened as the distance between the tissue
gathering end and the stabilizing end of the device is
lengthened.
[0531] In another aspect of the present invention, a COPD treatment
device is provided comprising: a medical device used to tension
lung tissue; having a tissue gathering end, a stabilizing end and a
tether joining the two ends that is made from a single continuous
length of plastic, metal, tubing, wire, or extrusion.
[0532] In another aspect of the present invention, a COPD treatment
device is provided comprising: a first portion having a first
bearing surface and defining a first local axis, the first portion
of the treatment device configured to engage a first portion of the
airway with the first bearing surface; and the treatment device
further comprising a second portion coupled to the first portion of
the treatment device, the second portion of the treatment device
having a second bearing surface and defining a second local axis,
the second portion of the treatment device configured to engage a
second portion of the airway with the second bearing surface, the
second portion of the airway being axially spaced apart from the
first portion of the airway; wherein, in a deployed configuration
within the lung, the first portion of the treatment device presses
against the first portion of the airway to urge it to a more
coaxial orientation relative to the second local axis, and the
second portion of the treatment device presses against the second
portion of the airway to urge it to a more coaxial orientation
relative to the first local axis, thereby straightening the path
through the airway in contact with the first and second portions of
the treatment device.
[0533] In another aspect of the present invention, a COPD treatment
device is provided comprising: a first portion having a structure
with a centroid defining a first local axis and a first bearing
surface, the first portion of the treatment device configured to
engage a first portion of the airway with the first bearing
surface; and the treatment device further comprising a second
portion coupled to the first portion of the treatment device, the
second portion of the treatment device having a structure with a
centroid defining a second local axis and a second bearing surface,
the second portion of the treatment device configured to engage a
second portion of the airway with the second bearing surface, the
second portion of the airway being axially spaced apart from the
first portion of the airway; wherein, in a deployed configuration
within the lung, the first portion of the treatment device presses
against the first portion of the airway to urge it to a more
coaxial orientation relative to the second local axis, and the
second portion of the treatment device presses against the second
portion of the airway to urge it to a more coaxial orientation
relative to the first local axis, thereby straightening the path
through the airway in contact with the first and second portions of
the treatment device
[0534] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to be deployed within an
airway of a lung of a patient for treating the lung of the patient,
the treatment device comprising: a first portion having a structure
with a centroid defining a first local axis and a first bearing
surface, the first portion of the treatment device configured to
engage a first portion of the airway with the first bearing
surface; and a second portion coupled to the first portion of the
treatment device, the second portion of the treatment device having
a structure with a centroid defining a second local axis and a
second bearing surface, the second portion of the treatment device
configured to engage a second portion of the airway with the second
bearing surface, the second portion of the airway being axially
spaced apart from the first portion of the airway; wherein, in a
deployed configuration within the lung, the first portion of the
treatment device presses against the first portion of the airway to
urge it to a more coaxial orientation relative to the second local
axis, and the second portion of the treatment device presses
against the second portion of the airway to urge it to a more
coaxial orientation relative to the first local axis, thereby
straightening the path through the airway in contact with the first
and second portions of the treatment device.
[0535] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to be deployed within more
than one airway of a lung of a patient for treating the lung of the
patient, the treatment device comprising: a first portion having a
first bearing surface and defining a first local axis, the first
portion of the treatment device configured to engage a first
portion of a first airway with the first bearing surface; and the
treatment device further comprising a second portion (can be a
portion of a proximal v clip) coupled to the first portion of the
treatment device, a second portion of the treatment device having a
second bearing surface and defining a second local axis, the second
portion of the treatment device configured to engage a second
portion of the first airway with the second bearing surface, the
second portion of the airway being axially spaced apart from the
first portion of the first airway; a third portion coupled to the
second portion of the treatment device having a third bearing
surface and defining a third local axis, the third portion of the
treatment device configured to engage a first portion of a second
airway with the third bearing surface; and a fourth portion (can be
another tissue gathering end) coupled to the third portion of the
treatment device, the fourth portion of the treatment device having
a fourth bearing surface and defining a fourth local axis, the
fourth portion of the treatment device configured to engage a
second portion of the second airway with the fourth bearing
surface, the second portion of the second airway being axially
spaced apart from the first portion of the second airway; wherein,
in a deployed configuration within the lung, the first portion of
the treatment device presses against the first portion of the first
airway to urge it to a more coaxial orientation relative to the
second local axis in the first airway, and the second portion of
the treatment device presses against the second portion of the
first airway to urge it to more a coaxial orientation relative to
the first local axis, thereby straightening the path through the
first airway in contact with the first and second portions of the
treatment device and the third portion of the treatment device
presses against the first portion of the second airway to urge it
to a more coaxial orientation relative to the fourth local axis in
the second airway, and the fourth portion of the treatment device
presses against the second portion of the second airway to urge it
to more a coaxial orientation relative to the third local axis,
thereby straightening the path through the second airway in contact
with the third and fourth portions of the treatment device.
[0536] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to be deployed within more
than one airway of a lung of a patient for treating the lung of the
patient, the treatment device comprising: a first portion having a
first bearing surface having a structure with a centroid defining a
first local axis, the first portion of the treatment device
configured to engage a first portion of a first airway with the
first bearing surface; a second portion (can be a portion of a
proximal v clip) coupled to the first portion of the treatment
device, the second portion of the treatment device having a second
bearing surface having a structure with a centroid defining a
second local axis, the second portion of the treatment device
configured to engage a second portion of the first airway with the
second bearing surface, the second portion of the first airway
being axially spaced apart from the first portion of the first
airway; a third portion coupled to the second portion of the
treatment device having a third bearing surface having a structure
with a centroid defining a third local axis, the third portion of
the treatment device configured to engage a first portion of a
second airway with the third bearing surface; and a fourth portion
(can be another distal end) coupled to the third portion of the
treatment device, the fourth portion of the treatment device having
a fourth bearing surface having a structure with a centroid
defining a fourth local axis, the fourth portion of the treatment
device configured to engage a second portion of the second airway
with the fourth bearing surface, the second portion of the second
airway being axially spaced apart from the first portion of the
second airway; wherein, in a deployed configuration within the
lung, the first portion of the treatment device presses against the
first portion of the first airway to urge it to a more coaxial
orientation relative to the second local axis in the first airway,
and the second portion of the treatment device presses against the
second portion of the first airway to urge it to more a coaxial
orientation relative to the first local axis, thereby straightening
the path through the first airway in contact with the first and
second portions of the treatment device and the third portion of
the treatment device presses against the first portion of the
second airway to urge it to a more coaxial orientation relative to
the fourth local axis in the second airway, and the fourth portion
of the treatment device presses against the second portion of the
second airway to urge it to more a coaxial orientation relative to
the third local axis, thereby straightening the path through the
second airway in contact with the third and fourth portions of the
treatment device.
[0537] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to be deployed within more
than one airway of a lung of a patient for treating the lung of the
patient, the treatment device comprising: a first portion having a
first bearing surface having a structure with a centroid defining a
first local axis, the first portion of the treatment device
configured to engage a first portion of a first airway with the
first bearing surface; a second portion (can be a portion of a
proximal v clip) coupled to the first portion of the treatment
device, the second portion of the treatment device having a second
bearing surface having a structure with a centroid defining a
second local axis, the second portion of the treatment device
configured to engage a second portion of the first airway with the
second bearing surface, the second portion of the first airway
being axially spaced apart from the first portion of the first
airway; a third portion coupled to the second portion of the
treatment device having a third bearing surface having a structure
with a centroid defining a third local axis, the third portion of
the treatment device configured to engage a first portion of a
second airway with the third bearing surface; and a fourth portion
(can be another distal end) coupled to the third portion of the
treatment device, the fourth portion of the treatment device having
a fourth bearing surface having a structure with a centroid
defining a fourth local axis, the fourth portion of the treatment
device configured to engage a second portion of the second airway
with the fourth bearing surface, the second portion of the second
airway being axially spaced apart from the first portion of the
second airway; wherein, in a deployed configuration within the
lung, the first portion of the treatment device presses against the
first portion of the first airway to urge it to a more coaxial
orientation relative to the second local axis in the first airway,
and the second portion of the treatment device presses against the
second portion of the first airway to urge it to more a coaxial
orientation relative to the first local axis, thereby straightening
the path through the first airway in contact with the first and
second portions of the treatment device and the third portion of
the treatment device presses against the first portion of the
second airway to urge it to a more coaxial orientation relative to
the fourth local axis in the second airway, and the fourth portion
of the treatment device presses against the second portion of the
second airway to urge it to more a coaxial orientation relative to
the third local axis, thereby straightening the path through the
second airway in contact with the third and fourth portions of the
treatment device; whereas the first and second portions of the
treatment device are urged closer to the third and fourth portions
of the treatment device in a deployed configuration within the
lung.
[0538] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to be deployed within more
than one airway of a lung of a patient for treating the lung of the
patient, the treatment device comprising: a first portion having a
first bearing surface having a structure with a centroid defining a
first local axis, the first portion of the treatment device
configured to engage a first portion of a first airway with the
first bearing surface; a second portion (can be a portion of a
proximal v clip) coupled to the first portion of the treatment
device, the second portion of the treatment device having a second
bearing surface having a structure with a centroid defining a
second local axis, the second portion of the treatment device
configured to engage a second portion of the first airway with the
second bearing surface, the second portion of the first airway
being axially spaced apart from the first portion of the first
airway; a third portion coupled to the second portion of the
treatment device having a third bearing surface having a structure
with a centroid defining a third local axis, the third portion of
the treatment device configured to engage a first portion of a
second airway with the third bearing surface; and a fourth portion
(can be another distal end) coupled to the third portion of the
treatment device, the fourth portion of the treatment device having
a fourth bearing surface having a structure with a centroid
defining a fourth local axis, the fourth portion of the treatment
device configured to engage a second portion of the second airway
with the fourth bearing surface, the second portion of the second
airway being axially spaced apart from the first portion of the
second airway; wherein, in a deployed configuration within the
lung, the first portion of the treatment device presses against the
first portion of the first airway to urge it to a more coaxial
orientation relative to the second local axis in the first airway,
and the second portion of the treatment device presses against the
second portion of the first airway to urge it to more a coaxial
orientation relative to the first local axis, thereby straightening
the path through the first airway in contact with the first and
second portions of the treatment device and the third portion of
the treatment device presses against the first portion of the
second airway to urge it to a more coaxial orientation relative to
the fourth local axis in the second airway, and the fourth portion
of the treatment device presses against the second portion of the
second airway to urge it to more a coaxial orientation relative to
the third local axis, thereby straightening the path through the
second airway in contact with the third and fourth portions of the
treatment device; whereas the first and second portions of the
treatment device are urged closer to the third and fourth portions
of the treatment device in a deployed configuration within the
lung; whereas the treatment device increases tension in lung tissue
in a deployed configuration within the lung.
[0539] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to be deployed within more
than one airway of a lung of a patient for treating the lung of the
patient, the treatment device comprising: a first portion having a
first bearing surface having a structure with a centroid defining a
first local axis, the first portion of the treatment device
configured to engage a first portion of a first airway with the
first bearing surface; a second portion (can be a portion of a
proximal v clip) coupled to the first portion of the treatment
device, the second portion of the treatment device having a second
bearing surface having a structure with a centroid defining a
second local axis, the second portion of the treatment device
configured to engage a second portion of the first airway with the
second bearing surface, the second portion of the first airway
being axially spaced apart from the first portion of the first
airway; a third portion coupled to the second portion of the
treatment device having a third bearing surface having a structure
with a centroid defining a third local axis, the third portion of
the treatment device configured to engage a first portion of a
second airway with the third bearing surface; and a fourth portion
(can be another distal end) coupled to the third portion of the
treatment device, the fourth portion of the treatment device having
a fourth bearing surface having a structure with a centroid
defining a fourth local axis, the fourth portion of the treatment
device configured to engage a second portion of the second airway
with the fourth bearing surface, the second portion of the second
airway being axially spaced apart from the first portion of the
second airway; wherein, in a deployed configuration within the
lung, the first portion of the treatment device presses against the
first portion of the first airway to urge it to a more coaxial
orientation relative to the second local axis in the first airway,
and the second portion of the treatment device presses against the
second portion of the first airway to urge it to more a coaxial
orientation relative to the first local axis, thereby straightening
the path through the first airway in contact with the first and
second portions of the treatment device and the third portion of
the treatment device presses against the first portion of the
second airway to urge it to a more coaxial orientation relative to
the fourth local axis in the second airway, and the fourth portion
of the treatment device presses against the second portion of the
second airway to urge it to more a coaxial orientation relative to
the third local axis, thereby straightening the path through the
second airway in contact with the third and fourth portions of the
treatment device; whereas the first and second portions of the
treatment device are urged closer to the third and fourth portions
of the treatment device in a deployed configuration within the
lung; whereas the second and third portions of the treatment device
are coupled by a resilient spring material.
[0540] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to be deployed within more
than one airway of a lung of a patient for treating the lung of the
patient, the treatment device comprising: a first portion having a
first bearing surface having a structure with a centroid defining a
first local axis, the first portion of the treatment device
configured to engage a first portion of a first airway with the
first bearing surface; a second portion (can be a portion of a
proximal v clip) coupled to the first portion of the treatment
device, the second portion of the treatment device having a second
bearing surface having a structure with a centroid defining a
second local axis, the second portion of the treatment device
configured to engage a second portion of the first airway with the
second bearing surface, the second portion of the first airway
being axially spaced apart from the first portion of the first
airway; a third portion coupled to the second portion of the
treatment device having a third bearing surface having a structure
with a centroid defining a third local axis, the third portion of
the treatment device configured to engage a first portion of a
second airway with the third bearing surface; and a fourth portion
(can be another distal end) coupled to the third portion of the
treatment device, the fourth portion of the treatment device having
a fourth bearing surface having a structure with a centroid
defining a fourth local axis, the fourth portion of the treatment
device configured to engage a second portion of the second airway
with the fourth bearing surface, the second portion of the second
airway being axially spaced apart from the first portion of the
second airway; wherein, in a deployed configuration within the
lung, the first portion of the treatment device presses against the
first portion of the first airway to urge it to a more coaxial
orientation relative to the second local axis in the first airway,
and the second portion of the treatment device presses against the
second portion of the first airway to urge it to more a coaxial
orientation relative to the first local axis, thereby straightening
the path through the first airway in contact with the first and
second portions of the treatment device and the third portion of
the treatment device presses against the first portion of the
second airway to urge it to a more coaxial orientation relative to
the fourth local axis in the second airway, and the fourth portion
of the treatment device presses against the second portion of the
second airway to urge it to more a coaxial orientation relative to
the third local axis, thereby straightening the path through the
second airway in contact with the third and fourth portions of the
treatment device; whereas the first and second portions of the
treatment device are urged closer to the third and fourth portions
of the treatment device in a deployed configuration within the
lung; whereas the second and third portions of the treatment device
are coupled by a resilient spring material; whereas at least one of
the portions of the treatment device is covered with a jacket to
increase the area that is engaged with a portion of an airway.
[0541] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to be deployed within more
than one airway of a lung of a patient for treating the lung of the
patient, the treatment device comprising: a first portion having a
first bearing surface having a structure with a centroid defining a
first local axis, the first portion of the treatment device
configured to engage a first portion of a first airway with the
first bearing surface; a second portion (can be a portion of a
proximal v clip) coupled to the first portion of the treatment
device, the second portion of the treatment device having a second
bearing surface having a structure with a centroid defining a
second local axis, the second portion of the treatment device
configured to engage a second portion of the first airway with the
second bearing surface, the second portion of the first airway
being axially spaced apart from the first portion of the first
airway; a third portion coupled to the second portion of the
treatment device having a third bearing surface having a structure
with a centroid defining a third local axis, the third portion of
the treatment device configured to engage a first portion of a
second airway with the third bearing surface; and a fourth portion
(can be another distal end) coupled to the third portion of the
treatment device, the fourth portion of the treatment device having
a fourth bearing surface having a structure with a centroid
defining a fourth local axis, the fourth portion of the treatment
device configured to engage a second portion of the second airway
with the fourth bearing surface, the second portion of the second
airway being axially spaced apart from the first portion of the
second airway; wherein, in a deployed configuration within the
lung, the first portion of the treatment device presses against the
first portion of the first airway to urge it to a more coaxial
orientation relative to the second local axis in the first airway,
and the second portion of the treatment device presses against the
second portion of the first airway to urge it to more a coaxial
orientation relative to the first local axis, thereby straightening
the path through the first airway in contact with the first and
second portions of the treatment device and the third portion of
the treatment device presses against the first portion of the
second airway to urge it to a more coaxial orientation relative to
the fourth local axis in the second airway, and the fourth portion
of the treatment device presses against the second portion of the
second airway to urge it to more a coaxial orientation relative to
the third local axis, thereby straightening the path through the
second airway in contact with the third and fourth portions of the
treatment device; whereas the first and second portions of the
treatment device are urged closer to the third and fourth portions
of the treatment device in a deployed configuration within the
lung; whereas the second and third portions of the treatment device
are coupled by a resilient spring material; whereas at least one of
the portions of the treatment device is covered with a jacket to
increase the area that is engaged with a portion of an airway;
whereas the first and fourth portions of the treatment device are
covered with a jacket to increase the area that is engaging the
first portion of the first airway and second portion of the second
airway.
[0542] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to be deployed within more
than one airway of a lung of a patient for treating the lung of the
patient, the treatment device comprising: a first portion having a
first bearing surface having a structure with a centroid defining a
first local axis, the first portion of the treatment device
configured to engage a first portion of a first airway with the
first bearing surface; a second portion (can be a portion of a
proximal v clip) coupled to the first portion of the treatment
device, the second portion of the treatment device having a second
bearing surface having a structure with a centroid defining a
second local axis, the second portion of the treatment device
configured to engage a second portion of the first airway with the
second bearing surface, the second portion of the first airway
being axially spaced apart from the first portion of the first
airway; a third portion coupled to the second portion of the
treatment device having a third bearing surface having a structure
with a centroid defining a third local axis, the third portion of
the treatment device configured to engage a first portion of a
second airway with the third bearing surface; and a fourth portion
(can be another distal end) coupled to the third portion of the
treatment device, the fourth portion of the treatment device having
a fourth bearing surface having a structure with a centroid
defining a fourth local axis, the fourth portion of the treatment
device configured to engage a second portion of the second airway
with the fourth bearing surface, the second portion of the second
airway being axially spaced apart from the first portion of the
second airway; wherein, in a deployed configuration within the
lung, the first portion of the treatment device presses against the
first portion of the first airway to urge it to a more coaxial
orientation relative to the second local axis in the first airway,
and the second portion of the treatment device presses against the
second portion of the first airway to urge it to more a coaxial
orientation relative to the first local axis, thereby straightening
the path through the first airway in contact with the first and
second portions of the treatment device and the third portion of
the treatment device presses against the first portion of the
second airway to urge it to a more coaxial orientation relative to
the fourth local axis in the second airway, and the fourth portion
of the treatment device presses against the second portion of the
second airway to urge it to more a coaxial orientation relative to
the third local axis, thereby straightening the path through the
second airway in contact with the third and fourth portions of the
treatment device; whereas the first and second portions of the
treatment device are urged closer to the third and fourth portions
of the treatment device in a deployed configuration within the
lung; whereas the second and third portions of the treatment device
are coupled by a resilient spring material; whereas at least one of
the portions of the treatment device is covered with a jacket,
selected from the materials defined as jacket materials in this
specification, to increase the area that is engaged with a portion
of an airway; whereas the first and fourth portions of the
treatment device are covered with a jacket to increase the area
that is engaging the first portion of the first airway and second
portion of the second airway.
[0543] In another aspect of the present invention, a pulmonary
treatment device is provided, configured with a jacket to increase
the area that is engaged with lung tissue.
[0544] In another aspect of the present invention, a pulmonary
treatment device is provided, configured with a jacket, made from
material listed in this specification defined as jacket materials,
to increase the area that is engaged with lung tissue.
[0545] In another aspect of the present invention, a pulmonary
treatment device is provided, configured with a jacket to increase
the area that is engaged with lung tissue.
[0546] In another aspect of the present invention, a pulmonary
treatment device is provided, configured with a jacket, made from a
polymer, to increase the area that is engaged with lung tissue.
[0547] In another aspect of the present invention, a pulmonary
treatment device is provided, configured with a jacket, made from a
polymer material, that regulates the rate of release of a
therapeutic drug.
[0548] In another aspect of the present invention, a pulmonary
treatment device is provided, configured with a jacket, made from a
polymer material, that regulates the rate of release of a
therapeutic drug; whereas the therapeutic drug reduces the rate of
wound healing, tissue remodeling, inflammation, generation of
granular tissue or a combination of these.
[0549] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to be deployed within an
airway of a lung of a patient for treating the lung of the patient,
the treatment device comprising: an elongate body having a proximal
end and a distal end; the elongate body configured to transition
between a delivery configuration and a deployed configuration; and
wherein the deployed configuration of the elongate body exerts
force on the airway to straighten a portion of the airway that is
axially spaced between the proximal and distal end of the treatment
device for reducing air flow resistance in the lung; and wherein
the elongate body is configured to increases tension in lung tissue
to bring benefits related to increasing lung tension.
[0550] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to be deployed within an
airway of a lung of a patient for treating the lung of the patient,
the treatment device comprising: an elongate body having a proximal
end and a distal end; the elongate body configured to transition
between a delivery configuration and a deployed configuration; and
wherein the deployed configuration of the elongate body exerts
force on the airway to straighten a portion of the airway that is
axially spaced between the proximal and distal end of the treatment
device for reducing air flow resistance in the lung; and wherein
the elongate body is configured to increases tension in lung tissue
to bring benefits related to increasing lung tension; and wherein
the elongate body is configured to elute a therapeutic drug.
[0551] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to be deployed within an
airway of a lung of a patient for treating the lung of the patient,
the treatment device comprising: an elongate body having a proximal
end and a distal end; the elongate body configured to transition
between a delivery configuration and a deployed configuration; and
wherein the deployed configuration of the elongate body exerts
force on the airway to straighten a portion of the airway that is
axially spaced between the proximal and distal end of the treatment
device for reducing air flow resistance in the lung; and wherein
the elongate body is configured to increases tension in lung tissue
to bring benefits related to increasing lung tension; and wherein
the elongate body is configured to elute a therapeutic drug;
wherein the therapeutic drug is configured to locally reduce a
wound healing rate.
[0552] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to be deployed within an
airway of a lung of a patient for treating the lung of the patient,
the treatment device comprising: an elongate body having a proximal
end and a distal end; the elongate body configured to transition
between a delivery configuration and a deployed configuration; and
wherein the deployed configuration of the elongate body exerts
force on the airway to straighten a portion of the airway that is
axially spaced between the proximal and distal end of the treatment
device for reducing air flow resistance in the lung; and wherein
the elongate body is configured to increases tension in lung tissue
to bring benefits related to increasing lung tension; and wherein
the elongate body is configured to elute a therapeutic drug;
wherein the therapeutic drug is configured to locally reduce tissue
remodeling.
[0553] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to be deployed within an
airway of a lung of a patient for treating the lung of the patient,
the treatment device comprising: an elongate body having a proximal
end and a distal end; the elongate body configured to transition
between a delivery configuration and a deployed configuration; and
wherein the deployed configuration of the elongate body exerts
force on the airway to straighten a portion of the airway that is
axially spaced between the proximal and distal end of the treatment
device for reducing air flow resistance in the lung; and wherein
the elongate body is configured to increases tension in lung tissue
to bring benefits related to increasing lung tension; and wherein
the elongate body is configured to elute a therapeutic drug;
wherein the therapeutic drug is configured to locally reduce
inflammation.
[0554] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to be deployed within an
airway of a lung of a patient for treating the lung of the patient,
the treatment device comprising: an elongate body having a proximal
end and a distal end; the elongate body configured to transition
between a delivery configuration and a deployed configuration; and
wherein the deployed configuration of the elongate body exerts
force on the airway to straighten a portion of the airway that is
axially spaced between the proximal and distal end of the treatment
device for reducing air flow resistance in the lung; and wherein
the elongate body is configured to increases tension in lung tissue
to bring benefits related to increasing lung tension; and wherein
the elongate body is configured to elute a therapeutic drug;
wherein the therapeutic drug is configured to reduce granular
tissue formation.
[0555] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to be deployed within an
airway of a lung of a patient for treating the lung of the patient,
the treatment device comprising: an elongate body having a proximal
end and a distal end; the elongate body configured to transition
between a delivery configuration and a deployed configuration; and
wherein the deployed configuration of the elongate body exerts
force on the airway to straighten a portion of the airway that is
axially spaced between the proximal and distal end of the treatment
device for reducing air flow resistance in the lung; and wherein
the elongate body is configured to increases tension in lung tissue
to bring benefits related to increasing lung tension; and wherein
the elongate body is configured to elute a therapeutic drug;
wherein the therapeutic drug is configured to reduce
hyperplasia.
[0556] In another aspect of the present invention, a pulmonary
treatment device is provided, configured to be deployed within an
airway of a lung of a patient for treating the lung of the patient,
the treatment device comprising: an elongate body having a proximal
end and a distal end; the elongate body configured to transition
between a delivery configuration and a deployed configuration; and
wherein the deployed configuration of the elongate body exerts
force on the airway to straighten a portion of the airway that is
axially spaced between the proximal and distal end of the treatment
device for reducing air flow resistance in the lung; and wherein
the elongate body is configured to increases tension in lung tissue
to bring benefits related to increasing lung tension; and wherein
the elongate body is configured to elute a therapeutic drug;
wherein the elongate body comprises a polymer material and wherein
the polymer material regulates a release of the therapeutic
drug.
[0557] In another aspect of the present invention, a method is
provided for treating a lung comprising: deploying an implantable
pulmonary treatment device to the airway of the lung, the treatment
device comprising an elongate body having a proximal end and a
distal end that can be repositioned; wherein the distal end of the
elongate body is deployed to anchor to lung tissue, the proximal
end of the elongate body is deployed to an initial position to
anchor to lung tissue in a repositionable way, the proximal end is
repositioned to a position farther from the distal end of the
treatment device than the proximal end initial deployed position so
that the elongate body and airway are urged to a more straight
configuration.
[0558] In another aspect of the present invention, a method is
provided for treating a lung comprising: deploying an implantable
pulmonary treatment device to the airway of the lung, the treatment
device comprising an elongate body having a proximal end and a
distal end that can be repositioned; wherein the distal end of the
elongate body is deployed to anchor to lung tissue, the proximal
end of the elongate body is deployed to an initial position to
anchor to lung tissue in a repositionable way, the proximal end is
repositioned to a position farther from the distal end of the
treatment device than the proximal end initial deployed position so
that the elongate body and airway are urged to a more straight
configuration; wherein the elongate body of the treatment device is
configured to tension lung tissue to bring benefits related to
increasing lung tension.
[0559] In another aspect of the present invention, a method is
provided for treating a lung comprising: deploying an implantable
pulmonary treatment device to the airway of the lung, the treatment
device comprising an elongate body having a proximal end and a
distal end that can be repositioned; wherein the distal end of the
elongate body is deployed to anchor to lung tissue, the proximal
end of the elongate body is deployed to an initial position to
anchor to lung tissue in a repositionable way, the proximal end is
repositioned to a position farther from the distal end of the
treatment device than the proximal end initial deployed position so
that the elongate body and airway are urged to a more straight
configuration; wherein the elongate body of the treatment device is
configured to increase tension of lung tissue that lie along
directional vectors between the treatment device and chest
wall.
[0560] In another aspect of the present invention, a method is
provided for treating a lung comprising: deploying a pulmonary
treatment device to the airway of the lung, the treatment device
comprising an elongate body having a proximal end and a distal end
that can be repositioned; wherein the distal end of the elongate
body is deployed to anchor to lung tissue, the proximal end of the
elongate body is deployed to an initial position to anchor to lung
tissue in a repositionable way, the proximal end is repositioned to
a position farther from the distal end of the treatment device than
the proximal end initial deployed position so that the elongate
body and airway are urged to a more straight configuration; wherein
the elongate body of the treatment device is configured to increase
tension of lung tissue that lies between the treatment device and
the chest wall.
[0561] In another aspect of the present invention, a method is
provided for treating a lung comprising: deploying a pulmonary
treatment device to the airway of the lung, the treatment device
comprising an elongate body having a proximal end and a distal end
that can be repositioned; wherein the distal end of the elongate
body is deployed to anchor to lung tissue, the proximal end of the
elongate body is deployed to an initial position to anchor to lung
tissue in a repositionable way, the proximal end is repositioned to
a position farther from the distal end of the treatment device than
the proximal end initial deployed position so that the elongate
body and airway are urged to a more straight configuration; wherein
the elongate body of the treatment device is configured to elute a
therapeutic drug.
[0562] In another aspect of the present invention, a method is
provided for treating a lung comprising: deploying a tissue
engaging end of a pulmonary treatment device into loose damaged
alveolar sac tissue distal to a lung passageway; pulling the tissue
engaging end toward the lung passageway so that a portion of the
lung associated with the loose damaged alveolar sac tissue is
re-tensioned; and seating a stabilizing end of the pulmonary
treatment device into the lung passageway so as to maintain
re-tensioning of the portion of the lung.
[0563] In another aspect of the present invention, a method is
provided to treat a lung comprising: providing a pulmonary
treatment device with a proximal end configured to be a stabilizing
end, a distal end configured to be a tissue gathering end and an
elastic midsection that is connected to the stabilizing end and the
tissue gathering ends and a delivery device configured to seat the
stabilizing end of the pulmonary treatment device into the lung
passageway; apply force to stress the elastic midsection of the
treatment device so it is strained to a longer length and the
distal tissue gathering end of the lung treatment device is
advanced further within the lung; fix the tissue engaging end of
the treatment device to the lung and then remove the delivery
device to allow the elastic midsection to stent the lumen of the
lung passageway while applying compressive stress on the lung
tissue near the treatment device and to tension portions of the
lung that are adjacent to the treatment device.
[0564] In another aspect of the present invention, a method is
provided for reducing the distance between two locations in a lung
to increase tension in locations in the lung that are not between
the two locations. The method includes the steps of providing a
device with at least two anchors and an elastic midsection that can
be elongated to store elastic recoil strain energy, anchoring at a
first location in the lung a first anchor, elongating the
midsection to store elastic recoil strain energy, anchoring at a
second location a second anchor where the second location is
distant from the first location, allow the midsection with stored
elastic recoil strain energy to reduce the distance between the
anchored first location and the anchored second location to
decrease the distance between the two locations to increase tension
in locations in the lung that are not between the two anchored
locations.
[0565] In another aspect of the present invention, a method is
provided for reducing the distance between two locations in a lung
to increase tension in locations in the lung that are not between
the two locations. The method includes the steps of providing a
device with at least two anchors and an elastic midsection that can
store elastic recoil strain energy, anchoring at a first location
in the lung a first anchor, anchoring at a second location a second
anchor where the second location is distant from the first
location, reducing the distance between the anchored first location
and the anchored second location to decrease the distance between
the two locations to increase tension in locations in the lung that
are not between the two anchored locations.
[0566] In another aspect of the present invention, a method is
provided for reducing the distance between two locations in a lung
to increase tension in locations in the lung that are not between
the two locations. The method includes the steps of providing a
device with at least two anchors and an elastic midsection that can
store elastic recoil strain energy, anchoring at a first location
in the lung a first anchor, anchoring at a second location a second
anchor where the second location is distant from the first
location, reducing the distance between the anchored first location
and the anchored second location to decrease the distance between
the two locations to increase tension in locations in the lung that
are not between the two anchored locations using stored elastic
recoil strain energy.
[0567] In another aspect of the present invention, a method is
provided for treating a lung comprising: advancing a lung treatment
device comprising a tissue gathering distal end, a stabilizing
proximal end, both connected to an elastic midsection; a delivery
device comprising a bronchoscope, a deployment sleeve and a
guidewire into a lung airway; advancing the treatment device
through a lung airway until the stabilizing end or proximal end of
the treatment device seats in the lung airway whereby the user
continues to advance the non-stabilizing proximal end portion of
the treatment device until the mid-section is extended or
lengthened; deploying a tissue anchoring feature of the distal end
of the pulmonary treatment device to allow the elastic midsection
of the treatment device to pull lung tissue towards the center of
the elastic midsection to increase tension in adjacent lung tissue.
After removing the delivery system, the lung elastic recoil tension
would be enhanced in the lung. By performing this method of
treatment, one end of the treatment device is fixed to lung tissue,
the treatment device is lengthened to store strain energy to fully
elastically lengthen the device and the distal portion is then
fixed to lung tissue. After removing the bronchoscope and related
delivery system components such as a guidewire and deployment
sleeve, the lung treatment device utilizes the stored strain energy
to recover back to an original unstressed length and this pulls the
tissue engaging end toward the lung passageway so that a portion of
the lung associated with the distal or loose damaged alveolar sac
tissue is re-tensioned and the seated stabilizing end of the
pulmonary treatment device is pulled into the lung tissue so as to
maintain re-tensioning of a large portion of the lung. The elastic
midsection of the treatment device may be configured to stent the
lung airway while enhancing lung tension as the airway tissue that
is in contact with the elastic mid-section may be compressed over
time and prone to allow lumen collapse during breathing. The
elastic midsection of the treatment device may be made from a laser
cut tube or a coiled or braided wire.
[0568] In another aspect of the invention, a method is provided to
advance and deploy a pulmonary treatment device using a guidewire a
deployment sleeve and a bronchoscope guide sleeve to 1) seat the
proximal anchor of the treatment device which has been described as
the stabilizing end of the treatment device, 2) advance the distal
anchor structure that has been defined in as the tissue gathering
end portion of the treatment device so that the midsection of the
treatment device is elongated in a fully reversibly elastic way, 3)
the deployment sleeve applies compressive force against the tissue
gathering end portion of the treatment device to maintain the
extended length of the mid-section while the bronchoscope is
removed, 4) withdrawing the bronchoscope activates the anchor
feature that is attached to the tissue gathering end so the distal
portion of the treatment device is fixed to the lung tissue while
5) the guidewire, deployment sleeve and bronchoscope are fully
removed from the lung to 6) allow the elastic recoil properties of
the pulmonary treatment device to re-tension the area of loose
damaged alveolar sac tissue, 7) pull the distal and proximal ends
of the treatment device closer together 8) reduce compliance of the
lung and 9) maintain the re-tension of the area of loose damaged
alveolar sac tissue to enhance radial outward force to airways so
symptoms of COPD are reduced or eliminated.
[0569] In another aspect of the present invention, a method is
provided for treating a lung comprising the steps of: advancing a
lung treatment system to a treatment location comprising a delivery
system element with a distal end, a proximal end and a lung
treatment device configured to at least partially encircle the
delivery system element while the system is used to treat a
patient, elongating the treatment device and deploying the device
into the lung to tension lung tissue.
[0570] In another aspect of the present invention, a method is
provided for treating a lung comprising the steps of: advancing a
lung treatment system to a treatment location comprising a delivery
system element with a distal end, a proximal end and a length which
is longer than 2 times the largest transverse dimension of the
element, a pulmonary treatment device configured to at least
partially encircle the delivery system element while the system is
advanced into a patient and elongating the treatment device and
deploying the device into the lung to enhance lung elastic
recoil.
[0571] In another aspect of the present invention, a method is
provided for treating a lung comprising the steps of: advancing a
lung treatment system comprising a delivery system element with a
distal end, a proximal end and a length which is longer than 2
times the largest transverse dimension of the element, a pulmonary
treatment device configured to at least partially encircle the
delivery system element while the system is advanced into a patient
to deliver the treatment device to a treatment location in the
lung, elongating the treatment device and deploying the device into
the lung to pull lung tissue towards the treatment device
centroid.
[0572] In another aspect of the present invention, a method is
provided for treating a lung comprising the steps of: advancing a
lung treatment system comprising a delivery system element with a
distal end, a proximal end and a length which is longer than 2
times the largest transverse dimension of the element and an
implantable pulmonary treatment device configured to at least
partially encircle the delivery system element while the system is
advanced into a patient to deliver the treatment device to a
treatment location in the lung, elongating the treatment device and
deploying the treatment device in the lung to beneficially stress
tissue in the lung.
[0573] In another aspect of the present invention, a method is
provided for treating a lung comprising the steps of: advancing a
lung treatment system comprising a delivery system canula with a
distal end, a proximal end and a length which is longer than 2
times the largest transverse dimension of the canula, a pulmonary
treatment device configured to at least partially encircle the
delivery system canula while the system is advanced into a patient
to deliver the treatment device to a treatment location in the lung
and implant the treatment device in the lung to enhance lung
elastic recoil and reduce symptoms of COPD.
[0574] In another aspect of the present invention, a method is
provided for treating a lung comprising the steps of: advancing a
lung treatment system comprising a delivery system canula with a
distal end, a proximal end and a length which is longer than 2
times the largest transverse dimension of the canula, a pulmonary
treatment device configured to at least partially encircle the
delivery system canula while the system is advanced into a patient
to deliver the treatment device to a treatment location in the
lung, elongate the treatment device and deploy the treatment device
in the lung to tension lung tissue.
[0575] In another aspect of the present invention, a method is
provided for treating a lung comprising the steps of: advancing a
lung treatment system comprising a bronchoscope with a distal end,
a proximal end and a length which is longer than 2 times the
largest transverse dimension of working length portion of the
bronchoscope, a pulmonary treatment device configured to at least
partially encircle the bronchoscope while the system is advanced
into a patient to deliver the treatment device to a treatment
location in the lung, elongate the treatment device and implanted
it in the lung to treat COPD.
[0576] In another aspect of the present invention, a lung treatment
method is provided for treating a lung comprising the steps of;
providing a bronchoscope with a distal end, a proximal end and a
length which is longer than 5 inches and a pulmonary treatment
device with a distal tissue gathering end, a proximal tissue
stabilizing end and a midsection. The treatment device is
configured to at least partially encircle the bronchoscope while
the system is advanced into a patient to deliver the treatment
device to a lung. The method includes anchoring the tissue
gathering end at a first location, anchoring the tissue stabilizing
end at a second location which is distant from the first location
and reducing the distance between the first and second locations to
increase tension in a portion of the lung that is not between the
first and second locations.
[0577] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of providing a
bronchoscope with a distal end, a proximal end and a length which
is longer than 5 inches, a pulmonary treatment device with a distal
tissue gathering end, a proximal tissue stabilizing end and a
midsection which is configured to be able to store elastic strain
energy. Additionally, the treatment device is configured to at
least partially encircle the bronchoscope while the system is
advanced into a patient to deliver the treatment device to a lung.
The method includes anchoring the tissue gathering end at a first
location, anchoring the tissue stabilizing end at a second location
which is distant from the first location and allowing stored
elastic strain energy to reduce the distance between the first and
second locations to increase tension in a portion of the lung that
is not between the first and second locations.
[0578] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of providing a
bronchoscope with a distal end, a proximal end and a length which
is longer than 5 inches, a lung treatment device with a distal
tissue gathering end, a proximal tissue stabilizing end and a
midsection which is configured to be able to store elastic strain
energy. The method includes anchoring the tissue gathering end at a
first location, anchoring the tissue stabilizing end at a second
location which is distant from the first location and allowing
stored elastic strain energy to reduce the distance between the
first and second locations to increase tension in a portion of the
lung that is not between the first and second locations.
[0579] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of providing an elongate
delivery system shaft with a distal end, a proximal end and a
length which is longer than 5 inches, a lung treatment device with
a distal tissue gathering end, a proximal tissue stabilizing end
and a midsection which is configured to be able to store elastic
strain energy. The method includes anchoring the tissue gathering
end at a first location, anchoring the tissue stabilizing end at a
second location which is distant from the first location and
allowing stored elastic strain energy to reduce the distance
between the first and second locations to increase tension in a
portion of the lung that is not between the first and second
locations.
[0580] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of providing an elongate
delivery system shaft with a distal end, a proximal end and a
length which is longer than 5 inches, a pulmonary treatment device
with a distal tissue gathering end, a proximal tissue stabilizing
end and a midsection which is configured to be able to store
elastic strain energy. Additionally, the pulmonary treatment device
is configured to at least partially encircle the elongate delivery
system shaft. The method includes anchoring the tissue gathering
end at a first location, anchoring the tissue stabilizing end at a
second location which is distant from the first location and
allowing stored elastic strain energy to reduce the distance
between the first and second locations to increase tension in a
portion of the lung that is not between the first and second
locations.
[0581] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of providing an elongate
delivery system shaft with a distal end, a proximal end and a
length which is longer than 5 inches, a pulmonary treatment device
with a distal tissue gathering end, a proximal tissue stabilizing
end and a midsection which is configured to be able to store
elastic strain energy. Additionally, the treatment device is
configured to at least partially encircle the elongate delivery
system shaft. The method includes anchoring the tissue gathering
end at a first location, anchoring the tissue stabilizing end at a
second location which is distant from the first location and
reducing the distance between the first and second locations to
increase tension in a portion of the lung that is not between the
first and second locations.
[0582] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of providing an elongate
delivery system shaft with a distal end, a proximal end and a
length which is longer than 5 inches, a pulmonary treatment device
with a distal tissue gathering end, a proximal tissue stabilizing
end and a midsection which is configured to be able to store
elastic strain energy. The method includes anchoring the tissue
gathering end at a first location, anchoring the tissue stabilizing
end at a second location which is distant from the first location
and reducing the distance between the first and second locations to
increase tension in a portion of the lung that is not between the
first and second locations.
[0583] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of providing a pulmonary
treatment device, a bronchoscope and a bronchoscope guide sleeve
whereas the treatment device is configured with a proximal end, a
distal end and a midsection that incorporates a lumen running
through the treatment device proximal end and midsection along the
central axis between the distal end and the proximal ends, a
bronchoscope guide sleeve is configured with a proximal end, a
distal end and a lumen running through the full length of the
bronchoscope guide sleeve along the central axis between the distal
end and proximal end; a bronchoscope that is configured to be
advanced through the bronchoscope guide sleeve and through the
proximal end and midsection of the treatment device in a way that
allows the lung treatment device length to be lengthened or
shortened by sliding the bronchoscope guide sleeve, which has been
attached to the lung treatment device, along the axis of the
coaxial bronchoscope. Further, the treatment device distal end is
anchored to a first location in the lung, the treatment device
proximal end is anchored to a second location in the lung which is
distant from the first location and the treatment device is
shortened to reduce the distance between the two locations in the
lung to increase tension in areas in the lung that are not between
the two locations.
[0584] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of providing a pulmonary
treatment device, a bronchoscope and a bronchoscope guide sleeve
whereas the lung treatment device is configured with a proximal
end, a distal end and a midsection. The treatment device can be
elongated to store elastic strain energy. The treatment device may
also be attached to the bronchoscope and the bronchoscope guide
sleeve. The bronchoscope guide sleeve is configured with a proximal
end, a distal end and a lumen running therethrough along its
longitudinal axis. The bronchoscope is configured to be advanced
through the bronchoscope guide sleeve and through the treatment
device in a way that allows the lung treatment device length to be
lengthened or shortened by sliding the bronchoscope guide sleeve
along the axis of the coaxial bronchoscope. Further, the treatment
device distal end is anchored to a first location in the lung, the
treatment device proximal end is anchored to a second location in
the lung which is distant from the first location and the treatment
device is shortened to reduce the distance between the two
locations in the lung to increase tension in areas in the lung that
are not between the first or second anchored locations.
[0585] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of providing a pulmonary
treatment device, a bronchoscope and a bronchoscope guide sleeve
whereas the treatment device is configured with a proximal end, a
distal end and a midsection. The treatment device can be elongated
to store elastic strain energy. The treatment device may also be
attached to the bronchoscope and the bronchoscope guide sleeve. The
bronchoscope guide sleeve is configured with a proximal end, a
distal end and a lumen running therethrough along its longitudinal
axis. The bronchoscope is configured to be advanced through the
bronchoscope guide sleeve and through the treatment device in a way
that allows the treatment device length to be lengthened or
shortened by sliding the bronchoscope guide sleeve along the axis
of the coaxial bronchoscope. Further, the treatment device is
elongated to store elastic strain energy, distal end is anchored to
a first location in the lung, the treatment device proximal end is
anchored to a second location in the lung which is distant from the
first location and the treatment device is shortened to reduce the
distance between the two locations in the lung to increase tension
in areas in the lung that are not between the first or second
anchored locations.
[0586] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of providing a pulmonary
treatment device, a bronchoscope and a bronchoscope guide sleeve
whereas the treatment device is configured with a proximal end, a
distal end and a midsection. The treatment device can be elongated
to store elastic strain energy. The treatment device may also be
attached to the bronchoscope and the bronchoscope guide sleeve. The
bronchoscope guide sleeve is configured with a proximal end, a
distal end and a lumen running therethrough along its longitudinal
axis. The bronchoscope is configured to be advanced through the
bronchoscope guide sleeve and through the lung treatment device in
a way that allows the lung treatment device length to be lengthened
or shortened by sliding the bronchoscope guide sleeve along the
axis of the coaxial bronchoscope. Further, the treatment device is
elongated to store elastic strain energy, distal end is anchored to
a first location in the lung, the lung treatment device proximal
end is anchored to a second location in the lung which is distant
from the first location and the stored elastic strain energy is
allowed to shorten the lung treatment device to reduce the distance
between the two locations in the lung to increase tension in areas
in the lung that are not between the first or second anchored
locations.
[0587] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of deploying the tissue
gathering end of a pulmonary treatment device in an airway at a
location more distal from a bifurcation than the length of the
pulmonary treatment device, pulling the undeployed portion of the
device proximally and then deploying the stabilizing end at the
bifurcation.
[0588] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of deploying the tissue
gathering end of a pulmonary treatment device in an airway at a
location more distal from a stabilizing end target location than
the length of the device, pulling the undeployed portion of the
device proximally and then deploying the stabilizing end at the
proximal stabilizing end target location.
[0589] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of deploying the tissue
gathering end of a pulmonary treatment device in an airway at a
location more distal from a bifurcation than the length of the
device, deploying the rest of the device and then tensioning the
stabilizing end of the device to place the stabilizing end at the
airway ostium or bifurcation.
[0590] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of deploying the tissue
gathering end of a pulmonary treatment device in an airway at a
location more distal from a stabilizing end target location than
the length of the device, deploying the rest of the device and then
tensioning the stabilizing end of the device to place the
stabilizing end at the stabilizing end target location.
[0591] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of deploying the tissue
gathering end of a pulmonary treatment device in an airway at a
location more distal from a bifurcation than the length of the
pulmonary treatment device, deploying the rest of the pulmonary
treatment device and then tensioning a portion of the pulmonary
treatment device to allow the stabilizing end to be placed at the
airway ostium or bifurcation.
[0592] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of deploying the tissue
gathering end of a pulmonary treatment device in an airway at a
location more distal from a stabilizing end target location than
the length of the pulmonary treatment device, deploying the rest of
the pulmonary treatment device and then tensioning a portion of the
pulmonary treatment device to allow the stabilizing end to be
placed at the stabilizing end target location.
[0593] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of installing a
shape-memory alloy medical device within a human lung so that the
device is substantially at body temperature wherein the
shape-memory alloy medical device displays reversible
stress-induced or strain induced martensite at body temperature to
straighten a lung airway, the method further comprising: deforming
the medical device into a deformed shape different from a final
shape; restraining the deformed shape of the medical device by the
application of a restraining mechanism; positioning the medical
device and restraining mechanism within the lung; and removing the
restraining mechanism to allow the device to recover from the
deformed shape into the final shape.
