U.S. patent application number 14/776575 was filed with the patent office on 2017-06-15 for prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods.
The applicant listed for this patent is TWELVE, INC.. Invention is credited to Maureen Bensing, Jean-Pierre Dueri, Hanson Gifford, III, Matt McLean, Katie Miyashiro, John Morriss, David Jerry Scott, David Trask, Kirsten Valley.
Application Number | 20170165057 14/776575 |
Document ID | / |
Family ID | 55266562 |
Filed Date | 2017-06-15 |
United States Patent
Application |
20170165057 |
Kind Code |
A9 |
Morriss; John ; et
al. |
June 15, 2017 |
PROSTHETIC HEART VALVE DEVICES, PROSTHETIC MITRAL VALVES AND
ASSOCIATED SYSTEMS AND METHODS
Abstract
Prosthetic heart valve devices for percutaneous replacement of
native heart valves and associated systems and method are disclosed
herein. A prosthetic heart valve device configured in accordance
with a particular embodiment of the present technology can include
an anchoring member having an upstream portion configured to engage
with tissue on or near the annulus of the native heart valve and to
deform in a non-circular shape to conform to the tissue. The device
can also include a mechanically isolated valve support coupled to
the anchoring member and configured to support a prosthetic valve.
The device can further include an atrial extension member extending
radially outward from the upstream portion of the anchoring member
and which is deformable without substantially deforming the
anchoring member. In some embodiments, the upstream portion of the
anchoring member and the extension member may be deformed while the
valve support remains sufficiently stable.
Inventors: |
Morriss; John; (San
Francisco, CA) ; McLean; Matt; (San Francisco,
CA) ; Bensing; Maureen; (Sunnyvale, CA) ;
Dueri; Jean-Pierre; (Los Gatos, CA) ; Gifford, III;
Hanson; (Woodside, CA) ; Miyashiro; Katie;
(San Francisco, CA) ; Scott; David Jerry; (Redwood
City, CA) ; Trask; David; (Redwood City, CA) ;
Valley; Kirsten; (Los Altos, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
TWELVE, INC. |
Menlo Park |
CA |
US |
|
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
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US 20160038280 A1 |
February 11, 2016 |
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|
Family ID: |
55266562 |
Appl. No.: |
14/776575 |
Filed: |
March 14, 2014 |
PCT Filed: |
March 14, 2014 |
PCT NO: |
PCT/US2014/029549 PCKC 00 |
371 Date: |
September 14, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13946552 |
Jul 19, 2013 |
9034032 |
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14776575 |
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13842785 |
Mar 15, 2013 |
9039757 |
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13946552 |
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PCT/US2012/061219 |
Oct 19, 2012 |
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13842785 |
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61605699 |
Mar 1, 2012 |
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61549044 |
Oct 19, 2011 |
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61898345 |
Oct 31, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/2433 20130101;
A61F 2230/0054 20130101; A61F 2250/0003 20130101; A61F 2/2409
20130101; A61F 2210/0014 20130101; A61F 2220/0066 20130101; A61F
2220/0025 20130101; A61F 2220/0016 20130101; A61F 2230/0071
20130101; A61F 2230/0065 20130101; A61F 2/2418 20130101; A61F
2230/0067 20130101; A61F 2220/0075 20130101; A61F 2220/005
20130101; A61F 2/2436 20130101; A61F 2250/0069 20130101; A61F
2230/0069 20130101; A61F 2/2445 20130101; A61F 2220/0041 20130101;
A61F 2220/0008 20130101; A61F 2250/006 20130101; A61F 2230/0078
20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. A prosthetic heart valve device for treating a native heart
valve having a native annulus and native leaflets, comprising: a
valve support having an upstream region and a downstream region
relative to blood flow direction through a native heart valve of a
human heart, the upstream region being configured to support a
prosthetic valve, the prosthetic valve having a plurality of
leaflets and having an undeformed shape in which the leaflets coapt
sufficiently to prevent backflow through the prosthetic valve; an
anchoring member arranged around the valve support and including an
outwardly-facing fixation portion having an engagement surface
configured to engage tissue at an implant site proximate the native
annulus, the fixation portion having a first cross-sectional shape
in an unbiased condition and being deformable into a second
cross-sectional shape to adapt to a shape of the tissue at the
implant site in a deployed state; and a connection structure
interconnecting the fixation portion to the valve support, the
fixation portion extending from the connection structure at a
transition zone, and the transition zone being configured to be
positioned at a subannular location below the native annulus and to
allow the fixation portion to deflect angularly relative to the
connection structure; wherein the tissue fixation portion of the
anchoring member is mechanically isolated from the upstream region
of the valve support such that the upstream region of the valve
support maintains the undeformed shape if the anchoring member has
deformed into the second cross-sectional shape.
2. The prosthetic heart valve device of claim 1 further comprising
a plurality of barbs extending in an upstream direction from the
fixation surface.
3. The prosthetic heart valve device of claim 1 wherein the
fixation portion is biased radially outward to apply a compressive
force to native tissue at the implant location.
4. The prosthetic heart valve device of claim 1 wherein, in an
unbiased condition, the connection structure extends in a
transverse direction relative to the blood flow direction, and the
engagement surface is disposed in a longitudinal direction at a
different angle relative to the blood flow direction than the
connection structure.
5. The prosthetic heart valve device of claim 1 wherein the
fixation portion has at least one tissue engagement feature
configured to engage tissue on a subannular aspect of the native
annulus.
6. The prosthetic heart valve device of claim 1 wherein the
transition zone is configured to be positioned under the native
annulus and the fixation portion is deflectable such that the
engagement surface is tapering inward in the upstream
direction.
7. The prosthetic heart valve device of claim 1 wherein the
connection structure comprises a plurality of struts each having an
inner end connected to the valve support and an outer end connected
to the anchoring member.
8. The prosthetic heart valve device of claim 1 wherein the
fixation portion and the connection structure comprise metal
struts, and the transition zone comprises a bend in the metal
struts from the connection structure to the fixation portion.
9. The prosthetic heart valve of claim 1 wherein the fixation
portion is attached to the connection structure by a fastener
configured to pivot, rotate or flex to an inward and/or outward
orientation.
10. The prosthetic heart valve device of claim 1 wherein the
connection structure has a flared portion that flares outwardly in
the upstream direction.
11. The prosthetic heart valve of claim 10 wherein the flared
portion of the connection structure extends inwardly in a
downstream direction from the fixation portion such that the
connection structure is disposed entirely downstream of the native
annulus when the anchoring member is at the implant site.
12. The prosthetic heart valve device of claim 10 wherein the
connection structure has an upstream end connected to the anchoring
member, and the upstream end being configured for positioning at or
below the native annulus when the anchoring member is at the
implant site.
13. The prosthetic heart valve device of claim 1 wherein the
connection structure comprises a flexible web coupling the fixation
portion to the valve support.
14. The prosthetic heart valve device of claim 13 wherein the
flexible web comprises a first portion at the upstream end of the
valve support and a second portion at the downstream end of the
valve support.
15. The prosthetic heart valve device of claim 1 wherein the
engagement surface is deflectable through a range of angles
relative to the connection structure.
16. The prosthetic heart valve device claim 1 wherein: the fixation
portion comprises a skirt covering an inward-facing surface
thereof; the valve support includes a tubular valve cover extending
around the valve support; and the skirt is attached to the valve
cover so as to inhibit blood flow therebetween.
17. The prosthetic heart valve device of claim 1 wherein the
fixation surface extends in a direction at least generally parallel
to a longitudinal axis of the anchoring member.
18. The prosthetic heart valve device of claim 1 wherein the
transition zone is configured to be positioned under the native
annulus.
19-92. (canceled)
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present application is a continuation-in-part of U.S.
patent application Ser. No. 13/946,552, filed Jul. 19, 2013,
entitled "PROSTHETIC HEART VALVE DEVICES, PROSTHETIC MITRAL VALVES
AND ASSOCIATED SYSTEMS AND METHODS," which is a continuation-in
part of U.S. patent application Ser. No. 13/842,785, filed Mar. 15,
2013, entitled "PROSTHETIC HEART VALVE DEVICES, PROSTHETIC MITRAL
VALVES AND ASSOCIATED SYSTEMS AND METHODS," which is a
continuation-in-part of International Application No.
PCT/US2012/61219, filed on Oct. 19, 2012, entitled "PROSTHETIC
HEART VALVE DEVICES, PROSTHETIC MITRAL VALVES AND ASSOCIATED
SYSTEMS AND METHODS," which claims priority to U.S. Provisional
Patent Application No. 61/605,699, filed Mar. 1, 2012, entitled
"SYSTEM FOR MITRAL VALVE REPLACEMENT," and to U.S. Provisional
Patent Application No. 61/549,044, filed Oct. 19, 2011, entitled
"CONFORMABLE SYSTEM FOR MITRAL VALVE REPLACEMENT," the disclosures
of which are incorporated herein in their entireties by reference.
