U.S. patent application number 10/103487 was filed with the patent office on 2003-09-25 for removable anchored lung volume reduction devices and methods.
This patent application is currently assigned to Spiration, Inc.. Invention is credited to Alferness, Clifton A..
Application Number | 20030181922 10/103487 |
Document ID | / |
Family ID | 28040404 |
Filed Date | 2003-09-25 |
United States Patent
Application |
20030181922 |
Kind Code |
A1 |
Alferness, Clifton A. |
September 25, 2003 |
Removable anchored lung volume reduction devices and methods
Abstract
An intra-bronchial device may be placed and anchored in an air
passageway of a patient to collapse a lung portion associated with
the air passageway. The device includes an obstructing member that
prevents air from being inhaled into the lung portion, and an
anchor that anchors the obstruction device within the air
passageway. The anchor may piercingly engage the air passageway
wall. The anchor may be releasable from the air passageway for
removal of the obstructing member. The anchor may be releasable by
collapsing a portion of the obstructing member, or by drawing the
obstructing member toward the larynx. The obstructing member may be
a one-way valve.
Inventors: |
Alferness, Clifton A.;
(Redmond, WA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Assignee: |
Spiration, Inc.
|
Family ID: |
28040404 |
Appl. No.: |
10/103487 |
Filed: |
March 20, 2002 |
Current U.S.
Class: |
606/108 |
Current CPC
Class: |
A61B 17/1204 20130101;
A61B 2017/22051 20130101; A61F 2002/043 20130101; A61B 2017/1205
20130101; A61B 17/12172 20130101; A61B 17/12159 20130101; A61B
17/12022 20130101; A61B 17/12104 20130101; A61B 2017/22067
20130101 |
Class at
Publication: |
606/108 |
International
Class: |
A61F 011/00 |
Claims
What is claimed is:
1. An intra-bronchial device for placement in an air passageway of
a patient to collapse a lung portion associated with the air
passageway, the device comprising: an obstructing member that
prevents air from being inhaled into the lung portion to collapse
the lung portion; and an anchor that anchors the obstruction device
within the air passageway when the anchor is deployed.
2. The intra-bronchial device of claim 1, wherein the anchor
engages the air passageway wall.
3. The intra-bronchial device of claim 1, wherein the anchor
pierces into the air passageway wall.
4. The intra-bronchial device of claim 1, wherein the obstructing
member and the anchor are simultaneously deployable.
5. The intra-bronchial device of claim 1, wherein the anchor is
releasable from the air passageway for removal of the obstructing
member.
6. The intra-bronchial device of claim 1 wherein a portion of the
intra-bronchial device is collapsible.
7. The intra-bronchial device of claim 6, wherein the anchor is
releasable from the air passageway for removal of the obstructing
member by collapsing a portion of the obstructing member.
8. The intra-bronchial device of claim 6, wherein the anchor is
releasable from the air passageway for removal of the obstructing
member by drawing the obstructing member proximally.
9. The intra-bronchial device of claim 1, wherein the anchor
includes a resilient material for imparting a force against the air
passageway to deform the air passageway to more positively anchor
the obstructing member.
10. The intra-bronchial device of claim 1, wherein the obstructing
member comprises material having memory of an original shape, and
resiliency to return the material to that shape.
11. The intra-bronchial device of claim 1, wherein the anchor
comprises material having memory of an original shape, and
resiliency to return the material to that shape.
12. The intra-bronchial device of claim 1, wherein the obstructing
member is a one-way valve.
13. A method of reducing the size of a lung by collapsing a portion
of the lung, the method including the steps of: providing an
intra-bronchial device comprising an obstructing member which is so
dimensioned when deployed in an air passageway communicating with
the portion of the lung to be collapsed to preclude air from being
inhaled, and an anchor that anchors the obstructing member when the
anchor is deployed; placing the obstructing member in the air
passageway; and deploying the anchor.
14. The method of claim 13, wherein the anchor is releasable for
removal of the obstructing member.
15. The method of claim 13, wherein the obstructing member forms a
one-way valve.
16. The method of claim 13, wherein a portion of the obstructing
member is collapsible.
17. A method of reducing the size of a lung by collapsing a portion
of the lung with a removable device, the method including the steps
of: providing an intra-bronchial device an obstructing member which
is so dimensioned when deployed in an air passageway communicating
with the portion of the lung to be collapsed to preclude air from
being inhaled, and an anchor that anchors the obstructing member
when the anchor is deployed; placing the obstructing member in the
air passageway; deploying an anchor; and removing the obstructing
member.
18. The method of claim 17, wherein the anchor is releasable from
the air passageway for removal of the intra-bronchial device, and
the step of removing the obstructing member includes the further
step of releasing the anchor.
19. The method of claim 17, wherein the obstructing member forms a
one-way valve.
20. The method of claim 17, wherein at least a portion of the
obstructing member is collapsible, and the step of removing the
obstructing member includes the further step of collapsing a
portion of the obstructing member.
21. An air passageway obstructing device comprising: obstructing
means for obstructing air flow within the air passageway; and
anchoring means to anchor the air passageway obstructing device
within the air passageway.
22. An air passageway obstructing device comprising: obstructing
means for obstructing air flow within the air passageway; and
anchoring means to anchor the air passageway obstructing device
within the air passageway, the anchoring means being releasable for
removal of the obstructing means from the air passageway.
Description
BACKGROUND
[0001] The present invention is generally directed to a removable
anchored device, system, and method for treating Chronic
Obstructive Pulmonary Disease (COPD). The present invention is more
particularly directed to providing an anchored intra-bronchial
obstruction that may be removable.
[0002] 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. 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 uphill. Later, it may be
noticed when simply walking in the kitchen. Over time, it may occur
with less and less effort until it is present all of the time. 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.
[0004] 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.
[0005] Pharmacotherapy may include bronchodilator therapy to open
up the airways as much as possible or inhaled beta-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 corticosteroids, may be required.
Lastly, antibiotics may be required to prevent infections and
influenza and pneumococcal vaccines may be routinely administered.
Unfortunately, there is no evidence that early, regular use of
pharmacotherapy will alter the progression of COPD.
[0006] 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 lung volume
reduction surgery (LVRS) procedure was abandoned. LVRS was later
revived. In the early 1990's, hundreds of patients underwent the
procedure. However, the procedure has fallen out of favor when
Medicare stopping reimbursing 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. 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
muscaulature, and improved right ventricular filling.