[0594] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of installing a
shape-memory alloy medical device within a human lung so that the
device is substantially at body temperature wherein the
shape-memory alloy medical device displays reversible
stress-induced or strain induced martensite at body temperature to
straighten a lung airway, the method further comprising: deforming
the medical device into a deformed shape different from a final
shape; restraining the deformed shape of the medical device by the
application of a restraining mechanism; positioning the medical
device and restraining mechanism within the lung; and removing the
restraining mechanism to allow the device to recover from the
deformed shape into the final shape; whereby the device tensions
lung tissue.
[0595] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of tensioning lung tissue
by: delivering to the lung a resilient medical device with a distal
end, a proximal end and a connected midsection; anchoring at least
a portion of the distal end at a first position in the lung;
displacing at least a portion of the proximal end to a position
that is distant from the anchored at least portion of the distal
end; anchoring at least a portion of the proximal end at a second
position in the lung.
[0596] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of tensioning lung tissue
by: delivering to the lung a resilient medical device with a distal
end, a proximal end and a connected midsection; anchoring at least
a portion of the distal end at a first position in the lung;
displacing at least a portion of the proximal end to a position
that is distant from the anchored at least portion of the distal
end; anchoring at least a portion of the proximal end at a second
position in the lung, whereas displacing the proximal end lengthens
the device.
[0597] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of tensioning lung tissue
by: delivering to the lung a resilient medical device with a distal
end, a proximal end and a connected midsection; anchoring a at
least portion of the distal end at a first position in the lung;
displacing a at least portion of the proximal end to a position
that is distant from the anchored at least portion of the distal
end to tension the device; anchoring at least a portion of the
proximal end at a second position in the lung.
[0598] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of straightening a lung
airway by: delivering to the lung a resilient medical device with a
distal end, a proximal end and a connected midsection; anchoring at
least a portion of the distal end at a first position in the lung;
displacing at least a portion of the proximal end to a position
that is distant from the anchored at least portion of the distal
end in a way that straightens the lung airway; anchoring at least a
portion of the proximal end at a second position in the lung.
[0599] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of tensioning a lung
airway by: delivering to the lung a resilient medical device a with
distal end, a proximal end and a connected midsection; anchoring at
least a portion of the distal end at a first position in a lung
airway; displacing at least a portion of the proximal end to a
position that is distant from the anchored at least portion of the
distal end in a way that tensions the lung airway; anchoring at
least at least a portion of the proximal end at a second position
in another lung airway.
[0600] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of tensioning a lung
airway by: delivering to the lung a resilient medical device with a
distal end, a proximal end and a connected midsection; anchoring at
least a portion of the distal end at a first position in a lung
airway; displacing at least a portion of the proximal end to a
position that is distant from the anchored at least portion of the
distal end in a way that tensions the lung airway; anchoring at
least at least a portion of the proximal end at a second position
in another at least portion of the same lung airway.
[0601] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of tensioning lung tissue
without causing lung volume reduction, the steps include:
delivering to the lung a resilient medical device a with distal
end, a proximal end and a connected midsection; anchoring at least
a portion of the distal end at a first position in a lung;
displacing at least a portion of the proximal end to a position in
the lung that is distant from the anchored at least portion of the
distal end to cause the midsection of the device to be elongated;
anchoring at least a portion of the proximal end at the distant
position in the lung, whereas all adjacent lung tissue has been
tensioned and no lung tissue has been compressed to cause lung
volume reduction.
[0602] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of tensioning lung tissue
without causing lung volume reduction, the steps include:
delivering to the lung a resilient medical device with a distal
end, a proximal end and a connected midsection; anchoring at least
a portion of the proximal end at a first position in the lung;
displacing a portion of the distal end to a position in the lung
that is distant from the anchored at least portion of the proximal
end to cause the midsection of the device to be elongated;
anchoring at least a portion of the distal end at the distant
position in the lung, whereas all adjacent lung tissue has been
tensioned and no lung tissue has been compressed to cause lung
volume reduction.
[0603] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of deploying a resilient
airway straightening medical device comprising an elongate body and
at least one end that can be attached to lung tissue; attaching the
end to at least a portion of a lung and; pulling the device to
cause the attached end to pull on lung tissue to straighten a
portion of a lung airway.
[0604] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of deploying a resilient
airway straightening medical device comprising an elongate body and
at least one end that can be attached to lung tissue; attaching the
end to at least a portion of a lung and; pulling the device to
cause the attached end to pull on lung tissue to straighten a
portion of a lung airway in a way that causes no lung volume
reduction or tissue compression to occur.
[0605] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of deploying a resilient
airway straightening medical device comprising an elongate body and
at least one end configured to be attached to lung tissue;
attaching the end to at least a portion of a lung; and pulling the
device to cause the attached end to pull on lung tissue to
straighten a portion of a lung airway.
[0606] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of deploying a pulmonary
treatment device from a delivery device within a lung airway; the
pulmonary treatment device comprising a tissue gathering end, a
stabilizing end, and a resilient tether extending between the
tissue gathering end and stabilizing end; the device configured
such that the distance between the ends is increased then the ends
are attached to lung tissue before releasing the pulmonary
treatment device from a delivery device.
[0607] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of deploying a pulmonary
treatment device from a delivery device within a lung airway; the
pulmonary treatment device comprising a tissue gathering end, a
stabilizing end, and a resilient tether extending between the
tissue gathering end and stabilizing end, the device configured
such that the distance between the ends is increased and the ends
are attached to a lung airway before releasing the pulmonary
treatment device from a delivery device; thus straightening the
lung airway.
[0608] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of deploying a pulmonary
treatment device from a delivery device within a lung airway; the
pulmonary treatment device comprising a tissue gathering end, a
stabilizing end, and a resilient tether extending between the
tissue gathering end and stabilizing end, the device configured
such that the distance between the ends is increased; the ends are
attached to lung tissue; the pulmonary treatment device is released
from the delivery device to increase tension between the ends.
[0609] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of deploying a pulmonary
treatment device from a delivery device within a lung airway; the
pulmonary treatment device comprising a tissue gathering end, a
stabilizing end, and a resilient tether extending between the
tissue gathering end and stabilizing end, the device configured
such that the distance between the ends is increased; and the ends
are attached to lung tissue before releasing the pulmonary
treatment device from a delivery device; allowing the tissue to
maintain the increased distance.
[0610] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of enhancing a breathing
efficiency of a patient with a lung having an airway, the method
comprising: advancing a treatment device distally through the
airway to a portion of the lung of the patient while the treatment
device is in a delivery configuration, the treatment device having
a proximal end and a distal end; deploying the treatment device in
a portion of the lung by transitioning the treatment device from
the delivery configuration to a deployed configuration, the
deployed configuration of the treatment device comprising at least
two helical sections with a transition section disposed between the
at least two helical sections; wherein the transition section is
configured to straighten lung tissue disposed between the at least
two helical sections when the device is in the second
configuration.
[0611] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of enhancing a breathing
efficiency of a patient with a lung having an airway, the method
comprising: advancing a treatment device distally through the
airway to a portion of the lung of the patient while the treatment
device is in a delivery configuration, the treatment device having
a proximal end and a distal end; deploying the treatment device in
a portion of the lung by transitioning the treatment device from
the delivery configuration to a deployed configuration, the
deployed configuration of the treatment device comprising at least
two helical sections with a transition section disposed between the
at least two helical sections; wherein the distal end is configured
to straighten lung tissue disposed more distal to the at least two
helical sections when the treatment device is transitioned to the
deployed configuration.
[0612] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of enhancing a breathing
efficiency of a patient with a lung having an airway, the method
comprising: advancing a treatment device distally through the
airway to a portion of the lung of the patient while the treatment
device is in a delivery configuration, the treatment device having
a proximal end and a distal end; deploying the treatment device in
a portion of the lung by transitioning the treatment device from
the delivery configuration to a deployed configuration, the
deployed configuration of the treatment device comprising at least
two helical sections with a transition section disposed between the
at least two helical sections; wherein the distal end is configured
to straighten lung tissue disposed more distal to the at least two
helical sections when the treatment device is transitioned to the
deployed configuration.
[0613] In another aspect of the present invention, a lung treatment
method is provided, comprising the steps of enhancing a breathing
efficiency of a patient with a lung having an airway, the method
comprising: advancing a treatment device distally through the
airway to a portion of the lung of the patient while the treatment
device is in a delivery configuration, the treatment device having
a proximal end and a distal end; deploying the treatment device in
a portion of the lung by transitioning the treatment device from
the delivery configuration to a deployed configuration, the
deployed configuration of the treatment device comprising at least
two helical sections with a transition section disposed between the
at least two helical sections; wherein the distal end is configured
to straighten lung tissue disposed more distal to the distal end
when the treatment device is transitioned to the deployed
configuration and the proximal end is repositioned more proximally,
relative to the deployed distal end.
[0614] In another aspect of the present invention, a system is
provided for treating a lung comprising: a delivery device having a
proximal end, a distal end and lumen therethrough, wherein the
distal end is configured to be advanced through a tracheobronchial
tree of the lung to an area of loose damaged alveolar sac tissue; a
pulmonary treatment device advanceable through the lumen of the
delivery device, wherein the pulmonary treatment device includes a
tissue gathering end and a stabilizing end; a deployment element
removably attached to the pulmonary treatment device and insertable
into the lumen of the delivery device, wherein together the
delivery device and deployment element 1) deploy the tissue
gathering end into the area of loose damaged alveolar sac tissue
while maintaining attachment of the pulmonary treatment device to
the deployment element, 2) pull the deployed tissue gathering end
so as to re-tension the area of loose damaged alveolar sac tissue,
and 3) deploy the stabilizing end within a lung passageway so as to
maintain the re-tension of the area of loose damaged alveolar sac
tissue.
[0615] In another aspect of the present invention, a system is
provided for treating a lung comprising: a delivery device having a
proximal end, a distal end and lumen therethrough, wherein the
distal end is configured to be advanced through a tracheobronchial
tree of the lung to an airway in the lung; a deployment sleeve
comprising a distal end and a proximal end and a lumen therethrough
which is sized to be advanced through the delivery device lumen, a
guidewire which may be passed through the lumen of the deployment
sleeve; a pulmonary treatment device having a distal tissue
gathering end, a proximal stabilizing end and a midsection spring
element that is mounted around the outside of the delivery device
in a configuration that allows the system to be advanceable through
the trachea and into lung airways and lung passageways, wherein the
pulmonary treatment device is configured to be advanced so that the
proximal stabilizing end is wedged into lung tissue; the delivery
device is configured to continue to advance the non-stabilizing
portion of the treatment device so that the midsection spring
element is strained to a longer state; the deployment sleeve is
configured to be advanced and held against distal end of the
treatment device to hold it in place in the patient while the
delivery device is removed. The system includes a guidewire which
is configured to hold the treatment device aligned in the same axis
as the delivery device lumen. The delivery device may be a
bronchoscope.
[0616] In another aspect of the present invention, a system is
provided for treating a COPD patient's lung comprising: a delivery
system element with a distal end, a proximal end and a lung
treatment device configured to at least partially encircle the
delivery system element while the system is used to treat a
patient.
[0617] In another aspect of the present invention, a system is
provided for treating a COPD patient's lung comprising: a delivery
system element with a distal end, a proximal end and a length which
is longer than 2 times the largest transverse dimension of the
element, a lung treatment device configured to at least partially
encircle the delivery system element while the system is advanced
into a patient.
[0618] In another aspect of the present invention, a system is
provided for treating a COPD patient's lung comprising: a delivery
system element with a distal end, a proximal end and a length which
is longer than 2 times the largest transverse dimension of the
element, a lung treatment device configured to at least partially
encircle the delivery system element while the system is advanced
into a patient to deliver the treatment device to a treatment
location in the lung.
[0619] In another aspect of the present invention, a system is
provided for treating a COPD patient's lung comprising: a delivery
system element with a distal end, a proximal end and a length which
is longer than 2 times the largest transverse dimension of the
element, a lung treatment device configured to at least partially
encircle the delivery system element while the system is advanced
into a patient to deliver the treatment device to a treatment
location in the lung.
[0620] In another aspect of the present invention, a system is
provided for treating a COPD patient's lung comprising: a delivery
system canula with a distal end, a proximal end and a length which
is longer than 2 times the largest transverse dimension of the
canula, a lung treatment device configured to at least partially
encircle the delivery system canula while the system is advanced
into a patient to deliver the treatment device to a treatment
location in the lung, whereas the lung treatment device is
implanted in the lung to enhance lung elastic recoil.
[0621] In another aspect of the present invention, a system is
provided for treating a lung comprising: a delivery system canula
with a distal end, a proximal end and a length which is longer than
2 times the largest transverse dimension of the canula, a pulmonary
treatment device configured to at least partially encircle the
delivery system canula while the system is advanced into a patient
to deliver the treatment device to a treatment location in the
lung, whereas the treatment device is implanted in the lung to
tension lung tissue.
[0622] In another aspect of the present invention, a system is
provided for treating a lung comprising: a bronchoscope with a
distal end, a proximal end and a length which is longer than 2
times the largest transverse dimension of working length portion of
the bronchoscope, a pulmonary treatment device configured to at
least partially encircle the bronchoscope while the system is
advanced into a patient to deliver the treatment device to a
treatment location in the lung, whereas the treatment device is
implanted in the lung to treat COPD.
[0623] In another aspect of the present invention, a system is
provided for treating a lung comprising: a bronchoscope with a
distal end, a proximal end and a length which is longer than 2
times the largest transverse dimension of working length portion of
the bronchoscope, a pulmonary treatment device configured to at
least partially encircle the bronchoscope while the system is
advanced into a patient to deliver the treatment device to a
treatment location in the lung, whereas the treatment device is
implanted in the lung to treat the symptoms relating to COPD.
[0624] In another aspect of the present invention, a system is
provided for treating a lung comprising: a bronchoscope with a
distal end, a proximal end and a length which is longer than 2
times the largest transverse dimension of working length portion of
the bronchoscope, a pulmonary treatment device configured to at
least partially encircle the bronchoscope while the system is
advanced into a patient to deliver the treatment device to a
treatment location in the lung, whereas the treatment device is
implanted in the lung to by making one or more of the beneficial
changes in the patient that are listed herein above.
[0625] In another aspect of the present invention, a system is
provided for treating a lung comprising: a bronchoscope with a
distal end, a proximal end and a length which is longer than 2
times the largest transverse dimension of working length portion of
the bronchoscope, a pulmonary treatment device configured to at
least partially encircle the bronchoscope while the system is
advanced into a patient to deliver the treatment device to a
treatment location in the lung, whereas the treatment device is
elongated before it is implanted in the lung to make one or more of
the beneficial changes in the patient that are listed herein
above.
[0626] In another aspect of the present invention, a system is
provided for treating a lung comprising: a bronchoscope with a
distal end, a proximal end and a length which is longer than 2
times the largest transverse dimension of working length portion of
the bronchoscope, a pulmonary treatment device configured to at
least partially encircle the bronchoscope while the system is
advanced into a patient to deliver the treatment device to a
treatment location in the lung, whereas the treatment device is
elongated to store elastic strain energy to be released in tissue
to make one or more of the beneficial changes in the patient that
are listed herein above.
[0627] In another aspect of the present invention, a system is
provided for treating a lung comprising: a bronchoscope with a
distal end, a proximal end and a lumen running therethrough, a
pulmonary treatment device configured to at least partially
encircle the bronchoscope while the system is advanced into a
patient to deliver the treatment device to a treatment location in
the lung, whereas the treatment device is elongated to store
elastic strain energy to be released in tissue to make one or more
of the beneficial changes in the patient that are listed herein
above.
[0628] In another aspect of the present invention, a system is
provided for treating a lung comprising: a bronchoscope with a
distal end, a proximal end and a lumen running therethrough, a
pulmonary treatment device configured to at least partially
encircle the bronchoscope while the system is advanced into a
patient to deliver the treatment device to a treatment location in
the lung, whereas the treatment device is elongated to store
elastic strain energy to be used to tension lung tissue.
[0629] In another aspect of the present invention, a system is
provided for treating a lung comprising: a bronchoscope with a
distal end, a proximal end and a lumen running therethrough, a
pulmonary treatment device configured to at least partially
encircle the bronchoscope while the system is advanced into a
patient to deliver the treatment device to a treatment location in
the lung and a bronchoscope guide sleeve with a distal end, a
proximal end and a lumen configured to allow the bronchoscope to be
advanced through the bronchoscope guide sleeve; whereas the
treatment device is elongated by the bronchoscope guide sleeve and
the bronchoscope to store elastic strain energy in the treatment
device to be used to tension lung tissue.
[0630] In another aspect of the present invention, a system is
provided for treating a lung comprising: a pulmonary treatment
device, a bronchoscope and a bronchoscope guide sleeve whereas the
treatment device is configured with a proximal end, a distal end
and a midsection and a lumen running through the treatment device
proximal end and midsection along the central axis between the
distal end and the proximal ends, the bronchoscope guide sleeve is
configured with a proximal end, a distal end and an open lumen
running through the full length of the bronchoscope guide sleeve
along the central axis between the distal end and proximal end; the
bronchoscope is configured to be advanced through the bronchoscope
guide sleeve and through the proximal end and midsection of the
lung treatment device so the treatment device length may be
adjusted by sliding the bronchoscope guide sleeve along the axis of
the coaxial bronchoscope.
[0631] In another aspect of the present invention, a system is
provided for treating a lung comprising: an assembly for
straightening a portion of a lung airway, the assembly comprising:
a straightening element; a first end configured for fixing to a
first portion of the lung, the straightening element attached to
the first end; a second end configured for fixing to a second
portion of the lung, the straightening element being attached to
the second end; a delivery device for delivering the first end to
the first portion of the lung and for delivering the second end to
the second portion of the lung.
[0632] In another aspect of the present invention, a system is
provided for treating a lung comprising: an assembly for
straightening a portion of a lung airway, the assembly comprising:
a straightening element; a first end configured for fixing to a
first portion of the lung, the straightening element attached to
the first end; a second end configured for fixing to a second
portion of the lung, the straightening element being attached to
the second end; a delivery device for delivering the first end to
the first portion of the lung and for delivering the second end to
the second portion of the lung; whereas the delivery device is a
bronchoscope.
[0633] In another aspect of the present invention, a system is
provided for treating a lung comprising: an assembly for
straightening a portion of a lung airway, the assembly comprising:
a straightening element; a first end configured for fixing to a
first portion of the lung, the straightening element attached to
the first end; a second end configured for fixing to a second
portion of the lung, the straightening element being attached to
the second end; a delivery device for delivering the first end to
the first portion of the lung and for delivering the second end to
the second portion of the lung; whereas the delivery device is a
tube.
[0634] In another aspect of the present invention, a system is
provided for treating a lung comprising: an assembly for
straightening a portion of a lung airway, the assembly comprising:
a straightening element; a first end configured for fixing to a
first portion of the lung, the straightening element attached to
the first end; a second end configured for fixing to a second
portion of the lung, the straightening element being attached to
the second end; a delivery device for delivering the first end to
the first portion of the lung and for delivering the second end to
the second portion of the lung; whereas the straightening element
is tensioned after at least one end is deployed.
[0635] In another aspect of the present invention, a system is
provided for treating a lung comprising: an assembly for
straightening a portion of a lung airway, the assembly comprising:
a straightening element; a first end configured for fixing to a
first portion of the lung, the straightening element attached to
the first end; a second end configured for fixing to a second
portion of the lung, the straightening element being attached to
the second end; a delivery device for delivering the first end to
the first portion of the lung and for delivering the second end to
the second portion of the lung; whereas the straightening element
and ends are made more co-axial before being released from the
delivery device than they are while being delivered to the
airway.
[0636] In another aspect of the present invention, a system is
provided for treating a lung comprising: an assembly for
straightening a portion of a lung airway, the assembly comprising:
a straightening element; a first end configured for fixing to a
first portion of the lung, the straightening element attached to
the first end; a second end configured for fixing to a second
portion of the lung, the straightening element being attached to
the second end; a delivery device for delivering the first end to
the first portion of the lung and for delivering the second end to
the second portion of the lung; whereas the first end is a
deformable spring.
[0637] In another aspect of the present invention, a system is
provided for treating a lung comprising: an assembly for
straightening a portion of a lung airway, the assembly comprising:
a straightening element; a first end configured for fixing to a
first portion of the lung, the straightening element attached to
the first end; a second end configured for fixing to a second
portion of the lung, the straightening element being attached to
the second end; a delivery device for delivering the first end to
the first portion of the lung and for delivering the second end to
the second portion of the lung; whereas the second end is a
deformable spring.
[0638] In another aspect of the present invention, a system is
provided for treating a lung comprising: an assembly for
straightening a portion of a lung airway, the assembly comprising:
a straightening element; a first end configured for fixing to a
first portion of the lung, the straightening element attached to
the first end; a second end configured for fixing to a second
portion of the lung, the straightening element being attached to
the second end; a delivery device for delivering the first end to
the first portion of the lung and for delivering the second end to
the second portion of the lung; whereas the straightening element
is a helix.
[0639] In another aspect of the present invention, a system is
provided for straightening more than one lung airway, the assembly
comprising: a first straightening element having a first end for
attaching to a first airway in the lung; a second straightening
element having a second end for attaching to a second airway in the
lung; a connector that connects the first straightening element to
the second straightening element; and a delivery device for
delivering the first end to the first airway in the lung and for
delivering the second end to the second airway in the lung.
[0640] In another aspect of the present invention, a system is
provided for straightening more than one lung airway, the assembly
comprising: a first straightening element having a first end for
attaching to a first airway in the lung; a second straightening
element having a second end for attaching to a second airway in the
lung; a connector that connects the first straightening element to
the second straightening element; and a delivery device for
delivering the first end to the first airway in the lung and for
delivering the second end to the second airway in the lung; whereas
the delivery device is a bronchoscope
[0641] In another aspect of the present invention, a system is
provided for straightening more than one lung airway, the assembly
comprising: a first straightening element having a first end for
attaching to a first airway in the lung; a second straightening
element having a second end for attaching to a second airway in the
lung; a connector that connects the first straightening element to
the second straightening element; and a delivery device for
delivering the first end to the first airway in the lung and for
delivering the second end to the second airway in the lung; whereas
the delivery device is a tube.
[0642] In another aspect of the present invention, a system is
provided for straightening more than one lung airway, the assembly
comprising: a first straightening element having a first end for
attaching to a first airway in the lung; a second straightening
element having a second end for attaching to a second airway in the
lung; a connector that connects the first straightening element to
the second straightening element; and a delivery device for
delivering the first end to the first airway in the lung and for
delivering the second end to the second airway in the lung; whereas
the first straightening element is tensioned after at least one end
is deployed.
[0643] In another aspect of the present invention, a system is
provided for straightening more than one lung airway, the assembly
comprising: a first straightening element having a first end for
attaching to a first airway in the lung; a second straightening
element having a second end for attaching to a second airway in the
lung; a connector that connects the first straightening element to
the second straightening element; and a delivery device for
delivering the first end to the first airway in the lung and for
delivering the second end to the second airway in the lung; whereas
the first straightening element and first end is made more co-axial
before being released from the delivery system than they are while
being delivered to the airway.
[0644] In another aspect of the present invention, a system is
provided for straightening more than one lung airway, the assembly
comprising: a first straightening element having a first end for
attaching to a first airway in the lung; a second straightening
element having a second end for attaching to a second airway in the
lung; a connector that connects the first straightening element to
the second straightening element; and a delivery device for
delivering the first end to the first airway in the lung and for
delivering the second end to the second airway in the lung; whereas
the second straightening element and second end is made more
co-axial before being released from the delivery device than they
are while being delivered to the airway.
[0645] In another aspect of the present invention, a system is
provided for straightening more than one lung airway, the assembly
comprising: a first straightening element having a first end for
attaching to a first airway in the lung; a second straightening
element having a second end for attaching to a second airway in the
lung; a connector that connects the first straightening element to
the second straightening element; and a delivery device for
delivering the first end to the first airway in the lung and for
delivering the second end to the second airway in the lung; whereas
the first tissue gathering end is a deformable spring.
[0646] In another aspect of the present invention, a system is
provided for straightening more than one lung airway, the assembly
comprising: a first straightening element having a first end for
attaching to a first airway in the lung; a second straightening
element having a second end for attaching to a second airway in the
lung; a connector that connects the first straightening element to
the second straightening element; and a delivery device for
delivering the first end to the first airway in the lung and for
delivering the second end to the second airway in the lung; whereas
the first straightening element is a helix.
[0647] In another aspect of the present invention, a system is
provided for straightening more than one lung airway, the assembly
comprising: a first straightening element having a first end for
attaching to a first airway in the lung; a second straightening
element having a second end for attaching to a second airway in the
lung; a connector that connects the first straightening element to
the second straightening element; and a delivery device for
delivering the first end to the first airway in the lung and for
delivering the second end to the second airway in the lung; whereas
the second straightening element is a helix.
[0648] In another aspect of the present invention, a system is
provided for straightening more than one lung airway, the assembly
comprising: a first straightening element having a first end for
attaching to a first airway in the lung; a second straightening
element having a second end for attaching to a second airway in the
lung; a connector that connects the first straightening element to
the second straightening element; and a delivery device for
delivering the first end to the first airway in the lung and for
delivering the second end to the second airway in the lung; whereas
the connector that connects the first straightening element to the
second straightening element is a v shaped spring.
[0649] In another aspect of the present invention, a system is
provided for straightening more than one lung airway, the assembly
comprising: a first straightening element having a first end for
attaching to a first airway in the lung; a second straightening
element having a second end for attaching to a second airway in the
lung; a connector that connects the first straightening element to
the second straightening element; and a delivery device for
delivering the first end to the first airway in the lung and for
delivering the second end to the second airway in the lung; whereas
the connector that connects the first straightening element to the
second straightening element is a v shaped spring.
[0650] In another aspect of the present invention, a system is
provided for straightening more than one lung airway, the assembly
comprising: a first straightening element having a first end for
attaching to a first airway in the lung; a second straightening
element having a second end for attaching to a second airway in the
lung; a connector that connects the first straightening element to
the second straightening element; and a delivery device for
delivering the first end to the first airway in the lung and for
delivering the second end to the second airway in the lung;
additionally, more components may be included to be used to
straighten a 3rd or 4th, 5th or 6th airway with a single
device.
[0651] In another aspect of the present invention, a lung airway
straightening system is provided for enhancing breathing efficiency
of a patient with an airway, the system comprising: an implantable
device configured to impart a straightening force on a lung airway,
the implantable device including a proximal end, and a distal end
with a transition section connecting the two ends that includes at
least one helical loop structure; furthermore, the device has a
first delivery configuration and a second deployed configuration,
the first configuration of the implantable device corresponds to a
deliverable length constrained condition, the second configuration
is configured so the distance between the start and end of at least
one of the helical loop structurer can be increased to straighten
the airway.
[0652] In another aspect of the present invention, a lung airway
straightening system is provided for enhancing breathing efficiency
of a patient with an airway, the system comprising: an implantable
device configured to impart tension on lung tissue, the implantable
device including a proximal stabilizing end, and a distal tissue
gathering end with a transition section connecting the two ends
that includes at least one helical loop structure with a start and
an end to the helical loop; furthermore, the device has a first
delivery configuration and a second deployed configuration, the
first configuration of the implantable device corresponds to a
deliverable condition and a finite distance between the start and
end of at least one of the helical loop structures, the second
configuration is configured so the distance between the start and
end of the same helical loop structures may be elastically strained
longer to apply tension to lung tissue.
[0653] In another aspect of the present invention, a lung airway
straightening system is provided for enhancing breathing efficiency
of a patient with an airway, the system comprising: an implantable
device configured to impart tension on lung tissue, the implantable
device including a proximal stabilizing end, and a distal tissue
gathering end with a transition section connecting the two ends
that includes at least one helical loop structure with a start and
an end to the helical loop; furthermore, the device has a first
delivery configuration and a second deployed configuration, the
first configuration of the implantable device corresponds to a
deliverable condition and a finite distance between the start and
end of at least one of the helical loop structures, the second
configuration is configured so the distance between the start and
end of the same helical loop structures may be elastically strained
longer to apply tension to lung tissue; wherein at least one of the
ends comprise a circular helical section when the implantable
device is in the second configuration.
[0654] In another aspect of the present invention, a lung airway
straightening system is provided for enhancing breathing efficiency
of a patient with an airway, the system comprising: an implantable
device configured to impart tension on lung tissue, the implantable
device including a proximal stabilizing end, and a distal tissue
gathering end with a transition section connecting the two ends
that includes at least one helical loop structure with a start and
an end to the helical loop; furthermore, the device has a first
delivery configuration and a second deployed configuration, the
first configuration of the implantable device corresponds to a
deliverable condition and a finite distance between the start and
end of at least one of the helical loop structures, the second
configuration is configured so the distance between the start and
end of the same helical loop structures may be elastically strained
longer to apply tension to lung tissue; wherein both of the ends
comprise a circular helical section when the implantable device is
in the second configuration.
[0655] In another aspect of the present invention, a lung airway
straightening system is provided for enhancing breathing efficiency
of a patient with an airway, the system comprising: an implantable
device configured to impart tension on lung tissue, the implantable
device including a proximal stabilizing end, and a distal tissue
gathering end with a transition section connecting the two ends
that includes at least one helical loop structure with a start and
an end to the helical loop; furthermore, the device has a first
delivery configuration and a second deployed configuration, the
first configuration of the implantable device corresponds to a
deliverable condition and a finite distance between the start and
end of at least one of the helical loop structures, the second
configuration is configured so the distance between the start and
end of the same helical loop structures may be elastically strained
longer to apply tension to lung tissue; wherein the implantable
device further comprises a jacket (jacket can be metallic, plastic,
coating, coil or extrusion made from a variety of materials, such
as metals (e.g. stainless steel, titanium, nitinol, nickel, cobalt
chrome, or a combination of these) or polymers (e.g. polycarbonate
urethane, polytetrafluoroethylene (PTFE), ethylene
tetrafluoroethylene (ETFE). fluorinated ethylene propylene (FEP),
polyimide film (e.g. Kapton.RTM.), polyimide, polyether ether
ketone (PEEK), polyethylene, ethylene-vinyl acetate (EVA) (also
known as poly (ethylene-vinyl acetate) (PEVA)), polypropylene,
polyvinyl alcohol (PVA), polyurethane, nylon, polyether block
amides (PEBA), acrylonitrile butadiene styrene (ABS), polybutyrate,
butyrate, polyethylene terephthalate (PET), polysulfone (PES),
ethylene tetrafluoroethylene (ETFE), polyvinylidene fluoride
(PVDF), thermoplastic polyurethane elastomers (e.g.
Pellethane.RTM.), aliphatic polyether-based thermoplastic
polyurethanes (TPUs) (e.g. Tecoflex.RTM.), metallocenes or a
combination of these) which covers a portion of the implantable
device, the jacket configured to reduce erosion into the airway by
a deployed implantable device (by maximizing the bearing area in
contact with the tissue to be greater than 9.81E-7 inches squared
of bearing area per linear inch of the implantable device).
[0656] In another aspect of the present invention, a lung airway
straightening system is provided for enhancing breathing efficiency
of a patient with an airway, the system comprising: an implantable
device configured to impart tension on lung tissue, the implantable
device including a proximal stabilizing end, and a distal tissue
gathering end with a transition section connecting the two ends
that includes at least one helical loop structure with a start and
an end to the helical loop; furthermore, the device has a first
delivery configuration and a second deployed configuration, the
first configuration of the implantable device corresponds to a
deliverable condition and a finite distance between the start and
end of at least one of the helical loop structures, the second
configuration is configured so the distance between the start and
end of the same helical loop structures may be elastically strained
longer to apply tension to lung tissue; wherein a jacket covers the
at least one helical sections.
[0657] In another aspect of the present invention, a lung airway
straightening system is provided for enhancing breathing efficiency
of a patient with an airway, the system comprising: an implantable
device configured to impart tension on lung tissue, the implantable
device including a proximal stabilizing end, and a distal tissue
gathering end with a transition section connecting the two ends
that includes at least one helical loop structure with a start and
an end to the helical loop; furthermore, the device has a first
delivery configuration and a second deployed configuration, the
first configuration of the implantable device corresponds to a
deliverable condition and a finite distance between the start and
end of at least one of the helical loop structures, the second
configuration is configured so the distance between the start and
end of the same helical loop structures may be elastically strained
longer to apply tension to lung tissue; wherein a jacket covers the
distal end of the implantable device.
[0658] In another aspect of the present invention, a lung airway
straightening system is provided for enhancing breathing efficiency
of a patient with an airway, the system comprising: an implantable
device configured to impart tension on lung tissue, the implantable
device including a proximal stabilizing end, and a distal tissue
gathering end with a transition section connecting the two ends
that includes at least one helical loop structure with a start and
an end to the helical loop; furthermore, the device has a first
delivery configuration and a second deployed configuration, the
first configuration of the implantable device corresponds to a
deliverable condition and a finite distance between the start and
end of at least one of the helical loop structures, the second
configuration is configured so the distance between the start and
end of the same helical loop structures may be elastically strained
longer to apply tension to lung tissue; wherein the distal end of
the implantable device is configured to couple with the airway.
[0659] In another aspect of the present invention, a lung airway
straightening system is provided for enhancing breathing efficiency
of a patient with an airway, the system comprising: an implantable
device configured to impart tension on lung tissue, the implantable
device including a proximal stabilizing end, and a distal tissue
gathering end with a transition section connecting the two ends
that includes at least one helical loop structure with a start and
an end to the helical loop; furthermore, the device has a first
delivery configuration and a second deployed configuration, the
first configuration of the implantable device corresponds to a
deliverable condition and a finite distance between the start and
end of at least one of the helical loop structures, the second
configuration is configured so the distance between the start and
end of the same helical loop structures may be elastically strained
longer to apply tension to lung tissue; wherein the proximal end of
the implantable device is atraumatic.
[0660] A method for treating a lung of a patient, the lung
including a lung passageway system having a first lung passageway
elongate axial region with an associated first local lung
passageway central axis and a second lung passageway elongate axial
region with an associated second local lung passageway central
axis, the method comprising: introducing an elongate body of an
implant system axially into the lung passageway system so that a
proximal portion of the elongate body is disposed within the first
axial lung passageway region and so that a distal implant portion
of the elongate body is disposed within the second axial lung
passageway region; tensioning a lung tissue volume disposed at
least in part distal to at least one of the lung passageway axial
regions by bending the elongate body between the proximal and
distal portions so as to urge the first local lung passageway axis
of the first lung passageway axial region laterally toward the
second lung passageway axial region while the proximal and distal
portions of the elongate body extend axially within the first and
second lung passageway axial regions, respectively.
[0661] A method for treating a lung of a patient, the lung
including a lung passageway system having a first lung passageway
elongate axial region with an associated first local lung
passageway central axis, and a second lung passageway elongate
axial region with an associated second local lung passageway
central axis, the method comprising: introducing an elongate body
of an implant system axially into the lung passageway system so
that a proximal portion of the elongate body is disposed within the
first axial lung passageway region and so that a distal implant
portion of the elongate body is disposed within the second axial
lung passageway region; tensioning a lung tissue volume disposed at
least in part distal to at least one of the lung passageway axial
regions by releasing strain energy that has been previously stored
in the elongate body to compress the elongate body between the
proximal and distal portions so as to urge the first local lung
passageway axis of the first lung passageway axial region laterally
toward the second lung passageway axial region while the proximal
and distal portions of the elongate body extend within the first
and second lung passageway axial regions, respectively.
[0662] A method for treating a lung of a patient, the lung
including a lung passageway system having a first lung passageway
elongate axial region with an associated first local lung
passageway central axis, and a second lung passageway elongate
axial region with an associated second local lung passageway
central axis, the method comprising: introducing an elongate body
of an implant system axially into the lung passageway system so
that a proximal portion of the elongate body is disposed within the
first axial lung passageway region and so that a distal implant
portion of the elongate body is disposed within the second axial
lung passageway region; tensioning a lung tissue volume by
releasing strain energy that has been previously stored in the
elongate body so as to urge the first local lung passageway axis of
the first lung passageway axial region laterally toward the second
lung passageway axial region while the proximal and distal portions
of the elongate body extend axially within the first and second
lung passageway axial regions, respectively.
[0663] A method for treating a lung of a patient, the lung
including an lung passageway system having a first lung passageway
elongate axial region with an associated first local lung
passageway central axis, and a second lung passageway elongate
axial region with an associated second local lung passageway
central axis, the method comprising: introducing an elongate body
of an implant system axially into the lung passageway system so
that a proximal portion of the elongate body is disposed within the
first axial lung passageway region and so that a distal implant
portion of the elongate body is disposed within the second axial
lung passageway region; tensioning a lung tissue volume by rotating
the elongate body.
[0664] In another aspect of the present invention, a lung airway
straightening system is provided for enhancing breathing efficiency
of a patient with an airway, the system comprising: an implantable
device configured to impart tension on lung tissue, the implantable
device including a proximal stabilizing end, and a distal tissue
gathering end with a transition section connecting the two ends
that includes at least one helical loop structure with a start and
an end to the helical loop; furthermore, the device has a first
delivery configuration and a second deployed configuration, the
first configuration of the implantable device corresponds to a
deliverable condition and a finite distance between the start and
end of at least one of the helical loop structures, the second
configuration is configured so the distance between the start and
end of the same helical loop structures may be elastically strained
longer to apply tension to lung tissue; wherein the proximal end of
the implantable device comprising one or more features selected
from the following: a ball, loop, break away link, threaded hole or
shaft, friction fit taper or hole, that is reversibly coupled to a
delivery system.
[0665] In another aspect of the present invention, a lung airway
straightening system is provided for enhancing breathing efficiency
of a patient with an airway, the system comprising: an implantable
device configured to impart tension on lung tissue, the implantable
device including a proximal stabilizing end, and a distal tissue
gathering end with a transition section connecting the two ends
that includes at least one helical loop structure with a start and
an end to the helical loop; furthermore, the device has a first
delivery configuration and a second deployed configuration, the
first configuration of the implantable device corresponds to a
deliverable condition and a finite distance between the start and
end of at least one of the helical loop structures, the second
configuration is configured so the distance between the start and
end of the same helical loop structures may be elastically strained
longer to apply tension to lung tissue; wherein the implantable
device is made of a metal alloy that contains nickel and
titanium.
[0666] In another aspect of the present invention, a lung airway
straightening system is provided for enhancing breathing efficiency
of a patient with an airway, the system comprising: an implantable
device configured to impart tension on lung tissue, the implantable
device including a proximal stabilizing end, and a distal tissue
gathering end with a transition section connecting the two ends
that includes at least one helical loop structure with a start and
an end to the helical loop; furthermore, the device has a first
delivery configuration and a second deployed configuration, the
first configuration of the implantable device corresponds to a
deliverable condition and a finite distance between the start and
end of at least one of the helical loop structures, the second
configuration is configured so the distance between the start and
end of the same helical loop structures may be elastically strained
longer to apply tension to lung tissue; wherein the implantable
device is made from a stainless-steel alloy.
[0667] In another aspect of the present invention, a lung airway
straightening system is provided for enhancing breathing efficiency
of a patient with an airway, the system comprising: an implantable
device configured to impart tension on lung tissue, the implantable
device including a proximal stabilizing end, and a distal tissue
gathering end with a transition section connecting the two ends
that includes at least one helical loop structure with a start and
an end to the helical loop; furthermore, the device has a first
delivery configuration and a second deployed configuration, the
first configuration of the implantable device corresponds to a
deliverable condition and a finite distance between the start and
end of at least one of the helical loop structures, the second
configuration is configured so the distance between the start and
end of the same helical loop structures may be elastically strained
longer to apply tension to lung tissue; wherein the implantable
device is made from a steel alloy containing chromium.
[0668] In another aspect of the present invention, a lung airway
straightening system is provided for enhancing breathing efficiency
of a patient with an airway, the system comprising: an implantable
device configured to impart tension on lung tissue, the implantable
device including a proximal stabilizing end, and a distal tissue
gathering end with a transition section connecting the two ends
that includes at least one helical loop structure with a start and
an end to the helical loop; furthermore, the device has a first
delivery configuration and a second deployed configuration, the
first configuration of the implantable device corresponds to a
deliverable condition and a finite distance between the start and
end of at least one of the helical loop structures, the second
configuration is configured so the distance between the start and
end of the same helical loop structures may be elastically strained
longer to apply tension to lung tissue; wherein the implantable
device is made from an alloy containing cobalt.
[0669] In another aspect of the present invention, a lung airway
straightening system is provided for enhancing breathing efficiency
of a patient with an airway, the system comprising: an implantable
device configured to impart tension on lung tissue, the implantable
device including a proximal stabilizing end, and a distal tissue
gathering end with a transition section connecting the two ends
that includes at least one helical loop structure with a start and
an end to the helical loop; furthermore, the device has a first
delivery configuration and a second deployed configuration, the
first configuration of the implantable device corresponds to a
deliverable condition and a finite distance between the start and
end of at least one of the helical loop structures, the second
configuration is configured so the distance between the start and
end of the same helical loop structures may be elastically strained
longer to apply tension to lung tissue; wherein the stabilizing end
comprises more helical loops than the tissue gathering end when the
implantable device is in the second configuration.
[0670] In another aspect of the present invention, a lung airway
straightening system is provided for enhancing breathing efficiency
of a patient with an airway, the system comprising: an implantable
device configured to impart tension on lung tissue, the implantable
device including a proximal stabilizing end, and a distal tissue
gathering end with a transition section connecting the two ends
that includes at least one helical loop structure with a start and
an end to the helical loop; furthermore, the device has a first
delivery configuration and a second deployed configuration, the
first configuration of the implantable device corresponds to a
deliverable condition and a finite distance between the start and
end of at least one of the helical loop structures, the second
configuration is configured so the distance between the start and
end of the same helical loop structures may be elastically strained
longer to apply tension to lung tissue; wherein the tissue
gathering end comprises less than one loop when the implantable
device is in the second configuration.
[0671] In another aspect of the present invention, a lung airway
straightening system is provided for enhancing breathing efficiency
of a patient with an airway, the system comprising: an implantable
device configured to impart tension on lung tissue, the implantable
device including a proximal stabilizing end, and a distal tissue
gathering end with a transition section connecting the two ends
that includes at least one helical loop structure with a start and
an end to the helical loop; furthermore, the device has a first
delivery configuration and a second deployed configuration, the
first configuration of the implantable device corresponds to a
deliverable condition and a finite distance between the start and
end of at least one of the helical loop structures, the second
configuration is configured so the distance between the start and
end of the same helical loop structures may be elastically strained
longer to apply tension to lung tissue; wherein the helical section
transitions into the proximal end via a bend that is disposed
between the proximal portion of the helical section and the
proximal end such that the helical section is straightened when
proximal end is repositioned more proximally relative to the
proximal portion of the helical section when the device is in the
second configuration.
[0672] In another aspect of the present invention, a lung airway
straightening system is provided for enhancing breathing efficiency
of a patient with an airway, the system comprising: an implantable
device configured to impart tension on lung tissue, the implantable
device including a proximal stabilizing end, and a distal tissue
gathering end with a transition section connecting the two ends
that includes at least one helical loop structure with a start and
an end to the helical loop; furthermore, the device has a first
delivery configuration and a second deployed configuration, the
first configuration of the implantable device corresponds to a
deliverable condition and a finite distance between the start and
end of at least one of the helical loop structures, the second
configuration is configured so the distance between the start and
end of the same helical loop structures may be elastically strained
longer to apply tension to lung tissue; wherein the implant
comprises a spring element and wherein the implant is constrained
to the delivery configuration during delivery and wherein the
implant is configured to naturally recover from the constrained
delivery configuration to the deployed configuration during
deployment.
[0673] In another aspect of the present invention, a lung
tensioning device is provided that tensions lung tissue with the
application of a rotating motion to turn the implant after a
portion of the implant has engaged tissue.
[0674] In another aspect of the present invention, a lung
tensioning device is provided that tensions lung tissue with the
application of a combination of rotating motion and longitudinal
translation motion to turn the implant and to apply longitudinal
translation of the implant after a portion of the implant has
engaged tissue.
[0675] These and other embodiments are described in further detail
in the following description related to the appended drawing
figures.
INCORPORATION BY REFERENCE
[0676] All publications, patents, and patent applications mentioned
in this specification are herein incorporated by reference to the
same extent as if each individual publication, patent, or patent
application was specifically and individually indicated to be
incorporated by reference.
BRIEF DESCRIPTION OF THE DRAWINGS
[0677] The novel features of the invention are set forth with
particularity in the appended claims. A better understanding of the
features and advantages of the present invention will be obtained
by reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention
are utilized, and the accompanying drawings of which:
[0678] FIG. 1 illustrates a healthy lung of a patient.
[0679] FIGS. 2-3 illustrates damaged lung tissue.
[0680] FIG. 4 illustrates a cross-sectional slice under computed
tomography (CT) of the lungs of a patient suffering from COPD.
[0681] FIG. 5 illustrates a lung of a patient suffering from
advanced COPD.
[0682] FIG. 6 illustrates an embodiment of a pulmonary treatment
device comprising an elongate shaft coiled into a helical shape to
form a tissue gathering end, a stabilizing end and an extendable
midsection therebetween.
[0683] FIG. 7 illustrates an embodiment of the pulmonary treatment
device expanding along its longitudinal axis.
[0684] FIG. 8 illustrates a pulmonary treatment device delivered by
a delivery device configured to be advanced to an area of loose
damaged alveolar sac tissue.
[0685] FIG. 9 illustrates retraction of the deployment element
which straightens and extends the surrounding airway.
[0686] FIG. 10 illustrates the pulmonary treatment device left in
place to maintain re-tensioning of the lung.
[0687] FIG. 11 illustrates the positioning of three pulmonary
treatment devices within the lung of a patient.
[0688] FIG. 12 illustrates a plurality of pulmonary treatment
devices positioned in both lungs of a patient.
[0689] FIG. 13 illustrates an embodiment of a tissue gathering end
of a pulmonary treatment device.
[0690] FIG. 14 illustrates a top view of the embodiment of FIG.
13.
[0691] FIG. 15 illustrates another embodiment of a tissue gathering
end of a pulmonary treatment device.
[0692] FIG. 16 illustrates a top view of the embodiment of FIG.
15.
[0693] FIG. 17 illustrates an embodiment of a tissue gathering end
of a pulmonary treatment device having multiple loops.
[0694] FIG. 18 illustrates a top view of the embodiment of FIG.
17.
[0695] FIG. 19 illustrates another embodiment of a tissue gathering
end of a pulmonary treatment device.
[0696] FIG. 20 illustrates a top view of the embodiment of FIG.
19.
[0697] FIG. 21 illustrates an embodiment of a tissue gathering end
wherein the shaft extends along the longitudinal axis through the
extendible midsection and then gradually bends radially outwardly
distal to the extendible midsection.
[0698] FIG. 22 illustrates a top view of the embodiment of FIG.
21.
[0699] FIG. 23 illustrates an embodiment of a tissue gathering end
wherein at least one of the loops of the tissue gathering end cross
at least a portion of another loop.
[0700] FIG. 24 illustrates a top view of the embodiment of FIG.
23.
[0701] FIG. 25 illustrates an embodiment of a pulmonary treatment
device having an extendible midsection connecting the tissue
gathering end with the stabilizing end.
[0702] FIG. 26 illustrates an embodiment of a pulmonary treatment
device having an attachment feature located distally of the
stabilizing end.
[0703] FIGS. 27A-27D illustrate example tips suitable for either
the distal tip or proximal tip.
[0704] FIGS. 28A-28D illustrate example methods of forming the tips
of FIGS. 27A-27D.
