U.S. patent application number 16/135466 was filed with the patent office on 2019-03-21 for systems and methods for implanting a prosthetic valve within a native heart valve.
This patent application is currently assigned to CARDIOVALVE LTD.. The applicant listed for this patent is CARDIOVALVE LTD.. Invention is credited to Aviram BAUM, Boaz HARARI, Ilia HARITON, Meni IAMBERGER.
Application Number | 20190083242 16/135466 |
Document ID | / |
Family ID | 65719087 |
Filed Date | 2019-03-21 |
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United States Patent
Application |
20190083242 |
Kind Code |
A1 |
HARITON; Ilia ; et
al. |
March 21, 2019 |
SYSTEMS AND METHODS FOR IMPLANTING A PROSTHETIC VALVE WITHIN A
NATIVE HEART VALVE
Abstract
Prosthetic heart valves and methods of implanting prosthetic
heart valves may be provided, including a method of implanting an
expandable prosthetic valve within a native mitral valve between a
heart atrium and a heart ventricle. The prosthetic valve may be
constrained from expansion during delivery and may include an
annular valve body, a plurality of ventricular anchors, and a
plurality of atrial anchors. The method may include releasing the
plurality of ventricular anchors within the atrium, releasing the
plurality of atrial anchors within the atrium, moving the released
ventricular anchors through the mitral valve and into the
ventricle, and after moving the released ventricular anchors from
the atrium to the ventricle, releasing the annular valve body. As a
result, the prosthetic valve may be anchored within the mitral
valve.
Inventors: |
HARITON; Ilia; (Zichron
Yaackov, IL) ; IAMBERGER; Meni; (Kfar Saba, IL)
; BAUM; Aviram; (Tel Aviv, IL) ; HARARI; Boaz;
(Ganey Tikva, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CARDIOVALVE LTD. |
Or Yehuda |
|
IL |
|
|
Assignee: |
CARDIOVALVE LTD.
|
Family ID: |
65719087 |
Appl. No.: |
16/135466 |
Filed: |
September 19, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62560384 |
Sep 19, 2017 |
|
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|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2250/007 20130101;
A61F 2/2418 20130101; A61F 2220/0008 20130101; A61F 2/246 20130101;
A61F 2/243 20130101; A61F 2/2466 20130101; A61F 2/2436 20130101;
A61F 2/2463 20130101; A61F 2210/0014 20130101; A61F 2/2454
20130101; A61F 2/2427 20130101; A61F 2/2409 20130101; A61F 2/2445
20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. A method of implanting an expandable prosthetic valve within a
native mitral valve between a heart atrium and a heart ventricle,
the prosthetic valve constrained from expansion during delivery and
including an annular valve body, a plurality of ventricular
anchors, and a plurality of atrial anchors, the method comprising:
releasing the plurality of ventricular anchors within the atrium;
releasing the plurality of atrial anchors within the atrium; moving
the released ventricular anchors through the mitral valve and into
the ventricle; and after moving the released ventricular anchors
from the atrium to the ventricle, releasing the annular valve body,
thereby anchoring the prosthetic valve within the mitral valve.
2. The method of claim 1, wherein the annular valve body is
released within the ventricle.
3. The method of claim 1, wherein the ventricular anchors are
released prior to release of the atrial anchors.
4. The method of claim 3, wherein the released ventricular anchors
are moved into the ventricle prior to release of the atrial
anchors.
5. The method of claim 1, wherein the atrial anchors are released
prior to release of the ventricular anchors.
6. The method of claim 1, wherein the annular valve body is
constrained from expansion during release of the ventricular
anchors and atrial anchors and during movement of the ventricular
anchors into the ventricle.
7. The method of claim 1, wherein terminal ends of the ventricular
anchors deflect radially outward relative to the annular valve body
when the ventricular anchors are released.
8. The method of claim 1, wherein terminal ends of the atrial
anchors deflect radially outward relative to the annular valve body
when the atrial anchors are released.
9. The method of claim 1, wherein the annular valve body radially
expands when released.
10. The method of claim 1, wherein release of the annular valve
body causes the ventricular anchors and atrial anchors to clamp
native valve tissue therebetween.
11. The method of claim 1, wherein an axial distance between the
released atrial anchors and the released ventricular anchors is
reduced during release of the annular valve body.
12. The method of claim 1, wherein the ventricular anchors and the
atrial anchors shift radially outward when the annular valve body
is released.
13. The method of claim 1, further comprising: prior to release of
the annular valve body, moving the released ventricular anchors in
an atrial direction such that the ventricular anchors engage tissue
of the native mitral valve.
14. The method of claim 13, wherein the ventricular anchors pull
distinct portions of the native mitral valve together.
15. The method of claim 13, wherein movement of the released
ventricular anchors in the atrial direction occurs prior to release
of the atrial anchors.
16. The method of claim 1, wherein each ventricular anchor includes
a connection point to the annular valve body; and wherein the
connection points of the ventricular anchors form: a first diameter
during movement of the ventricular anchors into the ventricle, and
a second diameter after release of the annular valve body, the
second diameter being larger than the first diameter.
17. A method of implanting an expandable prosthetic valve within a
native mitral valve between an atrium and a ventricle, the method
comprising: outwardly moving terminal ends of ventricular anchors
relative to a portion of an annular valve body positioned within
the atrium; after outwardly moving the terminal ends of the
ventricular anchors, advancing at least a portion of the expandable
prosthetic valve containing the ventricular anchors through the
native mitral valve into the ventricle; outwardly moving terminal
ends of atrial anchors relative to a portion of the annular valve
body while the atrial anchors are at least partially positioned
within the atrium; and after outwardly moving the terminal ends of
the ventricular anchors and outwardly moving the terminal ends of
the atrial anchors, radially expanding the annular valve body,
thereby anchoring native heart valve tissue between the atrial
anchors and ventricular anchors.
18. The method of claim 17, wherein the ventricular anchors and the
atrial anchors are biased to assume expanded configurations and are
constrained in non-expanded configurations, and wherein outwardly
moving the respective terminal ends of the ventricular anchors and
the atrial anchors includes respectively releasing constraints on
the ventricular anchors and the atrial anchors to thereby enable
the ventricular anchors and the atrial anchors to spring
outwardly.
19. The method of claim 17, wherein expanding the annular valve
body includes releasing the annular valve body from a constraint to
thereby enable the annular valve body to expand to a
pre-contraction expanded configuration.
20. The method of claim 17, wherein expanding of the annular valve
body anchors the prosthetic valve within the native mitral
valve.
21. The method of claim 17, wherein the annular valve body is
expanded within the ventricle.
22. The method of claim 17, further comprising: prior to expanding
the annular valve body, advancing the ventricular anchors in an
atrial direction such that the ventricular anchors engage tissue of
the native mitral valve.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims priority from U.S. Provisional
Patent Application No. 62/560,384, filed Sep. 19, 2017, which is
hereby incorporated by reference in its entirety.
TECHNICAL FIELD
[0002] This disclosure relates generally to systems and methods for
implanting prosthetic valves within a native heart valve. More
specifically, this disclosure relates to methods for implanting an
expandable prosthetic valve within a native mitral valve that
include releasing a plurality of ventricular anchors and a
plurality of atrial anchors within an atrium of the heart.
BACKGROUND
[0003] The native heart valves (the tricuspid valve, pulmonary
valve, mitral valve, and aortic valve) play an important role in
regulating flow of blood through the cardiovascular system.
However, the native heart valves may become damaged or impaired due
to, for example, cardiovascular diseases, infections, or congenital
malformations, thus limiting the ability of the native heart valves
to regulate blood flow. This deficiency may result in reduced
cardiovascular function or even death.
[0004] To treat these conditions, prosthetic heart valves may be
implanted at or near the site of a damaged or impaired native
valve. A prosthetic heart valve may assist or replace the
functionality of an impaired native valve, leading to better
regulation of blood flow and improved cardiovascular function.
However, many existing prosthetic heart valves require implantation
via an open heart procedure, which is highly-invasive and may cause
life-threatening complications. Other prosthetic valves may be
collapsed within a prosthetic valve delivery system and advanced
into the heart, at which point the prosthetic valve may be removed
from the delivery system and expanded at the native valve site.
However, many of these prosthetic valves are large in size and
therefore difficult to deliver into the heart without causing
damage to healthy tissue along the implantation route. In addition,
once these prosthetic valves are situated within the heart, they
may be difficult to securely implant at the native valve site due
to their complex structure and the limited maneuverability of
existing prosthetic valve delivery systems within the heart.
Moreover, many prosthetic valves are so large that they may
protrude several centimeters into surrounding heart chambers once
they are implanted, impairing cardiac filling and causing injury to
the anatomy within the heart.
[0005] Thus, there remains a need for prosthetic heart valves that
are smaller in size but that are still configured to assist or
replace the functionality of a diseased or damaged native heart
valve. In addition, there remains a need for prosthetic heart
valves that are more easily maneuvered into the heart and securely
implanted at the site of a native heart valve. Moreover, there
remains a need for improved prosthetic heart valve delivery systems
that are configured to securely implant a prosthetic heart valve at
an implantation site. The present disclosure provides prosthetic
heart valves with a reduced axial length such that the prosthetic
heart valves may be more easily delivered into the heart and may
exhibit less protrusion into the chambers of the heart. The present
disclosure also provides improved prosthetic heart valve delivery
systems and methods of implanting prosthetic heart valves, such
that prosthetic heart valves may be securely anchored at the
implantation site.
SUMMARY
[0006] The present disclosure discloses prosthetic valves for
implantation within a native mitral valve and methods for
implanting prosthetic valves within a native mitral valve.
Particular examples of the disclosure may pertain to a method of
implanting a prosthetic valve within a native mitral valve
including releasing a plurality of ventricular anchors and a
plurality of atrial anchors within an atrium.
[0007] According to an exemplary embodiment of the present
disclosure, a method of implanting an expandable prosthetic valve
within a native mitral valve between a heart atrium and a heart
ventricle is provided. The prosthetic valve is constrained from
expansion during delivery and includes an annular valve body, a
plurality of ventricular anchors, and a plurality of atrial
anchors. The method includes releasing the plurality of ventricular
anchors within the atrium. The method additionally includes
releasing the plurality of atrial anchors within the atrium. The
method additionally includes moving the released ventricular
anchors through the mitral valve and into the ventricle. The method
additionally includes after moving the released ventricular anchors
from the atrium to the ventricle, releasing the annular valve body,
thereby anchoring the prosthetic valve within the mitral valve.
[0008] The annular valve body is released within the ventricle. The
ventricular anchors are released prior to release of the atrial
anchors. The released ventricular anchors are moved into the
ventricle prior to release of the atrial anchors. The atrial
anchors are released prior to release of the ventricular anchors.
The annular valve body is constrained from expansion during release
of the ventricular anchors and atrial anchors and during movement
of the ventricular anchors into the ventricle. Terminal ends of the
ventricular anchors deflect radially outward relative to the
annular valve body when the ventricular anchors are released.
Terminal ends of the atrial anchors deflect radially outward
relative to the annular valve body when the atrial anchors are
released. The annular valve body radially expands when released.
Release of the annular valve body causes the ventricular anchors
and atrial anchors to clamp native valve tissue therebetween. An
axial distance between the released atrial anchors and the released
ventricular anchors is reduced during release of the annular valve
body. The ventricular anchors and the atrial anchors shift radially
outward when the annular valve body is released. The method
additionally includes prior to release of the annular valve body,
moving the released ventricular anchors in an atrial direction such
that the ventricular anchors engage tissue of the native mitral
valve. The ventricular anchors pull distinct portions of the native
mitral valve together. Movement of the released ventricular anchors
in the atrial direction occurs prior to release of the atrial
anchors. Each ventricular anchor includes a connection point to the
annular valve body. The connection points of the ventricular
anchors form a first diameter during movement of the ventricular
anchors into the ventricle, and a second diameter after release of
the annular valve body, the second diameter being larger than the
first diameter.
[0009] According to another exemplary embodiment of the present
disclosure, a method of implanting an expandable prosthetic valve
within a native mitral valve between an atrium and a ventricle is
provided. The method includes outwardly moving terminal ends of
ventricular anchors relative to a portion of an annular valve body
positioned within the atrium. The method additionally includes
after outwardly moving the terminal ends of the ventricular
anchors, advancing at least a portion of the expandable prosthetic
valve containing the ventricular anchors through the native mitral
valve into the ventricle. The method additionally includes
outwardly moving terminal ends of atrial anchors relative to a
portion of the annular valve body while the atrial anchors are at
least partially positioned within the atrium. The method
additionally includes after outwardly moving the terminal ends of
the ventricular anchors and outwardly moving the terminal ends of
the atrial anchors, radially expanding the annular valve body,
thereby anchoring native heart valve tissue between the atrial
anchors and ventricular anchors.
[0010] The ventricular anchors and the atrial anchors are biased to
assume expanded configurations and are constrained in non-expanded
configurations. Outwardly moving the respective terminal ends of
the ventricular anchors and the atrial anchors includes
respectively releasing constraints on the ventricular anchors and
the atrial anchors to thereby enable the ventricular anchors and
the atrial anchors to spring outwardly. Expanding the annular valve
body includes releasing the annular valve body from a constraint to
thereby enable the annular valve body to expand to a
pre-contraction expanded configuration. Expanding of the annular
valve body anchors the prosthetic valve within the native mitral
valve. The annular valve body is expanded within the ventricle. The
method additionally includes prior to expanding the annular valve
body, advancing the ventricular anchors in an atrial direction such
that the ventricular anchors engage tissue of the native mitral
valve.