The present application also claims priority to U.S. Provisional
Patent Application No. 61/898,345, filed Oct. 31, 2013, entitled
"PROSTHETIC HEART VALVE DEVICE," the disclosure of which is
incorporated in its entirety by reference. The present application
incorporates the subject matter of (1) International Patent
Application No. PCT/US2012/043636, entitled "PROSTHETIC HEART VALVE
DEVICES AND ASSOCIATED SYSTEMS AND METHODS," filed Jun. 21, 2012;
(2) U.S. Provisional Patent Application No. 61/549,037, entitled
"SYSTEM FOR MITRAL VALVE REPLACEMENT," filed Oct. 19, 2011; and (3)
International Patent Application No. PCT/US2012/61215, entitled
"DEVICES, SYSTEMS AND METHODS FOR HEART VALVE REPLACEMENT," filed
Oct. 19, 2012, in their entireties by reference.
TECHNICAL FIELD
[0002] The present technology relates generally to prosthetic heart
valve devices. In particular, several embodiments are directed to
prosthetic mitral valves and devices for percutaneous repair and/or
replacement of native mitral valves and associated systems and
methods.
BACKGROUND
[0003] Conditions affecting the proper functioning of the mitral
valve include, for example, mitral valve regurgitation, mitral
valve prolapse and mitral valve stenosis. Mitral valve
regurgitation is a disorder of the heart in which the leaflets of
the mitral valve fail to coapt into apposition at peak contraction
pressures, resulting in abnormal leaking of blood from the left
ventricle into the left atrium. There are a number of structural
factors that may affect the proper closure of the mitral valve
leaflets. For example, many patients suffering from heart disease
experience dilation of the heart muscle, resulting in an enlarged
mitral annulus. Enlargement of the mitral annulus makes it
difficult for the leaflets to coapt during systole. A stretch or
tear in the chordae tendineae, the tendons connecting the papillary
muscles to the inferior side of the mitral valve leaflets, may also
affect proper closure of the mitral annulus. A ruptured chordae
tendineae, for example, may cause a valve leaflet to prolapse into
the left atrium due to inadequate tension on the leaflet. Abnormal
backflow can also occur when the functioning of the papillary
muscles is compromised, for example, due to ischemia. As the left
ventricle contracts during systole, the affected papillary muscles
do not contract sufficiently to effect proper closure.
[0004] Mitral valve prolapse, or when the mitral leaflets bulge
abnormally up in to the left atrium, causes irregular behavior of
the mitral valve and may also lead to mitral valve regurgitation.
Normal functioning of the mitral valve may also be affected by
mitral valve stenosis, or a narrowing of the mitral valve orifice,
which causes impedance of filling of the left ventricle in
diastole.
[0005] Typically, treatment for mitral valve regurgitation has
involved the application of diuretics and/or vasodilators to reduce
the amount of blood flowing back into the left atrium. Other
procedures have involved surgical approaches (open and
intravascular) for either the repair or replacement of the valve.
For example, typical repair approaches have involved cinching or
resecting portions of the dilated annulus.
[0006] Cinching of the annulus has been accomplished by the
implantation of annular or peri-annular rings which are generally
secured to the annulus or surrounding tissue. Other repair
procedures have also involved suturing or clipping of the valve
leaflets into partial apposition with one another.
[0007] Alternatively, more invasive procedures have involved the
replacement of the entire valve itself where mechanical valves or
biological tissue are implanted into the heart in place of the
mitral valve. These invasive procedures are conventionally done
through large open thoracotomies and are thus very painful, have
significant morbidity, and require long recovery periods.
[0008] However, with many repair and replacement procedures, the
durability of the devices or improper sizing of annuloplasty rings
or replacement valves may result in additional problems for the
patient. Moreover, many of the repair procedures are highly
dependent upon the skill of the cardiac surgeon where poorly or
inaccurately placed sutures may affect the success of
procedures.
[0009] Less invasive approaches to aortic valve replacement have
been developed in recent years. Examples of pre-assembled,
percutaneous prosthetic valves include, e.g., the CoreValve
Revalving.RTM. System from Medtronic/Corevalve Inc. (Irvine,
Calif., USA) and the Edwards-Sapien.RTM. Valve from Edwards
Lifesciences (Irvine, Calif., USA). Both valve systems include an
expandable frame housing a tri-leaflet bioprosthetic valve. The
frame is expanded to fit the substantially symmetric, circular and
rigid aortic annulus. This gives the expandable frame in the
delivery configuration a symmetric, circular shape at the aortic
valve annulus, suitable to supporting a tri-leaflet prosthetic
valve (which requires such symmetry for proper coaptation of the
prosthetic leaflets). Thus, aortic valve anatomy lends itself to an
expandable frame housing a replacement valve since the aortic valve
anatomy is substantially uniform, symmetric, and fairly rigid.
[0010] Mitral valve replacement, compared with aortic valve
replacement, poses unique anatomical obstacles, rendering
percutaneous mitral valve replacement significantly more
challenging than aortic valve replacement. First, unlike the
relatively symmetric and uniform aortic valve, the mitral valve
annulus has a non-circular D-shape or kidney-like shape, with a
non-planar, saddle-like geometry often lacking symmetry. Such
unpredictability makes it difficult to design a mitral valve
prosthesis having the ability to conform to the mitral annulus.
Lack of a snug fit between the prosthesis and the native leaflets
and/or annulus may leave gaps therein, creating backflow of blood
through these gaps. Placement of a cylindrical valve prosthesis,
for example, may leave gaps in commissural regions of the native
valve, potentially resulting in perivalvular leaks in those
regions.
[0011] Current prosthetic valves developed for percutaneous aortic
valve replacement are unsuitable for adaptation to the mitral
valve. First, many of these devices require a direct, structural
connection between the device structure which contacts the annulus
and/or leaflets and the device structure which supports the
prosthetic valve. In several devices, the same stent posts which
support the prosthetic valve also contact the annulus or other
surrounding tissue, directly transferring to the device many of the
distorting forces exerted by the tissue and blood as the heart
contracts during each cardiac cycle. Most cardiac replacement
devices further utilize a tri-leaflet valve, which requires a
substantially symmetric, cylindrical support around the prosthetic
valve for proper opening and closing of the three leaflets over
years of life. If these devices are subject to movement and forces
from the annulus and other surrounding tissues, the prostheses may
be compressed and/or distorted causing the prosthetic leaflets to
malfunction. Moreover, the typical diseased mitral annulus is much
larger than any available prosthetic valve. As the size of the
valve increases, the forces on the valve leaflets increase
dramatically, so simply increasing the size of an aortic prosthesis
to the size of a dilated mitral valve annulus would require
dramatically thicker, taller leaflets, and might not be
feasible.
[0012] In addition to its irregular, unpredictable shape, which
changes size over the course of each heartbeat, the mitral valve
annulus lacks a significant amount of radial support from
surrounding tissue. The aortic valve, for example, is completely
surrounded by fibro-elastic tissue, helping to anchor a prosthetic
valve by providing native structural support. The mitral valve, on
the other hand, is bound by muscular tissue on the outer wall only.
The inner wall of the mitral valve is bound by a thin vessel wall
separating the mitral valve annulus from the inferior portion of
the aortic outflow tract. As a result, significant radial forces on
the mitral annulus, such as those imparted by an expanding stent
prostheses, could lead to collapse of the inferior portion of the
aortic tract with potentially fatal consequences.
[0013] The chordae tendineae of the left ventricle may also present
an obstacle in deploying a mitral valve prosthesis. This is unique
to the mitral valve since aortic valve anatomy does not include
chordae. The maze of chordae in the left ventricle makes navigating
and positioning a deployment catheter that much more difficult in
mitral valve replacement and repair. Deployment and positioning of
a prosthetic valve or anchoring device on the ventricular side of
the native mitral valve is further complicated by the presence of
the chordae.
[0014] The triscuspid valve on the right side of the heart,
although it normally has three leaflets, poses similar challenges
to less invasive treatment as the mitral valve. Therefore there is
a need for a better prosthesis to treat tricuspid valve disease as
well.
[0015] Given the difficulties associated with current procedures,
there remains the need for simple, effective, and less invasive
devices and methods for treating dysfunctional heart valves.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Many aspects of the present disclosure can be better
understood with reference to the following drawings. The components
in the drawings are not necessarily to scale. Instead, emphasis is
placed on illustrating clearly the principles of the present
disclosure. Furthermore, components can be shown as transparent in
certain views for clarity of illustration only and not to indicate
that the illustrated component is necessarily transparent.
[0017] FIGS. 1 and 2 are schematic illustrations of a mammalian
heart having native valve structures suitable for replacement with
various prosthetic heart valve devices in accordance with
embodiments of the present technology.
[0018] FIG. 3 is a schematic cross-sectional side view of a native
mitral valve showing the annulus and leaflets.
[0019] FIG. 4A is a schematic illustration of the left ventricle of
a heart having either i) prolapsed leaflets in the mitral valve, or
ii) mitral valve regurgitation in the left ventricle of a heart
having impaired papillary muscles, and which are suitable for
combination with various prosthetic heart valve devices in
accordance with embodiments of the present technology.
[0020] FIG. 4B is a schematic illustration of a heart in a patient
suffering from cardiomyopathy, and which is suitable for
combination with various prosthetic heart valve devices in
accordance with embodiments of the present technology.
[0021] FIG. 5A is a schematic illustration of a native mitral valve
of a heart showing normal closure of native mitral valve
leaflets.
[0022] FIG. 5B is a schematic illustration of a native mitral valve
of a heart showing abnormal closure of native mitral valve leaflets
in a dilated heart, and which is suitable for combination with
various prosthetic heart valve devices in accordance with
embodiments of the present technology.
