U.S. patent application number 16/292597 was filed with the patent office on 2019-06-27 for pedal thromboembolic protection device.
The applicant listed for this patent is Furqan Tejani. Invention is credited to Furqan Tejani.
Application Number | 20190192270 16/292597 |
Document ID | / |
Family ID | 57324932 |
Filed Date | 2019-06-27 |
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United States Patent
Application |
20190192270 |
Kind Code |
A1 |
Tejani; Furqan |
June 27, 2019 |
PEDAL THROMBOEMBOLIC PROTECTION DEVICE
Abstract
Disclosed herein are embolism protection devices that may be
deployed in the peripheral arterial system for the collection of
loosened or floating debris, such as embolic material dislodged
during or thrombi formed as a result of a peripheral intervention,
such as an angioplasty, stenting, or atherectomy. The disclosed
embolism protection devices are designed to be inserted distal to
lesion in a lower limb artery via one of the arteries of the foot,
such as the dorsalis pedis, posterior tibialis, or peroneal
(fibular) artery, and they include a compliant mesh portion
supported by a compliant wire support member, and the compliant
mesh portion extends to form or couples to a solid catheter portion
that extends out of the body during use, and that may be coupled to
a stopcock or syringe for removal of debris.
Inventors: |
Tejani; Furqan; (Yonkers,
NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Tejani; Furqan |
Yonkers |
NY |
US |
|
|
Family ID: |
57324932 |
Appl. No.: |
16/292597 |
Filed: |
March 5, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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14716706 |
May 19, 2015 |
10258453 |
|
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16292597 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/011 20200501;
A61F 2230/0067 20130101; A61F 2002/016 20130101; A61F 2/013
20130101; A61F 2/01 20130101 |
International
Class: |
A61F 2/01 20060101
A61F002/01 |
Claims
1. An intravascular embolism protection device comprising: a
compliant mesh portion comprising a funnel shape and having an open
distal end and an apex generally opposite the open distal end, the
compliant mesh portion having a pore size selected to allow blood
to pass therethrough while restricting the passage of potential
emboli; a compliant wire support member comprising a material
having a shape-memory function; the compliant wire support member
being coupled to the compliant mesh portion and biasing the
compliant mesh portion in and open position; a catheter portion
extending from the apex and having a lumen in communication with an
aperture in the apex; wherein the embolism protection device has a
collapsed state wherein the embolism protection device fits within
the lumen of a deployment catheter, and an expanded state wherein
the compliant mesh portion is sized to span the width of an artery
of the foot.
2. The intravascular embolism protection device of claim 1, wherein
the artery of the foot is a dorsalis pedis.
3. The intravascular embolism protection device of claim 1, wherein
the artery of the foot is a posterior tibialis.
4. The intravascular embolism protection device of claim 1, wherein
the artery of the foot is a peroneal (fibular) artery.
5. The intravascular embolism protection device of claim 1, wherein
the embolism protection device has a width dimension in the
expanded state of about 3-7 mm.
6. The intravascular embolism protection device of claim 1, wherein
the mesh material has a pore size of about 80-100 mm.
7. The intravascular embolism protection device of claim 1, wherein
the mesh material has a pore size of about 100 mm.
8. The intravascular embolism protection device of claim 1, wherein
the catheter portion has a proximal end and a distal end, wherein
the distal end comprises a coupling element.
9. The intravascular embolism protection device of claim 1, wherein
coupling element is a threaded coupler.
10. The intravascular embolism protection device of claim 1,
wherein coupling element is a Luer-lock coupler.
11. A kit for preventing embolisms during a peripheral artery
intervention, the kit comprising: a deployment catheter having a
proximal end and a distal end and being sized to be inserted into
an artery of the foot; an intravascular embolism protection device
comprising: a compliant mesh portion comprising a funnel shape and
having an open distal end and an apex generally opposite the open
distal end, the compliant mesh portion having a pore size selected
to allow blood to pass therethrough while restricting the passage
of potential emboli; a compliant wire support member comprising a
material having a shape-memory function; the compliant wire support
member being coupled to the compliant mesh portion and biasing the
compliant mesh portion in and open position; a catheter portion
extending from the apex and having a lumen in communication with an
aperture in the apex; wherein the embolism protection device has a
collapsed state wherein the embolism protection device fits within
the lumen of a deployment catheter, and an expanded state wherein
the compliant mesh portion is sized to span the width of an artery
of the foot; and a debris removal device configured to couple to a
distal end of the catheter portion.