[0007] Lastly, lung transplantation 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.
[0008] There is a need for additional non-surgical options for
permanently treating COPD without surgery. A promising new therapy
includes non-surgical apparatus and procedures for lung volume
reduction by permanently obstructing the air passageway that
communicates with the portion of the lung to be collapsed. The
therapy includes placing an obstruction in the air passageway that
prevents inhaled air from flowing into the portion of the lung to
be collapsed. Lung volume reduction with concomitant improved
pulmonary function may be obtained without the need for surgery.
The effectiveness of obstructions may be enhanced if it is anchored
in place. The effectiveness may also be enhanced if the obstruction
is removable. However, no readily available apparatus and method
exists for anchoring the obstruction, and for removal if
required.
[0009] In view of the foregoing, there is a need in the art for a
new and improved apparatus and method for permanently obstructing
an air passageway that is anchored in place, and that may be
removed if required. The present invention is directed to a device,
system, and method that provide such an improved apparatus and
method for treating COPD.
SUMMARY
[0010] The present invention provides an anchored intra-bronchial
device for placement in an air passageway of a patient to collapse
a lung portion associated with the air passageway. The device
includes an obstructing member that prevents air from being inhaled
into the lung portion to collapse the lung portion, and an anchor
that anchors the obstruction device within the air passageway when
the anchor is deployed. The anchor may engage the air passageway
wall, and may pierce into the air passageway wall. The obstructing
member and the anchor may be simultaneously deployable. The anchor
may be releasable from the air passageway for removal of the
obstructing member. A portion of the intra-bronchial device may be
collapsible. The anchor may be releasable from the air passageway
for removal of the obstructing member by collapsing a portion of
the obstructing member, or by drawing the obstructing member
proximally. The anchor may include a resilient material for
imparting a force against the air passageway to deform the air
passageway to more positively anchor the obstructing member. The
anchor may comprise material having memory of an original shape,
and resiliency to return the material to that shape. The
obstructing member may comprise material having memory of an
original shape, and resiliency to return the material to that
shape. The obstructing member may be a one-way valve.
[0011] In another embodiment of the present invention, a method of
reducing the size of a lung by collapsing a portion of the lung is
provided. The method includes the step of providing an
intra-bronchial device comprising an obstructing member which is so
dimensioned when deployed in an air passageway communicating with
the portion of the lung to be collapsed to preclude air from being
inhaled, and an anchor that anchors the obstructing member when the
anchor is deployed. The method further includes the steps of
placing the obstructing member in the air passageway, and deploying
the anchor. The anchor may be releasable for removal of the
obstructing member. The obstructing member may form a one-way
valve. A portion of the obstructing member may be collapsible.
[0012] In a further embodiment of the present invention, a method
of reducing the size of a lung by collapsing a portion of the lung
with a removable device is provided. The method includes the step
of providing an intra-bronchial device and an obstructing member
that is so dimensioned when deployed in an air passageway
communicating with the portion of the lung to be collapsed to
preclude air from being inhaled, and an anchor that anchors the
obstructing member when the anchor is deployed. The method includes
the additional steps of placing the obstructing member in the air
passageway, deploying an anchor, and removing the obstructing
member. The anchor is releasable from the air passageway for
removal of the intra-bronchial device, and the step of removing the
obstructing member includes the further step of releasing the
anchor. The obstructing member may form a one-way valve. At least a
portion of the obstructing member may be collapsible, and the step
of removing the obstructing member includes the further step of
collapsing a portion of the obstructing member.
[0013] In yet another embodiment of the present invention, an air
passageway-obstructing device is provided. The obstructing device
includes obstructing means for obstructing air flow within the air
passageway, and anchoring means to anchor the air passageway
obstructing device within the air passageway.
[0014] In yet a further embodiment of the present invention, an air
passageway-obstructing device is provided that includes obstructing
means for obstructing air flow within the air passageway, and
anchoring means to anchor the air passageway obstructing device
within the air passageway, the anchoring means being releasable for
removal of the obstructing means from the air passageway.
[0015] These and various other features as well as advantages which
characterize the present invention will be apparent from a reading
of the following detailed description and a review of the
associated drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] 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 like elements, and wherein:
[0017] FIG. 1 is a simplified sectional view of a thorax
illustrating a healthy respiratory system;
[0018] FIG. 2 is a sectional view similar to FIG. 1, but
illustrating a respiratory system suffering from COPD and the
execution of a first step in treating the COPD condition by
reducing the size of a lung portion in accordance with the present
invention;
[0019] FIG. 3 is perspective view, partially in section, and to an
enlarged scale, illustrating an intermediate step in the
treatment;
[0020] FIG. 4 is a perspective view of a conduit that may be
utilized in practicing the present invention;
[0021] FIG. 5 is a perspective view of an intra-bronchial device,
with anchors located proximally on peripheral portions of the
support members, as the device would appear when fully deployed in
an air passageway in accordance with the present invention;
[0022] FIG. 6 is a partial section view of the device of FIG. 5
showing additional details of the support structure;
[0023] FIG. 7 is a perspective view of the intra-bronchial device
of FIG. 5 anchored in an air passageway;
[0024] FIG. 8 illustrates an intra-bronchial device, with anchors
carried distally on the central support structure, fully deployed
in an air passageway in accordance with an alternative embodiment
of the invention;
[0025] FIG. 9 is a perspective view of an intra-bronchial device,
with proximal anchors carried on the central support structure, in
accordance with an alternative embodiment of the invention;
[0026] FIG. 10 is a side view of an intra-bronchial device, with
proximal anchors carried on the central support structure, in
accordance with an alternative embodiment of the invention;
[0027] FIG. 11 is an end view of an intra-bronchial device, with
proximal anchors carried on the central support structure, in
accordance with an alternative embodiment of the invention;
[0028] FIG. 12 is a perspective view of an intra-bronchial device,
with distal friction anchors carried on the central support
structure, in accordance with an alternative embodiment of the
invention;
[0029] FIG. 13 is a side view of an intra-bronchial device, with
distal friction anchors carried on the central support structure,
in accordance with an alternative embodiment of the invention;
[0030] FIG. 14 is an end view of an intra-bronchial device, with
distal friction anchors carried on the central support structure,
in accordance with an alternative embodiment of the invention;
[0031] FIG. 15 is a perspective view an intra-bronchial device
similar to that of FIGS. 12-14 anchored in an air passageway;
[0032] FIG. 16 is a perspective view illustrating an alternative
embodiment of a removable intra-bronchial device with proximal
anchors carried on a peripheral portion of a plurality of support
structure members in accord with the present invention;
[0033] FIG. 17 is a side view of the device of FIG. 16;
[0034] FIG. 18 is a perspective view of a device in its deployed
state with anchors carried on an obstructing member, in accordance
with an alternative embodiment of the invention;
[0035] FIG. 19 is a partial longitudinal sectional view of the
device of FIG. 18 in a collapsed state and located into a lumen for
placement in an air passageway;
[0036] FIG. 20 is a perspective view of the device of FIG. 18 in
its deployed and anchored state in an air passageway, in accordance
with the present invention;
[0037] FIG. 21 is a side view of an initial step in removing the
device of FIG. 18 from an air passageway;
[0038] FIG. 22 is a side view of an intermediate step in removing
the device of FIG. 18 from an air passageway;
[0039] FIG. 23 is a side view of another intermediate step in
removing the device of FIG. 18 from an air passageway;
[0040] FIG. 24 is a side view illustrating the collapse of the
device of FIG. 18 during its removal from an air passageway;
[0041] FIG. 25 is a perspective view of a device in its deployed
state with anchors carried on the obstructing member, in accordance
with an alternative embodiment of the present invention;
[0042] FIG. 26 illustrates the placement and securing of the
obstructing member of the device of FIG. 25 to a support member;
and
[0043] FIG. 27 is a perspective view of the intra-bronchial device
of FIG. 25 fully deployed and anchored in an air passageway, in
accordance with the present invention.