[0705] FIGS. 29A-29D illustrate example tips having an attachment
feature.
[0706] FIG. 30 illustrates an embodiment of a device configured
from a shaft comprising a hollow tube.
[0707] FIGS. 31A-31B illustrate an embodiment of a bronchoscope
used as a delivery device for delivering the pulmonary treatment
device.
[0708] FIG. 32 illustrates an embodiment of an introducer having a
pre-loaded pulmonary treatment device.
[0709] FIG. 33 illustrates another embodiment of an introducer
having a pre-loaded pulmonary treatment device.
[0710] FIG. 34 illustrates a pre-loaded introducer advanceable into
the working channel port of a bronchoscope.
[0711] FIG. 35 illustrates the insertion cord tip of the
bronchoscope positioned in the damaged tissue of the patient's
lung.
[0712] FIGS. 36-37 illustrate an embodiment wherein two devices are
joined with the use of a joining device.
[0713] FIG. 38 illustrates an embodiment of a delivery system for
delivering a pulmonary treatment device of the present
invention.
[0714] FIG. 39 illustrates an embodiment of a pulmonary treatment
device that is deliverable by the system of FIG. 38 and has a
flared stabilizing end.
[0715] FIG. 40 illustrates the treatment device of FIG. 39 mounted
on the delivery system of FIG. 38.
[0716] FIG. 41 illustrates deployment of the treatment device
within the target airway by advancing the delivery system so as to
push the tissue gathering end further along the target airway while
the extendible midsection expands, elongating the treatment
device.
[0717] FIG. 42 illustrates the beginning stages of decoupling the
device from the delivery system wherein the tissue gathering end is
unmounted from the bronchoscope.
[0718] FIG. 43 illustrates further steps of decoupling the device
from the delivery system, wherein the deployment sleeve and
guidewire have been removed from the bronchoscope allowing the
tissue gathering end to fully engage with the wall of the
airway.
[0719] FIG. 44 illustrates retraction and removal of the delivery
device from the lung anatomy, leaving the treatment device
behind.
[0720] FIG. 45 illustrates the treatment device after the stored
elastic strain energy that has been stored in at least the
midsection of the treatment device has urged the device to shorten
and recover elastically more closely to its original pre-elongated
length.
[0721] FIG. 46 illustrates another embodiment of a delivery system
for delivery of a treatment device, the delivery system comprises a
bronchoscope having a bronchoscope body and an insertion cord, a
guidewire, a deployment sleeve and a guide sleeve.
[0722] FIG. 47 illustrates an embodiment of a treatment device
releasably mounted on the delivery system of FIG. 46.
[0723] FIG. 48 illustrates elongation of the extendible midsection
due to retraction of the stabilizing end by the guide sleeve and
catch feature.
[0724] FIG. 49 illustrates another embodiment of a treatment
device, wherein the treatment device has a tissue gathering end and
extendible midsection which is similar to the device of FIG. 39,
however in this embodiment the stabilizing end differs.
[0725] FIG. 50 illustrates the treatment device of FIG. 49 loaded
onto a delivery system.
[0726] FIG. 51 illustrates deployment of the tissue gathering end
of the treatment device of FIG. 49 within an airway.
[0727] FIG. 52 illustrates extension of the midsection of the
treatment device of FIG. 49 by retracting the guide sleeve which
has a tether extending therethrough removably attached to the
extension loop of the device.
[0728] FIG. 53 illustrates anchoring of the stabilizing end of the
treatment device of FIG. 49 by retracting the bronchoscope from the
device.
[0729] FIG. 54 illustrates the treatment device of FIG. 49 after
the tether has been cut and removed, thereby allowing the
midsection to recoil toward its natural configuration over
time.
[0730] FIG. 55 illustrates the elastic recoil of the treatment
device of FIG. 54 supporting the airway tree A, B, C, D, E and F in
tension.
[0731] FIG. 56 illustrates an alternative method of treating a
patient wherein the pulmonary treatment device is deployed in the
lung anatomy and then expanded thereafter.
[0732] FIG. 57 illustrates an embodiment of a treatment device that
is collapsible into a small profile for optional delivery through a
lumen in a delivery device.
[0733] FIG. 58 illustrates the treatment device of FIG. 57 in a
collapsed configuration mounted on a guidewire.
[0734] FIG. 59A illustrates the treatment device in a non-stressed
configuration
[0735] FIG. 59B illustrates the treatment device and delivery
system in a lung with the treatment device partially deployed in
the lung
[0736] FIG. 60 illustrates a treatment device and delivery system
whereas the treatment device is partially deployed in the lung and
the tissue gathering end of the treatment device is being rotated
to apply torque to lung tissue to tension the lung tissue
[0737] FIG. 61 illustrates the treatment device deployed in the
lung after the tissue gathering end has been rotated to apply toque
to tension lung tissue and the anchoring end has been deployed in
another airway branch to maintain the torsion and lung tissue
tension
[0738] FIGS. 62A-62D illustrate the treatment device and delivery
system with sequential deployment steps including rotation motions
applied to the tissue gathering end and deployment of the anchoring
end to maintain the tissue gathering, rotation and tensioning.
[0739] FIG. 63A-63C illustrates embodiments of treatment devices
with a variety of tissue gathering and anchoring element
shapes.
[0740] FIG. 64 illustrates an embodiment of a treatment device with
a tissue gathering element that crosses over the longitudinal axis
of the device.
[0741] FIG. 65 illustrates an embodiment of a treatment device made
from two ribbon strips that have been bonded together.
[0742] FIG. 66 illustrates an embodiment of a treatment device that
has been crimped together.
[0743] FIG. 67 illustrates an embodiment of a treatment device with
a curvilinear tissue gathering element.
[0744] FIG. 68 illustrates an embodiment of a treatment device with
matching tissue gathering and anchoring elements.
[0745] FIG. 69 illustrates an embodiment of a treatment device with
strain relief sections that store energy during deployment.
[0746] FIGS. 70A-70B illustrates an embodiment of a treatment
device comprised of a tube having slots or cuts along at least a
portion of its length to increase bearing area against tissue.
[0747] FIG. 71A-71C illustrates alternative designs to increase
device bearing area on tissue.
[0748] FIG. 72 illustrates an embodiment of a treatment device with
a expandable anchoring element design.
[0749] FIG. 73 illustrates an embodiment of a treatment device with
hooks as anchoring elements.
[0750] FIG. 74 illustrates an embodiment of a treatment device with
a stent as an anchoring element.
[0751] FIG. 75 illustrates an embodiment of a treatment device
section made from two joined wires.
[0752] FIG. 76A-76B illustrates embodiments of treatment device
attachment end configurations.
[0753] FIG. 77 illustrates an embodiment of a treatment device
socketing attachment end.
[0754] FIG. 78 illustrates an embodiment of a treatment device
threaded attachment end.
[0755] FIG. 79 illustrates an embodiment of a treatment device with
an interlocking attachment end.
[0756] FIG. 80 illustrates an embodiment of a treatment device
attachment end that is controlled by forceps.
[0757] FIG. 81 illustrates an embodiment of a treatment device with
a stent anchoring element.
[0758] FIGS. 82A-82B illustrates an embodiment of a treatment
device made from a single wire shaft.
[0759] FIGS. 82C-82D illustrate additional embodiments of a
pulmonary treatment device having a tissue gathering element and an
anchoring element.
[0760] FIGS. 82E-82G illustrate steps in an example method of
deploying a torque-based pulmonary treatment device such as
illustrated in FIGS. 82A-82D.
[0761] FIGS. 83A-83I illustrates an embodiment of a treatment
device being deployed in lung tissue.
[0762] FIG. 84A-84E illustrates an embodiment of a dual tissue
gathering element treatment device and components.
[0763] FIG. 85 illustrates an embodiment of a treatment device and
delivery system inserted into an airway.
[0764] FIG. 86 illustrates an embodiment of a treatment device
tissue gathering elements deployed through the airway wall.
[0765] FIG. 87 illustrates an embodiment of a treatment device
being rotated to rotate and tension tissue.
[0766] FIG. 88 illustrates an embodiment of a treatment device
middle section being deployed from the catheter.
[0767] FIG. 89 illustrates an embodiment of a treatment device
anchoring end being deployed to the airway ostium.
[0768] FIG. 90 illustrates an embodiment of a treatment device
being decoupled from the delivery system control devices.
[0769] FIGS. 91A-91D illustrate design details of an embodiment of
a torqueing tool and connection.
[0770] FIG. 92 illustrates steps of an embodiment of a method that
includes basic treatment steps that utilize torque to affect
tissue.
[0771] FIG. 93 illustrates an example of two treatment devices
deployed into adjacent airways.
[0772] FIG. 94 illustrates steps of an embodiment of a method to
deploy two treatment devices in branching airways.
[0773] FIG. 95 illustrates steps of an embodiment of a method to
deploy a treatment device while seeking anatomical feedback.
[0774] FIG. 96 illustrates steps of an embodiment of a method to
deploy a treatment device while seeking physiologic feedback.
[0775] FIGS. 97A-97C illustrates an embodiment of a torsion-based
treatment device that is surgically installed.
[0776] FIG. 98 illustrates the treatment device of FIG. 97A
surgically installed.
[0777] FIGS. 99A-99D illustrate embodiments of distal tips having
twisted ends.
[0778] FIG. 100 illustrates an embodiment of a torque-based
pulmonary treatment device prepared for pre-loading in an
introducer.
[0779] FIG. 101 illustrates the device of FIG. 100 preloaded into
the introducer and prepared for advancement into a catheter.
[0780] FIG. 102 illustrates the distal tip of the catheter of FIG.
101 advanced beyond the distal tip of the bronchoscope and the
beginning steps of deployment of the device.
[0781] FIG. 103 illustrates exposure of the anchoring element for
anchoring of the device.
[0782] FIG. 104 illustrates expansion of the anchoring element.
[0783] FIG. 105 illustrates release of the device to be left behind
as an implant.
DETAILED DESCRIPTION OF THE INVENTION
[0784] Specific embodiments of the disclosed device, delivery
system, and method will now be described with reference to the
drawings. Nothing in this detailed description is intended to imply
that any particular component, feature, or step is essential to the
invention.
Anatomical Changes in COPD
[0785] FIG. 1 illustrates a healthy lung L of a patient. As shown,
the lung L includes a tracheobronchial tree which is the anatomical
and functional segment of the respiratory system that conducts air
from the larger upper airways to the lung parenchyma. It is
comprised of the trachea T and various intrapulmonary airways,
including the bronchi, bronchioles and terminal bronchioles. The
trachea and bronchi have cartilaginous walls which makes them
thick, fibrous and this allows them to maintain patency during
breathing. Bronchi undergo multiple divisions and eventually give
rise to the terminal bronchioles, which by definition, lack
cartilage. The most distal respiratory bronchioles and alveoli are
where gas exchanges into and out of the blood stream.
[0786] The trachea T is also referred to as the zero-generation
airway and it extends distally 10-12 cm and it then divides into
the right and left mainstem bronchi MB, commonly referred to as the
first-generation airways. The left mainstem bronchus MB (shown in
FIG. 1) is about 5 cm in length. The mainstem bronchus MB divides
into the lobar bronchi LB (secondary or second-generation airways)
and subsequently into the segmental bronchi SB (tertiary or third
generation). Subsegmental airways (fourth generation airways)
branch off from the segmental airways and they lead to the numerous
subsegmental portions that are found in each lobar segment. Bronchi
undergo multiple divisions (on average 23) along the bronchial
tree. The initial 16-17 generations of bronchi make up the
conducting zone of the airways and these do not normally
participate in gas exchange in healthy lungs. However, with the
progression of COPD and particularly with Emphysema, many of the
traditional pathways beyond about the fourth generation commonly
get destroyed and collateral pathways are formed that allow gas to
communicate and get trapped in places in the lung that can no
longer exchange gas as well as alveolar tissue in the lung that can
exchange gas.
[0787] As bronchi divide into smaller airways, the respiratory
epithelium undergoes histological changes and gives rise to
terminal bronchioles. The 17th to 19th generations of bronchioles
constitute the transitional zone. These bronchioles enter
pyramid-shaped pulmonary lobules separated from one another by a
thin septum, with the apex directed toward the hilum, comprising
5-7 terminal bronchioles. The last 2-3 generations of bronchioles
have some alveoli in their walls and make up the respiratory zone.
The area of the lung that is distal to a terminal bronchiole is
termed the acinus. The final division is called the respiratory
bronchiole, which further branches into multiple alveolar ducts.
Alveoli, the functional units of the respiratory system, start
appearing at the level of the respiratory bronchioles. This is
where the majority of gas is exchanged. It is important to note
that the majority of the healthy lung volume is comprised of
alveoli tissue. The airway network branches from the trachea
through the various portions of the lung to supply a volume of
oxygen and to expel carbon dioxide from alveoli that are positioned
almost everywhere within the lung. Only a small volume of the lung
is occupied by the airway tree and the arterial network that
transports blood from the right side of the heart through the lung
to the left side of the heart.
[0788] In a healthy lung L, the intrapulmonary airways are held
open by tension t (indicated by lines with facing arrows) between
the airways and the chest wall CW. The elastic nature of healthy
connective lung tissue and alveoli tissue communicates the tension.
The tension is required to hold airways open during normal
breathing as the airways experience higher external pressure,
relative to the internal air pressure, during exhalation breathing
cycles. Without this radial outward lung elastic recoil tension
holding the airways open, the airways would collapse during
exhalation which would not allow air to exit the lung. The lung L
is suspended in an expanded state due to negative pressure or
vacuum between the chest wall CW and the exterior lining of the
lung, or pleura PL, of the lung L. As a person inhales, the chest
wall CW and ribs R are expanded by the chest wall muscle CWM and
the diaphragm muscle D contracts to lower the diaphragm and reduce
the diaphragm arch DA which expands the lung L and its volume. By
expanding the volume, a negative pressure is created in the alveoli
which draws fresh oxygen into the airways and alveoli. Such
expansion causes the interior lung tissue to be stressed with
increased tension which dilates the airways and increases lung
elastic recoil. This increased lung elastic recoil greatly enhances
alveoli and airway contraction during exhalation. This ability to
stretch and undergo extreme elastic strain elongation with the
ability to fully recoil back to an original shape is made possible
by a fibrous protein called elastin. Elastin fibers are present in
virtually all vertebrate tissues, although it is only found in
abundance within a few structures, such as arteries, some
ligaments, and the lung. In these organs, elastin comprises an
appreciable percentage of the total protein.
[0789] In many respects, elastin is a perfectly designed protein
for its role in normal lung function. The unusual amino acid
composition and lysine derived crosslinks provide the elastin fiber
with great distensibility and recoil properties. They also lend
chemical stability to the fiber, which is susceptible to few
proteolytic enzymes and chemical injuries. Complications arise in
conjunction with this inherent stability. Mature elastin has an
extremely low turnover rate. Once the delicate architecture of the
alveolar walls has been constructed and the continuum of connective
tissue fibers is established, the components are meant to remain in
that configuration. After the fetal and early perinatal stages of
lung development there is no ability to initiate a new and
architecturally correct alveolus if the original structure has been
destroyed.
[0790] The introduction of tobacco smoke and other pollutants
signals macrophages and neutrophils to respond. As the neutrophils
degranulate and release their enzymes there is disparity between
the finely tuned ratio of elastase to antiprotease which
perpetuates destruction of the lung tissue and lung elastic
properties. Every injury sustained by alveolar elastin that is not
repaired hastens the inevitable cleavage of the alveolar wall. If
the injury is perpetuated, as is the case with cigarette smoke,
alveolar walls are slowly cleaved, leaving greatly enlarged air
spaces and a lung without elastic recoil properties. Coalescence of
damage leaves structural gaps in the tissue that further reduces
the lungs ability to maintain tissue integrity and lung elastic
recoil properties.
[0791] FIGS. 2-3 illustrate this change in lung composition. As the
alveolar sacs are destroyed, large open spaces form called
pulmonary blebs, bullae and giant bullae which can exceed several
centimeters in length, width or length. Pulmonary blebs are small
subpleural thin walled air containing spaces, not larger than 1-2
cm in diameter. Their walls are less than 1 mm thick. Pulmonary
bullae are, like blebs, cystic air spaces that have an
imperceptible wall (less than 1 mm) The difference between blebs
and bullae is generally considered to be their size, with the
cross-over being around 2 cm in diameter. Blebs may, over time,
coalesce to form bullae or giant bullae. FIG. 2 illustrates damage
that is typically seen in patients with early stage of severe
emphysema while FIG. 3 is more typical of tissue that would be seen
in a late stage emphysema patient who would typically present with
30% annual mortality rate. FIG. 4 illustrates a cross-sectional
slice acquired using computed tomography (CT) of the lungs of a
patient suffering from COPD. CT is a noninvasive, painless
procedure that uses low-dose x-ray images to visualize the lung
tissue. As shown, a large portion of the lung parenchyma has been
destroyed and the majority of the lungs are now mostly air pockets,
consisting of blebs and bullae.
[0792] FIG. 5 illustrates a lung L of a patient suffering from
advanced COPD. As in most COPD sufferers, this example shows
homogenous destruction of the lung parenchyma. This can be easily
identified by the fact that there is a similar amount of damage in
the upper, middle and lower portion of the lung. If only the upper
most portion of the lung was damaged, it would be considered a lung
with heterogeneous upper lobe predominant damage. Predominant
damage in the lower portion would be heterogeneous lower lobe
predominant. Some patients present with heterogeneous disease but
it may be upper lobe predominant in one lung and lower lobe
predominant in the other lung but the vast majority of heterogenous
patients present with upper lobe damage in both lungs or lower lobe
damage in both lungs. Over 60% to 75% of all patients present with
homogenous disease with a generally even distribution of damage
throughout the lung volumes. Visible damage in some patients may be
not be easily visible, even utilizing high resolution CT images
where the image slice thickness is less than 1.0 mm thick. However,
most patients present with damage that can be easily seen in these
images such as the pockets BU shown in FIG. 5. There is vast tissue
destruction beyond the 4.sup.th generation airways wherein diffuse
blebs BL and bullae BU fill the area of the lung L. Thus, late
stage COPD sufferers often do not have any anatomically normal
airways past the 4.sup.th generation. This is a discovery based on
the review of thousands of three-dimensionally reconstructed
computed tomography files that were acquired to study severe
emphysema patient's lungs. Basic medical and specialized
pulmonology education teachings indicate that medium to small
collagenous walled airways are preserved in late stage emphysema
patients and this is simply not true. CT reconstructions are
typically referred to as post processed CT files that show more
than just two-dimensional visual images of cross-sectional slices
of the lung. These detailed images of the inner structures of the
body can be reconstructed (post-processed) in a three-dimensional
format so tissue density and changes of density can reveal lung
tissue condition, anatomical boundaries as well as physiologic data
and dimensions. This data can be analyzed to summarize anatomical
and physiologic changes such as airway lumen diameter change during
breathing and airway volume change. Post processing can also be
used to measure the volume and density of blood vessels that remain
intact in damaged lungs. This is particularly useful to determine
the over-all gas exchange activity in lobes or regions of the lung.
Regions of lung tissue that trap gas or otherwise don't exchange
oxygen and CO.sub.2 efficiently experience accommodation which is
vascular contraction that prevents the flow of blood that is not
being properly prepared to be sent back into the vascular system.
By using post processing software, it's possible to measure dynamic
and static blood volumes in lungs, lobes and segments to evaluate
where to treat the patient, recommended dose and to determine if
additional treatments may be required later to maintain the
patients breathing mechanics. Effective treatment recruits
additional blood volume where it is otherwise insufficient or lower
than typically physiologically normal. Post processing can also
measure airway volume within areas of the lung during the
respiration cycle. The volume during inspiration can be compared to
the volume during expiration and the magnitude of airway collapse
can be calculated by subtracting the difference. This is a good
indicator of where air trapping occurs and it also indicates where
lung elastic recoil is suboptimal as the elastic recoil is what
normally holds the airways patent with volume. Areas with a greater
difference in airway volume during the breathing cycle need
treatment more than areas with less.
[0793] Emphysema related destruction severely reduces lung elastic
recoil and it eliminates or dramatically reduces gas exchanging
tissue surface area. The reduction of lung elastic recoil leads to
airway collapse during exhalation, air trapping and hyperinflation.
As previously mentioned, lung elastic recoil and its associated
outward radial pulling is necessary to hold airways open during
exhalation as the external pressure on and around the airways are
higher than the internal airway pressure. With reduced lung elastic
recoil, the outward radial pulling on the airway is reduced and the
airway collapses during exhalation. Air is still allowed to enter
the lungs during inhalation but no air is allowed to flow out
during exhalation. This leads to classic air trapping and
hyperinflation. The lung volume may increase but the patients
breathing capacity is reduced due to the lack of flow of fresh
oxygen. With these patients undergoing any form of exercise, the
airways collapse and trap air in the lung due to diminished tension
t (indicated by wavy lines with facing arrows) between the airways
and the chest wall CW. The air trapping and resulting increase in
lung volume increases pressure on the heart H and the coronary
arteries C. This in turn can lead to increased blood pressure,
increased heart rate and decreased blood ejection fraction from the
heart to the patient's arterial system.
[0794] It may be appreciated that in some instances there is no
obvious visual sign of tissue destruction in low or high-resolution
CT images, however there may still be numerous uniform small
pockets of damage throughout the parenchyma which can reduce the
surface area of the alveoli and therefor reduce gas exchange by as
much as 50% or sometimes more. In addition, there can be severe
damage to the elastin and loss of lung elastic recoil without the
presence of destruction that can be seen in CT images in the form
of blebs, bullae or other visual indicators of bulk enzymatic
tissue destruction. This renders a normal looking lung
dysfunctional due to airway collapse during breathing, etc. Most
patients, however, present with a combination of symptoms that
indicate a reduction of lung elastic recoil and also present with
lung tissue damage that can be seen in CT image
reconstructions.
Treatment Overview
[0795] Methods, systems and devices are provided which take into
account the vast tissue damage of advanced COPD sufferers and
provides treatment designed specifically to treat the particularly
compromised lung tissues that are present in these patients. Such
tissue damage has not been identified or acknowledged by previous
treatment plans which has led to insufficient treatment and
undesired outcomes in many cases. In particular, in some
embodiments, the degree of tissue damage is assessed and the
locations that the damage manifests in a lobe or lobes is utilized
in the determination of the treatment plan. Thus, the extent and
distribution of tissue damage is utilized in determining the number
of devices that may be desired to treat the patient and the most
optimal locations that the devices should be placed. These same
data may also be used to assess the patient over time to determine
if more devices should be implanted at the same locations as was
targeted in a previous procedure to enhance or restore the
improvement brought on in the first procedure or if implants might
be best deployed in new locations that were not previously treated
in order to restore the benefit brought on by an original
treatment. In some embodiments, damage that can be seen by looking
at CT image file reconstructions or post-processed CT image files
is used as an indicator for loss of tissue recoil properties,
compromised blood vessel communication or perfusion,
hyper-inflation, air trapping, airway lumen collapse, clogged or
congested airways. The extent and distribution of such tissue loss
is determined by a variety of comparisons, such as comparisons
between upper and lower lobes, comparisons between volumes of
affected tissue per lobe, and comparisons of areas of destruction
per CT slice integrated across number of slices. In some
embodiments, damage is quantified by analyzing CT files (CT
post-processing) and used to plan treatment or dose of therapeutic
implant. For example, in some embodiments, such analysis of CT
files utilizes software that analyzes and compares CT scans and
summarized detailed physiologic data that is acquired during a
patient's inspiration portion of a breath versus data acquired
during expiration, to measure the change in density and additional
metrics which indicate degree of airway collapse, blood flow
patterns through the breathing cycle, locations of trapped air,
regional lung volume changes, lobar lung volume changes, total lung
volume changes, diaphragm motion, vectors of motion and
displacement of motion of various regions of the lung which can be
used to evaluate levels of compliance in the lungs or regions of
the lungs. Areas with high compliance (large magnitudes of tissue
displacement during breathing) need treatment to restore elastic
recoil force that reduces compliance.
[0796] Blood vessel volume and total blood volume within a lung,
lobe, segment and sub-segments can be calculated using CT data
files and post-processing technology. Since blood vessels contract
where oxygen transfer is less than normal (below physiologic
levels, commonly called blood vessel accommodation) blood volume
reduction or signals such as data indicating that blood volume is
lower than normal can be used to determine where lung elastic
recoil needs to be improved, where the airways are collapsing and
trapping air, where lung elastic recoil is suboptimal, where
enzymatic activity is high and many other things that would
indicate that the devices should be placed in those regions.
Differences between lobes of more than 10% blood volume is
significant and less blood volume indicates more damage has been
done by the disease. Changes of more than 10% of lobar blood volume
over time indicates significant ongoing destruction and this
signals a target for minimally invasive therapy such as the
treatment described herein. Successful treatment increases the
lobar blood volume in most cases. Pre-treatment versus post
treatment CT analysis that indicates an increase of lobar blood
volume of 5% or more is considered significant.
[0797] In some instances, CT images that are acquired during
inhalation and others acquired during exhalation can be compared to
determine what regions or lobes experience the greatest amount of
volume expansion and contraction. High levels of motion and
relative volume change indicates that these regions perform with a
high level of compliance. Again, areas with high compliance is a
target where treatment can benefit the patient. Computational CT
analysis may be performed to measure the relative change in
position of thousands of easily identifiable points in the lungs
such as the many Corina branch points of the blood vessels and
airways during inhalation versus exhalation. If the distance
between 2 points moves more than the rest of the points in the lung
(on % basis or gross length change), the region between the points
is more compliant than other regions in the lung. Additionally, the
compliant regions may comprise elongated and slack tissue so the
distance between the two points move freely during chest expansion.
It may be appreciated that slack tissue is typically referred to as
high compliance or high compliance tissue. High compliance is a
strong indicator of slack tissue with low tissue elasticity and
patients will benefit from placement of devices that incorporate
strong spring elements where the compliance is highest. Thus,
devices may be deployed in parts of the lung that are the most
compliant as these devices are designed to reduce compliance to
bring the patients lung breathing mechanics closer to physiologic
breathing performance.
[0798] In some instances, CT images are acquired while the patient
inhales and others acquired while the patient exhales wherein they
are compared to determine what regions or lobes experience air
trapping. The volume of the lungs, lobes, segments or even
sub-segments of a lobe may be measured using CT quantitative
analysis to measure these volumes during inhalation and compare to
the same region during exhalation. If the volume of a region, as
measured while the patient exhales, is less than 40% of the
measured volume of the same region while the patient inhales, the
region is considered to be not trapping air. However, if the exhale
volume is more than 40% of the volume of the same region while the
patient inhales, the region is considered to be trapping air. This
is a strong indicator that the lung elastic recoil in the region
has been compromised and the tissue requires therapy to increased
tissue tensioning. The total volume of lung that is measured that
traps air indicates how much dose the patient needs. For instance,
therapy is recommended if the patient is found to trap air in 50
cc's of lung volume or more. Therapy that reduces more than 50 cc's
of lung volume improves breathing and this can be measured using
any of the measurable outcomes listed herein. The therapy devices
described herein provide lung volume reduction of at least 50 cc.
The therapies described herein may provide at least a 50 cc
reduction of lung volume that traps air, as measured by
quantitative CT analysis. The device embodiments described herein
are typically designed to provide at least 10 cc of volume
reduction or reduction of lung that traps air. Again, areas with
high compliance trap air during exhale and present a measurable and
quantitative parameter to use as a threshold to indicate treatment,
to recommend therapy dose and such areas also provide a target to
determine where treatment should be placed to most beneficially
treat the patient.
[0799] If the patient presents with homogenous destruction, the
pulmonary treatment devices can be delivered to the most severely
damaged regions, if they can be identified, or the devices can be
delivered to every major lobe so as to tension the entire lung
system uniformly. If the patient presents with strongly
heterogenous destruction, the pulmonary treatment devices can be
delivered to low attenuation (low density) or high compliance areas
of the lung, commonly the two upper lobes only. These areas
exchange gas less efficiently and therefore present as lower risk
locations to place implants rather than always placing devices in
all lobes, in order to preserve maximum lung and breathing
capacity. Devices may also be placed in high attenuation portions
of the lung (high density tissue) to gain additional traction if
the low attenuation portions are so destroyed that there is minimal
to no tissue for the device to engage. This is possible because the
devices restore the airway lumens and minimal tissue is being
compromised with device placement. If this is done, the
high-density tissue that has a significant amount of preserved
elastic recoil will not easily expand or elongate with tension but
the entire region of relatively preserved tissue will simply be
pulled to a new location and the adjacent low attenuation tissue
with low elastic recoil properties will still be tensioned.
Sometimes this involves pulling an entire lobe to a new position
and using the negative pressure in the fissure that separate the
lobes to communicate the tension to another lobe. This allows
tension and lung elastic recoil to be enhanced or created in places
that may not be ideal for implant placement. Device placement and
tensioning also lifts the diaphragm to restore basic diaphragm
movement to enhance breathing mechanics. By deploying the device in
a lung to cause tensioning, the lowest compliance tissues that are
connected in a serial fashion will be strained more than the higher
compliance areas and the lung tissue will be brought to equilibrium
with more uniform compliance and elastic recoil performance. This
strain also pulls airways radially outward and holds them open so
they cannot collapse during exhale events. This reduces air
trapping in the lung tissue.
[0800] Once the type and extent of damage has been accessed, the
treatment plan is devised, including choice and placement of
various treatment devices of the present invention designed
specifically for use in damaged lung tissue.
[0801] FIG. 6 illustrates an embodiment of a pulmonary treatment
device 10 of the present invention. In this embodiment, the device
10 comprises an elongate shaft 12 coiled into a helical shape to
form a tissue gathering element or tissue gathering end 14, an
anchoring element or stabilizing end 16 and an extendable
midsection 18 therebetween. Typically, each end 14, 16 is comprised
of 1-2 coil turns, however any suitable number of turns may be
used. The pulmonary treatment device 10 is configured to expand
along a longitudinal axis 19, as illustrated in FIG. 7, wherein the
bulk of the expansion occurs along the extendable midsection 18. In
some embodiments, the device 10 has a diameter of 2-50 mm and a
length of 0.25-10 inches, preferably 0.5-1 inch, in resting free
space. In such embodiments, the device 10 typically has a potential
longitudinal elongation of between 0.25 and 10 inches, but most
preferably 2-4 inches of potential elongation beyond the devices
original length. However, the dimensions of the device 10 after
deployment in the body may vary due to constraints of the airways
and pattern of disease. Devices 10 deployed into smaller airways
will have smaller diameters due to anatomical constraints.
Likewise, the extension of the midsection 18 may vary depending on
the location of the target treatment site within the
tracheobronchial tree. A brief overview of deployment will be
provided followed by a more detailed description of various
elements and features.
[0802] The pulmonary treatment device 10 is sized and configured to
be delivered by a delivery device configured to be inserted into
the lung, such as a steerable scope (e.g. bronchoscope 20), such as
illustrated in FIG. 8. In some embodiments, the pulmonary treatment
device 10 is configured to be delivered through a lumen in the
delivery device, such as by pushing the treatment device through a
lumen of a scope, catheter, introducer, sheath, sleeve or similar
device. In other embodiments, the pulmonary treatment device 10 is
configured to be delivered by mounting it on the outside of a
delivery device, such as on the outside of a scope, catheter (e.g.
a balloon catheter), introducer, sheath, sleeve, guidewire or
similar device. In some embodiments, when mounting on the outside
of a delivery device, the treatment device 10 freely slide along
the length of the delivery device. It may be appreciated that the
pulmonary treatment device 10 may be configured to be delivered
using a combination of these delivery device components such as
mounting the treatment device 10 on a guidewire or balloon catheter
shaft and delivering the assembly through the channel of the
bronchoscope. It may be appreciated that when using a guidewire,
the delivery system may be configured to be Over-The-Wire (OTW) or
Rapid Exchange (RX) wherein the guidewire exits the delivery system
at a particular location for the configuration. For example, in an
OTW design, the guidewire exits the delivery system at its proximal
end so that the guidewire that tracks along the full length of the
delivery device. In contrast, in the RX design, the guidewire only
tracks along a short section (about 25 cm) of the delivery device
and then exists at a side port. This design saves time compared
with advancing a guidewire through the full length of the delivery
device.
[0803] In some embodiments, the device 10 is loaded into a
bronchoscope port 22 and the bronchoscope 20 is advanced through
the tracheobronchial tree to a target location within the lung. In
patients with advanced COPD, lung tissue and airways are inflamed,
bleed easily and react to even slight trauma, such as by
advancement of a guidewire or catheter. Therefore, unlike
conventional endobronchial valves and coils, in these embodiments,
the device 10 may be deliverable without the use of a guidewire
and/or catheter. In this embodiment, the device 10 is loaded within
the bronchoscope port 22 so that the tissue gathering end 14 is
directed distally. The bronchoscope 20 is then steered through the
airways AW atraumatically, without digging its distal tip into the
airway walls W. Typically, the distal end of the bronchoscope 20 is
advanced into or well beyond the 4.sup.th generation airways, often
into the areas of the lung containing highly damaged tissue DT.
This is easily accomplished when the bronchoscope outer diameter is
less than 4.5 mm diameter. This is typically a bronchoscope with a
2.0 mm diameter channel and port. In these areas of damaged tissue,
large portions of parenchyma are often loose or missing, forming
coalesced blebs and bullae. Thus, normal lung passageways with
supportive walls are typically not available, and any existing
tissue is sponge-like and very weak. The tissue gathering end 14 of
the pulmonary treatment device 10 is deployed in this damaged
tissue DT, as illustrated in FIG. 8. This is typically achieved by
advancement of a deployment element 30 that extends through the
bronchoscope port 22 or by retraction of the bronchoscope 20 while
the deployment element 30 maintains its position relative to the
damaged tissue DT. The deployment element 30 comprises an elongate
shaft 32 having an attachment mechanism 36 near its distal end. The
attachment mechanism 36 engages an attachment feature 38 on the
device 10 so as to maintain connection between the deployment
element 30 and the device 10 during deployment. In this embodiment,
the attachment feature 38 comprises a loop 40 formed by the shaft
12 of the device 10. The loop 40 is disposed near or within the
stabilizing end 16, as more clearly illustrated in FIGS. 6-7.
Referring back to FIG. 8, in this embodiment, the attachment
mechanism 36 comprises a tether 42 (e.g. suture, metallic wire
(such as comprised of stainless steel, titanium, nitinol or other
nickel based alloy), monofilament or multifilament fiber, braid,
polymer or ceramic or glass fiber (such as comprised of
Kevlar.RTM., carbon fiber, nylon, polyurethane, polypropylene or
other durable material)) and a support rod 44 (such as comprised of
polymer, metal, ceramic or another durable material). The tether 42
extends through the loop 40 and around the support rod 44 so as to
secure the loop 40 to the support rod 44. Thus, the stabilizing end
16 of the device 10 is able to remain attached to the deployment
element 30 during deployment by the attachment mechanism 36. It may
be appreciated that other attachment features 38 include a ball, a
breakaway link, a threaded hole or shaft, or a friction fit taper
or hole, to name a few.
[0804] In some embodiments, as the tissue gathering end 14 is
released into the area of loose damaged DT, the tissue gathering
end 14 expands and rotates, gathering up the loose, damaged tissue
in a manner that fixedly engages the end 14 with the damaged tissue
DT. In other embodiments, the tissue gathering end 14 expands and
dilates the airway or passageway through the damaged tissue DT so
as to be effective in gathering tissue when the tissue gathering
end 14 is pushed or pulled longitudinally along the axis 19. Once
the tissue gathering end 14 has fixedly engaged within the damaged
tissue DT, the deployment element 30 is retracted into the
bronchoscope port 22. Since the deployment element 30 is attached
to the attachment feature 38 of the device 10, such retraction tugs
the device 10. This causes extension of the midsection 18 and
pulling of the damaged tissue DT engaged by the tissue gathering
end 14. Such pulling continues until a desired level of resistance
occurs or the damaged tissue DT has been pulled a desired amount.
This retraction may be observed using an integrated bronchoscope
camera or using one of many possible forms of X-ray imaging and
equipment such as real time fluoroscopic imaging, fluoroscopic CT
(computed tomography), biplane X-ray or other methods. The
retraction and tissue gathering magnitude may be measured by
observing the distance that the tissue gathering feature is moved.
In some embodiments, movement in a range of 1 cm to 25 cm,
preferably 7-8 cm, indicates substantial and adequate gathering of
tissue and axial pulling to cause lung tissue tensioning to
increase lung elastic recoil. Pulling force of 0.005 to 0.30 pounds
force are beneficial to the patient but preferably 0.01-0.20 pounds
force are applied to the tissues of the lung. The deployment
element 30 is then additionally retracted which further extends the
midsection 18. This straightens and extends the surrounding airway
AW, as illustrated in FIG. 9. By observing the increased length of
the midsection 18, using imaging methods, the user can observe and
adjust the amount of length change imparted on the midsection which
will ensure adequate recoil energy is stored in the midsection 18
of the device 10. It is important to store potential energy in the
device 10 so it remains in tension to continue to enhance lung
elastic recoil, even if the lung tissue relaxes and elongates over
time. Retraction of the deployment element 30 continues until the
stabilizing end 16 reaches a suitable airway for holding and
maintaining the stabilizing end 16. Typically, the deployment
element 30 is retracted until the stabilizing end 16 is positioned
within an ostium OS or point of branching within the
tracheobronchial tree. The larger diameter of the ostium OS allows
the stabilizing end 16 to expand and exert stabilizing radial force
against the walls W of the ostium OS, holding the expanded device
10 in place. If the midsection 18 is not desirably elongated, such
as 1-5 cm longer than it presents prior to retraction of the
stabilizing end 16, the device may be recaptured and redeployed
more distally so the midsection 18 may be elongated enough to
preserve the treatment effect over time. Once the stabilizing end
16 is secured within the airway AW, the attachment mechanism 36 is
released from the attachment feature 38. In this embodiment, the
tether 42 is severed which allows removal from the support rod 44.
The tether 42 is then removed along with the support rod 44. The
bronchoscope 20 is then removed, along with the deployment element
30, leaving the device 10 in place, as illustrated in FIG. 10.
[0805] Since the device 10 remains in an expanded configuration,
the coiled configuration holds potential energy and creates tension
between the damaged tissue DT and the ostium OS. This newly
acquired tension replaces the loss of tension caused by COPD. Thus,
the airway AW and tissue that is more distal and more proximal to
the device 10 is re-tensioned, providing renewed recoil strength.
This improves breathing and reduces air trapping and resultant
hyperinflation which is common in advanced COPD. In addition, the
stored potential energy provides continued tension as the damaged
tissue DT and/or airway AW naturally relaxes due to progression of
COPD. Thus, such re-tensioning continues even during disease
progression.
[0806] Thus, the pulmonary treatment device 10 provides a variety
of features which improve lung function and quality of life for
COPD sufferers, particularly those in advanced stages with few
treatment options. Since the device 10 has a coiled configuration
with an open central lumen, the device 10 does not obstruct airflow
when implanted. This is in contrast to many of the existing
implantable devices used to treat COPD, such as endobronchial
valves. Such valves are intended to obstruct the airway, blocking
off a portion of the lung so as to mimic LVRS. Thus, any
functioning alveolar sacs are obstructed and are unable to be used.
In contrast, the pulmonary treatment device 10 maintains access to
the damaged tissue DT so that remaining functioning alveolar sacs
can be utilized. The ends 14, 16 of the device 10 are coaxially
biased so that positioning of the device 10 within a tortuous
airway naturally straightens the airway AW along the longitudinal
axis 19 of the device 10. In addition, the elongation of the
midsection 18 of the device 10, elongates the airway AW providing a
more direct pathway with less resistance to airflow. This is in
contrast to endobronchial coils which are intended to bend and fold
airways, compressing tissue and creating resistance to airflow.
This blocks off regions of the lung so as to mimic LVRS.
[0807] In addition, at least some portions of the coiled
configuration are radially expandable. Thus, the pulmonary
treatment device 10 acts in a stent-like manner, supporting airway
walls W and improving airflow. In addition to providing tensioning
of the lung tissues to radially pull on airways to maintain patency
during exhalation (when airway collapse is common in these
patients), the stenting feature of the pulmonary treatment device
internally supports the inside diameter of the airways to maintain
patency during breathing. The act of deploying the device 10
(thereby re-tensioning the airways) holds the small airways, that
are smaller than 2.0 mm in diameter, open, further increasing
airflow. This act also displaces lung tissue closer to the trachea
and pulls tissue farther from the pleura, shifting lung tissue
closer to the heart. The trachea and central airways, such as the
first, second, third and fourth generation airways, are much better
reinforced by a pulmonary treatment device configured to be
anchored in airways comprising mostly cartilage as compared to
airways beyond the 4.sup.th generation so the tissues closer to the
heart function as a foundational support for device 10. As the
device 10 is elongated and anchored in the reinforced support
region, the distal tissue gathering end 14 can efficiently pull and
tension tissue that lies between the tissue gathering end 14 and
the chest wall. Most of the lung volume adjacent to the chest wall
comprises small airways and alveoli. This is a particularly fertile
region to retention in order to improve breathing mechanics as a
large percentage of air trapping happens in the beds of small
airways (commonly referred to as small airways disease). The coiled
configuration provides a spring-like or resilient quality to the
device 10 during breathing. During inhalation, the device 10
lengthens or elongates, and, during exhalation, the device 10
shortens or contracts. This ability to change dimension during
breathing while maintaining relatively uniform tension levels in
the lung allows device 10 to behave similar to normal healthy lung
tissue. The tension does not dramatically change during the breath
cycle.
[0808] It is important to point out that this type of lung elastic
recoil enhancing treatment device 10 can beneficially be made from
a single continuous element such as a single length of wire or
fiber. This single element design enjoys the benefit of not
comprising joints or links that may fail due to strain or bending
during the high number of breathing cycles the device may encounter
during the remainder of the patient's life. The single element may
be made with varying diameter sections or it can be made from
tapered diameter material as well as material that has totally
non-uniform size or cross section along its length. A single
component implant design is ideal. The treatment device 10 may also
be made from a number of components if different diameter shaft
material or if different materials are desired in the different
sections such as the mid-section versus the stabilizing end or the
mid-section versus the tissue gathering end. The mid-section is
most ideal if it's made from resilient material whereas the tissue
gathering distal end 14 and the stabilizing proximal end 16 may be
made from more rigid material. The difference in modulus between
the two portions may be as much as 500% or more different and they
would still be suitable. A single component structure may be
configured with tuned material properties in different locations of
the single element. Nitinol material may be adjusted by using local
heat treatment techniques to increase or decrease the stiffness or
modulus of elasticity in local portions of the wire. This is
beneficial in that the tissue gathering ends may be tuned to be
stiff to be most effective to engage tissue and the central spring
portion may be tuned to be less stiff to be ideally matched with
the stiffness of healthy lung tissue.
[0809] It may be appreciated that any number of pulmonary treatment
devices 10 may be positioned within a lung of a patient. FIG. 11
illustrates the positioning of three pulmonary treatment devices
10a, 10b, 10c within the lung L of a patient P. As shown, a
bronchoscope 20 is advanced down the trachea T and into the
bronchial tree of the lung L. A first pulmonary treatment device
10a is loaded within a port 22 and the bronchoscope 20 is advanced
through the airways of the bronchial tree to a first area of
damaged tissue DT1. The first pulmonary treatment device 10a is
deployed as described above so that the first area of damaged
tissue DT1 is drawn toward the trachea T and lung tissue in the
vicinity is re-tensioned. The bronchoscope 20 may then be retracted
and removed from the patient P. This allows the bronchoscope 20 to
be cleansed so as to avoid transferring bacteria and contaminating
other airways when re-introducing the bronchoscope 20. The second
pulmonary treatment device 10b is then loaded within the port 22
and the bronchoscope 20 is advanced through the airways of the
bronchial tree to a second area of damaged tissue DT2. The second
pulmonary treatment device 10b is deployed as described above so
that the second area of damaged tissue DT2 is drawn toward the
trachea T and lung tissue in the vicinity is re-tensioned. The
bronchoscope 20 may then again be retracted and removed from the
patient P. Again, the bronchoscope 20 may be cleansed and third
pulmonary treatment device 10c is loaded within the port 22 and the
bronchoscope 20 is advanced through the airways of the bronchial
tree to a third area of damaged tissue DT3. The third pulmonary
treatment device 10c is deployed as described above so that the
third area of damaged tissue DT3 is drawn toward the trachea T and
lung tissue in the vicinity is re-tensioned. The bronchoscope 20 is
then retracted and removed from the patient P. Alternatively, the
bronchoscope 20 may be left in the lung throughout the delivery of
the three devices 10a, 10b, 10c through the bronchoscope channel to
the locations shown in FIG. 11. Or, the devices 10a, 10b, 10c may
be delivered into the lung via a catheter that has been advanced
through the bronchoscope channel. As many as 25 devices may be
placed within each lobe. Pulmonary treatment devices may be placed
in a single lobe during a single procedure, in two or more lobes
during a single procedure or in all 4 major lobes during a single
procedure. Alternatively, one, two, three or 4 of the major lobes
may be treated over a sequence of several procedures with typically
1-4 weeks of recovery time between procedures. Lastly, one or more
pulmonary treatment devices may be placed in one or more lobes
during a single procedure and additional pulmonary treatment
devices may be implanted in sequential additional procedures.
[0810] FIG. 12 illustrates a plurality of pulmonary treatment
devices 10 positioned in both lungs L. The devices 10 are
preferably delivered into regions of the lung with the most tissue
destruction. If the patient suffers from upper lobe predominant
heterogenous disease, the upper lobes in the left and right lungs
are preferably treated. If the patient suffers from homogeneous
disease where the tissue destruction is diffuse throughout every
major lobe of both lungs, devices 10 are preferably placed in all
five lobes of the lung. This "total lung" treatment is ideal
because each device 10 is designed to restore and preserve lung
elastic recoil. Homogeneous patients need this enhancement in all
major lobes of the lung and unlike nearly every alternative
treatment, the devices 10 will not block or otherwise render lung
tissue non-functioning. By simply pulling tissue sufficiently to
eliminate slack in the lung tissue and restoring lung elastic
recoil without compromising gas exchange function of the tissue,
the devices 10 can be placed in locations throughout the lungs to
additively enhance breathing mechanics in these patients.
[0811] It may be appreciated that each pulmonary treatment device
10 may impart differing levels of re-tensioning in a lung L. But,
overall, the impact on the lung L is such that a variety of
clinical goals have been achieved. Such goals include returning
physiologic tension to make the lung perform in a more physiologic
way. The human lung normally behaves in a fully elastic manner in
which it expands between approximately 200 milliliters with the
application of pressure relating to approximately 20 centimeters of
H.sub.2O or 0.02 Bar or 0.02 atmospheres and 1200 milliliters with
the application of 40 centimeters of H.sub.2O pressure. The
pulmonary treatment device removes slack in the tissue, minimizes
tissue compression, restores lung elastic recoil, enhances
breathing mechanics by providing an elastic link to enhance spring
properties in the tissue, radially outwardly supports airways to
maintain airway lumen patency, internally stents airways to
maintain lumen patency and lifts the diaphragm to restore diaphragm
motion. This also increases the lumen diameter or caliber of the
airways and increases the radial outward support to the airways so
that the support is sufficient to hold the airways open. Airway
closure during expiration is delayed and the time that airways stay
open during expiration is increased. Likewise, airway resistance is
reduced along with air trapping in the lung. Such tensioning
reduces hyperinflation and the related increase in lung volume.
