U.S. patent application number 16/049946 was filed with the patent office on 2018-12-13 for devices and methods for closure of transvascular or transcameral access ports.
The applicant listed for this patent is THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN, TRANSMURAL SYSTEMS LLC, THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN. Invention is credited to Rany Busold, Robert J. Lederman, Stuart MacDonald, Koosha Rafiee, Nasser Rafiee, Toby Rogers.
Application Number | 20180353163 16/049946 |
Document ID | / |
Family ID | 57774785 |
Filed Date | 2018-12-13 |
United States Patent
Application |
20180353163 |
Kind Code |
A1 |
Rafiee; Nasser ; et
al. |
December 13, 2018 |
DEVICES AND METHODS FOR CLOSURE OF TRANSVASCULAR OR TRANSCAMERAL
ACCESS PORTS
Abstract
The present disclosure provides a variety of prostheses,
delivery systems and techniques to facilitate closure of
transvascular or transcameral access ports. Various embodiments of
prostheses are provided including a plurality of radially
expandable discs that can be filled with material to facilitate
coagulation and to reduce or stop leakage from punctures in vessel
walls.
Inventors: |
Rafiee; Nasser; (Andover,
MA) ; MacDonald; Stuart; (Andover, MA) ;
Lederman; Robert J.; (Chevy Chase, MD) ; Rogers;
Toby; (Bethesda, MD) ; Busold; Rany; (Andover,
MA) ; Rafiee; Koosha; (Andover, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
TRANSMURAL SYSTEMS LLC
THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE SECRETARY,
DEPARTMENT OF HEALTH AND HUMAN |
Andover
Bethesda |
MA
MA |
US
US |
|
|
Family ID: |
57774785 |
Appl. No.: |
16/049946 |
Filed: |
July 31, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15664642 |
Jul 31, 2017 |
10045765 |
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16049946 |
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PCT/US2017/029094 |
Apr 24, 2017 |
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15664642 |
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15277798 |
Sep 27, 2016 |
10058315 |
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15664642 |
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PCT/US2015/022782 |
Mar 26, 2015 |
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15277798 |
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62326710 |
Apr 23, 2016 |
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61971458 |
Mar 27, 2014 |
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62083192 |
Nov 22, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00601
20130101; A61B 2090/376 20160201; A61B 17/12145 20130101; A61B
2017/00991 20130101; A61B 17/12109 20130101; A61B 2017/00597
20130101; A61B 2017/00623 20130101; A61F 2/966 20130101; A61B
17/1215 20130101; A61F 2250/0098 20130101; A61B 17/12122 20130101;
A61B 2017/00964 20130101; A61B 17/12031 20130101; A61B 2017/00243
20130101; A61F 2230/0078 20130101; A61B 2017/00592 20130101; A61B
2017/00575 20130101; A61B 2017/1205 20130101; A61B 2017/00247
20130101; A61B 2090/3966 20160201; A61F 2/90 20130101; A61B
2017/3425 20130101; A61B 17/0057 20130101; A61F 2/0077 20130101;
A61F 2/88 20130101; A61B 2017/00606 20130101; A61B 2017/00557
20130101; A61B 2017/00641 20130101; A61F 2230/0091 20130101 |
International
Class: |
A61B 17/00 20060101
A61B017/00; A61F 2/00 20060101 A61F002/00; A61B 17/12 20060101
A61B017/12; A61F 2/88 20060101 A61F002/88; A61F 2/90 20130101
A61F002/90; A61F 2/966 20130101 A61F002/966 |
Goverment Interests
FEDERALLY-SPONSORED RESEARCH AND DEVELOPMENT
[0004] This invention was made with Government support under
contract no. 268201500012C awarded by the National Institutes of
Health. The U.S. Government has certain rights in the invention.
Claims
1. An implantable prosthesis comprising: a) an inflatable
bioresorbable body having a proximal end and a distal end, the body
being configured to be expanded radially by directing fluid into
the body; and b) at least one radially expandable strut attached to
each of the proximal end and distal end of the body, each of the
struts being configured to expand outwardly to prevent the
prosthesis from being pulled through an anatomical opening into
which it has been inserted.
2. The prosthesis of claim 1, further comprising a coupling located
at the proximal end of the prosthesis configured to be attached to
a delivery system.
3. The prosthesis of claim 1, wherein the coupling is configured to
permit inflation fluid to pass therethrough.
4. The prosthesis of claim 1, wherein the prosthesis defines a
guidewire lumen therethrough.
5. The prosthesis of claim 4, wherein the guidewire lumen defined
in the prosthesis is configured to register with a guidewire lumen
in the delivery system.
6. The prosthesis of claim 5, wherein the struts extend from a
radially central portion of the prosthesis to a radially outer
periphery of the prosthesis.
7. A method, comprising: a) providing a delivery system having a
prosthesis removably attached to a distal end thereof; b)
delivering the delivery system over a guidewire routed to a target
location within a patient's vasculature; c) deploying the
prosthesis at the target location to obstruct a vascular opening to
be sealed; d) detaching the prosthesis from the delivery system; e)
withdrawing the delivery system over the guidewire after the
prosthesis has been detached therefrom; f) advancing the delivery
system toward the target location over the guidewire after the
withdrawing step; g) reattaching the prosthesis to the delivery
system; and h) performing a further step with the prosthesis.
8. The method of claim 7, further comprising partially collapsing
the prosthesis after the deploying step.
9. The method of claim 7, further comprising at least partially
repositioning the prosthesis after the deploying step.
10. The method of claim 7, further comprising at least partially
repositioning the prosthesis after the detaching step.
11. The method of claim 7, further comprising collapsing and
withdrawing the prosthesis into the delivery system.
12. The method of claim 7, further comprising withdrawing the
delivery system with the prosthesis attached thereto over the
guidewire.
13. A method, comprising: a) providing a delivery system having a
prosthesis removably attached to a distal end thereof, the
prosthesis being configured to radially self-expand into at least
two axially spaced discs; b) delivering the delivery system over a
guidewire routed to a target location within a patient's
vasculature; c) deploying a first of said at least two discs
proximate a first side of a first wall of an anatomical structure
next to a vascular opening to be sealed; d) deploying a second of
said at least two discs proximate a second side of the first wall
of the anatomical structure the prosthesis at the target location
to obstruct the vascular opening; e) applying tension to at least
one tether routed through said at least two axially spaced discs to
cause the prosthesis to collapse axially.
14. The method of claim 13, wherein tension is applied to the at
least one tether until leaks through the vascular opening are
stopped.
15. The method of claim 13, further comprising securing the at
least one tether.
16. The method of claim 15, wherein the at least one tether is
secured by tying it off.
17. The method of claim 15, wherein the at least one tether is
secured by applying at least one clip to it.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This patent application is a continuation of U.S. patent
application Ser. No. 15/664,642, filed Jul. 31, 2017, issued as
U.S. Pat. No. 10,045,765 on Jun. 14, 2018, which in turn is a
continuation-in-part of and claims the benefit of priority to
International Application No. PCT/US2017/029094, filed Apr. 24,
2017, which in turn claims benefit of U.S. Provisional Patent
Application Ser. No. 62/326,710 filed Apr. 23, 2016.
[0002] This patent application is a continuation of U.S. patent
application Ser. No. 15/664,642, filed Jul. 31, 2017, which in turn
is a continuation-in-part of and claims the benefit of priority to
International Application No. PCT/US2017/029094, filed Apr. 24,
2017, which in turn is also a continuation-in-part of U.S. patent
application Ser. No. 15/277,798 filed Sep. 27, 2016, which in turn
is a continuation-in-part of and claims the benefit of priority to
International Application No. PCT/US2015/022782, designating the
United States of America, filed Mar. 26, 2015, which in turn claims
the benefit of priority to U.S. Provisional Patent Application Ser.
No. 61/971,458, filed Mar. 27, 2014 and U.S. Provisional Patent
Application Ser. No. 62/083,192, filed Nov. 22, 2014.
[0003] Each of the foregoing patent applications is incorporated by
reference herein in its entirety for any purpose whatsoever.
BACKGROUND
Field of the Disclosure
[0005] The present disclosure relates to a device and method for
transcatheter correction of cardiovascular abnormalities, such as
the delivery of prosthetic valves to the heart. The present
disclosure further relates to implants for closing a caval-aortic
iatrogenic fistula created by the introduction of a transcatheter
device from the inferior vena cava into the abdominal aorta.
Description of Related Art
[0006] Transcatheter procedures have been a milestone advance in
modern medicine. Percutaneous or transthoracic catheters are
advanced through the vascular system or other natural luminal
orifices to effect mechanical remodeling through angioplasty or to
effect occlusion or patency or valvular function through implants
of self-expanding or balloon-expanding occluders, stents, and
valves. These procedures can take the place of surgical repair in
selected patients.
[0007] Percutaneous vascular occluders are limited because usually
they require the operator to forego guidewire access between target
chambers. Recent innovations permit vascular occluders to be
engineered around a central guidewire lumen to enhance safety and
versatility of the occluder procedure.