DETAILED DESCRIPTION
[0044] In the following detailed description of exemplary
embodiments of the invention, reference is made to the accompanying
drawings that form a part hereof. The detailed description and the
drawings illustrate how specific exemplary embodiments by which the
invention may be practiced. These embodiments are described in
sufficient detail to enable those skilled in the art to practice
the invention. It is understood that other embodiments may be
utilized, and other changes may be made, without departing from the
spirit or scope of the present invention. The following detailed
description is therefore not to be taken in a limiting sense, and
the scope of the present invention is defined by the appended
claims.
[0045] Throughout the specification and claims, the following terms
take the meanings explicitly associated herein unless the context
clearly dictates otherwise. The meaning of "a", "an", and "the"
include plural references. The meaning of "in" includes "in" and
"on." Referring to the drawings, like numbers indicate like parts
throughout the views. Additionally, a reference to the singular
includes a reference to the plural unless otherwise stated or
inconsistent with the disclosure herein.
[0046] Additionally, throughout the specification, claims, and
drawings, the term "proximal" means nearest the trachea, and
"distal" means nearest the bronchioles.
[0047] Briefly stated, an aspect of the invention provides an
anchored intra-bronchial device for placement in an air passageway
of a patient to collapse a lung portion associated with the air
passageway. A further aspect of the invention provides removability
of the intra-bronchial device, either by releasing the anchors for
removal of the entire device or by separating the obstructing
member and removing it.
[0048] FIG. 1 is a sectional view of a healthy respiratory system.
The respiratory system 20 resides within the thorax 22 that
occupies a space defined by the chest wall 24 and the diaphragm
26.
[0049] The respiratory system 20 includes the trachea 28, the left
mainstem bronchus 30, the right mainstem bronchus 32, the bronchial
branches 34, 36, 38, 40, and 42 and sub-branches 44, 46, 48, and
50. The respiratory system 20 further includes left lung lobes 52
and 54 and right lung lobes 56, 58, and 60. Each bronchial branch
and sub-branch communicates with a respective different portion of
a lung lobe, either the entire lung lobe or a portion thereof. As
used herein, the term "air passageway" is meant to denote either a
bronchi or bronchiole, and typically means a bronchial branch or
sub-branch which communicates with a corresponding individual lung
lobe or lung lobe portion to provide inhaled air thereto or conduct
exhaled air therefrom.
[0050] 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.
[0051] 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 diaphragm 28. Instead, in order to create the negative
pressure in 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.
[0052] It has been found that the apex portions 62 and 66 of the
upper lung lobes 52 and 56, respectively, are most affected by
COPD. Hence, bronchial sub-branch obstructing devices are generally
employed 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. As will be further
appreciated by those skilled the in art, the present invention may
be used with any type of obstructing member to provide an anchored
obstructing device, which may be removed. The inventions disclosed
and claimed in U.S. Pat. Nos. 6,258,100 and 6,293,951, both of
which are incorporated herein by reference, provide an improved
therapy for treating COPD by obstructing an air passageway using an
intra-bronchial valve or plug. The present invention may be used
with the apparatus, system, and methods of these patents as will be
briefly described in conjunction with the disclosure of the
preferred embodiments of the present invention.
[0053] The insertion of an obstructing member treats COPD by
deriving the benefits of lung volume reduction surgery without the
need of performing the surgery. The treatment contemplates
permanent collapse of a lung portion. 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. The present invention supports
the use of intra-bronchial plugs to treat COPD by anchoring the
obstruction device in the air passageway. The present invention
further supports the use of intra-bronchial plugs by providing for
their removal if necessary. Use of anchors can allow the
obstructing member to be relatively loosely fitted against the air
passageway wall, which may provide increased mucociliary transport
of mucus and debris out of the collapsed lung portion.
[0054] FIG. 2 also illustrates a step in COPD treatment using an
obstructing member. Treatment is initiated by feeding a conduit or
catheter 70 down the trachea 28, into the right mainstem bronchus
32, into the bronchial branch 42 and into and terminating within
the sub-branch 50. The sub-branch 50 is the air passageway that
communicates with the lung portion 66 to be treated, and is also
referred to herein as air passageway 50. The catheter 70 is
preferably formed of flexible material such as polyethylene. Also,
the catheter 70 is preferably preformed with a bend 72 to assist
the feeding of the catheter from the right mainstem bronchus 32
into the bronchial branch 42.
[0055] FIG. 3 illustrates a further step in a method for placing an
obstructing member 90 in a bronchial sub-branch using a catheter.