[0011] Additional features and advantages of the disclosed
embodiments will be set forth in part in the description that
follows, and in part will be obvious from the description, or may
be learned by practice of the disclosed embodiments. The features
and advantages of the disclosed embodiments will be realized and
attained by the elements and combinations particularly pointed out
in the appended claims.
[0012] It is to be understood that both the foregoing general
description and the following detailed description are examples and
explanatory only and are not restrictive of the disclosed
embodiments as claimed.
[0013] The accompanying drawings constitute a part of this
specification. The drawings illustrate several embodiments of the
present disclosure and, together with the description, serve to
explain the principles of the disclosed embodiments as set forth in
the accompanying claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1A illustrates a front elevation view of an exemplary
frame for a prosthetic valve, consistent with various embodiments
of the present disclosure.
[0015] FIG. 1B illustrates a perspective view of the exemplary
frame of FIG. 1A, consistent with various embodiments of the
present disclosure.
[0016] FIG. 2A illustrates a front elevation view of another
exemplary frame for a prosthetic valve, consistent with various
embodiments of the present disclosure.
[0017] FIG. 2B illustrates a top plan view of the exemplary frame
of FIG. 2A, consistent with various embodiments of the present
disclosure.
[0018] FIG. 2C illustrates an enlarged view of an atrial anchoring
arm and a ventricular anchoring leg of the exemplary frame of FIG.
2A, consistent with various embodiments of the present
disclosure.
[0019] FIG. 2D illustrates another front elevation view of the
exemplary frame of FIG. 2A, consistent with various embodiments of
the present disclosure.
[0020] FIG. 2E illustrates another top plan view of the exemplary
frame of FIG. 2A, consistent with various embodiments of the
present disclosure.
[0021] FIG. 3A illustrates a front elevation view of an inner frame
of the exemplary frame of FIG. 2A, consistent with various
embodiments of the present disclosure.
[0022] FIG. 3B illustrates an enlarged view of an atrial anchoring
arm of the exemplary inner frame of FIG. 3A, consistent with
various embodiments of the present disclosure.
[0023] FIG. 3C illustrates a front elevation view of an outer frame
of the exemplary frame of FIG. 2A, consistent with various
embodiments of the present disclosure.
[0024] FIG. 3D illustrates an enlarged view of a ventricular
anchoring leg of the exemplary outer frame of FIG. 3C, consistent
with various embodiments of the present disclosure.
[0025] FIG. 4A illustrates a cross-sectional view of the exemplary
frame of FIG. 2A, consistent with various embodiments of the
present disclosure.
[0026] FIG. 4B illustrates an enlarged view of a volume between an
atrial anchoring arm and a ventricular anchoring leg of the
exemplary frame of FIG. 4A, consistent with various embodiments of
the present disclosure.
[0027] FIGS. 5A-5E illustrate structural changes in the exemplary
frame of FIG. 2A during transitioning of the frame between a
radially-contracted configuration and a radially-expanded
configuration, consistent with various embodiments of the present
disclosure.
[0028] FIG. 6A illustrates a front elevation view of an exemplary
prosthetic valve, consistent with various embodiments of the
present disclosure.
[0029] FIG. 6B illustrates a cross-sectional view of the exemplary
prosthetic valve of FIG. 6A without leaflets, consistent with
various embodiments of the present disclosure.
[0030] FIG. 6C illustrates a cross-sectional view of the exemplary
prosthetic valve of FIG. 6A with leaflets, consistent with various
embodiments of the present disclosure.
[0031] FIG. 6D illustrates a top plan view of the exemplary
prosthetic valve of FIG. 6A with uninflated leaflets, consistent
with various embodiments of the present disclosure.
[0032] FIG. 6E illustrates a top plan view of the exemplary
prosthetic valve of FIG. 6A with inflated leaflets, consistent with
various embodiments of the present disclosure.
[0033] FIG. 7A illustrates an exemplary prosthetic valve delivery
system, consistent with various embodiments of the present
disclosure.
[0034] FIG. 7B illustrates an enlarged view of a delivery capsule
of the exemplary prosthetic valve delivery system of FIG. 7A,
consistent with various embodiments of the present disclosure.
[0035] FIG. 7C illustrates an exemplary configuration of a
telescoping catheter assembly and the delivery capsule of the
exemplary prosthetic valve delivery system of FIG. 7A, consistent
with various embodiments of the present disclosure.
[0036] FIG. 7D illustrates another exemplary configuration of the
telescoping catheter assembly and delivery capsule of FIG. 7C,
consistent with various embodiments of the present disclosure.
[0037] FIG. 8A illustrates another enlarged view of the exemplary
delivery capsule of the prosthetic valve delivery system of FIG. 7A
in a closed configuration, consistent with various embodiments of
the present disclosure.
[0038] FIG. 8B illustrates the exemplary delivery capsule of FIG.
8A in an open configuration, consistent with various embodiments of
the present disclosure.
[0039] FIG. 8C illustrates an interior view of the exemplary
delivery capsule of FIG. 8A in the closed configuration, consistent
with various embodiments of the present disclosure.
[0040] FIG. 9 illustrates advancement of the exemplary prosthetic
valve delivery system of FIG. 7A into the left atrium, consistent
with various embodiments of the present disclosure.
[0041] FIGS. 10A-10H depict implantation of the prosthetic valve of
FIGS. 6A-6E within a native mitral valve by the exemplary
prosthetic valve delivery system of FIG. 7A, consistent with
various embodiments of the present disclosure.
DETAILED DESCRIPTION
[0042] Exemplary embodiments are described with reference to the
accompanying drawings. In the figures, which are not necessarily
drawn to scale, the left-most digit(s) of a reference number
identifies the figure in which the reference number first appears.
Wherever convenient, the same reference numbers are used throughout
the drawings to refer to the same or like parts. While examples and
features of disclosed principles are described herein,
modifications, adaptations, and other implementations are possible
without departing from the spirit and scope of the disclosed
embodiments. Also, the words "comprising," "having," "containing,"
and "including," and other similar forms are intended to be
equivalent in meaning and be open ended in that an item or items
following any one of these words is not meant to be an exhaustive
listing of such item or items, or meant to be limited to only the
listed item or items. It should also be noted that as used in the
present disclosure and in the appended claims, the singular forms
"a," "an," and "the" include plural references unless the context
clearly dictates otherwise.
[0043] In some embodiments of the present disclosure, an "atrial
direction" may refer to a direction extending towards an atrium of
the heart. For example, from a location within the left ventricle
or the mitral valve, an atrial direction may refer to a direction
extending towards the left atrium. Additionally, from a location
within an atrium (e.g., the left atrium), an atrial direction may
refer to a direction extending away from an adjacent
atrioventricular valve (e.g., the mitral valve) and further into
the atrium. For example, in FIGS. 10G and 10H, an atrial direction
may refer to a direction extending upwards from prosthetic valve
6000 towards atrium 9010. In some exemplary embodiments, an atrial
direction need not necessarily be parallel to a longitudinal axis
of a prosthetic valve (e.g., longitudinal axis 2800 illustrated in
FIG. 2A), so long as the direction is angled towards an atrium. The
atrial direction may be parallel to a longitudinal axis of a
prosthetic valve in some cases. In some embodiments, a
"non-ventricular direction" may refer to a direction that does not
extend towards a ventricle of the heart. A "non-ventricular
direction" may extend in an atrial direction, or it may extend
laterally in a direction perpendicular to a ventricular
direction.
[0044] In some exemplary embodiments of the present disclosure, a
"ventricular direction" may refer to a direction extending towards
a ventricle of the heart. From a location within the left atrium or
the mitral valve, a ventricular direction may refer to a direction
extending towards the left ventricle. Additionally, from a location
within a ventricle (e.g., the left ventricle), a ventricular
direction may refer to a direction extending away from an adjacent
atrioventricular valve (e.g., the mitral valve) and further into
the ventricle. For example, in FIGS. 10G and 10H, a ventricular
direction may refer to a direction extending downwards from
prosthetic valve 6000 towards ventricle 9020. In some exemplary
embodiments, a ventricular direction need not necessarily be
parallel to a longitudinal axis of a prosthetic valve (e.g.,
longitudinal axis 2800 illustrated in FIG. 2A), so long as the
direction is angled towards a ventricle. The ventricular direction
may be parallel to a longitudinal axis of a prosthetic valve in
some cases. In some embodiments, a "non-atrial direction" may refer
to a direction that does not extend towards an atrium of the heart.
A non-atrial direction may extend in a ventricular direction, or it
may extend laterally in a direction perpendicular to an atrial
direction.
[0045] Exemplary embodiments generally relate to prosthetic valves
for implantation within a native valve and methods for implanting
prosthetic valves within a native valve. In addition, exemplary
embodiments generally relate to systems and methods for
implantation of prosthetic valves by prosthetic valve delivery
systems. While the present disclosure provides examples relating to
prosthetic heart valves, and in particular prosthetic mitral
valves, as well as delivery systems for prosthetic heart valves, it
should be noted that aspects of the disclosure in their broadest
sense are not limited to a prosthetic heart valve. Rather, the
foregoing principles may be applied to other prosthetic valves as
well. In various embodiments in accordance with the present
disclosure, the term prosthetic valve refers generally to an
implantable valve configured to restore and/or replace the
functionality of a native valve, such as a diseased or otherwise
impaired native heart valve.
[0046] An exemplary prosthetic valve may include a prosthetic valve
configured to render a native valve structure non-functional, and
may thus replace the function of the native valve. For example, an
exemplary prosthetic valve may have a size and shape similar to the
valve being replaced and may include a number of leaflet-like
structures to regulate fluid flow and prevent backflow of blood
through the valve. Additionally, or alternatively, an exemplary
prosthetic valve may also include a prosthetic valve configured to
leave the native valve structure intact and functional. An
exemplary prosthetic valve may include a mitral valve, tricuspid
valve, aortic valve, or pulmonary valve, as well as a valve outside
of the heart, such as a venous valve, lymph node valve, ileocecal
valve, or any other structure configured to control and/or regulate
fluid flow in the body. An exemplary prosthetic valve may
additionally or alternatively be configured to replace a failed
bioprosthesis, such as a failed heart valve prosthesis.
[0047] FIG. 1A illustrates a front elevation view of an exemplary
frame 1000 for a prosthetic valve. FIG. 1B illustrates a
perspective view of frame 1000. Frame 1000 may be constructed of a
shape memory material such as nickel titanium alloy (Nitinol) and
may be configured to support other components of the prosthetic
valve, such as prosthetic leaflets and protective cover layers.
Frame 1000 may include an annular outer frame 1200 and an inner
frame 1400 situated at least partially within the outer frame 1200.
Annular outer frame 1200 and inner frame 1400 may be secured
together by pins, screws, welding, soldering, adhesive, magnets,
and/or any other suitable mechanism. For example, FIGS. 1A and 1B
depict annular outer frame 1200 and inner frame 1400 connected by a
plurality of connector pins 1040.
[0048] Annular outer frame 1200 may include an outer frame tubular
portion 1220, which may be formed of a plurality of struts
intersecting at junctions to form a wire mesh, stent-like, or
cage-like structure of the outer frame tubular portion 1220.
Annular outer frame 1200 may also include at least one ventricular
anchoring leg 1240, which may be configured to extend radially
outward from the outer frame tubular portion and which may contact,
or otherwise engage, tissue within or near the native valve to
anchor the prosthetic valve within the native valve. In some
embodiments, exemplary valve frame 1000 may include twelve
ventricular anchoring legs 1240, which may be configured to engage
ventricular tissue of a native atrioventricular valve.
[0049] Inner frame 1400 may include an inner frame tubular portion
1420, which may be formed of a plurality of struts intersecting at
junctions to form a wire mesh, stent-like, or cage-like structure
of the inner frame tubular portion 1420. Inner frame 1400 may also
include at least one atrial anchoring arm 1440, which may be
configured to extend radially outward from the inner frame tubular
portion and which may contact, or otherwise engage, tissue within
or near the native valve to anchor the prosthetic valve within the
native valve. In some embodiments, exemplary valve frame 1000 may
include twelve atrial anchoring arms 1440, which may be configured
to engage atrial tissue of a native atrioventricular valve.
[0050] Outer frame tubular portion 1220 and inner frame tubular
portion 1420 may together form an annular valve body 1020 of the
prosthetic valve, which may have at least one opening and from
which the ventricular anchoring legs 1240 and atrial anchoring arms
1440 may extend. Annular valve body 1020 may include an axial lumen
1022 extending through the annular valve body 1020 along a
longitudinal axis 1800 of the prosthetic valve. In some
embodiments, annular valve body 1020 may be configured to receive a
flow control device, such as one or more prosthetic leaflets,
within axial lumen 1022. Optionally, annular valve body 1020 may
include one or more atrial end delivery posts 1027 along an atrial
end (i.e., top end) of the annular valve body and/or one or more
ventricular end delivery posts 1028 along a ventricular end (i.e.,
bottom end) of the annular valve body. Delivery posts 1027 and 1028
may be configured to removably engage a delivery device of the
prosthetic valve, for example, to assist with placement of frame
1000 within or near a native valve.
[0051] FIG. 2A illustrates a front view of another exemplary frame
2000 for a prosthetic valve. FIG. 2B illustrates a top plan view of
the frame 2000. Frame 2000 may include an annular outer frame 2200
and an inner frame 2400 situated at least partially within the
annular outer frame 2200. Annular outer frame 2200 and inner frame
2400 may be secured together by pins, screws, welding, soldering,
adhesive, magnets, and/or any other suitable mechanism. For
example, FIGS. 2A and 2B depict annular outer frame 2200 and inner
frame 2400 connected by a plurality of connector pins 2040.
