U.S. patent application number 16/933259 was filed with the patent office on 2020-11-05 for prosthetic mitral valves and apparatus and methods for delivery of same.
This patent application is currently assigned to Tendyne Holdings, Inc.. The applicant listed for this patent is Tendyne Holdings, Inc.. Invention is credited to Mark Christianson, Michael Evans, Igor Kovalsky, Son Mai, John F. Otte, William Peckels, Chad Perrin, Robert Vidlund, Zachary R. Vidlund.
Application Number | 20200345487 16/933259 |
Document ID | / |
Family ID | 1000004961431 |
Filed Date | 2020-11-05 |
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United States Patent
Application |
20200345487 |
Kind Code |
A1 |
Christianson; Mark ; et
al. |
November 5, 2020 |
Prosthetic Mitral Valves And Apparatus And Methods For Delivery Of
Same
Abstract
Apparatus and methods are described herein for use in the
transvascular delivery and deployment of a prosthetic mitral valve.
In some embodiments, a method includes inverting an outer frame of
a prosthetic mitral valve when the valve is in a biased expanded
configuration. After inverting the outer frame, the prosthetic
mitral valve is inserted into a lumen of a delivery sheath such
that the mitral valve is moved to a collapsed configuration. The
distal end portion of the delivery sheath is inserted into a left
atrium of a heart. The prosthetic mitral valve is moved distally
out of the delivery sheath such that the inverted outer frame
reverts and the prosthetic mitral valve assumes its biased expanded
configuration. In some embodiments, actuation wires are used to
assist in the reversion of the outer frame. The prosthetic mitral
valve is then positioned within a mitral annulus of the heart.
Inventors: |
Christianson; Mark;
(Plymouth, MN) ; Vidlund; Zachary R.;
(Minneapolis, MN) ; Vidlund; Robert; (Forest Lake,
MN) ; Kovalsky; Igor; (Minnetonka, MN) ;
Peckels; William; (St. Paul, MN) ; Evans;
Michael; (Minneapolis, MN) ; Perrin; Chad;
(Andover, MN) ; Otte; John F.; (Minneapolis,
MN) ; Mai; Son; (Centerville, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Tendyne Holdings, Inc. |
St. Paul |
MN |
US |
|
|
Assignee: |
Tendyne Holdings, Inc.
St. Paul
MN
|
Family ID: |
1000004961431 |
Appl. No.: |
16/933259 |
Filed: |
July 20, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15626607 |
Jun 19, 2017 |
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16933259 |
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PCT/US2016/012305 |
Jan 6, 2016 |
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15626607 |
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PCT/US2015/014572 |
Feb 5, 2015 |
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PCT/US2016/012305 |
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62187896 |
Jul 2, 2015 |
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62137384 |
Mar 24, 2015 |
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62100548 |
Jan 7, 2015 |
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61935899 |
Feb 5, 2014 |
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62100548 |
Jan 7, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/2457 20130101;
A61F 2/246 20130101; A61F 2/2418 20130101; A61F 2/2436 20130101;
A61F 2250/0063 20130101; A61F 2220/0041 20130101; A61F 2220/0083
20130101; A61F 2/2439 20130101; A61F 2220/0075 20130101; A61F
2220/0016 20130101; A61F 2230/0093 20130101; A61F 2250/0098
20130101; A61F 2250/0039 20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. An apparatus, comprising: a delivery sheath defining a lumen; a
valve holder movably disposable within the lumen of the delivery
sheath; a prosthetic heart valve disposed at least partially within
the lumen of the delivery sheath in a collapsed configuration, the
prosthetic heart valve including an outer frame coupled to an inner
frame, the inner frame being removably coupled to a distal end
portion of the valve holder, the outer frame being movable between
a first configuration relative to the inner frame and a second
configuration relative to the inner frame in which the outer frame
is inverted relative to the inner frame, the prosthetic heart valve
being disposed within the lumen of the delivery sheath with the
outer frame in the second configuration; a first actuation wire
releasably coupled to a first portion of an open free end portion
of the outer frame; and a second actuation wire releasably coupled
to a second portion of the open free end portion of the outer
frame, each of the first actuation wire and the second actuation
wire having a first portion extending proximally from the outer
frame and a second portion extending proximally from the outer
frame, the first portion and the second portion of each of the
first actuation wire and the second actuation wire configured to be
pulled proximally to urge the outer frame from the second
configuration towards the first configuration relative to the inner
frame.
2. The apparatus of claim 1, wherein the outer frame includes a
plurality of loop members including at least a first loop member
and a second loop member disposed at the open free end portion, the
first actuation wire being inserted through at least the first loop
member from the plurality of loop members to releasably couple the
first actuation wire to the outer frame, the second actuation wire
being inserted through at least the second loop member from the
plurality of loop members to releasably couple the second actuation
wire to the outer frame.
3. The apparatus of claim 1, wherein the first portion of the first
actuation wire and the second portion of the first actuation wire
each extend proximally from the outer frame and through a first
side aperture defined by a wall of the delivery sheath and within
the lumen of the delivery sheath, and the first portion of the
second actuation wire and the second portion of the second
actuation wire each extend proximally from the outer frame and
through a second side aperture defined by the wall of the delivery
sheath and within the lumen of the delivery sheath.
4. The apparatus of claim 1, further comprising: an outer sheath,
the delivery sheath being movably disposed within a lumen defined
by the outer sheath.
5. The apparatus of claim 1, further comprising: an outer sheath,
the delivery sheath being movably disposed within a lumen defined
by the outer sheath, the first portion of the first actuation wire
and the second portion of the first actuation wire each extending
proximally from the outer frame and through a distal opening
defined by the delivery sheath and within the lumen of the delivery
sheath, and the first portion of the second actuation wire and the
second portion of the second actuation wire each extending
proximally from the outer frame and through a distal opening
defined by the delivery sheath and within the lumen of the delivery
sheath.
6. The apparatus of claim 1, further comprising: an outer sheath,
the delivery sheath being movably disposed within a lumen defined
by the outer sheath, the first portion of the first actuation wire
and the second portion of the first actuation wire each extending
proximally from the outer frame and through the lumen of the outer
sheath and along an outside wall of the delivery sheath, and the
first portion of the second actuation wire and the second portion
of the second actuation wire each extend proximally from the outer
frame and through the lumen of the outer sheath and along an
outside wall of the delivery sheath.
7. The apparatus of claim 3, wherein the first portion of the first
actuation wire and the second portion of the first actuation wire
each extend from within the lumen of the delivery sheath through
side apertures defined by the valve holder and within a lumen
defined by the valve holder, and the first portion of the second
actuation wire and the second portion of the second actuation wire
each extend from within the lumen of the delivery sheath through
side apertures defined by the valve holder and within the lumen of
the valve holder.
8. The apparatus of claim 1, wherein the inner frame includes a
plurality of couplers, the valve holder defining a plurality of
recesses, each coupler from the plurality of couplers configured to
be received within a different recess from the plurality of
recesses to releasably couple the inner frame to the valve
holder.
9. An apparatus, comprising: an outer sheath defining a lumen; an
inner sheath movably disposed within the lumen of the outer sheath
and defining a lumen; a tube member movably disposed within the
lumen of the outer sheath and defining a lumen; a valve holder
movably disposed within the lumen of the inner sheath and within a
lumen defined by the tube member; a prosthetic heart valve disposed
at least partially within the lumen of the outer sheath and at
least partially within the lumen of the inner sheath, the
prosthetic heart valve including an outer frame coupled to an inner
frame, the inner frame being removably coupled to a distal end
portion of the valve holder, the outer frame being movable between
a first configuration relative to the inner frame and a second
configuration relative to the inner frame in which the outer frame
is inverted relative to the inner frame, the prosthetic heart valve
being disposed within the lumen of the outer sheath and the lumen
of the inner sheath with the outer frame in the second
configuration; a first actuation wire releasably coupled to a first
portion of an open free end portion of the outer frame and
releasably coupled to the tube member at a first location on the
tube member; and a second actuation wire releasably coupled to a
second portion of the open free end portion of the outer frame and
releasably coupled to the tube member at a second location on the
tube member.
10. The apparatus of claim 9, wherein the lumen of the tube member
is a first lumen, the first actuation wire is coupled to the tube
member with a first pinning member, and the second actuation wire
is coupled to the tube member with a second pinning member, the
first pinning member being movably disposed within a second lumen
defined by the tube member, the second pinning member being movably
disposed within a third lumen defined by the tube member.
11. The apparatus of claim 9, wherein the outer frame includes a
plurality of loop members including at least a first loop member
and a second loop member disposed at the open free end portion, the
first actuation wire being inserted through at least the first loop
member from the plurality of loop members to releasably couple the
first actuation wire to the outer frame, the second actuation wire
being inserted through at least the second loop member from the
plurality of loop members to releasably couple the second actuation
wire to the outer frame.
12. The apparatus of claim 9, wherein the inner frame includes a
plurality of couplers, the valve holder defining a plurality of
recesses, each coupler from the plurality of couplers configured to
be received within a different recess from the plurality of
recesses to releasably couple the inner frame to the valve
holder.
13. The apparatus of claim 9, wherein the first actuation wire
extends between the first location on the outer frame and the first
location on the tube member proximally from the outer frame through
the lumen of the outer sheath and along an outside wall of the
inner sheath, the second actuation wire extends between the second
location on the outer frame and the second location on the tube
member proximally from the outer frame through the lumen of the
outer sheath and along an outside wall of the inner sheath.
14. The apparatus of claim 9, wherein the first actuation wire
includes a loop configured to be pinned by the first pinning member
to releasably couple the first actuation wire to the tube member,
the second actuation wire includes a loop configured to be pinned
by the second pinning wire to releasably couple the second
actuation wire to the tube member.
15. The apparatus of claim 9, further comprising: a third actuation
wire releasably coupled to a third portion of the open free end
portion of the outer frame and releasably coupled to the tube
member at a third location on the tube member; and a fourth
actuation wire releasably coupled to a fourth portion of the open
free end portion of the outer frame and releasably coupled to the
tube member at a fourth location on the tube member.
16. The apparatus of claim 10, further comprising: a third
actuation wire releasably coupled to a third portion of the open
free end portion of the outer frame and releasably coupled to the
tube member at a third location on the tube member; and a fourth
actuation wire releasably coupled to a fourth portion of the open
free end portion of the outer frame and releasably coupled to the
tube member at a fourth location on the tube member. the third
first pinning member being movably disposed within a third lumen
defined by the tube member, the fourth pinning member being movably
disposed within a fifth lumen defined by the tube member.
17. A method, comprising: inserting a distal end portion of a
delivery sheath into a left atrium of a heart, the delivery sheath
having a prosthetic mitral valve disposed within a lumen of the
delivery sheath, the prosthetic mitral valve having an outer frame
coupled to an inner frame, the outer frame being movable between a
first position relative to the inner frame and a second position
relative to the inner frame in which the outer frame is inverted
relative to the inner frame, the prosthetic mitral valve being
disposed within the lumen of the delivery sheath with the outer
frame in the second positon relative to the inner frame; moving the
prosthetic mitral valve distally out of the delivery sheath;
causing the outer frame of the prosthetic mitral valve to revert
back to the first position relative to the inner frame such that
the prosthetic mitral valve at least partially assumes a biased
expanded configuration; and positioning the prosthetic mitral valve
within a mitral annulus of the heart.
18. The method of claim 17, wherein the outer frame is coupled to
the inner frame with a plurality of coupling joints such that the
outer frame can be moved between the first position relative to the
inner frame and the second position relative to the inner
frame.
19. The method of claim 17, wherein the causing the outer frame to
revert back to the first position relative to the inner frame
includes pulling proximally a first actuation wire and a second
actuation wire, the first actuation wire being releasably coupled
to a first portion of an open free end portion of the outer frame,
the second actuation wire being releasably coupled to a second
portion of the open free end portion of the outer frame.
20. The method of claim 17, wherein the causing the outer frame to
revert back to the first position relative to the inner frame
includes pulling proximally a tube member movably disposed within
the lumen of the delivery sheath, the tube member being coupled to
the outer frame via a first actuation wire and a second actuation
wire, the first actuation wire being releasably coupled to a first
portion of an open free end portion of the outer frame and having a
first portion releasably coupled to the tube member at a first
location on the tube member and a second portion releasably coupled
to the tube member at a second location on the tube member, the
second actuation wire being releasably coupled to a second portion
of the open free end portion of the outer frame and having a first
portion releasably coupled to the tube member at a third location
on the tube member and a second portion releasably coupled to the
tube member at a fourth location on the tube member.
21. The method of claim 17, wherein the moving the prosthetic
mitral valve distally out of the delivery sheath includes at least
in part, moving distally an inner sheath movably disposed within
the delivery sheath, the prosthetic mitral valve being at least
partially disposed with a lumen of the inner sheath.
22. The method of claim 17, wherein the moving the prosthetic
mitral valve distally out of the delivery sheath includes at least
in part, moving distally a valve holder movably disposed within the
delivery sheath, the valve holder being releasably coupled to the
inner frame of the prosthetic mitral valve.
23. The method of claim 17, further comprising: after causing the
outer frame of the prosthetic mitral valve to revert back to the
first position relative to the inner frame and prior to positioning
the prosthetic mitral valve within a mitral annulus of the heart,
releasing the first actuation wire from one of the first location
on the tube member and the second location on the tube member;
releasing the second actuation wire from one of the third location
on the tube member and the fourth location on the tube member; and
after releasing the first actuation wire and the second actuation
wire, pulling the tube member proximally such that the first
actuation wire and the second actuation wire are released from the
outer frame.
24. The method of claim 19, further comprising: after the causing
the outer frame to revert back to the first position relative to
the inner frame and the prosthetic mitral valve at least partially
assumes the biased expanded configuration, pulling proximally on
the first actuation wire and the second actuation wire to move the
outer frame to at least a partially radially collapsed
configuration outside of the delivery sheath.
25. The method of claim 19, further comprising: after the causing
the outer frame to revert back to the first position relative to
the inner frame and the prosthetic mitral valve at least partially
assumes the biased expanded configuration, pulling proximally on
the tube member to move the outer frame to at least a partially
radially collapsed configuration outside of the delivery sheath.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation U.S. patent application
Ser. No. 15/626,607, filed Jun. 19, 2017, which is a continuation
of International Application No. PCT/US2016/012305, filed on Jan.
6, 2016, which claims priority to and is a continuation-in-part of
International Application No. PCT/US2015/014572, entitled
"Apparatus and Methods for Transfemoral Delivery of Prosthetic
Valve," filed Feb. 5, 2015, which claims priority to and the
benefit of U.S. Provisional Patent Application Ser. No. 61/935,899,
entitled "Transfemoral Delivery of Prosthetic Mitral Valve," filed
Feb. 5, 2014, and U.S. Provisional Patent Application No.
62/100,548, entitled "Apparatus and Methods for Transfemoral
Delivery of Prosthetic Mitral Valve," filed Jan. 7, 2015. The
disclosure of each of the foregoing applications is incorporated
herein by reference in its entirety.
[0002] International Application No. PCT/US2016/012305 also claims
priority to and the benefit of U.S. Provisional Patent Application
No. 62/100,548, entitled "Apparatus and Methods for Transfemoral
Delivery of Prosthetic Mitral Valve," filed Jan. 7, 2015. The
disclosure of which is incorporated herein by reference in its
entirety.
[0003] International Application No. PCT/US2016/012305 also claims
priority to and the benefit of U.S. Provisional Patent Application
Ser. No. 62/187,896, entitled "Apparatus and Methods for Delivery
of a Prosthetic Mitral Valve," filed Jul. 2, 2015, and U.S.
Provisional Patent Application Ser. No. 62/137,384, entitled
"Apparatus and Method for Delivery of a Prosthetic Mitral Valve,"
filed Mar. 24, 2015. The disclosure of each of the foregoing
applications is incorporated herein by reference in its
entirety.
BACKGROUND
[0004] Embodiments are described herein that relate to devices and
methods for use in the delivery and deployment of prosthetic
valves, and particularly to devices and methods for prosthetic
heart valves that provide for delivery of the prosthetic heart
valves to within a heart of a patient in an inverted
configuration.
[0005] Prosthetic heart valves can pose particular challenges for
delivery and deployment within a heart. Valvular heart disease, and
specifically, aortic and mitral valve disease is a significant
health issue in the United States (US); annually approximately
90,000 valve replacements are conducted in the US. Traditional
valve replacement surgery involving the orthotopic replacement of a
heart valve is considered an "open heart" surgical procedure.
Briefly, the procedure necessitates surgical opening of the thorax,
the initiation of extra-corporeal circulation with a heart-lung
machine, stopping and opening the heart, excision and replacement
of the diseased valve, and re-starting of the heart. While valve
replacement surgery typically carries a 1-4% mortality risk in
otherwise healthy persons, a significantly higher morbidity is
associated to the procedure largely due to the necessity for
extra-corporeal circulation. Further, open heart surgery is often
poorly tolerated in elderly patients. Thus elimination of the
extra-corporeal component of the procedure could result in
reduction in morbidities and cost of valve replacement therapies
could be significantly reduced.
[0006] While replacement of the aortic valve in a transcatheter
manner is the subject of intense investigation, lesser attention
has been focused on the mitral valve. This is in part reflective of
the greater level of complexity associated to the native mitral
valve apparatus, and thus, a greater level of difficulty with
regards to inserting and anchoring the replacement prosthesis. A
need exists for delivery devices and methods for transcatheter
mitral valve replacements.
[0007] Some known delivery methods include delivering a prosthetic
mitral valve through an apical puncture site. In such a procedure,
the valve is placed in a compressed configuration within a lumen of
a delivery catheter of, for example, 34-36 Fr (i.e. an outer
diameter of about 11-12 mm). Delivery of a prosthetic valve to the
atrium of the heart can be accomplished, for example, via a
transfemoral approach, transatrially directly into the left atrium
of the heart or via a jugular approach. In such cases, it is
desirable for the prosthetic valve to have a small outer perimeter
or profile to allow insertion through a smaller delivery catheter
of, for example, 28 Fr (i.e. an outer diameter of about 9 mm).
Thus, a need exist for prosthetic heart valves that can have a
small profile during delivery while still maintaining the size and
characteristics needed to perform their desired function within the
heart.
[0008] Thus, a need exist for prosthetic heart valves that can have
a small profile during delivery while still maintaining the size
and characteristics needed to perform their desired function within
the heart.
[0009] A need also exists for devices and methods for delivering
and deploying a prosthetic heart valve within a heart, with the
valve disposed within a small diameter delivery sheath and then
moving the valve to an expanded configuration within the heart.
SUMMARY
[0010] Apparatus and methods are described herein for various
embodiments of a prosthetic heart valve that can be moved to an
inverted configuration for delivery of the prosthetic heart valve
to within a patient's heart. In some embodiments, an apparatus
includes a prosthetic heart valve that includes an inner frame and
an outer frame coupled to the inner frame at multiple coupling
joints. The prosthetic valve is movable between a first
configuration and a second configuration. The multiple coupling
joints are configured to allow the outer frame to be moved between
a first position relative to the inner frame and a second position
relative to inner frame in which the outer frame is inverted
relative to the inner frame. The prosthetic valve is in the first
configuration when the outer frame is in the first position, and in
the second configuration when the outer frame is in the second
position.
[0011] In some embodiments, an apparatus includes a delivery sheath
that defines a lumen, a valve holder movably disposable within the
lumen of the delivery sheath, and a prosthetic heart valve disposed
at least partially within the lumen of the delivery sheath in a
collapsed configuration. The prosthetic heart valve includes an
outer frame coupled to an inner frame and the inner frame is
releasably coupled to a distal end portion of the valve holder. The
outer frame is movable between a first configuration relative to
the inner frame and a second configuration relative to the inner
frame in which the outer frame is inverted relative to the inner
frame. The prosthetic heart valve is disposed within the lumen of
the delivery sheath with the outer frame in the second
configuration. A first actuation wire is releasably coupled to a
first portion of an open free end portion of the outer frame and a
second actuation wire is releasably coupled to a second portion of
the open free end portion of the outer frame. Each of the first
actuation wire and the second actuation wire has a first portion
extending proximally from the outer frame and a second portion
extending proximally from the outer frame. The first portion and
the second portion of each of the first actuation wire and the
second actuation wire are configured to be pulled proximally to
urge the outer frame from the second configuration towards the
first configuration relative to the inner frame.