12. The kit of claim 11, wherein the debris removal device
comprises a stopcock.
13. The kit of claim 11, wherein the debris removal device
comprises a syringe.
14. A method of protecting a subject from embolism during a
peripheral artery procedure, comprising: advancing a guidewire
through the vasculature of the subject through a puncture site in
an artery of a foot; advancing a catheter and an embolism
protection device compressed within the catheter along the
guidewire to a position adjacent a peripheral arterial lesion, the
catheter having a proximal end and a distal end; wherein the
embolism protection device comprises: a compliant mesh portion
comprising a funnel shape and having an open distal end and an apex
generally opposite the open distal end, the compliant mesh portion
having a pore size selected to allow blood to pass therethrough
while restricting the passage of potential emboli; a compliant wire
support member comprising a material having a shape-memory
function; the compliant wire support member being coupled to the
compliant mesh portion and biasing the compliant mesh portion in
and open position; a catheter portion extending from the apex and
having a lumen in communication with an aperture in the apex;
wherein the embolism protection device has a collapsed state
wherein the embolism protection device fits within the lumen of a
deployment catheter, and an expanded state wherein the compliant
mesh portion is sized to span the width of an artery of the foot;
withdrawing the catheter through the puncture site in the artery of
the foot, thereby allowing the embolism protection device to
self-expand; performing the peripheral artery procedure; and
removing the embolism protection device from the vasculature of the
subject.
15. The method of claim 14, wherein the artery of the foot is a
dorsalis pedis, a posterior tibialis, or a peroneal (fibular)
artery.
16. The method of claim 14, wherein the steps of (1) advancing a
catheter along the guidewire to a position adjacent a peripheral
arterial lesion; and (2) advancing an embolism protection device
compressed within the catheter occur simultaneously.
17. The method of claim 14, wherein the steps of (1) advancing a
catheter along the guidewire to a position adjacent a peripheral
arterial lesion; and (2) advancing an embolism protection device
compressed within the catheter occur sequentially.
18. The method of claim 14, wherein the method further comprises
coupling an evacuation device to a distal end of the catheter
portion of the embolism protection device.
19. The method of claim 18, wherein the method further comprises
using the evacuation device to remove debris from the embolism
protection device.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The application is a continuation of U.S. patent application
Ser. No. 14/716,706, filed May 19, 2015, entitled "PEDAL
THROMBOEMBOLIC PROTECTION DEVICE," the entire disclosure of which
is incorporated by reference.
TECHNICAL FIELD
[0002] Embodiments relate to a thromboembolic protection device
that prevents the free flow of embolism-creating particles that are
created during peripheral vascular interventions.
BACKGROUND
[0003] Peripheral artery disease (PAD) includes stenosis and
occlusion of upper- or lower-extremity arteries due to
atherosclerotic or thromboembolic disease. PAD represents a
spectrum of disease severity, encompassing both asymptomatic and
symptomatic disease. In PAD, as blood vessels narrow, arterial flow
into the extremities worsens, and symptoms may manifest either as
classic intermittent claudication (IC) or as atypical claudication
or leg discomfort. As the disease progresses, patients may develop
more severe claudication, with reduced walking distance and
eventually with rest pain. In 5 to 10 percent of cases,
claudication progresses to a worsened severity of the disease,
called critical limb ischemia (CLI)--defined as ischemic rest pain
for more than 14 days, ulceration, or tissue loss/gangrene.
Patients with CLI have a mortality of 25 percent at one year.
[0004] Multiple types of interventions are used for
revascularization in patients with PAD, including open surgery,
angioplasty (e.g., cryoplasty or angioplasty with drug-coated,
cutting, or standard angioplasty balloons), stenting (e.g., with
self-expanding or balloon-expandable stents are available), and
atherectomy (e.g., using laser, directional, orbital, or rotational
atherectomy devices). With improvements in endovascular techniques
and equipment, the use of balloon angioplasty, stenting, and
atherectomy has led to application of endovascular
revascularization to a wider range of patients, both among those
with more severe symptoms and those with less severe symptoms.
