U.S. patent application number 10/199776 was filed with the patent office on 2002-12-12 for lung reduction apparatus and method.
This patent application is currently assigned to Spiration, Inc.. Invention is credited to Alferness, Clifton A., Jaeger, Wilfred E., Lin, Richard Y..
Application Number | 20020188171 10/199776 |
Document ID | / |
Family ID | 23499438 |
Filed Date | 2002-12-12 |
United States Patent
Application |
20020188171 |
Kind Code |
A1 |
Alferness, Clifton A. ; et
al. |
December 12, 2002 |
Lung reduction apparatus and method
Abstract
An apparatus and method reduces the size of a lung. The
apparatus includes a jacket of flexible fabric configured to cover
at least a portion of the lung. A lace, carried by the jacket,
collapses the jacket about the lung portion. The jacket may further
include a drawstring circumscribing the jacket at the base for
closing the open base of the jacket about the lung portion. The
collapsing of the jacket may be employed for both reducing the size
of the lung and maintaining the lung in a reduced size condition or
the lung portion may be deflated prior to the placement of the
jacket over the lung portion, in which case, the jacket serves to
prevent re-expansion of the lung portion.
Inventors: |
Alferness, Clifton A.;
(Redmond, WA) ; Lin, Richard Y.; (Redwood City,
CA) ; Jaeger, Wilfred E.; (Portola Valley,
CA) |
Correspondence
Address: |
GRAYBEAL, JACKSON, HALEY LLP
155 - 108TH AVENUE NE
SUITE 350
BELLEVUE
WA
98004-5901
US
|
Assignee: |
Spiration, Inc.
|
Family ID: |
23499438 |
Appl. No.: |
10/199776 |
Filed: |
July 18, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10199776 |
Jul 18, 2002 |
|
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09379973 |
Aug 24, 1999 |
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6416554 |
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Current U.S.
Class: |
600/37 ;
623/23.65 |
Current CPC
Class: |
A61B 17/00234 20130101;
A61B 17/12 20130101; A61F 2/0063 20130101 |
Class at
Publication: |
600/37 ;
623/23.65 |
International
Class: |
A61F 002/04 |
Claims
What is claimed is:
1. An implantable apparatus for reducing the size of a lung
comprising: a jacket of flexible fabric configured to cover at
least a portion of a lung; and collapsing means for collapsing the
jacket about the lung portion.
2. The apparatus of claim 1 wherein the flexible fabric is an open
mesh material.
3. The apparatus of claim 1 wherein the jacket includes an opening
for applying the jacket to the lung portion, and a closed end.
4. The apparatus of claim 3 wherein the jacket includes a base
defining the opening.
5. The apparatus of claim 4 wherein the collapsing means is carried
by the jacket and comprises at least one lace extending from the
closed end towards the base, the at least one lace including a cord
having a pair of free ends which, when drawn, collapse the jacket
about the lung portion.
6. The apparatus of claim 5 further including a guide tube having a
distal end and a proximal end and wherein the free ends of the cord
are threaded from the distal end of the guide tube to and through
the proximal end of the guide tube.
7. The apparatus of claim 6 wherein the distal end of the guide
tube is closely adjacent the base of the jacket.
8. The apparatus of claim 4 wherein the collapsing means includes a
draw string circumscribing the jacket at the base, the draw string
having a pair of free ends which, when drawn, close the open base
of the jacket about the lung portion.
9. The apparatus of claim 1 wherein the flexible fabric is formed
of polyester.
10. A method of reducing the size of a lung, the method including
the steps of: disposing a jacket of flexible fabric over at least a
portion of a lung; and collapsing the jacket about the lung
portion.
11. The method of claim 10 wherein the open flexible fabric is an
open mesh material.
12. The method of claim 11 wherein the open mesh material is a
polyester mesh.
13. The method of claim 10 including the step of providing the
jacket with a closed end and an opening to permit disposing the
jacket over the lung portion.
14. The method of claim 13 wherein the collapsing step includes
lacing a cord on the jacket from the closed end towards the
opening, the cord when laced having a pair of free ends, and
pulling on the free ends of the cord to cause the jacket to
collapse about the lung portion.
15. The method of claim 14 wherein the collapsing step further
includes tying the free ends of the cord together after the jacket
is collapsed about the lung portion.
16. The method of claim 13 wherein the collapsing step includes
circumscribing the opening with a cord, the cord having a pair of
free ends, and pulling on the free ends of the cord to collapse the
opening of the jacket about the lung portion.
17. The method of claim 16 wherein the collapsing step further
includes typing the free ends of the cord together after the
opening of the jacket is collapsed about the lung portion.