The invention disclosed herein is not limited to use with the
particular method illustrated herein. Catheter 70 includes an
optional inflatable sealing member 74 for use with a vacuum to
collapse lung portion 66 prior to insertion of obstructing member
90. The obstructing member 90 may be formed of resilient or
collapsible material to enable the obstructing member 90 to be fed
through the catheter 70 in a collapsed state. The obstructing
member 90 and its anchors (not shown) are collapsed and fed into
the catheter 70. The stylet 92 is used to push the obstructing
member 90 to the end 77 of the catheter 70 for placing the
obstructing member 90 within the air passageway 50 adjacent to the
lung portion 66 to be permanently collapsed. Optional sealing
member 74 is withdrawn after obstructing member 90 is inserted.
[0056] A function of the intra-bronchial device disclosed and
claimed in this specification, including the detailed description
and the claims, is described in terms of collapsing a lung portion
associated with an air passageway. In some lungs, a portion of a
lung may receive air from collateral air passageways. Obstructing
one of the collateral air passageways may reduce the volume of the
lung portion associated with the air passageway, but not completely
collapse the lung portion as that term may be generally understood.
As used herein, the meaning of "collapse" includes both a complete
collapse of a lung portion and a partial collapse of a lung
portion.
[0057] Once deployed, the obstructing member precludes inhaled air
from entering the lung portion to be collapsed. In accordance with
the present invention, it is preferable that the obstructing member
takes the form of a one-way valve. In addition to precluding
inhaled air from entering the lung portion, the member further
allows air within the lung portion to be exhaled. This results in
more rapid collapse of the lung portion. In addition, anchoring
obstructing members that preclude both inhaled and exhaled airflow
are contemplated as within the scope of the invention.
[0058] FIG. 4 illustrates the obstructing device in place within
air passageway 50. Obstructing member 90 has expanded upon
placement in the air passageway 50 to seal the air passageway 50.
This causes the lung portion 66 to be maintained in a permanently
collapsed state. The obstructing member 90 may be any shape
suitable for accomplishing its purpose, and may be a solid material
or a membrane.
[0059] More specifically, the obstructing member 90 has an outer
dimension 91, and when expanded, enables a contact zone with the
air passageway inner dimension 51. This seals the air passageway
upon placement of the obstructing member 90 in the air passageway
50 for maintaining the lung portion 66 in the collapsed state.
[0060] Alternatively, the lung portion 66 may be collapsed using
vacuum prior to placement of obstructing member 90, or sealing the
air passageway 50 with obstructing member 90 may collapse it. Over
time, the air within the lung portion 66 will be absorbed by the
body and result in the collapse of lung portion 66. Alternatively,
obstructing member 90 may include the function of a one-way valve
that allows air to escape from lung portion 66. Lung portion 66
will then collapse, and the valve will prevent air from being
inhaled.
[0061] FIG. 5 is a perspective view of an intra-bronchial device,
with anchors located proximally on peripheral portions of the
support members, as the device would appear when fully deployed in
an air passageway in accordance with the present invention.
Intra-bronchial device 100 includes a support structure 101, a
central support structure 109; support members 102, 104, 106, and
108; anchors 112, 114, 116, and 118; anchor ends 122, 124, 126, and
128; and an obstructing member 110.
[0062] The support structure 101 of intra-bronchial device includes
central support structure 109, and support members 102, 104, 106,
and 108. The support members 102, 104, 106, and 108, carry anchors
112, 114, 116, and 118; and anchor ends 122, 124, 126, and 128,
respectively. Central support structure 109 is a tubular member,
preferably hypodermic needle tubing. Support members 102, 104, 106,
and 108, are coupled mechanically to central support structure 109,
such as by crimping, or by other methods such as adhesive or
welding. Support members 102, 104, 106, and 108 are generally
similar to each other. The support members are preferably formed of
stainless steel, Nitinol, or other suitable material having a
memory of its original shape, and resiliency to return the material
to that shape.
[0063] Anchors 112, 114, 116, and 118 are extensions of support
members 102, 104, 106, and 108. The anchors are formed by bending
the support members to an angle that will result in a deployed
anchor engaging the air passageway wall by piercing it
approximately perpendicularly. In this preferred embodiment, the
bend angle is approximately a right angle. Anchor ends 122, 124,
126, and 128 may be shaped to promote piercing the air passageway
wall.
[0064] Obstructing member 110 is carried on the support structure
101, and includes a flexible membrane open in the proximal
direction and which may be formed of silicone or polyurethane, for
example. The obstructing member 110 is secured to the central
support structure 109, and may be additionally secured to the
support members at its larger diameter 91. It may be secured by
adhesive, or other manner known in the art. Obstructing member 110
may be loosely carried on support members 102, 104, 106, and 108,
such that it expands on inhalation to form a seal against a wall of
the air passageway, and contracts on exhalation to allow air and
mucociliary transport from the collapsed lung. This provides a
one-way valve function.
[0065] FIG. 6 is a partial section view of the device of FIG. 5
showing additional detail of the support structure. The linear
cross-section view of FIG. 6 exposes the arrangement of support
members 106 and 108 in their deployed configuration. The details of
support members 102 and 104 are omitted from FIG. 6 for clarity,
but are the same as support members 106 and 108. The distal end of
obstructing member 110 is carried on central support structure 109.
Support members 106 and 108 are shown emanating from central
support structure 109, and arranged to loosely support to
obstructing member 110 at its larger diameter 91. This allows
obstructing member 110 to expand on inhalation and seal at the
contact zone 129, and to partially contract on exhalation to allow
exhalation of air and mucociliary transport. In an alternative
embodiment, support members 106 and 108 do not actively support
obstructing member 110, and the expansion and contraction of
obstructing member 110 is governed by its elasticity.
[0066] FIG. 7 is a perspective view of the intra-bronchial device
of FIG. 5 anchored in an air passageway. Intra-bronchial device 100
is illustrated with anchors 112 and 116 piercing into the air
passageway wall 130 of air passageway 50. This anchors the
intra-bronchial device 100 in place.