BRIEF DESCRIPTION OF THE FIGURES
[0012] FIGS. 1A and 1B are schematic illustrations of a portion of
a prosthetic heart valve, according to an embodiment, shown in a
first configuration and a second configuration, respectively.
[0013] FIGS. 1C and 1D are schematic illustrations of the portion
of the prosthetic heart valve of FIGS. 1A and 1B, respectively,
shown disposed within a delivery sheath.
[0014] FIGS. 2A and 2B are schematic illustrations of the portion
of a prosthetic heart valve of FIGS. 1A and 1B, shown in the first
configuration and the second configuration, respectively.
[0015] FIGS. 3-5 are front, bottom, and top views of a prosthetic
heart valve according to an embodiment.
[0016] FIG. 6 is an opened and flattened view of the inner frame of
the prosthetic heart valve of FIGS. 3-5, in an unexpanded
configuration.
[0017] FIGS. 7 and 8 are side and bottom views, respectively, of
the inner frame of FIG. 6 in an expanded configuration.
[0018] FIG. 9 is an opened and flattened view of the outer frame of
the valve of FIGS. 3-5, in an unexpanded configuration.
[0019] FIGS. 10 and 11 are side and top views, respectively, of the
outer frame of FIG. 9 in an expanded configuration.
[0020] FIGS. 12-14 are side, front, and top views of an assembly of
the inner frame of FIGS. 6-8 and the outer frame of FIGS. 9-11.
[0021] FIG. 15 is a side perspective view of an assembly of an
inner frame and an outer frame shown in a biased expanded
configuration, according to an embodiment.
[0022] FIG. 16 is a side perspective view of the assembly of FIG.
15 with the outer frame shown inverted.
[0023] FIG. 17 is side view of the assembly of FIG. 16 shown in a
collapsed configuration within a lumen of a delivery sheath.
[0024] FIG. 18 is a side view of the assembly of FIG. 17 shown in a
first partially deployed configuration.
[0025] FIG. 19 is a side view of the assembly of FIG. 17 shown in a
second partially deployed configuration.
[0026] FIG. 20 is a side view of the assembly of FIG. 17 shown in a
third partially deployed configuration in which the inverted outer
frame is substantially deployed outside of the delivery sheath.
[0027] FIG. 21 is a side view of the assembly of FIG. 17 shown in a
fourth partially deployed configuration in which the outer frame
has reverted and assumed a biased expanded configuration.
[0028] FIGS. 22-24 illustrate steps of a portion of a method to
deliver the prosthetic valve of FIGS. 15-21 to an atrium of a heart
and within the native mitral annulus.
[0029] FIGS. 25-28 are cross-sectional side views of a prosthetic
valve, according to an embodiment, showing the progression of the
prosthetic valve being reconfigured and reoriented, and emerging
from a lumen of a portion of a delivery sheath.
[0030] FIG. 29A is a side view of a prosthetic valve, according to
an embodiment and shown in an inverted orientation, and FIGS. 29B
and 29C are each an enlarged detail view of a different portion of
the prosthetic valve of FIG. 29A.
[0031] FIG. 30A is a side view of a portion of a prosthetic heart
valve, showing a coupling joint and an outer frame of the valve in
a first configuration, according to an embodiment.
[0032] FIG. 30B is a side view of the portion of the prosthetic
valve of FIG. 30A, showing the coupling joint and the outer frame
in a second configuration.
[0033] FIG. 31A is a side view of a portion of a prosthetic heart
valve, showing a coupling joint and an outer frame of the valve in
a first configuration, according to an embodiment.
[0034] FIG. 31B is a side view of the prosthetic valve of FIG. 31A,
showing the coupling joint and the outer frame in a second
configuration.
[0035] FIG. 32A is a perspective view of a portion of a prosthetic
valve, according to an embodiment.
[0036] FIG. 32B is a detailed view of a portion of the valve of
FIG. 32A, showing a coupling portion that includes a tab and slot
arrangement in a disengaged position.
[0037] FIG. 32C is a detailed view of a portion of the valve of
FIG. 32A, showing a coupling portion in an engaged position.
[0038] FIG. 33A illustrates a portion of the valve of FIG. 32A
illustrating a coupling joint according to another embodiment.
[0039] FIG. 33B illustrates a portion of the valve of FIG. 32A
illustrating a coupling joint according to yet another
embodiment.
[0040] FIG. 34A is a side view of a portion of a prosthetic heart
valve, showing a coupling portion and an outer frame of the valve
in a first configuration, according to an embodiment.
[0041] FIG. 34B is a side view of the portion of the prosthetic
heart valve of FIG. 34A showing the coupling joint and the outer
frame in a second configuration.
[0042] FIG. 35 is a side view of a portion of a prosthetic heart
valve, showing a coupling portion that includes a pin joint,
according to an embodiment.
[0043] FIG. 36 is a side view of a portion of a prosthetic heart
valve, showing a coupling portion that includes a pin joint,
according to another embodiment.
[0044] FIG. 37 is a side view of a portion of a prosthetic heart
valve, showing a coupling portion that includes a suture hinge
mechanism, according to an embodiment.
[0045] FIG. 38 is a side view of a portion of a prosthetic heart
valve, showing a coupling portion that includes a suture hinge
mechanism, according to another embodiment.
[0046] FIG. 39 is a side view of a portion of a prosthetic heart
valve, showing a coupling portion that includes a movable joint and
tether mechanism, according to an embodiment.
[0047] FIG. 40 is a side view of a portion of a prosthetic heart
valve, showing a coupling portion that includes a movable joint and
tether mechanism, according to another embodiment.
[0048] FIG. 41A is a side view of a portion of an inner frame of a
prosthetic heart valve, according to an embodiment.
[0049] FIGS. 41B and 41C are a side view and a front view,
respectively, of encircled portion A in FIG. 41A.
[0050] FIG. 41D is a side view of the inner frame of the prosthetic
heart valve of FIG. 41A.
[0051] FIGS. 41E and 41F are a side view and a front view,
respectively, of encircled portion B in FIG. 41D, illustrating a
portion of suture attached to the inner frame.
[0052] FIG. 41G is a side view of the inner frame of FIG. 41A
coupled to an outer frame of the prosthetic heart valve.
[0053] FIGS. 41H and 41I are a side view and a front view,
respectively, of encircled portion C in FIG. 41G, illustrating a
portion of suture coupling the outer frame to the inner frame.
[0054] FIG. 42A is a front view of a portion of an inner frame of a
prosthetic heart valve, according to another embodiment.
[0055] FIGS. 42B and 42C area a front view and a side view,
respectively, of the portion of the inner frame of FIG. 42A shown
with a suture coupled thereto.
[0056] FIGS. 43-48 are each a cross-sectional illustration of a
heart with devices used during various stages in a procedure to
transfemorally deliver and deploy a prosthetic mitral valve.
[0057] FIG. 49 is a cross-sectional illustration of a heart with a
portion of a delivery sheath shown after deploying a prosthetic
mitral valve with the assistance of a wire assist structure,
according to an embodiment.
[0058] FIG. 50 is a perspective view of the wire assist structure
of FIG. 49 coupled to a portion of a prosthetic mitral valve,
according to an embodiment.
[0059] FIG. 51 is a perspective view of an assist member according
to another embodiment and coupled to a portion of a prosthetic
mitral valve, according to an embodiment.
[0060] FIG. 52 is a schematic illustration of a delivery device and
prosthetic heart valve, according to an embodiment.
[0061] FIGS. 53-56 are progressional cross-sectional side views of
a prosthetic valve being reconfigured and reoriented, and emerging
from a lumen of a portion of a delivery sheath, according to an
embodiment.
[0062] FIG. 57 is a perspective view of the outer frame assembly of
the prosthetic valve of FIGS. 53-56.
[0063] FIG. 58A is a side view of a portion of the prosthetic valve
of FIG. 53 shown within a within a delivery sheath and coupled to a
valve holder.
[0064] FIG. 58B is a side view of an attachment member of the
prosthetic valve of FIG. 58A.
[0065] FIG. 58C is an end view of the valve holder of FIG. 58A.
[0066] FIG. 59 is a cross-sectional side view of a prosthetic valve
in an inverted configuration inside of a delivery sheath, according
to an embodiment.
[0067] FIG. 60 is a cross-sectional side view of a prosthetic valve
in an inverted configuration inside of a delivery sheath, according
to an embodiment.
[0068] FIG. 61 is a cross-sectional side view of a prosthetic valve
in an inverted configuration inside of a delivery sheath, according
to an embodiment.
[0069] FIG. 62 is a cross-sectional side view of a prosthetic valve
in an inverted configuration inside of a delivery sheath, according
to an embodiment.
[0070] FIG. 63 is a partial cross-sectional side view of a delivery
system and prosthetic heart valve, according to an embodiment.
[0071] FIG. 64 is a cross-sectional view taken along line 64-64 in
FIG. 63 showing the actuation wires coupled to a tube member of the
delivery system.
[0072] FIG. 65 is a proximal end view of a tube member of the
delivery system of FIG. 63.
[0073] FIG. 66A is a side view of a portion of the tube member of
FIG. 65.
[0074] FIG. 66B is a side view of a portion of a multi-lumen tube
member according to another embodiment and a distal retention
element according to an embodiment.
[0075] FIG. 66C view of a portion of the multi-lumen tube member of
FIG. 66B and a distal retention element, according to another
embodiment.
[0076] FIGS. 67A-67D are each a side view of a different embodiment
of an actuation wire.
[0077] FIG. 68 is a partial cross-sectional side view of the
delivery system and prosthetic heart valve of FIG. 63, shown in a
first partially deployed configuration.
[0078] FIG. 69 is a partial cross-sectional side view of the
delivery system and prosthetic heart valve of FIG. 63, shown in a
second partially deployed configuration.
[0079] FIG. 70 is a partial cross-sectional side view of the
delivery system and prosthetic heart valve of FIG. 63, shown in a
third partially deployed configuration.
[0080] FIG. 71 is a cross-sectional view taken along line A-A in
FIG. 63 showing the actuation wires in a partially released
position.
[0081] FIG. 72 is a flowchart illustrating a method of delivering
and deploying a prosthetic mitral valve within a heart.
DETAILED DESCRIPTION
[0082] Apparatus and methods are described herein for prosthetic
heart valves, such as prosthetic mitral valves, that can be
configured to be moved to an inverted configuration for delivery of
the prosthetic valve to within a heart of a patient. As described
herein, in some embodiments, a prosthetic valve includes an outer
frame that can be inverted relative to an inner frame when the
prosthetic valve is in a biased expanded configuration. The
prosthetic mitral valve can be formed with, for example, a
shape-memory material. After inverting the outer frame, the
prosthetic valve can be inserted into a lumen of a delivery sheath
such that the prosthetic valve is moved to a collapsed
configuration.
[0083] The delivery sheath can be used to deliver the prosthetic
valve to within a patient's heart using a variety of different
delivery approaches for delivering a prosthetic heart valve (e.g.,
prosthetic mitral valve) where the inverted prosthetic valve would
enter the heart through the atrium of the heart. For example, the
prosthetic valves described herein can be delivered using a
transfemoral delivery approach as described in International
Application No. PCT/US15/14572 (the '572 PCT application)
incorporated by reference above or via a transatrial approach, such
as described in U.S. Provisional Patent Application Ser. No.
62/220,704, entitled "Apparatus and Methods for Transatrial
Delivery of Prosthetic Mitral Valve," filed Sep. 18, 2015 ("the
'704 provisional application"), which is incorporated herein by
reference in its entirety. In another example, an inverted valve as
described herein could be delivered via a transjugular approach,
via the right atrium and through the atrial septum and into the
left atrium. The prosthetic valves described herein can also be
delivered apically if desired. After the delivery sheath has been
disposed within the left atrium of the heart, the prosthetic mitral
valve is moved distally out of the delivery sheath such that the
inverted outer frame reverts and the prosthetic valve assumes its
biased expanded configuration. The prosthetic mitral valve can then
be positioned within a mitral annulus of the heart.
[0084] In some embodiments, an apparatus includes a prosthetic
valve that includes an inner frame and an outer frame coupled to
the inner frame at multiple coupling joints. The multiple coupling
joints are configured to allow the outer frame to be moved relative
to inner frame such that the prosthetic valve can be moved between
a first configuration and a second configuration. The outer frame
and the inner frame collectively define a first length of the
prosthetic valve when the prosthetic valve is in the first
configuration and a second length of the prosthetic valve when the
prosthetic valve is in the second configuration and the second
length is greater than the first length. The inner frame has a
length that is the same when the prosthetic valve is in both the
first configuration and the second configuration.
[0085] In some embodiments, an apparatus includes a prosthetic
heart valve that includes an inner frame and an outer frame coupled
to the inner frame at multiple coupling joints. The prosthetic
valve is movable between a first configuration and a second
configuration. The multiple coupling joints are configured to allow
the outer frame to be moved between a first position relative to
the inner frame and a second position relative to inner frame in
which the outer frame is inverted relative to the inner frame. The
prosthetic valve is in the first configuration when the outer frame
is in the first position, and in the second configuration when the
outer frame is in the second position.
[0086] In some embodiments, an apparatus includes a prosthetic
heart valve that includes an inner frame, and an outer frame
coupled to the inner frame at multiple coupling joints. The
multiple coupling joints are configured to allow the outer frame to
be moved relative to inner frame such that the prosthetic valve can
be moved between a first configuration and a second configuration.
The outer frame has an outer frame coupling portion coupled to the
inner frame at multiple coupling joints and an outer frame free end
portion. The inner frame has an inner frame coupling portion
coupled to the outer frame at the multiple coupling joints. A first
end portion and an inner frame free end portion are on an opposite
end of the inner frame from the first end portion. The multiple
coupling joints are disposed between the outer frame free end
portion and the first end portion of the inner frame when the
prosthetic valve is in the first configuration. The multiple
coupling joints are disposed between the inner frame free end
portion and the outer frame free end portion when the prosthetic
valve is in the second configuration.
[0087] In some embodiments, an apparatus includes a prosthetic
heart valve that includes an inner frame coupled to an outer frame
at multiple coupling joints. The multiple coupling joints are
configured to allow the outer frame to be moved relative to inner
frame such that the prosthetic valve can be moved between a first
configuration and a second configuration. The outer frame has an
outer frame coupling portion coupled to the inner frame at the
multiple coupling joints and an outer frame free end portion. The
inner frame has an inner frame coupling portion coupled to the
outer frame at the multiple coupling joints and an inner frame free
end portion. The outer frame free end portion and the inner frame
free end portion each open in the same direction when the
prosthetic valve is in the first configuration. The outer frame
free end portion and the inner frame free end portion open in
opposite directions when the prosthetic valve is in the second
configuration.
[0088] In some embodiments, an apparatus includes a delivery sheath
that defines a lumen, a valve holder movably disposable within the
lumen of the delivery sheath and a prosthetic heart valve disposed
at least partially within the lumen of the delivery sheath in a
collapsed configuration. The prosthetic heart valve includes an
outer frame coupled to an inner frame and the inner frame is
removably coupled to a distal end portion of the valve holder. The
outer frame is movable between a first configuration relative to
the inner frame and a second configuration relative to the inner
frame in which the outer frame is inverted relative to the inner
frame. The prosthetic heart valve is disposed within the lumen of
the delivery sheath with the outer frame in the second
configuration. A first actuation wire is releasably coupled to a
first portion of an open free end portion of the outer frame and a
second actuation wire is releasably coupled to a second portion of
the open free end portion of the outer frame. Each of the first
actuation wire and the second actuation wire have a first portion
extending proximally from the outer frame and a second portion
extending proximally from the outer frame. The first portion and
the second portion of each of the first actuation wire and the
second actuation wire are configured to be pulled proximally to
urge the outer frame from the second configuration towards the
first configuration relative to the inner frame.
[0089] In some embodiments, an apparatus includes an outer sheath
that defines a lumen, an inner sheath movably disposed within the
lumen of the outer sheath and defining a lumen, a tube member
movably disposed within the lumen of the outer sheath and defining
a lumen, a valve holder movably disposed within the lumen of the
inner sheath and within a lumen defined by the tube member and a
prosthetic heart valve disposed at least partially within the lumen
of the outer sheath and at least partially within the lumen of the
inner sheath. The prosthetic heart valve includes an outer frame
coupled to an inner frame and the inner frame is removably coupled
to a distal end portion of the valve holder. The outer frame is
movable between a first configuration relative to the inner frame
and a second configuration relative to the inner frame in which the
outer frame is inverted relative to the inner frame. The prosthetic
heart valve is disposed within the lumen of the outer sheath and
the lumen of the inner sheath with the outer frame in the second
configuration. A first actuation wire is releasably coupled to a
first portion of an open free end portion of the outer frame and
releasably coupled to the tube member at a first location on the
tube member. A second actuation wire is releasably coupled to a
second portion of the open free end portion of the outer frame and
releasably coupled to the tube member at a second location on the
tube member.
[0090] In some embodiments, a method includes inserting a distal
end portion of a delivery sheath into a left atrium of a heart. The
delivery sheath having a prosthetic mitral valve disposed within a
lumen of the delivery sheath and the prosthetic mitral valve has an
outer frame coupled to an inner frame such that the outer frame can
be moved between a first position relative to the inner frame and a
second position relative to the inner frame in which the outer
frame is inverted relative to the inner frame. The prosthetic valve
is disposed within the lumen of the delivery sheath with the outer
frame in the second positon relative to the inner frame. The
prosthetic mitral valve is moved distally out of the delivery
sheath causing the outer frame of the prosthetic mitral valve to
revert back to the first position relative to the inner frame such
that the prosthetic mitral valve at least partially assumes a
biased expanded configuration. The prosthetic mitral valve is
positioned within a mitral annulus of the heart.
[0091] FIGS. 1A and 1B are schematic illustrations of a portion of
a prosthetic heart valve 100, according to an embodiment, shown in
a first configuration and a second configuration respectively, and
FIGS. 1C and 1D illustrate the portions of the prosthetic heart
valve 100 of FIGS. 1A and 1B, respectively, shown disposed within a
lumen of a delivery sheath 126. FIGS. 2A and 2B illustrate a
portion of the prosthetic heart valve 100 of FIGS. 1A and 1B,
respectively, and show length dimensions for the prosthetic heart
valve in each of the first configuration and the second
configuration. The prosthetic heart valve 100 (also referred to
herein as "prosthetic valve" or "valve") can be, for example, a
prosthetic mitral valve. The valve 100 includes an outer frame 120
and an inner frame 150. The outer frame 120 and the inner frame 150
are each formed as a tubular structure as described in more detail
below with reference to FIGS. 3-15. The outer frame 120 and the
inner frame 150 can be coupled together at multiple coupling joints
146 disposed about a perimeter of the inner frame 150 and a
perimeter of the outer frame 120 as described in more detail below.
The valve 100 can also include other features, such as those
described with respect to FIGS. 3-15 below. For illustration
purposes, only the inner frame 150 and the outer frame 120 are
discussed with respect to FIGS. 1A-2B. The various characteristics
and features of valve 100 described with respect to FIGS. 1A-2B can
apply to any of the prosthetic valves described here.
[0092] The outer frame 120 is configured to have a biased expanded
or undeformed shape and can be manipulated and/or deformed (e.g.,
compressed or constrained) and, when released, return to its
original (expanded or undeformed) shape. For example, the outer
frame 120 can be formed of materials, such as metals or plastics,
which have shape memory properties. With regards to metals,
Nitinol.RTM. has been found to be especially useful since it can be
processed to be austenitic, martensitic or super elastic. Other
shape memory alloys, such as Cu--Zn--Al--Ni alloys, and Cu--Al--Ni
alloys, may also be used. The inner frame 150 can be formed from a
laser-cut tube of Nitinol.RTM.. The inner frame 150 can also have a
biased expanded or undeformed shape and can be manipulated and/or
deformed (e.g., compressed and/or constrained) and, when released,
return to its original (expanded or undeformed) shape. Further
details regarding the inner frame 150 and the outer frame 120 are
described below with respect to valve 200 and FIGS. 3-15.