[0008] Recently, Halabi and colleagues (JACC 2013; 61:1745), and
thereafter Greenbaum and colleagues (Transcatheter therapeutics
conference, San Francisco, 2013) reported a novel procedure to
introduce large vascular devices into the aorta from the adjoining
inferior vena cava. This enabled transcatheter aortic valve
replacement in patients otherwise ineligible because of no surgical
access to the thorax and insufficient iliofemoral artery caliber.
The "caval-aortic" access port, as it is called, was closed using
nitinol occluder devices marketed by St Jude Medical
(Amplatzer.RTM. muscular ventricular septal defect occluder or
Amplatzer.RTM. duct occluder) to close congenital cardiovascular
defects. These devices are inadequately hemostatic, do not allow
uninterrupted guidewire access, and are imperfectly suited for this
application.
[0009] Transcatheter structural left heart procedures are generally
performed through the femoral artery. However, femoral artery
caliber or intravascular disease precludes or complicates vascular
access in a significant minority of candidates for transcatheter
aortic valve replacement or aortic endograft therapy. Moreover, the
most frequent life-threatening complication of TAVR is vascular
complications of large introducer sheaths placed in the femoral
artery. Alternative transcatheter approaches to the heart would
therefore be desirable. The present disclosure provides solutions
for these and other problems as described herein.
SUMMARY OF THE DISCLOSURE
[0010] The purpose and advantages of the present disclosure will be
set forth in and become apparent from the description that follows.
Additional advantages of the disclosed embodiments will be realized
and attained by the methods and systems particularly pointed out in
the written description hereof, as well as from the appended
drawings.
[0011] To achieve these and other advantages and in accordance with
the purpose of the disclosure, as embodied herein, in one aspect,
the disclosure includes embodiments that solve problems of caval
aortic access based on considerable pre-clinical, animal, imaging,
and clinical experience in caval-aortic access. These approaches
differ substantially from the aforementioned prior art.
[0012] In certain embodiments, the problem of variable distance
between aortic and caval access points is solved using a telescopic
design as disclosed herein. The problem of inadequate hemostasis of
aortic and caval access tracts, in some implementations, is solved
using "billowing" nitinol weave to fill the vascular holes and by
using multiple disks to occlude each vascular rent.
[0013] In some implementations, a prosthesis is provided having a
proximal end and a distal end, the prosthesis having a radially
expandable body, the radially expandable body being configured to
expand into at least one distal disc after becoming unconstrained.
The at least one distal disc includes a radially outwardly
extending paddle attached to the at least one distal disc. The
paddle is configured to assume a radial orientation as the at least
one disc expands outwardly radially. The paddle is configured to
extend radially outwardly beyond an outer circumferential perimeter
of the at least one disc. The paddle is preferably configured and
arranged to facilitate confirmation of a location of a hole in a
lumenal wall in which the prosthesis is positioned by helping to
seat the prosthesis in the hole when the prosthesis is attached to
a delivery catheter, and to provide resistance to help prevent the
prosthesis from being pulled through the hole.
[0014] In some implementations, the at least one distal disc is
formed from a braided mesh body formed from a plurality of
filaments that can slide across one another during expansion. The
at least one distal disc defines a volume therein. The prosthesis
can further include a resilient member distinct from the braided
mesh body, the resilient member being attached to a proximal region
and a distal region of the prosthesis along an axis that defines a
central region of the prosthesis. The resilient member is
preferably configured to cause the prosthesis to shorten along the
axis and expand radially when the resilient member is relaxed. The
resilient member and paddle preferably cooperate to prevent the
prosthesis from being pulled through a hole formed in a wall of a
body lumen.
[0015] If desired, the prosthesis can further include at least one
radially expandable proximal disc connected to the resilient
member. The resilient member can cause the at least one radially
expandable proximal disc and a neck region of the prosthesis
separating the discs to both expand radially outwardly when the
resilient member is unconstrained and permitted to shorten axially.
In some embodiments, the prosthesis can further include an outer
annular fabric section extending between and joining the at least
one distal disc and the at least one radially expandable proximal
disc. The outer annular fabric section can be configured to
surround a portion of the resilient member disposed between the at
least one distal disc and the at least one radially expandable
proximal disc. In some implementations, the outer fabric can extend
to the full radial extent of an inwardly facing face of each of
said discs.
[0016] In some implementations, the paddle can include a wire
structural frame that is covered with fabric material that is
configured to enhance tissue ingrowth into the paddle, wherein the
fabric material is disposed at least on a face of the paddle that
faces proximally when deployed so as to face a vessel wall when
implanted to facilitate tissue ingrowth into the paddle. If
desired, the prosthesis can include a material disposed within the
mesh body that is configured to encourage hemostasis when exposed
to blood. The prosthesis can include at least one radiopaque marker
disposed proximate a proximally facing reduced diameter portion of
the at least one distal disc configured to reside in an opening in
a vessel wall that is to be occluded by the prosthesis. The
radiopaque marker can thusly be positioned so as to be located at
the opening in the vessel wall to indicate to a physician that the
prosthesis is positioned correctly within the opening in the vessel
wall, wherein the radiopaque marker is positioned proximate a
surface of a necked down section of the prosthesis that is located
proximally with respect to the at least one distal disc. For
example, the radiopaque marker can be located on a radially
inwardly disposed portion of the paddle.
[0017] In some implementations, the prosthesis can further include
at least one length limiting tether connecting the at least one
braided distal disc to a proximal portion of the prosthesis (such
as to a proximally located disc of the prosthesis), the at least
one length limiting tether is preferably configured and arranged to
prevent the resilient member from stretching beyond a predetermined
length.
[0018] The disclosure further provides embodiments of a system for
delivering prostheses as disclosed herein. An illustrative system
includes an outer tubular sheath having a proximal end and a distal
end and defining a first lumen therethrough along at least a
portion of its length, the distal end of the outer tubular member
being cut at an angle that is oblique with respect to a central
axis defined by the system, and the distal end further including a
radiopaque marker proximate the distal end making the angle at
which the distal end is cut being visible under fluoroscopy to help
reduce canting of the prosthesis during implantation. The system
further includes an intermediate tubular member disposed at least
partially within the first lumen and being slidably disposed with
respect to the outer tubular sheath, the intermediate tubular
member having a proximal end, a distal end, and, a flexible distal
portion configured to be protrudable distally beyond the distal end
of the outer tubular sheath, the intermediate tubular member
defining a second lumen therethrough along at least a part of its
length, the flexibility of distal portion of the intermediate
tubular member being configured and adapted to permit the
intermediate tubular member to be deformed into a reverse curved
geometry with respect to a central axis of a proximal portion of
the delivery system while inside a patient's lumen, wherein the
reverse curved geometry can resemble a question mark. The system
further includes an inner elongate member being disposed at least
partially within the second lumen, the inner elongate member being
slidably disposed with respect to the intermediate tubular member,
the inner elongate member having a proximal end and a distal end
configured to be displaced distally beyond the distal end of the
intermediate tubular member, wherein the inner elongate member is a
tubular member configured to permit a guidewire to pass
therethrough. A distal end of the inner elongate member can be
configured to abut against an inner face of an end region of the
prosthesis to form a guidewire lumen to permit the guidewire
passing through the inner elongate member to pass through a distal
face of the prosthesis. The system can be provided with any
prosthesis disclosed herein, removably mounted on the distal end of
the intermediate tubular member, wherein the prosthesis can be
longitudinally stretched by advancing the inner elongate member
distally with respect to the intermediate tubular member and
against the inner face of the end region of the prosthesis, and
further wherein said longitudinal stretch of said prosthesis causes
the prosthesis to collapse radially inwardly to permit said
prosthesis to be withdrawn into said distal end of said outer
tubular sheath.
[0019] If desired, the resilient member of the prosthesis can be a
coil spring that causes the prosthesis to collapse axially and the
discs to expand radially to prevent the prosthesis from being
pulled axially through an anatomical opening it has been delivered
through after it has been deployed. Preferably, the system is
configured and arranged to cause the paddle of the prosthesis to be
urged against an inner wall of a lumen adjacent an opening in the
lumen in which a portion of the prosthesis is situated to cause the
at least one distal disc to come into parallel alignment with the
inner wall of the lumen and prevent the at least one distal disc
from becoming canted in the lumen when said intermediate tubular
member is bent into the reverse curved geometry.
[0020] The system further provides an axially telescoping
prosthesis that includes a plurality of discrete radially
expandable braided mesh bodies, each of said bodies being formed
from a plurality of filaments that can slide across one another,
each of the braided mesh bodies being configured to self-expand
into at least one disc, each radially expandable braided mesh body
defining a volume therein, the plurality of mesh bodies being
axially displaceable with respect to one another. The prosthesis
further includes a resilient member structurally distinct from the
plurality of discrete mesh bodies and passing through a central
region of the mesh bodies configured and arranged to connect the
plurality of discrete radially expandable braided mesh bodies to
each other, wherein (i) the radially expandable braided mesh bodies
are selectively telescopically displaceable from one another along
a central longitudinal axis of the prosthesis by stretching or
relaxing the resilient member to accommodate differently sized
anatomies, (ii) the resilient member is substantially co-axial with
the central longitudinal axis of the prosthesis, and (iii) the
resilient member is configured to cause the prosthesis to shorten
along the axis and expand radially when the resilient member is
relaxed.