[0023] FIG. 5C is a schematic illustration of a mitral valve of a
heart showing dimensions of the annulus, and which is suitable for
combination with various prosthetic heart valve devices in
accordance with embodiments of the present technology.
[0024] FIG. 6A is a schematic, cross-sectional illustration of the
heart showing an antegrade approach to the native mitral valve from
the venous vasculature, in accordance with various embodiments of
the present technology.
[0025] FIG. 6B is a schematic, cross-sectional illustration of the
heart showing access through the inter-atrial septum (IAS)
maintained by the placement of a guide catheter over a guidewire,
in accordance with various embodiments of the present
technology.
[0026] FIGS. 7 and 8 are schematic, cross-sectional illustrations
of the heart showing retrograde approaches to the native mitral
valve through the aortic valve and arterial vasculature, in
accordance with various embodiments of the present technology.
[0027] FIG. 9 is a schematic, cross-sectional illustration of the
heart showing an approach to the native mitral valve using a
trans-apical puncture in accordance with various embodiments of the
present technology.
[0028] FIG. 10A shows an isometric view of a prosthetic heart valve
device in accordance with an embodiment of the present
technology.
[0029] FIG. 10B illustrates a cut-away view of a heart showing the
prosthetic treatment device of FIG. 10A implanted at a native
mitral valve in accordance with an embodiment of the present
technology.
[0030] FIGS. 10C-10F are side, perspective cut-away, top, and
bottom views, respectively, of a prosthetic heart valve device in
accordance with an embodiment of the present technology.
[0031] FIG. 11A is a side view of a valve support in an expanded
configuration in accordance with an embodiment of the present
technology.
[0032] FIGS. 11B-11D are isometric views of additional embodiments
of valve supports with prosthetic valves mounted therein in
accordance with the present technology.
[0033] FIGS. 11E-11G are side views of a valve support having
support bands and prosthetic valves mounted therein in accordance
with the present technology.
[0034] FIG. 11H shows an isometric view of a prosthetic heart valve
device in accordance with another embodiment of the present
technology.
[0035] FIGS. 12A-12C are side views of various longitudinal ribs
flexing in response to a distorting force in accordance with
further embodiments of the present technology.
[0036] FIG. 13A is a schematic, cross-sectional view of a
prosthetic heart valve device in accordance with another embodiment
of the present technology.
[0037] FIGS. 13B-13F are partial side views of prosthetic heart
valve devices illustrating a variety of longitudinal rib
configurations in accordance with additional embodiments of the
present technology.
[0038] FIG. 14A is a schematic top view of a native mitral valve
illustrating the major and minor axes.
[0039] FIGS. 14B-14C are schematic top views of an anchoring member
in an expanded configuration and in a deployed configuration,
respectively, in accordance with an embodiment of the present
technology.
[0040] FIG. 15 is an isometric view of a prosthetic heart valve
device illustrated in a deployed configuration in accordance with
an additional embodiment of the present technology.
[0041] FIG. 16A is a top view of a prosthetic heart valve device
illustrated in an expanded configuration in accordance with a
further embodiment of the present technology.
[0042] FIGS. 16B-16C are a first side view and a second side view,
respectively, of the prosthetic heart valve device of FIG. 16A.
[0043] FIG. 16D is a side view of a prosthetic heart valve device
showing the longitudinal axis of the anchoring member off-set from
the longitudinal axis of the valve support by a tilt angle in
accordance with another embodiment of the present technology.
[0044] FIG. 16E is a schematic top view of a native mitral valve in
the heart viewed from the left atrium and showing the prosthetic
treatment device of FIG. 16A-16C implanted at the native mitral
valve in accordance with an embodiment of the present
technology.
[0045] FIGS. 17A-17C are schematic top and first and second side
views of the prosthetic heart valve device of FIG. 16A showing
dimensions and taper angles of various aspects of the device in
accordance with embodiments of the present technology.
[0046] FIG. 18 is an isometric view of an anchoring member
illustrated in an expanded configuration in accordance with yet
another embodiment of the present technology.
[0047] FIGS. 19A-19C are isometric, side and top views,
respectively, of a prosthetic heart valve device having a sealing
member in accordance with a further embodiment of the present
technology.
[0048] FIG. 20A is an isometric view of a prosthetic heart valve
device without a sealing member in accordance with an embodiment of
the present technology.
[0049] FIGS. 20B-20E are isometric views of prosthetic heart valve
devices having sealing members in accordance with additional
embodiments of the present technology.
[0050] FIGS. 21A-21B are cross-sectional side and isometric views
of a prosthetic heart valve device having a tubular valve support
member in accordance with a further embodiment of the present
technology.
[0051] FIGS. 21C-21F are partial cross-sectional side views and an
isometric view of prosthetic heart valve devices having a tubular
valve support member in accordance with other embodiments of the
present technology.
[0052] FIGS. 22A-22G and 22I-22K are enlarged side views of various
mechanisms of coupling a valve support to an anchoring member in
accordance with additional embodiments of the present
technology.
[0053] FIG. 22H is a side view of a post in the prosthetic heart
valve device of FIG. 40G.
[0054] FIGS. 23A-23B are enlarged side views of additional
mechanisms for coupling an anchoring member to a valve support
member in accordance with further embodiments of the present
technology.
[0055] FIG. 24A is a perspective view of an integral connection
between a valve support and an anchoring member in accordance with
an additional embodiment of the present technology.
[0056] FIGS. 24B-24D are enlarged views of additional embodiments
of an integral connection between a valve support and an anchoring
member in accordance with the present technology.
[0057] FIG. 25A is a partial cross-sectional view of a prosthetic
heart valve device having an anchoring member and a valve support
in accordance with an embodiment of the present technology.
[0058] FIG. 25B is an enlarged view of the designated box shown in
FIG. 25A
[0059] FIGS. 26A-26D are schematic cross-sectional views of
prosthetic heart valve devices having atrial retainers and
implanted at a native mitral valve in accordance with various
embodiments of the present technology.
[0060] FIG. 27 is a side view of an anchoring member having a
vertical portion at the upstream end for engaging the annulus in
accordance with another embodiment of the present technology.
[0061] FIG. 28 is a side view of a prosthetic heart valve device in
an expanded configuration and having a plurality of stabilizing
elements in accordance with an embodiment of the present
technology.
[0062] FIG. 29 is an enlarged schematic, side view of a prosthetic
heart valve device having an extended arm in accordance with an
embodiment of the present technology.
[0063] FIGS. 30A-30C are enlarged partial side views of a
prosthetic heart valve device having arms coupled to the device at
various angles with respect to a longitudinal axis of the device in
accordance with further embodiments of the present technology.
[0064] FIGS. 31A-31C are enlarged, partial side views of a
prosthetic heart valve device having arms of various lengths
coupled to the device in accordance with additional embodiments of
the present technology.
[0065] FIGS. 32A, 32B, 32C, and 32D are cross-sectional views of a
heart with an implanted prosthetic heart valve device having arms
disposed on an inward-facing surface of the leaflets in accordance
with various embodiments of the present technology.
[0066] FIGS. 32A-1, 32B-1, 32C-1 and 32D-1 are enlarged views of
the arms engaging the inward-facing surface of the leaflets as
shown in FIGS. 32A, 32B, 32C and 32D, respectively in accordance
with various embodiments of the present technology.
[0067] FIGS. 33A-33C are schematic views illustrating various
embodiments of tissue engaging elements for use with prosthetic
heart valve devices in accordance with the present technology.
[0068] FIGS. 34A, 34B and 34C are cross-sectional views of a heart
with an implanted prosthetic heart valve device having arms with
tissue engaging elements disposed on an inward-facing surface of
the leaflets in accordance with various embodiments of the present
technology.
[0069] FIGS. 34A-1, 34B-1 and 34C-1 are enlarged views of the arms
engaging the inward-facing surface of the leaflets as shown in
FIGS. 34A, 34B and 34C, respectively in accordance with various
embodiments of the present technology.
[0070] FIGS. 35A-35C are side views of prosthetic heart valve
devices and shown implanted at a mitral valve (illustrated in
cross-section), the devices having arms for engaging an
outward-facing surface of the native leaflets in accordance with
further embodiments of the present technology.
[0071] FIG. 35C-1 is an enlarged view of the arm engaging the
inward-facing surface of the leaflets as shown in FIG. 35C in
accordance with various embodiments of the present technology.
[0072] FIG. 36A is a side view of a prosthetic heart valve device
and shown implanted at a mitral valve (illustrated in
cross-section), the device having arms for engaging an
outward-facing surface of the native leaflets and arms for engaging
an inward-facing surface of the native leaflets in accordance with
an additional embodiment of the present technology.
[0073] FIG. 36B is an enlarged view of the arms engaging the
inward-facing and outward-facing surfaces of the leaflets as shown
in FIG. 36A.
[0074] FIGS. 37A-37D are enlarged side views of additional
embodiments of arms suitable for use with a prosthetic heart valve
device in accordance with the present technology.
[0075] FIG. 38A is a side view of a prosthetic heart valve device
having a plurality of non-interconnected arms in accordance with a
further embodiment of the present technology.
[0076] FIG. 38B is a side view of a prosthetic heart valve device
having a plurality of circumferentially connected arms in
accordance with a further embodiment of the present technology.
[0077] FIGS. 39A-39D are schematic top views of arm location
patterns in accordance with additional embodiments of the present
technology.