This has a variety of beneficial effects on the heart and
circulation, including reducing pressure on the heart because
hyperinflated lungs push on the heart, reducing pressure on
coronary arteries, reducing pulmonary artery pressure, reducing
systolic and/or diastolic blood pressure, reducing blood
hypertension, reducing heart rate, increasing blood oxygen percent,
decreasing CO.sub.2 levels in blood stream and increasing blood
ejection fraction as relieving lung inflation related pressure on
the heart allows it to contract and refile more efficiently.
Additionally, treating patients with the pulmonary treatment device
will reduce the amount of Dyspnea, otherwise known as shortness of
breath, and quality of life is improved. Quality of life is
normally measured using validated patient surveys such as SGRQ
scoring surveys. As the patient's quality of life is improved, the
SGRQ survey score is decreased. Appropriate patients who a have
been treated with the pulmonary treatment devices described herein
will typically survey with reduced SGRQ scores of at least 1 point
but more preferably a reduction of 4 or more points will be
experienced.
[0812] In addition, beneficial effects of pulmonary treatment in
the lung can be measured by monitoring one or more of a number of
possible pulmonary indicators, including measuring benefit by
measuring increased forced expiratory volume during expiration,
increased lung emptying during expiration, reduced end-expiratory
lung volume, reduced functional residual capacity, reduced residual
volume left in the lung during or after expiration (RV), reduced
volume of gas that is trapped in the lung during or after
expiration reduced volume of gas that is trapped in a lobe during
or after expiration, reduced dynamic hyperinflation, decrease total
lung capacity, reduce RV/TLC ratio, increased tidal expiratory
volume change during tidal breathing at rest, increased inspiratory
reserve volume during tidal breathing at rest, increased forced
expiratory volume in the first second (FEV1), increased forced
vital capacity volume (FVC), and increase ratio FEV1/FVC, to name a
few.
[0813] Additionally, the beneficial effects of pulmonary treatment
in the lung can be measured by monitoring one or more of the
following measures, including reduced lung tissue density (e.g.
more than 5 HU (Hounsfield units) change in average lung tissue
density due to a treatment procedure), measuring lobar lung tissue
density in which more than 2% change is measured, measuring the
difference between lobes of lobar damage volume using a 950 HU
filter in which the volume difference between lobes is reduced and
a reduction of more than 3% volume of damaged tissue due to the
treatment is significant, measuring displacement of more than 2 mm
of fissure shift during the same portion of the breathing cycle is
significant, or reduction of folds of pleura that demarcate the
lobes in the lung, decreased lung compliance, decreased compliance
in lobes or regions of lung tissue, increased lung tissue
compliance uniformity between upper versus lower lobes, increased
lung tissue compliance uniformity between lung lobes in a patient,
and increased lung tissue compliance uniformity between lobar
segments, to name a few.
[0814] Overall, the patient typically has a variety of symptomatic
improvements, including reduced coughing (e.g. due to trapped air
and mucus), increased ability to clear mucus due to passageways
opening larger and for longer periods of time, increased mobility
(e.g. as measured by currently standard 6-min walk test), reduced
inspiratory effort, reduced dysthymia, decreased breathing rate,
reduced glottis closure sensitivity (by clearing mucus,
inflammation is reduced and coughing is reduced), reduced incidence
of respiratory failure and increase time between COPD exacerbation
events, to name a few.
Pulmonary Treatment Device Embodiments
[0815] Embodiments of the pulmonary treatment device 10 have
various features and design elements to achieve the above described
treatment effects and clinical goals. In addition, such features
and design elements may have varying alternatives, a variety of
which will be set forth herein.
[0816] Overall, the pulmonary treatment device 10 has a relatively
short length of between approximately 1 cm and 20 cm but preferably
2-3 cm in an unstrained condition so as to minimize its length
within the bronchoscope 20. This allows the bronchoscope 20 to be
advanced to or as close to the target area within the lung L for
deployment of the tissue gathering end 14. In some embodiments, the
distal end of the bronchoscope 20 positioned at the target area and
the tissue gathering end 14 is deployed by retraction of the
bronchoscope 20. Delivering the tissue gathering end 14 and
allowing it to recover to its deployed configuration at the target
area avoids pushing of the device 10 forward within the lung tissue
which causes tissue trauma.
[0817] Herein various aspects of the pulmonary treatment device 10
are described in more detail. It may be appreciated that although a
variety of aspects and features are described, embodiments of the
device 10 may include any combination of these aspects and
features. Likewise, some embodiments may not include all of the
aspects and features described. For example, in some embodiments,
the device 10 comprises a tissue gathering end 14 and a stabilizing
end 16 without an extendible midsection 18 therebetween.
A. Tissue Gathering End
[0818] As described previously, the tissue gathering end 14 of the
pulmonary treatment device 10 is designed to be deployed into
intact airways or the damaged tissue DT, comprised of loose,
sponge-like, weakened tissue and open areas of blebs and bullae, so
as to effectively engage the damaged tissue DT while minimizing any
trauma. A variety of design features are provided to achieve these
goals. In some embodiments, the tissue gathering end 14 expands and
is rotatable so as to gather up the loose, damaged tissue in a
manner that fixedly engages the end 14 with the damaged tissue DT.
Thus, the tissue gathering end 14 is configured to gather, connect
or hook into as much damaged soft tissue as possible. In some
embodiments, this involves rotating the tissue gathering end 14
which threads the end 14 into place, such as through existing holes
in the tissue. Due to the specialized design of the tissue
gathering end 14, such rotation does not twist or bend airways in
the lung.
[0819] FIG. 13 illustrates an embodiment of a tissue gathering end
14 of a pulmonary treatment device 10 of the present invention. In
this embodiment, the tissue gathering end 14 comprises a portion of
the elongate shaft 12 coiled into a helical shape, particularly
having a single coil turn to form a loop shape. In this embodiment,
the shaft 12 extends along the longitudinal axis 19 through the
extendible midsection 18 and then bends radially outwardly distal
to the extendible midsection 18, such as perpendicularly or at a 90
degree angle to the longitudinal axis, forming a loop 50 in the
same plane. Thus, the loop 50 has an opening 52 perpendicular to
the longitudinal axis 19. FIG. 14 illustrates a top view of the
embodiment of FIG. 13. Thus, as illustrated, the opening of the
loop 50 is perpendicular to the longitudinal axis 19, having a
circular shape. Likewise, in this embodiment, the loop extends
nearly 360 degrees around the longitudinal axis 19. In this
embodiment, the shaft 12 has a distal tip 54 which is "turned-up"
or facing in the distal direction. In some embodiments, the distal
tip 54 is aligned with the longitudinal axis 19 and in other
embodiments the distal tip 54 is offset from the longitudinal axis
19. In any case, the turned-up configuration aligns the distal tip
54 with or parallel with the direction of tension so as to avoid or
reduce any trauma to the surrounding tissue. The distal tip 54 may
have a variety of shapes including an end loop, coil, ball, bullet,
tear drop, cone or taper shape to minimize tissue trauma.
[0820] In this embodiment, the tissue gathering end 14 comprises a
single loop 50. However, it may be appreciated that the tissue
gathering end 14 may comprise any suitable number of loops 50 or
partial loops, including a quarter loop, a half loop, a
three-quarter loop, one loop, two loops, three loops, four loops,
five loops, six loops, more than six loops or any combination of
these. The loops 50 may have any suitable diameter, typically in
the range of 10 mm to 50 mm. Each of the loops 50 may have the same
diameter or differing diameters. In some embodiments, the loop
diameters taper, such as in a funnel or cone shape, wherein loop
diameters incrementally decrease in size along the tissue gathering
end 14. In such embodiments, the taper may be in the distal
direction or the proximal direction. In some embodiments, the
tissue gathering end 14 comprises a series of loops 50 having the
same diameter and then transitions into a taper, typically in the
distal direction, to the distal tip 54 or to a series of loops 50
having the same diameter which is smaller than the loops 50
disposed proximally. In some situations, these arrangements reduce
trauma to the tissue.
[0821] In some embodiments the tissue gathering end 14 comprises
more than one loop 50 to act as a spring that limits peak
tensioning force on the fragile lung tissue, like a tension fuse
between the tissue and the user. Typically, total pull force
applied to the tissue gathering end 14 during placement of the
device 10 is less than or equal to 9 Newtons. In preferred
embodiments, the total pull force is less than or equal to 0.9
Newtons but patients may utilize a range of force between 0.005 and
10 Newtons but preferably near 0.07 Newtons, depending on the
density of the tissue that is to be re-tensioned. The lower forces
are required for low density tissue and more force is required in
tissue that is denser and better preserved with more lung elastic
recoil. In any case, the tissue gathering end 14 is shaped to
optimize contact area to reduce lung tissue stress or pressure.
[0822] In some embodiments, the tissue gathering end 14 is
comprised of heavy gage core wire, such as core wire having a
diameter of 0.10-2.5 mm but most preferably between 0.25 mm and
0.30 mm. In some instances, the preferred diameter depends on the
shape and configuration of the tissue gathering end 14. For
example, if the tissue gathering end 14 comprises a loop shape
having a diameter of less than 25 mm, the preferred core wire
diameter may be 1 mm. If the tissue gathering end 14 comprises a
loop shape having a diameter of greater than or equal to 25 mm, the
preferred core wire diameter may be 1-2 mm.
[0823] FIG. 15 illustrates a similar embodiment of a tissue
gathering end 14 of a pulmonary treatment device 10. In this
embodiment, the shaft 12 extends along the longitudinal axis 19
through the extendible midsection 18 and then gradually bends
radially outwardly distal to the extendible midsection 18. Rather
than bending at a 90 degree angle to the longitudinal axis 19, the
shaft 12 bends at an angle less than 90 degrees, such as a 30-45
degree angle to the longitudinal axis 19. This creates an arch 56,
wherein the shaft 12 then bends downward at a distance from the
longitudinal axis 19 and ultimately forms a loop 50 in a plane
perpendicular to the longitudinal axis 19. Thus, the tissue
gathering end 14 comprises a distal facing arch 56 with a loop 50
extending around the longitudinal axis 19 proximal of the arch 56.
As the shaft 12 is retracted to tension lung tissue, arch 56 pulls
loop 50 down against distal tip 54 to create a shape that emulates
a concentric ring that gathers tissue. FIG. 16 illustrates a top
view of the embodiment of FIG. 15. As shown, the opening 52 of the
loop 50 is perpendicular to the longitudinal axis 19 having a
circular shape. Likewise, in this embodiment, the loop 50 extends
nearly 360 degrees around the longitudinal axis 19. In this
embodiment, the shaft 12 has a distal tip 54 which is not
"turned-up"; rather the distal tip 54 is disposed in the plane of
the loop 50.
[0824] FIG. 17 illustrates an embodiment of a tissue gathering end
14 of a pulmonary treatment device 10 having multiple loops 50. In
this embodiment, the shaft 12 extends along the longitudinal axis
19 through the extendible midsection 18 and then gradually bends
radially outwardly distal to the extendible midsection 18. Again,
rather than bending at a 90 degree angle to the longitudinal axis
19, the shaft 12 bends at an angle less than 90 degrees, such as a
30-45 degree angle to the longitudinal axis 19. This creates an
arch 56, wherein the shaft 12 then bends downward at a distance
from the longitudinal axis 19 and ultimately forms a first loop 50a
in a plane perpendicular to the longitudinal axis 19. The shaft 12
then bends to form additional loops, such as a second loop 50b and
a third loop 50b, each in a plane perpendicular to the longitudinal
axis 19 and parallel to each other. Thus, the tissue gathering end
14 comprises a distal facing arch 56 with a plurality of loops 50a,
50b, 50c extending around the longitudinal axis 19 proximal of the
arch 56. In some instances, the plurality of loops 50a, 50b, 50c
allows the grabbing of more damaged tissue DT and the entire anchor
may be pulled together to bind the tissue and trap tissue between
the loops to cause tissue traction that wouldn't otherwise be
achievable with a single loop shape. This configuration also stores
potential energy in the plurality of loops 50a, 50b, 50c that acts
to maintain tissue tension even after the lung disease continues
with elongation of tissue over time.
[0825] FIG. 18 illustrates a top view of the embodiment of FIG. 17.
Since the loops 50a, 50b, 50c have the same diameter, they are not
individually visible from the top view as they are overlaid. As
shown, the opening 52 of the loops 50a, 50b, 50c are perpendicular
to the longitudinal axis 19 and have a circular shape. Likewise, in
this embodiment, the loops 50a, 50b, 50c extend nearly 360 degrees
around the longitudinal axis 19. Again, in this embodiment, the
shaft 12 has a distal tip 54 which is not "turned-up"; rather the
distal tip 54 is disposed in a plane parallel to the planes of the
loops 50a, 50b, 50c.
[0826] FIG. 19 illustrates another embodiment of a tissue gathering
end 14 of a pulmonary treatment device 10 having multiple loops 50.
In this embodiment, the shaft 12 extends along the longitudinal
axis 19 through the extendible midsection 18 and then gradually
bends radially outwardly distal to the extendible midsection 18. In
this embodiment, the bending is in a first direction at a 90 degree
or lesser angle to the longitudinal axis 19. The shaft 12 then
bends in a second direction which is opposite to the first
direction and ultimately bends downward at a distance from the
longitudinal axis 19 on the opposite side of the extendible
midsection 18. This creates an arch 56 which straddles the
extendible midsection 18. The shaft 12 then forms a first loop 50a
in a plane perpendicular to the longitudinal axis 19 and bends to
form additional loops, such as a second loop 50b and a third loop
50b, each in a plane perpendicular to the longitudinal axis 19 and
parallel to each other. Thus, the tissue gathering end 14 comprises
a distal facing arch 56 with a plurality of loops 50a, 50b, 50c
extending around the longitudinal axis 19 proximal of the arch 56.
In this embodiment, the radius of the arch 56 is such that the arch
56 extends beyond the diameter of the loops 50a, 50b, 50c. This
configuration resists movement of the arch 56 through the loops
50a, 50b, 50c while positioning the device 10, such as when tugging
on the device 10 to re-tension the lung tissue.
[0827] FIG. 20 illustrates a top view of the embodiment of FIG. 19.
Since the loops 50a, 50b, 50c have the same diameter, they are not
individually visible from the top view as they are overlaid. As
shown, the opening 52 of the loops 50a, 50b, 50c are perpendicular
to the longitudinal axis 19 and have a circular shape. Likewise, in
this embodiment, the loops 50a, 50b, 50c extend nearly 360 degrees
around the longitudinal axis 19. This top view also illustrates
that the arch 56 extends beyond the diameters of the loops 50a,
50b, 50c. Again, in this embodiment, the shaft 12 has a distal tip
54 which is not "turned-up"; rather the distal tip 54 is disposed
in a plane parallel to the planes of the loops 50a, 50b, 50c.
[0828] In each of the above embodiments, the openings 52 of the one
or more loops 50 of the tissue gathering end 14 are substantially
concentric with the longitudinal axis 19. However, in other
embodiments, the openings 52 of the one or more loops 50 are not
substantially concentric with the longitudinal axis 19 and are
offset from the longitudinal axis 19. For example, FIG. 21
illustrates an embodiment wherein the shaft 12 extends along the
longitudinal axis 19 through the extendible midsection 18 and then
gradually bends radially outwardly distal to the extendible
midsection 18. Rather than bending at a 90 degree angle to the
longitudinal axis 19, the shaft 12 bends at an angle less than 90
degrees, such as a 30-45 degree angle to the longitudinal axis 19.
This creates an arch 56, wherein the shaft 12 then bends downward
at a distance from the longitudinal axis 19 and ultimately forms a
loop 50 in a plane perpendicular to the longitudinal axis 19. In
this embodiment, the loop 50 is extends over 360 degrees but does
not encircle the longitudinal axis 19. Instead, the loop 50 is
concentric with an axis 60 which is parallel to the longitudinal
axis 19 and offset by 3-30 mm, preferably 13 mm FIG. 22 illustrates
a top view of the embodiment of FIG. 21. As shown, the opening 52
of the loop 50 is perpendicular to the longitudinal axis 19 and
shifted to one side of the extendable midsection 18. Likewise, in
this embodiment, the loop 50 extends more than 360 degrees. In this
embodiment, the shaft 12 has a distal tip 54 which is not
"turned-up"; rather the distal tip 54 is disposed in the plane of
the loop 50.
[0829] This offset configuration allows the extendable midsection
18 to be positioned against the wall of a lung passageway rather
than extending through the center of the lung passageway lumen.
This may reduce any potential accumulation of mucus within the lung
passageway lumen, providing an open pathway for airflow. It may be
appreciated that when the tissue gathering end 14 is positioned
within damaged tissue DT, the loop 50 is not disposed within a
natural lung passageway having structured walls. Therefore, contact
between the loop 50 and the shaft 12 above the extendable
midsection 18 is not problematic as the tissue gathering end 14 is
not compressing the walls of a lung passageway.
[0830] In some embodiments, at least one of the loops 50 of the
tissue gathering end 14 crosses at least a portion of another loop
as illustrated in FIGS. 23-24. In particular, FIG. 23 illustrates
an embodiment wherein the shaft 12 extends along the longitudinal
axis 19 through the extendible midsection 18 and then bends
radially outwardly distal to the extendible midsection 18, such as
perpendicularly or at a 90 degree angle to the longitudinal axis,
forming a first loop 50a in the same plane. Thus, the first loop
50a has an opening 52 perpendicular to the longitudinal axis 19. In
this embodiment, the shaft 12 continues bending circumferentially
to form at least a portion of a second loop 50b, wherein the second
loop 50b has a smaller diameter than the first loop 50a. In
addition, the second loop 50b is disposed proximally to the first
loop 50a. FIG. 24 illustrates a top view of the embodiment of FIG.
23. Thus, as illustrated, the opening of the loops 50a, 50b are
perpendicular to the longitudinal axis 19. Likewise, in this
embodiment, the second loop 50b portion extends under the first
loop 50a. Thus, when the device 10 is tugged in the proximal
direction, during the re-tensioning step, the first loop 50a
captures the second loop 50b, applying the total area of the
combined length of both coils times the width of the shaft 12
material to present a broad efficient tissue gathering anchor to be
pulled in the proximal direction. This large area of contact
reduces the bearing pressure that is imparted on the tissue which
minimizes or eliminates the tendency for the device to grow through
or migrate through the tissue over time. With minimal migration,
the advantageous effect of the treatment is prolonged. It may be
appreciated that any number of loops 50 may be present, the
distal-most loop applying force to the more proximal loops.
B. Extendable Midsection
[0831] The extendible midsection 18 connects the tissue gathering
end 14 with the stabilizing end 16, as illustrated in FIG. 25. In
some embodiments, the tissue gathering end 14, extendible
midsection 18 and stabilizing end 16 are formed by shaping a single
shaft to form the desired configurations. However, it may be
appreciated that each or some of the parts may be formed
individually and joined together. In any case, the midsection 18 is
configured to be extendible from at least a relaxed state to an
extended state, wherein the midsection 18 stores potential energy.
As described previously, once the tissue gathering end 14 has
fixedly engaged the damaged tissue DT, the deployment element 30 is
retracted into the bronchoscope port 22 which tugs the device 10 in
the proximal direction. This causes extension of the midsection 18
and pulling of the damaged tissue DT engaged by the tissue
gathering end 14. Such pulling continues until a desired level of
resistance occurs or the damaged tissue DT has been pulled a
desired amount. The deployment element 30 is then additionally
retracted which further extends the midsection 18. This straightens
and extends the surrounding airway AW. Retraction of the deployment
element 30 continues until the stabilizing end 16 reaches a
suitable airway for holding and maintaining the stabilizing end 16.
Thus, the bulk of the expansion occurs along the extendable
midsection 18.
[0832] In some embodiments, the extendible midsection 18 has the
shape of an elastic spring or coil. Typically, the shaft 12 is
coiled into a helical shape to form the elastic spring or coil. In
some embodiments, the midsection 18 has a length in the range of
5-75 mm but preferably a length of less than 25 mm in resting free
space and a potential longitudinal elongation in the range of
10-200 mm but preferably more than 75 mm. However, the extension of
the midsection 18 while the device 10 is in use depends on the
location of the target treatment site within the tracheobronchial
tree, the extent of damage to the tissue and the desired level of
re-tensioning. In any event, in some embodiments the midsection 18
comprises at least 3 complete coils.
[0833] In some embodiments, the coiled extendible midsection 18 has
a diameter in the range of 0.5-10 mm, such as 2.5 mm, particularly
when the shaft 12 is comprised of a wire having a diameter in the
range of 0.10-0.75 mm, preferably 0.25-0.3 mm. It may be
appreciated that in some embodiments, the diameter of the shaft 12
forming the extendible midsection 18 is smaller than the diameter
of the shaft 12 forming the tissue gathering end 14 or the
stabilizing end 16. This may be achieved by necking down the shaft
12 in the area of the extendible midsection 18, such as by
grinding. In any case, the overall diameter of the extendible
midsection 18 is typically smaller than both the tissue gathering
end 14 and the stabilizing end 16.
[0834] In some embodiments, the extendible midsection 18
additionally supports the airway wall. In use, the device 10 draws
the loose damaged tissue DT inward toward the lung passageways that
have a maintained structure. Therefore, the extendible midsection
18 is located within an airway having structured walls when the
device 10 is implanted. However, such walls are often weakened and
benefit from the additional internal support offered by the
extendible midsection 18, particularly under the new level of lung
tensioning. As the midsection 18 of device 10 is elongated to store
energy, the adjacent airway wall, along the length of the
midsection, may be longitudinally compressed which will weaken it
and possibly allow it to collapse more easily. This is more than
offset by the coil of the midsection providing radial strength and
radial stenting support enough to prevent the airway, along this
midsection 18 length from collapsing. Likewise, the extendible
midsection 18 straightens the airway or the general path of the
overall airway system.
[0835] In some embodiments, the extendible midsection 18 is
axisymmetric with the tissue gathering end 14 and/or the
stabilizing end 16, such as illustrated in FIGS. 6-7. In such
embodiments, the midsection 18 typically has an open lumen forming
a tunnel to allow passage of air therethrough. However, it may be
appreciated that in some embodiments the extendible midsection 18
may not be axisymmetric and is disposed to one side of the tissue
gathering end 14, such as illustrated in FIG. 21, and/or the
stabilizing end 16. Thus, in these embodiments, the midsection 18
extends along the side of the airway (e.g. adjacent to the
wall).
[0836] In some embodiments, the extendible midsection 18 is joined
to a feature along the tissue gathering end 14 to keep the tissue
gathering end 14 from rotating.
C. Stabilizing End
[0837] As described previously, the stabilizing end 16 of the
pulmonary treatment device 10 is designed to hold the device 10,
and therefore the lung tissue, in tension by seating in an
appropriate portion of the tracheobronchial tree. As mentioned,
after the tissue gathering end 14 has been desirably positioned,
the deployment element 30 retracts and pulls the stabilizing end
16, which in turn pulls the extendable midsection 18 and tissue
gathering end 14. Such pulling continues and increasingly applies
tension to the lung, along with other physical benefits such as
straightening the airway and increasing airflow. Once the
stabilizing end 16 reaches a suitable airway for holding and
maintaining the stabilizing end 16, the stabilizing end 16 is
seated and released. Typically, the stabilizing end 16 is
positioned within an airway or ostium OS or point of branching
within the tracheobronchial tree. The larger diameter of the ostium
OS allows the stabilizing end 16 to expand and exert stabilizing
radial force against the walls W of the ostium OS, holding the
expanded device 10 in place. The end 16 stabilizes the device 10,
providing a base or anchor for the applied tension which is then
maintained throughout treatment of the patient as the device 10 is
left behind.
[0838] In some embodiments, the stabilizing end 16 comprises a
portion of the elongate shaft 12 coiled into a helical shape,
particularly having multiple coil turns, each having a loop shape.
In some embodiments, the stabilizing end 16 comprises single loop
70, as illustrated in FIG. 25. However, the stabilizing end 16 may
have additional loops, such as two loops, three loops, four loops
or any combination with partial loops, such as a half loop, one and
a half loops, two and a half loops or three and a half loops, to
name a few. The wire end at the far proximal end of the stabilizing
end 16 may be terminated using a crimp, compression sleeve, weld,
glue joint or tether to connect it to the previous loop. By
connecting the proximal loose end of the stabilizing end to the
previous loop, the hoop strength of the stability end is greatly
enhanced. This brings benefit in two ways. It reduces the
likeliness that the stabilizing end will be forced into a smaller
diameter and be pulled into the airway. By preventing this, the
odds of bringing long term benefit for the patient are greatly
increased. Also, there are circumstances in which the treatment
devices may need to be removed, such as times when the patient may
have severe lung infection or lung cancer. In order to recapture
and remove a device, large bronchoscope must be utilized to provide
a large bore channel and lumen for a forceps or other instrument
that will be used to connect to the treatment device. These scopes
typically provide a 2.0 mm channel and the scope outside diameter
normally exceeds 6 mm Large scopes such as the one we are
describing cannot be guided past the 3.sup.rd generation airways so
it is ideal that the stabilizing end of the treatment device can be
reliably fixed at the ostium that joins 3rd generation airways.
Most other devices that intend to treat these patients tend to
migrate deeper in the lung and they present the physician who is
charged to remove them with great difficulties.
[0839] In one embodiment, the shaft 12 forms the extendible
midsection 18 along the longitudinal axis 19 and then bends
radially outwardly distal to the extendible midsection 18, such as
perpendicularly or at a 90 degree angle to the longitudinal axis
19, forming a loop 70 in the same plane. Thus, the loop 70 has an
opening 72 perpendicular to the longitudinal axis 19 and has a
circular shape. Likewise, in this embodiment, the loop 70 extends
nearly 360 degrees around the longitudinal axis 19.
[0840] The loops 70 may have any suitable diameter, typically in
the range of 10 mm to 12 mm, particularly when formed from a shaft
12 having a diameter of 0.3 mm. Thus, the overall diameter of the
stabilizing end 16 is typically smaller than the diameter of the
tissue gathering end 14. When the stabilizing end 16 comprises a
plurality of loops 70, each of the loops 70 may have the same
diameter or differing diameters. Typically, the loops 70 are
expandable so as to enlarge within an ostium OS or other suitable
portion of the tracheobronchial tree.
[0841] Typically, the stabilizing end 16 is the portion of the
device 10 which is pulled to re-tension the lung and locate the
final placement of the device 10 for implantation. Therefore, in
such embodiments, the stabilizing end 16 includes an attachment
feature 38 to which the deployment element 30 of the bronchoscope
20 is coupled. In the embodiment of FIG. 25, the attachment feature
38 comprises a loop 40 formed by the proximal tip of the shaft 12
of the device 10. Such a loop-shaped attachment feature 38 may be
utilized with a compatible attachment mechanism 36 on the
deployment element 30, such as a tether 42 and a support rod 44, as
previously illustrated in FIGS. 8-9. The tether 42 extends through
the loop 40 and around the support 42 so as to secure the loop 40
to the support rod 44. Thus, the stabilizing end 16 of the device
10 is able to remain attached to the deployment element 30 during
deployment by the attachment mechanism 36.
[0842] In other embodiments, the attachment feature 38 is located
distally of the stabilizing end 16, such as illustrated in FIG. 26.
Here, the attachment feature 38 comprises a loop 40 formed by the
shaft 12 between the extendible midsection 18 and the stabilizing
end 16. Again, such a loop-shaped attachment feature 38 may be
utilized with a compatible attachment mechanism 36 on the
deployment element 30, such as a tether 42 and a support rod 44, as
previously illustrated in FIGS. 8-9. Since the attachment feature
38 is distal to the stabilizing end 16, the attachment feature 38
may be pulled proximally in a way that allows the stabilizing end
16 to expand and anchor freely in the ostium. Thus, the stabilizing
end 16 will be free to expand into the ostium OS while pulling on
the device 10 in the proximal direction during delivery.
[0843] It may be appreciated that other types of attachment
features 38 may be used, such as threaded couplers, hook like wire
forms, snap lock connections etc.
[0844] In some embodiments, the shaft 12 has a separate proximal
tip which is "turned-down" or facing in the proximal direction. In
some embodiments, the proximal tip is aligned with the longitudinal
axis 19 and in other embodiments the proximal tip is offset from
the longitudinal axis 19. In any case, the turned-down
configuration aligns the proximal tip 76 with or parallel with the
direction of tension so as to avoid or reduce any trauma to the
surrounding tissue, such as blunt end agitation on the airway wall
or bleeding or coughing that this brings. The proximal tip 76 may
have a variety of shapes including a coil, ball, end loop, cone
shape or other blunt end shape that will minimize tissue agitation
during breathing related motion.
D. Shaft Materials
[0845] The pulmonary treatment device 10 may be formed from a
single element, such as a continuous shaft 12, or from individual
parts that are joined together. When parts are joined together,
they may ultimately appear as a continuous shaft 12, however the
device 10 will include various transition zones where the parts are
joined. In some embodiments, the parts are comprised of differing
materials, etc. Thus, the shaft 12 will be described herein and may
refer to a single continuous shaft forming the tissue gathering end
14, extendible midsection 18 and stabilizing end 16, or a shaft
forming any one or more of these parts.
[0846] In some embodiments, the shaft 12 is comprised of a
shape-memory alloy, such as nickel titanium (nitinol). Nitinol
alloys exhibit two closely related and unique properties: shape
memory effect and super-elasticity or pseudo-elasticity. Shape
memory is the ability of nitinol to undergo deformation at one
temperature, then recover its original, undeformed shape upon
heating above its "transformation temperature". Super-elasticity
occurs at a temperature range above its transformation temperature;
in this case, the transformation temperature should be set under
that of body temperature so no heating is necessary to cause the
undeformed shape to recover, and the material exhibits enormous
elasticity, some 10-30 times that of ordinary metal.
[0847] Thus, the desired configuration of the shaft 12 (e.g. bends,
loops, etc.) is set during manufacturing of the device 10. The
device 10 is then able to be elongated, restrained, compressed or
deformed, such that when loaded within the delivery device, the
pulmonary treatment device recovers to its original shape in free
space. When the device 10 is delivered to a confined space, the
device 10 is able to recover toward its original shape, with
modifications according to the confined space. Recovery force is
tuned by adjusting Austenite final (A.sub.f) temperature using heat
treating of the alloy during manufacturing. An A.sub.f temperature
closer to body temperature (37.degree. C.) lowers recovering force.
An A.sub.f temperature farther below body temperature increases
recovery force. Thus, in some embodiments, an A.sub.f temperature
that is 5-50 degrees below body temperature is preferred. In other
embodiments, the pulmonary treatment device my beneficially be
produced with a gradation of A.sub.f temperatures. For instance, a
large wire may be used to produce the device so the distal and
proximal structures are strong, tuned with an A.sub.f of 15 degrees
C. to allow them to anchor into tissue reliably but the extendable
midsection, also constructed using the same large wire, may be
thermally tuned so the A.sub.f is 30 degrees C. (closer to 37
degrees C., typical body temperature) so the extendable midsection
is weaker and the spring stress versus strain ratio is lower. Any
number of A.sub.f temperatures may be set at any location on the
implant in order to enhance performance.
[0848] In some embodiments, the metallic surface of the nitinol is
stripped of contaminants and oxides to native metal. The nitinol is
then passivated to form a thin layer of titanium dioxide on the
surface for optimal biocompatibility. In some embodiments, the thin
layer is 0.5-10 .mu.m thick, preferably 2 .mu.m thick.
[0849] In some embodiments, the shaft 12 is comprised of a metal,
such as stainless steel, steel containing chromium, steel
containing cobalt, steel containing chrome, a metal alloy with
nickel and/or titanium, a biocompatible metal that is fully elastic
after being strained, or a combination of these, to name a few. In
some embodiments, the metallic surface of the metal is stripped of
contaminants and oxides to native metal. The metal is then
passivated to form a thin layer of chromium oxide (when the metal
is steel-based) on the surface for optimal biocompatibility. In
some embodiments, the thin layer is 0.5-10 .mu.m thick, preferably
2 .mu.m thick.
[0850] In some embodiments, the shaft 12 is comprised of other
materials, such as composites (e.g. carbon fiber) or ceramics,
polymers, polyimide film (e.g. Kapton.RTM.), para-aramid synthetic
fiber (e.g. Kevlar.RTM.), nylons, polyimides, metals such as
titanium, nickel alloys, nitinol, memory shape alloys such as
martensite nitinol or super-elastic forms of nitinol.
[0851] In some embodiments, the shaft 12 is comprised of wire, such
as round-section wire, or square or rectangular section ribbon. The
shaft 12 may be solid or hollow, such as comprised of tubing. All
edges of the shaft 12 are free of sharp edges to minimize
inflammation and the related granulation tissue that is formed from
cyclic agitation of the soft tissues in the lung.
[0852] In some embodiments, the shaft 12 has a diameter between
0.010 inches-0.080 inches, but preferably between 0.009 and 0.023
inches.
E. Shaft Tips
[0853] As mentioned, the shaft 12 has a distal tip 54 and a
proximal tip 76. In some embodiments, such tips 54, 76 are
optimized to assist in advancement of the device 10 from the
delivery device. Typically, the tips 54, 76 have a blunt surface to
reduce any potential injury or inflammation of tissue due to
delivery. In addition, in some embodiments, the tips 54, 76 include
a feature which assists in resisting relative motion between the
tips 54, 76 and the surrounding tissue. This helps to resist
sliding or movement of the tips 54, 76 towards the center of the
implant, such as toward the extendible midsection 18. Such
resistance to tip migration bolsters storage of potential energy in
the device 10 rather than losing energy during migration. Thus, for
example, the distal tip 54 can advance but resists moving
backwards, in the proximal direction, and the proximal tip 76 can
be pulled proximally but resists moving in the distal
direction.
[0854] FIGS. 27A-27D illustrate example tips 90 suitable for either
the distal tip 54 or proximal tip 76. Each of the tips 90 are
formed at the end of the shaft 12. FIGS. 28A-28B illustrate example
methods of forming such tips 90. To begin, FIG. 27A illustrates an
embodiment of a tip 90 having a ball shape. Such a ball shape may
be formed by melting the distal-most portion 92 of the shaft 12, as
illustrated in FIG. 28A. Here, a forming tool, such as a copper
mold 96 is positioned a distance d from the end of the shaft 12.
The copper mold 96 serves as a heat sink. The distal-most portion
92 of the shaft 12 is then melted while the copper mold 96 stops
the melt-back, forming the ball. Thus, the length of distance d
determines the size of the ball shaped tip 90.
[0855] FIG. 27B illustrates an embodiment of a tip 90 having a
cylindrical shape. Such a cylindrical shape may be formed by
melting the distal-most portion 92 of the shaft 12, as illustrated
in FIG. 28B. Here, a forming tool, such as a copper casting tool 98
or welding arc, is positioned a distance d from the end of the
shaft 12. The copper casting tool 98 serves as a heat sink and a
mold. The distal-most portion 92 of the shaft 12 is then melted
into the casting tool 98 forming a cylindrical shape. Again, the
length of distance d determines the size of the cylindrical shaped
tip 90.
[0856] FIG. 27C illustrates an embodiment of a tip 90 having a
blunt large bore shape. A tube is placed over wire and the wire and
tube are welded together, to yield a hemisphere tip and tube with a
chamfer or straight cut back edge to grab tissue.
[0857] FIG. 27D illustrates an embodiment of a tip 90 having a coil
spring and spherical end shape. By placing a coil over the wire,
positioning the coil end coincident with the wire end and striking
a welding arch at the end, a hemispherical weldment is created that
joins the coil and wire that is blunt and larger diameter than the
bare wire would be without the benefit of the coil. The wire coil
or tube used to make the tips can be made from titanium, nitinol or
a more radiopaque material such as tungsten, tantalum, gold or
platinum.
[0858] In each of these embodiments, the tip 90 is smooth to allow
removal of the device 10 if desired, but the increase in diameter
compared to the shaft 12 allows the tip 90 to catch on a portion of
tissue, particularly in an area of damaged tissue DT, which assists
in anchoring the tip the place.
[0859] It may be appreciated that in some embodiments, the tip 90
functions as an attachment feature 38. In such embodiments, the tip
90 includes a hole or opening 120, as illustrated in FIGS. 29A-29D,
which is used to connect with an attachment mechanism 36. Thus, a
tether 42 can be passed through the opening 120 and around a
support rod 44, so as to secure the tip 90 to the support rod 44.
This allows the device 10 to be attached to the deployment element
during delivery, as described previously.
F. Jacket
[0860] In some embodiments, the pulmonary treatment device 10
includes one or more jackets 80. A jacket 80 is a covering that
extends over the shaft 12, such as to increase the diameter of the
shaft 12, increase engagement quality with surrounding tissue,
increase surface area of the shaft 12, and/or to provide drug
delivery, to name a few. The jacket 80 may be formed from a variety
of materials, such as metals (e.g. stainless steel, titanium,
nitinol, nickel, cobalt chrome, or a combination of these) or
polymers (e.g. polycarbonate urethane, polytetrafluoroethylene
(PTFE), fluorinated ethylene propylene (FEP), polyimide film (e.g.
Kapton.RTM.), polyimide, polyether ether ketone (PEEK),
polyethylene, ethylene-vinyl acetate (EVA) (also known as poly
(ethylene-vinyl acetate) (PEVA)), polypropylene, polyvinyl alcohol
(PVA), polyurethane, nylon, polyether block amides (PEBA),
acrylonitrile butadiene styrene (ABS), polybutyrate, polyethylene
terephthalate (PET), polysulfone (PES), ethylene
tetrafluoroethylene (ETFE), polyvinylidene fluoride (PVDF),
thermoplastic polyurethane elastomers (e.g. Pellethane.RTM.),
aliphatic polyether-based thermoplastic polyurethanes (TPUs) (e.g.
Tecoflex.RTM.), or a combination of these). Likewise, the jacket 80
may be formed from a metallocene. A metallocene is a compound
typically comprising two cyclopentadienyl anions (Cp, which is
C.sub.5H.sup.-.sub.5) bound to a metal center (M) in the oxidation
state II, with the resulting general formula
(C.sub.5H.sub.5).sub.2M.
[0861] The jacket 80 may take a variety of forms. In some
embodiments, the jacket 80 comprises a wire, extrusion or sleeve
that is welded to, over-molded, shrunk to, glued to, adhered to,
compression fit to or otherwise joined with the shaft 12. In some
embodiments, the jacket 80 has the form of a coil which is advanced
over the shaft 12 in the desired area. In such embodiments, a ball
or other feature may be welded to the shaft 12 to hold the jacket
80 on the shaft 12. In other embodiments, the jacket 80 comprises a
coating.
[0862] Both FIG. 25 and FIG. 26 illustrate a pulmonary treatment
device 10 having a plurality of jackets 80. For example, the device
10 includes a first jacket 80a positioned over the tissue gathering
end 14. In some embodiments, the first jacket 80a covers the entire
tissue gathering end 14, as shown, and in other embodiments, the
first jacket 80a covers a portion of the tissue gathering end 14.
An example of such a first jacket 80a is a 20 mm diameter nitinol
coil; such a jacket may be suitable for positioning over, for
example, a shaft 12 comprising a 1.0 mm diameter wire. This allows
passage of the tissue gathering end 14 through a 2.0 mm channel of
a bronchoscope 20. However, it may be appreciated that other sized
jackets may be used, particularly in the range of 0.5-3.0 mm
diameter. For example, if a therapeutic scope is used as a delivery
device (having a 2.8 mm channel), a jacket having a 2.8 mm diameter
may be used. Increasing the cross sectional area of the tissue
gathering end increases the bearing area imparted on the tissue
which reduces the pressure imparted on the tissue and this reduces
implant migration or implant ingrowth through the tissue. These
benefits are important as they increase the durability of the
treatment.
[0863] In FIG. 25 and FIG. 26, the device 10 includes also includes
a second jacket 80b positioned over the stabilizing end 16. In some
embodiments, the second jacket 80b covers the entire stabilizing
end 16 (FIG. 25), and in other embodiments, the second jacket 80b
covers a portion of the stabilizing end 16 (FIG. 26). An example of
such a second jacket 80b is a 0.50-4 mm diameter nitinol coil but
most preferably a 2.5-2.8 mm diameter coil; such a jacket may be
suitable for positioning over, for example, a shaft 12 comprising a
0.2-0.3 mm diameter wire. This also allows passage of the
stabilizing end 16 through a 2.8 mm channel of a bronchoscope 20.
Again, it may be appreciated that other sized jackets may be used,
particularly in the range of 0.5-4.0 mm diameter. For example, if a
therapeutic scope is used as a delivery device (having a 2.8 mm
channel), a jacket having a 2.8 mm diameter may be used.
[0864] The second jacket 80b increases the area that is engaging
tissue. By maximizing the bearing area in contact with the tissue
to be greater than 9.81E-8 square inches but preferably more than
10E-7 square inches of bearing area per linear inch along the
implantable device centroid+, the potential for device migration
through tissue is nearly eliminated. This reduces erosion into the
airway by the device 10 to increase treatment effect durability. In
addition, the second jacket 80b prevents the stabilizing end 16
from "cheese wiring" or cutting through the soft ostium tissue.
[0865] In some embodiments, the jacket 80 provides controlled
delivery of an agent, such as a drug. In some instances, such
delivery reduces the rate of wound healing, tissue remodeling,
inflammation, generation of granular tissue, and hyperplasia, to
name a few.
Alternative Embodiments
[0866] It may be appreciated that the pulmonary treatment device 10
may take a variety of alternative forms. In such embodiments, the
device 10 may include elements similar in function but differing in
form. Or, the embodiments may include features which function
differently but still satisfactorily treat the lung. FIG. 30
illustrates an embodiment of a device 10 configured from a shaft 12
comprising a hollow tube. In this embodiment, the device 10
includes a tissue engaging end 14, an extendible midsection 18, and
a stabilizing end 16, each laser cut from the hollow tube. Here,
the tissue engaging end 14 includes one or more wings 100 which
extend radially outwardly from the longitudinal axis 19 when
deployed. Each wing 100 has an elongate shape formed from the shaft
12, such as by laser cutting longitudinal slits in the shaft 12
from the extendible midsection 18 to the distal tip 54. Thus, the
tissue engaging end 14 is configured to have a slim profile,
wherein the wings 100 extend in parallel to the longitudinal axis
19, while the tissue engaging end 14 is disposed within the
delivery device. Each wing 100 also has a predetermined bend
location 102, typically midway along the length of the wing 100.
Upon deployment, each wing 100 juts radially outwardly,
perpendicular to the longitudinal axis 19, by bending at its bend
location 102. This creates an expanded profile which allows the end
14 to engage the damaged tissue DT of the lung. As each wing 100
bends radially outwardly, the expandable midsection 18 and distal
tip 54 are drawn toward each other.
[0867] In this embodiment, the extendible midsection 18 is also
laser cut from the hollow tube shaft 12. Here, the hollow tube is
cut in a helical or spiral shape to form a spring or coil. Further,
in this embodiment, the stabilizing end 16 is also cut from the
hollow tube shaft 12. Here, the stabilizing end 16 includes at
least one prong 104 cut from the shaft 12. Each prong 104 may have
any suitable shape but is typically elongate having a free end with
an atraumatic tip 106. The stabilizing end 16 is configured to have
a slim profile, wherein the prongs 104 extend in parallel to the
longitudinal axis 19, while the stabilizing end 16 is disposed
within the delivery device. Each prong 104 also has a pre-curvature
which causes the prong 104 to bend radially outwardly, away from
the longitudinal axis, upon deployment. This allows the stabilizing
end 16 to expand in a desired lung area, such as an ostium, to
stabilize the position of the device 10 when implanted. In this
embodiment, the stabilizing end 16 also includes an attachment
feature 38 for attaching to an attachment mechanism 36 on the
deployment element 30 during deployment. In this embodiment, the
attachment feature 38 comprises a hole cut into the tubular shaft
12.
Delivery Device Embodiments
[0868] As mentioned previously, the pulmonary treatment device 10
is sized and configured to be delivered by a delivery device that
is insertable into the lung, such as a steerable scope (e.g.
bronchoscope 20), catheter or other delivery system. The delivery
device is configured to be advanced within any anatomical lumen in
the lung that is either innate or created within the lung, either
by disease or with the use of an instrument. An example delivery
device is a bronchoscope 20, an embodiment of which is illustrated
in FIG. 31A-31B. In this example, the bronchoscope 20 includes a
bronchoscope body 200 and an insertion cord 202. The insertion cord
202 is advanced into the endobronchial tree of the patient and the
bronchoscope body 200 remains outside of the patient, typically
grasped by the operator's non-dominant hand. The insertion cord 202
contains a fiberoptic bundle for light and image transmission, tip
bending control wires and a working channel. The average length of
the insertion cord 202 is 600 mm (range 500-650 mm). The working
channel continues into the bronchoscope body 200, exiting at the
working channel port 204. The bronchoscope body 200 also includes
an eye piece (which can be attached to a camera for display on a
screen-fiberoptic scopes have an eye piece; video scopes do not),
diopter ring (for focusing), and control lever. The control lever
is used to control the distal tip of the insertion cord 202.
Typically, the control lever is used to move the insertion cord tip
208 up/down and/or side-to-side, whereas rotation is typically
achieved by rotation of the bronchoscope body 200 with the
operator's wrist and shoulder. The bronchoscope 20 also includes a
light source which can be supplied via a cable 206 or a portable
battery powered source. The light source may be halogen,
incandescent or LED, to name a few. FIG. 31B illustrates an end
view of the insertion cord tip 208. As shown, the working channel
210 extends through the tip 208, allowing delivery of the pulmonary
treatment device 10 therefrom.
[0869] As mentioned previously, in some embodiments, the pulmonary
treatment device 10 is configured to be delivered through a lumen
in the delivery device, such as by pushing the treatment device
through a lumen of a scope, catheter, introducer, sheath, sleeve or
similar device. For example, in some embodiments, the pulmonary
treatment device 10 is loaded directly into the working channel
port 204 and advanced through the working channel 210 for delivery
from the insertion cord tip 208. However, in other embodiments, the
device 10 is pre-loaded into an introducer which is advanceable
into the working channel 210 for delivery therefrom. In other
embodiments, the treatment device 10 is mounted on a guidewire
which constrains portions of the device 10, preventing these
portions from expanding radially. The device 10 and guidewire are
advanced together into the working channel 210 for delivery
therefrom. In another embodiment, the device is pre-loaded on the
guidewire which is advanceable into the working channel 210 for
delivery therefrom.
[0870] FIG. 32 illustrates an embodiment of an introducer 220
having a pre-loaded pulmonary treatment device 10. In this
embodiment, the introducer 220 comprises an elongate tube 222
having a first end 224 and a second end 226. The elongate tube 222
is comprised of any suitable material, such as metal, stainless
steel, polymer or composite tubing. Typically, the elongate tube
222 has a bend to assist in insertion into the working channel port
204 or is bendable to both assist in insertion and to allow for
compact packaging (such as positioning into round track or square
track packaging without kinking) In any case, the introducer 220
should be strong enough to keep the device 10 from distorting from
a straight configuration and hard enough that the device 10 cannot
indent into the wall of the introducer 220, particularly during the
sterilization process that involves heating to 130-180.degree. C.
The introducer 220 can be any suitable length, such as a minimum of
2 inches longer than the device 10 therein and a maximum of half
the length of the deployment element 30. In some embodiments, the
introducer 220 has a length of 4 to 20 inches, preferably 10
inches.