However, such interventions frequently involve first traversing a
stenosis with a wire, catheter, or treatment device, which poses a
risk of embolizing debris even prior to the intervention
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] Embodiments will be readily understood by the following
detailed description in conjunction with the accompanying drawings.
Embodiments are illustrated by way of example and not by way of
limitation in the figures of the accompanying drawings.
[0006] FIGS. 1A and 1B illustrate an example of an embolism
protection device in an expanded state, shown in a perspective view
(FIG. 1A) and a partial cutaway view (FIG. 1B);
[0007] FIGS. 2A and 2B include an exploded view (FIG. 2A) and a
cross-sectional view (FIG. 2B) illustrating how the embolism
protection device shown in FIGS. 1A and 1B may be maintained in a
compressed state inside a deployment catheter;
[0008] FIG. 3 illustrates the embolism protection device shown in
FIGS. 1A and 1B in the process of being deployed from the
deployment catheter;
[0009] FIGS. 4A and 4B illustrate the major arteries of the foot
(FIG. 4A) and an example of a method of using the embolism
protection device of FIGS. 1A and 1B in the dorsalis pedis artery
during an intervention on a CTO upstream of the device (FIG.
4B);
[0010] FIG. 5 illustrates an example of using the embolism
protection device of FIGS. 1A and 1B in the popliteal artery;
and
[0011] FIGS. 6A and 6B illustrate an example of an embolism
protection device having a plurality of longitudinal compliant
support members shown in the closed (FIG. 6A) and open (FIG. 6B)
positions, all in accordance with various embodiments.
DETAILED DESCRIPTION OF DISCLOSED EMBODIMENTS
[0012] In the following detailed description, reference is made to
the accompanying drawings which form a part hereof, and in which
are shown by way of illustration embodiments that may be practiced.
It is to be understood that other embodiments may be utilized and
structural or logical changes may be made without departing from
the scope. Therefore, the following detailed description is not to
be taken in a limiting sense, and the scope of embodiments is
defined by the appended claims and their equivalents.
[0013] Various operations may be described as multiple discrete
operations in turn, in a manner that may be helpful in
understanding embodiments; however, the order of description should
not be construed to imply that these operations are order
dependent.
[0014] The description may use perspective-based descriptions such
as up/down, back/front, and top/bottom. Such descriptions are
merely used to facilitate the discussion and are not intended to
restrict the application of disclosed embodiments.
[0015] The terms "coupled" and "connected," along with their
derivatives, may be used. It should be understood that these terms
are not intended as synonyms for each other. Rather, in particular
embodiments, "connected" may be used to indicate that two or more
elements are in direct physical or electrical contact with each
other. "Coupled" may mean that two or more elements are in direct
physical or electrical contact. However, "coupled" may also mean
that two or more elements are not in direct contact with each
other, but yet still cooperate or interact with each other.
[0016] For the purposes of the description, a phrase in the form
"A/B" or in the form "A and/or B" means (A), (B), or (A and B). For
the purposes of the description, a phrase in the form "at least one
of A, B, and C" means (A), (B), (C), (A and B), (A and C), (B and
C), or (A, B and C). For the purposes of the description, a phrase
in the form "(A)B" means (B) or (AB) that is, A is an optional
element.
[0017] The description may use the terms "embodiment" or
"embodiments," which may each refer to one or more of the same or
different embodiments. Furthermore, the terms "comprising,"
"including," "having," and the like, as used with respect to
embodiments, are synonymous.
[0018] Embodiments herein provide embolism protection devices that
may be deployed in the peripheral arterial system for the
collection of loosened or floating debris, such as embolic material
dislodged during or thrombi formed as a result of a peripheral
intervention, such as an angioplasty, stenting, or atherectomy.
Prior to the present disclosure, most of the filters used to
prevent embolism during or after peripheral interventions were
devices that were advanced through the vasculature from above
(e.g., proximal to) the lesion, and deployed into the anatomy
distal to the lesion. During this process, the filter and the wire
had to traverse the lesion in order to be placed, which created a
risk of embolization even prior to the intervention.
[0019] By contrast, various embodiments disclosed herein are
embolism protection devices that are designed to be inserted distal
to lesion in a lower limb artery via one of the arteries of the
foot, such as the dorsalis pedis, posterior tibialis, or peroneal
(fibular) artery. In various embodiments, this approach may obviate
the problem of needing to traverse lesions to place a filter
device, and it therefore may avoid the risk of dislodging the
detritus that could cause an embolism.