[0052] Annular outer frame 2200 may include an outer frame tubular
portion 3605, which may be formed of a plurality of struts
intersecting at junctions to form a wire mesh, stent-like, or
cage-like structure of the outer frame tubular portion 3605. For
example, as illustrated in FIG. 2A, annular outer frame 2200 may
include outer frame atrial circumferential struts 3608a, outer
frame leg base struts 3608b, and outer frame ventricular
circumferential struts 3608c intersecting at atrial end outer frame
junctions 3602, leg attachment junctions 3802, outer frame
junctions 3804, and ventricular end outer frame junctions 3604 to
form outer frame tubular portion 3605. Annular outer frame 2200 may
also include at least one ventricular anchoring leg 2240, which may
extend from leg attachment junction 3802 of the outer frame tubular
portion 3605 and which may be configured to engage ventricular
tissue of a native valve to anchor the prosthetic valve in the
native valve. The at least one ventricular anchoring leg 2240 may
include a proximal leg end 3622, which may be the end of the leg
connected to the outer frame tubular portion, and a distal leg end
2244, which may be situated radially outward from the outer frame
tubular portion. As shown in FIG. 2B, the at least one ventricular
anchoring leg 2240 may include at least one opening 2242.
[0053] Inner frame 2400 may include an inner frame tubular portion
3005, which may be formed of a plurality of struts intersecting at
junctions to form a wire mesh, stent-like, or cage-like structure
of the inner frame tubular portion 3005. For example, as
illustrated in FIG. 2A, inner frame 2400 may include inner frame
atrial struts 3008a, inner frame intermediate struts 3008b, and
inner frame ventricular struts 3008c intersecting at atrial end
inner frame junctions 3002, arm attachment junctions 3202, inner
frame strut junctions 3204, and ventricular end inner frame
junctions 3004 to form inner frame tubular portion 3005. Inner
frame 2400 may also include at least one atrial anchoring arm 2440,
which may extend from arm attachment junction 3202 of the inner
frame tubular portion 3005 and which may be configured to engage
atrial tissue of a native valve to anchor the prosthetic valve in
the native valve. The at least one atrial anchoring arm 2440 may
include a proximal arm end 3020, which may be the end of the arm
connected to the inner frame tubular portion, and a distal arm end
2444, which may be situated radially outward from the inner frame
tubular portion. As shown in FIG. 2B, the at least one atrial
anchoring arm 2440 may include a proximal arm opening 2441 and a
distal arm opening 2442.
[0054] Outer frame tubular portion 3605 and inner frame tubular
portion 3005 may together form an annular valve body 2020 of the
prosthetic valve, which may have at least one opening and from
which the ventricular anchoring legs 2240 and atrial anchoring arms
2440 may extend. Annular valve body 2020 may include an axial lumen
2022 extending through the annular valve body 2020 along a
longitudinal axis 2800 of the prosthetic valve. Annular valve body
2020 may have an atrial end 2024, a ventricular end 2025 opposite
the atrial end, and an intermediate portion 2026 extending between
the atrial and ventricular ends. In some embodiments, the atrial
end may refer to the portion of the annular valve body configured
to be situated at a location within the atrium that is furthest
from an adjacent ventricle, when the prosthetic valve is implanted
in a native valve. Similarly, the ventricular end may refer to the
portion of the annular valve body configured to be situated at a
location within the ventricle that is furthest from an adjacent
atrium, when the prosthetic valve is implanted in a native valve.
The intermediate portion 2026 may extend between the atrial end
2024 and ventricular end 2025. In some embodiments, annular valve
body 2020 may include one or more ventricular end delivery posts
1028 along the ventricular end 2025 of the annular valve body.
Axial lumen 2022 may include an inlet opening 2032 at the atrial
end of the annular valve body, as well as an outlet opening 2036 at
the ventricular end of the annular valve body.
[0055] FIG. 2C illustrates an enlarged view of an atrial anchoring
arm 2440 and a ventricular anchoring leg 2240 of frame 2000.
Ventricular anchoring leg 2240 may include an inner,
atrially-facing leg surface 2248 and an outer, ventricularly-facing
leg surface 2249. Atrial anchoring arm 2440 may include an
atrially-facing arm surface 2448 and a ventricularly-facing arm
surface 2449. In some embodiments, atrial anchoring arm 2440 may
include an arm portion 2446 configured to be arranged in a common
lateral plane with leg portion 2246 of the ventricular anchoring
leg 2240. That is, leg portion 2246 and arm portion 2446 may be
positioned at the same axial position along longitudinal axis
2800.
[0056] FIG. 2D illustrates another front elevation view of frame
2000. The exemplary prosthetic valve, as well as frame 2000, may
have an axial height 2560, which may extend between terminal arm
ends 2444 and ventricular end 2025 of the annular valve body. Inner
frame tubular portion 3005 may have an axial height 2530, which may
extend between atrial end inner frame junctions 3002 and
ventricular end inner frame junctions 3004. Annular outer frame
2200 may have an axial height 2550, which may extend between
terminal leg ends 2244 and ventricular end 2025 of the annular
valve body. Outer frame tubular portion 3605 may have an axial
height 2570, which may extend between atrial end outer frame
junctions 3602 and ventricular end outer frame junctions 3604. In
some embodiments, frame 2000 may have a ventricular device
protrusion distance 2540, which may represent the distance over
which the prosthetic valve protrudes into a left ventricle when the
prosthetic valve is implanted in a native mitral valve. Annular
valve body 2020 may include a valve inlet radius 2520, which may be
the radius of atrial inlet opening 2032.
[0057] FIG. 2E illustrates another top plan view of frame 2000. The
atrial anchoring arms 2440 may have a length 2580, and the
ventricular anchoring legs 2240 may have a length 2590. The
terminal arm ends 2444 may define an atrial anchoring arm
circumference 2640. The terminal leg ends 2244 may define a
ventricular anchoring leg circumference 2620, which may be
concentric with atrial anchoring arm circumference 2640. Inflexible
portions 3402 of the atrial anchoring arms (illustrated in FIG. 3B)
may have a length 2581. Serpentine structures 3406 of the atrial
anchoring arms (illustrated in FIG. 3B) may have a length 2582.
[0058] FIG. 3A illustrates a front elevation view of inner frame
2400. The atrial end inner frame junctions 3002 and ventricular end
inner frame junctions 3004 may form the atrial end and ventricular
end, respectively, of inner frame 2400. Inner frame intermediate
portion 3006 may extend between atrial end inner frame junctions
3002 and ventricular end inner frame junctions 3004. Inner frame
tubular portion 3005 may have a radially inner surface 3018 and a
radially outer surface 3016. Inner frame atrial struts 3008a and
inner frame intermediate struts 3008b may intersect at atrial end
inner frame junctions 3002, arm attachment junctions 3202, and
strut junctions 3204 to form a first, atrial row of closed cells
3012. Inner frame intermediate struts 3008b and inner frame
ventricular struts 3008c may intersect at arm attachment junctions
3202, strut junctions 3204, and ventricular end inner frame
junctions 3004 to form a second, ventricular row of closed cells
3014. At least one inner frame atrial strut 3008a may have a
cross-sectional area 3010. At least one atrial anchoring arm 2440
may have a cross-sectional area 3022.
[0059] FIG. 3B illustrates an enlarged view of an atrial anchoring
arm 2440 of inner frame 2400. Atrial anchoring arm 2440 may include
a proximal arm portion 3502 configured to extend in an atrial
direction, intermediate arm portion 3504 configured to extend in a
ventricular direction, and distal arm portion 3506 configured to
extend in an atrial direction. Arm transition portion 3508 may
represent the transition between intermediate arm portion 3504 and
distal arm portion 3506. Atrial anchoring arm 2440 may also include
an inflexible portion 3402 extending to proximal arm end 3020, as
well as a serpentine structure 3406, which may be situated radially
external to the inflexible portion 3402. Inflexible portion 3402
may have a proximal end 3402p, a distal end 3402d, and a
cross-sectional area 3402c. Serpentine structure 3406 may have a
cross-sectional area 3406c. In some embodiments, atrial anchoring
arm 2440 may include a terminal arm region 3408 situated radially
external to serpentine structure 3406. Distal arm opening 2442 may
be situated within terminal arm region 3408.
[0060] FIG. 3C illustrates a front elevation view of outer frame
2200. The atrial end outer frame junctions 3602 and ventricular end
outer frame junctions 3604 may form the atrial end and ventricular
end, respectively, of annular outer frame 2200. Outer frame
intermediate portion 3606 may extend between atrial end outer frame
junctions 3602 and ventricular end outer frame junctions 3604.
Outer frame tubular portion 3605 may have a radially outer surface
3618 and a radially inner surface 3620. The outer frame atrial
circumferential struts 3608a, outer frame leg base struts 3608b,
and outer frame ventricular circumferential struts 3608c may
intersect at the atrial end outer frame junctions 3602, leg
attachment junctions 3802, outer frame junctions 3804, and
ventricular end outer frame junctions 3604 to form closed cells
3616. At least one outer frame atrial circumferential strut 3608a
may have a cross-sectional area 3610 and a width 3612. At least one
outer frame leg base strut 3608b may have a cross-sectional area
3614. At least one ventricular anchoring leg may have a
cross-sectional area 3624 and a radially outer surface width
3626.
[0061] FIG. 3D illustrates an enlarged view of a portion of a
ventricular anchoring leg 2240 of annular outer frame 2200.
Ventricular anchoring leg 2240 may include a first, proximal curved
portion 3807 and a second, distal curved portion 3808. In some
embodiments, proximal curved portion 3807 may face radially
outward. Additionally, or alternatively, distal curved portion 3808
may face radially inwards.
[0062] FIG. 4A illustrates a cross-sectional view of frame 2000,
and FIG. 4B illustrates an enlarged view of a portion of FIG. 4A
depicting a volume 4000 formed between the atrial anchoring arms
2440 and ventricular anchoring legs 2240. FIG. 4B also depicts an
outer surface 4010 and inner surface 4020 of annular valve body
2020. In some embodiments, volume 4000 may be bounded by the
ventricularly-facing surfaces 2449 of atrial anchoring arms 2440,
by the inner, atrially-facing surfaces 2248 of ventricular
anchoring legs 2240, and by the outer surface 4010 of the annular
valve body 2020.
[0063] FIG. 5A illustrates a configuration of the exemplary
prosthetic valve in which annular valve body 2020, atrial anchoring
arms 2440, and ventricular anchoring legs 2240 are arranged in a
radially-contracted configuration. In some embodiments, the
configuration illustrated in FIG. 5A may constitute a
radially-contracted configuration of the prosthetic valve.
[0064] FIG. 5B illustrates a configuration of the exemplary
prosthetic valve in which annular valve body 2020 and atrial
anchoring arms 2440 are arranged in a radially-contracted
configuration. In the configuration of FIG. 5B, the ventricular
anchoring legs 2240 may deflect radially outward away from annular
valve body 2020, into a radially-expanded configuration of the
ventricular anchoring legs 2240.
[0065] FIG. 5C illustrates a configuration of the exemplary
prosthetic valve in which annular valve body 2020 and ventricular
anchoring legs 2240 are arranged in a radially-contracted
configuration. In the configuration of FIG. 5C, the atrial
anchoring arms 2440 may deflect radially outward away from annular
valve body 2020, into a radially-expanded configuration of the
atrial anchoring arms 2440.
[0066] FIG. 5D illustrates a configuration of the exemplary
prosthetic valve in which the atrial anchoring arms 2440 and
ventricular anchoring legs 2240 may deflect radially outward away
from annular valve body 2020 into their respective
radially-expanded configurations, while annular valve body 2020
remains in a radially-contracted configuration. In the
configuration of FIG. 5D, an axial distance 5004 may be formed
between the atrial anchoring arms 2440 and the terminal ends 2244
of the ventricular anchoring legs 2240.
[0067] FIG. 5E illustrates a configuration of the exemplary
prosthetic valve in which annular valve body 2020, atrial anchoring
arms 2440, and ventricular anchoring legs 2240 are arranged in a
radially-expanded configuration. In some embodiments, the
configuration illustrated in FIG. 5E may constitute a
radially-expanded configuration of the prosthetic valve.
[0068] FIG. 6A illustrates a front elevation view of prosthetic
valve 6000. In some embodiments, prosthetic valve 6000 may be
assembled upon frame 2000. Prosthetic valve 6000 may be configured
for implantation within or near a native valve structure and may be
configured to restore and/or replace the functionality of a native
valve, such as a diseased or otherwise impaired native valve.
Prosthetic valve 6000 may include valve frame 2000, including
annular valve body 2020, the atrial anchoring arms 2440, and the
ventricular anchoring legs 2240. Prosthetic valve 6000 may also
include a skirt layer 6100 configured around an external surface of
a portion of the annular valve body. Prosthetic valve 6000 may
additionally include a first cuff sheet 6210, which may be
connected to skirt layer 6100 via stitching 6104, as well as a
second cuff sheet 6220, which may be connected to first cuff sheet
6210 via stitching 6420. In some embodiments, the first cuff sheet
6210 and second cuff sheet 6220 by extend around the terminal ends
2444 of the atrial anchoring arms 2440. Skirt layer 6100, first
cuff sheet 6210, and second cuff sheet 6220 may be constructed of
fluid-impermeable material and may accordingly be configured to
prevent passage of blood or other fluids through portions of the
prosthetic valve 6000 outside of the axial lumen 2022.