18. The method of claim 10 including the further step of deflating
the lung portion prior to disposing the jacket over the lung
portion.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention is generally directed to an apparatus
and method for treating Chronic Obstructive Pulmonary Disease
(COPD). The present invention is more particularly directed to such
an apparatus and method which may be implanted in the human body to
provide lung size reduction by constricting at least a portion of a
lung.
[0002] Chronic Obstructive Pulmonary Disease (COPD) has become a
major cause of morbidity and mortality in the United States over
the last three decades. COPD is characterized by the presence of
airflow obstruction due to chronic bronchitis or emphysema. The
airflow obstruction in COPD is due largely to structural
abnormalities in the smaller airways. Important causes are
inflammation, fibrosis, goblet cell metaplasia, and smooth muscle
hypertrophy in terminal bronchioles.
[0003] The incidence, prevalence, and health-related costs of COPD
are on the rise. Mortality due to COPD is also on the rise. In 1991
COPD was the fourth leading cause of death in the United States and
had increased 33% since 1979.
[0004] COPD affects the patient's whole life. It has three main
symptoms: cough; breathlessness; and wheeze. At first,
breathlessness may be noticed when running for a bus, digging in
the garden, or walking up hill. Later, it may be noticed when
simply walking in the kitchen. Overtime, it may occur with less and
less effort until it is present all of the time.
[0005] COPD is a progressive disease and currently has no cure.
Current treatments for COPD include the prevention of further
respiratory damage, pharmacotherapy, and surgery. Each is discussed
below.
[0006] The prevention of further respiratory damage entails the
adoption of a healthy lifestyle. Smoking cessation is believed to
be the single most important therapeutic intervention. However,
regular exercise and weight control are also important. Patients
whose symptoms restrict their daily activities or who otherwise
have an impaired quality of life may require a pulmonary
rehabilitation program including ventilatory muscle training and
breathing retraining. Long-term oxygen therapy may also become
necessary.
[0007] Pharmacotherapy may include bronchodilator therapy to open
up the airways as much as possible or inhaled -agonists. For those
patients who respond poorly to the foregoing or who have persistent
symptoms, Ipratropium bromide may be indicated. Further, courses of
steroids, such as corticosterocds, may be required. Lastly,
antibiotics may be required to prevent infections and influenza and
pheumococcal vaccines may be routinely administered. Unfortunately,
there is no evidence that early, regular use of pharmacotherapy
will alter the progression of COPD.
[0008] About 40 years ago, it was first postulated that the
tethering force that tends to keep the intrathoracic airways open
was lost in emphysema and that by surgically removing the most
affected parts of the lungs, the force could be partially restored.
Although the surgery was deemed promising, the procedure was
abandoned.
[0009] The lung volume reduction surgery (LVRS) was later revived.
In the early 1990's, hundreds of patients underwent the procedure.
However, the procedure has fallen out of favor due to the fact that
Medicare stopped remitting for LVRS. Unfortunately, data is
relatively scarce and many factors conspire to make what data
exists difficult to interpret. The procedure is currently under
review in a controlled clinical trial. However, what data does
exist tends to indicate that patients benefited from the procedure
in terms of an increase in forced expiratory volume, a decrease in
total lung capacity, and a significant improvement in lung
function, dyspnea, and quality of life.
[0010] Improvements in pulmonary function after LVRS have been
attributed to at least four possible mechanisms. These include
enhanced elastic recoil, correction of ventilation/perfusion
mismatch, improved efficiency of respiratory musculature, and
improved right ventricular filling.
[0011] Lastly, lung tranplantation is also an option. Today, COPD
is the most common diagnosis for which lung transplantation is
considered. Unfortunately, this consideration is given for only
those with advanced COPD. Given the limited availability of donor
organs, lung transplant is far from being available to all
patients.
[0012] In view of the foregoing, there in a need in the art for a
new and improved therapy for COPD. More specifically, there is a
need for such a therapy which provides more permanent results than
pharmacotherapy while being less traumatic than LVRS. The present
invention is directed to an apparatus and method which provide such
an improved therapy for COPD.
SUMMARY OF THE INVENTION
[0013] The present invention provides an implantable apparatus for
reducing the size of a lung. The apparatus includes a jacket of
flexible fabric configured to cover at least a portion of a lung
and collapsing means carried by the jacket for collapsing the
jacket about the lung portion.
[0014] The invention still further provides a method of reducing
the size of a lung. The method includes the steps of disposing a
jacket of flexible fabric over at least a portion of a lung. The
collapsing of the jacket may serve to both reduce the size of the
lung and maintain it in its reduced size condition. Alternatively,
the lung portion may first be deflated whereupon the collapsed
jacket serves to maintain the lung portion in a deflated, reduced
size condition.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The features of the present invention which are believed to
be novel are set forth with particularity in the appended claims.