[0067] Intra-bronchial device 100 is collapsible for insertion into
an internal lumen of a catheter. At least the support members 102,
104, 106, and 108, and the obstructing member 110, may be
collapsed. Intra-bronchial device 100 is inserted into the catheter
lumen, which is typically already placed in the air passageway 50
as generally illustrated in FIG. 3. Using the stylet,
intra-bronchial device 100 is advanced down the catheter lumen into
the air passageway 50 to where the device is to be deployed. Once
the point of deployment is reached, intra-bronchial device 100 is
expelled from the catheter and assumes its deployed shape as
illustrated in FIG. 5. Upon deployment, obstructing member 110
expands to form a contact zone 129 with the wall 130 of the air
passageway 50 to prevent air from being inhaled into the lung
portion to collapse the lung portion. Simultaneously upon
deployment, the memory and resiliency of the support members 102,
104, 106, and 108 impart a force on the anchor ends 122, 124, 126,
and 128, and urge the anchors 112, 114, 116, and 118 to engage air
passageway wall 130 by piercing. The anchors pierce into and become
embedded in the wall 130 of the air passageway 50, preferably
without projecting through the wall 130. Stops may be incorporated
into the anchors to limit piercing of the wall 130. For example,
the bend between the support member and the anchor may form a
stop.
[0068] The preclusion of air from being inhaled into the lung
portion may be terminated by eliminating the obstructing effect of
intra-bronchial device 100. The preclusion of air by the embodiment
illustrated in FIGS. 5-7 may be eliminated by releasing anchors
112, 114, 116, and 118 from the air passageway wall 130. The
anchors may be released by inserting a catheter into air passageway
50 in proximity to intra-bronchial device 100. A retractor device,
such as biopsy forceps, capable of gripping a portion of
intra-bronchial device 100 is inserted in the catheter. The forceps
are used to engage a portion of the support structure 101 of
intra-bronchial device 100, and draw it toward the catheter. The
drawing action releases anchors 112, 114, 116, and 118 from air
passageway wall 130. The intra-bronchial device 110 is then drawn
into the catheter with the forceps, causing the support structure
101 and obstructing member 110 to collapse. The collapsed device
100 now fully enters the catheter lumen for removal from the
patient. Alternatively, the obstructing effect may be eliminated by
grabbing the obstructing member 110, releasing it from the support
structure 101, and removing obstructing member 110 from the
patient.
[0069] FIG. 8 illustrates an intra-bronchial device, with anchors
carried distally on the central support structure, fully deployed
in an air passageway in accordance with an alternative embodiment
of the invention. The anchors 112, 114, 116, and 118 of
intra-bronchial device 140 are carried on portions of support
members 102, 104, 106, and 108 distal of the central support
structure 109. The support members are gathered together and
carried by the central support structure 109. Other than the
anchors 112, 114, 116, and 118 being formed and carried on distal
portions of support members 102, 104, 106, and 108, intra-bronchial
device 140 is substantially similar in construction, operation, and
removal as the intra-bronchial device 100 of FIG. 5.
[0070] When intra-bronchial device 140 is compressed for insertion
into the catheter lumen for placement in the air passageway, the
anchors 112, 114, 116, and 118 are collapsed into a first
configuration. In the first configuration, the anchor ends 122,
124, 126, and 128 are moved toward obstructing member 110, and
anchors 112, 114, 116, and 118 thereby folded toward obstructing
member 110. When intra-bronchial device 100 is deployed from the
catheter lumen, the memory and resiliency of the support members
102, 104, 106, and 108 impart a force that moves the anchors 112,
114, 116, and 118 into a second configuration to engage air
passageway wall 130. This is the deployed configuration illustrated
in FIG. 8. For removal, drawing intra-bronchial device 140 toward
the catheter causes the anchor ends 122, 124, 126, and 128 to move
away from obstructing member 110 to a third configuration. Anchors
112, 114, 116, and 118 are thereby folded away from obstructing
member 110 and are released from engagement with air passageway
wall 130 for removal of the intra-bronchial device 140. In an
alternative embodiment, the anchors 112, 114, 116, and 118 may be
formed on additional support members carried by central support
structure 109, instead of being formed from distal portions of
support members 102, 104, 106, and 108.
[0071] FIGS. 9-11 illustrate an intra-bronchial device, with
proximal anchors carried on the central support structure, in
accordance with an alternative embodiment of the invention. FIG. 9
is a perspective view, FIG. 10 is a side view, and FIG. 11 is an
end view of the device. Intra-bronchial device 150 is generally
similar in construction, operation, placement, and removal to the
intra-bronchial device 100 of FIG. 5. Its structure has six support
members and three anchors, with anchor stops. Anchors 112, 114, and
116 include stops 152, 154, and 156, respectively. Intra-bronchial
device 150 also includes an anchor base 160, an anchor base
aperture 165, anchor base angle 163, and additional support members
103 and 105.
[0072] Central support structure 109 extends both proximal and
distal of obstructing member 110, and carries anchor base 161
proximal of obstructing member 110, carries anchors 112, 114, and
116, and includes anchor base aperture 165. The linear plane of
anchors 112, 114, and 116 intersect anchor base 161 at anchor base
angle 163. Anchor base angle 163 is selected to optimize anchor
deployment force and anchor release. Stops 152, 154, and 156
include a flat area to limit the piercing of the air passageway
wall by anchor ends 122, 124, and 126. In alternative embodiments,
the stops can be any configuration or shape known to those skilled
in the art to limit the piercing.
[0073] In operation, when intra-bronchial device 150 is compressed
for insertion into the catheter lumen for placement in the air
passageway, anchors 112, 114, and 116 are collapsed into a first
configuration. In the first configuration, the anchor ends 122,
124, and 126 are moved toward obstructing member 110, thereby
decreasing anchor base angle 163 and folding anchors 112, 114, and
116 toward obstructing member 110. The anchor ends and the anchors
may be moved by sliding a catheter or hollow member over anchor
base 161 and toward obstructing member 110. When intra-bronchial
device 150 is deployed from the catheter lumen, the memory and
resiliency of the anchors 112, 114, and 116, anchor angle 163, and
anchor base 161 impart a force that moves the anchor members into a
second configuration, which is the deployed configuration, to
engage air passageway wall 130. The second or deployed
configuration is illustrated in FIGS. 9-11. Stops 152, 154, and 156
limit the piercing of the air passageway wall by anchor ends 122,
124, and 126.
[0074] For removal, a retractor device is deployed from a catheter
to engage anchor base 161 and restrain intra-bronchial device 150.