[0069] In some embodiments, prosthetic valve 6000 may additionally
include a protective sleeve 6102 wrapped around the rim 6800 of the
ventricular outlet opening of annular valve body 2020; protective
sleeve 6102 may be secured to annular valve body 2020 by stitching
6108. Additionally, or alternatively, prosthetic valve 6000 may
include at least one liner 6310 extending around an external
surface of the ventricular anchoring legs 2240, with at least one
protective layer 6330 positioned around the distal leg ends 2244
and at least one protective covering 6320 wrapped around the
proximal leg ends 3622. In some embodiments, the at least one
protective covering 6320 may be secured to the skirt layer 6100 via
stitching 6322.
[0070] FIG. 6B illustrates a cross-sectional view of prosthetic
valve 6000, without prosthetic leaflets situated within the axial
lumen 2022. As illustrated in FIG. 6B, prosthetic valve 6000 may
additionally include a liner 6400 covering at least a portion of
the inner surface 4020 of the annular valve body 2020. Liner 6400
may be secured to the annular valve body 2020 via stitching 6430
and to the second cuff sheet 6220 via stitching 6410. First cuff
sheet 6210, second cuff sheet 6220, and inner liner 6400 may
together form an inflatable cuff 6200 having an interior volume
6500. In some embodiments, inflatable cuff 6200 may be secured to
atrial anchoring arm 2440 via connector 6440. Blood may enter the
cuff 6200 through openings 6230, causing the cuff 6200 to inflate
radially outwards and axially in an atrial direction. In some
embodiments, cuff 6200 may inflate radially outwards and press
against tissue of the native valve. This engagement between the
cuff and tissue of the native valve may form a barrier to flow of
blood and other fluids around the outer circumference of the
prosthetic valve 6000.
[0071] FIG. 6C illustrates a cross-sectional view of prosthetic
valve 6000 with prosthetic leaflets 6602 and 6604 situated within
the axial lumen 2022. In some embodiments, prosthetic valve 6000
may also include a third prosthetic leaflet 6606, which may not be
visible in the view of FIG. 6C. The leaflets 6602, 6604, and 6606
may be secured to inner liner 6400 via stitching 6608 and may
include a connector 6610 wrapping around the ventricular end
delivery posts 2028 to secure the leaflets 6602, 6604, and 6606 to
the valve frame 2000.
[0072] FIG. 6D illustrates a top plan view of prosthetic valve
6000, with leaflets 6602, 6604, and 6606 arranged in an open,
uninflated configuration. In the open configuration, a space may be
formed in the middle of the leaflets, permitting fluid to pass
through the axial lumen 2022 of the prosthetic valve 6000. FIG. 6E
illustrates a top plan view of prosthetic valve 6000, with leaflets
6602, 6604, and 6606 arranged in a closed, coapted configuration.
In the closed configuration, the leaflets may press together such
that the opening between them is closed. For example, the point of
contact 6007 between two adjacent leaflets may extend to the center
of the axial lumen; as a result, the leaflets may block fluid
passage through the axial lumen 2022 of the prosthetic valve
6000.
[0073] FIG. 7A illustrates a prosthetic valve delivery system 7000.
Delivery system 7000 may be configured to deliver an implant
prosthetic valve 6000 within a native valve, such as a native
mitral valve. Prosthetic valve delivery system 7000 may include a
control handle assembly 7100, a telescoping catheter assembly 7200,
a delivery capsule 7300 configured to retain a prosthetic valve
(e.g. valve 6000), and, optionally, a stand 7400.
[0074] Control handle assembly 7100 may include an outer sheath
control handle 7120 having a steering knob 7122 configured to steer
an outer sheath 7210 of the telescoping catheter assembly 7200.
Control handle assembly 7100 may also include a guide catheter
control handle 7140 having a steering knob 7142 configured to steer
a guide catheter 7220 of the telescoping catheter assembly
7200.
[0075] Control handle assembly 7100 may also include an implant
catheter control handle 7160 having a steering knob 7168 configured
to steer an implant catheter 8100 of the telescoping catheter
assembly 7200. Implant catheter control handle 7160 may also
include a proximal capsule portion slider 7162, a distal capsule
portion knob 7170, and a distal capsule portion knob lock 7172
configured to control release of the prosthetic valve 6000 from
within delivery capsule 7300. Implant catheter control handle 7160
may also include a slide lock 7166 configured to lock the implant
catheter control handle 7160 at a position within track 7420 of
stand 7400.
[0076] Control handle assembly 7100 may also include a cradle 7180,
which may be secured to stand 7400 via a locking mechanism that can
be released by actuated of release button 7184. Cradle 7180 may
include a rotation knob 7182 configured to control rotation of the
outer sheath 7210 and guide catheter 7220. Cradle 7180 may also
include a rotation knob 7186 configured to control rotation of the
implant catheter 8100. Cradle 7180 may also include a knob 7188
configured to control relative axial movement between outer sheath
control handle 7120 (which may be secured to outer sheath 7210) and
guide catheter control handle 7140 (which may be secured to guide
catheter 7220).
[0077] FIG. 7B illustrates an enlarged view of delivery capsule
7300 of prosthetic valve delivery system 7000. Delivery capsule
7300 may include a proximal capsule portion 7320 and a distal
capsule portion 7340 with a nose cone 7360 secured to the distal
capsule portion 7340. A nose cone distal tip 7365 may form the
distal end of the delivery capsule 7300. The telescoping catheter
assembly 7200 may include a capsule shaft 7230 secured to, and
configured to control movement of, the proximal capsule portion
7320 (e.g., due to connection 8400 between the capsule shaft 7230
and proximal capsule portion 7320, as illustrated in FIG. 8C).
Implant catheter 8100 may extend within proximal capsule portion
7320 and may have a valve anchor disc 8200 connected to the distal
end of the implant catheter 8100. A torque shaft 8300 may extend
from the implant catheter 8100 and may be connected to distal
capsule portion 7340; accordingly, torque shaft 8300 may be
configured to control axial movement of the distal capsule portion
7340 relative to the implant catheter 8100 and valve anchor disc
8200. The proximal capsule portion 7320 and a distal capsule
portion 7340 may be configured to retain prosthetic valve 6000,
with the prosthetic valve 6000 secured against axial movement by
valve anchor disc 8200. Control handle assembly 7100 may be
configured to control movement of the proximal capsule portion 7320
and a distal capsule portion 7340, and thus may also control
release of the prosthetic valve 6000 from within the delivery
capsule 7300.
[0078] FIGS. 7C and 7D illustrate exemplary configurations of the
telescoping catheter assembly 7200. Outer sheath 7210 and guide
catheter 7220 may include respective bending portions 7215 and
7225, at which the outer sheath 7210 and guide catheter 7220 may be
configured to bend within their respective steering planes 7212 and
7222. In some embodiments, bending of the outer sheath 7210 within
the first steering plane 7212 may be controlled by the outer sheath
steering knob 7122 of the control handle assembly 7100.
Additionally, or alternatively, bending of the guide catheter 7220
within the second steering plane 7222 may be controlled by the
guide catheter steering knob 7142 of the control handle assembly
7100. In some embodiments, under control of the control handle
assembly 7100, the outer sheath 7210, guide catheter 7220, and
implant catheter 8100 may be steered so as to correctly position
the delivery capsule 7300 within a native valve for implantation of
the prosthetic valve.
[0079] FIG. 8A illustrates an enlarged view of delivery capsule
7300 in a closed configuration, while FIG. 8B illustrates an
enlarged view of delivery capsule 7300 in an open configuration. In
the closed configuration of FIG. 8A, the distal capsule portion
7340 and proximal capsule portion 7320 may be brought together to
form an enclosed compartment in which prosthetic valve 6000 may be
retained. In the open configuration of FIG. 8B, the distal capsule
portion 7340 and proximal capsule portion 7320 may be drawn apart.
In some embodiments, the delivery capsule 7300 may be configured
such that the distal capsule portion 7340 and proximal capsule
portion 7320 are moved apart from each other, the prosthetic valve
6000 may be sequentially deployed from within the delivery capsule
and implanted within a native valve.
[0080] FIG. 8C illustrates an interior view of delivery capsule
7300 with prosthetic valve 6000 retained within the delivery
capsule. Although only the valve frame 2000 of the prosthetic valve
6000 is illustrated in FIG. 8C, one of ordinary skill will
understand that the entire prosthetic valve 6000 depicted in FIGS.
6A-6E may be retained within delivery capsule 7300 in the
configuration illustrated in FIG. 8C.
[0081] In the embodiment illustrated in FIG. 8C, at least a portion
of the annular valve body 2020 and ventricular anchoring legs 2240
of the prosthetic valve 6000 may be retained within the distal
capsule portion. Additionally, or alternatively, at least a portion
of atrial anchoring arms 2440 may be retained within proximal
capsule portion 7320. In some embodiments, valve anchor disc 8200
may include a number of recesses 8205 configured to receive and
retain the ventricular end delivery posts 2028 of the prosthetic
valve 6000. For example, the valve anchor disc 8200 may include at
least the same number of recesses 8205 as there are delivery posts
2028 of the prosthetic valve 6000. In some embodiments, the
delivery posts 2028 may be retained within the recesses 8205 so
long as the annular valve body 2020 remains in a
radially-contracted configuration; the engagement between the valve
anchor disc 8200 and delivery posts 2028 may secure the prosthetic
valve 6000 against axial movement. Upon radial expansion of the
annular valve body 2020, the delivery posts 2028 may slide or
expand out of the recesses 8205, freeing the prosthetic valve 6000
from engagement with the valve anchor disc 8200.
[0082] FIG. 9 illustrates one exemplary advancement route of the
delivery capsule 7300 to the left atrium. In the example
illustrated in FIG. 9, the delivery capsule 7300 may be steered
through the vena cava into the right atrium 9210 and may pierce the
interatrial septum and enter the left atrium 9010. Alternatively,
the delivery capsule may be delivered to the heart by other routes.
FIG. 9 also depicts the left ventricle 9020, the mitral valve 9030,
the chordae tendineae 9022, the aortic valve 9045, and the aorta
9040.
[0083] FIGS. 10A-10H depict an exemplary implantation method of
prosthetic valve 6000 within a mitral valve 9030. In FIG. 10A, the
delivery capsule 7300 may be coaxially aligned with the mitral
valve 9030. In some embodiments, the prosthetic valve 6000 may be
held within the delivery capsule 7300 while the prosthetic valve is
arranged in the configuration of FIG. 5A. In FIG. 10B, the delivery
capsule 7300 may be distally advanced into the mitral valve 9030.
In FIG. 10C, the distal capsule portion 7340 may be distally
advanced relative to the rest of the delivery capsule 7300. This
may release the ventricular anchoring legs 2240 from the distal
capsule portion 7340, while the atrial anchoring arms 2440 and
annular valve body 2020 remain constrained within the delivery
capsule. In the example shown in FIG. 10C, the ventricular
anchoring legs 2240 may be released from the delivery capsule 7300
within the atrium 9010. In some embodiments, the prosthetic valve
6000 may assume the configuration of FIG. 5B when the ventricular
anchoring legs 2240 are released in the step depicted in FIG.
10C.
[0084] In FIG. 10D, the released ventricular anchoring legs 2240
may be passed through the mitral valve 9030 and into the left
ventricle 9020. In FIG. 10E, the released legs 2240 may be
proximally retracted until the ventricular anchoring legs come into
contact with the ventricular tissue of the mitral valve 9030. In
FIG. 10F, the proximal capsule portion 7320 may be retracted
proximally, thus releasing the atrial anchoring arms 2440 within
atrium 9010 while the annular valve body 2020 remains radially
constrained within the distal capsule portion 7340. In some
embodiments, the prosthetic valve 6000 may assume the configuration
of FIG. 5D when the atrial anchoring arms 2440 are released in the
step of FIG. 10F.
[0085] In FIG. 10G, the distal capsule portion 7340 may be advanced
further until the annular valve body 2020 is released from the
capsule and allowed to radially expand. Radial expansion of the
annular valve body 2020 may allow the prosthetic valve to assume
the fully-expanded configuration illustrated in FIG. 5E. At this
stage, prosthetic valve 6000 may be securely implanted within
mitral valve 9030. In FIG. 10H, the delivery system 7000, including
capsule 7300, may be removed.
[0086] Various embodiments in accordance with the present
disclosure relate to methods of implanting prosthetic valves within
the body. While the present disclosure provides examples of methods
of implanting prosthetic heart valves, and in particular methods of
implanting prosthetic mitral valves, it should be noted that
aspects of the disclosure in their broadest sense, are not limited
to methods of implanting prosthetic heart valves. Rather, it is
contemplated that aspects of the present disclosure may be applied
to methods for implanting other prosthetic or implantable devices
as well and are not limited to methods for implanting prosthetic
valves, heart valves, or mitral valves. Prosthetic heart valve
6000, illustrated in FIGS. 6A-6E, is one example of a prosthetic
valve in accordance with the present disclosure.