[0871] FIG. 32 illustrates the stabilizing end 16 and the
extendible midsection 18 loaded within the introducer 220. Here,
the tissue gathering end 14 is disposed outside of the introducer
220 and allowed to coil into its expanded state. In some
embodiments, the tissue gathering end 14 is packaged in this
configuration to reduce stress on the end 14 during transport and
sterilization. In such embodiments, the tissue gathering end 14 is
then retracted into the introducer 220 prior to use. In this
embodiment, the first end 224 of the introducer 220 is removably
joined with a funnel 230 to assist in retracting the tissue
gathering end 14 into the introducer 220. Thus, the funnel 230 has
a tapered shape which gradually draws the tissue gathering end 14
radially inward toward the interior lumen of the introducer 220.
Once the tissue gathering end 14 resides within the introducer 220,
the funnel 230 is removed.
[0872] In this embodiment, the device 10 is attached to a
deployment element 30 by tether 42. The deployment element 30
comprises an elongate shaft 32, typically having an interior lumen
extending therethrough. The elongate shaft 32 may take various
forms, including a coiled shape, as shown and may be comprised of a
variety of materials, such as metal or polymer. In some
embodiments, the shaft 32 is comprised of a wire or polymer coil
having a flexible exterior sheath or liner that minimizes kinking
as it is advanced through the working channel 210 of the
bronchoscope 20. Likewise, in some embodiments, the shaft 32
includes an interior liner, such as of polytetrafluoroethylene or
other polymer, to protect the tether 42 passing therethrough from
breaking. In other embodiments shaft 32 is comprised of a braided
frame with a liner (such as comprised of polytetrafluoroethylene)
and an outer jacket (such as comprised of thermoplastic elastomer
or flexible polyamide). It may be appreciated that in some
embodiments, the elongate shaft 32 has a solid center rather than a
hollow center. It may also be appreciated that the deployment
element 30 may have any suitable length, such as 13-45 inches,
preferably 34 inches.
[0873] When the elongate shaft 32 is hollow or has an interior
lumen, the tether 42 passes through the interior lumen, through the
attachment feature 38 and then back through the interior lumen of
the deployment element 30 creating two free ends 240 of the tether
42. The tether 42 may be comprised of any suitable material such as
a monofilament or braided high strength polymer, a carbon fiber, or
a thread or braid comprising metal, stainless steel, nitinol,
titanium, steel alloyed with chrome or cobalt,
polytetrafluoroethylene, and/or material from a family of
ultra-high molecular weight polymers, to name a few.
[0874] In this embodiment, the deployment element 30 extends out of
the second end 226 of the introducer 220 and culminates in a hub
242 which holds the free ends 240 of the tether 42. Thus, the
device 10 is able to remain attached to the deployment element 30
by tether 42 during deployment. In this embodiment, the hub 242 of
the deployment element 30 comprises a base 244 and a top 246. Here,
each of the base 244 and top 246 are thumb knob shaped for ease of
use. In this embodiment, the base 244 is crimped, glued or welded
to the shaft 32 of the deployment element 30. The free ends 240 of
the tether 42 extend from the shaft 32 and then pass through the
base 244, typically within a cavity 248 therein. Such passage
through the cavity 248 ensures that the tether 42 is not abraded by
the base 244. In this embodiment, the cavity 248 has tapered walls
leading to the shaft 32 so as to minimize the size of the cavity
248 while ensuring adequate space for the tether 42. The free ends
240 then pass through the top 246 where they are separated into
individual lumens 230. The lumens 230 are spaced apart to impart a
moment while twisting to make length reduction related tightening
more effective. In this embodiment, the free ends 240 then wrap
around a support 250 which reduces stress on the tether 42.
Typically, the support 250 has an atraumatic shape, such as a
cylinder or ball. The free ends 240 are then held together with a
clip 252.
[0875] FIG. 33 illustrates another embodiment of an introducer 220
having a pre-loaded pulmonary treatment device 10. In this
embodiment, the introducer 220 again comprises an elongate tube 222
having a first end 224 and a second end 226. The elongate tube 222
is comprised of any suitable material, such as metal or polymer. In
this embodiment, the device 10 comprises a tissue gathering end 14
and a stabilizing end 16, without an extendible midsection 18. FIG.
33 illustrates the tissue gathering end 14 and stabilizing end 16
loaded within the introducer 220.
[0876] In this embodiment, the deployment element 30 is attached to
the attachment feature 38 of the device 10 by tether 42. The
deployment element comprises an elongate shaft 32 having an
interior lumen extending therethrough. The elongate shaft 32 may
take various forms, including a coiled shape, as shown. The tether
42 passes through the interior lumen of the deployment element 30,
through the attachment feature 38 and then back through the
interior lumen of the deployment element 30 creating two free ends
240 of the tether 42. In this embodiment, the deployment element 30
extends out of the second end 226 of the introducer 220 and
culminates in a hub 242 which holds the free ends 240 of the tether
42. Thus, the device 10 is able to remain attached to the
deployment element 30 by tether 42 during deployment. In this
embodiment, the hub 242 of the deployment element 30 comprises a
base 244. In this embodiment, the base 244 is crimped, glued or
welded to the shaft 32 of the deployment element 30. In this
embodiment, the free ends 240 then wrap around a support 250 which
reduces stress on the tether 42. Typically, the support 250 has an
atraumatic shape, such as a cylinder or ball. The free ends 240 are
then held together with a clip 252.
[0877] In any case, the use of a pre-loaded introducer 220 allows
for ease in loading of the bronchoscope 20 for delivery of the
device 10 therethrough. The introducer 220 holds the device 20 in a
relatively straight configuration so it can easily be introduced
into the bronchoscope 20. In some embodiments, the introducer 220
also holds the device 20 in a radially compressed configuration so
that it can be advanced through the working channel 210 of a
bronchoscope 20 having a conventional inner diameter (e.g. 2.0 mm)
Thus, the operator is relieved from any manipulation of the device
10 during loading of the bronchoscope 20 and is ensured proper
orientation and delivery.
[0878] As illustrated in FIG. 34, the pre-loaded introducer 220 is
advanceable into the working channel port 204 of the bronchoscope
20, typically once the bronchoscope 20 has been desirably
positioned within the lung. In some embodiments, the introducer 220
has a shape, such as a male luer taper, that sockets into the
working channel port 204. Such advancement into the port 204
relieves the operator from holding the device 10 during delivery.
As shown, the device 10 is advanced from the first end 224 of the
introducer 220 and into the working channel 210 by advancement of
the deployment element 30. Thus, the deployment element 30 pushes
the device 10 through the introducer 220 and through the working
channel 210 of the bronchoscope 20.
[0879] FIG. 35 illustrates the insertion cord tip 208 of the
bronchoscope 20 positioned in the damaged tissue DT of the
patient's lung. The position of the insertion cord tip 208
indicates the delivery location of the tissue gathering end 14. The
tissue gathering end 14 is deployed at this delivery location by
retraction of the bronchoscope 20 while holding the deployment
element 30 fixed. Thus, the deployment element 30 and attached
device 10 remain fixed in relation to the anatomy while the
bronchoscope 20 is retracted. This exposes the tissue gathering end
14, allowing the tissue gathering end 14 to expand into a deployed
configuration. In this embodiment, the tissue gathering end 14
comprises a loop 50 deployed in a plane perpendicular to the
longitudinal axis 19 of the device 10.
[0880] Once the tissue gathering end 14 is deployed, the lung is
ready for re-tensioning. This can be achieved by a variety of
methods. In one embodiment, the deployment element 30 is fixed
relative to the bronchoscope 20 and together the deployment element
30 and bronchoscope 20 are retracted. Such retraction pulls the
tissue gathering end 14 toward the larger bronchioles and trachea,
which in turn pulls the damaged tissue DT, because the device 10 is
connected to the deployment element 30. This is continued until a
desired level of re-tensioning of the lung, has been achieved. It
may be appreciated that the deployment element 30 and bronchoscope
20 can be advanced and retracted together as needed to adjust the
level of re-tensioning, if desired.
[0881] As mentioned, other methods of delivery and re-tensioning
can be achieved with the pulmonary treatment device 10. In some
embodiments, the tissue gathering end 14, optional midsection 18,
and stabilizing end 16 are all deployed prior to the re-tensioning
step. Thus, once the device 10 has been deployed, re-tensioning can
be achieved by retracting the deployment element 30 and
bronchoscope 20 together as described previously. The retraction
pulls the device 10 toward the larger bronchioles and trachea,
which in turn pulls the damaged tissue DT. Retraction continues
until the stabilizing end 16 is seated in a desired portion of the
airway. Once the operator is satisfied with the placement of the
device 10, the device 10 is detached from the deployment element
30.
[0882] It may be appreciated that the device 10 may alternatively
be deployed from the bronchoscope 20 by advancing the deployment
element 30, thereby pushing the device 10 out of the working
channel 210 of the bronchoscope 20. In such embodiments, the
deployment element 30 typically has a low compressibility. Such
deployment of the device 10 can be achieved all at once or in
separate steps. Since the deployment element 30 is attached to the
device 10, re-tensioning can be achieved by the same methods as
described above (i.e. retraction of the deployment element 30 and
bronchoscope 20). Once the operator is satisfied with the placement
of the device 10, the device 10 is detached from the deployment
element 30.
[0883] It may be appreciated that in some embodiments, the device
10 is delivered to the desired location within the lung with the
use of a guidewire and/or catheter, passed through the working
channel 210 of a bronchoscope 20 or alone.
[0884] When more than one device 10 is to be implanted into the
patient during a procedure with the use of a bronchoscope 20, the
bronchoscope 20 is typically exchanged or cleaned before implanting
the next device 10. Since bronchoscopes 20 typically not
disposable, they are designed for such cleaning protocols. The
ability to easily exchange or clean the delivery device between
uses reduces any risk of cross-contamination from one portion of
the lung to another and/or from one lung to another. Previously,
when using conventional devices and treatment protocols, both lungs
of a patient could not be treated during the same procedure due to
risks of cross contamination between both lungs which could prove
fatal to the patient. However, the delivery methods and devices of
the present invention reduce or eliminate this risk.
[0885] It may be appreciated that an additional device 10' can be
implanted into the same airway as a previous implanted device 10.
In some embodiments, the additional device 10' is passed through
the previously implanted device 10 to reach a more distally located
area of the lung.
[0886] In some embodiments, the device 10, attached deployment
element 30 and introducer 220 are packaged or pouched as a single
unit. Each unit is used to treat a particular target location in
the lung. In some embodiments, the units are sold individually
since the number of devices 10 implanted in a single lung will vary
depending on the patient's disease state and a variety of other
features. In other embodiments, the units are sold by the box
wherein each box contains a plurality of units. In some
embodiments, 6-14 devices are delivered to a single lung during a
treatment session. If two lungs are treated during a single
treatment session, upwards of 30 devices may be used. It may be
appreciated that in some embodiments, the procedure has a flat cost
wherein an unlimited number of devices 10 may be used during the
procedure for the same cost. This allows the operator to focus on
the technical aspects of the procedure rather than on the cost of
using additional units.
[0887] It may be appreciated that in some embodiments, two or more
devices 10 are joined or fixed together within the lung anatomy.
FIGS. 36-37 illustrate an embodiment wherein two devices 10 are
joined with the use of a joining device 300. FIG. 36 illustrates a
first device 10a implanted at a first location within a lung L and
a second device 10b implanted at a second location within lung L.
In this embodiment, the first and second locations are along lung
passageways branching from the same ostium OS. As shown, the tissue
gathering ends 14 are disposed in damaged tissue DT and the
stabilizing ends 16 are located more proximal along the respective
lung passageways. In addition, each device 10a, 10b has a
respective tether 42a, 42b attached to its attachment feature 38.
The tethers 42a, 42b extend from the devices 10a, 10b to the
exterior of the patient. The delivery device is not shown in FIG.
36 for clarity, however the tethers 42a, 42b extend through the
delivery device to the exterior of the patient. The joining device
300 is then advanced over the free ends 240a, 240b of the tethers
42a, 42b. In this embodiment, the joining device 300 comprises a
clip having a first arm 302a and a second arm 302b, wherein the
arms 302a, 302b are connected by a connector 304. Each arm 302a,
302b has a respective lumen 306a, 306b through which an individual
tether passes. Thus, joining device 300 is advanced over the free
ends 240a, 240b so that the first tether 42a passes through the
lumen 306a of the first arm 302a and the second tether 42b passes
through the lumen 306b of the second arm 302b. The joining element
300 is then advanced along the tethers 42a, 42b until the arms
302a, 302b reach the devices 10a, 10b. As illustrated in FIG. 37,
the joining device 300 is then advanced so as to attach the first
arm 240a to the first device 10 and the second arm 240b to the
second device 10b. In this embodiment, the joining device 300
resides within the ostium OS, each arm 302a, 302b extending toward
a separate lung passageway, thereby creating a V or U shape. The
tethers 42a, 42b are removed and the joining device 300 is left in
place.
[0888] In other embodiments of the invention, the pulmonary
treatment device 10 is mounted on the outside of the bronchoscope
20. Mounting the device 10 on the outside of the bronchoscope 20
avoids packing the device 10 within a bronchoscope working channel
210 or catheter within a bronchoscope channel which involves
restraining the device 10 in a high strain configuration. Once
restrained, the device 10 would then transition to a more relaxed
configuration upon deployment. However, by mounting the device 10
on the outside of the bronchoscope 20, device 10 can be delivered
into the patient in a non-stressed and non-strained state. This
configuration provides the benefit of reliably delivering the
treatment device 10 along the delivery path in substantially the
same shape as it will be when it is inserted into the target
airway. In addition, the device 10 may be comprised of a broader
selection of materials, including high strength materials that
would typically be unsuitable for such restraint and relaxation. In
some embodiments, the treatment device 10 may be comprised of
titanium, steel, a stainless-steel alloy, one or more ferrous
metals, one or more non-ferrous metals, metals that contain nickel,
iron, and/or manganese, or any combination of these listed
materials. In other embodiments, the treatment device 10 may also
be comprised of a polymer material, a ceramic material or a
composite material that is made from any combination of plastic,
metal, carbon, carbon fiber or any other material that exhibits
resilience and biocompatibility performance, such as nitinol or an
alloy made from nickel and titanium. It may be appreciated that, in
some embodiments, materials that can perform in a fully reversible
elastic way up to a minimum of 1% strain are very suitable.
[0889] FIG. 38 illustrates an embodiment of a delivery system 301
for delivering a treatment device 10. In this embodiment, the
system 301 includes a bronchoscope 20 having a bronchoscope body
200 and an insertion cord 202 with an insertion cord tip 208.
Suitable bronchoscope outer diameters may be as large as 10 mm in
diameter but they may also be as small as 1 mm diameter. More
typically, the bronchoscope is between 2 mm and 3 mm outer
diameter. In this embodiment, the delivery system 301 further
includes a deployment sleeve 311 and a guidewire 313, both of which
may be utilized in delivering particular embodiments of the
treatment device 10. As shown, the deployment sleeve 311 includes a
proximal end 310 and a distal end 312. The deployment sleeve 311 is
advanceable through the working channel 210 of the bronchoscope 20,
such as extending through the working channel port 204 and beyond
the insertion cord tip 208, as shown. In some embodiments, the
deployment sleeve 311 is comprised of a polymer tube, a polymer or
metallic round wire coil, a ribbon coil, a braid reinforced sleeve,
an extrusion or any combination of these. In some embodiments, the
deployment sleeve 311 has an outer diameter of up to 5 mm but
preferably its outer diameter is between 2 mm and 4 mm with an
inside diameter as small as 0.010'', but more preferably it has an
inside diameter of 0.018-0.040 inches. Additionally, in some
embodiments, a guidewire 313 is advanceable through the deployment
sleeve 311, as illustrated in FIG. 38. In some embodiments, the
guidewire 313 is comprised of a stainless steel or nitinol core
wire with a stainless-steel or nitinol wound coil outer jacket. The
guidewire diameter may be as small as 0.010'' and as large as 3 mm,
ideally but it's ideally between 0.025-0.040 inches in diameter. In
some embodiments, the guidewire 313 and deployment sleeve 311 are
longer than 60 cm, preferably 90 to 110 cm. Other embodiments
include a much longer guidewire that is 90 cm to 250 cm long, with
sufficient length so that pulmonary treatment devices may be
removed from the patient or exchanged on and off of the guidewire
with enough excess guidewire length to allow the maneuvers to be
accomplished without ever needing to let go of the guidewire. This
insures that the guidewire stays in an appropriate position while
exchanges are being made FIG. 39 illustrates an embodiment of a
pulmonary treatment device 10 that is deliverable by the system 301
of FIG. 38. In this embodiment, the pulmonary treatment device 10
comprises a tissue gathering end 14, an extendible midsection 18
and a stabilizing end 16. In this embodiment, the stabilizing end
16 comprises a coil having a flared configuration, as illustrated
in FIG. 39. Here, the outer diameter of the stabilizing end 16
generally matches that of the extendible midsection 18 and then
gradually expands moving away from the midsection 18 forming the
flared configuration. The flared configuration can assist in
seating the stabilizing end 16 within the airway, particularly
within an ostium. In this embodiment, the stabilizing end 16 also
includes a connector 326 which assists in maintaining the shape of
the stabilizing end 16. When the stabilizing end 16 is comprised of
a coil, the free end of the coil is connected with the remainder of
the coil by the connector 326 to ensure that the free end does not
cause trauma to tissue, such as during delivery and deployment.
Such connection of the free end to the remainder of the coil forms
a complete hoop which increases the hoop strength of the most
proximal portion of the stabilizing end 16. In some instances, the
increased hoop strength assists in anchoring the stabilizing end 16
in a portion of the lung airway.
[0890] In this embodiment, the extendible midsection 18 also
comprises a coil, however the midsection 18 typically has a uniform
diameter. The diameter is typically chosen so as to be mountable on
a bronchoscope 20 or other delivery device, such as a guidewire.
The extendible midsection 18 is able to be elongated to store
elastic strain energy which urges the treatment device 10 to
recover back to a non-elongated length.
[0891] In this embodiment, the tissue gathering end 14 comprises an
anchor strut 322 which is extendable radially outwardly from the
longitudinal axis 19 to assist in anchoring the device 10 within a
lung passageway or within damaged tissue. Anchor strut 322 may
extend 1 mm to more than 30 mm but 6-12 mm is preferable. The
anchor strut 322 terminates in an anchor strut end 321, which may
have a variety of shapes including a coil, ball, sharp end barb, L
shaped pad, strain relief long coil or tapered coil. The anchor
strut 322 is configured to extend radially outwardly upon
deployment so at least the anchor strut end 321 engages an airway
wall W or damaged tissue DT, such as in the area of the alveolar
sacs. However, in some instances, the anchor strut 322 itself
additionally engages the airway wall W or damaged tissue DT.
[0892] During delivery and prior to deployment, the anchor strut
322 is held in a retracted or un-extended position so as to avoid
dragging along the airway walls W or traumatizing tissue. Such
retraction is maintained by an alignment element 320. In this
embodiment, the alignment element 320 has the form of a loop,
however it may be appreciated that the element 320 may have the
form of a partial loop or snap locking structure, partial loop,
hook shaped lock or spring lock mechanism. When the center of the
loop is aligned with the longitudinal axis 19, the anchor strut 322
is held parallel to or at a small angle in relation to the
longitudinal axis 19. Such alignment may be maintained by passing a
device, such as the bronchoscope 20 or guidewire, catheter, balloon
catheter, hitch lock wire, or other accessories related thereto,
through the center of the treatment device 10 and through the
alignment element 320 (as will be illustrated in later sections).
The tissue gathering end 14 is configured so as to bias the
alignment element 320 and attached anchor strut 322 radially
outwardly. Therefore, withdrawal of devices from the alignment
element 320 frees the alignment element 320 and allows the
alignment element 320 to rotate away from alignment with the
longitudinal axis 19. This, in turn, causes the anchor strut 322 to
extend radially outwardly, as illustrated in FIG. 39. Thus, in the
extended position, the alignment element 320 has an axis 19 which
is at an angle .theta. to the longitudinal axis 19. Typically, the
angle .theta. is in the range of 1 to 90 degrees but it's
preferably 20-65 degrees. In some embodiments, additional portions
of the tissue gathering end 14 are also biased to assist in
extension of the anchor strut 322 radially outwardly. For example,
in some embodiments, the tissue gathering end 14 includes a body
strut 323 which is connected to the anchor strut 322. In such
embodiments, the body strut 323 is biased so as to further extend
the anchor strut 322 radially outwardly. In the embodiment of FIG.
39, the body strut 323 is disposed opposite the anchor strut 322 so
that the alignment element 320 is disposed therebetween. Thus, when
the center of the alignment element 320 is aligned with the
longitudinal axis 19, the body strut 323 and anchor strut 322
reside on opposite sides of the longitudinal axis 19. In some
instances, release of the alignment element 320 allows both the
body strut 323 and anchor strut 322 to bias toward their relaxed
configurations (such as pushing both the body strut 323 and anchor
strut 322 outwardly in the same radial direction). This can allow
the body strut 323 and anchor strut 322 to spread fully elastically
at least 5 degrees but up to 90 degrees, and preferably 20 to 65
degrees, to push the anchor strut end 321 into or through the wall
of an airway or the diseased tissue to anchor the tissue gathering
end 14 in the lung tissue.
[0893] In some embodiments, the tissue gathering end 14 further
includes a guide element 319, such as illustrated in FIG. 39. In
this embodiment, the guide element 319 comprises a coil, however
the element 319 may have any suitable shape including a single
loop. In some embodiments, the guide element 319 helps keep the
device 10 centered on the end of the bronchoscope 20 or other
delivery device such as a guidewire, catheter or balloon catheter.
In some embodiments, the guide element 319 is arranged so that a
guidewire emerging from the insertion cord tip 208 of the
bronchoscope 20 passes through the guide element 319. This assists
in aligning the tissue gathering end 14 with the longitudinal axis
19 and holding the body strut 323 and anchor strut 322 in its
retracted position during delivery, prior to deployment. In some
embodiments, the guide element 319 comprises a coil partial coil,
hook, hitch lock system or snap lock geometry. In some instances,
the coil dictates the strength of the spreading force of the anchor
strut 322 radially outwardly.
[0894] FIG. 40 illustrates the treatment device 10 of FIG. 39
mounted on the delivery system 301 of FIG. 38. As shown, the
treatment device 10 is mountable on the bronchoscope 20, deployment
sleeve 311 and guidewire 313. In particular, the most distal
portion of the system 301 is advanced through the central lumen of
the treatment device 10, from the stabilizing end 16 toward the
tissue gathering end 14. Thus, the tissue gathering end 14 of the
treatment device 10 faces distally. In some embodiments, the
stabilizing end 16 and midsection 18 are mounted on the exterior of
the bronchoscope 20. In some embodiments, portions of the tissue
gathering end 14 are also mounted on the exterior of the
bronchoscope 20. For example, in some embodiments the alignment
element 320 is mounted on the bronchoscope 20, as shown in FIG. 40.
In this embodiment, portions of the tissue gathering end 14 extend
beyond the insertion cord tip 208 of the bronchoscope 20. In
particular, the guide element 319 is mounted on the guidewire 313
and held in place by the deployment sleeve 311. This is achieved by
having the inner diameter of the guide element 319 smaller than the
outer diameter of the deployment sleeve 311 so that the guide
element 319 abuts the deployment sleeve 311.
[0895] The delivery system 301 and mounted treatment device 10 are
then advanceable into the lung anatomy, the guidewire 313 guiding
the system 301 through the lung passageways. Once the target
location has been reached, the delivery system 301 is positioned so
as to seat the stabilizing end 16 at a desired location, such as
within an ostium OS. FIG. 40 illustrates the tissue stabilizing end
16 within an ostium OS at a bifurcation of two lung airways AW.
Here, at least a portion of the stabilizing end 16 resides in the
ostium OS while the midsection 18 and tissue gathering end 14
extend into the target airway AW. Thus, the flared configuration of
the stabilizing end 16 anchors the stabilizing end 16 within the
ostium OS by pressing against the walls W of the airway AW.
[0896] The treatment device 10 is then deployed within the target
airway AW by advancing the delivery system 301, as illustrated in
FIG. 41. Since the stabilizing end 16 is anchored within the ostium
OS and the treatment device 10 has a structure which allows
elongation along its longitudinal axis 19, advancement of the
delivery system 301 pushes the tissue gathering end 14 further
along the target airway AW while the treatment device 10 expands.
In particular, the extendible midsection 18 length elongates and
stores elastic recoil strain energy in its helix structure; the
elastic strain energy will be used to urge the treatment device 10
to recover to its original shorter length after the device 10 has
been fully deployed and the delivery system 301 has been decoupled
from the device 10.
[0897] FIG. 42 illustrates the beginning stages of decoupling the
device 10 from the delivery system 301. To begin, the tissue
gathering end 14 is unmounted from the bronchoscope 20. In
particular, the alignment element 320 is released from the
bronchoscope 20, such as by retracting the bronchoscope 20 or by
advancing the deployment sleeve 311 which in turn advances the
anchor strut 322 which pulls the alignment element 320 off the
insertion cord tip 208. The guidewire 313, and optionally the
deployment sleeve 311, are held in a fixed position within the
airway AW so as to maintain the elongated configuration of the
treatment device 10. Release of the alignment element 320 allows
the anchor strut 322 to extend radially outwardly toward its biased
configuration. Thus, as shown in FIG. 42, the anchor strut end 321
engages with the wall W of the airway AW in an anchoring manner. In
this embodiment, at least the anchor strut end 321 deforms a
portion of the wall W to make purchase at a location that is
distant from the stabilizing end 16.
[0898] FIG. 43 illustrates further steps of decoupling the device
10 from the delivery system 301. Here, the deployment sleeve 311
and guidewire 313 have been removed from the bronchoscope 20
allowing the tissue gathering end 14 to fully engage with the wall
W of the airway AW. Thus, the tissue gathering end 14 is fixed to
lung tissue within the target airway at a position distant from the
stabilizing end 16 within the ostium OS. The bronchoscope 20 can
then be fully retracted and removed from the lung anatomy, leaving
the treatment device 10 behind, as illustrated in FIG. 44.
[0899] The stored elastic strain energy of the extendible
midsection 18, and optionally any stored energy in the stabilizing
end 16 and/or tissue gathering end 14, creates an urging force to
recoil and shorten the treatment device 10 toward its original
configuration and length. Since the strength of the airway AW is
compromised, the walls W are unable to overcome this urging force.
Thus, the wall W, at least at the point of purchase or engagement
by the tissue gathering end 14, is carried with the tissue
gathering end 14 toward the stabilizing end 16. This retensions the
airway distal to the treatment device 10. FIG. 45 illustrates the
treatment device 10 after the stored elastic strain energy that has
been stored in at least the midsection 18 of the treatment device
10 has urged the device 10 to shorten and recover elastically more
closely to its original pre-elongated length. As described, this
shortens the length of the airway along the treatment device 10 yet
elongates the length of the airway distal to the treatment device
10 to cause restoration of lung tissue tension and elastic recoil
in the tissue that is distal, proximal and adjacent to the
treatment device 10. By tensioning the lung tissue, the device 10
has tensioned the entire bronchial tree that is distal to this
single airway which in turn expands the associated alveoli tissue.
By tensioning the airways and alveoli, the involved airways are
held in a dilated arrangement. In some instances, this simulates
the effects of bronchodilator drugs in patients who still respond
to this family of drugs (unfortunately, these late stage severe
emphysema and COPD patients typically no longer respond to these
drugs).
[0900] It may be appreciated that the delivery system 301 of FIG.
38 may be used to deliver treatment devices 10 in a variety of
ways. One such way, which was illustrated in FIGS. 40-43, involves
seating the stabilizing end 16 in an ostium, or other stable
portion of the lung anatomy, and advancing the stabilizing end 14
further along the airway. It may be appreciated that the treatment
devices 10 may be delivered by alternative methods. For example,
the tissue gathering end 14 may be positioned at a target location
and the stabilizing end 16 retracted to an ostium, or other stable
portion of the lung anatomy. This may be achieved with the use
another embodiment of the delivery system 301, such as illustrated
in FIG. 46.
[0901] FIG. 46 illustrates another embodiment of a delivery system
301 for delivery of a treatment device 10. In this embodiment, the
delivery system comprises a bronchoscope 20 (having a bronchoscope
body 200 and an insertion cord 202), a guidewire 313, a deployment
sleeve 311 and a guide sleeve 327. In some embodiments, the guide
sleeve 327 has a proximal end 328, a distal end 330 and length
extender catch feature 329 near its distal end 330. In this
embodiment, the catch feature 329 comprises a protrusion which
extends radially outwardly from the guide sleeve 327. The
protrusion may have a variety of shapes including a flap, a hook, a
knob, a nub, a clasp or any suitable shape for attaching to the
treatment device 10 itself or a corresponding feature on the
treatment device 10. The guide sleeve 327 is position able over the
insertion cord 202 of the bronchoscope 20 as shown and is able to
slide longitudinally over the insertion cord 202. In addition, the
catch feature 329 is configured to removably attach to the
treatment device 10, such as the stabilizing end 16 of the
treatment device 10, so that translation of the guide sleeve 327
along the insertion cord 202 of the bronchoscope 20 adjusts the
treatment device 10 length. For example, retraction of the guide
sleeve 327 (toward the proximal end of the bronchoscope 20)
increases the length of the device 10 by pulling the stabilizing
end 16 proximally. This in turn increases the stress and strain on
the treatment device 10. Such retraction can be undertaken to
achieve any desired treatment device stress, strain and length
configurations before advancing the treatment device 10 into the
lung, while advancing the treatment device 10 in the lung, just
before deployment of the treatment device 10 in the lung, after
anchoring the stabilizing end 16, after anchoring the tissue
gathering end 14, after anchoring both the stabilizing end 16 and
the tissue gathering end 14, or before or after any combination of
these actions to deploy the treatment device 10 in lung tissue. It
may be appreciated that in other embodiments the guide sleeve 327
may be advanced to push the treatment device 10 off of the
insertion cord 202 or the guide sleeve 327 may be held fixed to
support the stabilizing end 16 of the treatment device 10 to keep
the treatment device 10 from binding with the insertion cord 202.
Further, it may be appreciated that the guide sleeve 327 may be
used to pull the treatment device 10 out of the airway while the
insertion cord 202 is being withdrawn from the treatment
device.
[0902] FIG. 47 illustrates an embodiment of a treatment device 10
releasably mounted on the delivery system of FIG. 46. As shown, the
guide sleeve 327 is advanced over the insertion cord 202 and
disposed proximal to the insertion cord tip 208. The treatment
device 10 is mounted on the bronchoscope 20 so that the tissue
gathering end 14 is disposed over the insertion cord tip 208 and
the stabilizing end 16 is disposed over a portion of the guide
sleeve 327. Here, the catch feature 329 engages the stabilizing end
16, such as by hooking on to one or more turns of the coil forming
the stabilizing end 16. This constrains the stabilizing end 16 so
it cannot use stored elastic spring energy to open and increase the
longitudinal dimension of the treatment device 10. In addition, a
guidewire 313 has been advanced through the working channel port
204 of the bronchoscope 20 and through the guide coil 319 to guide
the advancement of the system 301. Likewise, the deployment sleeve
311 has been advanced through the working channel 210 of the
bronchoscope 20 and it is butted against the guide coil 319. As
mentioned, the guide sleeve 327 and catch feature 329 has been
connected to the stabilizing end 16 and adjusted relative to the
bronchoscope 20 so the midsection 18 is fixed in an unstressed and
unstrained configuration to allow the delivery system 301 and the
treatment device 10 to remain unstressed and flexible during
delivery for easy advancement to a treatment location.
[0903] Once the delivery system 301 has been advanced to the
treatment location within the lung anatomy, the tissue gathering
end 14 is desirably positioned within the treatment location. The
tissue gathering end 14 will substantially remain in this desired
position while the stabilizing end 16 is retracted. To accomplish
this, the tissue gathering end 14 is unmounted or deployed from the
bronchoscope 20. In particular, the alignment element 320 is
released from the bronchoscope 20, such as by retracting the
bronchoscope 20 or by advancing the deployment sleeve 311 which in
turn advances the anchor strut 322 which pulls the alignment
element 320 off the insertion cord tip 208. The guidewire 313, and
optionally the deployment sleeve 311, are held in a fixed position
within the airway AW so as to maintain the elongated configuration
of the treatment device 10. Release of the alignment element 320
allows the anchor strut 322 to extend radially outwardly toward its
biased configuration. Thus, the anchor strut end 321 engages with
the wall W of the airway AW in an anchoring manner. In this
embodiment, at least the anchor strut end 321 deforms a portion of
the wall W to make purchase at the desired location.
[0904] The stabilizing end 16 is then retracted, as illustrated in
FIG. 48. Here, the guide sleeve 327 and catch feature 329 has been
retracted relative to the insertion cord 202, pulling the
stabilizing end 16 proximally so that the extendible midsection 18
is elongated. This allows the stabilizing end 16 to be positioned
within an ostium or other stable area within the airway. The
treatment device 10 is then released from the delivery system 301.
The stored elastic strain energy of the extendible midsection 18,
and optionally any stored energy in the stabilizing end 16 and/or
tissue gathering end 14, creates an urging force to recoil and
shorten the treatment device 10 toward its original configuration
and length. Since the strength of the airway AW is compromised, the
walls W are unable to overcome this urging force. Thus, the wall W
at least the point of purchase or engagement by the tissue
gathering end 14 is carried with the tissue gathering end 14 toward
the stabilizing end 16. This retensions the airway distal to the
treatment device 10. By tensioning the lung tissue, the device 10
has tensioned the entire bronchial tree that is distal to this
single airway which in turn expands the associated alveoli
tissue.
[0905] FIG. 49 illustrates another embodiment of a treatment device
10. In this embodiment, the treatment device 10 has a tissue
gathering end 14 and extendible midsection 18 which is similar to
the device 10 of FIG. 39, however in this embodiment the
stabilizing end 16 differs. In this embodiment, the stabilizing end
16 is configured to resist movement relative to the lung tissue in
the distal direction. The stabilizing end 16 is comprised of
elastic material that is capable of storing elastic strain energy
and recovering to its initial stable shape. In this embodiment, the
initial shape of the stabilizing end 16, illustrated in FIG. 49,
comprises a plurality of loops which splay or deploy radially
outwardly due to stored elastic strain energy. In this embodiment,
the stabilizing end 16 comprises a body strut 331, an extension
loop 336, a spring loop 335, an anchor strut 334, an actuation loop
333, and an anchor strut end 332. The body strut 331 is generally
aligned with the longitudinal axis 19 of the device 10. The
extension loop 336 is used to tether the device 10 to the delivery
device 301. Alternatively, the delivery device may be a guidewire.
The anchor strut 334 is joined with the body strut 331 by the
spring loop 335 which biases the anchor strut 334 radially outward
at an angle .theta., such as between 5 and 90 degrees, preferably
about 45 degrees. The stabilizing end 16 is strained, against its
stable shape configuration, during delivery with the delivery
device 301 retaining the spring loop 335 and the actuation loop 333
in a condition that is coaxial with the longitudinal axis 19. This
keeps the anchor strut end 332 from being forced against lung
tissue until the user is ready to deploy the stabilizing end
16.
[0906] FIG. 50 illustrates the treatment device 10 of FIG. 49
loaded onto a delivery system 301. In this embodiment, the delivery
system 301 comprises a bronchoscope 20 (including a bronchoscope
body 200 and an insertion cord 202), a guidewire 313, a deployment
sleeve 311 and a guide sleeve 346. The guide sleeve 346 has a
proximal end 342 and a distal end 343. The guide sleeve 346 is
position able over the insertion cord 202 of the bronchoscope 20 as
shown and is able to slide longitudinally over the insertion cord
202. FIG. 50 illustrates the delivery system 301 advanced into lung
anatomy so that the treatment device 10 has been advanced through
airway A and into airway B via a bifurcation BF which also leads to
airway C. The tissue gathering end 14 and stabilizing end 16 are
constrained from actuating by the insertion cord 202 which is
holding the alignment element 320 and the actuation loop 333
coaxial with the longitudinal axis 19.
[0907] FIG. 51 illustrates deployment of the tissue gathering end
14 within airway B. In this embodiment, deployment is achieved by
advancing the deployment sleeve 311 so as to contact the guide coil
319. Additional advancement causes guide coil 319 and attached
anchor strut 322 to pull the alignment element 320 off of the
insertion cord tip 208 of the bronchoscope 20. Alternatively, in
other embodiments, deployment is achieved by retracting the
insertion cord tip 208 while maintaining position of the deployment
sleeve 311 so that the alignment element 320 is pulled off of the
insertion cord tip 208. In either situation, this releases the
stored elastic strain energy in the tissue gathering end 14 driving
the anchor strut end 321 into the airway wall W to anchor the
distal end of the treatment device 10 at the desired location in
airway B, as described previously in relation to the embodiment of
FIG. 39. It may be appreciated that in some embodiments the
alignment element 320 is configured as a structure that only
partially encircles the bronchoscope shaft 202 as shown in FIG. 51
wherein the anchor loop 320 has an opening 354 and the loop 320 is
then turned back around to form a blunt partial loop termination
355. It may be appreciated that the proximal anchor spring loop 335
and the proximal anchor actuation loop 333 may be similarly formed
so as to not fully encircle the bronchoscope and still be
effective. This allows for a bronchoscope or other delivery cannula
or delivery device shaft, such as a guidewire, that may have
diameter variation down the length to be translated to activate or
unlock these anchor assemblies without actually removing the
bronchoscope or delivery canula or delivery element. The proximal
extension loop 336 is utilized for connection to a wire, link or
tether 344 which may be pulled to move the device 10 or the
stabilizing end 16 more proximally so as to extend the length of
the midsection 18 while the device 10 is anchored into the lung
tissue. The tissue gathering end 14 is configured to resist moving
proximally in relation to the airway wall W, but it is configured
to easily be moved more distally relative to the airway wall W. The
stabilizing end 16 is configured to resist being advanced distally
in relation to the airway wall W but it is configured to be able to
be moved proximally relative to the airway wall W thereby extending
the midsection 18.
[0908] The midsection 18 is extended, as illustrated in FIG. 52. In
some embodiments, such extension is achieved by retracting the
guide sleeve 346 which has a tether 344 extending therethrough. The
tether 344 is removably attached to the extension loop 336 of the
device 10, as mentioned previously. Retraction of the guide sleeve
346 pulls the tether 344 which in turn pulls the stabilizing end 16
of the device 10. In other embodiments, the guide sleeve 346
remains in place and the tether 344 is retracted into or through
the guide sleeve 346. In some embodiments, this is achieved by
pulling a handle 351 which is attached to the tether 344. FIG. 52
illustrates an embodiment of such a handle 351. Here, the handle
351 comprises a shaft 353 having a hole 352 therethrough. The
tether 344 has two free ends which extend through or along the
guide sleeve 346, exiting the proximal end 342 of the guide sleeve
346. The free ends wrap around the shaft 353 of the handle 351 and
through the hole 352 to increase traction and efficiency when
pulling the tether 344. Thus, as the handle 351 is pulled away from
the patient, the tether 344 is tensioned and pulls on the extension
loop 336 of the device 10. By tensioning the tether 344, the tether
344, treatment device 10 and airway wall W become a tensile member
which straightens the tether 344, the treatment device 10 and the
airway wall W.
[0909] The pulling force is translated through the device 10 to the
tissue gathering end 14. If the tissue gathering end 14 is anchored
in stable lung tissue, the tissue gathering end 14 will remain in
place and the midsection 18 will expand longitudinally as the
stabilizing end 16 moves in the proximal direction. If the tissue
gathering end 14 is anchored in unstable or weakened lung tissue,
the tissue gathering end 14 will pull the weakened airway wall W
along with it in the proximal direction as the stabilizing end 16
moves in the proximal direction. This will continue until stronger
lung tissue is reached wherein the tissue gathering end 14 will
cease movement and the midsection 18 will expand longitudinally as
the stabilizing end 16 moves in the proximal direction. The
midsection 18 is extended until the stabilizing end 16 is desirably
positioned within the airway. The stabilizing end 16 is then
released and anchored in place.
[0910] FIG. 53 illustrates anchoring of the stabilizing end 16
within the airway B, just beyond the branch to airway C. This is
achieved by retracting the bronchoscope 20 from the device 10. Such
retraction releases the spring loop 335 of the device 10. As
mentioned previously, the spring loop 335 joins the body strut 331
with the anchor strut 334 which is biased radially outward. Thus,
release of the spring loop 335 allows the anchor strut 334 to
extend radially outwardly, toward the airway wall W, such as shown.
The anchor strut end 332 engages the airway wall W, anchoring the
stabilizing end 16 in place.
[0911] FIG. 54 illustrates the treatment device 10 after the tether
344 has been cut and removed. Removal of the pulling force from the
tether 344 allows the midsection 18 to recoil toward its natural
configuration over time. Since the stabilizing end 16 and the
tissue gathering end 14 are engaged with the airway walls W, the
engaged portions of the airway walls W travel along with the ends
14, 16. In some embodiments, both ends 14, 16 travel toward each
other as the longitudinal length of the midsection 18 shortens.
Thus, the lung tissue along the airway between the ends 14, 16
becomes minimally compressed, as illustrated in FIG. 54, and the
volume of the lung along the airway B becomes minimally reduced.
The airway between the ends 14, 16 is supported by the helical
structure of the midsection 18, acting as a stent to keep the
airway patent. Thus, COPD symptoms are reduced rather than
increased, which is the result when the airways are compressed
without internal support, exasperating the original problem in the
lung particularly during expiration breathing cycles. In addition,
the more proximal airway A structure and the proximal end of airway
B structure is now stronger and provides a better foundation and
base to stabilize lung tissue and lung treatment devices than the
distal end of airway B.
[0912] It may be appreciated that in some embodiments the ends 14,
16 travel equal distance toward the center of the midsection 18. In
other embodiments, the ends 14, 16 travel differing distances, such
as influenced by the stability of the portions of the airway wall W
engaged by the ends 14, 16. For example, the stabilizing end 16 is
typically positioned more proximally than the tissue gathering end
14, within a portion of the airway that is stronger and more
stable. In such instances, the stabilizing end 16 would travel a
smaller distance than the tissue gathering end 14 which is engaged
with weaker tissue. It may also be appreciated that in some
embodiments, only one of the ends 14, 16 moves while the other
remains stationary. In such instances, typically the tissue
gathering end 14 moves toward the stabilizing end 16. However, the
outcome would vary depending on the characteristics of the airway
and the treatment device 10. It may also be appreciated that as the
health of the patient changes over time, such as a progression of
the disease state, the device 10 will continue to shorten so as to
maintain tension in the lung.
[0913] FIG. 55 illustrates the elastic recoil of the treatment
device 10 causing midsection 18 shortening as has been previously
discussed. FIG. 55 also illustrates the branching of the distal
portion of airway B into an attached network of airways D, E (F is
the cross-section of the distal portion of airway B). The airways
B, D, E that are longitudinally tensioned and affected by the
deployment, elongation and tensioning of the treatment device 10.
The distal portion of airway B is shown to be supported and made to
remain round and patent as the patient successfully expires air as
connective tissue between the distal airways D and E connect to the
distal portion of airway B to hold the distal portion of airway B
more open and round (as shown in F) as tension is applied to the
entire lung airway system. By tensioning the lung tissue to support
the airway tree A, B, C, D, and E in tension, the symptoms listed
herein are reduced and one or more of the physiologic changes that
are listed in herein are changed to beneficially affect and treat
COPD patients who may suffer from emphysema. FIG. 56 illustrates an
alternative method to treating the patient wherein the device 10 is
deployed in the lung anatomy and then expanded thereafter. In this
embodiment, the treatment device 10 is similar to that of FIG. 49
and is deployable by a delivery device 301 into an airway of the
lung. In this embodiment, the device 10 is partially deployed
according to FIGS. 50-51, wherein the tissue engaging end 14 is
deployed and engaged with the airway wall W. However, in this
embodiment, the stabilizing end 16 is also deployed without
extending the midsection 18. This may be achieved by retracting the
bronchoscope 20 while the guide sleeve 346 is held against the
stabilizing end 16 so that the stabilizing end 16 is released and
deployed. Thus, the device 10 is deployed into the airway in a
substantially relaxed configuration, as illustrated in FIG. 56.
[0914] The device 10 maintains connection with the tether 344 which
extends through or along the guide sleeve 346. It may be
appreciated that the configuration of the tissue gathering end 14
and its engagement with the wall W creates resistance to movement
of the device 10 along the airway in the proximal direction. In
particular, the anchor strut 322 extends radially outwardly from
the longitudinal axis 19 forming an angle .theta. which faces the
proximal direction or midsection 18. Likewise, anchor strut end 321
faces the proximal direction or midsection 18 as it engages the
wall W. This creates an indent in the wall W and a tissue ledge
which impedes movement of the anchor strut end 321 along the wall W
in the proximal direction. Likewise, the configuration of the
stabilizing end 16 and its engagement with the wall W creates
resistance to movement of the device 10 along the airway in the
distal direction. In particular, the anchor strut 334 extends
radially outwardly from the longitudinal axis 19 forming an angle
.theta. which faces the distal direction or midsection 18.
Likewise, anchor strut end 332 faces the distal direction or
midsection 18 as it engages the wall W. This creates an indent in
the wall W and a tissue ledge which impedes movement of the anchor
strut end 332 along the wall W in the distal direction. However, it
may be appreciated that either or both of the tissue gathering end
14 and stabilizing end 16 are able to move along the airway away
from the midsection 18. In this embodiment, the stabilizing end 16
is tethered to the delivery device 301, particularly the guide
sleeve 346. Therefore, the stabilizing end 16 is able to be pulled
in the proximal direction by pulling the tether 344. However, the
tissue gathering end 14 resists movement along the wall W in the
proximal direction at least due to the tissue ledge impeding the
anchor strut end 321. If the wall W is weak, the wall W itself
moves in the proximal direction, being pulled by the anchor strut
end 321. This continues until a stronger portion of the wall W is
reached which is able to resist longitudinal compression. At that
point, the tissue gathering end 14 anchors in place and the
midsection 18 expands, increasing the overall longitudinal length
of the device 10. This continues incrementally as the stabilizing
end 16 is pulled along the airway. At any time, pulling may cease
and the stabilizing end 16 remains engaged at the new location
along the wall W due to resistance in the distal direction at least
due to the tissue ledge impeding the anchor strut end 332. Such
extension of the midsection 18 stores elastic strain energy in the
device 10. Since the wall W has compressed and adjusted during
positioning of the stabilizing end 16, the device 10 will likely
maintain its length and position upon release of pulling force.
However, over time, the stored elastic strain energy may cause the
midsection to contract, along with movement of the tissue gathering
end 14 and/or stabilizing end 16 toward the midsection 18.
[0915] It may be appreciated that such capability may allow the
length of the device 10 to be adjusted throughout the procedure to
achieve the desired re-tensioning of the airway. Once this has been
achieved, the tether 344 is removed along with the delivery device
301. It may be appreciated that in some embodiments the device 10
may be re-accessed and repositioned. This may be achieved by
re-tethering or re-connecting a device, such as a delivery device
301, to the stabilizing end 16 and further pulling the stabilizing
end so as to position the stabilizing end 16 at a new more proximal
location. This pulling motion further tensions the airway. Again,
once the desired effect has been achieved, the delivery device 301
is removed leaving the device 10 in place.
[0916] It may be appreciated that the pulmonary treatment devices
10 may be removed from the lung anatomy either during the
procedure, for repositioning or replacement, or at a later time
during a secondary procedure. Removal may be achieved by threading
a delivery device through the appropriate portions of the device
10, such as through the actuation loop 333 and/or alignment element
320, so as to re-engage the device 10. The device 10 is then pulled
proximally by the delivery device and extracted from the body. It
may also be appreciated that the device 10 may be pulled from the
anatomy by attachment to any suitable portion, such as the
stabilizing end 16, and applying sufficient force in the proximal
direction to withdraw the device 10. The same device 10 can then be
sanitized and reloaded on the delivery device for re-delivery to
the target treatment area or a new device 10 may be utilized.