[0020] Once positioned, the embolism protection device may be
allowed to open such that it filters the blood and excludes any
plaques, thrombi, or other emboli that may be dislodged, for
example due to mechanical and drag forces exerted upon them as
devices traverse the area of plaque or stenosis. Thus, in various
embodiments, the device may prevent atherosclerotic material and
other debris from entering the circulation, and may protect the
subject from embolism associated with peripheral interventions.
[0021] An embolus can be any particle comprising a foreign or
native material that enters the vascular system with potential to
cause occlusion of blood flow. Emboli can be formed from aggregated
fibrin, red blood cells, collagen, cholesterol, plaque, fat,
calcified plaque, bubbles, arterial tissue, and/or other
miscellaneous fragments. Each dislodged fragment, or embolus, is
carried along by the blood flow until it becomes lodged or trapped
in a smaller vessel and occludes blood flow, creating an embolism.
Since emboli reduce or cut off blood flow, damage to the body may
result, such as tissue damage.
[0022] In various embodiments, the embolism protection device may
have a first (distal) portion formed from a thin, compliant mesh
material having a pore size that is sufficiently large to allow
blood to flow freely therethrough, but that is sufficiently small
to prevent potential thrombi and emboli from passing through. In
various embodiments, the thin, compliant mesh material may be made
from Nitinol.TM., and in some embodiments, it may have a slippery
surface to ease the insertion of the device into the vascular
system. In various embodiments, the compliant mesh material may be
supported by a compliant wire support member that may be formed
from a material having a shape memory function, such as Nitinol.TM.
wire. In various embodiments, the compliant wire support member may
be coupled to or otherwise configured to stabilize and/or stretch
the compliant mesh material. In some embodiments, the compliant
wire support member may be biased to adopt an open configuration
(e.g., having a larger diameter in the open state than in the
closed state), and may be sized and shaped to secure or stretch or
open the compliant mesh material to abut the full circumference of
an arterial wall.
[0023] In various embodiments, the compliant mesh material and
compliant wire support member also may be compressed or collapsed
to adopt a very small outer circumference and/or outer diameter,
for instance by being inserted into the lumen of a small diameter
deployment catheter, such that the collapsed embolism protection
device may be advanced to a desired part of the peripheral arterial
system.
[0024] In some embodiments, the compliant mesh filter portion of
the embolism protection device may be generally conical or
cup-shaped, and the apex of the cone or cup may have an opening
that extends to form (or couples to) a slender, solid-walled
catheter portion having a lumen extending therethrough. In some
embodiments, the aperture in the apex of the cone or cup shaped
mesh filter portion may communicate with the lumen of the catheter
portion, for example, so that debris captured in the mesh filter
may be evacuated from the body via the catheter portion. In some
embodiments, the proximal end of the catheter portion (e.g.,
nearest the physician and outside the body) may include a threaded
or Luer-lock coupling mechanism, for example for coupling to a
syringe or stopcock. In some embodiments, the syringe or stopcock
may be used to draw debris captured by the embolism protection
device through the catheter portion and out of the body.
[0025] In various embodiments, in order to place the embolism
protection device, access is gained with a needle in one of the
arteries of the foot, such as the dorsalis pedis, posterior
tibialis, or peroneal (fibular) artery, and a small wire, such as a
0.014 inch wire, is inserted into the artery and advanced to a
position distal to the lesion. In various embodiments, the needle
is then withdrawn, leaving the wire in place. The embolism
protection device may then be advanced (in a compressed state
inside a deployment catheter) over the wire. In various
embodiments, the wire may be withdrawn once the filter is in place,
and before the embolism protection device is unsheathed.
[0026] In various embodiments, once the embolism protection device
has been placed in an appropriate position, the deployment catheter
may be slowly withdrawn, unsheathing the device progressively until
the device is fully unsheathed. In various embodiments, unsheathing
the embolism protection device may allow the compliant wire support
member to fully open the compliant mesh portion abut against the
walls of the artery, thus preventing any debris from passing beyond
that point. In various embodiments, the compliant mesh portion and
the compliant wire support member are positioned entirely within
the artery, while the catheter portion extends out of the body.