The invention, together with further objects and advantages
thereof, may best be understood by making reference to the
following description taken in conjunction with the accompanying
drawings, in the several figures of which like referenced numerals
identify identical elements, and wherein:
[0016] FIG. 1 is a simplified sectional view of a thorax
illustrating a healthy respiratory system;
[0017] FIG. 2 is a sectional view similar to FIG. 1 but
illustrating a respiratory system suffering from COPD;
[0018] FIG. 3 is a perspective view illustrating a lung
constriction apparatus embodying the present invention;
[0019] FIG. 4 is a sectional view of the respiratory system of FIG.
2 with a lung constriction apparatus embodying the present
invention being disposed over a lung portion to be reduced in
size;
[0020] FIG. 5 illustrates an initial step in collapsing the lung
constricting apparatus about the lung portion;
[0021] FIG. 6 illustrates a further step in collapsing the lung
constriction apparatus;
[0022] FIG. 7 illustrates the lung constricting apparatus being
fully collapsed about the lung portion; and
[0023] FIG. 8 illustrates the respiratory system after both left
and right side lung portions have been reduced in size in
accordance with the present invention.
DETAILED DESCRIPTION
[0024] Referring now to FIG. 1, it is a sectional view of a healthy
respiratory system. The respiratory system 20 resides within the
thorax 22 which occupies a space defined by the chest wall 24 and
the diaphragm 26.
[0025] The respiratory system 20 includes the trachea 28, the left
mainstem bronchus 30, the right mainstem bronchus 32, and the
bronchial branches 34, 36, 38, 40, and 42. The respiratory system
20 further includes left lung lobes 52 and 54 and right lung lobes
56, 58, and 60. Each bronchial branch communicates with a
respective different portion of a lung lobe, either the entire lung
lobe or a portion thereof.
[0026] Characteristic of a healthy respiratory system is the arched
or inwardly arcuate diaphragm 26. As the individual inhales, the
diaphragm 26 straightens to increase the volume of the thorax 22.
This causes a negative pressure within the thorax. The negative
pressure within the thorax in turn causes the lung lobes to fill
with air. When the individual exhales, the diaphragm returns to its
original arched condition to decrease the volume of the thorax. The
decreased volume of the thorax causes a positive pressure within
the thorax which in turn causes exhalation of the lung lobes.
[0027] In contrast to the healthy respiratory system of FIG. 1,
FIG. 2 illustrates a respiratory system suffering from COPD. Here
it may be seen that the lung lobes 52, 54, 56, 58, and 60 are
enlarged and that the diaphragm 26 is not arched but substantially
straight. Hence, this individual is incapable of breathing normally
by moving the diaphragm 28. Instead, in order to create the
negative pressure in the thorax 22 required for breathing, this
individual must move the chest wall outwardly to increase the
volume of the thorax. This results in inefficient breathing causing
these individuals to breathe rapidly with shallow breaths.
[0028] It has been found that the apex portion 62 and 66 of the
upper lung lobes 52 and 56, respectively, are most affected by
COPD. Hence, the preferred embodiment will be described for
treating the apex 66 of the right, upper lung lobe 56. However, as
will be appreciated by those skilled in the art, the present
invention may be applied to any lung portion without departing from
the present invention.
[0029] The apparatus and method of the present invention treats
COPD by deriving the benefits of lung volume reduction surgery
without the need of performing lung volume reduction surgery. As
will be seen hereinafter, the present invention contemplates
permanent collapse of a lung portion or lung portions most
affected. This leaves extra volume within the thorax for the
diaphragm to assume its arched state for acting upon the remaining
healthier lung tissue. As previously mentioned, this should result
in improved pulmonary function due to enhanced elastic recoil,
correction of ventilation/perfusion mismatch, improved efficiency
of respiratory musculature, and improved right ventricle
filling.
[0030] Referring now to FIG. 3, it illustrates a lung constriction
apparatus 70 embodying the present invention. The apparatus 70
takes the form of a jacket 72 formed of a flexible fabric such as
an open mesh of polyester. The jacket includes an open base 74 and
a curved surface 76 extending from the open base 74 and terminating
in a closed, domed-shape end or apex 78. The open base 74 is
dimensioned to be applied over and to cover the lung portion to be
reduced in size.
[0031] The constriction apparatus 70 further includes at least one
lace 80 extending from the apex 78 to the base 74. The cord 82
forming the lace 80 has a pair of free ends 84 and 86 which are
threaded through a guide tube 88 from the distal end 90 of the
guide tube 88 to the proximal end 92 of the guide tube 88.