The retractor device may be a biopsy forceps to engage anchor base
161, or a hooked device to engage anchor base aperture 165. A
catheter is then moved distally over anchor base 161, and in
contact with anchors 112, 114, and 116. The catheter is further
moved against anchors 112, 114, and 116, while intra-bronchial
device 150 is restrained at anchor base 161. This releases the
anchors 112, 114, and 116 from the air passageway wall. This
collapses the anchors into to the first configuration for removal.
Intra-bronchial device 150 is then further drawn into the catheter
by pulling on the retractor device used to engage anchor base 161.
This collapses support structure 101 and obstructing member 110 so
that they may be fully drawn into the catheter. Once drawn into the
catheter, intra-bronchial device 160 may be removed from the air
passageway and the patient.
[0075] FIGS. 12-14 illustrate an intra-bronchial device, with
distal friction anchors carried on the central support structure,
in accordance with an alternative embodiment of the invention. FIG.
12 is a perspective view, FIG. 13 is a side view, and FIG. 14 is an
end view. Intra-bronchial device 160 is generally similar in
construction, placement, and operation to the intra-bronchial
device 150 of FIGS. 9-11. Intra-bronchial device 160 is removed in
the manner described in conjunction with FIG. 7. However,
Intra-bronchial device 160 differs from intra-bronchial device 150
in that the structure includes four distal anchors with anchor ends
122, 124, 126, and 128 shaped into pads that deform and
frictionally engage the air passageway wall to more positively
anchor intra-bronchial device 160 without piercing. The structure
also includes an obstructing member support base 170.
[0076] Central support structure 109 extends distal of obstructing
member 110, and carries anchor base 161 distal of obstructing
member 110. Anchor base 161 carries anchors 112, 114, 116, and 118.
The linear plane of anchors 112, 114, 116, and 118 intersects
anchor base 161 at anchor angle 163. Anchor angle 163 is selected
to optimize anchor deployment force and anchor release. The anchors
112, 114, 116, and 118, and anchor base 161 may be constructed by
laser cutting a single piece of hypodermic tubing lengthwise to
form the anchors 112, 114, 116, and 118, and then bending the
anchors to form anchor angle 163. Anchor base 161 is secured to
central support structure 109. Support members 102, 103, 104, 105,
106, and 108, and the obstructing member support member base 170
may be constructed in a like manner. Obstructing member 110 is
secured to the obstructing member support base 170, and
alternatively to support members 102, 103, 104, 105, 106, and 108.
The assembly of obstructing member 110 and support base 170 is
secured to central support structure 109. Central support structure
109 may extend proximal of support member base 170 to provide a
surface for gripping the intra-bronchial device 160 for removal,
and may include an aperture to be engaged by a hooked device.
[0077] FIG. 15 is a perspective view an intra-bronchial device
similar to that of FIGS. 12-14 anchored in an air passageway. It
illustrates pad-shaped anchor ends 122-128 of intra-bronchial
device 180 deforming and frictionally engaging air passageway wall
130.
[0078] FIGS. 16 and 17 illustrate a removable intra-bronchial
device with proximal anchors carried on a peripheral portion of a
plurality of support structure members in accord with the present
invention. FIG. 16 is a perspective view, as the device would
appear when fully deployed in an air passageway. FIG. 17 is a side
view of FIG. 16. In a preferred embodiment, the support structure
101 of intra-bronchial device 190 includes six support members,
with two opposing pairs of support members carrying anchors and
each member of a pair being joined together by a retracting member.
Intra-bronchial device 190 includes a support structure 101 having
a central support structure 109 and support members 102, 103, 104,
105, 106, and 108; four anchors 113, 114, 116, and 118 having
anchor ends 123, 124, 126, and 128, respectively; two "U" shaped
retracting members 192 and 194 having an apex 193 and 195,
respectively; and obstructing member 110.
[0079] Intra-bronchial device 190 is generally similar in
construction, operation, placement, and removal to the
intra-bronchial device 150 of FIG. 9. Support structure 101 is a
tubular member, preferably hypodermic needle tubing, or stainless
steel, Nitinol, or other suitable material having a memory of its
original shape and resiliency to return the material to that shape.
Support members 102, 103, 104, 105, 106, and 108, and central
support structure 109 may be formed by laser cutting a single piece
of hypodermic needle tubing lengthwise, and bending the support
members to a required shape. Support members 102, 103, 104, 105,
106, and 108 are generally similar to each other. Anchors 113, 114,
116, and 118 are disposed on support members 103, 104, 106, and
108, respectively, in any manner available in the art. Anchors
113-118 are disposed on support members 103, 104, 106, and 108 to
be located proximally of obstructing member 110, and to engage an
air passageway wall when intra-bronchial device 190 is
deployed.
[0080] "U" shaped retracting member 192 is coupled to support
members 103 and 104, and "U" shaped retracting member 194 is
coupled to support members 106 and 108. "U" shaped retracting
members 192 and 194 may be constructed of any material suitable for
use within a patient, and may or may not be resilient as required
by the particular embodiment. When intra-bronchial device 190 is
fully deployed in an air passageway, the "U" shaped retracting
members 192 and 194 are arranged opposite each other, and they
partially overlap, with the apex of one lying within a space
bounded by the "U" shape of the other member. In the deployed
configuration, increasing the distance between apex 193 and apex
195 moves support member pairs 103-104 and 106-108 centrally.
[0081] In operation, when intra-bronchial device 190 is compressed
for insertion into a catheter lumen and placement in an air
passageway, support members 102, 103, 104, 105, 106, and 108 are
collapsed centrally into a first configuration. This causes the
anchor ends 123-124, and 126-128 to move centrally.
[0082] When intra-bronchial device 190 is deployed from the
catheter lumen, the memory and resiliency of the support member
pairs 103,104 and 106,108 impart a force that moves the anchors 113
and 114, and 116 and 118, and their anchor ends 123 and 124, and
126 and 128 into a second configuration, which is the deployed
configuration to engage air passageway wall. In addition,
deployment of intra-bronchial device 190 may include a step of
forcibly decreasing the distance between apexes 193 and 195 to
forcibly move the anchors 113 and 114, and 116 and 118 into
engagement with the wall of the air passageway. While the anchors
113 and 114, and 116 and 118 of this embodiment do not include
stops, the expansive or peripheral movement of the anchors will be
limited by obstructing member 90. This may limit the piercing of
the air passageway wall by anchors 113 and 114, and 116 and
118.