[0027] In various embodiments, a stopcock or syringe may be coupled
to the outside (proximal) portion of the device to cause
hemostasis, and in various embodiments, the stopcock may can be
opened periodically or the syringe used to withdraw blood and
debris to keep the filter clear of debris. In various embodiments,
upon completion of the procedure, the embolism protection device
may be simply pulled out in its expanded state because, due to the
low profile and pliable material of the device, the injury
potential is very low. Alternatively, in various embodiments,
theembolism protection device may be resheathed and the device
withdrawn in its compressed state.
[0028] In various embodiments, the mesh material of the compliant
mesh portion may have a pore size that is sized to allow vessel
perfusion (e.g., that allows the passage of red blood cells), while
still preventing potential emboli (e.g., atherothrombotic debris)
from passing. In various embodiments, the embolism protection
device may have an elongated shape, with a total length of about
10-15 cm, and an expanded width of about 3-7 mm.
[0029] FIGS. 1A and 1B illustrate an example of an embolism
protection device in an expanded state, shown in a perspective view
(FIG. 1A) and a partial cutaway view (FIG. 1B), in accordance with
various embodiments. As shown in FIG. 1A, the embolism protection
device 100 may include a first (distal) portion 102 that may be
formed from a compliant mesh material 104 and a compliant wire
support member 106 that biases the first portion 102 into a funnel
having a generally conical or cup-like shape. In various
embodiments, the first portion 102 may be sized and shaped such
that it may be inserted into an artery of the foot in a compressed
state, and it may be biased such that it naturally assumes a cone
or cup shape when released. In various embodiments, the outer
diameter of the distal portion 102 may be sized and shaped to abut
the walls of the artery when in an open state.
[0030] In various embodiments, the first portion 102 may be formed
from a thin, hydrophilic, compliant mesh material 104 having a pore
size that is sufficiently large to allow red blood cells and other
blood components to flow freely therethrough, but that is
sufficiently small to prevent potential thrombi and emboli from
passing through. For example, in some embodiments, the compliant
mesh material 104 may have a pore size of from about 80 microns to
about 100 microns, or from about 90 microns to about 100 microns.
In various embodiments, a compliant wire support member 106 may be
disposed within or otherwise coupled to the funnel-shaped compliant
mesh material 104, such that it provides support to the compliant
mesh material 104 and helps to support and form the compliant mesh
material 104 in the generally conical or cup shape. In various
embodiments, the compliant wire support member 106 may be formed
from a material having a shape memory function, such as Nitinol.TM.
wire, and may be biased to assume an open configuration.
[0031] As shown in FIG. 1B, the first portion 102 of the embolism
protection device 100 may include an aperture 108 at the apex or
base of the funnel that extends to form (or couples to) a slender,
solid-walled catheter portion 110 having a lumen 111 extending
therethrough. In some embodiments, the aperture 108 in the apex of
the cone or cup shaped first portion 102 may communicate with the
lumen of the catheter portion 110, for example, so that debris
captured in the compliant mesh material 104 may be evacuated from
the body via the catheter portion 110. In some embodiments, the
proximal end of the catheter portion (e.g., the end nearest the
physician and outside the body) may include a threaded or Luer-lock
coupling mechanism 112, for example for coupling to a syringe or
stopcock. In some embodiments, the syringe or stopcock may be used
to draw debris captured by the embolism protection device through
the catheter portion and out of the body.
[0032] FIGS. 2A and 2B include an exploded view (FIG. 2A) and a
cross-sectional view (FIG. 2B) illustrating how the embolism
protection device shown in FIGS. 1A and 1B may be maintained in a
compressed state inside a deployment catheter, in accordance with
various embodiments. In some embodiments, the embolism protection
device 100 may be collapsed when it is inserted into a
narrow-diameter catheter, such as the illustrated
deployment/retrieval catheter 120. As shown in FIG. 2B, in some
embodiments, the catheter portion 110 of the compressed embolism
protection device 100 may extend beyond the proximal end of the
deployment catheter 120, and may be grasped or manipulated by a
user, for example during placement of the device.