[0093] The valve 100 can be delivered and deployed within a left
atrium of a heart using a variety of different delivery approaches
including, for example, a transfemoral delivery approach, as
described in the '572 PCT application, or a transatrial approach,
as described in the '704 provisional application. As described
above, in some situations, such as when delivering a prosthetic
valve to the heart via a transfemoral or transatrial approach,
because of the smaller size of the lumen of the delivery sheath,
the size of the prosthetic valve during delivery should be sized
accordingly. Thus, it is desirable to have a prosthetic valve that
can be reconfigured between a biased expanded configuration for
implantation in the heart (e.g., within a native mitral annulus)
and a delivery configuration that has a smaller outer perimeter or
profile to allow for delivery within the lumen of the delivery
sheath. The prosthetic valve 100 and the embodiments of a
prosthetic valve described herein can be constructed and formed to
achieve these desired functions and characteristics.
[0094] More specifically, the valve 100 can have a biased expanded
configuration (as shown in FIGS. 1A and 2A), an inverted
configuration (as shown in FIGS. 1B and 2B), and a compressed or
collapsed configuration (as shown in FIGS. 1C and 1D). The expanded
configuration allows the valve 100 to function when implanted
within the heart. The valve 100 can be moved to the inverted
configuration and the compressed or collapsed configuration for
delivery of the valve 100 to the heart of a patient.
[0095] To enable the valve 100 to be moved to the inverted
configuration, the outer frame 120 can be coupled to the inner
frame 150 in such a manner to allow the outer frame 120 to move
relative to the inner frame 150. More specifically, the coupling
joints 146 can couple the outer frame 120 to the inner frame 150 in
such a manner to allow the outer frame 120 to be moved relative to
the inner frame 150. For example, in some embodiments, the coupling
joints 146 can be configured to allow the outer frame 120 to rotate
about the coupling joint 146 relative to the inner frame 150. In
some embodiments, coupling joints can provide a pivotal coupling
between the outer frame 120 and the inner frame 150. In some
embodiments, the coupling joints can provide a flexible attachment
between the outer frame 120 and the inner frame 150. The coupling
joints 146 can be a variety of different types and configurations
as described herein with reference to the various embodiments of a
prosthetic valve. For example, the coupling joints 146 can include
a living hinge, a flexible member, sutures, a suture wrapped
through an opening, a pin or tab inserted through an opening or any
combinations thereof.
[0096] To move the valve 100 from the expanded configuration (FIG.
1A) to the inverted configuration (FIG. 1B), the outer frame 120 is
moved to a prolapsed or inverted configuration relative to the
inner frame 150, as shown in FIGS. 1B, 1D and 2B, by moving (e.g.,
rotating, pivoting, flexing) the outer frame 120 about the coupling
joints 146. The elastic or superelastic structure of outer frame
120 of valve 100 also allows the outer frame 120 to be moved to,
and disposed in, the prolapsed or inverted configuration relative
to the inner frame 150. To move the outer frame 120 to the inverted
configuration relative to the inner frame 150, the outer frame 120
is folded or inverted distally (to the right in FIG. 1B) relative
to the inner frame 150 via the coupling joints 146. As shown in
FIGS. 1A and 2A, the outer frame 120 is in a first position
relative to the inner frame 150 prior to being inverted in which an
open or free end portion 116 (also referred to the atrium portion
116 of the outer frame 120) is disposed proximally or to the left
of the coupling joints 146 and in the same direction as a free end
portion 147 (also referred to as a second end portion of the inner
frame) of the inner frame 150. When the outer frame 120 is moved to
an inverted configuration (i.e., second positon relative to the
inner frame 150), the free end portion 116 is disposed distally of
the coupling joints 146 (or to the right in FIGS. 1B and 2B) and in
an opposite direction as the free end portion 147 of the inner
frame 150. Said another way, when the valve 100 is in a biased
expanded configuration (e.g., FIG. 1A), the coupling joints 146 are
disposed between a first end portion 144 (also referred to as a
tether coupling portion) of the inner frame 150 and the free end
portion 116 of the outer frame 120. When the valve 100 is in the
inverted configuration (e.g., FIG. 1B) (i.e., the outer frame 120
has been moved to an inverted configuration or position), the
coupling joints 146 are disposed between the free end portion or
second end portion 147 of the inner frame 150 and the free end
portion 116 of the outer frame 120.
[0097] When in the inverted configuration, an overall length of the
valve 100 is increased, but a length of the inner frame 150 and a
length of the outer frame 120 remains the same (or substantially
the same). For example, as shown in FIGS. 2A and 2B an overall
length L1 of the valve 100 in the biased expanded configuration
(prior to being inverted as shown in FIG. 2A) is less than the
overall length L2 of the valve 100 when in the inverted
configuration (FIG. 2B). A length Li of the inner frame 150 and a
length Lo of the outer frame 120 is substantially the same (or the
same) when the valve 100 is in both the biased expanded
configuration and the inverted configuration. In addition, in some
instances, depending on the specific configuration of the outer
frame, an overall outer perimeter or outer diameter of the valve
100 can be smaller when the valve 100 is in the inverted
configuration.
[0098] With the valve 100 in the inverted configuration, the valve
100 can be placed within a lumen of the delivery sheath 126 for
delivery of the valve 100 to the left atrium of the heart, as shown
in FIG. 1D. When placed within the lumen of the delivery sheath
126, the valve 100 is moved to the collapsed or compressed
configuration in which the outer diameter or outer perimeter of the
valve 100 is reduced. Because the valve 100 is in the inverted
configuration, the valve 100 is able to be placed within a smaller
delivery sheath 126 than would otherwise be possible. For example,
for comparison purposes, FIG. 1C illustrates the valve 100 placed
within a lumen of a delivery sheath 126' where the valve 100 has
not been moved to an inverted configuration prior to being disposed
within the delivery sheath 126'. As shown in FIG. 1C, an outer
diameter of the valve 100 is reduced, but not to as small of a
diameter as for the valve 100 when placed in a delivery sheath 126
when in the inverted configuration. Thus, in FIG. 1C, the valve 100
has an overall outer perimeter or outer diameter D1 and in FIG. 1D,
the valve 100 has an overall outer perimeter or outer diameter D2,
which is less than D1.
[0099] Thus, by disposing the outer frame 120 in the inverted
configuration, the valve 100 can be collapsed into a smaller
overall diameter, i.e. placed in a smaller diameter delivery sheath
126, than would be possible if the valve 100 were merely collapsed
radially. This is because when the valve is in the biased expanded
configuration, the inner frame 150 is nested within an interior of
the outer frame 120, and thus the outer frame 120 must be collapsed
around the inner frame 150. In some embodiments, the inner frame
150 and the outer frame are disposed concentrically. Whereas in the
inverted configuration, the inner frame 150 and the outer frame 120
are arranged axially with respect to each other (i.e., the inner
frame is not nested within the outer frame 150), such that the
outer frame 120 can be collapsed without needing to accommodate all
of the structure of the inner frame 150 inside it. In other words,
with the inner frame 150 disposed mostly inside or nested within
the outer frame 120, the layers or bulk of the frame structures
cannot be compressed to as small a diameter. In addition, if the
frames are nested, the structure is less flexible, and therefore,
more force is needed to bend the valve, e.g. to pass through
tortuous vasculature or to make tight turn in the left atrium after
passing through the atrial septum to be properly oriented for
insertion into the mitral valve annulus.
[0100] FIGS. 3-14 illustrate another embodiment of a prosthetic
heart valve that can be delivered and deployed within a left atrium
of a heart using a variety of different delivery approaches
including, for example, a transfemoral delivery approach or a
transatrial delivery approach. FIGS. 3-5 are front, bottom, and top
views, respectively, of a prosthetic heart valve 200 according to
an embodiment. Prosthetic heart valve 200 (also referred to herein
as "valve" or "prosthetic valve") is designed to replace a damaged
or diseased native heart valve such as a mitral valve. Valve 200
includes an outer frame assembly 210 and an inner valve assembly
240 coupled to the outer frame assembly 210.
[0101] As shown, outer frame assembly 210 includes an outer frame
220, covered on all or a portion of its outer face with an outer
covering 230, and covered on all or a portion of its inner face by
an inner covering 232. Outer frame 220 can provide several
functions for prosthetic heart valve 200, including serving as the
primary structure, as an anchoring mechanism and/or an attachment
point for a separate anchoring mechanism to anchor the valve to the
native heart valve apparatus, a support to carry inner valve
assembly 240, and/or a seal to inhibit paravalvular leakage between
prosthetic heart valve 200 and the native heart valve
apparatus.
[0102] Outer frame 220 has a biased expanded configuration and can
be manipulated and/or deformed (e.g., compressed and/or
constrained) and, when released, return to its original
unconstrained shape. To achieve this, outer frame 220 can be formed
of materials, such as metals or plastics that have shape memory
properties. With regards to metals, Nitinol.RTM. has been found to
be especially useful since it can be processed to be austenitic,
martensitic or super elastic. Other shape memory alloys, such as
Cu--Zn--Al--Ni alloys, and Cu--Al--Ni alloys, may also be used.
[0103] As best shown in FIG. 3, outer frame assembly 210 has an
upper end (e.g., at the atrium portion 216), a lower end (e.g., at
the ventricle portion 212), and a medial portion (e.g., at the
annulus portion 214) therebetween. The upper end or atrium portion
216 (also referred to as "outer free end portion") defines an open
end portion of the outer frame assembly 210. The medial or annulus
portion 214 of the outer frame assembly 210 has a perimeter that is
configured (e.g., sized, shaped) to fit into an annulus of a native
atrioventricular valve. The upper end of the outer frame assembly
210 has a perimeter that is larger than the perimeter of the medial
portion. In some embodiments, the perimeter of the upper end of the
outer frame assembly 210 has a perimeter that is substantially
larger than the perimeter of the medial portion. As shown best in
FIG. 5, the upper end and the medial portion of the outer frame
assembly 210 has a D-shaped cross-section. In this manner, the
outer frame assembly 210 promotes a suitable fit into the annulus
of the native atrioventricular valve.
[0104] Inner valve assembly 240 includes an inner frame 250, an
outer covering (not shown), and leaflets 270. As shown, the inner
valve assembly 240 includes an upper portion having a periphery
formed with multiple arches. The inner frame 250 includes six axial
posts or frame members that support the outer covering of the inner
valve assembly and leaflets 270. Leaflets 270 are attached along
three of the posts, shown as commissure posts 252 (best illustrated
in FIG. 4), and the outer covering of the inner valve assembly 240
is attached to the other three posts, 254 (best illustrated in FIG.
4), and optionally to commissure posts 252. Each of the outer
covering of the inner valve assembly 240 and leaflets 270 are
formed of approximately rectangular sheets of material, which are
joined together at their upper, or atrium end. The lower, ventricle
end of the outer covering may be joined to inner covering 232 of
outer frame assembly 210, and the lower, ventricle end of leaflets
270 may form free edges 275, though coupled to the lower ends of
commissure posts 252.
[0105] Although inner valve assembly 240 is shown as having three
leaflets, in other embodiments, an inner valve assembly can include
any suitable number of leaflets. The leaflets 270 are movable
between an open configuration and a closed configuration in which
the leaflets 270 coapt, or meet in a sealing abutment.
[0106] Outer covering 230 of the outer frame assembly 210 and inner
covering 232 of outer frame assembly 210, outer covering of the
inner valve assembly 240 and leaflets 270 of the inner valve
assembly 240 may be formed of any suitable material, or combination
of materials, such as those discussed above. In this embodiment,
the inner covering 232 of the outer frame assembly 210, the outer
covering of the inner valve assembly 240, and the leaflets 270 of
the inner valve assembly 240 are formed, at least in part, of
porcine pericardium. Moreover, in this embodiment, the outer
covering 230 of the outer frame assembly 210 is formed, at least in
part, of polyester.
[0107] Inner frame 250 is shown in more detail in FIGS. 6-8.
Specifically, FIGS. 6-8 show inner frame 250 in an undeformed,
initial state (FIG. 6), a side view of the inner frame 250 in an
expanded configuration (FIG. 7), and a bottom view of the inner
frame 250 in the expanded configuration (FIG. 8), respectively,
according to an embodiment.
[0108] In this embodiment, inner frame 250 is formed from a
laser-cut tube of Nitinol.RTM.. Inner frame 250 is illustrated in
FIG. 6 in an undeformed, initial state, i.e. as laser-cut, but cut
and unrolled into a flat sheet for ease of illustration. Inner
frame 250 can be divided into four portions, corresponding to
functionally different portions of the inner frame 250 in final
form: atrial portion 247, body portion 242, strut portion 243, and
tether clamp or connecting portion 244. Strut portion 243 includes
six struts, such as strut 243A, which connect body portion 242 to
tether connecting portion 244.
[0109] Tether connecting portion 244 (also referred to as first end
portion of inner frame) includes longitudinal extensions of the
struts, connected circumferentially by pairs of opposed, slightly
V-shaped connecting members (or "micro-Vs"). Tether connecting
portion 244 is configured to be radially collapsed by application
of a compressive force, which causes the micro-Vs to become more
deeply V-shaped, with the vertices moving closer together
longitudinally and the open ends of the V shapes moving closer
together circumferentially. Thus, tether connecting portion 244 can
be configured to compressively clamp or grip one end of a tether,
either connecting directly onto a tether line (e.g. braided
filament line) or onto an intermediate structure, such as a polymer
or metal piece that is in term firmly fixed to the tether line.
[0110] In contrast to tether connecting portion 244, atrial portion
247 (also referred to as "inner frame free end portion") and body
portion 242 are configured to be expanded radially. Strut portion
243 forms a longitudinal connection and radial transition between
the expanded body portion and the compressed tether connecting
portion 244. Body portion 242 provides an inner frame coupling
portion 245 that includes six longitudinal posts, such as post
242A. The inner frame coupling portion 245 can be used to attach
leaflets 270 to inner frame 240, and/or can be used to attach inner
assembly 240 to outer assembly 210, such as by connecting inner
frame 250 to outer frame 220. In the illustrated embodiment, the
posts include openings through which connecting members (such as
suture filaments and/or wires) can be passed to couple the posts to
other structures.
[0111] Inner frame 250 is shown in a fully deformed, i.e. the
final, deployed configuration, in side view and bottom view in
FIGS. 7 and 8, respectively.
[0112] Outer frame 220 of valve 200 is shown in more detail in
FIGS. 9-11. In this embodiment, outer frame 220 is also formed from
a laser-cut tube of Nitinol.RTM.. Outer frame 220 is illustrated in
FIG. 9 in an undeformed, initial state, i.e. as laser-cut, but cut
and unrolled into a flat sheet for ease of illustration. Outer
frame 220 can be divided into an outer frame coupling portion 271,
a body portion 272, and a cuff portion 273 (which includes the
atrium or free end portion 216), as shown in FIG. 9. Outer frame
coupling portion 271 includes multiple openings or apertures, such
as 271A, by which outer frame 220 can be coupled to inner frame
250, as discussed in more detail below.
[0113] Outer frame 220 is shown in a fully deformed, i.e. the
final, deployed configuration, in side view and top view in FIGS.
10 and 11, respectively. As best seen in FIG. 11, the lower end of
outer frame coupling portion 271 forms a roughly circular opening
(identified by "0" in FIG. 11). The diameter of this opening
preferably corresponds approximately to the diameter of body
portion 242 of inner frame 250, to facilitate coupling of the two
components of valve 200.
[0114] Outer frame 220 and inner frame 250 are shown coupled
together in FIGS. 12-14, in front, side, and top views,
respectively. The two frames collectively form a structural support
for a prosthetic valve such as valve 200. The frames support the
valve leaflet structure (e.g., leaflets 270) in the desired
relationship to the native valve annulus, support the coverings
(e.g., outer covering 230, inner covering 232, outer covering of
inner valve assembly 240) for the two frames to provide a barrier
to blood leakage between the atrium and ventricle, and couple to
the tether (e.g., tether assembly 290) (by the inner frame 250) to
aid in holding the prosthetic valve 200 in place in the native
valve annulus by the tether connection to the ventricle wall. The
outer frame 220 and the inner frame 250 are connected at six
coupling points (representative points are identified as "C"). In
this embodiment, the coupling points are implemented with a
mechanical fastener, such as a short length of wire, passed through
an aperture (such as aperture 271A) in outer frame coupling portion
271 and corresponding openings in inner frame coupling portion 245
(e.g., longitudinal posts, such as post 242A) in body portion 242
of inner frame 250. Inner frame 250 is thus disposed within the
outer frame 220 and securely coupled to it.
[0115] FIGS. 15-21 illustrate a method of reconfiguring a
prosthetic heart valve 300 (e.g., prosthetic mitral valve) prior to
inserting the prosthetic heart valve 300 into a delivery sheath 326
(see, e.g., FIGS. 17-21) for delivery into the atrium of the heart.
The prosthetic heart valve 300 (also referred to herein as "valve")
can be constructed the same as or similar to, and function the same
as or similar to the valves 100 and 200 described above. Thus, some
details regarding the valve 300 are not described below. It should
be understood that for features and functions not specifically
discussed, those features and functions can be the same as or
similar to the valve 200.
[0116] As shown in FIG. 15, the valve 300 has an outer frame 320
and an inner frame 350. As discussed above for valves 100 and 200,
the outer frame 320 and the inner frame 350 of valve 300 can each
be formed with a shape-memory material and have a biased expanded
configuration. The outer frame 320 and the inner frame 350 can be
moved to a collapsed configuration for delivery of the valve 300 to
the heart. In this example method of preparing the valve 300 for
delivery to the heart, the outer frame 320 of the valve 300 is
first disposed in a prolapsed or inverted configuration as shown in
FIG. 16. Specifically, the elastic or superelastic structure of
outer frame 320 of valve 300 allows the outer frame 320 to be
disposed in the prolapsed or inverted configuration prior to the
valve 300 being inserted into the lumen of the delivery sheath 326.
As shown in FIG. 16, to dispose the outer frame 320 in the inverted
configuration, the outer frame 320 is folded or inverted distally
(to the right in FIG. 16) such that an open free end 316 of the
outer frame 320 is pointed away from an open free end 347 of the
inner frame 350. As described above for valve 100, in this inverted
configuration, the overall outer perimeter or outer diameter of the
valve 300 is reduced and the overall length is increased. For
example, the diameter D1 shown in FIG. 15 is greater than the
diameter D2 shown in FIG. 16, and the length L1 (shown in FIG. 12
for valve 200) is less than the length L2 shown in FIG. 16 for
valve 300. With the outer frame 320 in the inverted configuration
relative to the inner frame 350, the valve 300 can be placed within
a lumen of a delivery sheath 326 as shown in FIG. 17 for delivery
of the valve 300 to the left atrium of the heart. By disposing the
outer frame 320 in the inverted configuration relative to the inner
frame 350, the valve 300 can be collapsed into a smaller overall
diameter, i.e. when placed in a smaller diameter delivery sheath,
than would be possible if the valve 300 in the configuration shown
in FIG. 15 were collapsed radially without being inverted. This is
because in the configuration shown in FIG. 15, the two frames are
concentric or nested, and thus the outer frame 320 must be
collapsed around the inner frame 350, whereas in the configuration
shown in FIG. 16, the two frames are substantially coaxial but not
concentric or nested. Thus, in the configuration shown in FIG. 16
the outer frame 320 can be collapsed without the need to
accommodate the inner frame 350 inside of it. In other words, with
the inner frame 350 disposed mostly inside or nested within the
outer frame 320, the layers or bulk of the frame structures cannot
be compressed to as small a diameter. In addition, if the frames
are nested, the structure is less flexible, and therefore, more
force is needed to bend the valve, e.g. to pass through tortuous
vasculature or to make tight turn in the left atrium after passing
through the atrial septum to be properly oriented for insertion
into the mitral valve annulus.