[0078] FIGS. 40A-40D are side views of prosthetic heart valve
devices having tissue engaging elements on varying structures of
the device in accordance with additional embodiments of the present
technology.
[0079] FIGS. 40E-40G are enlarged side views of tissue engaging
elements suitable for use with prosthetic heart valve devices in
accordance with other embodiments of the present technology.
[0080] FIGS. 40I-40T are enlarged side views of embodiments of
tissue engaging elements suitable for use with prosthetic heart
valve devices in accordance with additional embodiments of the
present technology.
[0081] FIG. 41 is an isometric view of a prosthetic heart valve
device having a plurality of annulus engaging elements in
accordance with a further embodiment of the present technology.
[0082] FIGS. 42A-42B are cross-sectional side and enlarged views of
a prosthetic heart valve device having tissue engaging elements
deployable from a plurality of tubular ribs in accordance with
another embodiment of the present technology.
[0083] FIGS. 43A-43B are an isometric view and an enlarged detail
view of a prosthetic heart valve device having a sealing member
configured with tissue engaging elements in accordance with another
embodiment of the present technology
[0084] FIGS. 44A-44F are enlarged side views of embodiments of
tissue engaging elements suitable for use with prosthetic heart
valve devices in accordance with additional embodiments of the
present technology.
[0085] FIG. 45A is an isometric view of a prosthetic heart valve
device having a plurality of tethers between the anchoring member
110 and the valve support 120 in accordance with an embodiment of
the present technology.
[0086] FIG. 45B is an isometric view of a prosthetic heart valve
device having a plurality of septa between the anchoring member 110
and the valve support 120 in accordance with another embodiment of
the present technology.
[0087] FIG. 46A is side partial cut-away view of a delivery system
in accordance with an embodiment of the present technology.
[0088] FIG. 46B is an enlarged cross-sectional view of a distal end
of a delivery system in accordance with an embodiment of the
present technology.
[0089] FIGS. 46C-46D are enlarged partial side views of a valve
support configured for use with the delivery system of FIG. 46B in
accordance with an embodiment of the present technology.
[0090] FIGS. 47A-47D are cross-sectional views of a heart showing
an antegrade or trans-septal approach to the mitral valve in
accordance with an embodiment of the present technology.
[0091] FIGS. 48A-48C are cross-sectional views of the heart
illustrating a method of implanting a prosthetic heart valve device
using a trans-septal approach in accordance with another embodiment
of the present technology.
[0092] FIGS. 49A-49B are cross-sectional views of the heart showing
a retrograde approach to the mitral valve via the aorta and left
ventricle in accordance with a further embodiment of the present
technology.
[0093] FIGS. 50A-50B are cross-sectional views of the heart
illustrating a further embodiment of a method of implanting the
prosthetic heart valve device using a trans-apical approach in
accordance with aspects of the present technology.
[0094] FIGS. 51A-51B are partial side views of a delivery system
wherein a prosthetic heart valve device is mounted on an expandable
balloon of a delivery catheter in accordance with another
embodiment of the present technology.
[0095] FIGS. 52A-52D are cross-sectional views of a heart showing a
method of delivering a prosthetic heart valve device having a valve
support movably coupled to an anchoring member in accordance with a
further embodiment of the present technology.
[0096] FIGS. 53A-53D are partial side views showing various
mechanisms for movably coupling the valve support to the anchoring
member in accordance with additional embodiments of the present
technology.
[0097] FIG. 53E is a partial top view of the device of FIG.
53D.
[0098] FIG. 53F is a side view of an alternative mechanism for
slideably coupling a valve support and anchoring member in
accordance with another embodiment of the present technology.
[0099] FIGS. 53G-53H are schematic side views of a prosthetic heart
valve device showing yet another mechanism for coupling the valve
support to the anchoring member in accordance with a further
embodiment of the present technology.
[0100] FIG. 54A is a cross-sectional side view of another
embodiment of a delivery system for the prosthetic heart valve
device in accordance with other aspects of the present
technology.
[0101] FIG. 54B is a partial cross-sectional side view of a distal
portion of the delivery system of FIG. 54A.
[0102] FIGS. 55A-55C are perspective views of the delivery system
of FIG. 46 illustrating the steps of delivering the prosthetic
treatment device of the invention.
[0103] FIG. 56 is a side cross-sectional view of a further
embodiment of a delivery system for the prosthetic treatment device
of the invention.
[0104] FIGS. 57A-57D are isometric views of prosthetic treatment
devices in accordance with additional embodiments of the present
technology.
[0105] FIG. 57E is a schematic cross-sectional view of the
prosthetic heart valve device of FIG. 57A implanted at a native
mitral valve in accordance with an embodiment of the present
technology.
[0106] FIGS. 58A-58D are cross-sectional views of a heart showing a
method of delivering a prosthetic heart valve device to a native
mitral valve in the heart using a trans-apical approach in
accordance with another embodiment of the present technology.
[0107] FIGS. 59A-59C are isometric views of prosthetic treatment
devices in accordance with additional embodiments of the present
technology.
[0108] FIG. 59D is a schematic cross-sectional view of a prosthetic
heart valve device implanted at a native mitral valve in accordance
with another embodiment of the present technology.
[0109] FIGS. 60A-60B are cross-sectional side views of a distal end
of a delivery catheter for delivering the prosthetic heart valve
device of FIG. 59C to a native mitral valve in the heart in
accordance with another embodiment of the present technology.
[0110] FIG. 61 is a side view of a prosthetic heart valve device
having first and second anchoring members for engaging
supra-annular and subannular tissue of the mitral valve,
respectively, in accordance with yet another embodiment of the
present technology.
[0111] FIGS. 62A-62C are partial cross-sectional side views of a
distal end of a delivery system showing delivery of the prosthetic
heart valve device of FIG. 61 at a mitral valve in accordance with
another embodiment of the present technology.
[0112] FIG. 63 is an isometric side view of a prosthetic heart
valve device having an anchoring member with a supra-annular
engaging rim and a subannular engaging ring in accordance with a
further embodiment of the present technology.
[0113] FIGS. 64A-64D are side views of the prosthetic heart valve
device of FIG. 63 showing embodiments of methods for deploying the
device at the mitral valve annulus in accordance with aspects of
the present technology.
[0114] FIG. 65A is a cross-sectional view of a prosthetic heart
valve device having an inflatable anchoring member and shown
implanted in a native mitral valve of a heart in accordance with
another embodiment of the present disclosure.
[0115] FIG. 65B is a partial cross-sectional side view of a distal
end of a delivery system suitable for delivery of the prosthetic
heart valve device of FIG. 65A in accordance with another
embodiment of the present technology.
[0116] FIGS. 66A-66D are cross-sectional views of prosthetic heart
valve devices having fillable chambers in accordance with
additional embodiments of the present technology.
[0117] FIGS. 67A-67B are isometric views of additional embodiments
of prosthetic heart valve devices in accordance with aspects of the
present technology.
[0118] FIGS. 68A-68B are side views of prosthetic heart valve
devices having a positioning element in accordance with an
additional embodiments of the present technology.
[0119] FIGS. 69A-69E are cross-sectional and side views of
prosthetic heart valve devices shown in an expanded configuration
and configured in accordance with an additional embodiment of the
present technology.
[0120] FIG. 70 is a cross-sectional side view of another prosthetic
heart valve device configured in accordance with an embodiment of
the present technology.
[0121] FIG. 71 is a cross-sectional side view of yet another
prosthetic heart valve device configured in accordance with an
embodiment of the present technology.
[0122] FIG. 72 is an isometric view of a prosthetic heart valve
device in accordance with another embodiment of the technology.
[0123] FIG. 73 is a side view of the prosthetic heart valve device
of FIG. 72.
[0124] FIG. 74 is a bottom view of the prosthetic heart valve
device of FIG. 72.
[0125] FIG. 75 is a side view of a prosthetic heart valve device in
accordance with another embodiment of the technology.
[0126] FIG. 76 is a bottom view of the prosthetic heart valve
device of FIG. 75.
[0127] FIG. 77 is a side view of a prosthetic heart valve device in
accordance with another embodiment of the technology.
[0128] FIG. 78 is an isometric view of a prosthetic heart valve
device in accordance with another embodiment of the technology.
[0129] FIGS. 79A and 79B are partial anatomical cross-sections of a
heart (H) and side views of an embodiment of a prosthetic heart
valve device being implanted in accordance with a method of the
present technology.
[0130] FIG. 79C is a partial anatomical cross-section of a heart
(H) showing the placement of the prosthetic heart valve device in
accordance with an embodiment of the technology.
[0131] FIG. 79D is a partial anatomical cross-section of a heart
(H) showing the placement of the prosthetic heart valve device in
accordance with an embodiment of the technology
[0132] FIGS. 80A-80Q are schematic cross-sectional views of several
embodiments of prosthetic heart valve devices in accordance with
the present technology.
[0133] FIG. 81A is a cross-sectional view of a prosthetic heart
valve device in accordance with another embodiment of the present
technology.
[0134] FIG. 81B is a top view of the prosthetic heart valve device
of FIG. 81A.
[0135] FIG. 82A is an isometric view of a prosthetic heart valve
device in accordance with another embodiment of the present
technology.
[0136] FIG. 82B is a cross-sectional view of the prosthetic heart
valve device of FIG. 82A taken along line 20B-20B.