[0033] FIG. 3 illustrates the embolism protection device shown in
FIGS. 1A and 1B in the process of being deployed from the
deployment catheter, in accordance with various embodiments. One
the deployment/retrieval catheter 120 has been advanced to a
desired position within the desired artery, such as the dorsalis
pedis, the embolism protection device 100 may be unsheathed and
allowed to expand. In various embodiments, because the compliant
wire support member 106 is biased in an open position, withdrawing
the deployment catheter 120 while leaving the embolism protection
device 100 in place may allow the compliant wire support member 106
to expand the first portion 102 as it is released from the
deployment catheter 120.
[0034] FIGS. 4A and 4B illustrate the major arteries of the foot
(FIG. 4A) and an example of a method of using the embolism
protection device of FIGS. 1A and 1B in the dorsalis pedis artery
during an intervention on a CTO upstream of the device (FIG. 4B),
in accordance with various embodiments. Depending on the location
of the CTO in the subject, and the particular vascular anatomy of
the subject, the embolism protection device 100 may be deployed in
the dorsalis pedis 122 as illustrated in FIG. 4B, or it may be
deployed in the posterior tibialis 124 or peroneal (fibular) artery
126. In various embodiments, any of these arteries may receive the
embolism protection devices disclosed herein, and may be selected
based on proximity to the lesion being treated. As illustrated in
FIG. 4B, once the embolism protection device 100 has been deployed
in a desired artery, the deployment catheter 120 may be withdrawn
to allow the compliant wire support member 106 to expand within the
artery 122, thus abutting and contacting the full circumference of
the arterial wall.
[0035] The intervention may then be performed upstream at the site
of the occlusion via equipment that is advanced from the femoral
artery, and any debris generated from the intervention may be
captured by the compliant mesh material of the embolism protection
device 100. If desired, in some embodiments, any captured debris
may be withdrawn from the body through the embolism protection
device, for example via a syringe 114. Once the intervention is
complete, the embolism protection device 100 may be withdrawn from
the artery 122. In some embodiments, prior to removal, the
deployment catheter 102 may be advanced over the compliant wire
support member 106, thereby collapsing the embolism protection
device 100 prior to removal. In other embodiments, the embolism
protection device 100 may be simply pulled from the artery 122
because, due to its compliant nature, it may be removed
atraumatically even in the expanded state.
[0036] FIG. 5 illustrates another example of using the embolism
protection device of FIGS. 1A and 1B, wherein the embolism
protection device is placed in the popliteal artery. In some
embodiments, it may be advantageous to advance the embolism
protection device 100 further proximally (e.g., further up the leg,
towards the trunk) in order to protect multiple arteries and
arterial branches in the foot and lower leg when the occlusion is
located more praximally, such as in the superficial femoral artery.
In these embodiments, the embolism protection device 100 may be
advanced through one of the arteries of the foot, such as the
dorsalis pedis 122, posterior tibialis 124, or peroneal (fibular)
artery (not shown) until it reaches the popliteal artery 128. Once
it has been positioned in this fashion, the device may be deployed
and used as described above with reference to FIGS. 4A and 4B.
[0037] FIGS. 6A and 6B illustrate an example of an embolism
protection device having a plurality of longitudinal compliant
support members shown in the closed (FIG. 6A) and open (FIG. 6B)
positions, in accordance with various embodiments. In various
embodiments, instead of the spiral-shaped compliant support members
shown in FIGS. 1A and 1B, the embolism protections device 600 may
instead include a plurality of longitudinal compliant support
members 606 that may be biased in an open position (FIG. 6B), such
that they open the first portion 602 of the embolism protection
device 600 when released from the deployment catheter 620,
stretching the compliant mesh 604 into a funnel or inverted
umbrella shape. In some embodiments, the compliant mesh 604 may
include a plurality of longitudinal pleats 630 corresponding to
each of the plurality of longitudinal compliant support members
606, which pleats 630 allow the first portion 602 to compress
tightly and fit within the deployment catheter 620 (FIG. 6A).
[0038] Although certain embodiments have been illustrated and
described herein, it will be appreciated by those of ordinary skill
in the art that a wide variety of alternate and/or equivalent
embodiments or implementations calculated to achieve the same
purposes may be substituted for the embodiments shown and described
without departing from the scope. Those with skill in the art will
readily appreciate that embodiments may be implemented in a very
wide variety of ways. This application is intended to cover any
adaptations or variations of the embodiments discussed herein.
Therefore, it is manifestly intended that embodiments be limited
only by the claims and the equivalents thereof.
* * * * *