[0117] FIGS. 22-24 illustrate a portion of a procedure to deliver
the valve 300 to the heart. In this embodiment, the valve 300 is
shown being delivered via a transfemoral delivery approach as
described, for example, in the '572 PCT application incorporated by
reference above. The delivery sheath 326, with the valve 300
disposed within a lumen of the delivery sheath 326 and in an
inverted configuration as shown in FIG. 17, can be inserted into a
femoral puncture, through the femoral vein, through the inferior
vena cava, into the right atrium, through the septum Sp and into
the left atrium LA of the heart. With the distal end portion of the
delivery sheath 326 disposed within the left atrium of the heart,
the valve 300 can be deployed outside a distal end of the delivery
sheath 326. For example, in some embodiments, a pusher device 338
can be used to move or push the valve 300 out the distal end of the
delivery sheath 326. As shown in FIGS. 22-24, a tether 336 can be
attached to the valve 300, and extend though the mitral annulus,
through the left ventricle LV, and out a puncture site at the apex
Ap. In some embodiments, the valve 300 can be moved out of the
delivery sheath 326 by pulling proximally on the tether 336. In
some embodiments, the valve 300 can be deployed by pushing with the
pusher device and pulling with the tether.
[0118] As the valve 300 exits the lumen of the delivery sheath 326,
the outer frame assembly 310 exits first in its inverted
configuration as shown in the progression of FIGS. 18-20 (see also
FIG. 22). After the outer frame assembly 310 is fully outside of
the lumen of the delivery sheath 326, the outer frame 320 can
revert to its expanded or deployed configuration as shown in FIGS.
21, 23 and 24. In some embodiments, the outer frame 320 can revert
automatically after fully exiting the lumen of the delivery sheath
due to its shape-memory properties. In some embodiments, a
component of the delivery sheath or another device can be used to
aid in the reversion of the outer frame assembly 310. In some
embodiments, the pusher device and/or the tether can be used to aid
in the reversion of the outer frame assembly 310. The valve 300 can
continue to be deployed until the inner frame 350 is fully deployed
with the left atrium and the valve 300 is in the expanded or
deployed configuration (as shown, e.g., in FIGS. 15 and 24). The
valve 300 and the tether 336 can then be secured to the apex of the
heart with an epicardial pad device 339 as shown in FIG. 24 and as
described in more detail in the '572 PCT application.
[0119] FIG. 25-28 illustrate another embodiment of a prosthetic
valve that can be moved between a biased expanded configuration and
an inverted configuration in which the outer frame is inverted
relative to the inner frame. The valve 400 can be constructed the
same as or similar to, and function the same as or similar to any
of the valves described herein and in the '572 PCT application,
with the addition of the following features. The valve 400 has an
outer frame 420 and an inner frame 450 coupled to the outer frame
420. In this embodiment, the outer frame 420 of the valve 400 is
formed of three portions (e.g., three cylinders), i.e., a first
portion 427, a second portion 428, and a third portion 429, all of
which are best shown in FIGS. 27 and 28. The portions 427, 428, 429
can be coupled to one another by any suitable coupling method to
allow the portions 427, 428 and 429 to be moved relative to each
other. As shown best in FIGS. 27 and 29, the first portion 427 is
movably coupled to the second portion 428 via a first joint J1, and
the second portion 428 is moveably coupled to the third portion 429
via a second joint J2. The first portion 427 of the outer frame 420
is also coupled to the inner frame 450 via a third joint J3 such
that the outer frame 420 can move (e.g., rotate or pivot) relative
to the inner frame 450 as described herein. For example, any of the
coupling methods described herein can be used (e.g. living hinge,
sutures, pins, tabs insertable through openings or slots, etc. or
any combination thereof) at each of the joints J1, J2, and J3.
[0120] Although the outer frame 420 is shown and described as being
formed of three separate portions which are joined together, in
other embodiments, an outer frame can be formed of any suitable
number of portions or cylinders (e.g., two portions, four portions,
five portions, six portions, etc.), which can then be joined to
form the outer frame.
[0121] As shown in FIG. 26, in use, to dispose the outer frame 420
in an inverted configuration relative to the inner frame 450, the
outer frame 420 is folded or inverted distally such that the open
free end portion of the outer frame 420 is pointed in an opposite
direction as an open free end of the inner frame 450. With the
outer frame 420 in the inverted configuration, the valve 400 can be
placed within a lumen of a delivery sheath 426 for delivery of the
valve 400 to the left atrium of the heart. The delivery sheath 426
can be the same as or similar to any of the delivery sheaths
described herein or in the '572 PCT application. In this
embodiment, a pusher device 438 is movably disposed within a lumen
of the delivery sheath 426 and removably attached to the valve 400.
Alternatively, a pusher device similar to pusher 338 can be used
that is not attached to the valve 400.
[0122] The joints (i.e., joint J1, J2 and joint J3) and outer frame
portions (i.e., the first portion 427, the second portion 428, and
the third portion 429) of the valve 400 can provide for an easier
(e.g., due to less rigidity of the outer frame 420 and/or more
focused and selective control of the outer frame 420) and/or faster
transition between an inverted and collapsed configuration of valve
400 and an expanded configuration, and vice versa. Further, the
joints and portions of the valve 400 can allow the valve 400 to
have a lower profile or footprint (e.g., occupy a smaller radial
space or diameter), e.g., when transitioning between configurations
and orientations.
[0123] In use, during reversion of the valve 400 from the inverted
and collapsed configuration (e.g., within the delivery sheath 426)
to its expanded configuration, the first portion 427 of the outer
frame 420, the second portion 428 of the outer frame 420, and the
third portion 429 of the outer frame 420 can revert sequentially
during the procedure. In other words, the portions 427, 428, 429 of
the outer frame 420 can revert in stages as the outer frame 420
exits the delivery sheath 426 within the atrium of the heart.
Examples of such stages are shown in FIGS. 26-28.
[0124] During delivery of the valve 400 from the delivery sheath
426, as shown by progression in FIGS. 26-28, the second joint J2
disposed between the second portion 428 of the outer frame 420 and
the third portion 429 of the outer frame 420 emerges from the
delivery sheath 426, allowing the third portion 429 to begin to
revert towards an expanded or deployed configuration (as shown, for
example, in FIG. 26). Next, as the valve 400 moves further towards
the exit (e.g., a distal end opening) of the delivery sheath 426,
the first joint J1 disposed between the second portion 428 of the
outer frame 420 and the first portion 427 of the outer frame 420
emerges from the delivery sheath 426, allowing the second portion
428 to further revert towards an expanded (as shown, for example,
in FIG. 27). Next, as the valve 400 moves even further towards the
exit of the delivery sheath 426, and the inner frame 450 begins to
emerge from the delivery sheath 426, including the third joint J3
between the inner frame 450 and the first portion 427 of the outer
frame 420, the outer frame 420 reverts into its expanded
configuration/size (as shown, for example, in FIG. 28).
[0125] Upon reversion of the outer frame 420 into its expanded
configuration, as shown best in FIG. 28, the inner frame 450 can be
decoupled from the pusher device 438 and/or forced out of the
delivery sheath 426 such that the inner frame 450 and/or the outer
frame 420 can expand further and be suitably seated in the native
annulus of the mitral valve.
[0126] Similar to the discussion above with respect to the valve
300, a tether 436 (see FIGS. 27 and 28), can be attached to the
valve 400 and used to help move the valve 400 out of the lumen of
the delivery sheath 426. As described for valve 300, the pusher
device 438 and/or the tether 436 can be used to deliver and deploy
the valve 400.
[0127] FIGS. 29A-29C illustrate another embodiment of a prosthetic
heart valve 500 (also referred to herein as "valve") that can be
delivered to a left atrium of a heart in a procedure similar to or
the same as the procedures described above, the procedures
described in the '572 PCT application, the '704 provisional
application or other delivery approach that delivers the valve to
the left atrium of the heart. Thus, some details regarding the
valve 500 and procedures performed therewith are not described
herein. It should be understood that for features and functions not
specifically discussed, those features and functions can be the
same as or similar to the valves described above or in the '572 PCT
application. The valve 500 has an outer frame 520 and an inner
frame 550 coupled to the outer frame 520. FIG. 29A illustrates the
outer frame 520 in an inverted configuration or position relative
to the inner frame 550 (as described above for previous
embodiments). In this embodiment, the outer frame 520 of the valve
500 includes two portions, i.e., a first portion 527 and a second
portion 528 that can be coupled together at joints, as described in
more detail below.
[0128] Similar to the discussion with respect to the portions 427,
428, 429 of the valve 400, and the joints J1 and J2, in this
embodiment, the first portion 527 of the outer frame 520 is coupled
to the second portion 528 of the outer frame 520 via a first joint
J1, and the first portion 527 is coupled to the inner frame 550 via
a second joint J2. In this embodiment, first portion 527 of the
outer frame 520 defines multiple apertures 521 and the inner frame
550 of the valve 500 defines multiple apertures 523 (see also,
e.g., the openings of the body portion 242 of the inner frame 550
of the valve 500, described above). As shown best in FIG. 29C, the
apertures 521 and the apertures 523 can be aligned, and one or more
connecting members 531 (e.g., sutures or wires) are passed through
the one or more apertures 521 of the first portion 527 of the outer
frame 520 and one or more apertures 523 of the inner frame 550 to
couple the first portion 527 of the outer frame 520 to the inner
frame 550 at the second joint J2. In this manner, the inner frame
550 of the valve 500 and the outer frame 520 of the valve 500 can
be coupled together such that the outer frame 520 can move relative
to the inner frame (e.g., rotate, pivot, articulate) between an
inverted positon relative to the inner frame 550 and a non-inverted
position in which the outer frame 520 can assume a biased expanded
configuration with the inner frame 550 nested within the outer
frame 520 as described above for previous embodiments.
[0129] As shown, for example, in FIG. 29B, the first joint J1
between the first portion 527 and the second portion 528 of the
outer frame 520 is formed by wrapping one or more connecting member
531 (e.g., suture or wire) around a strut of the first portion 527
and around a strut of the second portion 528. For example, the
strut of the first portion 527 and the strut of the second portion
528 can be aligned with one another prior to application of the
connecting member(s) 531 thereto. In an embodiment of a valve
having an outer frame with for example, three portions, such as
valve 400, the second portion and the third portion of the outer
frame can be coupled together using either of the coupling methods
described for joint J1 and J2 of valve 500. While the valve 500 is
shown as having a first joint J1 between the first portion 527 and
the second portion 528, and a second joint J2 between the inner
frame 550 and the outer frame 520, in some embodiments, any
suitable number or type of joints can be used to couple any
suitable number of portions of the outer frame 520 together, and
the inner frame 550 to the outer frame 520.
[0130] FIGS. 30A-42C illustrate various embodiments of a coupling
joint(s) for coupling an inner frame to an outer frame of a
prosthetic heart valve such that the valve can be reconfigured
between a biased expanded configuration for implantation in the
heart (e.g., within a native mitral annulus) and a delivery
configuration that has a smaller outer perimeter or profile (e.g.,
inverted configuration) as discussed above, for example, with
respect to valve 100. More specifically, the embodiments of FIGS.
30-42C illustrate various embodiments of different coupling joints
for coupling the outer frame to the inner frame such that the outer
frame can be moved (e.g., rotated, pivoted, flexed) relative to the
inner frame between a first configuration and a second
configuration in which the outer frame is inverted relative to the
inner frame. Each of the embodiments of a prosthetic heart valve
described with respect to FIGS. 30A-42C can include the same or
similar features and can function the same as or similar to the
prosthetic heart valves described above with respect to, for
example, valve 100, 200 and 300. Thus, some features and details of
the embodiments described with respect to FIGS. 30A-42C are not
described below.
[0131] FIGS. 30A and 30B illustrate a portion of a prosthetic heart
valve, which includes an inner frame assembly having an inner frame
650 and an outer frame assembly having an outer frame 620. The
prosthetic heart valve 600 (also referred to as "prosthetic valve"
or "valve") can be constructed similar to or the same as, for
example, the prosthetic heart valve 100 or valve 200 described
above. Specifically, FIGS. 30A and 30B illustrate a portion of the
outer frame 620 and a portion of the inner frame 650 shown with the
outer frame 620 in a first configuration and a second
configuration, respectively. The outer frame 620 and the inner
frame 650 are coupled via a coupling joint 646. In the illustrated
embodiment of FIGS. 30A and 30B, the coupling joint 646 includes a
hinge member 648. In some embodiments, the hinge member 648 can
include a living hinge. The hinge member 648 can be formed of a
material such that the hinge member 648 can flex or bend and permit
movement of the outer frame 620 relative to the inner frame 650.
For example, as described above for previous embodiments, the
coupling joint 646 (i.e., hinge member 648) allows the outer frame
620 to be moved from the first configuration as shown in FIG. 30A
to the second configuration, as shown in FIG. 30B, in which the
outer frame 620 is inverted relative to the inner frame 650.
[0132] The hinge member 648 can be made of any suitable material
including, but not limited to, a polymer, an extracted natural
tissue, an artificially engineered tissue, an elastic material
(including superelastics), and/or the like. In some embodiments,
the hinge member 648 is made of the same materials as the outer
frame 620 and/or the inner frame 650. In some embodiments, the
hinge member 648 can be integrally formed and/or fused with the
outer frame 620 and/or the inner frame 650. In other embodiments,
the hinge member 648 can be attached to the outer frame 620 and/or
the inner frame 650 by any suitable coupling technique, including
suturing, spin coating, and/or the like. As shown in FIG. 30B, when
the outer frame 620 is in the second configuration (i.e.,
inverted), the hinge member 648 flexes or bends with the outer
frame 620.
[0133] FIGS. 31A and 31B illustrate a portion of a prosthetic heart
valve 600' that includes the inner frame 650 and the outer frame
620. In this embodiment, the inner frame 650 and outer frame 620
are coupled at a coupling joint 646' that includes a hinge member
648' that is disposed in a substantially V-shape between the inner
frame 650 and the outer frame 620. As with the previous embodiment,
the hinge member 648' can be coupled to the outer frame 620 and the
inner frame 650 in such a manner so as to allow for the outer frame
620 to move relative to the inner frame 650 between a first
configuration as shown in FIG. 31A and a second configuration as
shown in FIG. 31B. The hinge member 648' can be formed with the
same or similar materials as described above for hinge member 648,
and can be coupled to the inner frame 650 and the outer frame 620
with any of the coupling techniques described for hinge member 648.
As shown in FIG. 31B, when the outer frame 620 is moved to the
second configuration (i.e., inverted), the hinge member 648' can
bend or flex with the outer frame 620.
[0134] FIGS. 32A-32C illustrate portions of a prosthetic heart
valve 700. The prosthetic heart valve (also referred to as
"prosthetic valve" or `valve") 700 includes an outer frame assembly
710 with an outer frame 720, and an inner frame assembly 740 with
an inner frame 750. The valve 700 also includes multiple coupling
joints 746 to couple the outer frame 720 to the inner frame 750
such that the outer frame can be moved between a first
configuration (as shown in FIGS. 32A-32C) and a second
configuration (not shown) in which the outer frame 720 is inverted
relative to the inner frame 750. As best illustrated in FIGS.
32B-32C, each coupling joint 746 includes a support member 721 that
defines two slots 722A and 722B, and corresponding coupling
portions 755 of the inner frame 750 that include tabs 761A and
761B. Also defined by the tabs 761A and 761B are holes 756A and
756B.
[0135] To couple the outer frame 720 to the inner frame 750, the
tabs 761A and 761B are inserted into the corresponding slots 722A
and 722B of the outer frame 720 as shown in FIGS. 32A and 32C.
Thus, the tab 756A is received within the slot 722A and the tab
756B is received within the slot 722B as best shown in FIG. 32C. In
this manner, mechanical attachment can be achieved between the
outer frame 720 and the inner frame 750. In some embodiments, the
support member 721 can be formed integrally with the outer frame
720. In such an embodiment, the outer frame 720 (and support member
755) can be made of any suitable, flexible material (e.g., a shape
memory metal such as Nitinol) that permits articulation between the
frame portions of the outer frame 720, such as frame portions 717
and 718 and the support member 721 such that the outer frame 720
can be moved between the first configuration and the second
configuration (i.e., inverted). In some embodiments, the frame
portions (e.g., frame portions 717, 718) can be formed separately
from the support member 721 and can be coupled to the support
member 721 with a pivot joint such as a ball and socket. In such an
embodiment, the outer frame 720 can pivot relative to the support
member 721 when moved between the first configuration and the
second (inverted) configuration.
[0136] The interlocking nature of the tabs 761A and 761B within the
slots 722A, 722B provides for load bearing without additional
components such as sutures. In some embodiments, as illustrated,
the tabs 761A, 761B can include the holes 760A, 760B that can
receive a stop member (not shown) such as, for example, a pin
and/or other component to prevent the tabs 761A, 761B from coming
out of the slots 722A, 722B. In some embodiments, one or more
strands or suture can be used as the stop member. For example, the
suture strands can be threaded through the holes 756A, 756B and/or
wrapped about the tabs 761A, 761B. As best illustrated in FIGS.
32B-32C, the coupling portion 755 of the inner frame 750 can also
include one or more holes 757 for aiding in attachment (e.g., via
sutures) of other components, such as, for example, the covering
232 illustrated in FIG. 3.
[0137] Although two tabs 761A, 761B and two slots 722A, 722B are
included at coupling joints 746, it should be understood that
variations from the illustrated embodiment in FIGS. 32A-32C are
within the scope of this disclosure. For example, any suitable
number of tabs and slots can be employed to attach the outer frame
720 and the inner frame 750, including a single tab/slot mechanism.
As another example, any suitable geometry of the support member 721
and/or the coupling portion 755 can be employed.
[0138] To deliver the valve 700 to a heart of a patient, in some
cases it may be desirable to deliver the outer frame 720 and the
inner frame 750 prior to being coupled together at the coupling
joints 746. In such an embodiment, the outer frame 720 and the
inner frame 750 can be loosely coupled with a suture strand 753 as
shown in FIGS. 33A and 33B. The suture strand 753 is threaded
through the opening 756 of the coupling portion 755 of the inner
frame 750 and through the slot 722 of the support member 721 of the
outer frame 720. Although a single suture strand 753 is shown, it
should be understood that a suture strand 753 can be disposed
through each of the slots 722 of the outer frame 720 and the
openings 756 of the inner frame 750. With the inner frame 750
coupled to the outer frame 720 via the suture strand 753, the outer
frame 720 can be inverted separately from the inner frame 750 and
then loaded into a delivery sheath (not shown) along with the inner
frame 750 such that the inner frame 750 is disposed proximal of the
outer frame 720 within the delivery sheath. As shown in FIG. 33A, a
clip 766 and a stop element 767 are coupled to the suture strand
753 and can be used to secure the inner frame 750 to the outer
frame 720 as described in more detail below.
[0139] More specifically, to deploy the valve 700 into the heart of
a patient, a distal end portion of the delivery sheath is disposed
within the left atrium and the outer frame 720 is moved outside of
the distal end of the delivery sheath and into the left atrium.
Upon being moved outside of the delivery sheath, the outer frame
720 can revert and assume a biased expanded configuration. The
inner frame 750 can be moved into a nested position within the
outer frame 720 and the tabs 761A and 761B can be disposed within
corresponding slots 722A and 722B of the support member 721 of the
outer frame 720. The suture strand 753 can be pulled proximally
such that the stop element 767 (coupled to the suture strand 753)
is pulled against a distal side of the support member 721, and the
clip 766 can be slid distally toward the support member 721 to
secure the inner frame 750 to the outer frame 720. The clip 766 can
be capable of sliding along the suture strand 753 while having
sufficient friction force to hold the clip 766 to the suture strand
753 in a desired location.
[0140] FIG. 33B illustrates a variation to the above embodiment in
that the suture strand 753 does not have a clip or stop element
coupled thereto. In this example embodiment, the suture strand 753
is threaded through the slot 722 of the support member 721 from a
distal side, through the opening 759 of the tab 761, and then back
through the slot 722 from a proximal side such that the two end
portions of the suture strand 753 extend from the distal side of
the support member 721. The two end portions of the suture strand
753 can extend through a gap between the native mitral annulus,
through the left ventricle and out of the apex of the heart. For
example, a procedural catheter can be inserted through a puncture
site at the apex and the two ends of the suture strand 753 can
extend through a lumen of the procedural catheter. The outer frame
720 and the inner frame 750 can be deployed as described for FIG.