[0137] FIG. 83 is a schematic cross-sectional view of a prosthetic
heart valve device in accordance with another embodiment of the
present technology.
[0138] FIGS. 84A-84C are schematic cross-section views of the
operation of prosthetic heart valve devices in accordance with the
present technology.
[0139] FIGS. 85A-85C are schematic side views of a portion of
prosthetic heart valve devices in accordance with the present
technology.
[0140] FIGS. 86A-86B are side and isometric views of a prosthetic
heart valve device in accordance with another embodiment of the
technology.
[0141] FIGS. 87A-87B are side and top views of another prosthetic
heart valve device in accordance with another embodiment of the
technology.
[0142] FIGS. 88A-88C are cross-sectional views of a heart showing a
method of delivering a prosthetic heart valve device to a native
mitral valve in the heart using a trans-apical approach in
accordance with another embodiment of the present technology.
[0143] FIGS. 89A and 89B are schematic top views of a native mitral
valve in the heart viewed from the left atrium and showing the
prosthetic treatment device of FIGS. 86A and 86B implanted at the
native mitral valve in accordance with the present technology.
[0144] FIGS. 90A-90F are schematic illustrations showing how the
prosthetic heart valve device of FIGS. 86A and 86B mechanically
isolates the valve support in accordance with additional
embodiments of the present technology.
[0145] FIG. 91A is an isometric illustration of a prosthetic heart
valve device in accordance with yet another embodiment of the
technology.
[0146] FIG. 91B is a cross-sectional view of the device shown in
FIG. 91A.
[0147] FIG. 92 is a top view of a prosthetic heart valve device in
accordance with a further embodiment of the technology.
[0148] FIG. 93 is a top view of a prosthetic heart valve device in
accordance with another embodiment of the technology.
[0149] FIG. 94 is a top view of a prosthetic heart valve device in
accordance with yet another embodiment of the technology.
[0150] FIGS. 95A and 95B are top views of prosthetic heart valve
devices in accordance with further embodiments of the
technology.
[0151] FIG. 96A is an isometric view a prosthetic heart valve
device in accordance with yet another embodiment of the
technology.
[0152] FIGS. 96B and 96C are enlarged schematic views of portions
of the prosthetic heart valve device of FIG. 96A.
[0153] FIGS. 97A and 97B are top and isometric views of a
prosthetic heart valve device in accordance with an embodiment of
the technology.
[0154] FIGS. 98A-98C are top views of prosthetic heart valve
devices in accordance with further embodiments of the
technology.
[0155] FIG. 99 is a top view of a prosthetic heart valve device in
accordance with yet another embodiment of the technology.
[0156] FIG. 100A is a side view showing a method of delivering a
prosthetic heart valve device in accordance with a further
embodiment of the technology.
[0157] FIG. 100B is a top view of the prosthetic heart valve device
of FIG. 100A.
[0158] FIG. 101 is a top view of a prosthetic heart valve device in
accordance with another embodiment of the technology.
[0159] FIG. 102 is an isometric view of a prosthetic heart valve
device in accordance with an embodiment of the technology.
[0160] FIG. 103 isometric view of a prosthetic heart valve device
in accordance with a further embodiment of the technology.
[0161] FIGS. 104A and 104B are side views of prosthetic heart valve
devices in accordance with further embodiments of the
technology.
[0162] FIG. 105 is an isometric view of a prosthetic heart valve
device in accordance with a yet another embodiment of the
technology.
[0163] FIGS. 106A and 106B are schematic cross-sectional views of
embodiments of prosthetic heart valve devices in accordance with
the present technology.
[0164] FIGS. 107A and 107B are isometric views showing a method of
delivering a prosthetic heart valve device in accordance with a
further embodiment of the technology.
DETAILED DESCRIPTION
[0165] Specific details of several embodiments of the technology
are described below with reference to FIGS. 1-107B. Although many
of the embodiments are described below with respect to devices,
systems, and methods for percutaneous replacement of a native
mitral valve using prosthetic valve devices, other applications and
other embodiments in addition to those described herein are within
the scope of the technology. Additionally, several other
embodiments of the technology can have different configurations,
components, or procedures than those described herein. A person of
ordinary skill in the art, therefore, will accordingly understand
that the technology can have other embodiments with additional
elements, or the technology can have other embodiments without
several of the features shown and described below with reference to
FIGS. 1-107B.
[0166] With regard to the terms "distal" and "proximal" within this
description, unless otherwise specified, the terms can reference a
relative position of the portions of a prosthetic valve device
and/or an associated delivery device with reference to an operator
and/or a location in the vasculature or heart. For example, in
referring to a delivery catheter suitable to deliver and position
various prosthetic valve devices described herein, "proximal" can
refer to a position closer to the operator of the device or an
incision into the vasculature, and "distal" can refer to a position
that is more distant from the operator of the device or further
from the incision along the vasculature (e.g., the end of the
catheter). With respect to a prosthetic heart valve device, the
terms "proximal" and "distal" can refer to the location of portions
of the device with respect to the direction of blood flow. For
example, proximal can refer to an upstream position or a position
of blood inflow, and distal can refer to a downstream position or a
position of blood outflow. For ease of reference, throughout this
disclosure identical reference numbers and/or letters are used to
identify similar or analogous components or features, but the use
of the same reference number does not imply that the parts should
be construed to be identical. Indeed, in many examples described
herein, the identically numbered parts are distinct in structure
and/or function. The headings provided herein are for convenience
only.
Overview
[0167] Systems, devices and methods are provided herein for
percutaneous replacement of native heart valves, such as mitral
valves. Several of the details set forth below are provided to
describe the following examples and methods in a manner sufficient
to enable a person skilled in the relevant art to practice, make
and use them. Several of the details and advantages described
below, however, may not be necessary to practice certain examples
and methods of the technology. Additionally, the technology may
include other examples and methods that are within the scope of the
claims but are not described in detail.
[0168] Embodiments of the present technology provide systems,
methods and apparatus to treat valves of the body, such as heart
valves including the mitral valve. The apparatus and methods enable
a percutaneous approach using a catheter delivered intravascularly
through a vein or artery into the heart. Additionally, the
apparatus and methods enable other less-invasive approaches
including trans-apical, trans-atrial, and direct aortic delivery of
a prosthetic replacement valve to a target location in the heart.
The apparatus and methods enable a prosthetic device to be anchored
at a native valve location by engagement with a subannular surface
of the valve annulus and/or valve leaflets. Additionally, the
embodiments of the devices and methods as described herein can be
combined with many known surgeries and procedures, such as known
methods of accessing the valves of the heart (e.g., the mitral
valve or triscuspid valve) with antegrade or retrograde approaches,
and combinations thereof.
[0169] The devices and methods described herein provide a valve
replacement device that has the flexibility to adapt and conform to
the variably-shaped native mitral valve anatomy while mechanically
isolating the prosthetic valve from the anchoring portion of the
device. Several embodiments of the device effectively absorb the
distorting forces applied by the native anatomy. The device has the
structural strength and integrity necessary to withstand the
dynamic conditions of the heart over time, thus permanently
anchoring a replacement valve and making it possible for the
patient to resume a substantially normal life. The devices and
methods further deliver such a device in a less-invasive manner,
providing a patient with a new, permanent replacement valve but
also with a lower-risk procedure and a faster recovery.
[0170] In accordance with various embodiments of the present
technology, a device for repair or replacement of a native valve of
a heart is disclosed. The native valve has an annulus and leaflets,
and the device includes an anchoring member having a first portion
configured to engage tissue on or under the annulus and to deform
in a non-circular shape to conform to the tissue. The anchoring
member also can include a second portion. The device also includes
a valve support coupled to the second portion of the anchoring
member and configured to support a prosthetic valve and having a
cross-sectional shape. In various embodiments, the first portion of
the anchoring member is mechanically isolated from the valve
support such that the cross-sectional shape of the valve support
remains sufficiently stable so that the prosthetic valve remains
competent when the anchoring member is deformed in the non-circular
shape.
[0171] Some embodiments of the disclosure are directed to
prosthetic heart valve devices for implantation at a native mitral
valve wherein the mitral valve has an annulus and leaflets. In one
embodiment, the device can have an anchoring member positionable in
a location between the leaflets, wherein a first portion of the
anchoring member is expandable to a dimension larger than a
corresponding dimension of the annulus. In this embodiment,
upstream movement of the anchoring member is blocked by engagement
of the upstream portion with tissue on or near the annulus. The
anchoring member can also include a second portion. The device can
also include a valve support coupled to the second portion of the
anchoring member, wherein an upstream region of the valve support
is spaced radially inward from at least the first portion of the
anchoring member. The valve support can be configured to support a
prosthetic valve.
[0172] In another arrangement, a device for implantation at a
native valve having an annulus and leaflets can include a
hyperboloidic anchoring member having an upstream end configured to
engage an inward facing surface of the leaflets downstream of the
annulus and a downstream end, wherein the upstream end has a larger
cross-sectional area than the downstream end. The device can also
include a valve support positioned in the anchoring member and
configured to support a prosthetic valve. The valve support is
coupled to the anchoring member at a location spaced substantially
downstream from the upstream end and is uncoupled to the anchoring
member at the upstream end.