[0021] The prosthesis can further include at least one length
limiting tether attaching the plurality of discrete radially
expandable braided mesh bodies to each other, the at least one
length limiting tether acting to prevent the resilient member from
elongating beyond a predetermined length. If desired, the
prosthesis can further include (i) at least one fabric disc
disposed within each of the radially expandable mesh bodies, and
(ii) a tubular fabric portion attached to at least one of the
fabric discs, the tubular fabric portion extending proximally into
a neck region of the prosthesis. The resilient member can be a coil
spring surrounded by fabric that causes the prosthesis to collapse
axially and the radially expandable braided mesh bodies to expand
radially to prevent the prosthesis from being pulled axially
through an anatomical opening it has been delivered through after
it has been deployed. A neck region of the prosthesis can span
between the radially expandable braided mesh bodies including the
coil spring surrounded by the fabric, and the neck region can
expand radially outwardly when the coil spring is unconstrained to
help achieve hemostasis.
[0022] If desired, the resilient member can be a tension coil
spring. In some implementations, the prosthesis can define a lumen
along its length through both discs along an axial centerline of
the prosthesis. The lumen can be configured and arranged to act as
an adjustable shunt having an adjustable length when the prosthesis
is deployed to connect two lumens. If desired, various prostheses
disclosed herein can be configured to seal at least one hole in one
lumen.
[0023] The disclosure still further provides a prosthesis that
includes a plurality of radially expandable braided mesh bodies
connected by mesh material, each of said bodies being formed from a
plurality of filaments that can slide across one another, each of
the braided mesh bodies being configured to self-expand into at
least one disc, each radially expandable braided mesh body defining
a volume therein. The prosthesis further includes a resilient
member structurally distinct from the mesh material connecting the
plurality of radially expandable braided mesh bodies, the radially
expandable braided mesh bodies being spaced from one another along
a central longitudinal axis of the prosthesis, the resilient member
being substantially co-axial with the central longitudinal axis of
the prosthesis, and the resilient member being configured to cause
the prosthesis to shorten along the axis and for the plurality of
radially expandable braided mesh bodies to expand radially when the
resilient member is relaxed. The prosthesis further includes an
outer fabric covering connecting the plurality of radially
expandable braided mesh bodies, the outer fabric being disposed
outside of the braiding of the plurality of radially expandable
braided mesh bodies.
[0024] In some implementations, the prosthesis can define a lumen
along its length through both discs along an axial centerline of
the prosthesis. The lumen can be configured and arranged to act as
an adjustable shunt having an adjustable length when the prosthesis
is deployed to connect two lumens. The outer fabric can be
annularly shaped and be configured to surround at least a portion
of the resilient member disposed in a neck region of the prosthesis
spanning between the radially expandable braided mesh bodies. The
fabric in the neck region can expand radially outwardly when the
resilient member is unconstrained to facilitate the achievement of
hemostasis.
[0025] In some embodiments, the outer fabric extends between and
connects adjacent faces of the at least one disc formed by each of
the plurality of radially expandable braided mesh bodies. If
desired, the prosthesis can further include interior fabric
disposed within each of the plurality of radially expandable
braided mesh bodies. The interior fabric can be substantially
radially coextensive with each disc formed by each of the radially
expandable braided mesh bodies.
[0026] The disclosure still further provides a prosthesis including
a radially expandable mesh body that is configured to self-expand
into a plurality of discs after becoming radially unconstrained,
the radially expandable mesh body defining a volume therein when
expanded, and at least one tether directed through a distal disc of
said plurality of discs configured to cause the plurality of discs
to collapse together axially when tension is applied to the at
least one tether.
[0027] In some implementations, the radially expandable mesh body
is configured to self-expand into at least two discs connected by a
neck region after becoming radially unconstrained, a first disc of
the two discs being configured to mitigate high pressure leaks in
an artery, and a second disc of the two discs being configured to
mitigate low pressure leaks originating from a vein, and further
wherein the neck region is configured to cooperate with the first
and second discs to prevent leakage from the artery and the vein,
and further wherein applying tension to said at least one tether
also acts to pull at least one of said discs against a vascular
wall to prevent canting of the prosthesis. If desired, at least one
of (i) the radially expandable mesh body and (ii) the at least one
tether can be formed from radiopaque material to permit real time
visualization of installation of the prosthesis and said axial
collapse of said discs under fluoroscopy.
[0028] If desired, the aforementioned prosthesis can further
include a coupling located at the proximal end of the prosthesis
configured to be attached to a delivery system. The coupling can be
configured to permit inflation fluid to pass therethrough.
[0029] In a further embodiment, a prosthesis is provided as
described herein having a mesh body that is configured to
self-expand into at least two discs connected by a neck region
after becoming radially unconstrained. A first disc of the at least
two discs can be configured to mitigate leaks, and a second disc of
the at least two discs can be configured to cause appropriate
positioning of the prosthesis in the presence of cardiovascular
motion. Such a prosthesis can be used, for example, to address high
pressure leaks from an artery or a cardiac chamber. In some
implementations, such a prosthesis can be used to address a
ventricular septal defect (VSD) (i.e., a hole in the heart). This
is a common heart defect that's present at birth (congenital). The
hole occurs in the wall that separates the heart's lower chambers
(septum) and allows blood to pass from the left to the right side
of the heart. The oxygen-rich blood then gets pumped back to the
lungs instead of out to the body, causing the heart to work harder.
The prosthesis can be delivered and deployed into the defect and
deployed, sealing the hole.
[0030] In further embodiments, such a prosthesis can be used for
various transcardiac applications, wherein the second disk assures
retention in position of the prosthesis. For example, such a
prosthesis can be used to seal an access opening through the aortic
arch that is formed for accessing the aortic valve after the valve
is replaced. Similarly, such an approach can be used to seal
openings formed in lumenal or vascular walls such as apical access
procedures for sealing openings formed through the ventricular
wall, for sealing openings formed in a septum (e.g., patent foramen
ovale (PFO)) and the like.
[0031] Unique benefits of the disclosed prosthesis and delivery
system include that the prosthesis can be adjusted, or even removed
after being installed in a vascular opening, for any desired
reason. Thus, in some embodiments, the disclosure provides a method
that includes a delivery system as described herein including a
prosthesis as disclosed herein mounted thereon, delivering the
delivery system over a guidewire routed to a target location, and
fully deploying the prosthesis at the target location to obstruct a
vascular opening to be sealed. The prosthesis can then be detached
from the delivery system. The delivery system can then be withdrawn
over the guidewire after the prosthesis has been detached
therefrom. Then, if desired, the delivery system can be once again
advanced over the guidewire after withdrawing it, and the
prosthesis can be reattached to the delivery system. A further step
can then be performed with the prosthesis including at least one
of: (i) partially collapsing the prosthesis, (ii) repositioning the
prosthesis, and (iii) collapsing and withdrawing the prosthesis
into the delivery system, and removing the delivery system and
prosthesis over the guidewire. The disclosed method is facilitated
by the use of a pushrod (preferably a tubular pushrod) as disclosed
herein.
[0032] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and are intended to provide further explanation of the embodiments
disclosed herein.
[0033] The accompanying drawings, which are incorporated in and
constitute part of this specification, are included to illustrate
and provide a further understanding of the method and system of the
disclosure. Together with the description, the drawings serve to
explain the principles of the disclosed embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0034] The foregoing and other objects, aspects, features, and
advantages of exemplary embodiments will become more apparent and
may be better understood by referring to the following description
taken in conjunction with the accompanying drawings, in which:
[0035] FIGS. 1A-1D depict a distal portion of an illustrative
delivery system for delivery of a prosthesis for closure of
transvascular or transcameral access ports and the prosthesis
itself.
[0036] FIGS. 2A-2D illustrate various aspects of the prosthesis
delivered by the device of FIG. 1.
[0037] FIG. 3A illustrates an embodiment of a further prosthesis in
accordance with the disclosure.
[0038] FIGS. 3B-3C illustrate examples of prior art prostheses.
[0039] FIGS. 4A-4C illustrate a further embodiment of an
implantable device in accordance with the disclosure mounted on the
distal end of a delivery system.
[0040] FIG. 4D illustrates a further embodiment of an implantable
device in accordance with the disclosure.
[0041] FIGS. 5A-5C illustrate a prosthesis mounted on the distal
end of a delivery system, showing articulation of the delivery
cable shaft.
[0042] FIGS. 6A-6C illustrate variations of windings that can be
used to help form the prosthesis.
[0043] FIG. 7 illustrates a portion of a delivery system in
accordance with the disclosure without a prosthesis mounted thereon
and with an outer portion of the system removed.
[0044] FIG. 8 is an illustration of an exemplary embodiments of a
delivery system with a prosthesis mounted thereon.
[0045] FIGS. 9A and 9B illustrate a further adjustable, compliant,
maneuverable, retrievable and repositionable four disc/lobe closure
system.
[0046] FIGS. 10A-10B illustrate a three disc/lobe embodiment
wherein a central disc is located between the aorta and inferior
vena cava.
[0047] FIG. 11A-11B illustrate a four disc and three disc
embodiment of a prosthesis.
[0048] FIG. 12A-12B illustrate the prosthesis in a deployed
condition with the end disc flattened.