33A, and then the two suture end portions can be pulled taut to
secure the tab 756 within the slot 722. For example, the two suture
end portions can be tied to form a knot on the distal side of the
support member 721 or otherwise secured in place to prevent the tab
761 from pulling out of the slot 722.
[0141] FIGS. 34A and 34B illustrate a portion of an outer frame 820
and a portion of an inner frame 850 of a prosthetic heart valve
800, according to an embodiment. The outer frame 820 is coupled to
the inner frame 820 at a coupling joint 846 such that the outer
frame 820 can be moved (e.g., rotated, pivoted) between a first
configuration relative to the inner frame 850, as shown in FIG.
34A, and a second configuration relative to the inner frame 850, as
shown in FIG. 34B, in which the outer frame 820 is inverted
relative to the inner frame 850. In this embodiment, the coupling
joint 846 includes holes 856A and 856B defined by the inner frame
850 and a suture 858 that is threaded or wrapped through the holes
856A and 856B. More specifically, a portion of the outer frame 820
is disposed against a portion of the inner frame 850 and the suture
858 is wrapped around the portion of the outer frame 820 and
through the holes 856A and 856B. One or more sutures 858 can be
used and/or the suture(s) 858 can be wrapped multiple times around
the portion of the outer frame 820 and through the holes 856A and
856B. The suture 858 can be made of any suitable material,
including shape memory polymers, polyester, tissue, and/or the
like. In some embodiments (not shown), an interface layer of
Nitinol or other suitable material can be disposed between the
outer frame 820 and the inner frame 850 to prevent abrasive
contact. Such an interface material is described with respect to
valve 1100.
[0142] As also illustrated in FIGS. 34A and 34B, the outer frame
820 includes protrusions 857A, 857B formed thereon. The protrusions
857A, 857B are sized and located such that, after the outer frame
820 and the inner frame 850 are coupled with the suture 858, the
protrusion 857A is located on one side of the suture 858, and the
protrusion 857B is located on the opposite side of the suture 858.
In this manner, the outer frame 820 has limited lateral mobility
with respect to the inner frame 850 due to the suture 858 being
constrained between the protrusions 857A, 857B.
[0143] In some embodiments, the position of the protrusions 857A,
857B can be manipulated to affect the desired lateral mobility of
the outer frame 820. In some embodiments, while the holes 856A,
856B are illustrated as positioned to have a distance between them
that is greater than the diameter/width of the outer frame 820, in
some embodiments, the outer frame 820 can have a greater
diameter/width than the distance between the holes 856A, 856B. In
other words, the outer frame 820 overlaps a portion of the holes
856A, 856B.
[0144] FIG. 35 illustrates a portion of an outer frame 920 and a
portion of an inner frame 950 of a prosthetic heart valve 900,
according to another embodiment. The outer frame 920 is coupled to
the inner frame 920 at a coupling joint 946 such that the outer
frame 920 can be moved (e.g., rotated, pivoted) between a first
configuration relative to the inner frame 950, as shown in FIG. 35,
and a second configuration relative to the inner frame 850 (not
shown), in which the outer frame 920 is inverted relative to the
inner frame 950. In this embodiment, the coupling joint 946
includes a pin assembly 925 that can be received through
through-holes 933A and 933B defined by frame portions 917 and 918,
respectively, of outer frame 920 and through a corresponding
through-hole 956 defined by the inner frame 950.
[0145] The pin 925 includes stops 934 disposed on the ends to
prevent the pin 925 from being removed. One or both of the stops
934 can be removably coupled to the ends of the pin 925. For
example, the stops 934 can be coupled to the pin 925 in any
suitable manner including, but not limited to, threaded attachment,
compression fit, adhesive (including pressure sensitive adhesives)
and/or the like. The diameter/width of the pin 925 is less than the
diameter/width of the through-hole 956 and the diameter/width of
the through-holes 933A and 933B, and the diameter/width of the
stops 934 is greater than the diameter/width of the through-hole
956 and the diameter/width of through-holes 933A, 933B. In this
manner, the stops 934 can restrict lateral movement between the
outer frame 920 and the inner frame 950, but permit the relative
rotation of the outer frame 920 about an axis defined by the length
of the pin 925.
[0146] In some embodiments, the pin 925 can be made of any suitable
rigid material, such as metal. In other embodiments, the pin 925
can be made of any suitable flexible material, such as a polymer.
In some embodiments (not shown), sutures are employed instead of
the pin assembly 958 to restrict lateral movement between the outer
frame 920 and the inner frame 950.
[0147] FIG. 36 illustrates a portion of an outer frame 1020 and a
portion of an inner frame 1050 of a prosthetic heart valve 1000,
according to an embodiment. The outer frame 1020 is coupled to the
inner frame 1050 at a coupling joint 1046 such that the outer frame
1020 can be moved (e.g., rotated, pivoted) between a first
configuration relative to the inner frame 1050, as shown in FIG.
36, and a second configuration relative to the inner frame 1050
(not shown), in which the outer frame 1020 is inverted relative to
the inner frame 1050. The coupling joint 1046 is described in
detail below.
[0148] In this embodiment, the inner frame 1050 includes a loop
structure 1051 that includes arms 1051A, 1051B that define an
opening 1015 between the arms 1051A, 1051B. The loop structure 1051
also includes through-holes 1056A, 1056B defined by arms 1051A,
1051B, respectively.
[0149] The outer frame 1020 includes a stub portion 1013 sized to
be disposable within the opening 1015 of the inner frame 1050 and
defines a through-hole 1033 configured to be substantially aligned
with the through-holes 1056A, 1056B of inner frame 1050.
[0150] To couple the outer frame 1020 to the inner frame 1050, a
pin 1025 is inserted through the through-hole 1056A, the
through-hole 1033 and the through-hole 1056B. Similar to the pin
925, and as illustrated in FIG. 36, the pin 1025 can include stops
1034 on ends thereof to prevent the pin 1025 from being removed.
The pin 1025 and the stops 1034 can be constructed the same as or
similar to the pin 925 and stops 934 described above. The
diameter/width of the pin(s) 1025 is less than the diameter/width
of the through-holes 1056A, 1056B and the diameter/width of the
through-hole 1033, while the diameter/width of the stops 1034 is
greater than the diameter/width of the through-holes 1056A, 1056B
and the diameter/width of the through-hole 1033. In this manner,
the pin 1025 can restrict lateral movement between the outer frame
1020 and the inner frame 1050, but permit the relative rotation of
the outer frame 1020 about an axis defined by the length of the pin
1025.
[0151] FIG. 37 illustrates a portion of an outer frame 1120 and a
portion of an inner frame 1150 of a prosthetic heart valve 1100,
according to an embodiment. The outer frame 1120 is coupled to the
inner frame 1120 at a coupling joint 1146 such that the outer frame
1120 can be moved (e.g., rotated, pivoted) between a first
configuration relative to the inner frame 1150, as shown in FIG.
37, and a second configuration (not shown) relative to the inner
frame 1150, in which the outer frame 1120 is inverted relative to
the inner frame 1010. In this embodiment, the coupling joint 1146
includes sutures attached to the inner frame 1150 and to the outer
frame 1120 via holes defined in each as described in more detail
below.
[0152] More specifically, the inner frame 1150 defines an opening
1156. The outer frame 1150 includes frame portions 1117 and 1118
disposed on each side of the inner frame 1150. The frame portions
1117 and 1118 each define a hole 1133A and 1133B, respectively.
[0153] As shown in FIG. 37, a suture portion 1158A is threaded or
looped through the opening 1133A and the opening 1156 and a suture
portion 1158B is threaded or looped through the opening 1133B and
the opening 1156. The suture portions 1158A, 1158B can be tied or
otherwise secured in position. The suture portions 1158A, 1158B
thus secure the frame portions 1117 and 1118 to the inner frame
1150, while allowing motion of the frame portions 1117 and 1118
relative to the inner frame 1150 to move the outer frame 1120
between the first configuration and the second inverted
configuration. The sutures 1158A, 1158B provide for a hinge-like
effect. It is understood that while sutures 1158A, 1158B are shown
to be independent of each other, any suitable suture pattern can be
employed, such as the use of a single suture running through the
opening 1156 and the openings 1133A, 1133B, a suture running
between the openings 1133A and 1133B, combinations thereof, and/or
the like. Furthermore, each of the suture portions 1158A and 1158B
can include one or more suture strands and/or one or more wraps of
the suture portion through the openings.
[0154] FIG. 37 also illustrates interface members 1149A, 1149B that
can be disposed between the inner frame 1150 and the frame portions
1117 and 1118, respectively, of outer frame 1120. The interface
members 1149A, 1149B are sized and located to substantially prevent
abrasive contact between the inner frame 1150 and the outer frame
1120, and/or to substantially prevent slippage of the outer frame
1120. In some embodiments (not shown), the interface members 1149A,
1149B can be continuous with each other, and can encircle the inner
frame 1150, save for openings consistent with the opening 1156. The
interface members 1149A, 1149B can be formed of any suitable
material, such as, for example, polyester.
[0155] FIG. 38 illustrates a portion of an outer frame 1220 and a
portion of an inner frame 1250 of a prosthetic heart valve 1200,
according to an embodiment. The outer frame 1220 is coupled to the
inner frame 1250 via coupling joints 1246. This embodiment is
similar to the previous embodiment in that the coupling portion
1246 includes sutures attached to holes in the outer frame 1220 and
holes in the inner frame 1250.
[0156] More specifically, the inner frame 1250 defines a pair of
openings 1256A and 1256B. The outer frame 1250 includes frame
portions 1217 and 1218 disposed on each side of the inner frame
1250. The frame portion 1217 defines a pair of openings 1233A and
1233A' and the frame portion 1218 defines a pair of openings 1233B
and 1233B'. In this embodiment, a suture portion 1258 is threaded
or looped through the openings 1233A, 1133A' then a portion of the
suture 1258 is inserted through a front side of the opening 1256A,
back through the opening 1256B, into the opening 1233B and looped
through the opening 1233B'. The suture 1258 can be tied or
otherwise secured in position.
[0157] The suture 1258 thus secures the frame portions 1217 and
1218 to the inner frame 1250, while allowing motion of the frame
portions 1217 and 1218 relative to the inner frame 1250 to move
(e.g., rotate, pivot) the outer frame 1220 between a first
configuration (as shown in FIG. 38) and a second inverted
configuration (not shown). The single suture 1258 through openings
1256A and 1256B may help reduce binding during movement of the
outer frame 1220. Although a single suture 1258 is shown, it should
be understood that the suture 1258 can include one or more strands
of suture material. In addition, any suitable suture pattern can
alternatively be employed and the suture 1258 one or more wraps of
the suture through the openings. Also shown in FIG. 38, interface
members 1249A and 1249B can be included to prevent abrasive contact
between the inner frame 1250 and the outer frame 1220. The
interface members 1249A, 1249B can be the same as the interface
members 1149A, 1149B described above.
[0158] FIG. 39 illustrates a portion of an outer frame 1320 and a
portion of an inner frame 1350 of a prosthetic heart valve 1300,
according to another embodiment. The outer frame 1320 is coupled to
the inner frame 1350 via coupling joints 1346. In this embodiment,
the coupling joint 1346 includes a hinge member 1348 and a tether
assembly 1365 as described in more detail below.
[0159] The hinge member 1348 can be the same as or similar to the
hinge member 648 described above for valve 600. The hinge member
1348 can be flexible to allow the outer frame 1320 to move relative
to the inner frame 1350 between the first configuration and the
second inverted configuration. In some embodiments, the hinge
member 1348 can limit the plane of motion of the outer frame 1320
with respect to the inner frame 1350. The hinge member 1348 can
function, for example, as a living hinge.
[0160] As shown in FIG. 39, the tether assembly includes a tether
1368, a stop member 1367 and an optional clip 1366. The tether 1368
can be received through a through-hole 1356 defined by the inner
frame 1350 and a through-hole 1333 defined by the outer frame 1320.
Similar to as described above with respect to the suture 753 for
valve 700 (FIG. 33A), the stop member 1367 can be disposed on an
end of the tether 1368 and the clip 1368 can be slidably coupled to
the tether 1368. The stop member 1367 can be for example, a knot
formed on the end of the tether 1368, or any other suitable stop
member with a size/diameter larger than the through-holes, 1356 and
1333. The clip 1366 can be configured to be slidable along the
tether 1368, yet have sufficient friction to maintain a desired
position along the tether 1368. In some cases, a clip 1366 may not
be desired. For example, when the clip 1366 is disposed toward the
apex side of the valve, as shown in FIG. 39, unidirectional forces
on the tether 1368 can be sufficient to maintain the stop member
1367 against the outer side portion of the outer frame 1320. Thus,
the clip member 1366 can optionally be excluded.
[0161] The tether 1368 can be, for example, a flexible member
similar to the tether 290 described above for valve 200. The tether
1368 can be formed with any suitable material such as, for example,
a braided string/thread. The stop member 1367 is configured to be
disposed outside the through-hole 1356 and the through-hole 1333,
on an outer side of the outer frame 1320. The clip 1366 is disposed
on an outer side of the inner frame 1350 and can be configured to
be slidable along the tether 1368, yet have sufficient friction to
maintain its position along the tether 1368. Thus, the inner frame
1350 and the outer frame 1320 can be disposed between the stop
member 1367 and the clip 1366.
[0162] In use, the tether 1368 can be pulled in a direction of
arrow A such that the stop member 1367 is pulled against the outer
side of the outer frame 1320, and the clip 1366 can be slid up
against the outer side of the inner frame 1350. Thus, although the
hinge member 1348 can couple the inner frame 1350 to the outer
frame 1320 in a similar manner as described for valve 600, the
tether 1368 can be used to provide further securement without
interfering with the ability of the outer frame 1320 to rotate or
pivot about the hinge member 1348. In addition, the tether 1368 can
be used in place of the proximal struts of the valve 1300 (see,
e.g., struts 243A in FIGS. 6 and 8).
[0163] In some embodiments, the tether assembly 1365 can be used
alone to couple the inner frame 1350 to the outer frame 1320,
without the hinge member 1348. In such an embodiment, as described
for valve 700 with respect to FIGS. 33A and 33B, the outer frame
1320 and inner frame 1350 can be delivered prior to being securely
coupled together. For example, the outer frame 1320 and the inner
frame 1350 can be loosely coupled via the tether assembly 1365 and
be loaded into a delivery sheath (not shown) with the outer frame
inverted upon itself and disposed distal of the inner frame 1350. A
distal end portion of the delivery sheath can be disposed within
the left atrium and the outer frame 1320 can be moved outside of
the delivery sheath and into the left atrium. Upon being moved
outside of the delivery sheath, the outer frame 1320 can revert and
assume a biased expanded configuration. The inner frame 1350 can be
moved into a nested position within the outer frame 1320 and the
tether 1368 can be pulled such that the stop member 1367 is pulled
against the outer side of the outer frame 1320 and the clip 1366
can be slid toward the outer side of the inner frame 1350 to secure
the inner frame 1350 to the outer frame 1320.
[0164] FIG. 40 illustrates a portion of an outer frame 1420 and a
portion of an inner frame 1450 of a prosthetic heart valve 1400,
according to some embodiments. In this embodiment, the outer frame
1420 is coupled to the inner frame 1450 via a coupling joint 1446
that includes a hinge member 1448 that can be the same as or
similar to and function the same as or similar to the hinge member
648 of valve 600. The valve 1400 also includes a tether assembly
1465 that includes a tether 1468 and a stop member 1467. As shown
in FIG. 40, in this embodiment, the tether 1468 is disposed through
only a through-hole 1433 defined by the outer frame 1420. Thus, the
tether assembly 1468 in this embodiment serves only to replace the
proximal struts of the valve 1400.
[0165] FIGS. 41A-41K illustrate a portion of a prosthetic heart
valve 1500, according to an embodiment. The prosthetic heart valve
1500 (also referred to as "prosthetic valve" or "valve") includes
an inner frame assembly 1540 having an inner frame 1550, and an
outer frame assembly 1510 having an outer frame 1520 (see FIGS.
41G-41I). The outer frame 1520 is coupled to the inner frame 1550
via a coupling joint 1546 (see FIGS. 41G-41I). In this embodiment,
the coupling joint 1546 includes sutures wound about the inner
frame 1550 and the outer frame 1520 as described in more detail
below.
[0166] As shown in FIGS. 41B and 41C, which are detail side and
front views, respectively, of encircled area A in FIG. 41A, frame
portions of the inner frame 1550 define a pair of openings 1556A
and 1556B. Each of the through-holes 1556A, 1556B is generally in a
half-circle shape, although other shapes are within the scope of
the disclosure. For example, FIGS. 42A-42C illustrate an example
embodiment of an inner frame 1650 having through-holes 1656A, 1656B
that are generally round. As shown in FIGS. 42B and 42C, a suture
1658 can be wound about the inner frame 1650 through through-holes
1656A and 1656B in a similar manner as described below for valve
1500.
[0167] As shown in FIGS. 41E and 41F, a portion of suture 1558 is
wound through the through-holes 1556A, 1556B and around a portion
of the inner frame 1550 disposed between the through-holes 1556A,
1556B. The half-circle shape of the through-holes 1556A, 1556B
provides a relatively flat surface such that when the suture 1558
is wound about the portion of the inner frame 1550, a relatively
flat platform is provided for interfacing with additional sutures
used to attach the outer frame 1550 to the inner frame 1550 (see
FIGS. 40G-401, described in detail later).
[0168] Referring to FIGS. 41G-41I, which illustrate the outer frame
1520 coupled to the inner frame 1550, the frame members of the
outer frame 1520 define a through-hole 1533 through which a second
suture 1558' is received. More specifically, the second suture
1558' is wound through the through-hole 1533, around an end of the
outer frame 1520 and then wound through the through-holes 1556A and
1556B of the inner frame 1550, as best shown in FIG. 41H. The
second suture 1558' can be wound to form multiple layers of
windings that run through the through-the 1533, and the
through-holes 1556A, 1556B. Thus the suture 1558' is disposed over
portions of the suture 1558 that is wound about the inner frame
1550 within the through-holes 1556A, 1556B, providing frictional,
non-sliding contact. The end portion of the outer frame 1520 abuts
the portion of the suture 1558 disposed on an exterior surface of
the inner frame 1550 as shown in FIG. 41H. In this manner, the
suture 1558 prevents abrasive contact between the outer frame 1520
and the inner frame 1550, while permitting the outer frame 1520 to
move (e.g., pivot, rotate) between the first configuration and the
second inverted configuration relative to the inner frame 1550. The
suture 1558 and/or the suture 1558' can independently be made of
any suitable material including, but not limited to, nylon,
polyester, polyvinylidene fluoride (PVDF), polypropylene,
combinations thereof, and/or the like.
[0169] FIGS. 43-48 illustrate an alternative method of delivering a
prosthetic valve within an annulus of a heart via a transfemoral
delivery approach. As shown in FIG. 43, a procedural catheter 1735
is inserted through an apical puncture (e.g., a 5F apical puncture)
in a ventricular wall at the apex Ap of the heart H. A guide wire
1737 is inserted through a lumen (not shown) of the procedural
catheter 1735 and extended through the left ventricle LV, through a
mitral valve gap and into the left atrium LA. A delivery sheath
1726 is introduced through a femoral vein puncture and extended
through the inferior vena cava, into the right atrium, and then
through a transseptal puncture of the septum Sp of the heart H, and
into the left atrium LA of the heart H. A snare device 1719 is
movably disposed within the delivery sheath 1726 and used to grab
or snare a distal end portion of the guide wire 1737, as shown in
FIG. 43. The snare device 1719 can be used to pull the guide wire
1737 through the delivery sheath 1726 such that the distal end
portion of the guide wire 1737 extends outside the femoral vein and
a proximal end of the guide wire 1737 is disposed through the
ventricular wall at the apex Ap of the heart H, as shown in FIG.