[0173] Other aspects of the disclosure are directed to prosthetic
heart valve devices for repair or replacement of a native heart
valve of a patient, wherein the heart valve has an annulus and
leaflets. In one embodiment, the device includes an anchoring
member having a first portion having a first cross-sectional
dimension and second portion having a second cross-sectional
dimension less than the first cross-sectional dimension. The first
portion is configured to engage cardiac tissue to retain the
anchoring member in a fixed longitudinal position relative to the
annulus. The device can also include a valve support coupled to the
second portion of the anchoring member and configured to support a
prosthetic valve. The valve support can be radially separated from
the first portion of the anchoring member such that the first
portion can deform inwardly without substantially deforming the
valve support.
[0174] In a further arrangement, the present disclosure also is
directed to a device for implantation at a native heart valve. The
device can include an anchoring member having an upstream end
configured to engage tissue on or downstream of a native annulus of
the heart valve, and a valve support configured to support a
prosthetic valve. The valve support can be coupled to the anchoring
member. In some arrangements, the anchoring member can resist
upstream migration of the device without an element of the device
extending behind native valve leaflets.
[0175] In another embodiment, the device can include an anchoring
member positionable between the leaflets of the native valve. The
anchoring member can have a plurality of tissue engaging elements
on an upstream end and/or on an exterior surface which are
configured to engage cardiac tissue on or near the annulus so as to
prevent migration of the device in the upstream direction. The
device can also include a valve support positioned within an
interior of the anchoring member and coupled to a downstream
portion of the anchoring member, wherein the valve support is
radially separated from at least an upstream portion of the
anchoring member.
[0176] Further embodiments of the disclosure are directed to a
device for repair or replacement of a native mitral valve having an
annulus and a pair of leaflets that include a support structure
having an upper region, a lower region, and an interior to retain a
prosthetic valve. The device can also include an anchoring member
surrounding at least a portion of the support structure, wherein
the anchoring member is positionable between the leaflets and has a
plurality of flexible elements (e.g., wires, laser cut metal
elements, etc.) arranged in a diamond pattern, an upper portion,
and a lower portion. The upper portion of the anchoring member can
be flared outwardly in a proximal direction such that proximal ends
of the flexible elements point radially outward so as to engage
cardiac tissue on or near the annulus and inhibit migration of the
device in the upstream direction. The lower region of the support
structure can be coupled to the lower portion of the anchoring
member, and the lower region of the support structure can be
mechanically isolated from at least deformation of the flared upper
portion of the anchoring member.
[0177] Other embodiments of the disclosure are directed to
prosthetic heart valve devices having a cylindrical support and an
anchor defined by a structure separate from the cylindrical
support. The cylindrical support can have a longitudinal axis and
an interior along the longitudinal axis through which blood may
flow. The anchor can have a non-circular cross-section with an
outwardly flared upstream end configured to engage subannular
tissue of a mitral valve. The anchor can also surround the
cylindrical support and be coupled to the support at a downstream
end opposite the upstream end.
[0178] In a further embodiment, the device can include an
expandable valve support configured for placement between the two
leaflets. The support can have a first region, a second region and
an interior in which a valve may be coupled. The device can also
include an anchoring member having a first portion and a second
portion, the second portion coupled to the second region of the
valve support. The first portion of the anchoring member can extend
outwardly away from the second portion. The anchoring member can
have a first perimeter at the first portion configured to engage
tissue on or near the annulus. The anchoring member can be
mechanically isolated from the valve support such that a force
exerted radially at or near the first perimeter will not
substantially alter a shape of the valve support.
[0179] Additional embodiments are directed to devices to treat a
heart valve of a patient that include an inner frame and an outer
frame coupled to the inner frame. The inner frame can have an outer
surface and an inner surface that is configured to support a
prosthetic valve. The outer frame can have an upper portion with a
cross-sectional dimension greater than a corresponding
cross-sectional dimension of an annulus of the mitral valve,
wherein the upper portion is configured to engage tissue at or
below the annulus of the mitral valve. The upper portion can also
prevent migration of the device in an upward or upstream direction
during ventricular systole. Further, the upper portion of the outer
frame can be mechanically isolated from the inner frame.
[0180] In a further embodiment, the device can include a
cylindrical inner skeleton and an outer skeleton coupled to the
inner skeleton and positionable between the leaflets downstream of
the annulus. The outer skeleton can be deformable to a non-circular
cross-section while the inner skeleton remains substantially
circular in cross-section. The inner skeleton can have an interior
to which a prosthetic valve may be coupled. The outer skeleton can
have a plurality of flexible elements (e.g., wires, laser cut metal
elements, etc.), wherein at least a portion of the flexible
elements can be configured to engage native subannular tissue so as
to prevent migration of the device in an upstream direction. In one
embodiment, the plurality of flexible wires are arranged in a
diamond configuration.
[0181] In yet a further embodiment, a prosthetic mitral valve
device can include a valve support having upstream and downstream
ends, an interior in which a valve may be coupled, and a perimeter.
The device can also include an anchoring member having a flared
upstream portion and a downstream portion coupled to the perimeter
of the valve support. The upstream portion can be mechanically
isolated from the valve support and can be configured to engage
subannular tissue of a native mitral valve. Additionally, the
device can be moveable into a plurality of configurations including
a first configuration in which the valve support and the anchoring
member are radially contracted, and wherein the valve support has a
first cross-sectional shape. The device can also move into a second
configuration in which the valve support and the anchoring member
are radially expanded and in which the valve support has a second
cross-sectional shape. Additionally, the device can move into a
third configuration in which the anchoring member is engaged with
and deformed by the subannular tissue while the valve support
remains in the second cross-sectional shape.
[0182] In some embodiments, the device may comprise an atrial
retainer extending from the anchoring member or the valve support
to a position at least partially upstream of the native mitral
annulus. The atrial extension member may comprise an atrial
engagement structure adapted to engage an upstream surface (e.g.,
supra-annular surface) of the annulus and/or an interior wall of
the atrium for further stabilizing or anchoring the device. For
example, the atrial retainer can block downstream movement of the
device.
[0183] Some embodiments of the device may further comprise one or
more stabilizing members to inhibit the device from tilting or
being displaced laterally. The stabilizing members may comprise a
plurality of arms extending radially outwardly from the valve
support and/or the anchoring member. The arms may be configured to
extend behind the native leaflets and/or into engagement with the
ventricular wall or papillary muscles.
[0184] A further embodiment, in accordance with another aspect of
the present disclosure, is directed to a device for implantation at
a native mitral valve, wherein the native mitral valve has an
annulus and leaflets. The device can include a valve support having
upstream and downstream ends, an interior in which a valve may be
coupled, and an outer surface, and include a first anchoring member
having a first flared upstream portion and a first downstream
portion coupled to the outer surface of the valve support. In other
embodiments, the first downstream portion can be coupled to inner
surface of the valve support, or in some embodiments, to an end of
the valve support. The device can also include a second anchoring
member at least partially surrounding the first anchoring member.
The first upstream portion of the first anchoring member can be
mechanically isolated from the valve support and configured to
engage supra-annular tissue of the native mitral valve. The second
anchoring member can have a second flared upstream portion and a
second downstream portion coupled to the outer surface of the valve
support, wherein the second upstream portion can be mechanically
isolated from the valve support and is configured to engage
subannular tissue of the native mitral valve.
[0185] In yet a further embodiment, the device for implantation can
include a radially expandable anchoring member configured to engage
native tissue on or downstream of the annulus. The anchoring member
can have a first longitudinal length on a posterior leaflet-facing
side and a second length on an anterior leaflet-facing side. In
certain embodiments, the first length can be greater than the
second length such that occlusion of a left ventricle outflow tract
(LVOT) is limited. The device can also include a valve support, or
alternatively a prosthetic valve, coupled to an interior or to an
end of the anchoring member.
[0186] Other embodiments of the present technology provide a device
for implantation at a native mitral valve having an annulus and
leaflets, wherein the device includes a valve support having
upstream and downstream ends, an interior in which a valve may be
coupled, and an outer surface. The device can also include an
anchoring member having a flared upstream portion and a downstream
portion coupled to the outer surface of the valve support, wherein
the upstream portion can have an upper ring and a lower ring
coupled to the upper ring. The device can further include a
plurality of flexible annulus engaging elements distributed around
a circumference of the anchoring member and coupling the upper ring
to the lower ring. The lower ring is configured to move in an
upstream direction toward the upper ring such that the annulus is
received between the upper and lower rings and within the annulus
engaging elements.
[0187] The disclosure further provides systems for delivery of
prosthetic valves and other devices using endovascular or other
minimally invasive forms of access. For example, embodiments of the
present technology provide a system to treat a mitral valve of a
patient, in which the mitral valve has an annulus. The system
comprises a device to treat the mitral valve as described herein
and a catheter having a lumen configured to retain the device
within the catheter.
[0188] In other aspects, a system for replacing a native valve in a
patient is provided. The system can include an elongated catheter
body having a distal end and a proximal end, and a housing coupled
to the distal end of the catheter body and having a closed end and
an open end. The system can also include a plunger within the
housing which is axially movable relative to the housing, and an
actuator at the proximal end of the catheter body and coupled to
the plunger such that moving the actuator moves the housing axially
relative to the plunger. The system can further include a
prosthetic valve device having a collapsed configuration and an
expanded configuration. The prosthetic valve device can be
positionable in the housing in the collapsed configuration and can
be releasable proximally from the housing by moving the
actuator.