[0049] FIG. 13A-13B illustrate the prosthesis in a deployed
condition with the end disc flattened.
[0050] FIG. 14A-14B illustrate the prosthesis and delivery catheter
with tethers running through all four and three prosthesis and into
a guiding sheath of the delivery catheter.
[0051] FIGS. 15A-15B and FIGS. 16A-16B illustrate a complete
deployment of a three disc embodiment from beginning to end.
[0052] FIGS. 17A-22 present further illustrative embodiments of
telescopic closure prostheses in accordance with the disclosure and
method of use thereof.
DETAILED DESCRIPTION
[0053] Reference will now be made in detail to the present
preferred embodiments of the disclosure, examples of which are
illustrated in the accompanying drawings. The method and
corresponding steps of the disclosed embodiments will be described
in conjunction with the detailed description of the system.
[0054] The exemplary embodiments illustrated herein can be used to
more effectively close transvascular or transcameral access
ports.
[0055] For purposes of illustration, and not limitation, as
embodied herein and as illustrated in FIG. 1, a delivery system 200
is provided including prosthesis 100 mounted thereon. An
illustration of a full exemplary system can be seen in each of FIG.
7 and FIG. 8, which are discussed in further detail below.
[0056] As referred to herein, the term "prosthesis" is intended to
refer to a structural element that may or not be resorbable in
whole or in part that can be used to replace a portion of anatomy
and/or to close an opening in anatomy, particularly within the
vasculature of the cardiovascular system. The prosthesis typically
includes an adjustable framework or other body that can be used to
close the openings in vasculature.
[0057] As illustrated, the distal region of the system 200 includes
a distal end of an outer tubular member 124 that can be introduced
through a lumen of a guiding catheter (not shown) that is used to
deliver a prosthesis or perform some other function via a
transvascular or transcameral access port. The distal end of the
outer tubular member 124 is preferably provided with a distal
radiopaque marker 120, such as one made at least in part from
silver, gold, platinum or other radiopaque material, as desired.
The distal tip 122 of the outer tubular member can be cut on a
bevel and be provided with a marker that is aligned with the bevel
near the beveled tip to facilitate guiding the device across the
wall of the inferior vena cava into the aorta, for example. The
bevel may be at any suitable angle, but is preferably offset from a
central axis of the catheter by an angle between about 30 degrees
and about sixty degrees, or any angular increment therebetween of
about one degree. In an illustrative embodiment, the angle can be
about 45 degrees. It has been found that such beveling of the tip
helps to reduce "canting" or undesirable tilting of the implant
during installation as it permits alignment of the bevel and the
wall of the vessel that it engages. It is also desirable in some
embodiments to have a rotational marker that at the distal end of
the prosthesis at a particular rotational position (such as at the
end of the tapered cut at the very end of the outer tubular member)
that can be used to rotationally align the prosthesis when it is
being collapsed and pulled into the distal end of the outer tubular
member. The outer tubular member can be articulable or steerable at
its distal end to facilitate maneuverability of the system.
However, as discussed further below, the intermediate member 118 is
preferably flexible, and can help eliminate the need for a
steerable outer tubular member.
[0058] Outer tubular member 124 may be made from a variety of
materials. For example, the sheath 120 can include a multi-layered
co-extrusion, such as those described in U.S. Pat. No. 6,464,683 to
Samuelson or U.S. Pat. No. 5,538,510 to Fontirroche. Each of the
aforementioned patents is incorporated by reference herein in its
entirety.
[0059] Any surface of various components of the catheters described
herein or portions thereof can be provided with one or more
suitable lubricious coatings to facilitate procedures by reduction
of frictional forces. Such coatings can include, for example,
hydrophobic materials such as Polytetrafluoroethylene ("PTFE") or
silicone oil, or hydrophilic coatings such as Polyvinyl Pyrrolidone
("PVP"). Other coatings are also possible, including, echogenic
materials, radiopaque materials and hydrogels, for example.
[0060] Within the outer tubular member 124 of the delivery system
200 a tubular delivery cable, or intermediate tubular member 118,
is slidably disposed defining therethrough a central lumen along
its length for slidably receiving a pushrod 180 therethrough,
discussed in detail below. A distal region of the intermediate
tubular member 118 can be configured to be of a lower stiffness, or
durometer, than a proximal region of the cable to make it easier to
articulate the distal end of the system, such as embodiments
wherein the outer tubular member 124 have an articulable distal end
or region. As illustrated, the intermediate tubular member 118
terminates in a coupling 116 for attachment to the prosthesis 100.
The illustrated coupling 116 is a female member that receives a
corresponding male coupling portion 114 on the prosthesis 100, but
it will be appreciated that the coupling 116 on the delivery system
can be male and that the coupling on the prosthesis can be female.
In some implementations, a female coupling can be provided on the
prosthesis that is defined by the inside of a coiled member,
discussed in further detail below, that is received by a male
threaded coupling on the delivery system. The coupling may be a
threaded coupling but can also be a twist and lock coupling or the
like.
[0061] As further illustrated in FIGS. 1A-1B, a first exemplary
embodiment of a prosthesis 100 is provided having a proximal end
that connects to the delivery system, and a distal end 104 through
which a guidewire can extend via a guidewire lumen 106. As
illustrated, the prosthesis 100 includes an interior coil tension
spring 101 that is configured to be contracted into a relaxed state
when not being stretched. This results in the prosthesis being in a
shortened, compressed state when relaxed. This is most evident in
FIG. 1C, showing a compressed prosthesis 100 when the tension
spring 101 is in a relaxed, unelongated condition. By stretching
the coil spring, such as by pulling both ends of the prosthesis
apart, the prosthesis takes on a more elongated profile with a
smaller radial profile, such as depicted in FIG. 1A or 2C.
[0062] The coil spring 101 can have a substantially uniform outer
and inner diameter along its length from a proximal end of the
prosthesis to the distal end of the prosthesis. Alternatively, as
illustrated in FIG. 6A, the coil spring 101 can have a first
portion that has a larger diameter than a second portion, wherein
the smaller diameter portion can be directed toward the proximal or
distal end of the prosthesis. As illustrated in FIG. 6B, the coil
spring can have three regions of different diameters, wherein a
central region of the coil spring can have an enlarged diameter
with respect to the diameter of either end portion. The end
portions can be of the same or different diameters. Having an
enlarged central portion can help prevent leakage after the
prosthesis is installed as the coil can urge against the graft
and/or mesh material within the adjustable neck 110 region of the
deployed prosthesis between the lumens to cause the neck to bulge
outwardly against the outer lumen walls to facilitate sealing and
to help prevent leakage. The windings of the coil spring that is
attached to the high pressure disc on the distal end of the
prosthesis can be sized and shaped to prevent the hypotube from
passing out of the distal end of the prosthesis, but to permit the
guidewire to pass through. Similarly, the portion of the coil
spring at the proximal end of the prosthesis that faces the
delivery system can have a coil spring that is configured to be
threaded onto a male end of the intermediate tubular member 118 to
attach the prosthesis to the delivery system.
[0063] It will be appreciated that while a coil spring is primarily
illustrated herein and is preferred, other resilient or elastic
members can be used in place of the coil spring, or the prosthesis
may instead be provided with retractable tethers (discussed in
detail below with respect to FIG. 9 onward). For example, a single
or a loop Elastic band that is attached to the radially expandable
discs can be used, and/or any suitable material that can act as a
tension spring and have a suitably low profile.
[0064] The prosthesis 100 further includes a mesh covering that may
be braided from a variety of materials such as NiTi alloys or
bioresorbable materials. It should be noted that, in some
implementations, the prosthesis can be made from bioresorbable
materials in its entirety. Suitable bioresorbable materials and
techniques for construction can be found, for example, in U.S.
patent application Ser. No. 11/398,363, filed Apr. 4, 2006, and
U.S. patent application Ser. No. 14/461,159, filed Aug. 5, 2014,
each of which is incorporated by reference herein in its entirety
for any purpose whatsoever.
[0065] The mesh covering preferably defines at least one proximal
lobe, or disc 112 and at least one distal lobe, or disc 102 joined
by a narrowed neck 110 region that can be adjustable in radial
dimension so as to permit a custom fit during implantation to
minimize or eliminate leakage from the aorta and IVC. The mesh
covering is joined at each of the proximal and distal ends to the
respective proximal and distal ends of the coil spring. If desired,
the disc 102 can be a high pressure endolumenal disc configured for
placement against an inner arterial wall and disc 112 can be a low
pressure disc configured for placement, for example, against an
inner wall of the inferior vena cava.
[0066] The interior of the mesh can be filled with a woven graft
material 108 and/or an elastomer with a coagulating coating, such
as polyethylene glycol (PEG), or other non-thrombogenic, bio-inert
polymer or polymer precursor.