44. Although not shown in FIGS. 43 and 44, the procedural catheter
1735 is disposed outside the patient's body, the distal end of the
guide wire 1737 extends outside the femoral vein and outside the
patient's body, and the proximal end of the guide wire 1737 extends
outside the apex Ap and outside the patient's body. Although the
above described snare process describes delivering the guide wire
1737 to the left atrium of the heart and then snaring the guide
wire 1737 using the snare device 1719, in alternative embodiments,
the guide wire 1737 can be delivered to the left ventricle LV and
the snare device 1719 and delivery sheath 1726 can be inserted
through the mitral annulus and into the left ventricle LV to grab
or snare the guide wire 1737 as described above.
[0170] After the guide wire 1737 has been extended between the apex
Ap and the access site to the femoral vein, the delivery sheath
1726 can be removed. A leader tube 1724 is loaded over the guide
wire 1737 starting outside the heart (and outside the procedural
catheter 1735) and exiting the femoral vein at the femoral puncture
site as shown in FIG. 45. As shown in FIG. 45, the leader tube 1724
includes a balloon dilator member 1711 that is inserted into a
distal end of the delivery sheath 1726 and disposed partially over
a distal end portion of the prosthetic valve 1700. For example, the
balloon dilator member 1711 can have a collapsed or uninflated
configuration (not shown) for delivery over the guide wire 1737 and
can then be inflated or otherwise moved to an expanded
configuration as shown in FIG. 45. Also shown in FIG. 45, a pusher
1738 is disposed within the lumen of the delivery sheath 1726 and
can be used to move or push the prosthetic valve 1700 into the left
atrium LA, as described in more detail below. With the leader tube
1724 disposed between the femoral puncture site and the apex of the
heart, the guide wire 1737 can be removed. Although not shown in
FIGS. 45-47, the procedural catheter 1735 remains inserted into the
left ventricle LV of the heart as shown in FIGS. 43 and 44.
[0171] The prosthetic valve 1700 can be configured the same as or
similar to the prosthetic valves described herein. The prosthetic
valve 1700 (shown schematically within the delivery sheath 1726 in
FIG. 45) can be disposed in an inverted configuration within the
delivery sheath 1726 to reduce the overall outer perimeter of the
prosthetic valve 1700. A tether 1736 is coupled to a distal end
portion of the prosthetic valve 1700 (see FIGS. 47 and 48). The
tether 1736 can be threaded through the leader tube 1724 prior to
the leader tube 1724 being disposed within the distal end of the
delivery sheath 1726. For example, as previously described, the
tether 1736 can include a valve leader member (not shown). The
valve leader member can have a tapered distal end to aid in the
insertion and maneuvering of the valve leader member through the
leader tube 1724. The valve leader member can be attached at a
proximal end portion of the tether 1736, which is attached to the
valve 1700. The tether 1736 can be formed, for example, as a
braided rope or cord. The tether 1736 can be threaded through the
leader tube 1724 with the valve leader member extended out the apex
of the proximal end of the leader tube 1724 outside the apex of the
heart. Thus, the tether 1736 extends between the apex Ap and the
femoral puncture site where it is coupled to the valve 1700.
[0172] The delivery sheath 1726 can then be inserted through the
femoral puncture site and moved through the femoral vein, through
the inferior vena cava, into the right atrium, and then through the
septum Sp until a distal end portion of the delivery sheath 1726
(with the valve 1700) is disposed within the left atrium LA, as
shown in FIG. 46. The dilator balloon member 1711 can provide a
smooth lead-in to assist in maneuvering the distal end of the
delivery sheath 1726 through the femoral vein and within the heart.
Although the delivery sheath 1726 is used to deliver both the snare
device 1719 and the valve 1700, in other embodiments, a different
delivery sheath can be used to deliver the snare device 1719 than
is used to deliver the valve 1700.
[0173] With the distal end of the delivery sheath 1726 within the
left atrium LA, the leader tube 1724 can be removed through the
apex Ap, leaving the tether 1736 extended between the valve 1700
and outside the apex Ap of the heart (see FIG. 47). For example,
the balloon dilator member 1711 can be moved back to a collapsed
configuration for removal through the procedural catheter 1735. The
procedural catheter 1735 can then also be removed. The pusher 1738
can be used to push or move the valve 1700 out the distal end of
the delivery sheath 1726 and within the left atrium LA of the heart
as shown in FIG. 47. As the valve exits the distal end of the
delivery sheath 1726 the valve 1700 can revert and return to its
original undeformed shape as described above, for example, for
valve 200. For example, the valve 1700 can be formed with a
shape-memory material and can have a biased undeformed shape and
can be manipulated and/or deformed (e.g., compressed and/or
expanded) and, when released, return to its original undeformed
shape. The valve can be, for example, a valve constructed the same
as or similar to, and function in the same or similar manner as,
the prosthetic heart valve 200, described above.
[0174] As shown in FIG. 47, the tether 1736 extends from the valve
1700 through the apical puncture and outside the patient's body. As
the delivery sheath 2026 is advanced, the tether 1736 can
optionally be pulled at the apex end to help move the delivery
sheath 1726, with the valve 200 disposed therein, through the
femoral vein, through the septal puncture and into the left atrium
LA. The valve 1700 can then be fully deployed within the left
atrium LA, as shown in FIG. 48, by using the pusher 1738 described
above and/or by pulling the apex end portion of the tether 1736
until the valve 1700 is pulled out of the lumen of the delivery
sheath 1726 and disposed within the left atrium LA.
[0175] In some embodiments, the pusher 1738 can also be used to aid
in positioning the valve 1700 in a desired radial orientation
within the left atrium LA. For example, the pusher device 1738 can
define an internal lumen (not shown) that can be placed over an
inner frame portion of the valve 1700 to hold the inner frame
portion in a small diameter, which can help enable the valve 1700
to be positioned in a desired radial orientation and be seated
within the annulus of the mitral valve. Further examples of such a
valve assist device are described below with reference to FIGS.
49-51.
[0176] As shown in FIG. 48, as the valve 1700 is deployed within
the left atrium LA, the valve 1700 is allowed to assume its biased
expanded or deployed configuration. The delivery sheath 1726 can
then be removed from the patient and the valve 1700 can be
positioned and tensioned using the tether 1736 to obtain the
desired or optimal location in the native mitral annulus and
minimize perivalvular leaks. An epicardial pad device 1739 (as
described above) can be used to secure the tether 1736 and valve
1700 in position within the mitral annulus. In some embodiments,
rather than securing the prosthetic mitral valve with a tether and
epicardial pad, the prosthetic mitral valve can be secured with
clips or other coupling methods to a portion(s) of the mitral valve
apparatus and/or the ventricular wall of the heart.
[0177] FIGS. 49 and 50 illustrate an optional wire assist structure
that can be used during a procedure to deliver a prosthetic heart
valve, for example, transfemorally as described above for previous
embodiments. A wire assist structure 1801 can be releasably coupled
to a valve 1800 as shown in FIG. 49. The valve 1800 can be
constructed the same as or similar to, and function the same as or
similar to, the valves described above for previous embodiments.
For example, the valve 1800 can include an outer frame 1820 and an
inner frame 1850. The wire assist structure 1801 can be releasably
coupled to the inner frame 1850 as shown in FIGS. 49 and 50. For
example, releasable connectors (not shown) can be used to couple
the wire assist structure 1801 to the inner frame 1850.
[0178] In use, the wire assist structure 1801 can be movably
disposed within a delivery sheath 1826 used to deliver the valve
1800 to the heart. The wire assist structure 1801 can hold the
inner frame 1850 and provide positioning control of the valve 1800
(i.e., clocking and advancement) while the outer frame 1850 of the
valve 1800 is fully expanded, which allows the valve 1800 to be
functioning during the positioning phase. When the valve 1800 is in
the desired final position, the wire assist structure 1801 can be
released from the inner frame 1850 and removed with the delivery
sheath 1826.
[0179] FIG. 51 illustrates another optional assist member that can
be used during a procedure to deliver a prosthetic heart valve
transfemorally. An assist member 1902 can be in the form of a
tubular member defining a lumen with a diameter sized to receive at
least a portion of the inner frame 1950 of a valve 1900. The valve
1900 can be constructed the same as or similar to, and function the
same as or similar to, the valves described above for previous
embodiments. For example, the valve 1900 can include an outer frame
(not shown) and the inner frame 1950 as described above for
previous embodiments.
[0180] In use, the assist member 1902 can be movably disposed
within a delivery sheath (not shown) used to deliver the valve 1900
and be disposed over at least a portion of the inner valve assembly
(e.g., inner frame 1950). As with the wire assist structure 1801,
the assist member 1902 can hold the inner frame 1950 in a small
compact configuration and allow for positioning control of the
valve 1900 (i.e., clocking and advancement) while the outer frame
of the valve 1900 is being expanded. This can in some cases allow
the valve 1900 to be functioning (or at least partially
functioning) during the positioning phase of the valve 1900. With
the inner frame 1950 held in a compact or small diameter form
factor, the valve 1900 can be more easily positioned to help seal
the annulus with the outer frame (not shown) of the valve 1900.
When the valve 1900 is in the desired final position, the assist
member 1902 can be removed.
[0181] FIG. 52 is a schematic illustration of delivery system that
can be used to deliver and deploy a prosthetic heart valve within a
heart of patient with, for example, a transvascular approach. In
this embodiment, a delivery system 2005 includes a delivery sheath
2026, a valve holder 2038 (also referred to as a "pusher"), and one
or more actuation wires 2074 and 2076. In this schematic
illustration, only two actuation wires are illustrated, but in
other embodiments, only one actuation wire or more than two
actuation wires can be used.
[0182] The delivery sheath 2026 can be used to deliver a valve 2000
that includes an inner valve assembly 2040 including an inner frame
(not labeled in FIG. 52) and an outer valve assembly 2010 including
an outer frame (not labeled in FIG. 52). The valve 2000 can be
constructed the same as or similar to, and function the same as or
similar to, for example, the prosthetic valves described herein
(e.g., valves 100, 200, 300, 400, etc.) and can be moved between a
deployed or expanded configuration and a delivery configuration in
which the outer frame is disposed in an inverted positon relative
to the inner frame as described above. As shown in FIG. 52, the
valve 2000 can be disposed within a lumen of the delivery sheath
2026 when the valve is in the delivery configuration (i.e., the
outer frame is inverted relative to the inner frame). The valve
holder 2038 is coupled to the inner valve assembly 2040 and the
actuation wires are coupled to the outer fame assembly 2010. The
valve holder 2038 can be releasably coupled to the inner frame
assembly 2040 with couplers, as described in more detail below with
reference to FIGS. 53-58C.
[0183] The actuation wires 2074 and 2076 can be coupled to the
outer fame of the outer valve assembly 2010 with a variety of
different coupling methods. For example, the outer frame 2010 can
include loops (as described in more detail below with reference to
specific embodiments (see, e.g., FIG. 57)) through which the
actuation wires 2074 and 2076 can be received or threaded. The
number of loops on the outer frame can vary and the number of loops
through which each actuation wire is connected can vary. For
example, in some embodiments, the outer frame includes 12 loops and
a first actuation wire is threaded through 6 of the loops and a
second actuation wire is threaded through 6 of the loops. In other
embodiments, the outer frame can include 12 loops and there can be
4 actuation wires, each coupled to 3 of the loops. In some
embodiments, a single actuation wire is coupled through all of the
loops of the outer frame.
[0184] The delivery sheath 2026 can be used to deliver the valve
2000 to the left atrium of the heart as described above for
previous embodiments. When the distal end of the delivery sheath
2026 is disposed within the left atrium, the valve 2000 is moved
out of the lumen of the delivery sheath 2026 using the actuation
wires 2074, 2076 to assist in pulling the valve 2000 out of the
delivery sheath 2026. In some case, the valve holder 2038 can also
be used to push the valve 2000 out of the delivery sheath 2026.
More specifically, the actuation wires 2074 and 2076 can extend
from the outer valve assembly 2010 out a distal end of the delivery
sheath and extend proximally. In some embodiments, the actuation
wires 2074, 2076 extend proximally outside the delivery sheath
2126, then pass back into the lumen of the delivery sheath 2026
through side apertures or holes (not shown) and then out a proximal
end of the delivery sheath 2026. Thus, a user (e.g., physician) can
pull the proximal end portions of the actuation wires 2074 and 2076
to in turn pull the outer frame assembly 2010 out of the distal end
of the delivery sheath 2026. In some embodiments, the actuation
wires 2074, 2076 extend proximally from the outer valve assembly
2010, back through the distal end of the delivery sheath 2026 and
within the lumen of the delivery sheath, and then out a proximal
end of the delivery sheath 2026. Various different embodiments and
configurations are described in more detail below.
[0185] As the outer frame assembly 2010 exits the delivery sheath
2026 it will still be in an inverted configuration relative to the
inner frame assembly 2040. After the outer frame assembly 2010 is
at least partially outside of the lumen of the delivery sheath
2026, the outer frame assembly 2010 can begin to revert to its
expanded or deployed configuration (not shown in FIG. 52). In this
embodiment, however, the actuation wires 2074 and 2076 can function
to selectively (e.g., by an operator) assist and/or control the
expansion, deployment and/or articulation of the valve 2000 as the
valve 2000 is delivered to the heart. In this manner, in use, the
proximal end portions of the actuation wires 2074, 2076 can be
pulled distally to manipulate the outer frame assembly 2010 to
assist and control the transition of the outer frame assembly 2010
from its inverted configuration relative to the inner frame
assembly 2040 to its expanded or deployed configuration (not
shown). In some embodiments, the actuation wires 2074, 2076 can be
manually grasped by a user to pull the actuation wires proximally.
In some embodiments, the actuation wires 2074, 2076 can be
operatively coupled to the delivery system 2005 such that the user
does not have to manually handle the actuation wires. For example,
the actuation wires can be coupled to a delivery sheath and/or to a
handle assembly (not shown) of the delivery system 2005. Various
embodiments of a delivery system are described in more detail
below.
[0186] FIGS. 53-56 illustrate a delivery system 2105 and method for
delivering and deploying a prosthetic heart valve 2100 into a
heart. The prosthetic heart valve 2100 (also referred to herein as
"valve") can be constructed the same as or similar to, and function
the same as or similar to, any of the valves described herein.
Thus, some details regarding the valve 2100 are not described
herein.
[0187] As shown in FIG. 53, the valve 2100 has an outer valve
assembly 2110 with an outer frame 2120, an inner valve assembly
2140 with an inner frame 2150, and a tether 2136 coupled to the
inner frame 2150. As described above for previous embodiments
(e.g., valve 100, 200, 300 etc.), the outer frame 2120 and the
inner frame 2150 of valve the 2100 can each be formed with a
shape-memory material and have a biased, expanded or deployed
configuration. The valve 2100 can also include an outer covering
2130. The outer frame 2120 and the inner frame 2150 can be moved to
a collapsed or undeployed configuration for delivery of the valve
2100 to the heart in which the outer frame 2120 is in an inverted
configuration relative to the inner frame 2150. In this example
method of preparing the valve 2100 for delivery to the heart, the
outer frame 2120 of the valve 2100 is first disposed in the
prolapsed or inverted configuration as shown in FIG. 53.
Specifically, the elastic or superelastic structure of outer frame
2120 of valve 2100 allows the outer frame 2120 to be disposed in
the prolapsed or inverted configuration relative to the inner frame
2150.
[0188] To dispose the outer frame 2120 in its inverted
configuration, the outer frame 2120 is folded or inverted distally
such that the outer frame 2120 is pointed away from the inner frame
2150. With the outer frame 2120 in the inverted configuration, the
valve 2100 can be placed within a lumen of a delivery sheath 2126
as shown in FIG. 53 for delivery of the valve 2100 to the left
atrium of the heart. As discussed above, by disposing the outer
frame 2120 of the valve 2100 in the inverted configuration, the
valve 2100 can be collapsed into a smaller overall diameter, i.e.,
placed in a smaller diameter delivery sheath, than would be
possible if the valve 2100 were collapsed radially when the inner
frame 2150 and the outer frame 2120 are disposed concentric to one
another. Said another way, when the two frames (i.e., the inner
frame 2150 and the outer frame 2120) are concentric, the outer
frame 2120 must be collapsed around the inner frame 2150, whereas
in the inverted configuration, the two frames are coaxial but not
concentric, such that the outer frame 2120 can be collapsed without
needing to accommodate the inner frame 2150 nested inside it.
[0189] In this embodiment, a valve holder 2138 (also referred to as
a "pusher") is coupled to the inner frame 2150. In this manner, the
valve holder 2138 can be used to hold the valve 2100 to aid in the
control and manipulation of the valve 2100 as it is being deployed
within a heart. In addition, the valve holder 2138 can limit radial
expansion of the inner frame 2150 as the valve 2100 is moved within
the lumen of the delivery sheath 2126 and during deployment. In
this embodiment, the valve holder 2138 is coupled to the inner
frame 2150 via couplers 2106 that are attached to the inner frame
2150 and that can be releasably received within corresponding
recesses 2104 defined in the valve holder 2138 as best shown in
FIGS. 58A-58C. In this embodiment, the couplers 2106 are in the
form of a T-bar or hammer shape. It should be understood that
couplers with other configurations and shapes can be used.
[0190] As shown in FIG. 58A, the couplers 2106 are received within
the recesses 2104 and the valve 2100 and the valve holder 2138 can
be disposed within the lumen of the delivery sheath 2126. The inner
diameter of the delivery sheath 2126 can be sized such that when
the valve holder 2138 and valve 2100 are disposed therein, the
couplers 2106 are unable to exit the recesses 2104. In other words,
the inner walls of the delivery sheath 2126 maintain the couplers
2106 within the recesses 2104. When the valve 2100 is moved outside
of the delivery sheath 2126, the couplers 2106 will be able to
freely exit the recesses 2104 releasing the inner frame 2150 from
the valve holder 2138.
[0191] In alternative embodiments, the valve holder 2138 can be
removably coupled to the valve 2100 (e.g., the inner frame 2150 of
the valve 2100) via wires or sutures that can be cut after delivery
of the valve 2100 to he heart. In some cases, the valve holder 2138
can be decoupled from the valve 2100 when the valve is still
disposed within the delivery sheath 2126, while in other instances
the valve holder 2138 can be decoupled from the valve 2100 after
the valve 2100 exits the delivery sheath 2126 within the heart.
[0192] Although not shown, in other embodiments, the valve holder
can contact and push the valve 2100 towards the distal end portion
of the delivery sheath 2126, as described for previous embodiments,
without securing the inner frame 2150 to the valve holder 2138. In
such embodiments, in some instances, radial expansion of the inner
frame 2150 can be restricted by the delivery sheath 2126 when the
inner frame 2150 is disposed therein.
[0193] As with the embodiment of FIG. 52, in this embodiment a
first actuation wire 2174 and a second actuation wire 2176 are
coupled to the outer valve assembly 2110. More specifically, the
outer frame 2120 of the outer valve assembly 2110 includes loops
2162 through which the first and second actuation wires 2174 and
2176 can be threaded or received therethrough. In this embodiment,
the outer frame 2120 includes 12 loops 2162. The actuation wire
2174 is threaded through 6 of the loops 2162 and the actuation wire
2176 is threaded through 6 of the loops 2162. In other embodiments,
there can be a different number of loops disposed on the outer
frame 2120 and there can be more than two actuation wires or a
single actuation wires. Further, each actuation wire can be
threaded or received through a different number of loops than shown
for this embodiment.
[0194] When the valve 2100 is disposed within the lumen of the
delivery sheath 2126 as shown in FIG. 53, the actuation wires 2174
and 2176 extend out the distal end of the delivery sheath 2126,
along the outside of the delivery sheath 2126, back through side
apertures 2109 defined by the delivery sheath 2126, within the
lumen of the delivery sheath 2126 and the two end portions of each
of the actuation wires extend out a proximal end of the delivery
sheath 2126. A user (e.g., physician) can grasp (directly, or via a
control device, not shown) the end portions of the actuation wires
2174, 2176 to manipulate and control movement of the valve 2100
during deployment within a heart as described in more detail below.
As described previously, in some embodiments, the actuation wires
2174, 2176 can be operatively coupled to the delivery system such
that the user does not have to manually handle the actuation wires.
For example, the actuation wires can be coupled to a delivery
sheath and/or to a handle assembly (not shown) of the delivery
system 2105.