[0083] In an alternative embodiment, support member pairs 103,104
and 106,108 may be compressed for insertion into a catheter lumen
by a device that increases the distance between apex 193 and apex
195. Such a device could be a tool with spreading jaws, or a
tapered member inserted between the apexes. The device could be
left in engagement after insertion into the catheter, and then
withdrawn to allow support member pairs 103-104 and 106-108 to move
apart and engage their anchors into the wall of the air
passageway.
[0084] For removal, a retractor device is deployed from a catheter
lumen to engage apex 193 and 195, and restrain intra-bronchial
device 190. The retractor device may be any device that fits into
the space defined by apexes 193 and 195 when the intra-bronchial
device 190 is in its fully deployed configuration. The retractor
device is used to increase the distance between apexes 193 and 195
until anchors 113-114 and 116-118, and anchor ends 123-124 and
126-128 are released from the air passageway wall. This collapses
the anchors into to the first configuration for removal.
Intra-bronchial device 190 is then further collapsed, and drawn
into the catheter by pulling on the retractor device. This
additionally collapses support structure 101 and obstructing member
110 into the first position so that they may be fully drawn into
the catheter. Once drawn into the catheter, intra-bronchial device
190 may be removed from the air passageway and the patient.
[0085] FIG. 18 is a perspective view of an intra-bronchial device
200 with anchors carried on an obstructing member as the device
would appear when fully deployed in an air passageway, in
accordance with an alternative embodiment of the invention.
Intra-bronchial device 200 includes an obstructing member 90,
anchors 111, 112, 113, 114, 115, 116, 117, and 118 (hereafter
collectively referred to as anchors 111-118), and anchor ends 121,
122, 123, 124, 125, 126, 127, and 128(hereafter collectively
referred to as anchor ends 121-128).
[0086] Obstructing member 90 may be a single piece made from a
collapsible, resilient material, such as silicone, polyurethane,
rubber, or foam, and typically will be collapsible to at least
one-half of its expanded size. In an alternative embodiment,
obstructing member 90 may include multiple pieces, some being of
collapsible material. In a further alternative embodiment,
obstructing member 90 may include a membrane carried by a support
structure such as described in conjunction with FIGS. 5-17.
[0087] Anchors 111-118 comprise material having memory of an
original shape, and resiliency to return the material to that
shape, and typically have a diameter small enough that penetration
through an air passageway wall may not adversely effect a patient.
Anchors 111-118 may be 0.003-inch diameter 316 stainless steel with
a wire spring temper, Nitinol, or other resilient material. Anchor
ends 121-128 may be shaped to promote or control piercing of the
air passageway wall. In an alternative embodiment, the length of
the anchors 111-118 may be limited to allow the anchors 111-118 to
penetrate into but not through the air passageway wall. In the
preferred embodiment illustrated in FIG. 18, the anchors include
four pieces of material pushed through obstructing member 90. The
four pieces would lie in approximately the same cross-sectional
plane, and cross each other at approximately the centerline of
obstructing member 90, with approximately equal portions of the
anchor material projecting from opposite sides of the obstructing
member 90. In this embodiment, for example, anchors 112 and 116
would be opposite portions of a single piece of material. Anchors
111-118 may be secured to control their position. For example, a
centerline opening may be made in obstructing member 90 exposing
the several pieces of anchoring material. The several pieces of
material could them be joined together, or to obstructing member
90, at a location within the centerline opening by an adhesive,
crimping, welding, or other method of mechanically joining
materials known to those in the art.
[0088] In an alternative embodiment, the anchors may be formed by
individual pieces of material. The individual pieces of material
may be coupled to obstructing member 90 either at its periphery, or
within its periphery.
[0089] FIG. 19 is a partial longitudinal sectional view of the
intra-bronchial device of FIG. 18 collapsed and located into a
delivery catheter lumen for placement in an air passageway to
collapse a lung portion associated with the air passageway, in
accordance with the present invention. Intra-bronchial device 200
is generally placed in an air passageway as described in FIGS. 2
and 3.
[0090] More specifically, intra-bronchial device 200 is collapsed
and placed into delivery catheter lumen 70. Obstructing member 90
is collapsed into approximately a cylindrical shape. Anchors
111-118 are collapsed to a position in proximity to or against the
outer periphery of collapsed obstructing member 90. Intra-bronchial
device 200 is inserted into catheter lumen 70, the distal end of
which is typically already placed in the air passageway 50 as
generally illustrated in FIG. 3. Using stylet 92, intra-bronchial
device 200 is advanced through the catheter lumen 70 into the air
passageway to where it is to be deployed. Once the point of
deployment is reached, intra-bronchial device 200 is expelled from
catheter lumen 70, and assumes a deployed shape as illustrated in
FIG. 18.
[0091] FIG. 20 is a perspective view of the intra-bronchial device
of FIG. 18 in its fully deployed and anchored state in an air
passageway, in accordance with the present invention.
Intra-bronchial device 200 is illustrated after having been
expelled from the catheter lumen in substantially the manner
described in conjunction with FIG. 3, and having deployed anchors
112 and 116 by piercing into and through air passageway wall 130 of
air passageway 50. The piercing engages the air passageway wall and
anchors intra-bronchial device 200 within the air passageway
50.
[0092] The resiliency of obstructing member 90 imparts a force to
expand the obstructing member 90 from the collapsed state to a
deployed state. In its deployed state, obstructing member 90 forms
a contact zone 129 with the wall 130 of air passageway 50
preventing air from being inhaled into the lung portion. The
resiliency of the anchor members 111-118 moves them from their
collapsed state illustrated in FIG. 19 to their deployed state. The
resiliency of obstructing member 90 may assist anchor members
111-118 in deployment. In the alternative embodiment where the
length of anchors 111-118 is limited to allow the anchors 111-118
to penetrate into but not through the air passageway wall, the
anchors penetrate the air passageway wall 150 in the manner
illustrated in FIG. 7.