[0087] In some embodiments, exemplary methods may be provided for
implanting a prosthetic valve at a treatment site within the body,
such as within or adjacent to a native mitral valve between a heart
atrium (i.e., the left atrium) and a heart ventricle (i.e., the
left ventricle). In some embodiments, the exemplary method may
include delivery of the prosthetic valve to the implantation site
(e.g., a native mitral valve) via a variety of approaches, such as
transapically, transatrially, and/or transseptally. In some
embodiments, the method may include implantation of the prosthetic
valve in the annulus or orifice of a native heart valve structure
(e.g., a native mitral valve). For example, FIGS. 10A-10H
illustrate an example of implanting a prosthetic valve 6000 within
a native mitral valve 9030 between a heart atrium 9010 and a heart
ventricle 9020. Exemplary methods may include firmly anchoring a
prosthetic valve within the native heart valve structure, thus
preventing the prosthetic valve from migrating or dislodging from
within the native valve structure.
[0088] In some embodiments, exemplary methods may be provided for
implanting an expandable prosthetic valve. For example, an
exemplary prosthetic valve may be expandable, such as between a
radially-contracted configuration (e.g., a crimped state) and a
radially-expanded configuration. FIG. 5A illustrates an example of
a valve frame 2000 of a prosthetic valve in a radially-contracted
configuration. The diameter of the prosthetic valve may be reduced
in the radially-contracted configuration. In some embodiments, the
prosthetic valve may be held in the radially-contracted
configuration, such as within a delivery device, during delivery of
the prosthetic valve to the implantation site. Accordingly, in some
embodiments, the radially-contracted configuration may also be a
delivery configuration, in which the prosthetic valve is arranged
for delivery to the implantation site. Once at or near the
implantation site, the prosthetic valve may be radially expanded to
a radially-expanded configuration, in which the prosthetic valve
may be anchored at the implantation site. FIG. 5E illustrates an
example of valve frame 2000 in a radially-expanded configuration.
In some embodiments, the radially-expanded configuration may also
be a deployed configuration, in which the prosthetic valve is
released from the delivery tool and seated at the implantation
site.
[0089] In some embodiments, the exemplary prosthetic valve may be
configured for self-expansion to the radially-expanded
configuration; that is, the prosthetic valve may be biased to
assume the radially-expanded configuration due to, at least in
part, the design and/or material composition of the prosthetic
valve. The self-expanding prosthetic valve may be constructed of a
shape memory material such as nickel titanium alloy (Nitinol),
which may permit the prosthetic valve to expand to a pre-determined
diameter upon removal of a constraining force and/or application of
heat or energy. For example, the prosthetic valve may be contracted
and held in the radially-contracted configuration by a constraining
device, such as a sheath, catheter, stent, or delivery capsule. An
example of such a constraining device is illustrated in FIGS. 7B
and 8C, which illustrate an exemplary prosthetic heart valve 6000
held in a radially-contracted configuration within a delivery
capsule 7300. When the prosthetic valve is positioned at or near
the implantation site, the constraining force may be removed (e.g.,
valve 6000 may be removed from capsule 7300) and the prosthetic
valve allowed to self-expand to the radially-expanded
configuration. Additionally, or alternatively, an exemplary
prosthetic valve may be configured to expand due to application of
radially expansive forces thereupon. For example, the prosthetic
valve may be placed, in its radially-contracted configuration, upon
an expansion device such as a balloon catheter. Upon positioning at
the implantation site, the expansion device may exert an
outwardly-directed force upon the prosthetic valve, causing it to
expand to the fully-expanded configuration.
[0090] In some embodiments, an exemplary prosthetic valve may be
configured for implantation within a native atrioventricular valve
and may regulate blood flow between the atrium and ventricle. For
example, prosthetic heart valve 6000 illustrated in FIGS. 6A-6C may
include a fluid-impervious cuff 6200 configured to extend from an
inner lumen 2022 of the prosthetic valve to terminal arm ends 2444
of a plurality of atrial anchoring arms 2440. Because cuff 6200 is
constructed of a fluid-impervious material, cuff 6200 may be
configured to minimize or block flow of blood and other fluids
through any portion of the prosthetic valve 6000 except for lumen
2022. In addition, atrial anchoring arms 2440 of the prosthetic
valve (including terminal arm ends 2444) may be configured to
contact and, in some embodiments, press against atrial tissue of a
native heart valve. This is illustrated in FIGS. 10G-10H, which
depict atrial anchoring arms 2440 of prosthetic valve 6000 arranged
in contact with, and exerting a ventricularly-directed force (that
is, a force directed downwards toward ventricle 9020) upon atrial
tissue of native mitral valve 9030. As a result, cuff 6200 of
prosthetic valve 6000 may also be configured to minimize or block
passage of blood and other fluids between the prosthetic valve 6000
(including terminal arm ends 2444) and native valve tissue, a
condition known as perivalvular leakage. As a result, prosthetic
valve 6000 may be configured to prohibit passage of blood and other
fluids between atrium 9010 and ventricle 9020, except by passage
through inner lumen 2022, in which leaflets 6602, 6604, and 6606
may be situated.
[0091] In some embodiments, the prosthetic valve may include an
annular valve body. The annular valve body may be configured to
receive or otherwise support a flow control device, such as one or
more leaflets, for regulating flow of blood or other bodily fluids
through the prosthetic valve. As a result, when the prosthetic
valve is implanted within a native heart valve, the flow control
device may regulate fluid passage through the native heart valve,
thus restoring and/or replacing the functionality of the native
valve. In some embodiments, the exemplary valve body may be annular
or ring-shaped and may thus have at least one opening therein. In
some embodiments, the at least one opening may extend
longitudinally along the entire length of the annular valve body.
For example, FIG. 6D illustrates an exemplary prosthetic heart
valve 6000 including an annular valve body 2020 having an axial
lumen 2022 extending longitudinally therethrough. Annular valve
body 2020 may receive a flow control device, such as leaflets 6602,
6604, and 6606, within lumen 2022. In some embodiments, the annular
valve body may be sized and configured to be seated within the
orifice of a native mitral valve. For example, as depicted in FIG.
10H, annular valve body 2020 may be situated within the orifice of
mitral valve 9030, including between native leaflets 9032. In some
embodiments, the annular valve body may be configured to have a
smaller diameter, when fully-expanded, than the diameter of the
orifice of the native mitral valve. In such embodiments, the
annular valve body may be anchored in the native mitral valve by
anchoring structures, such as atrial anchors and/or ventricular
anchors. Alternatively, the annular valve body may be configured to
expand to an equal or greater diameter than the diameter of the
mitral valve orifice such that the annular valve body is anchored
within the mitral valve. The annular valve body may have a
circular, oval-shaped, elliptical, or D-shaped cross-section and
may be symmetrical about at least one axis thereof.
[0092] In some embodiments, the prosthetic valve may additionally
or alternatively include a plurality (that is, one or more) of
ventricular anchors and a plurality (that is, one or more) of
atrial anchors. The ventricular and atrial anchors may be
configured to anchor the prosthetic valve within the native mitral
valve. For example, the ventricular anchors may be configured to
engage ventricular tissue of the native mitral valve and the atrial
anchors may be configured to engage atrial tissue of the native
mitral valve, so as to anchor the prosthetic valve within the
mitral valve. In some embodiments, the ventricular anchors may be
configured to be positioned at least partially within a ventricle
upon implantation of the prosthetic valve, and to engage
ventricular tissue of a native mitral valve. Similarly, the atrial
anchors may be configured to be positioned at least partially
within an atrium upon implantation of the prosthetic valve, and to
engage atrial tissue of a native mitral valve. For example, FIGS.
10G and 10H illustrate an exemplary prosthetic heart valve 6000
having a plurality of atrial anchoring arms 2440 and a plurality of
ventricular anchoring legs 2240. Atrial anchoring arms 2440 are
situated within atrium 9010 and may engage the atrial side of
native mitral valve 9030 and ventricular anchoring legs 2240 are
situated within ventricle 9020 and may engage the ventricular side
of native mitral valve 9030, so as to secure prosthetic heart valve
6000 within the mitral valve 9030. Accordingly, ventricular
anchoring legs 2240 may be considered ventricular anchors in
various embodiments. Additionally, or alternatively, atrial
anchoring arms 2440 may be considered atrial anchors in various
embodiments.
[0093] The prosthetic valve may include one atrial anchor and/or
ventricular anchor, two atrial anchors and/or ventricular anchors,
three atrial anchors and/or ventricular anchors, four atrial
anchors and/or ventricular anchors, five atrial anchors and/or
ventricular anchors, six atrial anchors and/or ventricular anchors,
seven atrial anchors and/or ventricular anchors, eight atrial
anchors and/or ventricular anchors, nine atrial anchors and/or
ventricular anchors, ten atrial anchors and/or ventricular anchors,
eleven atrial anchors and/or ventricular anchors, twelve atrial
anchors and/or ventricular anchors, thirteen atrial anchors and/or
ventricular anchors, fourteen atrial anchors and/or ventricular
anchors, fifteen atrial anchors and/or ventricular anchors, sixteen
atrial anchors and/or ventricular anchors, seventeen atrial anchors
and/or ventricular anchors, eighteen atrial anchors and/or
ventricular anchors, nineteen atrial anchors and/or ventricular
anchors, twenty atrial anchors and/or ventricular anchors, or any
other suitable number of atrial anchors and ventricular anchors.
For example, exemplary prosthetic valve 6000 depicted in FIG. 2B
may include twelve atrial anchoring arms 2440 and twelve
ventricular anchoring legs 2240.
[0094] In some embodiments, the atrial and ventricular anchors may
be connected to the annular valve body. For example, in FIG. 2A,
atrial anchoring arms 2440 (i.e., the exemplary atrial anchors) may
be connected to annular valve body 2020 at arm attachment junctions
3202 and ventricular anchoring legs 2240 (i.e., the exemplary
ventricular anchors) may be connected to annular valve body 2020 at
leg attachment junctions 3802. In some embodiments, the atrial
anchors and/or the ventricular anchors may be physically connected
to the annular valve body, such as by welding or adhesive. In some
alternative embodiments, the atrial anchors and/or the ventricular
anchors may be integrally formed with the annular valve body. In
some embodiments, one or both of the atrial and ventricular anchors
(or portions thereof) may be configured to extend radially outward
from the annular valve body. For example, FIGS. 5D and 5E
illustrate embodiments in which at least a portion of the atrial
anchoring arms 2440 and ventricular anchoring legs 2240 extend
radially outward from annular valve body 2020 (that is, extend in a
direction away from the longitudinal axis of the prosthetic valve).
Additionally, or alternatively, one or both of the atrial anchors
and ventricular anchors may be arranged in a position in which the
atrial anchors and/or ventricular anchors do not extend radially
outward from the annular valve body. For example, FIG. 5A
illustrates an embodiment in which atrial anchoring arms 2440 and
ventricular anchoring legs 2240 do not extend radially outward from
annular valve body 2020, but are instead arranged substantially
parallel to the longitudinal axis of the prosthetic valve. The
configuration illustrated in FIG. 5A may correspond to a radially-
contracted configuration of the prosthetic valve.
[0095] In some embodiments, the locations of connection between the
atrial anchors and annular valve body may be spaced at a regular
interval about a circumference of the annular valve body. For
example, in FIG. 2A, the atrial anchoring arms 2440 (i.e., the
exemplary atrial anchors) may extend from the annular valve body
2020 at arm attachment junctions 3202. Arm attachment junctions
3202 may be spaced at a regular interval about the circumference of
annular valve body 2020. Additionally, or alternatively, the
locations of connection between the atrial anchors and annular
valve body may be arranged along a plane perpendicular to the
longitudinal axis of the prosthetic valve. For example, in FIG. 2A,
the arm attachment junctions 3202 may be arranged along a plane
perpendicular to longitudinal axis 2800. That is, the arm
attachment junctions 3202 may be situated at the same axial
position along longitudinal axis 2800.
[0096] Additionally, or alternatively, the locations of connection
between the ventricular anchors and annular valve body may be
spaced at a regular interval about a circumference of the annular
valve body. For example, in FIG. 2A, the ventricular anchoring legs
2240 (i.e., the exemplary ventricular anchors) may extend from the
annular valve body 2020 at leg attachment junctions 3802. Leg
attachment junctions 3802 may be spaced at a regular interval about
the circumference of annular valve body 2020. Additionally, or
alternatively, the locations of connection between the ventricular
anchors and annular valve body may be arranged along a plane
perpendicular to the longitudinal axis of the prosthetic valve. For
example, in FIG. 2A, the leg attachment junctions 3802 may be
arranged along a plane perpendicular to longitudinal axis 2800.
That is, the leg attachment junctions 3802 may be situated at the
same axial position along longitudinal axis 2800.
[0097] In some embodiments and as illustrated in FIG. 5A, the
ventricular anchoring legs 2240 (i.e., the exemplary ventricular
anchors) may be retained against or substantially flush with the
annular valve body 2020 when the ventricular anchoring legs are in
the radially-contracted configuration. For example, in FIG. 5A, the
radially-contracted ventricular anchoring legs 2240 may be held
against or flush with the inner valve tubular portion 3005, which
may constitute a portion of the annular valve body 2020. In some
embodiments, at least a portion of the ventricular anchoring legs
2240 may contact a portion of the inner valve tubular portion 3005
when the ventricular anchoring legs are in the radially-contracted
configuration.
[0098] In some embodiments, the prosthetic valve may be constrained
from expansion, including radial expansion, during delivery of the
prosthetic valve to an implantation site. For example, the
prosthetic valve may be received at least partially within a
delivery device, which may exert a radially-constraining force on
the prosthetic valve, constraining the prosthetic valve against
radial expansion. For example, FIG. 8C illustrates prosthetic valve
6000 received within, and radially constrained by, delivery capsule
7300. Prosthetic valve 6000 may be delivered into the heart within
and deployed within the mitral valve 9030 by the delivery capsule
7300. In some alternative embodiments, the prosthetic valve may be
constrained from expansion during delivery by other means, such as
a sheath, catheter, or stent. In some embodiments, the exemplary
prosthetic valve may be arranged in the configuration illustrated
in FIG. 5A during delivery.