[0067] For example, as illustrated in FIG. 1D, which presents a
cross section of prosthesis 100, the distal face of the distal lobe
or disc can include a first disc shape graft portion 108a that has
a continuous surface except for a small hole or aperture 108b at
the center thereof for surrounding the distal end of the coil
spring 101 where it meets the mesh to permit the guidewire to pass
through the distal end of the prosthesis. This first disc shaped
portion 108a can be joined about its outer periphery (e.g., by
weaving or stitching) to a second disc shaped portion 108c which
also defines therein a central aperture 108d which may be slightly
larger than 108b to permit passage therethrough of the coil spring
which in turn is sized and shaped to permit passage therethrough of
a pushrod (e.g., a stainless steel or NiTi hypotube, or polymeric
(e.g., PEEK) or composite (e.g., carbon fiber) tubular member) of
the delivery system containing the guidewire (discussed below). A
further tubular graft portion 108e can be attached to and depend in
a proximal direction from the proximal face of second disc shaped
portion 108c to line the neck region of the prosthesis 100 and to
surround the central region of the coil spring 101. If desired,
portion 108e can be stitched at one or more locations to the mesh
structure. In some implementations, the graft material 108 can
still further include a third disc-shaped portion 108f attached to
the proximal end of tubular portion 108e also defining a central
aperture therein 108g for permitting passage of the coil 101. Disc
108f can similarly be joined about its periphery via weaving or
stitching to a fourth, proximal disc 108h defining therein a
central aperture 108i, which in turn surrounds the proximal end of
the spring where it meets the proximal portion of the mesh to seal
around the spring. The outer periphery of the four aforementioned
discs may be stitched to each other and to the mesh to ensure
proper registration of the mesh with the graft material.
[0068] As further illustrated in FIG. 1C, a pushrod 180 is slidably
disposed within the lumen of the intermediate tubular member 118.
The pushrod includes a proximal end attached to an articulable
proximal handle (see e.g., FIGS. 7 and 8) and a distal end that
abuts an inner surface of the distal end portion of the prosthesis
100. Specifically, the distal central opening of prosthesis 100 is
large enough to permit a guidewire to pass therethrough, such as
between 0.010 and 0.060 inches or other suitable diameter.
Preferably, the aperture is small enough for the distal end of the
pushrod 180, which defines a central lumen to slidably house the
guidewire, to not pass through the opening, and instead urge
against the inner distal surface of the prosthesis. Instead, the
distal end of the pushrod (or push tube, as desired), abuts an
inner distal surface of the prosthesis at or near the location of
the opening. For example, the inner distal surface of the
prosthesis can define a shoulder about the opening that the push
rod pushes against, or if desired, the windings of spring 101 can
be such that the most distal windings permit the guidewire to pass
through, but not the push rod/push tube.
[0069] FIG. 2A is a schematic cross sectional representation of the
prosthesis 100 in an extended or longitudinally stretched state
wherein the coil spring 101 is in a stretched condition, and FIG.
2B illustrates the prosthesis in a relaxed condition in situ after
installation gripping both sides of a lumenal passage. FIG. 2C
similarly depicts an outer view of a prototype prosthesis 100 in an
expanded condition wherein the push rod/push tube is urged distally
within the delivery system (not shown) against the distal end of
the prosthesis to cause the coil spring to stretch longitudinally.
FIG. 2D illustrates the same prosthesis in a relaxed condition
after the push rod/push tube is withdrawn. As can be appreciated,
the coil spring 101 forces each of the lobes or discs including the
exterior mesh with graft material inside to flatten and better
contact the wall of the vessel (or chamber, depending on the
application) and thereby better achieve hemostasis.
[0070] FIG. 3 illustrates relative performance between a disclosed
embodiment and prior art embodiment. For example, an exemplary
embodiment having a first disc section constructed as described
above is presented in FIG. 3a. This embodiment resists pull-through
the lumenal or chamber wall because the spring, or elastic member,
is attached to the center of the distal or "high-pressure" disk
(that could be located within an artery, for example), which causes
the distal disk to flatten. Prior art embodiments (FIGS. 3B &
3C), such as Amplatzer Duct Occluder product, does not have such an
elastic member or spring, and therefore assumes an oblong
configuration during the retraction phase of deployment (arrow) and
therefore is susceptible to inadvertent pull-through, which
naturally leads to a potentially dangerous situation for the
patient.
[0071] FIGS. 4A-4C illustrate a further embodiment of a prosthesis
that, in addition to having all of the aforementioned structural
features, additionally include additional elongate radially
oriented struts or "wings" 136, 138 that are attached to the mesh
of the prosthesis at the distal and proximal faces of the
prosthesis, extending from a radially central portion of the
prosthesis to an outer periphery of the prosthesis. These struts
enhance the collapsibility of the prosthesis under the action of
the spring or elastic member. While these wings or struts can be
constructed as loops, they can be made in any desirable or suitable
manner. FIG. 4A illustrates such a prosthesis in a longitudinally
expanded configuration wherein the mesh envelope is stretched
longitudinally over the graft material and spring, whereas FIG. 4B
illustrates the prosthesis in a relaxed condition wherein it can
seal against one or more lumenal walls. FIG. 4C further illustrates
the prosthesis in a fully longitudinally expanded configuration
wherein the push rod/push tube is fully extended causing the
prosthesis to collapse radially inwardly so that it can be inserted
into a delivery sheath. Significantly, this design permits the
device to be retrieved and removed, or removed and repositioned and
reimplanted and moved as desired. In other words, the combination
of the elastic member or spring and delivery system with a push rod
or push tube greatly enhances deliverability and placement of the
prosthesis.
[0072] FIG. 4D illustrates an alternative embodiment of a
prosthesis 140 that includes a main body formed from an inflatable,
preferably bioresorbable material that is configured to seal a
transcameral or transvascular access port, or other anatomical
opening to be sealed. As illustrated, the prosthesis 140 has a
proximal end attached to coupling 114 that in turn is removably
attached to a coupling 116 located at the distal end of the
intermediate tubular member 118. A lumen (not visible) passing
through member 118 can carry fluid therethrough for inflating
prosthesis 140 during delivery. Fluids, such as biodegradable
polymer, resin or saline can be used to inflate prosthesis 140.
[0073] Fluid ports (not visible) can be provided in each of members
114, 116 to facilitate the inflation. Optionally, a guidewire port
106 can additionally be included. Wings 136, 138 can also be
included to hold against the interior surfaces of the aorta and
inferior vena cava, for example, while the inflatable body of the
prosthesis 140 spans the gap between the two vessels and protrudes
slightly into each vessel. The prosthesis 140 can be radially
compressed within the distal end of outer tubular member 124 as
with prosthesis 100. The compressed prosthesis 140 can be delivered
to the site at which it is to be implanted, and the wings 136 can
be deployed inside the aorta, for example, or other first location.
The outer tubular member/sheath 124 can be retracted proximally
thereby exposing the entire prosthesis 140 to the surrounding
anatomy. A fluid actuator (e.g., fluid plunger that is actuated
linearly or rotationally with a rotating handle driving screw) can
then be depressed/actuated causing inflation fluid to be directed
through the delivery system and into the prosthesis 140. The
prosthesis 140 can be inflated to a desired extent to block
leakage, and the wings 138 can be deployed (before, during or after
inflation), causing the prosthesis to be lodged within the desired
location. The wings/struts 136/138 could be wire loops that pass
through the body of prosthesis, or can be mounted on either end of
the prosthesis 140. Wings 136/138 are preferably shaped so they can
be easily collapsed and retrieved into the delivery system.
[0074] If it is desired to move or remove the prosthesis 140, the
fluid can be evacuated from the prosthesis by moving the fluid
actuator in the opposing direction. The prosthesis can then be
repositioned and implanted, or withdrawn into the distal end of
outer tubular member 124, as desired. If desired, a push rod or
push tube can be used to assist in retrievability of the prosthesis
100.
[0075] FIGS. 5A-5C further illustrate an embodiment of the
prosthesis in a collapsed state on a delivery system in various
articulated/steered positions allowing for adapting to the oblique
angle of the device necessary for deployment and final release of
the device.
[0076] FIG. 7 is an end to end illustration of a portion of an
example of delivery system in accordance with the disclosure
without the prosthesis mounted thereon and with the outer tubular
member removed. As can be seen in FIGS. 7 and 8, the device itself,
as well as the outer tubular member, intermediate tubular member,
and push rod or push tube each have proximal end attached to a
handle or control knob and a distal end. The intermediate tubular
member as illustrated in FIG. 7 includes a relatively stiff
proximal portion attached to a back end 150, and a transition
segment 148 that is in turn attached to a distal flexible segment
that terminates in coupling 116.
[0077] As illustrated in FIG. 8, the outer tubular member 124, or
main delivery catheter, includes a back end 160 including a handle
and steering knob configured to articulate the distal end of main
delivery catheter/outer tubular member 124 that is attached to a
proximal tubular region which in turn is connected to a distal
tubular region terminating in beveled tip 122 that preferably also
includes a marker that tracks the bevel to facilitate installation
and reduce canting, or tilting, of the prosthesis during
installation. The actuator 160 can take on a variety of forms, such
as those depicted in U.S. Pat. No. 6,488,694 to Lau and U.S. Pat.
No. 5,906,619 to Olson, the specifications of which are
incorporated herein by reference in their entireties.