[0917] Likewise, it may be appreciated that previously positioned
devices 10 may be adjusted at a later time during a secondary
procedure. This may be achieved by accessing a previously
positioned device 10 with a delivery device and attaching thereto.
This can be achieved by threading a delivery device through the
appropriate portions of the device 10, such as through the
actuation loop 333 and/or alignment element 320, so as to re-engage
the device 10. Typically, the actuation loop 333 is re-engaged so
as to attach to the stabilizing end 16 of the device 10. Or, the
stabilizing end 16 is grasped such as with the use of a catch
feature 329. In such instances, the stabilizing end 16 is pulled
proximally so as to further re-tension the airway AW. This may be
desired if the disease has progressed over time beyond the ability
of the device 10 to compensate. The stabilizing end 16 is then
secured in a new location to maintain the re-tensioning. The
delivery device is then disengaged from the pulmonary treatment
device 10 which is left behind as an implant.
[0918] It may be appreciated that a variety of approaches have been
described herein, including treatment devices 10 which are
introduced through a lumen in a delivery device (including being
pushed or pulled through the lumen by itself, within an introducer
or mounted on an additional device such as a catheter or guidewire
which is advanceable within the lumen), and treatment devices 10
which are introduced by mounting on an exterior portion of a
delivery device, such as the insertion cord tip 208 of a
bronchoscope 20 or on a catheter, wherein the treatment device 10
is pushed or pulled from the mounted position by an external or
internal sleeve or device. It may be appreciated that in some
embodiments the treatment device 10 is deployed as it is released
from the delivery device and in other embodiments, the treatment
device 10 is released from the delivery device and then deployed,
such as by the removal of an element or device which holds the
treatment device 10 in a constrained configuration (e.g. a
guidewire or sleeve). It may be appreciated that in some
embodiments, a single treatment device 10 is deliverable from a
delivery device at a time and in other embodiments multiple
treatment devices 10 (including two, three, four, five, six or
more) are deliverable from the delivery device at a time. It may be
appreciated that the treatment devices 10 may be pre-loaded on or
within the delivery device or may be loaded by the user. It may
also be appreciated that in some embodiments the tissue gathering
end 14 is anchored initially in the lung passageway and the
stabilizing end 16 is pulled so as to re-tension the airway. In
other embodiments, the stabilizing end 16 is anchored initially in
the lung passageway and the tissue gathering end 14 is pushed so as
to re-tension the airway. It may be appreciated that pulling of the
stabilizing end 16 or pushing of the tissue gathering end 14 may be
achieved while the end 14, 16 is held in a contracted state for
ease of movement or after the end 14, 16 has been deployed (wherein
the end 14,16 has been specially designed to allow such
movement).
[0919] FIG. 57 illustrates another embodiment of a treatment device
10. In this embodiment, the treatment device 10 is optionally
introduce able through a lumen in a delivery device. Thus, it is
collapsible into a small profile. It is held in the collapsed or
constrained configuration by the use of a catheter or guidewire
which holds the treatment device 10 in the constrained
configuration. In some embodiments, a guidewire is preferred due to
its small diameter and ability to be advanced into distant branches
of the lung passageways. Once the treatment device 10 is desirably
positioned within the lung passageway, the guidewire is removed,
thereby allowing the device 10 to deploy either at once or in
stages.
[0920] FIG. 57 illustrates the treatment device 10 in its deployed
or expanded state. In this embodiment, the treatment device 10 has
a tissue gathering end 14, unextendible midsection 18 and a
stabilizing end 16. The treatment device 10 may have a single
component structure or may be comprised of a number of components.
In any case, individual stiffnesses of the tissue gathering end 14,
extendible midsection 18 and stabilizing end 16 may be tuned to
maximize effectiveness of both anchoring and supporting likeness to
healthy lung tissue. Likewise, the tissue gathering end 14 and
stabilizing end 16 are flexible so as to collapse along
longitudinal axis 19 and deploy or expand to the relaxed
configuration shown in FIG. 57. Such expansion is typically
achieved by self-expansion due to spring loading.
[0921] FIG. 58 illustrates the treatment device 10 of FIG. 57 in a
collapsed configuration. Here, the device 10 is mounted on a
guidewire 313. Thus, each of the tissue gathering end 14,
midsection 18 and stabilizing end 16 form at least one loop or
partial loop through which the guidewire 313 is passable so that
the treatment device 10 is mountable on the guidewire 313 and the
tissue gathering end 14 and stabilizing end 16 are held in a
constrained configuration (storing elastic strain energy). In this
collapsed or constrained configuration, the guidewire 313 and
treatment device 10 are passable through a lumen in a delivery
device, such as a working channel 210 of a bronchoscope 20. In some
embodiments, the guidewire 313 and treatment device 10 are passable
through a working channel 210 having an inner diameter that is
sized between 1.3 and 3.2 mm. In this embodiment, the extendible
midsection 18 comprises a coil wherein the guidewire 313 is
passable therethrough. Thus, the extendible midsection 18 is able
to be elongated to store elastic strain energy which urges the
treatment device 10 to recover back to a non-elongated length. In
some embodiments, the midsection 18 has a uniform diameter.
However, in other embodiments, the midsection 18 has a tapering
diameter, particularly tapering downward toward the stabilizing end
14 of the treatment device 10. Such tapering may mimic the tapering
diameter of a lung passageway within which the device 10 is
implanted.
[0922] As more easily visualized in FIG. 58, the tissue gathering
end 14 comprises a body strut 323, a guide element 319, an anchor
strut 322, an alignment element 320 and an anchor strut end 321. In
this embodiment, the body strut 323 extends from the flexible
midsection 18 and is generally parallel to the longitudinal axis
19. The body strut 323 is connected with a guide element 319 which
typically forms the distal-most portion of the treatment device 10.
In this embodiment, the guide element 319 comprises a coil, however
the element 319 may have any suitable shape including a single
loop. In this embodiment, the guide element 319 is arranged so that
the guidewire 313 coaxially passes through the guide element 319.
The guide element 319 also stores the strain energy which allows
the anchor strut 322 to deploy and extend outwardly. In some
instances, the coil dictates the strength of the spreading force of
the anchor strut 322 radially outwardly. During delivery and prior
to deployment, the anchor strut 322 is held in a retracted or
un-extended position so as to avoid dragging along the airway walls
W or traumatizing tissue. Such retraction is maintained by
alignment element 320. In this embodiment, the alignment element
320 has the form of a coil, however it may be appreciated that the
element 320 may have the form of a single loop, a partial loop or
snap locking structure, a hook shaped lock or spring lock
mechanism, to name a few. When the center of the element 320 is
aligned with the longitudinal axis 19, the anchor strut 322 is held
parallel to or at a small angle in relation to the longitudinal
axis 19. Such alignment is maintained by passing the guidewire 313
or similar device through the center of the treatment device 10 and
through the alignment element 320 (as illustrated in FIG. 58). The
tissue gathering end 14 is configured so as to bias the alignment
element 320 and attached anchor strut 322 radially outwardly.
Therefore, withdrawal of guidewire 313 from the alignment element
320 frees the alignment element 320 and allows the alignment
element 320 to rotate away from alignment with the longitudinal
axis 19. This, in turn, causes the anchor strut 322 to extend
radially outwardly. In some embodiments, the anchor strut 322
extends 1 mm to more than 30 mm but 6-12 mm is preferable. The
anchor strut 322 terminates in an anchor strut end 321, which may
have a variety of shapes including a coil, ball, sharp end barb, L
shaped pad, strain relief long coil or tapered coil, to name a few.
The anchor strut 322 is configured to extend radially outwardly
upon deployment so at least the anchor strut end 321 engages an
airway wall W or damaged tissue DT, such as in the area of the
alveolar sacs. However, in some instances, the anchor strut 322
itself additionally engages the airway wall W or damaged tissue
DT.
[0923] In the extended position, the alignment element 320 has an
axis which is at an angle .theta. to the longitudinal axis 19.
Typically, the angle .theta. is in the range of 1 to 90 degrees,
preferably 20-65 degrees. In some embodiments, additional portions
of the tissue gathering end 14 are also biased to assist in
extension of the anchor strut 322 radially outwardly. For example,
in some embodiments, the body strut 323 is biased so as to further
extend the anchor strut 322 radially outwardly. In the embodiment
of FIG. 39, the body strut 323 is disposed opposite the anchor
strut 322 so that the alignment element 320 is disposed
therebetween. Thus, when the center of the alignment element 320 is
aligned with the longitudinal axis 19, the body strut 323 and
anchor strut 322 reside on opposite sides of the longitudinal axis
19. In some instances, release of the alignment element 320 allows
both the body strut 323 and anchor strut 322 to bias toward their
relaxed configurations (such as pushing both the body strut 323 and
anchor strut 322 outwardly in the same radial direction). This can
allow the body strut 323 and anchor strut 322 to spread fully
elastically at least 5 degrees but up to 90 degrees, and preferably
20 to 65 degrees, to push the anchor strut end 321 into or through
the wall of an airway or the diseased tissue to anchor the tissue
gathering end 14 in the lung tissue.
[0924] In this embodiment, the stabilizing end 16 comprises a body
strut 331, a spring loop 335, an extension loop 336, an anchor
strut 334, an actuation loop 333, and an anchor strut end 332. The
body strut 331 and spring loop 335 are generally aligned with the
longitudinal axis 19 of the device 10 in both the relaxed and
constrained configurations. The anchor strut 334 is joined with the
body strut 331 by the spring loop 335 which biases the anchor strut
334 radially outward at an angle .theta., such as between 5 and 90
degrees, preferably about 45 degrees. The spring loop 335 also
allows the anchor strut 334 to be moved toward the longitudinal
axis 19 so that the actuation loop 333 is aligned coaxially with
the longitudinal axis 19 for passage of the guidewire 313
therethrough. This keeps the anchor strut end 332 from being forced
against lung tissue until the user is ready to deploy the
stabilizing end 16.
[0925] Referring again to FIG. 58, the treatment device 10 of FIG.
57 is shown loaded onto a guidewire 313. In this embodiment, the
delivery system comprises the guidewire 313, a pusher coil 370 and
a tether 344 that is looped, tied, attached (such as with a hitch
knot) or otherwise removably attached to the pulmonary treatment
device 10, such as to extension loop 336. The pusher coil 370 has a
proximal end 372 and a distal end 373. The coil shape allows the
pusher coil 370 to bend and flex easily through the anatomy. The
pusher coil 370 Is typically comprised of a metal material to
assist in cleaning and steam sterilization however other materials
may be used such as polymers. The pusher coil 370 is positionable
over the guidewire 313, proximal to the treatment device 10, as
shown, and is able to slide longitudinally over the guidewire 313.
To deploy the treatment device 10, the pusher coil 370 is advanced
over the guidewire 313 so as to push the treatment device 10 in the
distal direction while the guidewire 313 remains in place.
Consequently, the treatment device 10 is pushed off of the
guidewire 313 wherein it deploys to its relaxed and expanded
configuration. This may be achieved in stages or all at once. For
example, in some embodiments, the tissue gathering end 14 is pushed
off the distal end of the guidewire 313 with the use of the pusher
coil 370 so that the anchor strut 322 expands and at least the
anchor strut end 321 engages the lung passageway wall. This is
achieved while the remainder of the treatment device 10 remains
mounted on the guidewire 313. The proximal end of the treatment
device 10 is then pulled in the proximal direction by applying
pulling force to the tether 344. Since the tissue anchoring end 14
is anchored in the lung passageway, the lung passageway is pulled
proximally, re-tensioning the airway, while the midsection 18 also
expands. Once airway is desirably re-tensioned, the stabilizing end
16 is deployed by advancing the pusher coil 370, thereby pushing
the stabilizing end 16 off of the guidewire 313. This allows the
stabilizing end 16 to anchor in place. The guidewire 313 and pusher
coil 370 are then removed from the patient. In addition, the tether
344 is removed from the treatment device 10.
[0926] It may be appreciated that the delivery system of FIG. 58
and treatment device 10 mounted thereon may be passed through a
lumen of a scope or other instrument, particularly through a
working lumen of a bronchoscope 20. Or, the delivery system of FIG.
58 and treatment device 10 mounted thereon can be advanced through
the trachea and into the lung by itself, without the use of a
bronchoscope.
Torque-Based Pulmonary Treatment Device Embodiments
Torque-Based Treatment Overview
[0927] The above described embodiments rely primarily on linear or
curvilinear pulling and pushing of lung tissue to re-tension the
lung in patients suffering from COPD, particularly advanced COPD
where tissue is highly damaged. Here, methods and devices are
provided which rely primarily on torque, twisting and rotation to
re-tension the lung, optionally in addition to linear or
curvilinear pulling and pushing. Such embodiments are particularly
suitable for patients with advanced emphysema, such as patients who
are diagnosed as GOLD stage II, III, and IV, where the lung
contains highly damaged tissue, particularly into and well beyond
the lobar airways and typically beyond the bifurcations that lead
to regions of the lung that would normally contain the 3rd
generation airways or more distal generations of airways in a
healthy person. Lung airways and bronchi are comprised of smooth
muscle, submucosa, mucosa, connective tissue made of collagen, a
subepithelial basement membrane and epithelium. Among other things,
the COPD disease progresses to allow enzymes to dissolve bronchi,
airway components and complete airways. The disease also destroys
elastin in tissue that survives the enzymatic bulk reduction of
airways and lung tissue. Late stage Emphysema patient lungs are
compromised to the point that these patients commonly communicate
gases through paths or passageways that are largely without
airways. In these areas of damaged tissue, large portions of
parenchyma are often loose or missing, forming coalesced blebs and
bullae. Thus, normal lung passageways with supportive walls are
typically not available, and any existing tissue is sponge-like.
These pulmonary treatment devices and methods consider the vast
tissue damage of advanced COPD sufferers and are designed
specifically to treat these patients. It may be appreciated that
although the previously described pulmonary treatment devices rely
primarily on linear or curvilinear pulling and pushing of lung
tissue to treat the lung, particular embodiments may also be used
to apply torque to the lung tissue in such treatment.
[0928] FIG. 59A illustrates an example of a torque-based pulmonary
treatment device 400 and FIG. 59B illustrates the treatment device
400 deployed into a lung L. Referring to FIG. 59A, in this
embodiment the device 400 comprises a tissue gathering element 402
and an anchoring element 404, both of which join with an attachment
end 406. The attachment end 406 may be used to attach a delivery
device thereto, such as a torqueing tool 408. Thus, the attachment
end 406 typically has a non-round cross-section shape, such as a
square, rectangular, polygonal or oval shape, to assist in
maintaining rotational torque coupling and torque transmission
during rotational or torqueing motion of the torqueing tool 408. It
may be appreciated that in some embodiments the attachment end 406
is formed from portions of the tissue gathering element 402 and
anchoring element 404 themselves, such the joining of their
respective proximal ends. In other embodiments, the attachment end
406 includes an attachment element 410 to assist in joining the
elements 402, 404 and forming a desired shape for attachment and
torqueing. And yet in other embodiments, the attachment end 406
resides at the proximal end of the tissue gathering element 402 or
the anchoring element 404 and the elements 402, 404 are joined to
each other distally of the attachment end 406.
[0929] In this embodiment, the tissue gathering element 402 is
comprised of a shaft 412 extending in a first direction from the
attachment end 406 and then bending laterally outwardly in a second
direction to form a circular, inwardly spiraled shape. The shaft
412 may reside in a single plane (e.g. x-y plane) or may pass
through additional planes throughout the spiral shape (e.g. in the
z direction) so that portions of the shaft 412 reside out of the
x-y plane. Typically, the tissue gathering element 402 has a shape
which is approximately 0.25 to 3 inches in diameter, preferably
approximately 0.5 to 1.5 inches in diameter. In this embodiment,
the shaft 412 is comprised of wire, such as metal (e.g. nitinol,
austenite or martensite nitinol, spring steel, stainless steel,
cobalt steel alloys, titanium etc.) or polymeric compounds,
ceramic, carbon fiber and/or other biocompatible materials. Such
wire is typically extruded, drawn or sintered into near net shapes
or wire form shapes, wherein the wire has a constant diameter
between 0.005 inches up to 0.200 inches but preferably round wire
between 0.013 and 0.070 inches in diameter or ribbon wire that is
0.005 to 0.040 inches thick and 0.010 to 0.100 wide. The ribbon
width or thickness may be different at the distal tissue gathering
element 402 as compared to the proximal anchoring element 404. In
some embodiments, the distal tissue gathering element 402 is made
from ribbon that is 0.015 to 0.030 inches thick and 0.045 to 0.080
inches wide while the and the proximal anchoring element 404 is
made from ribbon that is 0.010 to 0.030 inches thick and 0.010 to
0.030 wide. In some embodiments, the shaft 412 is comprised of a
single wire and in other embodiments, the shaft 412 is comprised of
more than one wire (such as twisted together) and/or includes
additional features and/or elements to increase its diameter and/or
increase its ability to gather lung tissue, as will be described in
later sections. It may be appreciated that the one or more wires
may have any suitable cross-sectional shape including round, oval,
square, rectangular, etc. Further, the one or more wires may have a
cross-sectional shape which changes along the length of the shaft
412. Likewise, the one or more wires may be made from tapered wire
or wire that varies in diameter at different locations along the
tissue gathering element 402. It may be appreciated that the tissue
gathering element 402 may be comprised of any combination of these
materials and geometries. In other embodiments, the shaft 412
includes additional features and/or elements to increase its
diameter and/or increase its ability to gather lung L tissue, as
will be described in later sections.
[0930] In this embodiment, the anchoring element 404 is comprised
of a shaft 412 which extends from the attachment end 406, as shown
in FIG. 59A, in the same direction as the tissue gathering element
402, generally along a longitudinal axis 411. In this embodiment,
the shaft 420 of the anchoring element 404 bows outwardly, away
from the longitudinal axis 411 and tissue gathering element 404,
such as to form the shape of a bifurcation. This bifurcation
typically mimics the bifurcations found in the airway network
branches from the trachea through the various portions of the lung
L. In some embodiments, this aspect allows the anchoring element
404 to anchor the device 400 in the lung anatomy.
[0931] Referring to FIG. 59B, the treatment device 400 is sized and
configured to be delivered through a delivery device which is
insertable into the lung L, such as a steerable scope (e.g.
bronchoscope 20). In this embodiment, the device 400 is loaded
within a catheter 430 or similar delivery device which is
advanceable through a lumen in the bronchoscope 20. During such
advancement, the device 400 is constrained within the catheter 430
to allow for ease of movement. In this embodiment, such constraint
is achieved by retraction of the device 400 of FIG. 59A into a
lumen in the catheter 430 so that the anchoring element 404 and
tissue gathering element 402 are drawn together and the tissue
gathering element 402 is uncoiled and straightened. The device 400
remains within the catheter 430 until the distal tip of the
catheter 430 is desirably positioned within the lung L.
[0932] In some embodiments, the distal tip of the catheter 430 is
advanced beyond the distal tip of the bronchoscope 20. This allows
the catheter 430 to reach locations that are beyond the reach of
the bronchoscope 20 due to size constraints (i.e. the smaller
diameter of the catheter 430 can pass through small diameter or
contorted passageways that the larger diameter bronchoscope is
restricted from entering). Thus, in some instances, the catheter
430 is able to reach far distal portions of the lung L, such as the
apical portions of the upper lobes and the lateral corners of the
lower lobes, which are typically unreachable by the bronchoscope
alone.
[0933] In some embodiments, the catheter 430 is advanced with the
use of a guidewire. This may be within an airway or beyond the
natural airways into damaged tissue, parenchyma, alveoli,
artificially created passageways or other types of lung tissue. In
such instances, the device 400 is not pre-loaded into the catheter
430, rather the device 400 is inserted at a later time once the
catheter 430 is desirably positioned. This is because the guidewire
typically fills the catheter lumen. The guidewire fills the
catheter lumen so as to minimize digging of the catheter leading
edge into tissue during advancement and to provide a flexible,
blunt, atraumatic tip. The guidewire then acts as a rail or support
shaft to further advance the catheter 430. Alternating advancement
of the guidewire and catheter in blood vessels is known as the
Seldinger Wire Technique. In some embodiments, the guidewire and
catheter 430 are advanced within the lung using a modified
Seldinger Wire Technique. It may be appreciated that when using a
guidewire, the delivery system components may be configured to be
delivered Over-The-Wire (OTW) or Rapid Exchange (RX). In an OTW
design, the guidewire exits the delivery system at its proximal end
so that the guidewire that tracks along the full length of the
delivery device. In contrast, in the RX design, the guidewire exits
the delivery system at a side port. Thus, the guidewire only tracks
along a short section (about 25 cm) of the delivery device and then
exists at the side port. This design saves time compared with
advancing a guidewire through the full length of the delivery
device.
[0934] It may be appreciated that the guidewire is configured to be
compatible with advancement within lung tissue, particularly to
contact lung tissue with minimal or no incident or injury. In some
embodiments, the guidewire is comprised of a wire cable, wire
bundles, continuous braid, twisted wire, or twisted wire bundle
shaft structure with blunt tip (typically formed by crimping,
gluing or welding the tip of the guidewire shaft structure). In
some embodiments, the guidewire has a diameter in a range of 0.005
to 0.100 inches, preferably in a range of 0.018 to 0.070 inches.
Typically, the guidewire fills the catheter lumen in a way that
presents no gaps or very minimal gapping while the guidewire is
curved or bent during delivery. In some embodiments, the guidewire
is configured so that no portion of the guidewire which contacts
tissue creates a gap which opens more than 0.030 inches, preferably
in a range of 0 and 0.020 inches during bending around a radius
that is 0.5 inches or smaller, to minimize catching tissue in the
gaps. This is in contrast to conventional vascular guidewires made
with a central core wire and a coiled spring outer jacket. When
such vascular guidewires are used in the lung, the adjacent coils
in the coil spring jacket tend to separate more than 0.030 inches
which creates gaps that allow lung tissue to intrude and be caught
during bending through lung passageways. Thus, when the vascular
guidewire is retracted, the pulling/withdrawing motion straightens
the wire and closes the gaps more than 0.001 inches smaller which
causes the lung tissue to be pinched or caught in the coil spring
jacket. Such outcomes are avoided with the specially configured
guidewire embodiments described herein.
[0935] Once the distal tip of the catheter 430 is positioned near a
target location for placement of the treatment device 400, the
device 400 is deployed. If a guidewire was used, the guidewire is
removed and the device 400 is inserted and advanced through the
catheter 430 using a pusher, cable, or link, such as torqueing tool
408. In some embodiments, the torqueing tool 408 is attachable to
the device 400 near the attachment end 406, and in other
embodiments the torqueing tool 408 is attachable at a location
between the tissue gathering element 402 and the attachment end
406.
[0936] Deployment from the catheter 430 may be achieved by a
variety of methods or a combination of multiple methods. In some
embodiments, the device 400 is self-expanding. In such instances,
the catheter 430 may be retracted to expose the device 400. Once
exposed, the device 400 self-expands, tending toward its pre-formed
or natural configuration. Alternatively, the device 400 may be
advanced beyond the distal tip of the catheter 430 allowing
self-expansion, again due to release of tension or compression. In
either case, the self-expanding device 400 is recovered to a
programmed or pre-bent curved shape. When the device 400 is
comprised of nitinol, the super-elastic or pseudo-elastic
properties of nitinol force the curved shape to recover. When the
device 400 is comprised of a memory shape alloy, the heat energy
provided by the body temperature of the patient causes the device
400 to resume a pre-programmed curved shape. In other embodiments,
the device 400 is not self-expanding. For example, in some
embodiments the tissue gathering element 402 is bent into a
deployed shape within the lung L by the user or the tissue
gathering element is actuated into a deployed shape by use of a
mechanical mechanism, such as a mechanism that bows the tissue
gathering element 402 (e.g. by retracting a suture that is attached
to the distal most tip of the tissue gathering element 402).
[0937] Deployment allows the distal tip of the tissue gathering
element 402 to engage the surrounding tissue, curving through
and/or against the tissue. Such deployment may be in an airway or
beyond the natural airways into damaged tissue, parenchyma,
alveoli, artificially created passageways, disease created
passageways or other types of lung tissue. It may be appreciated
that the distal tip of the tissue gathering element 402 may be
sharp or blunt, including a ball tip or other shapes. The ability
to pierce the tissue may be due to a combination of factors,
including tissue type, tissue condition and tip shape, to name a
few. Thus, in some embodiments, the tissue gathering element 402
pierces through lung tissue during deployment from the catheter 430
and in other embodiments the tissue gathering element 402 deploys
within the tissue without piercing. And, in some embodiments, the
tissue gathering element 402 pierces some tissue and not other
tissue. In any case, the deployed tissue gathering element 402 has
an expanded configuration within the lung L.
[0938] The device 400 is then rotated, as illustrated in FIG. 60.
Rotation is achieved by applying torqueing, twisting or rotational
force to at least a portion of the device 400 with the use of the
torqueing tool 408 or other such device. In some embodiments, the
torqueing tool 408 includes a handle 435 which is graspable by a
user so as to manually applying the rotational force. Since the
torqueing tool 408 is attached to the device 400, the device 400
(and therefore tissue gathering element 402) rotates as well. The
arrows indicating rotation of the proximal and distal end of the
torqueing tool 408 in FIG. 60 indicate that the torqueing tool 408
may be rotated both clock-wise or counter clock-wise directions.
This gathers up the surrounding lung tissue onto and around the
tissue gathering element 402 as the element 402 rotates, such as
like twisting a fork in spaghetti to gather the spaghetti onto the
fork. Thus, loose parenchyma, portions of blebs and bullae, damaged
alveolar sacs and other distended, slackened or stretched tissue is
pulled inwardly, twisted and/or gathered up by the tissue gathering
element 402. Rotation continues, gathering the loose, slackened
tissue, until tension is achieved in the tissue. With each
additional rotation, the lung tissue will be increasingly strained
or tensioned. Likewise, the diameter of tissue that is spooled up
around the tissue gathering element 402 will grow to further
improve the effectiveness of the device 400. In some instances, as
lung parenchyma is gathered around the tissue gathering element
402, it is compressed around the tissue gathering element 402
and/or compressed between layers of tissue that is wrapped around
the tissue gathering element 402. It may be appreciated that the
device 400 may be effective at gathering, tensioning or compressing
lung tissue even if there is no compression of tissue or lung
volume reduction that is performed within the center of the distal
tissue gathering element 402 or within coils of a helix shape.
[0939] Recall, it is the inward pulling tension of the lung tissue
that lifts the diaphragm and is balanced by the outward recoil
pressure or outward pulling of the chest wall. The lung is
suspended in an expanded state due to negative pressure or vacuum
between the chest wall and the exterior lining of the lung. This
vacuum keeps the lung expanded and pinned to the chest wall.
Because the lungs are held in a generally expanded state, applying
torque with the device 400 in the interior of the lung L stresses
and tensions diseased lung tissue (restoring lung elastic
resistance to elongation, commonly referred to as lung elastic
recoil). This tension, throughout the lung, pulls radially outward
on the airways to hold these airways open and the tension helps to
allow air to be squeezed out of the lungs during the expiration
breathing cycle. Thus, the tissue gathering element 402 is rotated
until re-tensioning of the lung is achieved to mimic the natural,
healthy state of the lung.
[0940] In some embodiments, the device 400 is rotationally rigid so
that rotational force that is applied to by the torqueing tool 408
is transmitted directly to the lung tissue. However, in other
embodiments, at least a portion of the device 400 is designed to be
intentionally less torque transmissive. This allows the portion to
twist more easily so as to store rotational energy within the
structure of the device 400. In some embodiments, the proximal end
of the device 400 is rotatable up to 1000 degrees more than the
tissue gathering element 402, preferably up to 720 degrees more
than the tissue gathering element 402. In some embodiments, the
tissue gathering element 402 and/or other portions of the device
400 are torqued sufficiently to be distorted and strained in a way
that stores elastic spring energy. By storing this potential
elastic energy using torque forces (e.g. rotation and twisting),
the resulting lung tissue tensioning and lung elastic recoil
restoration effects may be prolonged because chronic tensioning
force is maintained on the lung tissue even if continued effects
from the disease allow the tissue to elongate over time. As the
tissue elongates, portions of the device 400 may be allowed to
incrementally recover a small amount over a time period of months
or years in a rotational recovery or strain relaxing orientation.
However, if sufficient elastic strain energy is stored in the
device 400, some residual chronic tension and restoration of lung
elastic recoil will be maintained throughout this period and
possibly for the remainder of the patient's lifetime. Thus, the
stored elastic strain energy in the device 400 enhances the acute
and chronic benefits to the patient. For example, the stored
elastic strain energy provides chronic tension that is maintained
even if the lung tissue continues to degrade and elongate. Thus,
the stored rotational strain energy continues to provide benefit to
the patient over time as the patient progresses with complications
relating to COPD, even as the lung tissue slowly elongates into the
future. In some embodiments, this time period is up to 10 years or
up to a lifetime, but even a period of 3 years is considered a very
acceptable time period.
[0941] Once the lung L is desirably re-tensioned, the device 400 is
anchored to maintain the rotated arrangement. This is achieved by
deployment of the anchoring element 404. In this embodiment, the
anchoring element 404 is comprised of a shaft 420 which extends
from the attachment end 406 in the same direction as the tissue
gathering element 402, generally along a longitudinal axis 411.
Thus, upon deployment, the shaft 420 of the anchoring element 420
bows outwardly, away from the longitudinal axis 411 and tissue
gathering element 420, such as to form the shape of a bifurcation.
The anchoring element 404 is then advanced into an adjacent or
nearby airway, as illustrated in FIG. 61. In some embodiments,
deployment is achieved by retracting the catheter 430 to expose the
anchoring element 404, thereby allowing its deployment. Thus, the
catheter 430 and device 400 are positioned so that such deployment
of the anchoring element 404 is possible, such as in an airway,
proximal to a bifurcation. This may involve pulling the proximal
end of the device 400 in the proximal direction prior to deployment
of the anchoring element 404. Likewise, in some embodiments, the
device 400 is rotated an additional amount so that the anchoring
element 404 is aligned with the direction that the bifurcation
branches off. Visualization may be achieved with a variety of
methods, including fluoroscopy and/or imaging through the
bronchoscope camera. Once desirably positioned, the anchoring
element 404 is deployed and advanced into an airway. For example,
the tissue gathering element 402 resides in a first airway while
the anchoring element is deployed and advanced into a second
airway, adjacent or nearby the first airway. The rigidity and
robustness of the airways minimizes or prevents rotation or
unwinding of the device 400. This is maintained even after the
torqueing tool 408 is removed.
[0942] The torque that is applied to the lung tissue is a function
of the diameter of the distal tissue gathering element 402 or the
width of any shape that is used as the tissue gathering element
402. If the tissue gathering element 402 is less than 0.5 inches
wide or in diameter, a range of 0 to 2.0 inch-pounds of torque will
be typically applied. If the width or diameter is greater than 0.5
inches, a range of torque between 0.3 and 3.0 inch-pounds is
typically applied. It is advantageous that any loss of stored
energy due to relaxation of the lung tissue after removing the
torqueing tool 408 will be stored in the lung tissue through
counter rotation and contact between the anchoring element 404 and
the adjacent airway or other lung parenchyma or lung structure that
the anchoring element 404 has been deployed into. As an example, if
the torqueing tool 408, tissue gathering end 402, remainder of
device 400 and the catheter is rotated 180 degrees in a clockwise
direction to apply 1.0 inch ounce of torque to the distal tissue
gathering element 402, while the remaining portion of the device
400 is still inside the catheter 430, the torque may be
communicated to tissue effectively through portions of the tissue
gathering element 402 bearing on the tissue and the tissue may
present resistance and a propensity to unwind the device 400 with
an equal amount of torque in the opposite counter clockwise
direction. This unwinding may happen if the torqueing tool 408 were
to be uncoupled and removed. To counter this, the anchoring element
404 is deployed and coupled to tissue to prevent this from
happening in a gross way. However, after deploying the anchoring
element 404, it is simply wedged against the tissue to hold the
device fixed with respect to the airway or lung tissue it has been
deployed into. The anchoring element 404 may not have been rotated
to rotationally load the anchoring element 404 against the
bifurcation branch or ostium it has been placed into to resist
counter rotation of the device 400, as the torqueing tool 408 is
removed. Also, the tissue may not have been conditioned to resist
rotation such as being loaded in a rotated way to gather loose
tissue to create rotational resistance. As such, removal of the
torqueing tool 408 may allow up to 90 degrees of counter-rotation
or unwinding of the entire device 400 in a counter clockwise
direction until the anchoring element 404 rotationally loads the
lung tissue it has been deployed into in this same counter
clockwise direction. In this example, as much as 0.5 inch-pounds of
torque may have been lost at the distal end when the tissue
gathering element 404 was allowed to unwind 90 degrees in the
counter clockwise direction. However, the tissue anchoring element
404 will be rotated 90 degrees in the counter clockwise direction
which loads proximal lung tissue in a rotational direction which
improves lung mechanics as previously described herein. The amount
of rotational work energy that is potentially lost at the distal
end of the device will be gained at the proximal end of the device,
as the torqueing tool 408 is removed. It is possible that the 90
degrees that the tissue anchoring element 404 is counter rotated
may apply as much as 0.5 inch-pounds of torque to tissue that is
adjacent to the proximal end of the device 400 and adjacent to the
anchoring element 404. The force rotational applied to tissue by
the distal tissue gathering element 402 will be balanced by the
forces that are applied by the anchoring element 404 to rotate the
proximal lung tissue. The anchoring element 404 will be anchored
into lung tissue that is structurally stiffer than the tissue that
the tissue gathering element 402 will be anchored into because lung
tissue that is closer to the trachea is normally reinforced by
cartilage. As a result, the rotational torqueing loads that are
applied to the tissue may be balanced but the angle of rotation
experienced by the tissue may not be the same between the two
regions of lung tissue.
[0943] It may be appreciated that the anchoring element 404 may be
deployed to anchor the device 400 in many possible structures of
the lung L to maintain the lung tension but it is often beneficial
to deploy the anchoring element 404 in a bifurcation that can be
accessed by a bronchoscope. This provides support to prevent the
continued recovery of the tissue gathering element 402 from pulling
the device into a more distal position, over time. By hooking the
attachment end 406 of the device 400 around the carina of the
airway bifurcation, there is strong support to keep the device 400
in a position to be later accessed, such as by using a
bronchoscope, to remove the device 400 if the need arises. This is
very advantageous to be nearly guaranteed that the implanted device
400 can be accessed with a bronchoscope, such with the use of a
bronchoscope camera alone. This is in contrast to conventional lung
volume reduction coils which tend to migrate so far distally that
bronchoscopes, appropriately sized to guide recapture
instrumentation, cannot be advanced far enough and cannot fit in
the portion of the lung that the proximal coil eventually resides
within.
[0944] In some instances, the device 400 is rotated further in the
same direction that the torqueing tool 408 rotated the device 400
while the anchoring element 404 is being deployed from the
bronchoscope 20 or delivery system catheter 430 or other delivery
system component. If the anchoring element 404 is shaped in the
form of a helix, removal of the constraining device, such as by
retracting a catheter 430, in the proximal direction will drive
rotation of device 400. The direction of spiral of the helix shape
will dictate the direction that the device 400 will be rotated.
Thus, the helix may be configured to add rotation and torque in the
same direction that the torqueing tool 408 has been used to rotate
device 400 further or the helix may be configured in the opposite
direction to remove some rotation or torque to relieve some of the
torque force during deployment of the anchoring element.
[0945] In some instances, the device 400 is pulled proximally
(along its longitudinal axis) to further tension the lung tissue
distal to the device 400 and/or to position the anchoring element
404 at a more proximal location. Thus, in some embodiments, the
device 400 applies both radial re-tensioning within the lung and
linear re-tensioning toward the trachea T. In some embodiments, the
proximal pulling of the device 400 may be as much as 5 inches, but
more preferably it will be 0.5 to 3 inches of linear proximal
displacement. In these embodiments, the tissue gathering element
402 is strategically positioned within the lung L so that such
pulling in the proximal direction is at least partially maintained
after the anchoring element 404 is deployed so that the device 400
applies both radial re-tensioning within the lung and linear
re-tensioning toward the trachea T.
[0946] Once desirably positioned and anchored, the device 400 is
left in place as an implant. Thus, the torqueing tool 408 is
detached from the attachment end 406 of the device 400 and
withdrawn along with the catheter 430 and bronchoscope 20. Chronic
tension is maintained on the tissue to restore lung elastic recoil.
In some instances, the patient's COPD will progress and the device
400 may gradually unwind, releasing increments of stored energy, to
maintain tensioning of the lung. And, in some advanced cases, the
device 400 may ultimately fully untwist so that the device 400 has
recovered to a zero-strain state due to continued elongation of
tissue because of the progressive nature of the COPD disease. This
can be easily detected, using common medical imaging techniques, by
comparing the rotational position of the tissue gathering element
402 relative to the anchoring element 404 to determine if they are
similar to an unconstrained device 400 before it is deployed in the
patient. If the tissue has relaxed sufficiently that the twist in
the device 400 has been substantially eliminated, additional
devices 400 may be deployed to restore lung function back to the
patient or the existing previously implanted device 400 may be
accessed again with a torqueing system that can rotate the device
400 again to energize and restore the rotational strain back into
the previously implanted device 400. Additionally, the anchoring
element 404 may be pulled from its anchored position so rotation
can be applied and then the anchoring element 404 may be advanced
back into the same airway branch, a new airway branch or it may be
anchored at another anatomical location in the lung to resist
unwinding of the device 400.
[0947] Medical imaging techniques may be used to visualize device
400 delivery, the deployment of the device 400 from delivery system
constraints, rotation or torqueing of device 400, deployment of the
anchoring element 404, deployment of the tissue gathering element
402, decoupling of the torqueing tool 408 from the device 400,
reattachment of the torqueing tool 408 to device 400, recapture of
device 400 by attaching a recapture tool (e.g. a forceps instrument
or suture or specialized recapture tool designed to couple to a
feature of device 400), attaching a guide tool to device 400 to
guide a catheter to be advanced to recapture device 400, to name a
few. Likewise, other maneuvers may be used to visualize any of the
measurable physiologic changes listed herein to improve breathing
in COPD patients during the implantation procedure or after the
procedure or in comparison to determine change in breathing
function by comparing the physiologic difference in the patient as
a result of placing one or more device 400 in the patient. Medical
imaging may be used to assist in selecting a device 400 size before
implantation and any other maneuver that would benefit from
visualization while delivering device 400, recapturing device 400
or evaluating any of the outcome parameters. Medical imaging
includes the use of all forms of equipment that allows for real
time imaging, recording or computer processing that outputs an
image of devices, organs or tissue within the human body without
needing to expose the devices, organs or tissue to be visualized
using a direct line of site by the human eye. These medical imaging
techniques may typically benefit by the emission of low to high
frequency electro-magnetic energy or sound energy which may include
the use of one or more video cameras such as the ones bronchoscopes
are equipped with, computed tomography, biplane imaging,
fluoroscopy, ultrasound or standard planar x-ray machines.
[0948] FIGS. 62A-62D additionally illustrate an embodiment of
delivering a torque-based pulmonary treatment device 400. FIG. 62A
illustrates the device 400 loaded within the catheter 430 which is
advanceable through a lumen of a delivery device, such as a
bronchoscope. Thus, the device 400 is constrained within the
catheter 430 to allow for ease of movement. The anchoring element
404 and tissue gathering element 402 are drawn together and the
tissue gathering element 402 is uncoiled and straightened. The
device 400 remains within the catheter 430 until the distal tip of
the catheter 430 is desirably positioned within the lung L. In this
embodiment, the catheter 430 is then retracted, as illustrated in
FIG. 62B, while the torqueing tool 408 remains in place. This
exposes the tissue gathering element 402, allowing the element 402
to deploy. In this embodiment, the tissue gathering element 402 has
a curved shape, particularly an S-shape, wherein a first wing 440
extends in a first direction (radially outwardly from a
longitudinal axis 442 of the device 400 and joined torqueing tool
408) and a second wing 444 extends in a second direction (radially
outwardly from the longitudinal axis 411). In this embodiment, the
first and second directions are directly opposite to each other.
However, it may be appreciated that the first and second directions
may be at an angle to each other. Referring to FIG. 62C, the handle
435 is then twisted to rotate the tissue gathering element 402.
This causes at least the wings 440, 444 to rotate around the
longitudinal axis 411. This rotation draws the surrounding tissue
toward the longitudinal axis 411, as the wings 440, 444 capture and
pull the tissue. The tissue gathering element 402 is then anchored
in place by deployment of the anchoring element 404, as illustrated
in FIG. 62D. Here, the catheter 430 is further retracted exposing
the more proximally positioned anchoring element 404 which curves
or bows radially outwardly, away from the longitudinal axis 411. As
mentioned, in some embodiments, additional torque is applied to the
torqueing tool 408 in order to align the anchoring element 404 with
an available airway branch so that the anchoring element 404 is
advanceable into the airway branch so as to keep the device 400
from unwinding upon release of the torqueing tool 408. The
torqueing tool 408 is then removed from the attachment end 406 and
the device 400 is left behind.
A. Tissue Gathering Element
[0949] It may be appreciated that the tissue gathering element 402
may be comprised of a variety of materials, may take a variety of
forms or shapes, and may include a variety of features.
[0950] In some embodiments, device 400 is formed from a single
shaft (e.g. wire, cable, braid), wherein the shaft is curved or
bent to form the tissue gathering element 402 and an anchoring
element 404. In such embodiments, the attachment end 406 is created
by a loop, bend, U shaped bend, coil or other feature of the shaft
that allows for grasping or other mechanisms of attachment to a
suitable delivery system. Examples of attachment include attachment
to a pusher, grasper, forceps, suture, or catheter, to name a
few.
[0951] FIGS. 63A-63C illustrate a variety of embodiments of
torque-based pulmonary treatment devices 400. As illustrated, each
device 400 includes at least one tissue gathering element 402 and
at least one anchoring element 404 which meet at an attachment end
406. More than one tissue gathering elements 402 may be attached to
a single device 400 to improve lung function. More than one
anchoring element 404 may be attached to a single device 400 to
improve lung function. It may also be appreciated that the
embodiments illustrated in FIGS. 63A-63C may be formed from a
single shaft to create the tissue gathering element 402 and
anchoring element 404, as described above, or may be formed from
multiple shafts, etc. It may also be appreciated that the tissue
gathering elements 402 may include a distal tip 405, and the tip
405 is often not the distal-most portion of the tissue gathering
element 402. For example, FIGS. 63A-63C illustrate devices 400
having tissue gathering elements 402 comprising a partial loop
which curves radially outwardly from the longitudinal axis 411. In
some embodiments, the loop extends such that the distal tip 405 is
directed back toward the longitudinal axis 411 (e.g. FIG. 63A-63B).
In other embodiments, the distal tip 405 is directed substantially
parallel to the longitudinal axis 411 in the distal direction, such
as extending around a full circle (e.g. FIG. 63C). In such
embodiments, the tissue gathering element 402 may be described as
having a radius R. As the radius R of the tissue gathering end is
increased, the circumference of the loop is increased by a factor
of 2.pi. (i.e. 2.times.3.1415). Thus, increasing the size of the
loop increases the volume of tissue that can be gathered,
particularly by .pi.R.sup.2 (i.e. the area of a circle; the square
of R times 3.1415). In some instances, it is desirable for the loop
to extend as far as feasibly possible to create a maximum radius to
increase effectiveness in gathering tissue. Such feasibility
depends on a variety of factors, including shaft construction, loop
design, and desired function, to name a few. In some instances, it
is desired that the loop has increased torsional strength so as to
more efficiently gather tissue.
[0952] In other embodiments, the tissue gathering element 402 may
not be circular so the effective dimension may be described as
having a width W. Looking at FIG. 63A, if the tissue gathering
element 402 was not circular, what is shown as R would be described
as W. Stated another way, W is the extreme maximum width of a
non-circular tissue gathering element shape. As the width W of the
tissue gathering element 402 is increased, the path length around
the tissue gathering element 402 is increased by a factor of
2.times.W to describe the length of lung tissue that is pulled
towards the longitudinal axis 411 by rotating the tissue gathering
element 360 degrees. Thus, increasing the width W of the tissue
gathering element 402 increases the length of tissue that can be
gathered, particularly by 2 times the width W. In some instances,
it is desirable for the tissue gathering element 402 width W to
extend as far as feasibly possible to create a maximum width to
increase effectiveness in gathering tissue. Such feasibility
depends on a variety of factors, including shaft construction,
tissue gathering element 402 design, and desired function, to name
a few. In some instances, it is desired that the loop has increased
torsional strength so as to more efficiently gather tissue. The
tissue gathering width W may be produced in a range between 0.25
and 3 inches but a range between 0.5 and 1.0 inches is preferable.
If ribbon is used to make the tissue gathering element 402, it's
preferable to use ribbon between 0.005 and 0.030 inches thick if
it's made from metallic material. The width of the ribbon is
typically between 0.005 and 0.100 inches but preferably between
0.040 and 0.075 inches wide to withstand the torqueing forces and
to resist deforming to such a degree that it no longer effectively
gathers tissue.
[0953] In some embodiments, the loop shape is designed to increase
strength during torsion. For example, in some embodiments, the loop
has a "D" or "P" shape wherein the loop extends over the
longitudinal axis 411, crossing the portion of the tissue gathering
element 402 that extends along the longitudinal axis 411 (e.g. FIG.
64). By forming a shape in the shaft 412 that crosses over itself,
the circular section of the "D" or "P" shape or other looping shape
is stiffened to resist twist or torsional deformation. Stiffening
is provided because the free end (distal tip 405) is stabilized at
the crossing point, against the portion of the shaft that it
crosses. These crossing points or points of contact may optionally
be held together with a reinforcing element, such as a crimped tube
connector, or they may be joined together, such as by brazing or
welding (e.g. with an arc or using laser light or any combination),
to geometrically stiffen the attachment end 406, the anchoring
element 404 or the tissue gathering element 402.
[0954] When rotating the tissue gathering element 402 around the
longitudinal axis 411 the direction of the cross-over, so that the
tissue presses the shaft 412 against itself at the cross-over
point, the cross-over resists deformation of the loop. By arresting
the deformation in this way, the looped portion of the tissue
gathering element 402 is made more effective to transmit torque or
rotation energy directly to the tissue. When rotating the tissue
gathering element 402 in the opposite direction, the tissue
gathering element 402 will deform because the free distal tip 405
is not supported to prevent the deformation. In some instances,
this may be beneficial because the deformation stores elastic
strain energy in the device 400 that can continue to perform work
on the lung L after the delivery system has been removed (like
loading a spring and leaving it in the body to continue pulling on
tissue).
[0955] It may be appreciated that the distal tip 405 may have a
variety of forms. In some embodiments, the distal tip 405 is
atraumatic and has a blunt shape, such as a ball or other rounded
shape (e.g. FIG. 63A). In this configuration, the tissue gathering
element 402 may be more inclined to track along the inside lumen of
an airway if the airways are still preserved. However, in nearly
all cases, they are not. If the distal tip includes a ball that is
smaller than 0.060 inches diameter, it will still be capable of
penetrating the wall of an airway to engage connective alveoli
instead of manipulating airways alone. In other embodiments, the
distal tip 405 has a sharp shape, configured to pierce and/or
penetrate tissue (e.g. FIG. 63B). In other embodiments, the distal
tip 405 has an anchoring shape, such as a fish-hook or other shape
which is configured for piercing or penetrating tissue while
resisting withdrawal from the tissue (FIG. 63C).