[0099] As illustrated in FIG. 8C, capsule 7300 may be a hollow
structure, such as a vessel, container, receptacle, or the like,
configured to hold the prosthetic valve 6000 at least partially
therein. The capsule 7300 may include a proximal capsule portion
7320 and a distal capsule portion 7340 configured to move relative
to each other so as to selectively retain and release the
prosthetic valve 6000. In some embodiments, the distal capsule
portion 7340 may be configured to retain at least a portion of the
annular valve body 2020 and at least a portion of the ventricular
anchoring legs 2240 (i.e., the exemplary ventricular anchors)
therein. Distal (i.e., ventricular) movement of the distal capsule
portion 7340 may release the annular valve body 2020 and
ventricular anchoring legs 2240 from the distal capsule portion,
thus permitting the valve body and ventricular anchors to radially
expand (e.g., due to their shape memory properties). In some
embodiments, the proximal capsule portion 7320 may be configured to
retain at least a portion of the atrial anchoring arms 2440 (i.e.,
the exemplary atrial anchors) therein. Proximal (i.e., atrial)
movement of the proximal capsule portion 7320 may release the
atrial anchoring arms 2440 from the proximal capsule portion, thus
permitting the atrial anchors to radially expand (e.g., due to
their shape memory properties).
[0100] FIGS. 9 and 10A illustrate an exemplary method of delivering
the prosthetic valve to the heart and into the left atrium 9010, so
that the prosthetic valve may be implanted within the native mitral
valve. The prosthetic valve may be retained within delivery capsule
7300 during delivery; as illustrated in FIG. 7A, delivery capsule
7300 may be situated at the distal end of exemplary prosthetic
valve delivery system 7000. As illustrated in FIG. 9, delivery
capsule 7300 may be transfemorally delivered into the heart, such
as along a guidewire; that is, the delivery system may advance the
capsule from the femoral vein and through the vena cava 9300 into
the right atrium 9210. The delivery system may pass the capsule
7300 through the septum and into the left atrium 9010. In
alternative embodiments, other techniques may be utilized to
position capsule 7300 within the left atrium 9010, such as a
transaortic approach or a transapical approach.
[0101] As illustrated in FIG. 7A, exemplary prosthetic valve
delivery system 7000 may include an outer sheath 7210, guide
catheter 7220, and implant catheter 8100 configured to correctly
align the capsule 7300 with the native mitral valve and control
advancement of the capsule through the mitral valve. In some
embodiments, outer sheath 7210 and guide catheter 7220 may be
steered via controlled, independent bending of both the outer
sheath 7210 and guide catheter 7220, as well as controlled rotation
of the outer sheath 7210 and guide catheter 7220 about their
respective longitudinal axes. As a result, outer sheath 7210 and
guide catheter 7220 may be bent and/or rotated to co-linearly align
the capsule 7300 with the native mitral valve 9030, as illustrated
in FIG. 10A. The capsule 7300 may then be distally advanced towards
the mitral valve 9030 until at least a portion of the capsule is
situated within the mitral valve, as illustrated in FIG. 10B. In
some embodiments, distal and proximal advancement of the capsule
7300 may be controlled by implant catheter control handle 7160 of
FIG. 7A. For example, implant catheter control handle 7160 may be
connected to, and configured to control axial movement of, implant
catheter 8100, which may in turn control advancement of the
prosthetic valve and of delivery capsule 7300. Accordingly, in some
embodiments, the advancement of the prosthetic valve and of
delivery capsule 7300 towards the mitral valve 9030, as illustrated
in FIG. 10B, may be controlled by implant catheter control handle
7160.
[0102] In some embodiments, the exemplary method for implanting an
expandable prosthetic valve may include releasing the plurality of
ventricular anchors within the atrium. For example, the plurality
of ventricular anchors may be removed, at least in part, from a
delivery device configured to radially constrain the ventricular
anchors (e.g., distal capsule portion 7340). In some embodiments,
the terminal ends of the ventricular anchors may deflect radially
outward relative to the annular valve body when the ventricular
anchors are released; this may be due, at least in part, to the
shape memory properties of the ventricular anchors. In some
embodiments, the entire length of the ventricular anchors may be
released within the atrium; alternatively, a portion of the
ventricular anchors, including the terminal ends of the ventricular
anchors, may be released within the atrium. For example, FIG. 10C
illustrates an embodiment in which ventricular capsule portion 7340
is advanced distally (i.e., towards ventricle 9020) until at least
a portion of the ventricular anchoring legs 2240 (i.e., the
exemplary ventricular anchors) are released from the distal capsule
portion 7340. As a result, the terminal leg ends 2244 may deflect
radially outwards, relative to the annular valve body 2020. In some
embodiments, the proximal capsule portion 7320 may remain
stationary during the distal advancement of the distal capsule
portion 7340 to release of the ventricular anchoring legs 2240. As
FIG. 10C illustrates, the ventricular anchoring legs 2240 may be
released from the distal capsule portion 7340 when the ventricular
anchoring legs 2240 are situated within atrium 9010. In some
embodiments, the entire radial length of the ventricular anchors
may be released (e.g., from distal capsule portion 7340) within the
atrium. In some alternative embodiments, a portion of the
ventricular anchors, including their terminal ends, may be released
within the atrium. In some embodiments, the exemplary prosthetic
valve may be arranged in the configuration illustrated in FIG. 5B
after release of the ventricular anchors. As FIG. 5B illustrates,
the terminal leg ends 2244 may deflect radially outwards while the
annular valve body 2020 and, optionally, the atrial anchoring arms
2440 (i.e., the exemplary atrial anchors) remain radially
constrained.
[0103] In some embodiments, the exemplary method for implanting an
expandable prosthetic valve may include releasing the plurality of
atrial anchors within the atrium. For example, the plurality of
atrial anchors may be removed, at least in part, from a delivery
device configured to radially constrain the atrial anchors (e.g.,
proximal capsule portion 7320). In some embodiments, the terminal
ends of the atrial anchors may deflect radially outward relative to
the annular valve body when the atrial anchors are released; this
may be due, at least in part, to the shape memory properties of the
atrial anchors. In some embodiments, the entire length of the
atrial anchors may be released within the atrium; alternatively, a
portion of the atrial anchors, including the terminal ends of the
atrial anchors, may be released within the atrium. For example,
FIG. 1OF illustrates an embodiment in which proximal capsule
portion 7320 is advanced proximally (i.e., towards atrium 9010)
until the atrial anchoring arms 2440 (i.e., the exemplary atrial
anchors) are released from the proximal capsule portion 7320. As a
result, the terminal arm ends 2444 may deflect radially outwards,
relative to the annular valve body 2020. As FIG. 1OF illustrates,
the atrial anchoring arms 2440 may be released from the proximal
capsule portion 7320 when the atrial anchoring arms 2440 are
situated within atrium 9010. In some embodiments, the entire radial
length of the atrial anchors may be released within the atrium, as
illustrated in the embodiment of FIG. 10F. In some alternative
embodiments, a portion of the atrial anchors, including their
terminal ends, may be released within the atrium.
[0104] In some embodiments, the ventricular anchors may be released
within the atrium prior to release of the atrial anchors within the
atrium. For example, the atrial anchors may remain
radially-constrained with a delivery device during release of the
ventricular anchors within the atrium. FIGS. 10C-10G illustrate an
exemplary method in which the ventricular anchoring legs 2240
(i.e., the exemplary ventricular anchors) are released from the
distal capsule portion 7340 (FIG. 10C) while the atrial anchoring
arms 2440 (i.e., the exemplary atrial anchors) remain
radially-constrained with the proximal capsule portion 7320. After
release of the ventricular anchoring legs 2240, the atrial
anchoring arms 2440 may be released from the proximal capsule
portion 7320 (FIG. 10G). In some embodiments, the exemplary
prosthetic valve may be arranged in the configuration illustrated
in FIG. 5B prior to release of the atrial anchors, and may be
arranged in the configuration illustrated in FIG. 5D after release
of the atrial anchors. For example, FIG. 5D illustrated an
embodiment in which atrial anchoring arms 2440 and ventricular
anchoring legs 2240 have been released, thus allowing terminal arm
ends 2444 and terminal leg ends 2244 to deflect radially outward.
However, annular valve body 2020 may remain radially-constrained in
the configuration of FIG. 5D. In some alternative embodiments, the
atrial anchors may be released within the atrium prior to release
of the ventricular anchors within the atrium. For example, the
ventricular anchors may remain radially-constrained with a delivery
device during release of the atrial anchors within the atrium. In
some embodiments, the exemplary prosthetic valve may be arranged in
the configuration illustrated in FIG. 5C in the event that the
atrial anchors are released prior to release of the ventricular
anchors. As FIG. 5C illustrates, the terminal arm ends 2444 may
deflect radially outwards while the annular valve body 2020 and,
optionally, the ventricular anchoring legs 2240 remain radially
constrained.
[0105] In some embodiments, the exemplary method for implanting an
expandable prosthetic valve may include moving the ventricular
anchors, after they are released within the atrium, through the
mitral valve and into the ventricle. For example, FIGS. 10C and 10D
illustrate advancement of the released ventricular anchoring legs
2240 (i.e., the exemplary ventricular anchors) from the atrium
9010, where the ventricular anchoring legs 2240 were released, and
through the mitral valve 9030 into the ventricle 9020. The
ventricular anchoring legs 2240 and atrial anchoring arms 2440
(i.e., the exemplary atrial anchors) may remain fixed in their
positions relative to the distal capsule portion 7340 and proximal
capsule portion 7320, respectively, during advancement of the
ventricular anchoring legs into the ventricle 9020. In some
embodiments, advancement of the released ventricular anchoring legs
2240 into the ventricle 9020 may be controlled by implant catheter
control handle 7160 illustrated in FIG. 7A. For example, the
released ventricular anchoring legs 2240, as well as the rest of
the prosthetic valve, may be secured relative to implant catheter
8100 of FIGS. 7B and 8C, which may be connected to, or otherwise
secured relative to, the implant catheter control handle 7160.
Accordingly, the implant catheter control handle 7160 may be
utilized to control advancement of the deployed ventricular
anchoring legs 2240 into the ventricle.
[0106] In some embodiments, the mitral valve tissue may be
deflected by advancement of the released ventricular anchors
through the mitral valve, after which the mitral valve tissue may
flex back into its natural position. This is illustrated in FIGS.
10C and 10D, which depict deflection of mitral valve leaflets 9032
during passage of ventricular anchoring legs 2240 (i.e., the
exemplary ventricular anchors) through the mitral valve 9030. In
some embodiments, the ventricular anchors may be advanced so far
into the ventricle that at least a portion of the atrial anchors
may be positioned in the ventricle; alternatively, the atrial
anchors may remain in the atrium.
[0107] In some embodiments, the released ventricular anchors may be
moved into the ventricle prior to release of the atrial anchors
within the atrium. That is, the ventricular anchors may be released
in the atrium and moved into the ventricle prior to release of the
atrial anchors within the atrium. For example, the atrial anchors
may remain constrained within a delivery device during release of
the ventricular anchors and movement of the ventricular anchors
into the ventricle. This is illustrated in FIGS. 10C and 10D, which
depict at least a portion of atrial anchoring arms 2440 (i.e., the
exemplary atrial anchors) constrained within proximal capsule
portion 7320 during release of the ventricular anchoring legs 2240
within atrium 9010 and passage of the ventricular anchoring legs
into the ventricle 9020. In some embodiments, the exemplary
prosthetic valve may be arranged in the configuration illustrated
in FIG. 5B while the released ventricular anchors are moved into
the ventricle. As FIG. 5B illustrates, the terminal leg ends 2244
may deflect radially outwards while the annular valve body 2020 and
atrial anchoring arms 2440 remain radially constrained.
Advantageously, movement of the ventricular anchors into the
ventricle prior to release of the atrial anchors may permit the
ventricular anchors to be properly positioned relative to the
mitral valve prior to release of the atrial anchors. That is, by
retaining the atrial anchors in their radially-constrained
configuration, the atrial anchors may not hinder the placement of
the ventricular anchors in the ventricle.
[0108] In some embodiments, the exemplary method for implanting an
expandable prosthetic valve may include releasing the annular valve
body after moving the released ventricular anchors from the atrium
to the ventricle. As a result of releasing the annular valve body,
the prosthetic valve may be anchored within the mitral valve. In
some embodiments, release of the annular valve body may also occur
after releasing the ventricular anchors and atrial anchors within
the atrium. For example, the annular valve body may remain
radially-constrained within a delivery device during release of the
atrial and ventricular anchors and during movement of the released
ventricular anchors from the atrium into the ventricle, after which
the annular valve body may be released from the delivery device.
FIG. 10G illustrates an embodiment in which annular valve body 2020
is released from distal capsule portion 7340 after the ventricular
anchoring legs 2240 (i.e., the exemplary ventricular anchors) are
released from the distal capsule portion 7340 (FIG. 10C), after the
released ventricular anchoring legs 2240 are moved into the
ventricle 9020 (FIG. 10D), and after the atrial anchoring arms 2440
(i.e., the exemplary atrial anchors) are released from the proximal
capsule portion 7320 (FIG. 10F). In the embodiment shown in FIG.