[0078] Before the system is introduced into the patient via a
guiding catheter (not shown), the push rod 180 is fully distally
extended to radially collapse the prosthesis, after which the
intermediate tubular member can be withdrawn into the distal end of
the main delivery catheter 124. The intermediate tubular member
118, or delivery cable shaft, thus preferably has variable
stiffness along its length with a softer distal segment allowing
for adapting to the oblique angle of the device necessary for
deployment and final release of the device. If a paddle as
discussed herein is provided on the prosthesis, the paddle, or
other portion of the prosthesis can be radially aligned with
respect to the outer tubular sheath, such as with respect to a
marker, such as a radiopaque marker, provided in a selected
rotational location on (at or near) the end of the outer tubular
sheath.
[0079] However, the present disclosure provides additional
embodiments. For example, if desired, the prosthesis can be
provided with more than two discs or lobes.
[0080] For purposes of illustration, and not limitation, FIGS. 9A
and 9B illustrate a further adjustable, compliant, maneuverable,
retrievable and repositionable four disc/lobe closure system that
resembles the two lobe system discussed above, except that two
additional discs or lobes are provided between the proximal and
distal lobes. While the discs are depicted as being formed from a
NiTi alloy, it will be appreciated that any suitable material can
be used.
[0081] As illustrated in FIGS. 9A and 9B, in an installed
formation, the prosthesis includes a first high pressure or artery
facing disc 16 that is deployed in the aorta, for example. The
caval wall 4 and arterial wall 2 are presented with the prosthesis
mounted therein. A next proximal disc 12 is provided for deployment
against the outer wall of the aorta. A marker band 6 is also
provided to enhance retention of the prosthesis. A third external
caval disc 10 is provided for urging against the exterior of the
inferior vena cava, and a fourth disc 8 is provided to seat within
the IVC. One or more of the four discs can be provided with an
exterior curvature or taper 14 that facilitates sealing, and all
four discs can be formed from a mesh as with embodiment 100. A
spring need not be located within the prosthesis of FIG. 9, but it
can be. Collapsing of the prosthesis can be facilitated with
tethers 62 that run through all four and three prosthesis and into
a guiding sheath 64 of the delivery catheter as illustrated in FIG.
14A-B. As illustrated in FIGS. 16A-B, the tethers can be withdrawn
and pulled and the delivery catheter can be held fast to tighten
the tethers until all leaks are stopped. The tethers can then be
tied off or clipped, and the delivery system can be removed
accordingly.
[0082] FIG. 9A shows the prosthesis after deployment but before the
tethers are cinched, while FIG. 9B shows the tethers after
cinching. FIGS. 10A-B similarly show a three disc/lobe embodiment
wherein a central disc 28 is located between the aorta and inferior
vena cava. The construction is otherwise the same as the embodiment
of FIG. 9, and may be constructed with an interior spring if
desired as with embodiment 100 if desired, and/or can be provided
with tethers as the embodiment of FIGS. 9A-9B. The embodiment of
FIGS. 10A-B may also be provided with a guidewire lumen 30.
[0083] FIG. 11A depicts a four disc embodiment of a prosthesis
wherein a radiopaque and/or elastomer covered neck 36 is provided
between the high pressure disc 38 and the second disc 12, wherein
the elastomer 34 is designed to help prevent leakage. Also visible
are the low pressure caval disc 40 and third disc 10, wherein discs
10, 12 and 40 each have radiopaque markers disposed therebetween.
FIG. 12A shows the prosthesis in a deployed position wherein the
end discs are flattened and the middle discs are not fully
flattened. FIG. 11B similarly provides a three disc version wherein
like reference numbers indicate like structures.
[0084] FIG. 12A illustrates a four disc embodiment in a deployed
condition wherein the caval disc 50 and aortic disc 52 are
compressed and fixed, and the intermediate discs 10, 12 are
expanded to express a taper 14 to facilitate sealing and prevent
leakage. FIG. 12B illustrates a three lobed prosthesis wherein the
caval 52 and aortic 50 discs are fully deployed and flattened, and
further wherein the central disc 28 is deployed to define a tapered
sealing surface 14. FIGS. 13A-B show a further variant of a four
disc embodiment in a semi deployed condition and in a simulated
installed condition in anatomy.
[0085] FIGS. 14A-14B illustrate four and three disc prosthesis
embodiments respectively with tethers 62 routed through them,
wherein the aortic disc 16 is located at a distal end of the
assembly, and a most proximate disc 8 is also provided. The tethers
62 are directed through the prosthesis, and then proximally through
a tubular member, or tether lumen 64, toward the proximal end of
the delivery system 68 through a port and/or handle 66. A handle 70
is further provided that is attached to an elongated member or
closure holding shaft 72 (e.g., tube or rod) that is attached to
the prosthesis via a removable coupling, such as a holding,
releasing and/or retrieval articulating screw with wire lumen.
FIGS. 15-16 show a complete deployment of a three disc embodiment
from beginning to end.
[0086] FIGS. 17-19 present a further illustrative embodiment of a
telescopic closure prosthesis in accordance with the disclosure.
The prosthesis can be delivered using the delivery catheter
described herein above.
[0087] FIGS. 17A-17E illustrate particular structural aspects of
the prosthesis 1700. As illustrated, prosthesis 1700 includes a
distal disc 1702 and a proximal disc 1712 as with preceding
prostheses described herein, connected by a tension coil spring
1701. However, prosthesis 1700 differs quite significantly in
structure from any of the foregoing prostheses described herein. In
pertinent part, although the discs 1702, 1712 are formed of a
braided material, they are not connected by braided material, but
are instead connected by the spring 1701, as well as the
illustrated expansion limiting tethers 1736, 1738, or the disclosed
outer fabric covering. Prosthesis 1700 is presented in a compacted
form, as illustrated in FIG. 17D wherein the tension spring 1701
has fully collapsed the device axially. FIG. 17E, in contrast,
illustrates the prosthesis 1700 in an axially expanded format.
[0088] Disc 1702 is also provided with a further structure, or
"paddle" that extends radially outwardly from the disc 1702 when
deployed that is preferably covered by fabric that is configured to
cause tissue ingrowth therein. The paddle can be attached to the
structure of the inner face of disc 1702 such that its orientation
is parallel to a longitudinal axis of the delivery system when the
prosthesis 1700 is collapsed. Since the paddle is attached to the
planar inner face of disc 1702, it then reorients to being
generally transverse, or even perpendicular, to the longitudinal
axis of the delivery system when deployed. If desired, the paddle
can be attached to any face of the prosthesis 1700, depending on
how it is being delivered. Moreover, multiple paddles can be
provided attached to the same or different discs. In one
embodiment, two paddles are attached to the proximal face of the
distal disc rather than one as illustrated that are positioned at
the same general circumferential location of the disc (next to each
other) or spaced apart from each other, such as by 180 degrees. In
another embodiment, three or more (e.g., four five) paddles are
provided that may be spaced from each other circumferentially
uniformly or non-uniformly.
[0089] The paddle can be a wire frame as depicted and may be
partially or completely covered by synthetic or living tissue or
graft material, or may be uncovered. In the illustrated embodiment,
a polyethylene terephthalate ("PET") fabric is used. Generally,
with respect to prosthesis, fabric provided within the mesh discs
(e.g., 1702) is made from a polyester with a non-stretchable weave,
such as a braided polyester material. The material serves to reduce
or prevent the flow of blood across the disc 1702. The fabric is
preferably between about 0.003 to about 0.004 inches thick, and
more generally can range from about 0.0005 to about 0.010 inches
thick, or any increment therebetween of 0.0001 inches, as
desired.
[0090] The outer fabric that resides over the neck region of the
prosthesis 1700 extending over the proximal face of the disc 1702
and proximally over the neck of the prosthesis, for example, is
preferably a knitted polyester and has conformability to the shape
of the disc. Although this material is knitted and defines pores
therein, it facilitates hemostasis, preferably immediate
hemostasis, when disc 1702 is deployed. The material is also
suitably configured to facilitate tissue ingrowth after
implantation of the prosthesis. The outer fabric is preferably
about 0.009 inches thick, and more generally can range from about
0.002 to about 0.010 inches thick, or any increment therebetween of
0.001 inches, as desired.
[0091] In use, the paddle provides pullout resistance when the
prosthesis is deployed, but also helps a physician locate the hole
in the lumen (e.g., artery) due to the geometry of the paddle and
prosthesis. Specifically, during delivery of the prosthesis,
significant force is exerted by the prosthesis against the inner
arterial wall above the opening through which the prosthesis
extends. The paddle extends upwardly above the opening in the
artery parallel to the direction of the artery (i.e., in the
cranial direction). When the prosthesis is pulled on by the
delivery system, the paddle is urged against the arterial wall
above the hall, and prevents the prosthesis from being pulled out
of the artery, but the paddle also acts as a fulcrum, and causes
the prosthesis to rotate about the tip of the paddle, pulling the
opposing end of the disc into alignment with the vessel wall to
prevent canting, and enhance alignment. This is done in cooperation
of the reverse curve configuration that the intermediate tubular
member of the delivery system can assume, which pulls the
prosthesis "up" and into an orthogonal relationship with the vessel
(e.g., artery).