[0956] In some embodiments, the device 400 is made from round wire.
It may be appreciated that in some embodiments the round wire has
been flattened at the distal tip or any other portion of the tissue
gathering element 402 to add bearing area. For example, FIG. 65
illustrates an embodiment of a device 400 formed from flattened
wire. In this embodiment, the tissue gathering element 402 is
formed from a shaft 412 and the anchoring element 404 is formed
from a shaft 420, wherein the shafts 412, 420 are fixed together to
form the attachment end 406. Each shaft 412, 420 has a flattened,
broader surface, such as a ribbon, wherein the flattened surfaces
are mated so as to increase contact for fixing to each other.
Fixing the elements together may be accomplished by welding,
gluing, thermally friction bonding, crimping, locking together
using puzzle lock patterns, locking extrusion sections within each
other, wrapping with a spring, riveting, locking together with
threaded fasteners, by joining using locking hardware that is known
in the art. In some embodiments, the flattened or broader surface
is arranged to be perpendicular to the direction the shaft 412
contacts tissue to prevent the tissue gathering element 402 from
cutting or migrating through tissue over time. Thus, the flattened
or broader surface serves as the bearing area. In some instances,
this is particularly useful along curved portions of the tissue
gathering element 402 so as to prevent the curved portion of the
tissue gathering element 402 from cutting or migrating through
tissue over time.
[0957] FIG. 66 illustrates an embodiment of a device 400 formed
from oval wire. In this embodiment, the tissue gathering element
402 is formed from a shaft 412 and the anchoring element 404 is
formed from a shaft 420, wherein the shafts 412, 420 are fixed
together with the use of an attachment element 410. The attachment
element 410 assists in joining the shafts 412, 420 and forming a
desired shape for attachment and torqueing. In this embodiment, the
broader side of the oval wire is arranged to be perpendicular to
the direction the shaft 412 contacts tissue to prevent the tissue
gathering element 402 from cutting or migrating through tissue over
time.
[0958] FIGS. 65-66 also illustrate tissue gathering elements 402
having a shape which is more similar to an arc or arch than a loop.
In FIG. 65, the shaft 412 bends radially outwardly from the
longitudinal axis 411 to form a curved arch wherein the distal tip
405 is parallel to the longitudinal axis 411 facing the proximal
direction. In FIG. 66, the shaft 412 bends radially outwardly from
the longitudinal axis 411 to form a curved arc wherein the distal
tip 405 parallel to the longitudinal axis 411 facing the radially
outwardly from the longitudinal axis 411.
[0959] It may be appreciated that the tissue gathering element 402
may have irregular shapes or compound curvatures. For example, FIG.
67 illustrates a tissue gathering element 402 having a shape formed
by the shaft 412 curving radially outwardly from the longitudinal
axis 411 and forming a first curvature 450, a second curvature 452
and then a third curvature 454. The first curvature 450 has an arc
shape which then transitions into an inverse arc shape for the
second curvature 452. This then transitions into a semi-circle or
arch shape which directs the distal tip 405 toward the longitudinal
axis 411. This compound curvature (combination of curvatures 450,
452, 454) creates a hook shape which may be particularly beneficial
for gathering tissue in both a twisting fashion and a pulling
fashion. The partial loop shape extending radially outwardly from
the longitudinal axis 411 assists in gathering tissue during
torqueing, as described above. And, the hooking shape (distal tip
405 facing the longitudinal axis 411) assists in holding the tissue
when pulling the device 400 in the proximal direction, such as
along the longitudinal axis 411.
[0960] It may also be appreciated that the tissue gathering element
402 may have a variety of other shapes, including bends and arcs
which are rounded or angular, in the same direction or opposite
directions, and in a variety of configurations. FIG. 68 illustrates
a tissue gathering element 402 similar to that illustrated in FIGS.
62A-62D. In this embodiment, the tissue gathering element 402 has a
curved shape, particularly an S-shape, wherein a first wing 440
extends in a first direction (radially outwardly from a
longitudinal axis 411) and a second wing 444 extends in a second
direction (radially outwardly from the longitudinal axis 411). In
this embodiment, the first and second directions are directly
opposite to each other. However, it may be appreciated that the
first and second directions may be at an angle to each other. In
addition, this embodiment illustrates the distal tip 405 aligned
with the longitudinal axis 411, particularly facing in the distal
direction.
[0961] It may be appreciated that the shaft 412 may include various
additional bends or curvatures to provide particular features. For
example, FIG. 69 illustrates an embodiment wherein the shaft 412 is
configured to provide strain relief. Here, the shaft 412 has one or
more bends, switchbacks or wings in succession configured to act as
a strain relief while manipulating the device 400. In this
embodiment, the strain relief portion 460 is disposed proximal to
the tissue gathering end 404. Thus, pulling in the proximal
direction, such as along the longitudinal axis 411, would expand
the strain relief portion 460 leaving the tissue gathering end 404
in position. This may be desired in situations wherein it is
preferred to maintain position of the tissue gathering end 404 when
pulling the attachment end 406, such as when positioning the
anchoring element 404.
[0962] It may be appreciated the shaft 412 of the tissue gathering
end 404 may vary in terms of construction and materials so as to
provide various features. In some embodiments, as illustrated in
FIGS. 70A-70B, the shaft 412 is comprised of a tube 461 having
slots or cuts 462 along at least a portion of its length. Such cuts
462 may be fabricated by laser cutting of the tube 461. In
addition, a pull cord 464 is positioned within or along the tube
461 extending distal to the cuts 462. The cuts 462 are aligned
along the tube 461 so as to allow flexibility of the tube 461 while
the pull cord 464 is slack (FIG. 70A), and to allow curvature along
a predetermined arc or arch when the pull cord 464 is pulled (FIG.
70B). Such pulling closes the slots or cuts 462, holding the shaft
412 in the curved formation. This construction provides increased
torque strength and allows the tissue gathering end 404 to transmit
higher levels of torque. It may be appreciated that although the
shaft 412 is illustrated with a needle tip, any suitable tip shape
may be used.
[0963] In other embodiments, the shaft 412 is comprised of a
twisted pair of wires or a combination of more than 2 wires. In
other embodiments, the shaft may be pressure cast or made from
powder metal to form a near net shape that varies in dimension
along its length. Near net shapes are limited only to the shape of
a mold that is used to forge the powder metal together to form a
high performance metalized composite material of nearly any shape.
In another embodiment, the shaft 412 is made from a twisted pair of
wires, the preferable direction of rotation that the user should
use to rotate the tissue gathering element 402 within the lung is
the same direction that was used to produce the twist in the
twisted pair of wires. This same direction will further tighten the
twist to maintain a reasonably small diameter of the tissue
gathering element 402. This will also transmit the greatest amount
of torque through the delivery system and the device 400 to the
tissue. This is the direction that will transmit the maximum torque
force to the lung tissue.
[0964] In some embodiments, the tissue gathering element 402
comprises a jacket which extends over at least a portion of the
shaft 412 so as to increase gripping of the lung tissue and reduce
cutting through lung tissue (i.e. "cheese wiring"). FIGS. 71A-71C
illustrate example embodiments of jackets 470. FIG. 71A illustrates
a jacket 470 comprising a coil 472 which extends over a portion of
the shaft 412 to increase bearing area on the tissue. In some
embodiments, the coil 472 comprises a spring coil that is tight
wound to grip the shaft 412. In some embodiments, gaps between coil
turns are spaced between 0.003 and 0.100 inches so as to increase
friction between the tissue gathering element 402 and the tissue,
therefore enhancing tissue gathering. In some embodiments, a
suitable coil 472 outer diameter would be larger than 0.018'' and
smaller than 0.130'' to be suitable to fit in a typical
bronchoscope. FIG. 71B illustrates a jacket 470 comprising a
flexible sleeve 474. In some embodiments, the flexible sleeve 474
comprises a woven material, such as Dacron or polyester. In other
embodiments, the flexible sleeve 474 comprises a braided tube. In
either case, the flexible sleeve 474 increases bearing area on the
tissue and increases friction or gripping. In other embodiments,
the flexible sleeve 474 comprises silicone. In other embodiments,
the flexible sleeve 474 comprises shrink fit tubing. FIG. 71C
illustrates a jacket 470 comprising a combination of a coil 472 and
a sleeve 474. In this embodiment, the coil 472 extends over the
shaft 412 and the sleeve 474 extends over the coil 472. Thus, the
jacket 470 may be comprised of a coil 472 having shrink fit tubing
thereover.
[0965] In some embodiments, the distal tip of the tissue gathering
element 402 comprises a balloon expandable or self-expanding stent
structure that grips an airway wall or that grips to lung tissue as
the stent is dilated to minimize the distal tip from being pulled
out of the tissue as the device 400 is rotated, to further increase
the effectiveness of the tissue gathering.
B. Anchoring Element
[0966] It may be appreciated that the anchoring element 404 may be
comprised of a variety of materials, may take a variety of forms or
shapes, and may include a variety of features.
[0967] As mentioned previously, in some embodiments, the device 400
is formed from a single shaft (e.g. wire, ribbon, cable, braid),
wherein the shaft is curved or bent to form the tissue gathering
element 402 and the anchoring element 404. In such embodiments, the
attachment end 406 is created by a loop, bend, U shaped bend, coil
or other feature of the shaft that allows for grasping or other
mechanisms of attachment to a suitable delivery system. Examples of
attachment include attachment to a pusher, grasper, forceps,
suture, or catheter, to name a few.
[0968] As mentioned previously, FIGS. 63A-63C illustrate a variety
of embodiments of torque-based pulmonary treatment devices 400. As
illustrated, each device 400 includes a tissue gathering element
402 and an anchoring element 404 which meet at an attachment end
406. It may be appreciated that the embodiments illustrated in
FIGS. 63A-63C may be formed from a single shaft to create the
tissue gathering element 402 and anchoring element 404 or may be
formed from multiple shafts, etc. As shown in these embodiments,
the anchoring element 404 is typically comprised of a shaft 420
which extends from the attachment end 406 in the same direction as
the tissue gathering element 402, generally along a longitudinal
axis 411. Thus, upon deployment, the shaft 420 of the anchoring
element 420 bows outwardly, away from the longitudinal axis 411 and
tissue gathering element 420, such as to form the shape of a
bifurcation. The anchoring element 404 is then advanced into an
adjacent or nearby airway to anchor the device 400.
[0969] FIG. 63A illustrates an anchoring element 404 comprising a
loop which curves radially outwardly from the longitudinal axis
411. In some embodiments, the loop extends such that its distal tip
407 is directed back toward the longitudinal axis 411. In some
embodiments, the distal tip 405 is directed so that the loop
extends substantially around a full circle. In such embodiments,
the anchoring element 404 may be described as having a radius R.
Increasing R increases the moment on fixing the proximal end of the
device 400. Torque resistance=R.times.F (friction in the tissue).
By increasing R, less friction is needed to hold the device 400
from counter rotating. Some embodiments may include barbs or hooks
that penetrate the airway wall and increase the R dimension to
reinforce anchoring and resistance to counter rotating with respect
to the torqueing force that had been applied to the tissue
gathering element 402 and tissue.
[0970] FIG. 63B illustrates an anchoring element 404 which bows
radially outwardly away from the longitudinal axis 411 and then
curves back toward the longitudinal axis 411 and extends along the
longitudinal axis 411 in the distal direction. In this embodiment,
the proximal end of the tissue gathering element 402 similarly bows
radially outwardly from the longitudinal axis 411, substantially
symmetrical to the anchoring element 404.
[0971] FIG. 63C illustrates a plurality of anchoring elements 404
on a single device 400. In this embodiment, three anchoring
elements 404 extend from the attachment end 406, however any number
may be present including one, two, three, four, five, or more. In
this embodiment, each anchoring element 404 extends in a different
radial direction from the longitudinal axis. This provides the user
with a variety of options when anchoring the device 400. In
particular, the anchoring element 404 most suitably positioned for
anchoring within the particular anatomy may be used to anchor the
device 400. Or, more than one anchoring element 404 may be used in
the same or differing airways for additional anchoring support.
[0972] It may be appreciated that in some embodiments, such as
illustrated in FIGS. 65-66, the anchoring element 404 has a shape
which is more similar to an arc or arch than a loop. In FIG. 65,
the shaft 420 bends radially outwardly from the longitudinal axis
411 to form a curved arch wherein the distal tip 407 is parallel to
the longitudinal axis 411 facing the proximal direction. In FIG.
66, the shaft 420 bends radially outwardly from the longitudinal
axis 411 to form a curved arc wherein the distal tip 407 parallel
to the longitudinal axis 411 facing the radially outwardly from the
longitudinal axis 411.
[0973] It may also be appreciated that the anchoring element 404
may have a variety of other shapes, including bends and arcs which
are rounded or angular, in the same direction or opposite
directions, and in a variety of configurations. FIG. 68 illustrates
an anchoring element 404 having a curved shape, particularly an
S-shape, wherein a first wing 441 extends in a first direction
(radially outwardly from a longitudinal axis 411) and a second wing
445 extends in a second direction (radially outwardly from the
longitudinal axis 411). In this embodiment, the first and second
directions are directly opposite to each other. However, it may be
appreciated that the first and second directions may be at an angle
to each other. In addition, this embodiment illustrates the distal
tip 407 aligned with the longitudinal axis 411, particularly facing
in the distal direction.
[0974] It may be appreciated that in any of the embodiments, the
tissue gathering element 402 and anchoring element 404 may extend
radially outwardly from the longitudinal axis 411 in the same or
different directions. Likewise, it may be appreciated that in any
of the embodiments, the tissue gathering element 402 and anchoring
element 404 may have the same or similar shapes or different
shapes.
[0975] It may be appreciated that in some embodiments the anchoring
element 404 maintains position in an airway or area of the lung
anatomy by simple entrapment of the anchoring element 404, such as
insertion into an airway that is separate from the pathway to the
tissue gathering element 402. In such instances, the anchoring
element 404 may be "loose" within the airway yet pressed against a
portion of the airway due to forces applied via the attachment end
406 so as to anchor the device 400. Such anchoring elements 404 may
be easily removable by releasing the forces applied via the
attachment end 406 or applying sufficient pulling force in the
proximal direction. In other embodiments, the anchoring element 404
is actively anchored within the airway so as to maintain anchoring
without relying on forces applied via the attachment end 406 for
anchoring. FIG. 72 illustrates an embodiment of an anchoring
element 404 comprising an expandable basket 480. In this
embodiment, the expandable basket 480 is insertable into an airway
or other anatomy and expandable so as to apply radial outward force
upon the airway. This holds the basket 480 within the airway
resisting movement within the airway. This, in turn, anchors the
device 400 and holds the tissue gathering element 402 in place.
FIG. 73 illustrates an embodiment of an anchoring element 404
comprising one or more anchoring hooks 486. In this embodiment, the
one or more anchoring hooks 486 are insertable into an airway or
other anatomy and expandable so as to puncture or penetrate the
wall of the airway. This holds the one or more anchoring hooks 486
within the airway resisting movement within the airway. This, in
turn, anchors the device 400 and holds the tissue gathering element
402 in place. FIG. 74 illustrates an embodiment of an anchoring
element 404 comprising an expandable stent 490. The stent 490 may
be comprised of a variety of materials, such as nitinol, steel,
etc. Likewise, the stent 490 may be braided or laser cut, to name a
few. In this embodiment, the expandable stent 490 is insertable
into an airway or other anatomy (such as alone or with the use of a
guidewire) and expandable so as to circumferentially expand against
the inner walls of the airway. In some embodiments, the stent 490
is self-expanding and in other embodiments the stent 490 is
expandable with assistance, such as by balloon inflation. This
holds the stent 490 within the airway resisting movement within the
airway. This, in turn, anchors the device 400 and holds the tissue
gathering element 402 in place.
C. Attachment End
[0976] As mentioned previously, the torque-based pulmonary
treatment device 400 typically comprises an attachment end 406
where the tissue gathering element 402 and an anchoring element 404
join. The attachment end 406 may be used to attach a delivery
device thereto, such as a torqueing tool 408. Thus, the attachment
end 406 typically has a non-round cross-section shape, such as a
square, rectangular, polygonal or oval shape, to assist in
maintaining rotational toque coupling and torque transmission
during rotational or torqueing motion of the torqueing tool 408. It
may be appreciated that in some embodiments the attachment end 406
is formed from portions of the tissue gathering element 402 and
anchoring element 404 themselves, such the joining of their
respective proximal ends. In other embodiments, the tissue
gathering element 402 and anchoring element 404 are formed from a
continuous shaft and the attachment end 406 is formed from a bend
or crimp in the shaft therebetween. In some embodiments, the
attachment end 406 includes an attachment element 410 to assist in
joining and/or holding the elements 402, 404 and forming a desired
shape for attachment and torqueing. And yet in other embodiments,
the attachment end 406 resides at the proximal end of the tissue
gathering element 402 or the anchoring element 404 and the elements
402, 404 are joined to each other distally of the attachment end
406.
[0977] As mentioned, in some embodiments, the attachment end 406 is
formed from portions of the tissue gathering element 402 and
anchoring element 404 themselves, such the joining of their
respective proximal ends. FIG. 75 illustrates such an embodiment
wherein the proximal ends of the tissue gathering element 402 and
anchoring element 404 are bonded together by gluing or welding but
they may also be joined by riveting, using threaded fasteners,
crimping using a tubing or spring coupler, press fit together using
a coupler or interlocking features such as threading a hitch pin,
it may also be sutured together or tied using metal or plastic
wire, cable, fibers, string, or they may be fused together by
congealing biologic material they may be held adjacent to each
other using magnetic attraction force with magnetic materials.
Thus, FIG. 75 illustrates bonding material 510 between and
optionally covering outer portions of the tissue gathering element
402 and anchoring element 404.
[0978] As mentioned, in some embodiments, the tissue gathering
element 402 and anchoring element 404 are formed from a continuous
shaft 412 and the attachment end 406 is formed from a bend or crimp
in the shaft therebetween. FIG. 76A illustrates such an embodiment
wherein the attachment end 406 has the form of a bend, in
particular a loop-shaped bend. FIG. 76B illustrates an example of
usage of the embodiment of FIG. 76A. Here, the attachment end 406
is connected with another device, such as a torqueing tool 408 or
removal tool, using a hitch pin 503 with a ball end 505. The hitch
pin 503 releasably attaches the devices together. Removal of the
hitch pin 503 detaches the devices from each other. It may be
appreciated that this design may also be used to pin the tissue
gathering element 402 and the anchor element 404 together.
[0979] FIG. 77 illustrates a portion of an attachment end 406 of a
device 400 having torqueing tool socket 507 that has been slipped
thereover. The torqueing tool socket 507 has a shape that allows
for a slip fit over the portion of the attachment end 406. The
socket 507 is attached to or part of a torqueing tool 408 so that
rotation of the torqueing tool 408 is transmitted through the
torqueing tool socket 507 and translated to the attachment end 406.
Likewise, the torqueing tool 408 is able to be translated
longitudinally to be released from the device 400 without requiring
any actuation of any mechanism to release the slip fit
connection.
[0980] In some embodiments, the attachment end 406 is configured to
mate with a torqueing tool 408 in a manner which temporarily locks
the device 400 and tool 408 together. In some instances, this
assists in positioning the device 400 wherein the device 400 can be
easily advanced and retracted with the use of the tool 408. For
example, in FIG. 78 the attachment end 406 has a threaded outer
surface and the torqueing tool 408 includes threaded inner surface.
This allows the attachment end 406 to join with a torqueing tool
408 in a screw-type manner. In this embodiment, the torqueing tool
408 has a threaded receptacle 550 configured to receive the
attachment end 406 so as to mate the threading surfaces together.
It may be appreciated that such joining may be achieved by rotation
of the torqueing tool 408, wherein continued rotation in the same
direction then rotates or torques the tissue gathering element 402.
Once desired rotation has been achieved, the anchoring element 404
is actuated and the torqueing tool 408 is then unscrewed from the
attachment end 406. FIG. 79 illustrates an attachment end 406 which
keys into the torqueing tool 408. In this embodiment, the
attachment end 406 includes an extension 570 which extends away
from the longitudinal axis 411 of the device 400. The extension 570
may have any suitable shape including a rod, protrusion, bump, etc.
In this embodiment, the torqueing tool 408 includes a receptacle
580 having a groove or cutaway 582 configured to receive the
extension 570 upon mating of the attachment end 406 with the
receptacle 580. Typically, the cutaway 582 extends along a first
direction, such as along the longitudinal axis 411 and then extends
along a second direction, such as angular or perpendicular to the
longitudinal axis 411. As the attachment end 406 is joined with the
torqueing tool 408, the extension 570 is advanced along the cutaway
582 (along the first and second directions) which typically
involves rotating the torqueing tool 408 to allow advancement of
the extension along the second direction. Positioning of the
extension 570 within the cutaway 582 along the second direction
temporarily locks the attachment end 406 to the torqueing tool 408
during pulling or pushing along the longitudinal axis 411. It may
be appreciated that continued rotation of the torqueing tool 408 in
the same direction rotates or torques the device 400. since the
extension 570 is unable to slide out of the cutaway 582. Once
desired rotation has been achieved, the anchoring element 404 is
actuated and the torqueing tool 408 is then rotated in the reverse
direction to release the extension 570 from the receptacle 580.
[0981] In other embodiments, the attachment end 406 includes one or
more accessories configured to assist in rotation of the device
400. For example, FIG. 80 illustrates an embodiment of an
attachment end 406 having at least one protrusion 590 which extends
radially outwardly from the longitudinal axis 411. The at least one
protrusion 590 provides a larger surface area for attachment to the
torqueing tool 408. In this embodiment, the torqueing tool 408
comprises a grasper which grasps the at least one protrusion 590.
Rotation of the torqueing tool 408 thus rotates the device 400. The
torqueing tool 408 is then disengaged from the device 400 by
releasing the grasper.
[0982] In some embodiments, the anchoring element 404 is
positionable within the same airway or passageway as the tissue
gathering element 402 or within an airway or passageway which is
proximal to that of the tissue gathering element 402. FIG. 81
illustrates an embodiment of such a device 400. Here, the anchoring
element 404 is disposed in the opposite direction as the tissue
gathering element 402, along the longitudinal axis 411. Here, the
anchoring element 404 comprises an expandable stent 490. Thus, the
tissue gathering element 402 may be advanced into an airway and
desirably positioned. The device 400 is then anchored in place by
expanding the stent 490 proximally of the tissue gathering element
402. This may be particularly useful in situations wherein a nearby
airway is not available for anchoring due to anatomical
configuration or lack of strength.
[0983] FIGS. 82A-82B illustrate another embodiment wherein the
anchoring element 404 is positionable within the same airway or
passageway as the tissue gathering element 402. Here, the anchoring
element 404 is disposed in the opposite direction as the tissue
gathering element 402, along the longitudinal axis 411. Here, the
anchoring element 404 comprises a coil 491. Thus, the tissue
gathering element 402 may be advanced into an airway or through the
wall of the airway into destroyed fragile lung tissue and desirably
positioned. The device 400 is then anchored in place by deploying
the coil 491 which expands within a luminal passageway or airway
proximally of the tissue gathering element 402. In this embodiment,
the device 400 includes an attachment feature 610 near the proximal
end of the coil 491 and an additional attachment feature 610'
disposed between the tissue gathering element 402 and the anchoring
element 404. Thus, the torqueing tool 408 may be attached to either
attachment feature 610, 610' for the most desirable outcome.
Alternatively, more than one torqueing tool 408 may be attached to
device 400 to apply torque and to help deploy the anchoring element
404. One or both of the torqueing tools may also be used to remove
the device 400 from the lung in a coordinated way if this is
desirable. FIG. 82B illustrates the device 400 of FIG. 82A rotated
90 degrees about the longitudinal axis 411. In this embodiment, the
tissue gathering element 402 has a hook or loop shape. It may be
appreciated that the loop of the tissue gathering element 402 may
curve within a single plane. However, in this embodiment, the loop
of the tissue gathering element 402 curves within multiple planes,
as illustrated in FIG. 82B. This may be beneficial when the tissue
gathering element 402 is less rigid and therefore less capable of
moving tissue. The out-of-plane curvature accounts for such
flexibility wherein rotation of the tissue gathering element 402
causes the tissue to align the loop toward a single plane. The
tissue gathering element 402 then has increased ability to move
tissue.
[0984] FIG. 82C illustrates another embodiment of a pulmonary
treatment device 400 having a tissue gathering element 402 and an
anchoring element 404. In this embodiment, the device 400 is formed
from a continuous shaft 412 which bends to form the elements 402,
404. Here, the device 400 generally extends along a longitudinal
axis 411. The tissue gathering element 402 is formed by the shaft
412 bending radially outwardly away from the longitudinal axis 411
forming a loop around an axis 413 that is perpendicular to the
longitudinal axis 411. In some embodiments, the outer diameter of
the loop that is formed around the axis 413 in the range of 0.400
inches to 3.0 inches in diameter or any size between. Most
preferably, the loop may have an outer diameter in the range of
0.75 inches and 1.25 inches. In this embodiment, the loop continues
into a full loop shape around the axis 413, however it may be
appreciated that in other embodiments the loop is a partial loop
forming an arc shape. In this embodiment, the anchoring element 404
is formed by the shaft 412 bending into a coiled shape, wherein
each turn of the coil extends at least partially around the
longitudinal axis 411. In this embodiment, the shaft 412 has a
flattened, ribbon shape. In some embodiments, the ribbon shape is
between 0.005 and 0.030 inches wide and between 0.005 and 0.030
inches thick in dimension. The ribbon may be blasted or tumbled in
abrasive media to round the edges so it more closely appears like a
round cross-section wire. Alternatively, the anchoring element 404
may be made from round cross section wire, for example having a
diameter between 0.003 and 0.050 inches. The coiled shape may be
configured to form a coil shaped stent or helix with an outer
diameter of the helix that is between 5 mm and 17 mm in diameter
but more preferably it is between 6 mm and 10 mm in diameter. Thus,
the tissue gathering element 402 has a stiffness sufficient to move
lung tissue, particularly to move lung tissue around the
longitudinal axis 411. Thus, in such a situation the longitudinal
axis 411 becomes a rotational axis.
[0985] FIG. 82D illustrates another embodiment of a pulmonary
treatment device 400 having a tissue gathering element 402 and an
anchoring element 404. In this embodiment, the device 400 is formed
from a continuous shaft 412 which bends to form the elements 402,
404 in a shape similar to that of FIG. 82C. Likewise, the tissue
gathering element 402 has a flattened, ribbon shape. However, in
this embodiment, the ribbon is twisted along its length in at least
one location 415 so as to rotate at least one portion of a flat
surface of the ribbon 417 toward an edge of the ribbon, as shown.
In particular, the ribbon is twisted along its length at multiple
locations 415 so as to rotate a series of portions of the flat
surface 417 of the ribbon toward the edge of the ribbon. Thus, when
the device 400 is rotated about the longitudinal axis 411, the
series of portions of the flat surface of the ribbon are posed to
engage the surrounding tissue. This adds 300-500% more bearing area
against the tissue for engagement. This reduces the stress on the
tissue to less than 20% compared to when the edge of the ribbon
engages the tissue.
[0986] It may be appreciated that the anchoring elements 404
described herein may be positioned within an airway, lung
passageway, blood vessel, parenchyma, or destroyed tissue, to name
a few. The choice of design used for the anchoring element 404 is
typically chosen based on the anatomy or environment within which
the element 404 is to be positioned. For example, a stent 490
design may be more suitable for a luminal passageway while an
anchoring hook 486 design may be more suitable for damaged
tissue.
[0987] FIGS. 82E-82G illustrate steps in an example method of
deploying a torque-based pulmonary treatment device 400 such as
illustrated in FIGS. 82A-82D. In this embodiment, deployment begins
(FIG. 82E) by pushing the device 400 through a catheter 430 and out
its distal end so that the tissue gathering element 402 extends
from the distal end of the catheter 430 and curves radially
outwardly from the longitudinal axis 411. As the tissue gathering
element 402 is further advanced additional portions of the tissue
gathering element 402 extend from the distal end of the catheter
430, curving around into a loop shape, as shown. FIG. 83F
illustrates rotation of the device 400, such as by rotation of the
catheter 430 around the longitudinal axis 411. The forces on the
tissue adjacent the tissue gathering element 402 move the tissue
around the longitudinal axis 411 into a torqued configuration. This
tensions the surrounding tissue. Once the lung has been desirably
tensioned, the device 400 is then anchored to maintain the
tensioning or resist unwinding of the device from the torqued
configuration. In this embodiment, this is achieved by deploying
the anchoring element 404, as illustrated in FIG. 82G. In this
embodiment, the anchoring element 404 had a coil shape and is
concentrically aligned with the longitudinal axis 411. In this
embodiment, deployment of the anchoring element 404 is achieved by
retracting the catheter 430 so as to allow the coils of the
anchoring element 404 to expand. In this embodiment, a torqueing
tool 108 remains attached to the device 400 at this stage of
delivery. The torqueing tool 408 is then removed from the device
400. The device 400 is then left in place as an implant while the
catheter 430 is removed.
[0988] FIGS. 83A-83J provide a more detailed illustration of steps
in an example method of deploying a torque-based pulmonary
treatment device 400 such as illustrated in FIGS. 82A-82D. To begin
(FIG. 83A), the device 400 is loaded within a catheter 430 or
similar delivery device which is configured to be advanceable
through a lumen in an endoscope, such as a bronchoscope 20. The
device 400 is constrained within the catheter 430 (along
longitudinal axis 411) to allow for ease of placement. The device
400 is attached to a torqueing tool 408 which extends from the
distal end of the catheter 430. In this embodiment, the torqueing
tool 408 includes a handle 435. In this embodiment, deployment
begins by advancing the torqueing tool 408 into the catheter 430 so
as to begin pushing the device 400 through the catheter 430 and out
its distal end. FIG. 83A illustrates the distal tip 405 of the
tissue gathering element 402 extending from the distal end of the
catheter 430 along the longitudinal axis 411. As the torqueing tool
408 is additionally advanced, as illustrated in FIG. 83B,
additional portions of the tissue gathering element 402 extend from
the distal end of the catheter 430. Due to pre-curves set into the
tissue gathering element 402 the distal tip 405 begins curving
radially outwardly from the longitudinal axis 411. As the torqueing
tool 408 is yet further advanced, as illustrated in FIG. 83C,
additional portions of the tissue gathering element 402 extend from
the distal end of the catheter 430, curving around into a loop
shape. Here, the distal tip 405 is directed toward a sample tissue
area 600 located off-set from the longitudinal axis 411. The sample
tissue area 600 is demarked to illustrate how the sample tissue
area 600 may move in response to torqueing the device 400. However,
it may be appreciated that a larger mass of tissue surrounding the
sample tissue area 600 is moved by rotation of the device 400.
[0989] FIG. 83D illustrates the start of rotating the torqueing
tool 408; as indicated by arrow 602, the torqueing tool 408 is
rotated in the counter-clockwise direction in this embodiment. It
may be appreciated that in other embodiments, the torqueing tool
408 may be rotated in the clockwise direction. In this embodiment,
slight resistance of the tissue is illustrated wherein the
torqueing tool 408 rotates while the tissue gathering element 402
flexes. The forces on the sample tissue area 600 begin to pull the
surrounding tissue creating tension, as illustrated by arrow 604.
FIG. 83E illustrates further rotation of the torqueing tool 408. At
this point the curved portion of the tissue gathering element 402
has rotated around the longitudinal axis 411 pulling the sample
tissue area 600 along with it. This further tensions the
surrounding tissue as illustrated by arrow 606. Additionally, in
this embodiment, the torqueing tool 408 is pulled back, in the
proximal direction along the longitudinal axis 411, as indicated by
arrow 608. This additionally applies longitudinal force to the
sample tissue area 600 as indicated by arrow 611. As illustrated in
FIG. 83F, the torqueing tool 408 is then retracted further in this
embodiment, as illustrated by arrow 608. Because the tissue
gathering element 402 has been distorted due to the rotational and
longitudinal motions illustrated in FIG. 83E, the tissue gathering
element 402 has been interlocked into tissue to allow additional
rotation and translation motions and applied forces to tissue that
would not normally have been possible without pulling the tissue
gathering element 402 out of tissue. Designing the tissue gathering
element in a way that allows it to be rotated and translated so it
is distorted to converge more closely to occupy a plane that is
periductular to axis 411 locks it into tissue to allow more extreme
torsion and translational forces to be applied to tissue. In this
embodiment, the device 400 is then additionally rotated, as
illustrated in FIG. 83G, so as to further wrap the surrounding
tissue around the tissue gathering element 402. Thus, the sample
tissue area 600 continues rotating around the longitudinal axis
411, applying further radial and longitudinal tension on the
surrounding lung. Once the lung has been desirably tensioned, the
device 400 is then anchored to maintain the tensioning. In this
embodiment, this is achieved by deploying the anchoring element
404. In this embodiment, the anchoring element 404 had a coil shape
and is concentrically aligned with the longitudinal axis 411. FIG.
83H illustrates deployment of the anchoring element 404 wherein the
catheter 430 is retracted to allow the coils of the anchoring
element 404 to expand. In this embodiment, the torqueing tool 108
remains attached to the device 400 at this stage of delivery. In
particular, in this embodiment, the torqueing tool 408 has a curved
distal tip (e.g. a 90 degree curvature away from the longitudinal
axis) which passes through an attachment feature 610 (e.g. a loop)
on the device 400, maintaining attachment. The torqueing tool 408
is then removed from the attachment feature 610 by retracting the
torqueing tool with sufficient force as to straighten the curved
end of the torqueing tool 408 to pull it out of the attachment
feature 610, as illustrated in FIG. 83I. The device 400 is then
left in place as an implant while the catheter 430 is removed. In
some embodiments, the torqueing tool 408 is be made from a
resilient material such as Nitinol or titanium in which the modulus
of elasticity is less than 30E6 pounds per square inch. In other
embodiments, the torqueing tool 408 is made from ferrous or
non-ferrous metals with a cross section area less than 0.005 square
inches. These dimensions allow for the wire to be deformed. In some
embodiments, the torqueing tool 408 is made from stainless steel
wire that has a dimension between 0.010 and 0.030 inches in
diameter.
D. Alternative Embodiment
[0990] It may be appreciated that the torque-based pulmonary
treatment device 400 may take a variety of forms and include a
variety of features, such as those of the pulmonary treatment
devices 10 described herein above which are applicable to
torque-based methods and treatments. FIGS. 84A-84E illustrate
another embodiment of a torque-based pulmonary treatment device
400. Here, the device 400 includes a plurality of tissue gathering
elements 402. In particular, two tissue gathering elements 402 are
shown, however it may be appreciated that additional tissue
gathering elements 402 may be present including three, four, five,
six or more. In this embodiment, the tissue gathering elements 402
extend radially outwardly away from the longitudinal axis 411,
particularly in opposite directions from each other. Thus, in this
embodiment, the device 400 includes a first tissue gathering
element 402' and a second tissue gathering element 402'', each
extending outwardly from the longitudinal axis 411 and then curving
around and back toward the longitudinal axis 411 in a loop shape.
In this embodiment, each loop forms half of the diameter of the
distal end of the device 400 which rotates within the tissue.
Therefore, each loop may be considered as forming a radius R as
indicated in FIG. 84A. In this embodiment, each loop forms a radius
R wherein R=0.5 inches. It may be appreciated that in other
embodiments radius R may vary including R values in the range of
0.3 to 3.0 inches.
[0991] Each tissue gathering element 402', 402'' is comprised of
shaft 412 made from a suitable material, such as nitinol wire,
stainless steel wire, etc.). In this embodiment, the tissue
gathering elements 402', 402'' are comprised of 0.020 inch thick
ribbon that is 0.020 to 0.100 inches wide. In particular, in this
embodiment, each tissue gathering element 402', 402'' is comprised
of a wire ribbon. In addition, here each tissue gathering element
402', 402'' terminates in a distal tip 405 which is formed by
bending back and overlapping the ribbon to form a blunt end. FIG.
84B provides a closer view of a distal tip 405 of FIG. 84A. In this
embodiment, the ribbon material is curved back upon itself forming
a bend having an outer thickness of approximately 0.065 inches at
its thickest location. FIG. 84C provides another embodiment of a
distal tip 405 wherein the ribbon material is curved back upon
itself forming a bullet-nose shape. In this embodiment, the folded
material creates an opening 620 within the distal tip 405 that has
a length l and width w. In some embodiments, the opening 620 has a
length of 1=5 mm. Likewise, in some embodiments, the distal tip 405
has a thickness th wherein the thickness has a maximum of 0.065
inches. It may be appreciated that the tissue gathering elements
402', 402'' may be formed from separate shafts or from one
continuous shaft.
[0992] Referring back to FIG. 84A, in this embodiment, the device
400 also includes an anchoring element 404. Here, the anchoring
element 404 is disposed in the opposite direction as the tissue
gathering element 402, concentrically along the longitudinal axis
411. Here, the anchoring element 404 comprises a coil 491. Thus,
the tissue gathering element 402 may be advanced into an airway and
desirably positioned. The device 400 is then anchored in place by
deploying the coil 491 which expands within a luminal passageway or
airway proximally of the tissue gathering element 402. In this
embodiment, tissue gathering elements 402', 402'' are joined
therebetween by a crimp, weld, glue joint, rivet, threaded
fastener, spring element that is wrapped around parts to clamp
components together. In this embodiment, the device 400 includes an
attachment feature 610. Thus, the torqueing tool 408 is attached to
the attachment feature 610 as will be described in more detail
herein below.
[0993] FIG. 84D illustrates a possible position of the tissue
gathering elements 402', 402'' during rotation and torqueing of the
device 400. As shown, the resistance of the surrounding lung tissue
may initially bend the elements 402', 402'' as the device 400
rotates within the lung. Thus, the elements 402', 402'' are
somewhat flexible while imparting force on the tissue. The tissue
gathering elements 402' and 402'' are shaped with a twist so that
the resistance of surrounding tissue deforms them to be more
in-plane with respect to each other and along axis 411. If the
tissue gathering elements 402' and 402'' are shaped so they deform
to a more vertical structure along axis 411, the tissue gathering
elements 402' and 402'' will present the greatest amount of contact
and the greatest amount of bearing area on effected tissue possible
as the device 400 is rotated.
[0994] FIG. 84E provides a top view of this embodiment of the
device 400 as produced or once implanted. In this embodiment, the
elements 402', 402'' both curve downward toward the proximal end of
the device 400. However, this view shows the elements 402', 402''
out of plane (i.e. not in the same plane) which is a common
position when advanced into tissue, particularly after rotation of
the device 400. Thus, the first tissue gathering element 402' is
shown set back from the second tissue gathering element 402''. FIG.
84E also illustrates that the coil design of the anchoring element
404 leaves an open passageway therethrough once deployed. Thus,
anchoring of the device 400 does not impinge upon or block airflow
through the airway within which the device 400 is anchored.
[0995] FIGS. 85-90 illustrate example method steps of delivering a
device 400 having double tissue gathering elements 402', 402'',
such as in the device of FIG. 84A. Referring to FIG. 85, the device
400 is loaded within the catheter 430 or other suitable delivery
device such as a loading cartridge so that the tissue gathering
elements 402', 402'' are positioned near the distal end of the
catheter 430, ready for deployment. In this embodiment, the portion
of device 400 that protrudes from the catheter forms a blunt tip
that allows the catheter to be advanced through fragile airways or
fragile lung tissue without causing trauma. In this embodiment, the
catheter 430 includes at least one leverage element 700 which
resides outside of the body when the distal end of the catheter 430
is positioned within the patient's body. The at least one leverage
element 700 assist the user in manipulating the catheter 430, such
as applying torque to the catheter 430 or moving the catheter 430
longitudinally in the proximal or distal direction. In this
embodiment, the device 400 is attached to a torqueing tool 408
which extends through the catheter 430 and exits the proximal end
of the catheter 430. In this embodiment, the torqueing tool 408
includes a torqueing handle 704 disposed near its proximal end to
assist the user in grasping and applying torque to the torqueing
tool 408. In this embodiment, the device 400 is also attached to a
tether 702 (e.g. suture, metallic wire (such as comprised of
stainless steel, titanium, nitinol or other nickel based alloy),
monofilament or multifilament fiber, braid, polymer or ceramic or
glass fiber (such as comprised of Kevlar.RTM., carbon fiber, nylon,
polyurethane, polypropylene or other durable material)). The tether
702 may be used to manipulate portions of the device 400, typically
other than torqueing, such as pulling the anchoring element 404 in
the proximal direction or removing the device 400, to name a few.
Thus, in this embodiment, the tether 702 includes a tether handle
706 disposed near its proximal end to assist the user in grasping
and manipulating the tether 702. The manipulating tether may also
be a second torqueing tool that is located at proximal end of the
anchoring element 404. FIG. 85 illustrates advancement of the
distal end of the catheter 430 through at least one airway AW to a
target location within a lung L. Thus, in this example, the
distal-most end of the catheter 430 is disposed within an airway
AW. Likewise, a blood vessel BV is shown residing nearby the airway
AW along with alveolar or connective lung tissue surrounding the
airway AW. It may be appreciated that FIGS. 85-90 are not drawn to
scale; rather, the distal and proximal ends of the delivery devices
are prominent for focus and detail. It may be appreciated that the
catheter 430 is much longer than depicted to allow for advancement
through the trachea to various airways, including advancement along
airways past the 4.sup.th generation. Likewise, it may be
appreciated that the airway AW is illustrated as bisected for the
purpose of clear viewing of the device 400 and delivery devices
disposed therein.
[0996] FIG. 86 illustrates delivery of the tissue gathering
elements 402', 402''. Here, the tissue gathering elements 402',
402'' are deployed by pushing the torqueing tool 408 in the distal
direction which in turn pushes the device 400 toward the distal end
of the catheter 430, revealing the tissue gathering elements 402',
402''. This allows each element 402', 402'' to extend radially
outwardly, through the airway wall W, and curve around through the
tissue surrounding the airway AW. In this example, the tissue
gathering element 402'' passes in front of the blood vessel BV.
[0997] FIG. 87 illustrates torqueing steps of the method. In this
embodiment, the catheter 430 and device 400 together are rotated or
torqued, such as by grasping the at least one leverage element 700
and applying a torqueing force. As the device 400 rotates, the
tissue gathering elements 402', 402'' gather up the tissue
surrounding the airway AW, along with the blood vessel BV which is
now shown wrapping around the airway AW. This step tensions the
tissue, as indicated by the diagonal orientation of the lines
depicting the tissue, by drawing in the surrounding tissue toward
the device 400. FIG. 88 illustrates further withdrawal of the
catheter 430, such as by pulling the at least one leverage element
700 in the distal direction. Torque is maintained or adjusted with
the use of the torqueing tool 408. The torqueing tool 408 is
attached to device 400 at the location such as the attachment
feature 610.
[0998] The device 400 is then anchored within the airway W, as
illustrated in FIG. 89. In this embodiment, this is achieved by
retracting the catheter 430 so as the expose the anchoring element
404 while maintaining position of the device 400 or pushing the
anchoring element 404 in the distal direction by manipulation of
the tether handle 706 to actuate the tether 702. In this
embodiment, the anchoring element 404 comprises a coil which
expands against the inner surface of the airway AW. It may be
appreciated that in some embodiments the coil is wound in the
opposite direction as the torqueing applied to the tissue gathering
elements 402', 402''. Thus, over time, any unwinding of the device
400 will cause the coil to expand, further anchoring the device
400. Referring to FIG. 90, the torqueing tool 408 and tether 702
are then disengaged from the device 400 and removed along with the
catheter 430. Thus, the device 400 is left behind as an implant. It
may be appreciated that the implant is typically so securely
positioned that it is unable to move around sufficiently to cause
coughing and other uncomfortable symptoms for the patient.
[0999] It may be appreciated that in some embodiments, the
torqueing tool 408 is configured to assist in detachment from the
device 400. FIGS. 91A-91C illustrate an embodiment of such a
torqueing tool 408. FIG. 91A illustrates a torqueing tool 408
comprising a shaft 720 having a hooked end 722. The hooked end 722
is formed from an approximately 90 degree bend in the shaft 720
adjacent to its distal tip but the bend can range from 10 to 90
degrees to allow the hook to be easily pulled off the device 400 or
it may range from 90 to 180 degrees to hook through and around the
attachment end 406 (shown in FIG. 91C) of device 400 so traction is
maintained. In addition, the shaft 720 has a curvature 724 set a
distance proximally from the hooked end 722. In some embodiments,
the curvature 724 is disposed 0.05 to 1.0 inches from the hooked
end 722 of the tool 408. The curvature 724 bends the shaft 720
radially outwardly from a longitudinal axis 726 extending through
the proximal end of the shaft 720. In some embodiments, the
curvature 724 bends the shaft 720 radially outwards by 0 degrees,
wherein 0 is in the range of 1 to 90 degrees. The torqueing tool
408 is comprised of a flexible or resilient material which allows
the curvature 724 to straighten when retracted into a tube or
catheter 430. FIG. 91B illustrates the tool 408 retracted within a
catheter 430. The hooked end 722 is sized to maintain its hooked
shape while retracted within the catheter 430. Thus, the length of
the hooked end 722 (and therefore, overall width of the distal end
of the torqueing tool 408) typically does not exceed 0.070 inches.
Consequently, the torqueing tool 408 is able to remain attached to
an attachment end 406 of a torque-based pulmonary treatment device
400 while the hooked end 722 resides within the catheter 430. This
allows the tool 408 to torque the device 400 as desired. Once the
desired torqueing has been achieved, the torqueing tool 408 may be
removed from the attachment end 406 by simply advancing the tool
408. This allows the hooked end 722 to spring radially outwardly
due to the preset curvature 724, as illustrated in FIG. 91C. This
disengages the hooked end 722 from the attachment end 406. The tool
408 can then be retracted into the catheter 430 once again and
removed, leaving the device 400 behind.
[1000] In some embodiments, as illustrated in FIG. 91D, the
torqueing tool 408 includes a cross drilled end hole 725 which
passes through the hooked end 722 of shaft 720, so a hitch wire 727
can be threaded through the hole 725. This holds the torqueing tool
408 in engagement with the device 400, such as to the attachment
end 406 or to an attachment fixation feature 610. The end hole 725
may be drilled through the torqueing tool 408 in any orientation,
relative to the axis along the length of the shaft 720 of the
torqueing tool 408. FIG. 91D illustrates the torqueing tool 408
that has been inserted through hole or slot of an attachment
feature 610. The hitch wire 727 has been threaded through the
torqueing tool 408 end hole 725 to connect the torqueing tool 408
to the device 400. In some embodiments, the hitch wire 727 is made
from metallic wire, nitinol, suture, polymer, monofilament line,
braided material, glass, organic fiber or shape memory NiTi wire.
The distal end of the hitch wire 727 is typically shaped to form a
non-straight end shape, such as a curl or loop, that is designed to
create drag or pulling resistance as it is pulled through the
torqueing tool 408 end hole 725. This prevents the hitch wire 727
from accidentally being pulled out prematurely. In some
embodiments, the hitch wire 727 is a suture that is threaded
through the end hole 725 and tied to form a complete loop that is
exposed outside the delivery system so as to be accessible to the
user. By forming a loop, the hitch wire 727 cannot be accidentally
removed. Alternatively, the user can easily cut the loop and
withdraw the hitch wire 727 at any time the torqueing tool 408
needs to be removed from device 400.