[0093] FIGS. 21-24 are side views showing an embodiment of the
present invention for removing the intra-bronchial device 200 from
air passageway 50. The preclusion of air from being inhaled into
the lung portion may be terminated by eliminating the obstructing
effect of intra-bronchial device 200. The preclusion of air by the
embodiment illustrated in FIG. 18 may be eliminated by releasing
anchors 111-118 from the air passageway wall 130.
[0094] A bronchoscope 74 is placed in proximity to intra-bronchial
device 200 in the air passageway 50. A catheter 70 having an
internal lumen 71 is fed into the bronchoscope 74 and advanced to
the proximal end of the intra-bronchial device 200. A retractor
device, such as biopsy forceps 76, capable of gripping a portion of
intra-bronchial device 200, is inserted in the catheter 70 of the
bronchoscope 74 and advanced to the intra-bronchial device 200. The
jaws of the forceps 76 are used to engage a portion of the
obstructing member 90. The engagement may collapse a portion of
obstructing member 90. The engagement with the obstructing member
90 is maintained and obstructing member 90 is drawn toward the
catheter lumen 71 by the forceps 76. The drawing action releases
anchors 111-118 from air passageway wall 130. The intra-bronchial
device 200 is then drawn into the catheter lumen 71 with the
forceps 76. The collapsed device 200 now fully enters the catheter
lumen 71 for removal from the patient.
[0095] FIG. 25 is a perspective view of an intra-bronchial device
with anchors projecting from a periphery of an obstructing member
as the device would appear when fully deployed, in accordance with
an alternative embodiment of the present invention. The
intra-bronchial device 210 includes support members 102, 104, 106,
and 108; an obstructing member 110; "s" shaped bends 212, 214, 216,
and 218; and anchors 112, 114, 116, and 118.
[0096] The support members 102, 104, 106, and 108 form a support
structure carrying obstructing member 110, and include anchors 112,
114, 116, and 118; and anchor ends 122, 124, 126, and 128,
respectively. The support members 102, 104, 106, and 108 may be
tubular members, and are preferably hypodermic needle tubing.
Support members 102, 104, 106, and 108 form a support structure by
being joined together at a location toward the distal portion of
intra-bronchial device 210. They may be joined by a mechanical
method, such as by crimping, or by other methods such as adhesive
or welding. In an alternative embodiment, two support members may
be formed from a single piece of material by bending it in the
middle. Support members 102, 104, 106, and 108 are generally
similar to each other. The support members are preferably formed of
stainless steel, Nitinol, or other suitable material having a
memory of its original shape, and resiliency to return the material
to that shape.
[0097] Anchors 112, 114, 116, and 118 are extensions of support
members 102, 104, 106, and 108. The anchors are formed by forming
"s" shaped bends 212, 214, 216, and 218 in proximal portions of the
support members. Anchor ends 122, 124, 126, and 128 may be shaped
to promote piercing the air passageway wall.
[0098] The obstructing member 110 is carried on the support
structure formed by support members 102, 104, 106, and 108.
Obstructing member 110 includes a flexible membrane open in the
proximal direction and which may be formed of silicone or
polyurethane, for example. The obstructing member 110 includes
openings 222, 224, 226, and 228 sized to sealingly admit the "s"
shaped bends 212, 214, 216, and 218 of support members 102, 104,
106, and 108, respectively. FIG. 26 illustrates the placement and
securing of the obstructing member 110 to support member 102 at "s"
bend 212. Obstructing member 110 is fitted over the anchor end 122
and anchor 112 at opening 222. Obstructing member 110 engages the
peripheral apex of the "s" shaped bend 212, and thus secures it.
The obstructing member 110 is placed and secured to the other "s"
bends 214, 216, and 218 in a similar manner. Obstructing member 110
may be loosely carried on support members 102, 104, 106, and 108
such that it expands on inhalation to form a seal against a wall of
the air passageway, and contracts on exhalation to allow air and
mucociliary transport from the collapsed lung. This provides a
one-way valve function.
[0099] FIG. 27 is a perspective view of the intra-bronchial device
of FIG. 25 fully deployed and anchored in an air passageway, in
accordance with the present invention. Intra-bronchial device 210
is illustrated after having been expelled from the catheter lumen
in substantially the manner described in conjunction with FIG. 3,
and having deployed anchors 112, 114, 116, and 118 by piercing into
air passageway wall 130 of air passageway 50. The piercing engages
the air passageway wall and anchors intra-bronchial device 210
within the air passageway 50.
[0100] Deploying obstructing member 210 is much like opening an
umbrella. Upon deployment, the memory and resiliency of the support
members 102, 104, 106, and 108, expand obstructing member 210. The
expanded obstructing member 210 forms a contact zone 129 with the
wall 130 of the air passageway 50 to prevent air from being inhaled
into the lung portion to collapse the lung portion. Simultaneously
upon deployment, the memory and resiliency of the support members
102, 104, 106, and 108 impart a force on the anchor ends 122, 124,
126, and 128, and urge the anchors 112, 114, 116, and 118 to engage
air passageway wall 130 by piercing. The anchors pierce into and
become embedded in the wall 130 of the air passageway 50,
preferably without projecting through the wall 130. Stops may be
incorporated into the anchors to limit piercing of the wall 130.
For example, the "s" bends 212, 214, 216, and 218 may form a
stop.
[0101] The preclusion of air from being inhaled into the lung
portion may be terminated by eliminating the obstructing effect of
intra-bronchial device 210. The preclusion of air by the embodiment
illustrated in FIGS. 25-27 may be eliminated by releasing anchors
112, 114, 116, and 118 from the air passageway wall 130. The
anchors are released and the intra-bronchial device 210 is removed
from air passageway 50 in substantially the same manner described
in conjunction with FIGS. 7, and 21-24. The forceps are used to
engage a portion of intra-bronchial device 210, and maneuvered to
release anchors 112, 114, 116, and 118 from the air passageway wall
130. Intra-bronchial device 210 is then drawn into the catheter for
removal from the patient. Alternatively, the obstructing effect may
be eliminated by engaging the obstructing member 210, releasing it
from the support members 102, 104, 106, and 108, and drawing
obstructing member 110 into the catheter for removal from the
patent.
[0102] Although the present invention has been described in
considerable detail with reference to certain preferred
embodiments, other embodiments are possible. Therefore, the spirit
or scope of the appended claims should not be limited to the
description of the embodiments contained herein. It is intended
that the invention resides in the claims hereinafter appended.
* * * * *