[0092] As can be appreciated from the figures, distal disc 1702 is
configured for placement in an arterial environment, wherein graft
material is disposed in the disc in a manner similar to the
embodiment of FIG. 1C herein. Specifically, the distal face of the
distal disc 1702 can include a first disc shape graft portion 1708a
that has a continuous surface except for a small hole or aperture
1708b at the center thereof for surrounding the distal end of the
coil spring 1701 where it meets the mesh to permit a guidewire to
pass through the distal end of the prosthesis. This first disc
shaped portion 1708a can be joined about its outer periphery (e.g.,
by weaving or stitching) to a second disc shaped portion 1708c
which also defines therein a central aperture 1708d which may be
slightly larger than 1708b to permit passage therethrough of the
coil spring 1701 which in turn is sized and shaped to permit
passage therethrough of a pushrod (e.g., a stainless steel or NiTi
hypotube, or polymeric (e.g., PEEK) or composite (e.g., carbon
fiber) tubular member) of the delivery system containing the
guidewire, as with the embodiment of FIG. 1. A further tubular
graft portion 1708e can be attached to and depend in a proximal
direction from the proximal face of second disc shaped portion
1708c to line a neck region of the distal disc 1702 and to surround
a portion of the coil spring 1701. In contrast to the embodiment of
FIG. 1, distal disc 1702 of prosthesis 1700 further includes a
concave graft portion 1708f defining an aperture 1708g in a center
thereof to accommodate the coil spring 1701, as well as a distal
floating sleeve or marker band 1732 that is configured to slide
over an outer surface of the coil spring 1701 when the spring
expands, whereas the distal face of disc 1702 is attached at its
central region to the coil spring 1701.
[0093] The graft portions 1708a, 1708c, 1708e, 1708f cooperate with
the exterior surface of the spring 1701 to define an interior
compartment 1709 that can be used for a variety of purposes. For
example, compartment 1709 can be used to include a beneficial
agent, such as a coagulating gel, or other beneficial agent such as
a pharmaceutical compound or other material. The concavity defined
on the distal disc 1702 permits the sleeve 1734 of the proximal
disc to be nested within the mesh of the distal disc, thus
permitting a very compact configuration if needed. Instead of or in
addition to a woven graft material, an elastic polymer and/or a
hydrophilic polymer layer can be sued to enhance closure and
placement of prosthesis 1700, especially in a calcified
fistula.
[0094] Proximal disc 1712 is similar in many respects to disc 112
of the embodiment of FIG. 1, except that it is not attached to the
distal disc 1712 at its distal end, and is instead attached to a
proximal floating sleeve or marker band 1734 that is configured to
slide over an outer surface of spring 1701, as with distal floating
sleeve or marker band 1732. Discs 1702, 1712 are illustrated as
being connected at sleeve/marker bands 1734, 1732 by way of
expansion limiter tethers 1736, 1738. The net result is that when
the prosthesis 1700 is expanded axially as illustrated in FIGS.
17A, 17E, the discs 1702, 1712 maintain a relaxed condition as when
deployed fully until the expansion limiter tethers 1736, 1738 begin
to be placed under tension. When expansion limiter tethers 1736,
1738 are placed under tension, the discs 1702, 1712 will deform by
decreasing in radial dimension, which can be useful when loading
the prosthesis 1700 into a delivery sheath as described herein, or
if it is desired to remove the prosthesis and reposition it in situ
during the procedure. Expansion limiter tethers 1736, 1738 further
act to prevent the coil spring 1701 from being overly stretched or
yielded (e.g., deformed plastically), and can also act to hold the
prosthesis 1700 together in the event that spring 1701
fractures.
[0095] Prosthesis 1700 provided additional advantages as compared
to the other prostheses described above. By virtue of the inner
ends of the discs 1702 and 1712 being able to freely slide over the
coil tension spring 1701 independently of each other, it is
possible to have a truly telescoping prosthesis. This permits the
discs 1702, 1712 to be in an optimal configuration when installed,
yet allow for different distances between the discs 1702, 1712,
thus permitting a prosthesis 1700 of the same design to be used in
multiple patients having larger or smaller distances between
adjacent lumens that incorporate the prosthesis 1700. Further, the
discs 1702, 1712 of prosthesis 1700 can be made in whole or in part
from bioresorbable material metallic or polymeric materials.
[0096] In addition to providing true telescoping ability,
decoupling the discs 1702, 1712 from each other greatly facilitates
articulation of the prosthesis. As seen in FIG. 18, the distal disc
1702 can easily be articulated with respect to the proximal disc
1712, by an angle that is almost 90 degrees (e.g., 60, 70, 80
degrees). If desired, a backend push rod extension limiter 1780,
such as in the form of a bushing over the shaft of the delivery
catheter (FIG. 17F) can be provided to avoid overly stretching the
prosthesis axially.
[0097] The delivery system can be used to collapse discs for
loading, full retrieval even after full deployment and individual
control of discs. For example, as illustrated in FIG. 19A, an
implant is loaded within the delivery system and delivered to a
target site for deployment. The distal disc 1702 is then advanced
from the catheter into an artery, for example, as illustrated in
FIG. 19B. FIG. 19C illustrates the distal aortic disc 1702 fully
deployed, and preparing it to be seated. FIG. 19D illustrates axial
extension of spring 1701, by pushing on pushrod 180. The proximal
venous disc 1712 is then deployed as shown in FIG. 19E. FIG. 19F
illustrates the proximal venous disc 1712 in a fully deployed
condition to be seated. FIG. 19G illustrates releasing the
prosthesis 1700 from the delivery system, which can then be
removed, as illustrated in FIG. 19H. It will be appreciated that
the prosthesis of FIG. 19 is not illustrated as having the paddle
shown in other figures, but a paddle can be provided on the
prosthesis if desired.
[0098] FIG. 20 illustrates further aspects of the prosthesis and
delivery system, showing the advantages of using the paddle
described above that is attached to disc 1702. The prosthesis is
illustrated in FIG. 20A in a deployed condition resting on the
delivery system with a guidewire passing through the central lumen
of the system and out of the distal end. FIG. 20B illustrates the
paddle framework independently of the prosthesis. As illustrated,
the framework can simply be a loop of metallic or other suitable
material that is then attached to the framework of the prosthesis
1700. Markers can be provided along a portion or the entirety of
the paddle structure, or the paddle structure can be formed of
radiopaque material, for example, such as 70% NiTi and 30% platinum
wire, known as "DFT" wire. Moreover, it is preferred to provide a
marker at a radially inward location of the paddle that is distinct
under fluoroscopy, or otherwise at a structural location that
corresponds directly with the upper extremity of the hole in the
lumen (e.g., artery) when the prosthesis is pulled into place. This
is because the marker, under visualization, is visible to the
physician, who will then be informed when the prosthesis is in the
hole (e.g., of the artery), and this even helps the physician
"locate" or confirm, the location of the hole in the lumen. In
short, the marker greatly aids the physician in correctly
positioning the prosthesis in the vessel wall.
[0099] FIG. 20C illustrates prosthesis 1700 in a collapsed
condition with the paddle attached to the disc 1702, and further
wherein the paddle includes graft material attached thereto. FIG.
20D illustrates a proximal-distal view of prosthesis mounted on the
delivery system, illustrating the proximal face of the proximal
disc. FIG. 20E is a side view of the expanded prosthesis
illustrating the positioning of the paddle attached to the distal
disc. FIGS. 20F and 20G further illustrate side views of the
prosthesis 1700 particularly illustrating the placement of graft
fabric material on the inner face of each of the proximal and
distal discs and between the discs such that the graft material
forms a "saddle" shape that presents as a concave projection when
viewed from the side that has a minimum diameter near the middle of
the neck region of the prosthesis 1700 that gradually widens toward
each disc. This shape of the graft material as supported by the
underlying structure of the prosthesis is believed to be
advantageous in providing an effective seal after implantation,
especially with respect to the arterial wall, such as the abdominal
aorta. In some embodiments, the prosthesis 1700 is configured so as
to not provide a complete seal with respect to the proximal disc
that urges against the inner wall of the inferior vena cava (IVC),
for example. In certain instances, complete sealing of the IVC of
the implant may not be desired. This can be the case where it is
desired for the vein to intake blood that is leaked from the
corresponding artery that is being sealed by the distal disc. In
practice, since the vein may not have significant positive
pressure, the need for sealing may be negligible, and it may be
advantageous, in fact, to maintain some degree of fluid
communication between the vein and the space between the vessels
via the hole in the vein as a part of the procedure.