[0189] In yet another aspect, embodiments of the present technology
provide a method of treating a heart valve of a patient. The mitral
valve has an annulus and leaflets coupled to the annulus. The
method can include implanting a device as described herein within
or adjacent to the annulus. The device, in some embodiments, can
include a valve support coupled to and at least partially
surrounded by an anchoring member. The anchoring member can be
disposed between the leaflets and an upstream portion of the
anchoring member can be configured to engage tissue on or
downstream of the annulus to prevent migration of the device in an
upstream direction. Further, the valve support can be mechanically
isolated from the anchoring member at least at the upstream
portion.
[0190] In yet a further aspect, embodiments of the present
technology provide a method for replacement of a native mitral
valve having an annulus and leaflets. The method can include
positioning a device as described herein between the leaflets,
while the device is in a collapsed configuration. The method can
also include allowing the prosthetic device to expand such that an
anchoring member of the prosthetic device is in a subannular
position in which it engages tissue on or downstream of the
annulus. The anchoring member can have a diameter larger than a
corresponding diameter of the annulus in the subannular position.
The method can further include allowing a valve support to expand
within the anchoring member, wherein the valve support is coupled
to the anchoring member. In various embodiments, the valve support
can be mechanically isolated from the anchoring member such that
deformation of the anchoring member when the anchoring member
engages the tissue does not substantially deform the valve support.
In some arrangements, certain regions of the valve support may
deform, but a support region suitable for retaining a prosthetic
valve does not substantially deform such that leaflet coaptation of
the prosthetic valve would not be compromised.
[0191] The disclosure further provides prosthetic heart valve
devices that can include an anchoring member having a tubular
fixation frame with an inlet end and an outlet end. The device can
also include a tubular valve support that has a first portion
coupled to the anchoring member and a second portion mechanically
isolated from the anchoring member such that the inlet end of the
anchoring member is radially deformable without substantially
deforming the second portion. The device can further include a
valve coupled to the valve support. The valve can have at least one
leaflet movable from a closed position in which blood flow is
blocked through the valve support and an open position in which
blood flow is allowed through the valve support in a downstream
direction. The device can also include an extension member coupled
to the fixation frame and extending radially outward therefrom. A
deformable portion of the extension member can be mechanically
isolated from the anchoring member such that the deformable portion
of the extension member is radially deformable without
substantially deforming the anchoring member.
[0192] Additional aspects of the disclosure are directed to
prosthetic heart valve devices that can include an anchoring member
that has a connection structure and a radially expandable fixation
frame. The connection structure can have a first end coupled to the
fixation frame, a second end coupled to a valve support and a
lateral portion that spaces the fixation frame apart from the valve
support. The device can also include a valve coupled to the valve
support and which has at least one leaflet movable from a closed
position in which blood flow is blocked through an interior and an
open position in which blood flow is allowed through the interior
in a flow direction from an inlet end toward an outlet end. The
Device can further include an extension member having a brim and a
support structure coupled to the brim. The brim can include a sheet
of flexible material coupled to the fixation frame and extending
radially outward therefrom. In various embodiments, the support
structure can be more rigid than the brim. In one embodiment, the
brim can be deflectable relative to the fixation frame about an
axis transverse to the flow direction and the fixation frame is
configured to deform at least partially independently of the valve
support.
[0193] Additional prosthetic heart valve devices can include an
anchoring member having a tubular fixation frame with an interior
and having an upstream end and a downstream end, and a valve
coupled to the anchoring member. The valve can have at least one
leaflet movable from a closed position in which blood flow is
blocked through the interior and an open position in which blood
flow is allowed through the interior in a flow direction from the
upstream end toward the downstream end. The device can also include
an extension member having a brim and a resilient support structure
coupled to the brim. The brim can include a sheet of flexible
material coupled to the anchoring member near the upstream end
thereof and extending radially outward therefrom. The support
structure can be structurally independent from the fixation frame.
Further, the extension member can be radially deformable without
substantially deforming the anchoring member.
[0194] In yet a further aspect, a prosthetic heart valve device can
include an anchoring member having a radially expandable frame with
an interior and having an upstream end and a downstream end. In
some embodiments, the upstream end includes a tissue fixation
portion configured to engage tissue located at and/or downstream of
a native annulus of a heart valve in a subject and configured to be
at least partially deformable to conform to a shape of the tissue.
The device can also include a valve positioned relative to the
anchoring member and having at least one leaflet movable from a
closed position in which blood flow is blocked through the interior
and an open position in which blood flow is allowed through the
interior in a flow direction from the upstream end toward the
downstream end. The valve can be spaced inwardly apart from the
tissue fixation portion of the anchoring member such that the valve
remains competent when the tissue fixation portion is deformed to
conform to the shape of the tissue. The device can further include
an extension member flexibly coupled to the anchoring member
proximate the upstream end of the expandable frame, wherein the
extension member extends longitudinally along the flow direction in
a low-profile configuration and is biased to project laterally
relative to the flow direction in a deployed configuration. The
extension member can be configured to deform relative to the
expandable frame in the deployed configuration.
[0195] Additional aspects of the technology are directed to methods
of replacing a native heart valve. In one embodiment, a method can
include positioning a prosthesis in a first heart chamber upstream
of a native annulus with a delivery device when the prosthesis
being is a collapsed configuration, and deploying an extension
member of the prosthesis in the first heart chamber so that the
extension member at least partially expands into an expanded shape
while an anchoring member of the prosthesis remains at least
partially collapsed. The method can also include moving the
prosthesis to cause an indicator portion of the extension member to
deflect by engagement with a wall of the first heart chamber
surrounding the native heart valve, and visualizing the indicator
portion of the extension member to determine a position of the
prosthesis relative to a native annulus based on the deflection of
the indicator portion. The method can further include deploying the
anchoring member of the prosthesis such that it expands into
engagement with heart tissue downstream of the native annulus so as
to anchor the prosthesis in place.
[0196] Another method of replacing a native heart valve can include
positioning a prosthesis in a first heart chamber upstream of a
native annulus with a delivery device when the prosthesis is in a
collapsed configuration, and deploying an extension member of the
prosthesis in the first heart chamber so that the extension member
at least partially expands into an expanded shape while an
anchoring member of the prosthesis remains at least partially
collapsed. The method can also include deploying the anchoring
member of the prosthesis such that it expands into engagement with
heart tissue downstream of the native annulus so as to anchor the
prosthesis in place. The method can further include allowing the
extension member to radially deform to a greater extent than any
deformation of the anchoring member.
[0197] An additional method of replacing a native heart valve can
include positioning a collapsed prosthesis in a first heart chamber
upstream of a native annulus with a delivery device, and deploying
an extension member of the prosthesis in the first heart chamber so
that the extension member at least partially expands into an
expanded shape while a fixation member of the prosthesis remains at
least partially collapsed. The method can also include moving the
prosthesis in a downstream direction such that the expanded
extension member folds at least partially inwardly and positions
the fixation member at a desired location relative to the native
valve annulus. The method can further include deploying the
fixation member of the prosthesis such that it expands into
engagement with heart tissue downstream of the native annulus so as
to anchor the prosthesis in place.
[0198] The devices and methods disclosed herein can be configured
for treating non-circular, asymmetrically shaped valves and
bileaflet or bicuspid valves, such as the mitral valve. It can also
be configured for treating other valves of the heart such as the
tricuspid valve. Many of the devices and methods disclosed herein
can further provide for long-term (e.g., permanent) and reliable
anchoring of the prosthetic device even in conditions where the
heart or native valve may experience gradual enlargement or
distortion.
Cardiac and Mitral Valve Physiology
[0199] FIGS. 1 and 2 show a normal heart H. The heart comprises a
left atrium that receives oxygenated blood from the lungs via the
pulmonary veins PV and pumps this oxygenated blood through the
mitral valve MV into the left ventricle LV. The left ventricle LV
of a normal heart H in systole is illustrated in FIG. 2. The left
ventricle LV is contracting and blood flows outwardly through the
aortic valve AV in the direction of the arrows. Back flow of blood
or "regurgitation" through the mitral valve MV is prevented since
the mitral valve is configured as a "check valve" which prevents
back flow when pressure in the left ventricle is higher than that
in the left atrium LA.
[0200] The mitral valve MV comprises a pair of leaflets having free
edges FE which meet evenly, or "coapt" to close, as illustrated in
FIG. 2. The opposite ends of the leaflets LF are attached to the
surrounding heart structure via an annular region of tissue
referred to as the annulus AN. FIG. 3 is a schematic
cross-sectional side view of an annulus and leaflets of a mitral
valve. As illustrated, the opposite ends of the leaflets LF are
attached to the surrounding heart structure via a fibrous ring of
dense connective tissue referred to as the annulus AN, which is
distinct from both the leaflet tissue LF as well as the adjoining
muscular tissue of the heart wall. The leaflets LF and annulus AN
are comprised of different types of cardiac tissue having varying
strength, toughness, fibrosity, and flexibility. Furthermore, the
mitral valve MV may also comprise a unique region of tissue
interconnecting each leaflet LF to the annulus AN, referred to
herein as leaflet/annulus connecting tissue LAC (indicated by
overlapping cross-hatching). In general, annular tissue AN is
tougher, more fibrous, and stronger than leaflet tissue LF.