[1001] FIG. 92 outlines steps of an example method of treating a
patient with a torque-based pulmonary treatment device 400. To
begin, the first step 800 describes that the device 400 is advanced
into a lung. It may be appreciated that in some embodiments such
advancement is through the mediastinum, through the trachea,
through an airway, through the chest wall, through an opening in
the chest, through blood vessels, through wall or barriers that
define the previously described structures in the body or between
ribs, to name a few. Likewise, in some embodiments, such
advancement is with the use of a trocar, guide introducer,
catheter, endoscope or bronchoscope. The second step 802 describes
coupling the device 400 to lung tissue. In some embodiments, such
coupling includes pulling back to engage the lung tissue, advancing
to engage the lung tissue, rotating to engage the lung tissue,
unsheathing at least a portion of the device 400 to allow expansion
of the device 400, unsheathing at least a portion of the device 400
to allow bending of the device 400, advancing at least a portion of
the device 400 through an airway wall, removing a constraint to
allow expansion of the device 400 (such as removing a sleeve,
removing a pin, removing a hitch wire, cable or knot, melting a
polymer, unzipping a seam, splitting a sheath wall, applying a
current to melt a metal connection, etc.), deploying a balloon to
expand at least a portion of the device 400, pulling a draw string
to actuate at least a portion of the device 400, pushing a push rod
to actuate at least a portion of the device 400, shortening a
structure to radially expand at least a portion of the device 400,
pulling a tether to pull at least a portion of device 400, bending
or rotating a torqueing tool to rotate at least a portion or
feature of device 400, barbing at least a portion of the device 400
into tissue, or allowing self-expansion of at least a portion of
the device 400, to name a few. The third step 804 describes
rotating the device 400 to apply torque to lung tissue. In some
embodiments, such rotation includes twisting to apply torque,
pulling tissue along tangent, pulling tissue in an arc direction,
curvilinear pulling, creating tension along a perpendicular plane
relative to a longitudinal axis of the device, non-uniaxial
tensioning of tissue, lung volume reduction by rolling tissue
around a hub or tissue gathering element 402 spooling tissue on the
device, winding tissue around the device, shortening tissue in the
lung by winding, compressing lung volume or reducing lung volume by
compressing tissue around a tissue gathering element 402 or by
compressing tissue by wrapping tissue over itself as it's wound
around a tissue gathering element 402 to name a few. Optionally, a
fourth step 806 is included which describes pulling the device 400
to create a uni-axial displacement, translation, stress, strain or
tension in the lung. And the fifth step 808 describes anchoring the
device 400 within the lung. In some embodiments, this includes
releasing stored elastic energy to engage an anchoring element 404,
hooking an anchoring element 404 into tissue, expanding the
anchoring element 404 against lung tissue or otherwise coupling the
anchoring element 404 to lung tissue so counter rotation of device
400 is resisted by the tissue the anchoring element 404 is coupled
to.
[1002] FIG. 93 illustrates an embodiment of the placement of two
torque-related pulmonary treatment devices (a first torque-related
pulmonary treatment device 400' and a second torque-related
pulmonary treatment device 400''). In this embodiment, each device
400', 400'' is comprised of a tissue gathering element 402a and
another tissue gathering element 402b, each extending outwardly and
then curving around and back in a loop shape, such as illustrated
in FIG. 84A. Likewise, the first device 400' includes a first
anchoring element 404' and the second device 400'' includes a
second anchoring element 404''. Referring back to FIG. 93, the
first torque-related pulmonary treatment device 400' is positioned
so that its tissue gathering elements 402a, 402b are disposed
within a first airway AW1. Similarly, the second torque-related
pulmonary treatment device 400'' is positioned so that its tissue
gathering elements 402a, 402b are disposed within a second airway
AW2. Torque is applied to each device 400', 400'' either
simultaneously or in series, so that their tissue gathering
elements 402a, 402b to gather up the surrounding tissue (as
indicated by the twisted configuration of the blood vessels BV). In
some embodiments, torque is applied to the first device 400' in a
first direction and torque is applied to the second device 400'' in
an opposite direction. In any case, torqueing re-tensions the lung,
as described hereinabove. In this embodiment, the devices 400',
400'' are then both anchored within a common airway proximal to the
first and second airways AW1, AW2, such as in an ostium OS. In this
embodiment, each anchoring element 404', 404'' has the shape of a
coil. In such embodiments, it is desirable that the coil is wound
in a direction opposite to the direction of the torque/rotation of
the tissue gathering elements 402a, 402b. Thus, any unwinding of
the torque would further expand the corresponding anchoring
element. In FIG. 93, the anchoring elements 404', 404'' are
positioned within the ostium OS so as to overlap with each other.
In some embodiments, the anchoring elements 404', 404'' are
positionable so as to overlap and in other embodiments, the
anchoring elements 404', 404'' are manufactured as intertwined so
as to be delivered in an intertwined configuration. In any case,
the anchoring elements 404', 404'' take up minimal space when
positioned in the same or overlapping portions of the ostium OS or
airway. Likewise, when the devices 400', 400'' are torqued in
opposite directions, the devices 400', 400'' are able to
counterbalance each other, thereby placing less load on the ostium
OS or airway at the point of anchoring.
[1003] FIG. 94 outlines steps of an example method of treating a
patient with two pulmonary treatment devices. The pulmonary
treatment devices may be torque based or linear so as to lead to
the following combinations: two linear pulmonary treatment devices
10, two torque-based pulmonary treatment devices 400 or one linear
pulmonary treatment device 10 and one torque-based pulmonary
treatment device 400. To begin, the first step 820 describes
advancing a first pulmonary treatment device (torque-based on
linear) into a lung at a first target location. The second step 822
describes advancing a second pulmonary treatment device
(torque-based on linear) into the lung at a second target location.
The third step 824 describes actuating the first and/or second
pulmonary treatment devices to tension the lung. And, the fourth
step 826 describes coupling the pulmonary treatment devices
together to maintain tensioning of the lung.
[1004] FIG. 95 outlines steps of an example method of treating a
patient with a pulmonary treatment device while monitoring with
imaging. The pulmonary treatment device may be linear or
torque-based. To begin, the first step 828 describes advancing the
pulmonary treatment device into a lung. The second step 830
describes coupling a first portion of the pulmonary treatment
device to lung tissue. The third step 832 describes manipulating
the pulmonary treatment device to cause lung volume reduction. The
fourth step 834 describes acquiring a chest image, such as via
computed tomography (CT), fluoroscopy or any other imaging method
or modality that has been described herein or other data may be
assessed such as any of the measurable physiologic changes listed
herein that indicate improved breathing in COPD patients. The chest
image or data is then analyzed to determine if the diaphragm is
desirably elevated (as described in the fifth step 836) or to
determine if any of the measurable physiologic changes listed
herein that indicate improved breathing in COPD patients has been
shown. If not, the method is then repeated from the third step 832
wherein the pulmonary treatment device is further manipulated. If
so, then manipulation ceases, as indicated in the sixth step 838.
The device is then anchored in place, as indicated in the seventh
step 840.
[1005] FIG. 96 outlines steps of an example method of treating a
patient with a pulmonary treatment device while monitoring with the
use of a ventilator. The pulmonary treatment device may be linear
or torque-based. To begin, the first step 842 describes attaching
the patient to the ventilator. The ventilator should be set to
provide breathable gas into the patient until a constant peak
pressure is achieved during each breathing cycle. The required
volume of delivered breathable gas to achieve the constant peak
pressure should be noted. The second step 843 describes advancing
the pulmonary treatment device into a lung. The third step 844
describes coupling a first portion of the pulmonary treatment
device to lung tissue. The fourth step 845 describes manipulating
the pulmonary treatment device to cause lung volume reduction. The
fifth step 846 describes monitoring a decrease in ventilation
volume of breathable gas that is required to achieve the constant
peak pressure. In some instances, a volume reduction of 20-1500 cc
is desired, however, a volume reduction of 300-500 cc is typically
considered desirable. The volume reduction is then analyzed to
determine if it is sufficiently reduced (as described in the sixth
step 847). If not, the method is then repeated from the fourth step
845 wherein the pulmonary treatment device is further manipulated.
Alternatively, an additional device 400 may be installed to further
reduce the volume of breathable gas that must be ventilated into
the patient to achieve the constant peak pressure during each
breathing cycle. If the volume reduction is sufficiently reduced
(as described in the sixth step 847), then manipulation ceases, as
indicated in the seventh step 848. The device is then anchored in
place, as indicated in the eighth step 849.
[1006] In some embodiments, the torque-based pulmonary treatment
device 400 is positioned in the lung by a surgical procedure, such
as a minimally invasive video assisted portal procedure or an open
procedure. In such embodiments, the device 400 is not anchored in
place by stabilization within an ostium or airway. Rather, the
device 400 is anchored within lung tissue by suturing or balancing
torque forces. FIGS. 97A-97C illustrate an embodiment of a device
400 which may be positioned in the lung by a surgical procedure.
Here, the device 400 has a first pair of tissue gathering elements
402a, 402b, each tissue gathering element 402a, 402b extending
outwardly radially outwardly from a longitudinal axis 411 and then
curving around and back toward the longitudinal axis 411 in a loop
shape, such as illustrated in FIG. 84A. The device 400 also has a
second pair of tissue gathering elements 402c, 402d. In this
embodiment, these tissue gathering elements 402c, 402d mirror the
first pair of tissue gathering elements 402a, 402b around an axis
850 which is perpendicular to the longitudinal axis 411. Thus, in
this embodiment, both pairs of tissue gathering elements (402a,
402b) (402c, 402d) extend radially outwardly from the longitudinal
axis 411 and then curve toward the axis 850 before curving back
toward the longitudinal axis 411. In some embodiments, the device
400 includes a coupler 852 to connect the tissue gathering elements
401a and 402b and possibly the anchoring elements 402c and 402d. In
some embodiments, the device 400 includes an attachment feature 854
which is used to attach a torqueing tool 408 to the device 400 to
rotate the distal end of device 400 to apply torqueing loads to the
surrounding lung tissue. A suture or other fixation device may be
used to attach the attachment feature 854 to the lung tissue within
the lung L.
[1007] FIG. 98 illustrates the device 400 of FIGS. 97A-97C in use.
FIG. 96 shows access to lung tissue of the lung L with the use of a
trocar or cannula 860. The device 400 loaded within a distal end of
delivery catheter 430 and the distal end of the catheter 430 is
advanced through the cannula 860 to a target location within the
lung L. The first pair of tissue gathering elements 402a, 402b are
then deployed and torqued so as to gather up a first portion of
lung tissue LT1. The second pair of tissue gathering elements 402c,
402d are then deployed and torqued so as to gather up a second
portion of lung tissue LT2. In this embodiment, the first portion
of lung tissue LT1 and the second portion of lung tissue LT2 are
torqued in opposite directions. Such torqueing in opposite
directions creates a counter-balance, anchoring the device 400 in
place. Alternatively or in addition, the device 400 may be anchored
in place by joining the fixation feature 854 to the lung tissue
with the use of a fixation element, such as a suture, staple,
tissue glue, coagulated blood or by using other devices that are
sufficiently biocompatible and designed to connect tissue and
device components to tissue.
[1008] It may be appreciated that in some embodiments, one or more
torque-based pulmonary treatment devices 400 may be used to "wad
up" tissue, so as to close off airways, close communication of gas
in diseased tissue or close off gas exchange in the lung. This may
be utilized to tune where preferential filling occurs. Thus, it may
be desired to block flow to severely diseased parts of the lung so
that filling preferentially occurs in the less severe parts of the
lung. Any devices described herein may be used to block the flow of
gas in one or both directions to cause atelectasis or shrinkage of
volumes of the lung. Ideally, portions of the lung can be
completely blocked off to cause atelectasis. Such methods may also
may be used to stop chronic air leaks in lung fistulas that are
currently very difficult to treat effectively. Such small leaks in
the pleura typically cause repeated pneumothorax incidents. Thus,
the torque-based pulmonary treatment devices may be a minimally
invasive treatment to block the leak by twisting tissue to block
air flow.
[1009] Additionally, these devices and methods may be used to
block, reduce or generally regulate the flow of blood through the
lung so as to minimize the flow of insufficiently or minimally
oxygenated blood that flows through areas of lung with severe
damage. Patients will benefit by reducing the flow of blood that is
under-oxygenated because mixing this blood with fully oxygenated
blood, as the blood streams exit the lungs, allows for oxygen
dilution that leads to reduced oxygen as a percentage of blood
volume in the patient's vascular system. Blocking the flow of
under-oxygenated blood before the blood exits the lungs actually
increases the percentage of blood oxygen in the patient's system.
The other benefit to blocking the flow of blood through areas in
the lung that are severely damaged by emphysema is that the CO2
that is normally not sufficiently transported out of the blood in
these damage regions so it should not be allowed to be mixed with
low CO2 or normally conditioned blood where the blood streams
combine and exit the lungs. By blocking blood flow in severe areas
of the lung, the blood that does exit the lungs carries a higher
percentage of oxygen and a lower percentage of CO2 than the levels
of these gases that would otherwise be present in typical emphysema
or COPD patients.
E. Placement
[1010] Many of the pulmonary treatment devices (torque-based and
linear) described herein may be placed in any lung, lobe, mainstem
segment, segment, sub-segment or even farther down the airway tree.
Likewise, many of the devices may be placed directly through the
chest wall into the lung or through the wall of the main bronchi to
access pockets of destroyed parenchyma. Many of the devices may be
implanted via open chest procedure or with the use of any type of
endoscope.
[1011] The number, type and placement location of the devices are
chosen to best treat the disease type and disease state of the
patient. Restoring tension and lung elastic recoil in the lung with
these devices mitigates the symptoms typically experienced by COPD
patients and patients suffering from other lung conditions. The
devices described herein are capable of producing a tremendous
amount of work to tension lung tissue. These lung treatments have
been shown to induce biologic feedback in the lungs that further
enhances the reduction of symptoms, restoration of lung elastic
recoil, enhancement of the lifting displacement of the diaphragm
and general restoration of breathing mechanics in patients.
Treatment magnitude, during each device deployment, is controlled
by controlling the amount of force that is placed on the tissue,
the linear distance that the proximal or distal end of the device
is translated or the amount of rotation that is applied to a
treatment device that acts upon tissue with the application of
torque. Additionally, linear force and linear translation as well
as the application of torque may be combined with any of the
embodiments provided herein to enhance the amount of work performed
on the lung tissue. By controlling these forces, a patient may be
treated with one or more devices in a single major lobe of the
patient's lung, more than one major lobe or all of the major lobes.
It may be appreciated that a patient has four major lobes in the
lung. It may also be appreciated that major lobes may also include
the middle lobe in the right lung and the Lingula in the left lung
of a patient.
[1012] In some embodiments, the first treatments target the lobes
with the maximum amount of tissue damage, as can be determined
using quantitative computed tomography (CT) analysis (CT image file
post processing) that analyzes the least dense portions of the
lung. Any number of CT analyses may be studied to determine the
most severe portions of each lobe and the magnitude and nature of
the damage. Patients with heterogeneous lung damage typically
present with severely damaged upper lobes and generally preserved
lower lobes. These patients should be treated with implantation in
the upper lobes and possibly not in the lower lobes during the
initial treatments. If the patient doesn't respond adequately,
additional devices may be implanted and those may be added to the
upper lobes or they may be implanted in the lower lobes to balance
the tensioning forces in the lungs.
[1013] Homogeneous patients generally present with mild to severe
damage in all four major lobes. It is preferable to treat one, two
or three lobes in a single lung during a single intervention or
implantation event so that mucus, bacteria, fungus or other
infectious contaminants are not transferred from one lung to the
other during a treatment. That way bilateral infections are
avoided. If all major lobes are to be treated, it is preferable to
treat each lung during one of two total procedures. A single lobe
may be treated during a single procedure or a combination of lobes
may be treated during a series of treatments. If the delivery
methods described herein may be used to deliver into a patient each
device 400 in less than 10 minutes or with the use of 10 or less
minutes of energized fluoroscope time, patient risk to x-ray
exposure and risk of hypoxemia will be reduced. In homogeneous
patients, it is important to treat at least all four major lobes.
In order to uniformly lift the diaphragm, all patients preferably
benefit by receiving treatment in at least one lobe in each of the
patient's two lungs. Treatment success requires that the treatment
gathers a threshold amount of relatively loose tissue to a slightly
tightened condition that is approximately physiologically normal.
If a patient does not respond positively to a treatment, this only
indicates that the dose was not sufficient and more devices should
be placed to transcend the threshold minimum tissue displacement to
tension the loose elongated tissue, hold airways open to allow
expiration of gas during exhale events and to lift the diaphragm
enough to restore diaphragm pumping motion. The pulmonary function
tests listed herein are excellent indicators of positive and
adequate response.
[1014] It may be appreciated that the more severely affected
patients may require treatments that are delivered in stages that
progressively build a dose level to accomplish several possible
outcomes. For these patients, low doses may result in some
elimination of slack in the lung tissue but inadequate tensioning
to lift the diaphragm enough or it may provide an inadequate dose
to delay airway closure during exhalation. With implantation of
additional devices, the patient may experience sufficient
tensioning to lift the diaphragm and hold airways open enough to
show positive reduction of symptoms described herein but not enough
of a dose to adequately tension the majority of the lung volume.
With implantation of additional devices, the patient may show
positive reduction of symptoms on a large number of the symptoms
listed herein. At this stage, the treatment may be successful, but
the duration of the benefit may still be improved. Implantation of
a larger number of devices or implantation with a higher degree of
displacement, force, or torque (or higher level of a combination of
displacement, force, and torque) will present such a high degree of
stress and strain on the lung tissue that it responds in the same
way that tissue responds to typical tissue injury. This can be
quite beneficial to the patient.
[1015] The lung tissue is quite radio transparent using typical
medical imaging such as fluoroscopy, computed tomography (CT), and
X-ray imaging. However, if the lung tissue is stressed
sufficiently, the tissue hydrates and this presents in images as
consolidation with opacities that sometime present with local
consolidates. The tissue goes into a wound healing cascade that
manifests as opacities in the tissue between devices, between
devices and the pleura, and between anatomical features of the
lung. Wherever the tissue is stressed and strained sufficiently,
bands of opaque shades present in the images that indicate that the
treatment dose has been applied sufficiently to yield a maximum
effect that is possible in these severe COPD and emphysema
patients. As the wound healing cascade progresses, the end stage
presents as tissue healing and contraction which further enhances
the lifting of the diaphragm and tensioning of the lung tissue
throughout the patient's lung. This contraction adds a high impact
to boost the benefit of the treatment and the combination of slight
scaring in the contracted tissue seems to reinforce the tissue in a
way that allows the effect to be maintained for long periods of
time such as 1 to 10 years but normally 3-5 years. The wound
healing cascade can be managed using steroidal treatments to
control the rate of healing, slightly alleviate contraction and the
magnitude of effect. This also manages the pain that is sometime
associated with the high degree of tensioning that this presents.
In addition, this minimizes symptoms that often lead the attending
physicians into erroneously believing that the patient suffers from
pneumonia, such as elevated body temperature and flu symptoms.
Additionally, because these patients already present with
compromised immune mechanisms, they are more susceptible to the
effects of infection and colonization of inherent fungus in the
lung, so the use of steroid treatment to manage stress induced
opacity, is recommended. Normally antibiotic treatments tend to
mitigate the effect of steroids so a mix of antibiotic treatments
may be prescribed but the major drug regimen should be dominated by
steroids or some nonsteroidal anti-inflammatory drug such as the
(NSAID) class that is commonly referred to as Ibuprofen.
[1016] After straining lung tissue, airway walls, blood vessels,
pulmonary arteries, pulmonary veins, alveoli, alveolar ducts,
smooth muscle, interstitial connective tissue, capillary beds,
elastic fibers and collagen fibrils sufficiently to cause a wound
healing response, the inflammatory phase is the first phase of
healing and is characterized by hemostasis and inflammation.
Hemostasis is initiated during the exposure of collagen during
wound formation that activates the intrinsic and extrinsic clotting
cascade in the available vasculature. In addition, the injury to
tissue causes a release of thromboxane A2 and prostaglandin 2-alpha
to the wound bed causing a potent vasoconstrictor response.
Furthermore, the extravasation of blood constituents provides the
formation of the blood clot reinforcing the hemostatic plug. This
initial response helps to limit hemorrhage and provides an initial
extracellular matrix for cell migration. Platelets are among the
first response cells that play a key role in the formation of the
hemostatic plug. They secrete several chemokines such as epidermal
growth factor (EGF), fibronectin, fibrinogen, histamine,
platelet-derived growth factor (PDGF), serotonin, and von
Willebrand factor. These factors help stabilize the wound through
clot formation and also attract and activate macrophages and
fibroblasts. They also act to control bleeding and limit the extent
of injury. Platelet degranulation activates the complement cascade,
specifically C5, a potent neutrophils chemotactic protein.
Vasoactive mediators and chemokines are released by the activated
coagulation cascade, complement pathways, and parenchymal cells
which play a key role in the recruitment of inflammatory leukocytes
to injured skin.
[1017] After hemostasis is achieved, capillary vasodilatation and
leakage result secondary to local histamine release by the
activated complement cascade. The increased blood flow and altered
vascular permeability allow for the migration of inflammatory cells
to the wound bed. The presence of foreign organisms further
stimulates the activation of the alternate complement pathway.
Complement C3 activation results in a cascade of non-enzymatic
protein cleavage and interactions that eventually stimulate
inflammatory cells and the lysis of bacteria.
[1018] The second response cell to migrate to the wound after
complement activation and platelet recruitment is the neutrophil.
It is responsible for debris scavenging, complement-mediated
opsonization and lysis of foreign organisms, and bacterial
destruction via oxidative burst mechanisms (i.e., superoxide and
hydrogen peroxide formation). Neutrophils kill bacteria and
decontaminate the wound from foreign debris. These wastes are later
extruded with the eschar or phagocytosed by macrophages.
Macrophages are important phagocytic cells that play a key role in
wound healing. They are formed from monocytes stimulated by
fragments of the extracellular matrix protein, transforming growth
factors and monocyte chemoattractant protein 1. In addition to
direct phagocytosis of bacteria and foreign materials, macrophages
secrete numerous enzymes and cytokines; collagenases, which debride
the wound; interleukins and tumor necrosis factor (TNF), which
stimulate fibroblasts and promote angiogenesis; and transforming
growth factor (TGF), which stimulates keratinocytes. Macrophages
also secrete platelet-derived growth factor and vascular
endothelial growth factor which initiate the formation of
granulation tissue and thus initiate the transition into the
proliferative phase and tissue regeneration.
[1019] The proliferative phase is the second phase of wound healing
and it is marked by epithelialization, angiogenesis, granulation
tissue formation, and collagen deposition. Epithelialization occurs
within hours after injury in wound repair. With an intact basement
membrane, the epithelial cells migrate upwards in the normal
pattern as occurs in a first-degree skin burn whereby the
epithelial progenitor cells remain intact below the wound and the
normal layers of epidermis are restored in 2-3 days. If the
basement membrane has been damaged, then the wound periphery
re-epithelializes the wound. Neovascularization is necessary to
deliver nutrients to the wound and help maintain the granulation
tissue bed. Angiogenesis has been attributed to many molecules
including fibroblast growth factor, vascular endothelial growth
factor, transforming growth factors, angiogenin, angiotropin,
angiopoietin 1, tumor necrosis factor alpha, and thrombospondin. In
emphysematous lung tissue where there is little to no
vascularization, this critical nutrient supply by capillaries is
insufficient to sustain the tissue deposition in the granulation
phase and may result in a chronically unhealed wound in some
portions of the patient's lungs. The proliferative phase ends with
granulation tissue formation. This new stroma begins to invade the
wound space close to four days after injury. The new blood vessels
at this time have provided a facilitated entry point into the wound
to cells such as macrophages and fibroblasts. Macrophages continue
to supply growth factors stimulating further angiogenesis and
fibroplasia. The secreted platelet-derived growth factor and
transforming growth factors along with the extracellular matrix
molecules stimulate fibroblasts differentiation to produce ground
substance and then collagen. Fibroblasts are the key players in the
synthesis, deposition, and remodeling of the extracellular matrix
providing strength and substance to the wound.
[1020] The third and final phase of wound healing is the
maturational phase. This is characterized by the transition from
granulation tissue to scar formation. Close to two weeks after
injury, the wound undergoes contraction, ultimately resulting in a
smaller amount of apparent scar tissue. Collagen deposition by
fibroblasts continues for a prolonged period with a net increase in
collagen deposition reached after three weeks from tissue injury.
The entire process is a dynamic continuum dictated by numerous
growth factors and cells with an overlap of each of the three
phases of wound healing to provide continued remodeling. The wound
is estimated to reach its maximal strength at one year, with a
maximal tensile strength that is 70% of normal lung parenchyma.
F. Implant Removal
[1021] It may be appreciated that in some instances the device 400
may need to be removed. It may be determined that the device 400
may need to be removed to be repositioned if the initial deployment
isn't ideal or this may be determined after the deployment has been
performed. If the initial deployment has been misplaced or too much
torque has been applied to the tissue, it may be desired to
recapture and adjust the device 400 to remove torque based stress
on the lung tissue. Or it may be desired to recapture and adjust
the device 400 to reduce linear or uniaxial tension that the device
400 is imparting on the lung tissue. It may also be appreciated
that a torqueing tool 408 may be releasably coupled to the far
proximal end of the device 400 at an attachment feature 610 near
the proximal end that allows the user to control the deployment of
the anchoring element 404 and to allow for the possibility of
removing the device 400 in an orderly manner.
G. Torqueing Tool
[1022] It may be appreciated that in some instances the torqueing
tool 408 is provided to the end user already attached to device
400. In some embodiments, one or more torqueing tools 408 are
releasably attached to the device 400 during a manufacturing step
to spare the end user from making the attachments during the
procedure. In other embodiments, the tool 408 is attached by the
user, such as just before delivering device 400 to the patient or
while delivering device 400 to the patient. In some embodiments,
the torqueing tool 408 is made from metal or organic materials such
as carbon fiber, ceramic, plastic, glass or a combination of these
materials. In some embodiments, the torqueing tool 408 is
terminated with a handle or a wire form loop that can accommodate a
finger or thumb to facilitate rotation. The distal end section of
the torqueing tool 408 is resilient so as to pass through bends in
human anatomy or common bends in a typical endoscope or
bronchoscope. However, stiffness of the shaft 720 may vary to
reliably transmit torque efficiently.
[1023] In some embodiments, torque transmission is such that a
single turn at the control or user actuated end results in at least
1/10.sup.th of a rotation or more at the device 400 end. The
torqueing tool 408 may be inserted through a hole, slot or loop in
the device 400 to retain the torqueing tool 408 so torque
transmission may be communicated to device 400. The torqueing tool
408 may be snap fit, interference fit, or loosely fit through the
device 400 attachment feature 6104 so that it may be easily removed
during a desired time. As described previously, the distal tip of
the torqueing tool 408 may be cross drilled to accept a hitch pin,
wire or thread that locks the torqueing tool 408 engaged in the
attachment feature 610 of device 400 until such time as the hitch
pin, wire or thread has been pulled out or broken to allow the
release of the torqueing tool 408.
H. Distal Tip
[1024] As mentioned previously, the distal tip 405 of the tissue
gathering elements 402 may have a variety of forms. As previously
shown in FIG. 63A, in some embodiments, the distal tip 405 is
atraumatic and has a blunt shape, such as a ball or other rounded
shape. In this configuration, the tissue gathering element 402 may
be more inclined to track along the inside lumen of an airway if
the airways are still preserved. However, in nearly all cases, they
are not. If the distal tip includes a ball that is smaller than
0.060 inches diameter, it will still be capable of penetrating the
wall of an airway to engage connective alveoli instead of
manipulating airways alone. In other embodiments, as previously
shown in FIG. 63B, the distal tip 405 has a sharp shape, configured
to pierce and/or penetrate tissue. In other embodiments, as
previously shown in FIG. 63C, the distal tip 405 has an anchoring
shape, such as a fish-hook or other shape which is configured for
piercing or penetrating tissue while resisting withdrawal from the
tissue.
[1025] As mentioned previously, in some embodiments, the device 400
is made from round wire and in some embodiments the round wire has
been flattened at the distal tip or any other portion of the tissue
gathering element 402 to add bearing area. Likewise, in other
embodiments, the device 400 is made from ribbon which already has a
flattened shape. In such instances, the ribbon can optionally be
twisted so as to form the distal tip 405. FIG. 99A illustrates such
twisting of a ribbon 900. Here, the ribbon 900 is shown extending
in a plane wherein its free end 902 is twisted 90 degrees so as to
reside in a perpendicular plane.
[1026] FIGS. 99B-99D illustrate additional embodiments of distal
tips 405 having twisted ends. FIG. 99B illustrates a portion of a
tissue gathering element 402, particularly its distal tip 405.
Here, the distal tip 405 is formed from a ribbon 900 that is
twisted so that its free end 902 is flat forming a planar surface
903 that resides in a plane configured to maximize contact area
with tissue when engaging the tissue gathering elements 402 with
the tissue, such as during torqueing. In some embodiments, the
twist is approximately 90 degrees, however it may be appreciated
that any amount of twist may be used including various degrees up
to 90 degrees or in a range of 1 to 90 degrees. In other
embodiments, the twist is beyond 90 degrees. In addition, in this
embodiment, the edge 904 of the free end 902 is blunt or rounded.
This assists in smooth advancement of the distal tip 405 through
delivery devices. FIG. 99C illustrates another embodiment of the
distal tip 405 formed from a ribbon 900 that is twisted so that its
free end 902 is flat forming a planar surface 903 that resides in a
plane configured to maximize contact area with tissue when engaging
the tissue gathering elements 402 with the tissue, such as during
torqueing. In this embodiment, the edge 904 of the free end 902 has
a point 906 to assist in forward penetration but has angled corners
908 straddling the point 906 so as to reduce any friction or
digging into delivery devices during advancement. FIG. 99D
illustrates another embodiment of the distal tip 405 formed from a
ribbon 900 that is twisted so that its free end 902 is flat forming
a planar surface 903 that resides in a plane configured to maximize
contact area with tissue when engaging the tissue gathering
elements 402 with the tissue, such as during torqueing. In this
embodiment, the edge 904 of the free end 902 has an elongate taper
ending in a ball 914. In some embodiments, this distal tip 405 is
formed by putting a very slow long taper on the ribbon 900 and
melting its tip back to form the ball 914.
Example System for Torque-Based Treatment
[1027] Both the pulmonary treatment device 10 and the torque-based
pulmonary treatment device 400 are sized and configured to be
delivered by a delivery device that is insertable into the lung,
such as a steerable scope (e.g. bronchoscope 20), catheter or other
delivery system. As described previously, such as in relation to
FIGS. 31A-31B, an example delivery device is a bronchoscope 20. In
this example, the bronchoscope 20 includes a bronchoscope body 200
and an insertion cord 202. The insertion cord 202 is advanced into
the endobronchial tree of the patient and the bronchoscope body 200
remains outside of the patient, typically grasped by the operator's
non-dominant hand. The insertion cord 202 contains a fiberoptic
bundle for light and image transmission, tip bending control wires
and a working channel. The working channel continues into the
bronchoscope body 200, exiting at the working channel port 204. The
working channel 210 extends through the tip 208, allowing delivery
of the pulmonary treatment devices 10, 400 therefrom.
[1028] In some embodiments, the pulmonary treatment device 10 is
loaded directly into the working channel port 204 and advanced
through the working channel 210 for delivery from the insertion
cord tip 208. However, in other embodiments, the device 10 is
pre-loaded into an introducer which is advanceable into the working
channel 210 for delivery therefrom.
[1029] FIG. 32 previously illustrated an embodiment of an
introducer 220 having a pre-loaded pulmonary treatment device 10.
In this embodiment, the introducer 220 comprises an elongate tube
222 having a first end 224 and a second end 226. The introducer 220
is typically strong enough to keep the device 10 from distorting
from a straight configuration and hard enough that the device 10
cannot indent into the wall of the introducer 220, particularly
during the sterilization process that involves heating to
130-180.degree. C.
[1030] FIG. 100 illustrates an embodiment of a torque-based
pulmonary treatment device 400 prepared for pre-loading in an
introducer 220. Here, the device 400 is prepared for pre-loading by
having the torqueing tool 408, hitch wire 727 and tether 702
attached thereto. In particular, the torqueing tool 408 is attached
to an attachment feature 610 on the device 400. Thus, the torqueing
tool 408 is able to torque the device 400 by rotation of its
handle. In this embodiment, its handle has a loop shape for easy
grasping and rotational leverage. The hitch wire 727 is attached to
the torqueing tool 408 to maintain its engagement as previously
described in relation to FIG. 91D. In this embodiment, its handle
has a T shape for ease of pulling and pushing the hitch wire 727.
The tether 702 is attached to the anchoring element 404 and its
handle is shaped for ease of use and to distinguish from the other
handles. These tools (i.e. torqueing tool 408, hitch wire 727,
tether 702) extend through the introducer 220 so that the device
400 resides beyond the first end 224 of the introducer 220 and the
handles of the tools reside proximal to the second end 226 of the
introducer 220. Thus, in this arrangement, the device 400 is not
confined within the introducer 220 in a straightened configuration.
In some instances, implantable materials, such as nitinol, can be
damaged if they are stressed in packaging and then exposed to heat
that exceeds 25 degrees C. during shipment as the stress on the
device is elevated with the additional heat. In some embodiments,
the device 400 is packaged in this manner so that any heating due
to transit or sterilization will not introduce any potential damage
or inadvertent shape setting while the device 400 is constrained in
a straightened configuration. It is advantageous to ship the device
400 in an unstressed configuration. It is also advantageous to ship
the device 400 in an unstressed configuration but already attached
to the torqueing tool 408, tether 702 and the hitch wire 727 so the
assembly does not have to be attached by the user and the device
400 may be quickly and easily be retracted into the introducer 220
by simply pulling on one or more of the attached tools to pull
device 400 into the introducer 220 through the first end 224.
[1031] FIG. 101 illustrates the device 400 preloaded into the
introducer 220. This can be achieved by retracting the device 400
into the introducer 220 by pulling the tether 702. Alternatively,
or in addition, the introducer may be advanced over the device 400.
Finally, device 400 may be advanced into the introducer 220 by
advancing the tissue gathering element 402 into the introducer 220
by inserting it into the second end 226 of the introducer 220.
Thus, the device itself is disposed within the introducer 220 while
the handles of the torqueing tool 408, hitch wire 727, tether 702
extend from the second end 226 of the introducer 220. The
introducer 220 is then ready to be advanced into or coupled to a
bronchoscope 20 working channel or a catheter 430 or similar
delivery device which is advanceable through a lumen in the
bronchoscope 20. The device 400 is constrained within the catheter
430 to allow for ease of advancement through the bronchoscope. The
device 400 remains within the catheter 430 until the distal tip of
the catheter 430 is desirably positioned within the lung L.
Alternatively, a guidewire 313 may be used to guide the catheter
430 through and distal to the bronchoscope 20 to an optimal
position within the lung L before the introducer 220 is coupled to
it.
[1032] As illustrated in FIG. 102, the distal tip of the catheter
430 is advanced beyond the distal tip of the bronchoscope 20. This
allows the catheter 430 to reach locations that are beyond the
reach of the bronchoscope 20 due to size constraints (i.e. the
smaller diameter of the catheter 430 can pass through small
diameter or contorted passageways that the larger diameter
bronchoscope is restricted from entering). Thus, in some instances,
the catheter 430 is able to reach far distal portions of the lung
L, such as the apical portions of the upper lobes and the lateral
corners of the lower lobes, which are typically unreachable by the
bronchoscope alone.
[1033] Once the distal tip of the catheter 430 is positioned near a
target location for placement of the treatment device 400, the
device 400 is deployed. Deployment from the catheter 430 may be
achieved by a variety of methods or a combination of multiple
methods. In this embodiment, the device 400 is pushed beyond the
catheter 430, such as with the use of the torqueing tool 408, to
allow the tissue gathering element 402 bend toward its pre-formed
or natural configuration (e.g. radially outwardly and around into a
loop shape as illustrated in FIG. 102). In this embodiment, the
tissue gathering element 402 has a distal tip 405 having a free end
902 shaped as an elongate taper ending in a ball 914. Thus,
deployment allows the distal tip of the tissue gathering element
402 to engage the surrounding tissue, curving through and/or
against the tissue. Such deployment may be in an airway or beyond
the natural airways into damaged tissue, parenchyma, alveoli,
artificially created passageways, disease created passageways or
other types of lung tissue.
[1034] The device 400 is then rotated by applying torqueing,
twisting or rotational force to at least a portion of the device
400 with the use of the torqueing tool 408. As shown, the torqueing
tool 408 includes a handle which is graspable by a user so as to
manually applying the rotational force. Since the torqueing tool
408 is attached to the device 400, the device 400 (and therefore
tissue gathering element 402) rotates as well. This gathers up the
surrounding lung tissue onto and around the tissue gathering
element 402 as the element 402 rotates. Thus, loose parenchyma,
portions of blebs and bullae, damaged alveolar sacs and other
distended, slackened or stretched tissue is pulled inwardly,
twisted and/or gathered up by the tissue gathering element 402.
Rotation continues, gathering the loose, slackened tissue, until
desired tension is achieved in the tissue.
[1035] It may be appreciated that although such rotation is applied
around the longitudinal axis 411, such rotation may occur in the
tissue around other axes. Such other axes may be at a variety of
angles to the longitudinal axis 411 and on either side of the
longitudinal axis. This may occur due to bending of portions of the
device 400, such as bending of the tissue gathering element 402,
during advancement of the tissue gathering element 402 or during
rotation itself. Such bending may cause the torque applied around
the longitudinal axis 411 to be transmitted around one or more
different axes. Such other axes are typically in the range of 1 to
90 degrees from the longitudinal axis 411.
[1036] It may be appreciated that the desired amount of torque
imposed by the device may vary depending on the patient anatomy and
disease state, to name a few. In some embodiments, the desired
level of torque is determined by tactile feedback to the user. For
example, in some instances, torque is applied until the user
encounters desired resistance to rotation, ranging from minimal
resistance to complete obstruction of further rotation. Such
resistance may simply be felt by the user as manual rotation is
attempted. Typically, torque is applied quite easily while slack
tissue is gathered until a sudden increase in tension is reached.
In some patients, a minimal amount of tension is desired wherein
torque application is ceased as soon as the increase in tension is
reached. In other embodiments, torque is measured by a torque
measurement mechanism, such as a torque sensor, torque transducer
or torque meter attached to or incorporated within the torqueing
tool 408. In some instances, torque sensors or torque transducers
use strain gauges applied to a rotating shaft. With this method, a
mechanism to power a strain gauge bridge is present as well as a
means to receive the signal from the rotating shaft. This can be
accomplished using slip rings, wireless telemetry, or rotary
transformers, to name a few. In some embodiments, SAW devices are
attached to the shaft and remotely interrogated. The strain on
these tiny devices as the shaft flexes are read remotely and output
without the need for attached electronics on the shaft. In other
embodiments, torque is measured by way of twist angle measurement
or phase shift measurement, whereby the angle of twist resulting
from applied torque is measured by using two angular position
sensors and measuring the phase angle between them. In some
embodiments, a predetermined level of torque is established wherein
the torque measurement mechanism indicates when the predetermined
level of torque has been reached, such as by a visual or auditory
signal or by obstruction of further rotation. In some embodiments,
the predetermined amount of torque is approximately 0 to 3 in-oz,
preferably approximately 0.1 to 0.5 in-oz, more preferably
approximately 0.1 to 0.3 in-oz.
[1037] In other embodiments, torque is applied until a
predetermined amount of rotation has been achieved. In some
instances, the amount of rotation is visually monitored such as by
watching rotation of the tissue gathering element 402 by
visualization with a variety of methods, including fluoroscopy
and/or imaging through a bronchoscope camera. Typically, when the
desired amount of rotation is observed, the user ceases rotation.
In other instances, the amount of rotation is measured by a
rotational measurement mechanism, such as attached to or
incorporated within the torqueing tool 408. In some embodiments, a
predetermined amount of rotation is established wherein the
rotation measurement mechanism indicates when the predetermined
level of rotation has been reached, such as by a visual or auditory
signal or by obstruction of further rotation. In some embodiments,
the predetermined amount of rotation is up to 10 degrees, up to 20
degrees, up to 30 degrees, up to 40 degrees, up to 45 degrees, up
to 50 degrees, up to 60 degrees, up to 70 degrees, up to 80
degrees, up to 90 degrees, up to 100 degrees, up to 110 degrees, up
to 120 degrees, up to 130 degrees, up to 135 degrees, up to 140
degrees, up to 150 degrees, up to 160 degrees, up to 170 degrees,
up to 180 degrees, up to 225 degrees, up to 270 degrees, up to 315
degrees, up to 360 degrees, or over 360 degrees.
[1038] Once the lung L is desirably re-tensioned, the device 400 is
anchored to maintain the rotated arrangement. This is achieved by
deployment of the anchoring element 404. FIG. 103 illustrates such
deployment. Here the catheter 430 is retracted to expose the
anchoring element 404. Here, the tether 702 is still attached to
proximal end of the device 400, particularly to the anchoring
element 404, and holds the anchoring element 404 in a stretched
configuration. The anchoring element 404 is then expanded, such as
by advancement of the tether 702 in relation to the torqueing tool
408. Alternatively, or in addition, the torqueing tool 408 may be
retracted. This assists in shortening the anchoring element 404,
allowing the coils to reform as illustrated in FIG. 104. It may be
appreciated that anchoring may be verified by observation of any
unwinding of the device 400. Typically, any unwinding of the device
400 pulls on the airway until the airway is unable to rotate any
further. Thus, anchoring is established.
[1039] The device 400 is then released, as illustrated in FIG. 105.
The torqueing tool 408 is released from the device 400 by removal
of the hitch wire 727. Removal of the hitch wire 727 allows the
hooked end 722 the torqueing tool 408 withdraw from the attachment
feature 610. Likewise, the tether 702 is removed from the anchoring
element 404. The tools (torqueing tool 408, hitch wire 727, tether
702) are then removed and the device 400 is left behind as an
implant.
[1040] Patients suffering from severe COPD typically have a high
chance of having an inflammatory response to implantation of the
device 400. In such instances, the inflammatory response can be
beneficial to implantation since it typically causes higher volume
contraction, lung volume reduction and lung tensioning. For such
patients, a lower level of torque may be applied in anticipation of
the effects of the inflammatory response.
[1041] It may be appreciated that in some embodiments, a similar
inflammatory response is actively induced in a patient so as to
obtain similar benefits. In some embodiments, the tissue gathering
element 402, or other portions of the device 400, includes sharp
edges which cause a fibrotic reaction or thickening of the tissue.
This in turn causes increased contraction. In other embodiments,
fibrosis is achieved by increasing tissue tension because the wound
healing and the formation of scar tissue is accelerated. In some
embodiments, the tissue gathering element 402, or other portions of
the device 400, are texturized to enhance epithelium adhesion and
fibrotic reaction around the implanted device 400. For example, in
some embodiments, the device 400 is texturized by etching lines
along its surface, such as lines that are spaced 2-30 micrometers
apart to help drive macrophage propulsion along the surface and to
preserve macrophage health that minimizes collateral tissue growth
formations that may occur in the airway. It may be appreciated that
the tissue gathering element 402, or other portions of the device
400, may be coated to reduce infection. Examples of coating include
silver plating, which is known to inhibit bacteria. Other coatings,
coverings or plating materials may be applied to the device to
inhibit colonization of bacteria, inhibit growth of granulation
tissue, random collagen or other foreign growths that would
compromise breathing. Coatings, coverings or plating materials may
be provided to enhance epithelium attachment and health, cause
fibrosis formation to enhance the structure of the emphysema lung
tissue and to reduce friction between the device and delivery
system components during delivery into the patient. It may be
appreciated that any reduction of coating over time may be
inconsequential since it may be most desired during and shortly
after implantation.
[1042] In some embodiments, natural and/or induced inflammatory and
wound healing responses are controlled with the use of agents, such
as steroidal drugs. Coatings may be applied to the device to
efficiently carry anti-inflammatory drugs to the lung airway in the
form of a gel that rubs into the airway wall or lung tissue, in the
form of a resorbable polymer that releases the drugs over time or
in the form of film on the surface of the device. These drugs may
include, for example, Sirolimus, Rapamune, Rapamycin, Paclitaxel,
Taxol or a combination thereof. In some instances, such control may
allow for more precise treatments, such as more precise levels of
torque application depending on patient condition and anatomy.
[1043] In some embodiments, various therapies are used in
combination with implantation of one or more devices 400. For
example, in some instances, radiotherapy is used in combination
with implantation of one or more devices 400. Radiotherapy or X-ray
therapy cross-links and shrinks lung tissue so as to cause
additional tissue contraction, tensioning the lung tissue which
adds more elastic recoil and reduced compliance.
[1044] It may be appreciated that the methods, devices and systems
provided herein may be used in combination with a variety of
conventional treatments for COPD and other lung conditions. For
example, in some instances, the methods, devices and systems
provided herein may be used in combination with lung volume
reduction surgery (LVRS). Likewise, in some instances, the methods,
devices and systems provided herein may be used in combination with
conventional implantable therapeutic devices, such as conventional
endobronchial valves and conventional endobronchial coils. Example
conventional endobronchial valves include those developed by
Emphasys Medical (now Pulmonx--Redwood City, Calif.) as a minimally
invasive alternative to lung volume reduction surgery for
emphysema. Emphasys was purchased by Pulmonx in 2009, and Pulmonx
currently markets the Zephyr.RTM. endobronchial valve (developed by
Emphasys). Other example conventional endobronchial valves include
those developed by Spiration (Seattle, Wash.) which was acquired by
Olympus in 2010. Example conventional endobronchial coils include
those developed by PnemRx (Mountain View, Calif.) which has been
acquired by BTG. Based in London, BTG is an international
specialist healthcare company that is active in interventional
medicine and specialty pharmaceuticals. BTG has since been acquired
by Boston Scientific.
[1045] Likewise, the methods, devices and systems provided herein
may be used in combination with conventional lung airway bypass
products that cause venting of trapped air, such as conventional
pulmonary stents. Example conventional pulmonary stents include the
Ultraflex.TM. Tracheobronchial Stent System (Boston Scientific),
the Polyflex.TM. Self-Expanding Silicone Airway Stent (Boston
Scientific) and the Dynamic.TM. (Y) Stent Bifurcated
Tracheobronchial Stent (Boston Scientific).
[1046] Likewise, the methods, devices and systems provided herein
may be used in combination with conventional devices that inject
steam to cause tissue trauma, scarring and cell death, such as the
InterVapor.RTM. Bronchoscopic Thermal Vapor Ablation (BTVA.RTM.)
system which has returned to the market after a brief hiatus as the
asset sale of Uptake Medical Corporation was being completed to
Broncus Holding Co. A new company, Uptake Medical Technology, Inc
was formed in Seattle, Wash., USA and has received a new CE Mark
for the technology. Likewise, the methods, devices and systems
provided herein may be used in combination with conventional
sealants, such as the AeriSeal.RTM. System. The AeriSeal.RTM.
System is foam-based lung sealant system wherein polymers are mixed
and blown with air to create foam in the damaged regions of lung.
The foam turns to a state like hard rubber blocking holes and
damages in the lung and stays for several months while the lung
shrinks in its normal size. The AeriSeal.RTM. System was developed
by Aeris Therapeutics and was later acquired by Pulmonx.RTM..
[1047] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that methods and structures
within the scope of these claims and their equivalents be covered
thereby.
* * * * *