[0100] FIG. 20H illustrates positioning of the delivery system that
can be effected by virtue of the flexible distal portion of
intermediate tubular member 118. The flexibility of distal portion
of intermediate tubular member 118 can be extremely advantageous as
its flexibility permits it to be deformed into a geometry that
permits it to effectively bend about 90 degrees with respect to a
central axis of a proximal portion of the delivery system, as
illustrated in FIG. 20H. Specifically, when implanting the
prosthesis 1700 on the arterial side, the paddle is urged against
the upper (i.e., cranial) wall above the hole in the artery (e.g.,
the abdominal aorta) to prevent the prosthesis 1700 from being
pulled through the hole. However, during this alignment step, the
paddle urging on the upper, inner wall of the artery can
advantageously be used as a fulcrum, or "pivot point" to rotate the
prosthesis into alignment horizontally such that the lower portion
of the distal disc is also pulled against the inner wall of the
artery, below the access hole through which the prosthesis 1700
extends. This movement about the "fulcrum" is effectuated by
exposing the distal, flexible portion of intermediate tubular
member 118 and pushing the delivery system distally into the vein
(e.g., IVC) so that a bowing of the intermediate tubular member 118
occurs to obtain a serpentine configuration that resembles the
shape of a reversed question mark ("?"), as illustrated in FIG. 20
by virtue of the prosthesis 1700 being constrained due to partial
implantation. This maneuvering pulls the proximal face of the
distal disc flush against the arterial wall, completing the
implantation of the distal disc, and thus minimizing arterial
leakage. It can be particularly advantageous to provide a marker at
the base of the paddle where the paddle meets the prosthesis distal
disc, because such a marker, when so positioned, is very useful for
indicating the location of the arterial hole under fluoroscopy
because the marker is thus located at the "fulcrum" or pivot point,
discussed above. Including a fabric on the paddle can provide
additional resistance to pullout of the prosthesis during
implantation as the inner surface of the arterial wall can be rough
due to plaque formation. The fabric of the paddle can urge against
and somewhat adhere to this uneven surface, facilitating
implantation of prosthesis 1700.
[0101] FIGS. 21A-E illustrate various stages of deployment of the
prosthesis with respect to the delivery system. FIG. 21A
illustrates the prosthesis 1700 in a deployed condition with the
paddle extending radially outwardly with respect to the prosthesis.
As illustrated, the distal tip 122 of the outer tubular member can
be cut on a bevel to facilitate guiding the device across the wall
of the inferior vena cava into the aorta, for example. It is also
advantageous to provide a marker band, as illustrated, that is also
in an angle at the beveled end of the distal tip 122. Such a marker
band is very helpful in alignment of the device in use, but it also
informs the user when the distal tip 122 is traversing the walls of
the artery and vein as it is being withdrawn proximally to implant
the prosthesis 1700. The net result is that the beveled end and
marker permits superior alignment that helps reduce tilting, or
canting, of the prosthesis during implantation. This reduced
canting is further aided by the flexibility of the distal end of
member 118.
[0102] FIG. 21B illustrates the prosthesis 1700 in a semi-collapsed
state, showing the rotation of the paddle (at upper right) from a
radial outward orientation toward an axial orientation to match the
orientation of the proximal face of the distal disc. FIG. 21C shows
the prosthesis 1700 partially drawn proximally into the distal tip
122 of the delivery catheter, whereas FIG. 21D shows the prosthesis
fully withdrawn proximally into the delivery catheter. Finally,
FIG. 21E shows the lateral orientation of the delivery system and
prosthesis as it is envisioned in use during the implantation
procedure, with the paddle extending upwardly in an orientation
where it can contact the arterial wall above the access
opening.
[0103] FIG. 22 illustrates placement of the disclosed system in
situ in actual use, wherein the delivery catheter is advanced
through the inferior vena cava, and the guidewire and prosthesis
extend into the abdominal aorta. As illustrated, portion 118 of the
delivery system is permitted to flex into the disclosed reverse
question mark shape, facilitating alignment and placement of the
prosthesis 1700 by rotating the prosthesis about the paddle that is
urged against the arterial wall above the access opening into the
abdominal aorta. Also pointed out are the location of the marker at
the base of the paddle, as well as the marker on the beveled tip
122 of the delivery catheter. As mentioned above, the marker at the
base of the paddle (or other marker that could be provided at that
location in other embodiments of prostheses herein) helps the
physician locate the hole in the vessel wall, and to more
accurately install the prosthesis successfully.
[0104] In further accordance with the disclosure, embodiments are
also provided, but not specifically illustrated, that adds the
tethering features of the embodiments of FIGS. 14-17 to any other
embodiment disclosed herein, including but not limited to the
embodiments of any of FIGS. 1-13, whether or not such embodiments
are constructed with a resilient member or coil spring.
[0105] In further accordance with the disclosure, any prosthesis
disclosed herein can be formed at least in part from a composite
wire. In some embodiments, the composite wire can be drawn filled
wire. For example, the drawn filled wire can include a first
material, and a second material in a different region of the drawn
filled wire that has greater radiopacity than the first material.
The first and second materials can include metallic components
and/or bioresorbable components. If desired, the second material
can be located along a core region of the wire, and first material
can surround or substantially surround the first material. The
first material can include a NiTi alloy, and the second material
can include platinum, for example. Other suitable examples for
making such composite materials can be found in U.S. patent
application Ser. No. 10/524,387, filed Sep. 13, 2004, which is
incorporated by reference herein in its entirety for any purpose
whatsoever.
[0106] The devices disclosed herein can be implanted via the
delivery system in transmural or transcameral applications using
techniques similar to those presented in International Patent
Application No. PCT/US2013/072344, filed Nov. 27, 2013 and
published Feb. 12, 2015 as WO/2015/020682 A1, which is incorporated
by reference herein in its entirety for any purpose whatsoever.
However, the presently disclosed embodiments permit easier
deployment, adjustment, and retrievability by virtue of the elastic
member and pushrod, among other things.
[0107] Thus, an exemplary method for use of any of the devices
herein can be in conjunction with a method of transcatheter
delivery of a device to the cardiovascular system. The method can
include advancing a puncture device through a femoral vein to a
venous crossing site, the venous crossing site being located along
an iliac vein or the inferior vena cava. The method can further
include using the puncture device to puncture a venous wall at the
venous crossing site and then puncture an adjacent arterial wall at
an arterial crossing site. The arterial crossing site is preferably
located along an iliac artery or the abdominal aorta. The method
can further include advancing at least a portion of the puncture
device into the iliac artery or the abdominal aorta, thereby
forming an access tract between the venous crossing site and the
arterial crossing site.
[0108] The method can further include advancing a catheter through
the access tract from the venous crossing site to the arterial
crossing site, and delivering the device into the iliac artery or
the abdominal aorta through the catheter. The device can be a
prosthetic heart valve, aortic endograft, left ventricular assist
device, or cardiopulmonary bypass device among other potential
devices. In some embodiments, the puncture device can be
selectively electrically energized to puncture the venous wall and
the arterial wall. The puncture device can include inner and outer
coaxial members, wherein the inner member comprises a guide wire or
needle that is advanced to initially puncture the venous and
arterial walls, and the outer member can be advanced over the inner
member to enlarge the initial punctures and facilitate introduction
of larger devices through the access tract. A target device can be
advanced through a peripheral artery to adjacent the arterial
crossing site. The target device can be used to guide an operator
in directing the path of the puncture device through the arterial
wall and into the iliac artery or the abdominal aorta.
[0109] After the access tract is formed, a guidewire can be
introduced through the access tract. The catheter can then be
advanced over the guidewire through the access tract into the iliac
artery or the abdominal aorta to deliver the device. After
delivering the device, an occlusion device as described herein can
be delivered over a guidewire into the access tract to close the
access tract. The occlusion device is preferably radially
compressible for transcatheter delivery and radially expandable for
implantation. The occlusion device can include an arterial portion
for placement at the arterial crossing site, a venous portion for
placement at the venous crossing site, and a neck portion for
placement in the access tract. The occlusion device can include a
guidewire channel extending through the venous portion, the neck
portion, and the arterial portion. This portion of the procedure
can be implemented by deploying a delivery catheter as disclosed
herein and advancing it into the artery and deploying a first
portion, such as a lobe or disc, of the prosthesis into the artery,
optionally deploying one or more discs between the artery and vein,
and deploying a disc or lobe into the vein. If the prosthesis
includes a spring as described herein or tethers, the device can be
collapsed by pushing on the push rod to partially collapse the
prosthesis to permit it to be repositioned and redeployed, or fully
collapsed and withdrawn back into the delivery system. The implant
is preferably configured to be implanted across an arteriovenous
fistula or tract connection between an artery and a vein with the
arterial end portion positioned in the artery, wherein the venous
end portion is positioned in the vein, and a neck portion is
positioned in the fistula or tract connection.
[0110] The systems disclosed herein can be used to close congenital
heart defects including atrial septal defect, ventricular septal
defect, persistently patent ductus arteriosus. The system can be
used to closed iatrogenic heart defects including extra-anatomic
vascular access ports from the chest across the wall of the left or
right ventricle into the respective lumen, or from the chest across
the wall of the left or right atrium into the respective lumen,
both to achieve temporary transcatheter access to the heart to
allow therapeutic catheter interventional procedures or
implantation such as mitral valve or tricuspid valve or aortic
valve or pulmonic valve or prosthesis or annuloplasty implantation
or modification or repair of Paravalvular leaks.
[0111] All statements herein reciting principles, aspects, and
embodiments of the invention, as well as specific examples thereof,
are intended to encompass both structural and functional
equivalents thereof. Additionally, it is intended that such
equivalents include both currently known equivalents as well as
equivalents developed in the future, i.e., any elements developed
that perform the same function, regardless of structure.
[0112] The methods and systems of the present disclosure, as
described above and shown in the drawings, provide for improved
techniques for treating lumenal systems of patients. It will be
apparent to those skilled in the art that various modifications and
variations can be made in the devices, methods and systems of the
present disclosure without departing from the spirit or scope of
the disclosure. Thus, it is intended that the present disclosure
include modifications and variations that are within the scope of
the subject disclosure and equivalents.
* * * * *