10G, the annular valve body may be released when the annular valve
body is positioned in the ventricle. In other embodiments, the
annular valve body may be released in a different portion of the
heart. In some embodiments, the exemplary prosthetic valve may be
arranged in the configuration illustrated in FIG. 5E after release
of the annular valve body. As FIG. 5E illustrates, annular valve
body 2020, atrial anchoring arms 2440, and ventricular anchoring
legs 2440 may be fully deployed upon release of the annular valve
body. In some embodiments, the annular valve body may radially
expand when released, thus anchoring the prosthetic valve within
the mitral valve.
[0109] In some embodiments, the annular valve body, atrial anchors,
and ventricular anchors may be arranged within a delivery device
according to the configuration illustrated in FIG. 8C. As shown in
FIG. 8C, at least a portion of each atrial anchoring arm 2440
(i.e., the exemplary atrial anchors) may be retained within the
proximal capsule portion 7320, including the distal arm ends 2444.
The proximal capsule portion 7320 may be configured for proximal
movement relative to the atrial anchoring arms 2440 (i.e., the
exemplary atrial anchors); upon movement of the proximal capsule
portion 7320 to a position in which the atrial anchoring arms 2440
are no longer retained therein, the atrial anchoring arms may
deflect radially outwards (as illustrated in FIG. 10F).
[0110] Additionally, or alternatively, the annular valve body 2020
and ventricular anchoring legs 2244 illustrated in FIG. 8C may be
retained within the distal capsule portion 7340 in such a fashion
that the terminal leg ends 2244 may be situated in closer proximity
to the open, proximal end of the distal capsule portion (that is,
the right side of distal capsule portion 7340 in FIG. 8C) than is
the annular valve body. The distal capsule portion 7340 may be
configured for longitudinal movement relative to the ventricular
anchoring legs 2240 (i.e., the exemplary ventricular anchors) and
annular valve body 2020. In some embodiments, the distal capsule
portion 7340 may be configured to advance distally until it reaches
a position in which the terminal leg ends 2244 are no longer
retained within the distal capsule portion 7340. As the ventricular
anchoring legs 2240 emerge from the distal capsule portion 7340,
they may be free from radially-constraining forces and may deflect
radially outward (e.g., due to their shape-memory properties). The
distal capsule portion 7340 may be moved distally until at least a
portion of the ventricular anchoring legs 2240 are no longer
contained within the distal capsule portion 7340, allowing the
ventricular anchoring legs to deflect radially outwards (as
illustrated in FIG. 10C). However, at least a portion of the
annular valve body 2020 remains retained within the distal capsule
portion 7340 at this longitudinal position of the distal capsule
portion. Accordingly, the annular valve body 2020 remains
radially-constrained by the distal capsule portion 7340 and may be
prevented from radially expanding. The distal capsule portion 7340
may then be further moved in the distal direction until the annular
valve body 2020 is no longer contained within the distal capsule
portion. At such a point, the annular valve body 2020 may be free
from radially-constraining forces and may expand radially outward
due to its shape-memory properties (as illustrated in FIG.
10H).
[0111] In some embodiments, the annular valve body may be
constrained from expansion (including radial expansion) during
release of the ventricular anchors and atrial anchors and during
movement of the ventricular anchors into the ventricle. For
example, as illustrated in FIGS. 10C-10H, the annular valve body
2020 may remain constrained within the distal capsule portion 7340
during distal movement of the distal capsule portion 7340 to
release the ventricular anchoring legs 2240 (i.e., the exemplary
ventricular anchors) (FIG. 10C), during passage of the released
ventricular anchoring legs 2240 into the ventricle 9020 (FIG. 10D),
and during proximal movement of the proximal capsule portion 7320
to release the atrial anchoring arms 2440 (i.e., the exemplary
atrial anchors) (FIG. 10F). For example, after movement of the
distal capsule portion 7340 to the position at which the
ventricular anchoring legs 2240 are released, further movement of
the distal capsule portion may be prevented until release of the
annular valve body 2020 is desired. In some embodiments,
constraining the annular valve body against expansion may permit
the atrial anchors and ventricular anchors to be positioned at
their desired locations, such as within the atrium and ventricle,
respectively. Upon expansion of the annular valve body, the
prosthetic valve may be secured within the mitral valve.
[0112] After release of the atrial anchors and ventricular anchors,
but prior to release of the annular valve body (i.e., the
configuration of FIG. 10F), the prosthetic valve may be configured
to assume a configuration similar to the configuration of the
prosthetic valve illustrated in FIG. 5D. FIG. 5D illustrates a
configuration in which atrial anchoring arms 2440 and ventricular
anchoring legs 2240 have been released, but annular valve body 2020
remains radially constrained. In the configuration of FIG. 5D, the
terminal leg ends 2244 may be spaced apart from the atrial
anchoring arms 2440 (in particular, from arm portions 3504 and
3506) by distance 5004. Due to the presence of the space
represented by distance 5004 between the atrial anchoring arms 2440
and ventricular anchoring legs 2240, mitral valve tissue may be
retained between the atrial anchoring arms 2440 and ventricular
anchoring legs. However, because the atrial anchoring arms and
ventricular anchoring legs do not clamp on tissue when the
prosthetic valve is in this configuration, the prosthetic valve may
be configured for small axial and lateral movements relative to the
mitral valve tissue. As a result, the prosthetic valve may be
maneuvered into the desired position with respect to the mitral
valve tissue, with the native valve tissue arranged at the desired
position between the atrial anchoring arms 2440 and legs 2240.
[0113] Upon release of the annular valve body, the annular valve
body may radially expand due to the lack of radially-constraining
forces on the annular valve body. Upon release of the annular valve
body, the prosthetic valve may assume the configuration illustrated
in FIGS. 10G and 10H, in which the prosthetic valve 6000 is
securely anchored within mitral valve 9030; the configuration of
the prosthetic valve in FIGS. 10G and 10H may be similar to the
configuration of the prosthetic valve illustrated in FIG. 5E. In
some embodiments, and as illustrated in FIG. 5E, the axial distance
5004 between the released atrial anchors and the released
ventricular anchors may be reduced or eliminated upon release of
the annular valve body. For example, in FIG. 5E, the axial distance
between terminal leg ends 2244 and portions 3504 and 3506 of atrial
anchoring arms 2440 (i.e., the exemplary atrial anchors) may be
reduced or, in some embodiments, completely removed, relative to
their respective positions in FIG. 5D. As a result, the atrial
anchors and ventricular anchors may be configured to grasp or clamp
tissue of the native mitral valve to securely anchor the prosthetic
valve in place. For example, in the configuration illustrated in
FIGS. 10G and 10H, atrial anchoring arms 2440 may exert a
ventricularly-directed force (that is, a force directed downwards
towards ventricle 9020 in FIGS. 10G and 10H) on the mitral valve
tissue. Similarly, ventricular anchoring legs 2240 (i.e., the
exemplary ventricular anchors) may exert an atrially-directed force
(that is, a force directed upwards towards atrium 9010 in FIGS. 10G
and 10H) on the mitral valve tissue. These opposing forces may
clamp or "sandwich" the mitral valve tissue between the atrial
anchoring arms 2440 and ventricular anchoring legs 2240. In some
embodiments, reduction of the axial distance between the atrial
anchoring arms 2440 and ventricular anchoring legs 2240 may reduce
the volume between the atrial anchoring arms and ventricular
anchoring legs in which mitral valve tissue is retained. This
reduction in volume may cause the tissue to slightly deform the
atrial anchoring arms 2440 and ventricular anchoring legs 2240. Due
to their shape memory characteristics, the atrial anchoring arms
2440 and ventricular anchoring legs 2240 may resist the deformation
and exert a strengthened clamping force on the mitral valve tissue
between the atrial anchoring arms and ventricular anchoring legs.
This clamping or "sandwiching" effect may firmly anchor prosthetic
valve 6000 within mitral valve 9030. Accordingly, in some
embodiments, release of the annular valve body may cause the
ventricular anchors and atrial anchors to clamp native valve tissue
therebetween.
[0114] Additionally, or alternatively, the ventricular anchors and
the atrial anchors may shift radially outward when the annular
valve body is released. That is, the ventricular anchors and atrial
anchors may be positioned in closer proximity to the longitudinal
axis of the prosthetic valve prior to release of the annular valve
body than after release of the annular valve body. This may be due,
at least in part, to the fact that the ventricular anchors and
atrial anchors are secured to the annular valve body in some
embodiments. Thus, release and radial expansion of the annular
valve body may cause the ventricular anchors and the atrial anchors
to shift radially outward. For example, FIG. 5D illustrates an
embodiment of a valve frame 2000 of an exemplary prosthetic valve
prior to expansion of the annular valve body 2020, and FIG. 5E
illustrates an embodiment of the valve frame 2000 after expansion
of the annular valve body 2020. As FIGS. 5D and 5E illustrate, the
entire length of atrial anchoring arms 2440 (i.e., the exemplary
atrial anchors) and ventricular anchoring legs 2240 (i.e., the
exemplary ventricular anchors) may shift radially outward upon
expansion of annular valve body 2020. For example, terminal arm
ends 2444 and terminal leg ends 2244 may shift radially outward
upon expansion of annular valve body 2020. Additionally, or
alternatively, proximal arm ends 3020 and proximal leg ends 3622
may shift radially outward upon expansion of annular valve body
2020.
[0115] In some embodiments, each ventricular anchor may include a
connection point to the annular valve body. The connection point
may be a weld, an adhesion, an over-mold, or a continuous
integration of the ventricular anchor to or with the annular valve
body. Accordingly, the number of ventricular anchors of the
prosthetic valve may equal the number of connection points. In
FIGS. 2A, 5D, and 5E, ventricular anchoring legs 2440 may be
connected to annular valve body 2020 at leg attachment junctions
3802; accordingly, in some embodiments the leg attachment junctions
3802 may constitute the connection points of the ventricular
anchors to the annular valve body.
[0116] In some embodiments, the connection points of the
ventricular anchors may be configured to form a first diameter
during movement of the ventricular anchors into the ventricle. That
is, after release of the ventricular anchors in the atrium and
prior to release of the annular valve body, the connection points
may be positioned around a circumference of the annular valve body
in a substantially circular arrangement having a first diameter.
For example, in FIGS. 5B and 5D, leg attachment junctions 3802
(i.e., the exemplary connection points of the ventricular anchors)
may be arranged in a substantially circular arrangement having a
diameter equal to the first diameter. In some embodiments, the
first diameter may be equal to the diameter formed by the
connection points of the ventricular anchors prior to release of
the ventricular anchors. Alternatively, the first diameter may be
larger than or smaller than the diameter formed by the connection
points of the ventricular anchors prior to release of the
ventricular anchors. FIGS. 10C and 10D illustrate an example in
which the released ventricular anchoring legs 2240 (i.e., the
exemplary ventricular anchors) are moved into the ventricle 9020
while the leg attachment junctions 3802 (i.e., the exemplary
connection points of the ventricular anchors) form the first
diameter.
[0117] In some embodiments, the connection points of the
ventricular anchors may be configured to form a second diameter
after release of the annular valve body. The second diameter of the
connection points of the ventricular anchors may be larger than the
first diameter of the connection points of the ventricular anchors.
For example, after release of the annular valve body, the
connection points may be positioned around a circumference of the
annular valve body in a substantially circular arrangement having a
second diameter that is larger than the first diameter. For
example, in FIG. 5E, leg attachment junctions 3802 (i.e., the
exemplary connection points of the ventricular anchors) may be
arranged in a substantially circular arrangement having a diameter
equal to the second diameter. As illustrated by FIGS. 5D and 5E,
the second diameter of leg attachment junctions 3802 (shown in FIG.
5E) is larger than the first diameter of the leg attachment
junctions 3802 (shown in FIG. 5D). FIGS. 10G and 10H illustrate an
example in which the annular valve body 2020 has been released.
Accordingly, in FIGS. 10G and 10H, the leg attachment junctions
3802 (i.e., the exemplary connection points of the ventricular
anchors) form the second diameter.
[0118] In some embodiments, the exemplary method for implanting an
expandable prosthetic valve may include prior to release of the
annular valve body, moving the released ventricular anchors in an
atrial direction such that the ventricular anchors engage tissue of
the native mitral valve. This may occur, for example, after the
ventricular anchors are released in the atrium and moved into the
ventricle. Once the released ventricular anchors are in the
ventricle, the ventricular anchors may be moved in an atrial
direction to a position at which the ventricular anchors engage
ventricular tissue of the native mitral valve. An example of this
movement is illustrated in FIGS. 10D and 10E. In FIG. 10D, the
released ventricular anchoring legs 2240 (i.e., the exemplary
ventricular anchors) are moved into ventricle 9020. In FIG. 10E,
the released ventricular anchoring legs 2240 are then moved in an
atrial direction (that is, towards atrium 9010) until legs 2240
engage the ventricular-side tissue of mitral valve 9030. In some
embodiments, movement of the released ventricular anchors in an
atrial direction may occur prior to release of the annular valve
body and prior to release of the atrial anchors. In the example
illustrated in FIGS. 10D and 10E, atrial anchoring arms 2440 (i.e.,
the exemplary atrial anchors) may remain constrained within
proximal capsule portion 7320 and annular valve body 2020 may
remain constrained within distal capsule portion 7340 during
movement of the released ventricular anchoring legs 2240 into the
ventricle 9020 and the subsequent movement of the ventricular
anchoring legs in the atrial direction.