[0032] The guide tube 88 serves to maintain the free ends 84 and 86
of the cord 82 together. When the free ends 84 and 86 of the cord
82 are drawn while holding the guide tube distal end 90 adjacent
the base 74, the jacket 72 is collapsed to reduce the inner volume
of the jacket. This constriction of the jacket serves to collapse
the jacket about the lung portion to be reduced in size.
[0033] As will be seen hereinafter, a plurality of laces may be
carried by the jacket. As each lace is drawn, the jacket will be
collapsed to a greater and controlled extent.
[0034] The jacket 72 further includes a piping 94 at the base 74. A
draw string 96 is threaded through the piping to circumscribe the
jacket 72 and the base 74. The draw string has a pair of free ends
98 and 100. As will be seen hereinafter, after the laces are drawn
to collapse the jacket 72 about the lung portion, the free ends 98
and 100 of the draw string 96 may be pulled and drawn to close the
open base 74 of the jacket 72 about the lung portion. This will
provide additional constriction to assure that the lung portion
does not reinflate. It also serves to cut off all blood circulation
to the lung portion. This promotes infarction and fibrosis.
[0035] Referring now to FIG. 4, it illustrates the constriction
device 70 after it has been placed over the apex of the upper right
lung lobe 56 to cover the lung portion 66 of the right upper lobe
56 referred to previously with respect to FIG. 2. The jacket 72
covers the lung portion 66. At this point, the free ends 84 and 86
of the cord forming the lace 80 have not been drawn.
[0036] Referring now to FIG. 5, here it may be seen that the lace
80 has been drawn by the pulling of the free ends 84 and 86 of the
lace cord while holding the guide tube 88 such that its distal end
90 is closely adjacent the base 74 of the jacket 72. As will be
observed in FIG. 5, because the jacket 72 has been collapsed about
the lung portion 66 of the upper lobe 56, the lung portion 66 has
been reduced in size due to the constriction of the jacket 72.
[0037] FIG. 6 illustrates the jacket 72 with additional laces 110
and 112 which have also been drawn. When the laces are drawn
tightly, the free ends of the cords forming the laces may be tied
off and then cut as illustrated. The lung portion 66 of the upper
right lobe 56 is now more fully reduced in size by the constriction
of the jacket 72.
[0038] FIG. 7 illustrates the further constriction provided by the
drawstring after being pulled. The free ends of the drawstring
after being pulled may be then tied together and cut as
illustrated. As can be seen in FIG. 7, the lung portion 66 of the
upper right lobe 56 has been drastically reduced in size. Further,
the drawstring constriction will cut off circulation to the lung
portion 66 to promote infarction and fibrosis.
[0039] FIG. 8 illustrates the respiratory system after both the
lung portion 66 of the upper right lobe 56 and the lung portion 62
of the upper left lobe 52 have been treated as described above.
Here it can be seen that the volumes of the right upper lung lobe
56 and left upper lung lobe 52 have been reduced in size by the
jacket 72. This causes the lung lobes to occupy less volume within
the thorax 22 to permit the diaphragm 26 to assume its arched state
for acting upon the remaining healthier lung tissue. As previously
mentioned, this should result in improved pulmonary function due to
enhanced elastic recoil, correction of ventilation/perfusion
mismatch, improved efficiency of respiratory musculature, and
improved right ventricle filling.
[0040] As can thus be seen from the foregoing, the present
invention provides an apparatus and method for treating COPD by
lung volume reduction. The lung volume reduction is achieved
through the permanent collapsing of one or more lung portions, or
lobes, or portions of lobes. The foregoing is achieved without the
need for removing lung tissue. Following the treatment, the lung
tissue within the thorax will occupy a lesser volume than
previously occupied providing room for the diaphragm to assume its
arcuate state to assist in normal breathing and to achieve the
benefits of lung volume reduction.
[0041] While particular embodiments of the present invention have
been shown and described, modifications may be made. For example,
while the jacket may be employed for reducing the size of a lung by
constriction, the invention is not intended to be so limited.
Rather, the lung portion may become deflated during surgery on its
own or by other means known in the art. The jacket may then be
placed on the lung portion while it is in a deflated condition. The
jacket may then be collapsed about the lung portion to cinch down
over the lung to maintain it in its deflated, reduced volume
condition. The jacket would thus prevent re-expansion of the
captured lung portion. The remaining portions of the lung may then
be expanded, if necessary, by means known in the art. Hence, it is
intended in the appended claims to cover all such changes and
modifications which fall within the true spirit and scope of the
invention.
* * * * *