[0195] The procedure to deliver the valve 2100 to the heart can be
the same as or similar to any of the procedures described herein or
in '572 PCT Application incorporated by reference above. For
example, the valve 2100 can be delivered to the left atrium of the
heart in the same or similar manner as described above with
reference to FIGS. 43-48. With the distal end portion of the
delivery sheath 2126 disposed within the left atrium of the heart,
the valve 2100 can be deployed outside of the delivery sheath 2126.
In this embodiment, to deploy the valve 2100, the user can pull
proximally on the actuation wires 2174 and 2176 to pull the outer
frame 2120 out of the delivery sheath in a controlled manner and
such that the reversion of the outer frame 2120 from its inverted
configuration relative to the inner frame 2150 can be controlled.
In some cases, the tether 2136 coupled to the valve 2100 can be
used to help pull the valve 2100 out of the lumen of the delivery
sheath 2126. Alternatively, or in addition to, the valve holder
2138 can be used to push the valve 2100 distally out of the
delivery sheath 2126. Thus, the valve 2100 can be moved outside of
the delivery sheath 2126 by pushing with the valve holder 2138,
pulling with the tether 2136, and/or pulling on the actuation wires
2174 and 2176. As the valve 2100 exits the lumen of the delivery
sheath 2126, the outer frame 2120 exits first in its inverted
configuration as shown in the progression of FIGS. 53-56. When the
outer frame 2120 is at least partially outside of the lumen of the
delivery sheath 2126, the outer frame 2120 can begin to revert to
its expanded or deployed configuration, as shown in the progression
of FIGS. 54-56, which can be similar to the progression described
above with respect to FIGS. 15-21 and valve 300. In this
embodiment, however, as shown in FIGS. 53-56, the actuation wires
2174 and 2176 can be used to selectively (e.g., by an operator)
assist and/or control expansion, deployment and/or articulation of
the valve 2100 as the valve 2100 is delivered to the heart. As
shown in the progression of FIGS. 54-56, as the outer frame 2120 is
moved outside of the lumen of the delivery sheath 2126 using the
actuation wires 2174 and 2176, the outer frame 2120 can be
transitioned from its inverted configuration to its expanded
configuration as shown in FIG. 55.
[0196] In addition, in some instances, the actuation wires 2174 and
2176 can assist in the articulation and placement of the valve 2100
into its destination (e.g., a native annulus of an atrioventricular
valve of a heart). For example, as shown in FIG. 56, the actuation
wires 2174 and 2176 can also be used to constrain, collapse, or
otherwise bias the valve 2100 (e.g., radially compress the outer
frame 2120 of the valve 2100) after the valve 2100 exits the
delivery sheath 2126 and is in its reverted, expanded or partially
expanded configuration. In this manner, the actuation wires 2174
and 2176 can be used to move or urge the valve 2100 to a smaller
configuration (i.e., smaller than its fully deployed, unbiased
configuration). This may be desirable, for example, to reposition
the valve 2100 within the heart before fully deploying the valve
2100. This is best shown by the sequence between FIG. 55 and FIG.
56.
[0197] As shown in FIG. 55, when the outer frame 2120 of the valve
2100 is disposed in its non-inverted and at least partially
expanded configuration, the valve 2100 has a diameter D1. As shown
in FIG. 56, when the outer frame 2120 of the valve 2100 is then
moved to a compressed or restrained configuration, the valve 2100
has a diameter D2. As shown, D1 is greater than D2.
[0198] When the valve 2100 is positioned in a desired location
within the heart, the actuation wires 2174 and 2176 can be released
such that the outer fame 2120 can then move to its expanded
configuration. The inner frame 2150 of the valve 2100 can then be
moved distally out of the delivery sheath 2129 by moving the valve
holder 2138 distally and/or by pulling on the tether 2136. When the
valve holder 2138 is outside of the delivery sheath 2126 a
sufficient distance to clear the recesses 2104, the couplers 2106
on the inner frame 2150 can freely be moved out of the recesses
2104, decoupling the inner frame 2150 from the valve holder
2138.
[0199] The actuation wires 2174 and 2176 can be decoupled from the
outer frame 2120 either before or after deploying the inner frame
2150. For example, in this embodiment, to decouple the actuation
wires 2174 and 2176 from the outer frame 2120, one end of each of
the actuation wires 2174, 2176 can be pulled proximally, which will
pull the opposite end of the actuation wires 2174 and 2176 out
through the loops 2162. In alternative embodiments, where the
actuation wires are tied or otherwise attached to the outer frame,
the actuators can be cut, for example, to release the outer frame
from the actuation wires.
[0200] Further, the actuation wires 2174 and 2176 can be decoupled
from the outer frame 2120 at any suitable sequence or time period
within the procedure. For example, in some instances, the actuation
wires 2174 and 2176 can be released after the valve 2100 has at
least partially exited the delivery sheath 2126 but before the
valve 2100 is seated within the native annulus of the
atrioventricular valve. In other instances, for example, the
actuation wires 2174 and 2176 can be released after the valve 2100
has at least partially exited the delivery sheath 2126 and after
the valve 2100 is seated within the native annulus of the
atrioventricular valve.
[0201] FIG. 59 illustrates another embodiment of a delivery system
2205 that can be used to deliver and deploy a prosthetic heart
valve 2200 (also referred to herein as "valve") within a heart in a
procedure similar to or the same as the procedures described above
with respect to previous embodiments. Thus, some details regarding
the valve 2200 and procedures performed therewith are not described
herein. It should be understood that for features and functions not
specifically discussed, those features and functions can be the
same as or similar to the valves described above. The valve 2200
can be constructed the same as or similar to, and function the same
as or similar to any of the valves described herein. For example,
the valve 2200 includes an outer valve assembly 2210 that has an
outer frame 2220, an inner valve assembly 2240 that has an inner
frame 2250, and a tether 2236 coupled to the inner valve assembly
2240.
[0202] As with previous embodiments, the valve 2200 can be moved
from a biased expanded configuration to an inverted configuration
for delivery of the valve 2200 to the heart. More specifically, to
place the valve 2200 in the inverted configuration, the outer frame
2220 can be moved to an inverted configuration relative to the
inner frame 2250. In this embodiment, the valve 2200 is placed at
least partially within a lumen of an inner sheath 2208 when the
valve 2200 is in the inverted configuration, and disposed near a
distal end of the inner sheath 2208. A valve holder 2238 is also
disposed within the lumen of the inner sheath 2208. The inner frame
2250 can be releasably coupled to the valve holder 2238 with
couplers 2206 in the same or similar manner as described above for
valve 2100. Similarly, the outer frame 2220 includes loops 2262
through which actuation wires 2274 and 2276 can be threaded through
in the same or similar manner as described above for valve 2100.
The inner sheath 2208 is movably disposed within an outer delivery
sheath 2226. As shown in FIG. 59, a portion of the valve 2200 is
disposed outside of the inner sheath 2208 and within the lumen of
the outer delivery sheath 2226. In some cases, the entire valve can
be disposed within the lumen of the inner sheath 2208 prior to
performing the procedure to deploy the valve.
[0203] In this embodiment, the inner sheath 2208 defines side
apertures 2209 through which the actuation wires 2274 and 2276 can
pass through. More specifically, as shown in FIG. 59, when the
valve 2200 is disposed within the lumen of the inner sheath 2208,
the actuation wires 2274 and 2276 extend proximally from the outer
frame 2220, along the outside of the inner sheath 2208 and within
the lumen of the outer delivery sheath 2226, back through side
apertures 2209 defined by the inner sheath 2208, within the lumen
of the inner sheath 2208, and the two end portions of each of the
actuation wires 2274 and 2276 extend out a proximal end of the
inner sheath 2208. A user (e.g., physician) can grasp the end
portions of the actuation wires 2274, 2276 to manipulate and
control movement of the valve 2200 during deployment within a heart
as described above for valve 2100. As described previously, in some
embodiments, the actuation wires 2274, 2276 can be operatively
coupled to the delivery system such that the user does not have to
manually handle the actuation wires. For example, the actuation
wires 2274, 2276 can be coupled to a delivery sheath and/or to a
handle assembly (not shown) of the delivery system 2205.
[0204] In this embodiment, at least a portion of the actuation
wires 2274 and 2276 can be disposed within the interior of the
delivery sheath 2226, thus limiting the exposure of the actuation
wires 2274, 2276 to areas external to the delivery sheath 2226 for
at least a portion of the delivery and/or deployment of the valve
2200. The proximal end portions of the actuation wires 2274, 2276
can be used by the operator performing the delivery procedure to
manipulate and control the deployment of the valve 2200. Although
the side apertures 2209 defined by the inner sheath 2208 are shown
as disposed at or near the distal end portion of the inner sheath
2208, in other embodiments, side apertures 2209 can be disposed at
any suitable location along the length of the inner sheath 2208
(e.g., towards a middle portion or a proximal portion of the
management sheath).
[0205] In this embodiment, to deliver the valve 2200 to the heart,
the distal end of the outer delivery sheath 2226, with the valve
2200, inner sheath 2208 and valve holder 2238 disposed therein, is
disposed within the left atrium of the heart. The delivery sheath
2226 can be pulled proximally to expose a portion of the valve 2200
and/or the inner sheath 2208 and valve holder 2238 can be moved
distally to move at least the outer frame 2220 of the valve 2200
outside of the delivery sheath 2226. The actuation wires 2274 and
2276 can then be used to pull the distal end portions of the outer
frame 2220 (e.g., where the loops 2262 of the outer frame 2220 are
disposed) proximally to revert the outer frame to an uninverted
configuration relative to the inner frame 2250. In addition, the
tether 436 can also be used to help pull at least a portion of the
valve 2200 out of the lumen of the inner sheath 2208 and the lumen
of the outer delivery sheath 2226 during the delivery of the valve
2200 as discussed above for previous embodiments. Alternatively, or
in addition to, the valve holder 2238 can be used to deliver and
deploy the valve 2200. Thus, the valve 2200 can be deployed by
pushing with the pusher device 480, pulling with the tether 436, or
both.
[0206] When the outer frame has been reverted, the inner frame 2250
can be moved distally out of the inner sheath 2208 and decoupled
from the valve holder 2238 in the same manner as described above
for valve 2100. When released from the valve holder 2238, the inner
frame 2250 can assume a biased expanded configuration. The
actuation wires 2274 and 2276 can also be released from the outer
frame 2220 in the same manner as described above for valve 2100.
With both the outer frame 2220 and inner frame 2250 disposed within
the atrium and in their biased expanded configurations, the valve
2200 can be seated in a desired position within the native annulus
of the atrioventricular valve (e.g., the mitral valve).
[0207] FIG. 60 illustrates another embodiment of a delivery system
that can be used to deliver and deploy a prosthetic heart valve
2300 (also referred to as "valve") within a heart in a procedure
similar to or the same as the procedures described above with
respect to previous embodiments. Thus, some details regarding the
valve 2300 and procedures performed therewith are not described
with respect to this embodiment. It should be understood that for
features and functions not specifically discussed, those features
and functions can be the same as or similar to the valves and
associated components described above for previous embodiments.
[0208] As shown in FIG. 60, the valve 2300 has an outer valve
assembly 2310 that has an outer frame 2320, an inner valve assembly
2340 that has an inner frame 2350 and a tether 2336 coupled to the
inner valve assembly 2340. As with previous embodiments, the valve
2300 can be moved from a biased expanded configuration to an
inverted configuration for delivery of the valve 2300 to a heart.
More specifically, to place the valve 2300 in the inverted
configuration, the outer frame 2320 can be moved to an inverted
configuration relative to the inner frame 2350. In this embodiment,
the valve 2300 is placed at least partially within a lumen of an
inner sheath 2308 when the valve 2300 is in the inverted
configuration, and disposed near a distal end of the inner sheath
2308. A valve holder 2338 is also disposed within the lumen of the
inner sheath 2308. The inner frame 2350 can be releasably coupled
to the valve holder 2338 with couplers 2306 received within
recesses 2304 defined by valve holder 2338 in the same or similar
manner as described above for valve 2100. Similarly, the outer
frame 2320 includes loops 2362 through which actuation wires 2374
and 2376 can be threaded through in the same or similar manner as
described above for valve 2100. The inner sheath 2308 is movably
disposed within an outer delivery sheath 2326. As shown in FIG. 60,
a portion of the valve 2300 is disposed outside of the inner sheath
2308 and within the lumen of the outer delivery sheath 2326. In
some cases, the entire valve can be disposed within the lumen of
the inner sheath 2308 prior to performing the procedure to deploy
the valve.
[0209] In this embodiment, the actuation wires are routed from the
outer frame 2320 of the valve 2300, into the lumen of the outer
delivery sheath 2326, through a distal end opening of the inner
sheath 2308 and into the lumen of the inner sheath 2308. The wire
actuators 2374 and 2376 extend proximally along an outer surface of
the valve holder 2338, and the two end portions of each of the wire
actuators 2374 and 2376 extend out a proximal end of the inner
sheath 2308. Thus, a user (e.g., physician) can grasp the end
portions of the actuation wires 2374, 2376 to manipulate and
control movement of the valve 2300 during deployment within a heart
as described above for valves 2100 and 2200. As described above, in
some embodiments, the actuation wires 2374, 2376 can be operatively
coupled to the delivery system 2305 such that the user does not
have to manually handle the actuation wires. For example, the
actuation wires 2374, 2376 can be coupled to a delivery sheath
and/or to a handle assembly (not shown) of the delivery system
2305. As described for the previous embodiment, with the actuation
wires 2374 and 2376 disposed within the interior of the delivery
system (e.g., the lumen of the delivery sheath 2326 and lumen of
the inner sheath 2308), limits the exposure of the actuation wires
2374, 2376 to areas external to the delivery system 2305 for at
least a portion of the delivery and/or deployment of the valve
2300.
[0210] FIG. 61 illustrates a variation of the delivery system 2305
in which the actuation wires 2374 and 2376 are routed or passed
between the outer delivery sheath 2326 and the inner sheath 2208
(i.e., through the lumen of the outer delivery sheath 2326 and
external to the inner sheath 2308).
[0211] The delivery system 2305 (i.e., shown in FIG. 59 and FIG.
60), can be used in a procedure similar to or the same as the
procedures described above with respect to valve 2200 to deliver
and deploy the valve 2300 within a heart.
[0212] FIG. 62 illustrates another embodiment of a delivery system
that can be used to deliver and deploy a prosthetic heart valve
2400. In this embodiment, a procedure similar to or the same as the
procedures described above with respect to previous embodiments can
be performed to deliver the prosthetic heart valve 2300 (also
referred to herein as "valve"). Thus, some details regarding the
valve 2400 and procedures performed therewith are not described
herein. It should be understood that for features and functions not
specifically discussed, those features and functions can be the
same as or similar to the valves and associated components
described above for previous embodiments.
[0213] As shown in FIG. 62, the valve 2400 includes an outer valve
assembly 2410 having an outer frame 2420, an inner valve assembly
2440 having an inner frame 2450 and a tether 2436 coupled to the
inner valve assembly 2440. As described above for previous
embodiment, the outer frame 2420 of the valve 2400 can be moved
between a biased expanded configuration and an inverted
configuration in which the outer frame 2420 is inverted relative to
the inner frame 2450. In this embodiment, with the outer frame 2420
in the inverted configuration, the valve 2400 is placed at least
partially within a lumen of an inner sheath 2408, and disposed near
a distal end of the inner sheath 2408. A valve holder 2438 is also
disposed within the lumen of the inner sheath 2408. The inner frame
2450 is releasably coupled to the valve holder 2438 with couplers
2406 in the same or similar manner as described above for valve
2100. Similarly, the outer frame 2420 includes loops 2462 through
which actuation wires 2474 and 2476 can be threaded through in the
same or similar manner as described above for valve 2100. The inner
sheath 2408 is movably disposed within an outer delivery sheath
2426. As shown in FIG. 62, a portion of the valve 2400 is disposed
outside of the inner sheath 2408 and within the lumen of the outer
delivery sheath 2426. In some cases, the entire valve can be
disposed within the lumen of the inner sheath 2408 prior to
performing the procedure to deploy the valve.
[0214] In this embodiment, the actuation wires 2474 and 2476 are
routed from the outer frame 2420 of the valve 2400, into the lumen
of the outer delivery sheath 2426, through side apertures 2409
defined by the inner sheath 2408 and into the lumen of the inner
sheath 2408, and then through apertures 2407 defined by the valve
holder 2438 and within a lumen defined by the valve holder 2438.
The two end portions of each of the actuation wires 2474 and 2476
extend out a proximal end of the lumen of the valve holder 2438.
Thus, a user (e.g., physician) can grasp the end portions of the
actuation wires 2474, 2476 to manipulate and control movement of
the valve 2400 during deployment within a heart as described above
for previous embodiments. As described above, in some embodiments,
the actuation wires 2474, 2476 can be operatively coupled to the
delivery system 2405 such that the user does not have to manually
handle the actuation wires. For example, the actuation wires 2474,
2476 can be coupled to a delivery sheath and/or to a handle
assembly (not shown) of the delivery system 2405. The delivery
system 2405 can be used in a procedure similar to or the same as
the procedures described above with respect to valve 2400 to
deliver and deploy the valve 2400 within a heart.
[0215] In an alternative embodiment (not shown), including a
delivery apparatus that includes an outer delivery sheath, an inner
sheath and a valve holder, the actuation wires can be routed or
passed from a distal end of the valve, through a lumen of the outer
delivery sheath, through a distal end opening of the valve holder,
and through a lumen of the valve holder. In some embodiments, the
actuation wires can be routed from the outer frame of the valve,
through side apertures defined by the outer delivery sheath, into
the lumen of the delivery sheath, through a distal end opening of
the inner sheath and into the lumen of the inner sheath, through
side apertures of the valve holder and into the lumen of the valve
holder. In other embodiments, various other routing paths for the
actuation wires can be defined depending on the particular
configuration of the delivery sheath (e.g., with or without side
apertures), the inner sheath (e.g., with or without side apertures)
and/or the valve holder (with or without a lumen and/or with or
without side apertures).
[0216] FIGS. 63-71 illustrate a delivery system 2505 for delivering
and deploying a prosthetic heart valve, such as, prosthetic heart
valve 2500, within a heart, according to another embodiment. The
prosthetic heart valve 2500 (also referred to herein as "valve")
can be constructed the same as or similar to, and function the same
as or similar to any of the valves described herein. Thus, some
details regarding the valve 2500 are not described herein. As shown
in FIG. 63, the valve 2500 has an outer valve assembly 2510 with an
outer frame 2520 and an inner valve assembly 2540 with an inner
frame 2550, and a tether 2536 coupled to the inner frame 2550. As
described above for previous embodiments (e.g., valve 100, 200, 300
etc.), the outer frame 2520 and the inner frame 2550 of valve the
2500 can each be formed with a shape-memory material and have a
biased, expanded or deployed configuration. The outer frame 2520
and the inner frame 2550 can be moved to a collapsed or undeployed
configuration for delivery of the valve 2500 to the heart in which
the outer frame 2520 is inverted relative to the inner frame 2550.
To prepare the valve 2500 for delivery to the heart, the outer
frame 2520 of the valve 2500 is first disposed in a prolapsed or
inverted configuration as shown in FIG. 63. Specifically, the
elastic or superelastic structure of outer frame 2520 of valve 2500
allows the outer frame 2520 to be disposed in the prolapsed or
inverted configuration relative to the inner frame 2550 as
described above, for example with respect to valve 100.
[0217] For example, to dispose the outer frame 2520 in its inverted
configuration relative to the inner frame 2550, the outer frame
2520 is folded or inverted distally such that the outer frame 2520
is pointed away from the inner frame 2550. With the outer frame
2120 in the inverted configuration, the valve 2500 can be placed
within a lumen of the delivery system 2505 as shown in FIG. 63 for
delivery of the valve 2500 to the left atrium of the heart. As
discussed above, by disposing the outer frame 2520 of the valve
2500 in the inverted configuration, the valve 2500 can be collapsed
into a smaller overall diameter, i.e., placed in a smaller diameter
delivery sheath, than would be possible if the valve 2500 were
collapsed radially when the inner frame 2550 and the outer frame
2520 are disposed concentric to one another.