[0119] In some embodiments, the ventricular anchors may be
configured to pull distinct portions of the native mitral valve
together. For example, the ventricular anchors may be configured to
pull distinct portions of the native mitral valve together when the
released ventricular anchors are positioned in the ventricle and
moved in an atrial direction to engage tissue of the mitral valve.
In some embodiments, the expression "distinct portions of the
native mitral valve" may refer to portions of the mitral valve
situated apart from each other or configured for movement relative
to each other. For example, "distinct portions of the native mitral
valve" may refer to the leaflets of the native mitral valve, which
may be configured to move apart from and towards each other to form
open and closed positions of the mitral valve. In some embodiments,
the deployed ventricular anchors may be configured to firmly grasp
the mitral valve leaflets and pull the leaflets together, due in
part to the shape memory properties of the ventricular anchors. In
some embodiments, the ventricular anchors may be configured to pull
the mitral valve leaflets together until the leaflets are
positioned against the radially-constrained atrial anchors and
annular valve body, thus grasping and pulling the native mitral
valve substantially closed. For example, as depicted in FIG. 10E,
the ventricular anchoring legs 2240 are radially extended and grasp
the mitral valve leaflets 9032, pulling the leaflets together until
the leaflets are held against the constrained atrial anchoring arms
2440 (i.e., the exemplary atrial anchors) and annular valve body
2020. As a result, mitral valve 9030 may be held in a closed
position by the deployed ventricular anchoring legs 2240.
[0120] After the released ventricular anchors are moved atrially to
engage the ventricular side of the mitral valve, the atrial anchors
may then be released, thus retaining the tissue between the atrial
anchors and ventricular anchors. For example, as depicted in FIG.
10F, after the atrial anchoring arms 2440 are released, the mitral
valve tissue may be held between the atrial anchoring arms 2440 and
the ventricular anchoring legs 2240 (i.e., the exemplary
ventricular anchors). Upon radial expansion of the annular valve
body, illustrated in FIG. 10G, the annular anchors and ventricular
anchors may grasp or "sandwich" the tissue, thus anchoring the
prosthetic valve in the mitral valve.
[0121] In some alternative embodiments of the present disclosure, a
method of implanting an expandable prosthetic valve within a native
mitral valve between an atrium and a ventricle may be provided. In
some embodiments, the exemplary method of implanting an expandable
prosthetic valve may include outwardly moving terminal ends of
ventricular anchors relative to a portion of an annular valve body
positioned within the atrium. For example, the ventricular anchors
and annular valve body may be radially-constrained within the
atrium, such as within a delivery device. At least a portion of the
ventricular anchors may be released from the delivery device, such
that the terminal ends of the ventricular anchors may deflect
radially outwards. However, the annular valve body may remain
radially-constrained within the delivery device; accordingly, the
terminal ends of the ventricular anchors may move outwardly
relative to the constrained annular valve body. In some
embodiments, the terminal ends of the ventricular anchors may be
configured to move outwardly relative to a portion of the
constrained annular valve body positioned within an atrium. For
example, FIG. 10C illustrates an embodiment in which distal
movement of the distal capsule portion 7340 releases the
ventricular anchoring legs 2240 (i.e., the exemplary ventricular
anchors). As a result, the terminal leg ends 2244 move radially
outward relative to the annular valve body 2020, while the annular
valve body 2020 remains constrained within the distal capsule
portion 7340. As illustrated in FIG. 10C, at least a portion of the
annular valve body 2020 may be positioned within the atrium
9010.
[0122] In some embodiments, the exemplary method of implanting an
expandable prosthetic valve may include advancing at least a
portion of the expandable prosthetic valve containing the
ventricular anchors through the native mitral valve into the
ventricle after outwardly moving the terminal ends of the
ventricular anchors. In some embodiments, the atrial anchors and
annular valve body may remain constrained (e.g., within delivery
capsule 7300) during movement of the portion of the prosthetic
valve containing the ventricular anchors into the ventricle. In
some embodiments, the entire prosthetic valve, including the
ventricular anchors, may be advanced into the ventricle.
Alternatively, at least a portion of the prosthetic valve,
including the ventricular anchors, may be advanced into the
ventricle while at least another portion of the prosthetic valve
remains in the atrium and/or within the orifice of the mitral
valve. For example, at least a portion of the atrial anchors may
remain in the atrium and/or within the orifice of the mitral valve
when the portion of the prosthetic valve containing the ventricular
anchors is advanced into the ventricle. For example, FIG. 10D
illustrates an embodiment in which at least a portion of the
prosthetic valve, including the deployed ventricular anchoring legs
2240 (i.e., the exemplary ventricular anchors), is advanced through
the mitral valve 9030 and into the ventricle 9020. In the example
illustrated in FIG. 10D, annular valve body 2020 and atrial
anchoring arms 2440 (i.e., the exemplary atrial anchors) may remain
constrained within distal capsule portion 7340 and proximal capsule
portion 7320, respectively.
[0123] In some embodiments, the exemplary method of implanting an
expandable prosthetic valve may include outwardly moving terminal
ends of atrial anchors relative to a portion of the annular valve
body while the atrial anchors are at least partially positioned
within the atrium. For example, the atrial anchors may be released
from a delivery device while the atrial anchors are at least
partially positioned within the atrium. As a result, the terminal
ends of the atrial anchors may deflect radially outwards. However,
the annular valve body may remain radially-constrained within the
delivery device; accordingly, the terminal ends of the atrial
anchors may move outwardly relative to the constrained annular
valve body. In some embodiments, the terminal ends of the atrial
anchors may be moved outwardly after the terminal ends of the
ventricular anchors are moved outwardly. In some embodiments, the
terminal ends of the atrial anchors may be moved outwardly after
the portion of the expandable prosthetic valve containing the
deployed ventricular anchors is advanced through the mitral valve
into the ventricle. For example, FIG. 1OF illustrates an embodiment
in which proximal movement of the proximal capsule portion 7320
releases the atrial anchoring arms 2440 (i.e., the exemplary atrial
anchors). As a result, the terminal arm ends 2444 may move radially
outward relative to the annular valve body 2020, which remains
constrained within the distal capsule portion 7340. As illustrated
in FIG. 10F, at least a portion of the atrial anchoring arms 2440
may be positioned within the atrium 9010 during outward movement of
the terminal arm ends 2444.
[0124] In some embodiments, the exemplary method of implanting an
expandable prosthetic valve may include radially expanding the
annular valve body after outwardly moving the terminal ends of the
ventricular anchors and outwardly moving the terminal ends of the
atrial anchors. Radial expansion of the annular valve body may
anchor native heart valve tissue between the atrial anchors and
ventricular anchors. For example, the annular valve body may be
removed from the delivery device, such that it may be free of
radially-constraining forces. As a result of its shape memory
properties, the annular valve body may expand radially outward,
which may anchor the prosthetic valve in the mitral valve. In some
embodiments, the annular valve body may be expanded within the
ventricle. For example, FIG. 10G illustrates an embodiment in which
distal movement of the distal capsule portion 7340 releases the
annular valve body 2020 within ventricle 9020. As a result, the
annular valve body 2020 may radially expand, causing the
ventricular anchoring legs 2240 (i.e., the exemplary ventricular
anchors) and atrial anchoring arms 2440 to firmly clamp the native
valve tissue, thus anchoring prosthetic valve 6000 within mitral
valve 9030. As a result, in some embodiments, expansion of the
annular valve body may anchor the prosthetic valve within the
native mitral valve.
[0125] In some embodiments, the ventricular anchors and the atrial
anchors may be biased to assume expanded configurations and may be
constrained in non-expanded configurations. For example, the
ventricular anchors and atrial anchors may be biased to assume
expanded configurations due to their shape memory properties. In
some embodiments, the ventricular anchors and atrial anchors may be
constrained by a delivery device (e.g., delivery capsule) which may
be configured to exert a radially- constraining force on the
ventricular anchors and atrial anchors. As a result, the
ventricular anchors and atrial anchors may be constrained in a
non-expanded configuration and may be prevented from deflecting
radially outward. For example, FIG. 8C illustrates an embodiment in
which atrial anchoring arms 2440 (i.e., the exemplary atrial
anchors) and ventricular anchoring legs 2240 are constrained in
non-expanded configurations by proximal capsule portion 7320 and
distal capsule portion 7340, respectively, of delivery capsule
7300. In some embodiments, delivery capsule 7300 may be configured
to retain the prosthetic valve in the prosthetic valve
configuration illustrated in FIG. 5A.
[0126] In some embodiments, outwardly moving the respective
terminal ends of the ventricular anchors and the atrial anchors may
include respectively releasing constraints on the ventricular
anchors and the atrial anchors. Releasing the constraints on the
ventricular anchors and atrial anchors may enable the ventricular
anchors and the atrial anchors to spring outwardly. For example,
the ventricular anchors and atrial anchors may be released from the
delivery device, thus freeing the ventricular anchors and atrial
anchors from the radially-constraining forces exerted by the
delivery device. As a result of the shape memory properties of the
ventricular anchors and atrial anchors, the terminal ends of the
ventricular anchors and atrial anchors may be configured to deflect
radially outward, relative to the annular valve body. For example,
releasing constraints on the ventricular anchors and atrial anchors
may permit the prosthetic valve to transition from the
configuration illustrated in FIG. 5A to the configuration
illustrated in FIG. 5D. In the example depicted in FIG. 5D, the
atrial anchoring arms 2440 and ventricular anchoring legs 2240
(i.e., the exemplary ventricular anchors) may be free from
radially-constraining force; accordingly, the terminal arm ends
2444 and terminal leg ends 2244 may deflect radially outwards from
the annular valve body 2020. However, the annular valve body 2020
may remain radially-constrained, such as within distal capsule
portion 7340.
[0127] In some embodiments, expanding the annular valve body may
include releasing the annular valve body from a constraint. As a
result, the annular valve body may be enabled to expand to a
pre-contraction expanded configuration. In some embodiments, the
annular valve body may be biased to assume a radially-expanded
configuration; this may be due, at least in part, to the shape
memory properties of the annular valve body. As a result, the
annular valve body may expand back into the radially-expanded
configuration after being radially contracted. For example, FIG. 5E
illustrates an exemplary annular valve body 2020 in a
radially-expanded configuration. Annular valve body 2020 may be
biased to expand to the configuration illustrated in FIG. 5E, due
in part to the shape memory properties of the annular valve body.
In some embodiments, a constraint (e.g., a radially-constraining
delivery device) may exert a radially-contracting force on the
annular valve body, causing it to radially contract and preventing
the annular valve body from expanding. Upon removal of the
constraining force, the annular valve body may be configured to
expand back to its pre-contraction expanded configuration (e.g.,
the configuration illustrated in FIG. 5E).
[0128] In some embodiments, the exemplary method of implanting an
expandable prosthetic valve may include advancing the ventricular
anchors in an atrial direction prior to expanding the annular valve
body. As a result of advancing the ventricular anchors in an atrial
direction, the ventricular anchors may engage tissue of the native
mitral valve. In some embodiments, advancing the ventricular
anchors in an atrial direction may occur after the ventricular
anchors are released in the atrium and moved into the ventricle and
prior to release of the atrial anchors and annular valve body. In
some embodiments, the ventricular anchors may engage ventricular
tissue of the native mitral valve; for example, the ventricular
anchors may grasp the mitral valve tissue and hold it in place
during expansion of the remainder of the prosthetic valve. An
example of advancing the ventricular anchors in an atrial direction
is illustrated in FIGS. 10D and 10E. In FIG. 10D, the released
ventricular anchoring legs 2240 (i.e., the exemplary ventricular
anchors) are moved into ventricle 9020. In FIG. 10E, the released
ventricular anchoring legs 2240 are then moved in an atrial
direction (that is, towards atrium 9010) until legs 2240 engage the
ventricular-side tissue of mitral valve 9030.
[0129] The foregoing description has been presented for purposes of
illustration. It is not exhaustive and is not limited to precise
forms or embodiments disclosed. Modifications and adaptations of
the embodiments will be apparent from consideration of the
specification and practice of the disclosed embodiments. For
example, while certain components have been described as being
coupled to one another, such components may be integrated with one
another or distributed in any suitable fashion.
[0130] Moreover, while illustrative embodiments have been described
herein, the scope includes any and all embodiments having
equivalent elements, modifications, omissions, combinations (e.g.,
of aspects across various embodiments), adaptations and/or
alterations based on the present disclosure. The elements in the
claims are to be interpreted broadly based on the language employed
in the claims and not limited to examples described in the present
specification or during the prosecution of the application, which
examples are to be construed as nonexclusive. Further, the steps of
the disclosed methods can be modified in any manner, including
reordering steps and/or inserting or deleting steps.
[0131] The features and advantages of the disclosure are apparent
from the detailed specification, and thus, it is intended that the
appended claims cover all systems and methods falling within the
true spirit and scope of the disclosure. As used herein, the
indefinite articles "a" and "an" mean "one or more." Similarly, the
use of a plural term does not necessarily denote a plurality unless
it is unambiguous in the given context. Words such as "and" or "or"
mean "and/or" unless specifically directed otherwise. Further,
since numerous modifications and variations will readily occur from
studying the present disclosure, it is not desired to limit the
disclosure to the exact construction and operation illustrated and
described, and, accordingly, all suitable modifications and
equivalents may be resorted to, falling within the scope of the
disclosure.
[0132] Other embodiments will be apparent from consideration of the
specification and practice of the embodiments disclosed herein. It
is intended that the specification and examples be considered as
example only, with a true scope and spirit of the disclosed
embodiments being indicated by the following claims.
* * * * *