[0218] In this embodiment, the delivery system 2505 includes an
outer delivery sheath 2526, an inner sheath 2508, a valve holder
2538 (also referred to as a "pusher") and a multi-lumen elongate
tube member 2503 (also referred to as "tube" or "tube member" or
"multi-lumen elongate member"). As shown in FIGS. 63 and 68-70, the
tube member 2503 is movably disposed within a lumen 2582 defined by
the outer delivery sheath 2526. The inner sheath 2508 is movably
disposed within the lumen 2582 and within a lumen 2580 defined by
the tube member 2503. The valve holder 2538 is movably disposed
within a first lumen 2583 and a second lumen 2585 defined by the
inner sheath 2508 that are in fluid communication with each
other.
[0219] To deploy the valve 2500 within a heart, the outer frame
2520 of the valve 2500 is first moved or placed in its inverted
configuration relative to the inner frame 2550. As shown in FIG.
63, a portion of the valve 2500 is placed within the lumen 2582 of
the outer sheath and a portion of the valve 2500 is placed within
the lumen 2583 of the inner sheath 2508. As described above for
previous embodiments, when the valve 2500 is placed within the
delivery system (e.g., outer sheath 2526 and inner sheath 2508) the
valve 2500 can be compressed or collapsed to a smaller
configuration (e.g., a smaller outer perimeter).
[0220] The inner frame 2550 can be releasably coupled to the valve
holder 2538 via couplers 2506 that are received within
corresponding recesses 2504 defined by the valve holder 2538 in the
same manner as described above for delivery system 2105 (see, e.g.,
FIGS. 58A-58C). In this manner, the valve holder 2538 can be used
to hold the valve 2500 to aid in the control and manipulation of
the valve 2500 as it is being deployed within a heart. In addition,
the valve holder 2538 can limit radial expansion of the inner frame
2550 as the valve 2500 is moved within the lumen of the delivery
sheath 2526 and during deployment outside of the delivery sheath
2526. As described above for valve 2100, an inner diameter 2582 of
the inner sheath 2508 can be sized such that when the valve holder
2538 and valve 2500 are disposed therein, the couplers 2506 are
unable to exit the recesses 2504. In other words, the inner walls
of the inner sheath 2508 maintain the couplers 2506 within the
recesses 2504. When the valve 2500 is moved outside of the inner
sheath 2508, the couplers 2506 will be able to freely exit the
recesses 2504, releasing the inner frame 2550 from the valve holder
2538.
[0221] In alternative embodiments, the valve holder 2538 can be
removably coupled to the valve 2500 (e.g., the inner frame 2550 of
the valve 2500) via wires or sutures that can be cut after delivery
of the valve 2500 to he heart. In some cases, the valve holder 2538
can be decoupled from the valve 2500 when the valve is still
disposed within the outer delivery sheath 2526, while in other
instances the valve holder 2538 can be decoupled from the valve
2500 after the valve 2500 exits the delivery sheath 2526 within the
heart.
[0222] Although not shown, in other embodiments, the valve holder
2538 can merely contact and push the valve 2500 during deployment,
as described for previous embodiments, without securing the inner
frame 2550 to the valve holder 2538. In such embodiments, in some
instances, radial expansion of the inner frame 2550 can be
restricted by the inner sheath 2508 when the inner frame 2550 is
disposed therein.
[0223] In this embodiment a first actuation wire 2576, a second
actuation wire 2574, a third actuation wire 2576 and a fourth
actuation wire 2577 are each coupled to the outer valve assembly
2510. More specifically, the outer frame 250 of the outer valve
assembly 2510 includes loops 2562 through which the actuation wires
2574-2577 can be threaded or received therethrough. In this
embodiment, the outer frame 2520 includes 12 loops 2562 and each
actuation wire 2574-2577 is threaded through 3 of the loops 2562.
In other embodiments, there can be a different number of loops
disposed on the outer frame 2520 and there can be a different
number of actuators. Further, each actuation wire can be threaded
or received through a different number of loops than shown for this
embodiment.
[0224] When the valve 2500 is disposed within the delivery system
2505 as shown, for example, in FIG. 63, the actuation wires
2574-2577 each extend from the outer frame 2520 proximally within
the lumen 2582 of the outer sheath and along an outside wall of the
inner sheath 2508, are tucked or placed behind one or more seals
2581 or other holding device, and pinned by an elongate pinning
member 2578-1, 2578-2, 2578-3, 2578-4 (collectively referred to as
pinning members 2578) to the tube member 2503. The seal 2581 can be
configured such that the actuation wires 2574-2577 can slide
relative to the seal 2581 during actuation and deployment of the
valve 2500 as described in more detail below.
[0225] As shown in FIGS. 63 and 68-70, a first end of the actuation
wire 2574 and a first end of the actuation wire 2575 are pinned by
a pinning member 2578-2, and a first end of the actuation wire 2576
and a first end of the actuation wire 2577 are pinned by a pinning
member 2578-1. A second end of the actuation wire 2574 and a second
end of the actuation wire 2576 are pinned by a pinning member
2578-4 (not shown in the partial cross-sectional views of FIGS. 63
and 68-70), and a second end of the actuation wire 2575 and a
second end of the actuation wire 2577 are pinned by a pinning
member 2578-3 (not shown in the partial cross-sectional views of
FIGS. 63 and 68-70). The second ends of the actuation wires are
shown detached in FIGS. 63 and 68-70 for ease of illustration.
[0226] FIG. 64 is a cross-sectional view taken along line 64-64 in
FIG. 63 and illustrates the pinning of the actuation wires
2574-2577. The actuation wires 2574-2577 are shown unattached to
the outer frame for illustration purposes. FIG. 67A illustrates the
actuation wire 2574 and is representative of the other actuation
wires 2575-2577. FIGS. 67B, 67B and 67C illustrate alternative
embodiments for the actuation wires labeled 2574', 2574'' and
2574''. As shown in FIG. 67A, the actuation wires 2574-2577 each
include a loop on both ends of the actuation wire, which is pinned
by the pinning members 2578. In FIG. 67B, the pinning members can
pin the smaller loop on one end of the actuation wire 2574' and the
end of the larger loop on the opposite end of the actuation wire
2574'. In FIG. 67C, the actuation wire 2475'' is in the form of a
closed loop and each end of the loop can be pinned by a pinning
member. In FIG. 67D, the actuation wire 2574''' includes two
elongate loops and a center smaller loop. In this embodiment, the
actuation wire 2574''' can be pinned by three pinning members, a
first pinning member can pin an end of one of the larger loops, a
second pinning member can pin an end of the other larger loop, and
the small loop can be pinned by a third pinning member. In each of
the embodiments of FIGS. 67B-67D, a double layer of the actuation
wire would be passed or threaded through the loops of the outer
frame of the valve. Other alternative configurations can also be
used.
[0227] As shown in FIGS. 65 and 66A, the multi-lumen tube member
2503 defines four pinning member lumens 2579-1, 2579-2, 2579-3,
2579-4 (collectively referred to as pinning member lumens 2579).
The end portions of the actuation wires 2574-2577 are placed within
the circumferential recess or groove 2584 defined by the tube
member 2503, where the pinning members 2578 are received through
the loops on the ends of the actuation wires 2574-2577, pinning the
actuation wires 2574-2577 to the tube member 2503. Thus, during
deployment of the valve 2500 within a heart, a user (e.g.,
physician) can use the tube member 2503, to which the actuation
wires 2574-2577 are coupled, to control and/or manipulate movement
of the valve 2500 as described in more detail below.
[0228] FIGS. 66B and 66C, illustrate an alternative embodiment of a
multi-lumen tube member 2603 that can be used with a distal
retention element 2686 as shown in FIG. 66B, or a distal retention
element 2786 as shown in FIG. 66C. The distal retention elements
2686 and 2786 can be disposed abutting a distal end of the
multi-lumen tube member 2603 and can define at least in part a
recess area to receive the loop ends of the actuation wires, and
can provide increased overall strength and durability to the
multi-lumen tube member 2603 during delivery and deployment of the
prosthetic valve. The distal retention element 2686, 2786 can be
formed with the same or a different material as the multi-lumen
tube member 2603. In some embodiments, in may be desirable for the
distal retention element 2686, 2786 to be formed of a material
having greater strength characteristics than the multi-lumen tube
member 2603. For example, the distal retention element 2686, 2786
can be formed with a metal or rigid plastic.
[0229] As shown in FIGS. 66B and 66C, the multi-lumen tube member
2603 (also referred to herein as "tube member") can define a center
lumen 2680 and multiple pinning member lumens, including pinning
member lumens 2679-3 and 2679-4 (collectively referred to as 2679)
shown in FIGS. 66B and 66C that can receive therein pinning
members, such as pinning members 2578-3 and 2578-4, respectively.
Although not show, the tube member 2603 can also define pinning
member lumens that can receive pinning members 2578-1 and 2578-2 as
shown for tube member 2503 in FIG. 65.
[0230] As shown in FIG. 66B, the distal retention element 2686 can
be received within the lumen 2680 and can define a lumen 2687
through which the valve holder 2538 can be slidably received.
Although not shown, the distal retention element 2686 can be
coupled to the tube member 2603 using various different coupling
methods. For example, in some embodiments, the distal retention
element 2686 can be bonded to the tube member 2603. In some
embodiments the distal retention element 2686 can include a
feature(s), such as barbs, that allow it to be inserted into the
tube member 2603, but not removed. In some embodiments the distal
retention element 2686 can include notches that interlock with a
corresponding feature o the tube member 2603 and/or the tube member
2603 can be reflowed or molded over the retention element 2686.
Various other coupling methods and/or combinations of securement
strategies could be used to couple the distal retention element
2686 to the tube member 2603. In some embodiments, the distal
retention element 2686 can extend proximally within the lumen 2680
of the tube member 2603 and be coupled at a proximal end portion of
the tube member 2603.
[0231] The distal retention element 2686 also defines pinning
member lumens 2669 that align with the pinning member lumens 2679
of the multi-lumen tube member 2603 such that the pinning members
2578 can be received therein. A proximal shoulder 2688 can be
disposed abutting a distal end of the multi-lumen tube member 2603.
The distal retention element 2686 also defines a circumferential
recess area 2684 defined between the proximal shoulder 2688 and a
distal end portion of the distal retention element 2686. As shown
in FIG. 66B, the loop ends of the actuation wires 2574-2577 can be
received within the recess area 2684 and pinned by the pinning
members 2578 as described above for multi-lumen tube member
2503.
[0232] FIG. 66C illustrates a distal retention element 2786
disposed abutting the distal end of the multi-lumen tube member
2603. As with the previous embodiment, the distal retention element
2786 can be received within the lumen 2680 and can define a lumen
2787 through which the valve holder 2538 can be slidably received.
The distal retention element 2786 can be coupled to the tube member
2603 in the same manner as described above for distal retention
element 2686. The distal retention element 2786 also includes a
proximal shoulder 2788 configured to abut the distal end of the
multi-lumen tube member 2603. The distal retention element 2786
also defines a circumferential recess area 2784 that can receive
the loop ends of actuation wires 2574''-2577'', which can be pinned
by the pinning members 2578 (2578-3 and 2578-4 shown in FIG. 66C).
In this example, the actuation wires are configured as a closed
loop as shown for actuation wire 2574'' in FIG. 67C.
[0233] The procedure to deliver the valve 2500 to the heart can be
the same as or similar to any of the procedures described herein or
in '572 PCT Application incorporated by reference above. For
example, the valve 2500, disposed within the delivery system 2505
in an inverted configuration, can be delivered to the left atrium
of the heart in the same or similar manner as described above with
reference to FIGS. 43-48. With the distal end portion of the
delivery sheath 2526 disposed within the left atrium of the heart,
the valve 2500 can be deployed outside of the delivery sheath 2526.
For example, as shown in FIG. 68, the inner sheath 2508, valve
holder 2538 and tube member 2503 can be moved distally relative to
the outer sheath 2526, moving or pushing the valve 2500 outside the
lumen 2582 of the outer sheath 2526. In addition, or alternatively,
the outer sheath 2526 can be moved or pulled proximally, leaving at
least a portion of the valve 2500 disposed within the heart. In
some cases, the tether 2536 coupled to the valve 2500 can be used
to help pull the valve 2500 out of the lumen of the outer sheath
2526.
[0234] As described above for previous embodiments, as the outer
frame 2520 becomes unconstrained by the outer sheath 2526, the
outer frame 2520 can begin to revert to its expanded or uninverted
configuration. The actuation wires 2575-2577 can be used to control
the reversion of the outer frame 2520. More specifically, the tube
member 2503 can be pulled proximally such that the actuation wires
(pinned to the tube member 2503) pull the distally disposed portion
of the outer frame 2520 proximally (as shown in FIG. 69) in a
controlled manner and such that the reversion of the outer frame
2520 from its inverted configuration relative to the inner frame
2550 can be controlled.
[0235] In addition, in some instances, the actuation wires
2574-2577 can assist in the articulation and placement of the valve
2500 into its destination (e.g., a native annulus of an
atrioventricular valve of a heart). For example, as shown in FIG.
70, the actuation wires 2574-2577 can also be used to constrain,
collapse, or otherwise move the valve 2500 (e.g., radially compress
the outer frame 2520 of the valve 2500) after the valve 2500 exits
the outer sheath 2526 and is in its reverted, expanded or partially
expanded configuration. More specifically, in this embodiment, the
tube member 2503 with the actuation wires 2574-2577 pinned thereto,
can be manipulated by a user to move or urge the outer frame to a
more compressed configuration (as shown in FIG. 70) by pulling or
moving the tube member 2503 proximally. This may be desirable, for
example, to reposition the valve 2500 within the heart before fully
deploying the valve 2500.
[0236] Referring back to FIG. 69, when the outer frame 2520 of the
valve 2500 is disposed in its non-inverted and at least partially
expanded configuration, and is in a desired positon within the
heart, the inner frame 2550 can be deployed. As described above for
valve 2100, to decouple the inner frame 2550 from the valve holder
2538, the valve holder 2538 can be moved distally and/or the inner
sheath 2508 can be moved proximally such that the valve holder 2538
is disposed outside of the lumen 2583 of the inner sheath 2508. As
such, the couplers 2506 can be released from the recesses 2504
releasing or decoupling the inner frame 2550 from the valve holder
2538. In some embodiments, the tether 2536 can be pulled to help
move the inner frame 2550 outside of the inner sheath 2508. When
the inner frame 2550 is released from the valve holder 2538 and
disposed outside the inner sheath 2508, the inner frame 2550 can
assume its biased expanded configuration.
[0237] The actuation wires 2574-2577 can also be released or
decoupled from the outer frame 2520 before or after the inner frame
2550 is released form the valve holder 2538. To decouple the
actuation wires 2574-2577 from the outer frame 2520, one end of
each of the actuation wires 2574-2577 can be unpinned or decoupled
from the tubular member 2503. For example, as shown in FIG. 71, the
pinning member 2578-3 (See FIG. 64) can be withdrawn proximally
from groove 2584 such that the second end of the actuation wire
2577 and the second end of the actuation wire 2575 are each
released or unpinned from the tube member 2503, but remain pinned
by pinning members 2578-2 and 2578-1, respectively. Similarly, the
pinning member 2578-4 (see FIG. 64) can be withdrawn proximally
from groove 2584 such that the second end of the actuation wire
2574 and the second end of actuation wire 2576 can each be released
or unpinned from the tube member 2503, but remain pinned by pinning
members 2578-2 and 2578-1, respectively. With one end of each of
the actuation wires 2575-2577 coupled to the tube member 2503 (via
pinning members 2578-1 and 2578-2 in this example), the tube member
2503 can be pulled proximally, which in turn will pull the opposite
ends of the actuation wires 2574-2577 out of the loops 2562 of
outer frame 2520. Thus with the actuation wires 2574-2577 detached
from the outer frame 2520, the outer frame can assume a biased
expanded or partially expanded configuration.
[0238] Although in the above example, the pinning members 2578-3
and 2578-4 are shown withdrawn to release the ends of the actuation
wires 2574-2577, alternatively, the pinning members 2578-1 and
2578-2 can be withdrawn leaving the actuation wires 2574-2577
pinned by pinning members 2578-3 and 2578-4. Further, the actuation
wires 2574-2577 can be decoupled from the outer frame 2520 at any
suitable sequence or time period within the procedure. For example,
in some instances it may be desirable for the actuation wires
2574-2577 to be released after the valve 2500 has at least
partially exited the delivery sheath 2526 but before the valve 2500
is seated within the native annulus of the atrioventricular valve.
In other instances, for example, the actuation wires 2574-2577 can
be released after the valve 2500 has at least partially exited the
outer delivery sheath 2526 and after the valve 2500 is seated
within the native annulus of the atrioventricular valve.
[0239] FIG. 72 is a flowchart illustrating a method of delivering
and deploying a prosthetic mitral valve within a heart. The method
includes at 2889, inserting a distal end portion of a procedural
catheter through a puncture site at the apex of the heart, and
positioning the distal end within the left ventricle of heart. At
2891, a guide wire is inserted through the procedural catheter and
a distal end of the guide wire is moved into the left atrium of the
heart. At 2892, a distal end portion of the guide wire is captured
with a snare and pulled through a delivery sheath. The delivery
sheath can be inserted through a puncture site, for example, in the
femoral vein as described above with reference to FIGS. 43-48. In
some embodiments, the delivery sheath can be inserted through a
different puncture site and inserted transatrially (i.e., directly
into the left atrium) or transjugularly. At 2893, a leader tube is
moved or run over the guide wire from outside the apex, through the
heart and out the puncture site. At 2894, the guide wire can be
removed through the apex puncture site on the heart. At 2895, the
nose cone of a balloon dilator member on the leader tube can be
inflated.
[0240] At 2896, the delivery sheath with a prosthetic valve
disposed therein in an inverted configuration along with the leader
tube are moved into the left atrium of the heart. For example, the
outer frame of the valve is in an inverted configuration relative
to the inner frame of the valve. At 2897, the leader tube can be
removed through the apex puncture site of the heart. At 2898, the
prosthetic valve is deployed into the left atrium of the heart such
that prosthetic valve reverts and assumes a biased expanded
configuration. For example, in some embodiments, the outer frame of
the valve can be moved to an un-inverted or expanded configuration
relative to the inner frame by actuating actuation wires coupled to
the outer frame. At 2899, the prosthetic valve is positioned within
the native mitral annulus, the procedural catheter can be removed
and an epicardial pad is secured to the apex of the heart.
[0241] While various embodiments have been described above, it
should be understood that they have been presented by way of
example only, and not limitation. Where methods described above
indicate certain events occurring in certain order, the ordering of
certain events may be modified. Additionally, certain of the events
may be performed concurrently in a parallel process when possible,
as well as performed sequentially as described above
[0242] Where schematics and/or embodiments described above indicate
certain components arranged in certain orientations or positions,
the arrangement of components may be modified. While the
embodiments have been particularly shown and described, it will be
understood that various changes in form and details may be made.
Any portion of the apparatus and/or methods described herein may be
combined in any combination, except mutually exclusive
combinations. The embodiments described herein can include various
combinations and/or sub-combinations of the functions, components,
and/or features of the different embodiments described.
[0243] For example, although not specifically described for each
embodiment, any to the embodiments of a delivery system can include
a dilator device or member such as balloon dilator member 1711
shown and described with respect to FIGS. 43-48 and the method of
delivery of FIG. 72. Further, the prosthetic heart valves described
herein can be secured to a heart using an epicardial pad device as
described with respect to FIGS. 43-48 and 72.
[0244] Further, although not shown, any of the embodiments of a
delivery device or system can include a handle or handle assembly
to which the various delivery sheaths and components can be
operatively coupled and which a user (e.g., physician) can grasp
and use to manipulate the delivery device or system.
[0245] In addition, the systems and methods described herein can
also be adapted for use with a prosthetic tricuspid valve. For
example, in such a case, a procedural catheter can be inserted into
the right ventricle of the heart, and the delivery sheath delivered
to the right atrium of the heart either directly (transatrial), or
via the jugular or femoral vein.
* * * * *