[0201] Referring to FIG. 2, the free edges FE of the mitral
leaflets LF are secured to the lower portions of the left ventricle
LV through chordae tendineae CT (referred to hereinafter "chordae")
which include a plurality of branching tendons secured over the
lower surfaces of each of the valve leaflets LF. The chordae CT in
turn, are attached to the papillary muscles PM, which extend
upwardly from the lower wall of the left ventricle LV and
interventricular septum IVS.
[0202] Referring now to FIGS. 4A to 4B, a number of structural
defects in the heart can cause mitral valve regurgitation. Ruptured
chordae RCT, as shown in FIG. 4A, can cause a valve leaflet LF2 to
prolapse since inadequate tension is transmitted to the leaflet via
the chordae. While the other leaflet LF1 maintains a normal
profile, the two valve leaflets do not properly meet and leakage
from the left ventricle LV into the left atrium LA will occur, as
shown by the arrow.
[0203] Regurgitation also occurs in the patients suffering from
cardiomyopathy where the heart is dilated and the increased size
prevents the valve leaflets LF from meeting properly, as shown in
FIG. 4B. The enlargement of the heart causes the mitral annulus to
become enlarged, making it impossible for the free edges FE to meet
during systole. The free edges of the anterior and posterior
leaflets normally meet along a line of coaptation C as shown in
FIG. 5A, but a significant gap G can be left in patients suffering
from cardiomyopathy, as shown in FIG. 5B.
[0204] Mitral valve regurgitation can also occur in patients who
have suffered ischemic heart disease where the functioning of the
papillary muscles PM is impaired, as illustrated in FIG. 4A. As the
left ventricle LV contracts during systole, the papillary muscles
PM do not contract sufficiently to effect proper closure. One or
both of the leaflets LF1 and LF2 then prolapse. Leakage again
occurs from the left ventricle LV to the left atrium LA.
[0205] FIGS. 5A-5C further illustrate the shape and relative sizes
of the leaflets L of the mitral valve. Referring to FIG. 5C, it may
be seen that the overall valve has a generally "D"-shape or
kidney-like shape, with a long axis MVA1 and a short axis MVA2. In
healthy humans the long axis MVA1 is typically within a range from
about 33.3 mm to about 42.5 mm in length (37.9+/-4.6 mm), and the
short axis MVA2 is within a range from about 26.9 to about 38.1 mm
in length (32.5+/-5.6 mm) However, with patients having decreased
cardiac function these values can be larger, for example MVA1 can
be within a range from about 45 mm to 55 mm and MVA2 can be within
a range from about 35 mm to about 40 mm. The line of coaptation C
is curved or C-shaped, thereby defining a relatively large anterior
leaflet AL and substantially smaller posterior leaflet PL (FIG.
5A). Both leaflets appear generally crescent-shaped from the
superior or atrial side, with the anterior leaflet AL being
substantially wider in the middle of the valve than the posterior
leaflet. As illustrated in FIG. 5A, at the opposing ends of the
line of coaptation C the leaflets join together at corners called
the anterolateral commissure AC and posteromedial commissure PC,
respectively.
[0206] FIG. 5C shows the shape and dimensions of the annulus of the
mitral valve. The annulus is an annular area around the
circumference of the valve comprised of fibrous tissue which is
thicker and tougher than that of the leaflets LF and distinct from
the muscular tissue of the ventricular and atrial walls. The
annulus may comprise a saddle-like shape with a first peak portion
PP1 and a second peak portion PP2 located along an interpeak axis
IPD, and a first valley portion VP1 and a second valley portion VP2
located along an intervalley axis IVD. The first and second peak
portion PP1 and PP2 are higher in elevation relative to a plane
containing the nadirs of the two valley portions VP1, VP2,
typically being about 8-19 mm higher in humans, thus giving the
valve an overall saddle-like shape. The distance between the first
and second peak portions PP1, PP2, referred to as interpeak span
IPD, is substantially shorter than the intervalley span IVD, the
distance between first and second valley portions VP1, VP2.
[0207] A person of ordinary skill in the art will recognize that
the dimensions and physiology of the patient may vary among
patients, and although some patients may comprise differing
physiology, the teachings as described herein can be adapted for
use by many patients having various conditions, dimensions and
shapes of the mitral valve. For example, work in relation to
embodiments suggests that some patients may have a long dimension
across the annulus and a short dimension across the annulus without
well-defined peak and valley portions, and the methods and device
as described herein can be configured accordingly.
Access to the Mitral Valve
[0208] Access to the mitral valve or other atrioventricular valve
can be accomplished through the patient's vasculature in a
percutaneous manner. By percutaneous it is meant that a location of
the vasculature remote from the heart is accessed through the skin,
typically using a surgical cut down procedure or a minimally
invasive procedure, such as using needle access through, for
example, the Seldinger technique. The ability to percutaneously
access the remote vasculature is well-known and described in the
patent and medical literature. Depending on the point of vascular
access, the approach to the mitral valve may be antegrade and may
rely on entry into the left atrium by crossing the inter-atrial
septum. Alternatively, approach to the mitral valve can be
retrograde where the left ventricle is entered through the aortic
valve. Once percutaneous access is achieved, the interventional
tools and supporting catheter(s) may be advanced to the heart
intravascularly and positioned adjacent the target cardiac valve in
a variety of manners, as described herein.
[0209] Using a trans-septal approach, access is obtained via the
inferior vena cava IVC or superior vena cava SVC, through the right
atrium RA, across the inter-atrial septum IAS and into the left
atrium LA above the mitral valve MV.
[0210] As shown in FIG. 6A, a catheter 1 having a needle 2 may be
advanced from the inferior vena cava IVC into the right atrium RA.
Once the catheter 1 reaches the anterior side of the inter-atrial
septum IAS, the needle 2 may be advanced so that it penetrates
through the septum, for example at the fossa ovalis FO or the
foramen ovale into the left atrium LA. At this point, a guidewire
may be exchanged for the needle 2 and the catheter 1 withdrawn.
[0211] As shown in FIG. 6B, access through the inter-atrial septum
IAS may usually be maintained by the placement of a guide catheter
4, typically over a guidewire 6 which has been placed as described
above. The guide catheter 4 affords subsequent access to permit
introduction of the device to replace the mitral valve, as
described in more detail herein.
[0212] In an alternative antegrade approach (not shown), surgical
access may be obtained through an intercostal incision, preferably
without removing ribs, and a small puncture or incision may be made
in the left atrial wall. A guide catheter may then be placed
through this puncture or incision directly into the left atrium,
sealed by a purse string-suture.
[0213] The antegrade or trans-septal approach to the mitral valve,
as described above, can be advantageous in many respects. For
example, the use of the antegrade approach will usually allow for
more precise and effective centering and stabilization of the guide
catheter and/or prosthetic valve device. Precise positioning
facilitates accuracy in the placement of the prosthetic valve
device. The antegrade approach may also reduce the risk of damaging
the chordae tendinae or other subvalvular structures during
catheter and interventional tool introduction and manipulation.
Additionally, the antegrade approach may decrease risks associated
with crossing the aortic valve as in retrograde approaches. This
can be particularly relevant to patients with prosthetic aortic
valves, which cannot be crossed at all or without substantial risk
of damage.
[0214] An example of a retrograde approach to the mitral valve is
illustrated in FIGS. 7 and 8. The mitral valve MV may be accessed
by an approach from the aortic arch AA, across the aortic valve AV,
and into the left ventricle LV below the mitral valve MV. The
aortic arch AA may be accessed through a conventional femoral
artery access route, as well as through more direct approaches via
the brachial artery, axillary artery, radial artery, or carotid
artery. Such access may be achieved with the use of a guidewire 6.
Once in place, a guide catheter 4 may be tracked over the guidewire
6. Alternatively, a surgical approach may be taken through an
incision in the chest, preferably intercostally without removing
ribs, and placing a guide catheter through a puncture in the aorta
itself. The guide catheter 4 affords subsequent access to permit
placement of the prosthetic valve device, as described in more
detail herein.
[0215] In some specific instances, a retrograde arterial approach
to the mitral valve may be selected due to certain advantages. For
example, use of the retrograde approach can eliminate the need for
a trans-septal puncture. The retrograde approach is also more
commonly used by cardiologists and thus has the advantage of
familiarity.
[0216] An additional approach to the mitral valve is via
trans-apical puncture, as shown in FIG. 9. In this approach, access
to the heart is gained via thoracic incision, which can be a
conventional open thoracotomy or sternotomy, or a smaller
intercostal or sub-xyphoid incision or puncture. An access cannula
is then placed through a puncture, sealed by a purse-string suture,
in the wall of the left ventricle at or near the apex of the heart.
The catheters and prosthetic devices of the invention may then be
introduced into the left ventricle through this access cannula.
[0217] The trans-apical approach has the feature of providing a
shorter, straighter, and more direct path to the mitral or aortic
valve. Further, because it does not involve intravascular access,
the trans-apical procedure can be performed by surgeons who may not
have the necessary training in interventional cardiology to perform
the catheterizations required in other percutaneous approaches.
[0218] The prosthetic treatment device may be specifically designed
for the approach or interchangeable among approaches. A person of
ordinary skill in the art can identify an appropriate approach for
an individual patient and design the treatment apparatus for the
identified approach in accordance with embodiments described
herein.
[0219] Orientation and steering of the prosthetic valve device can
be combined with many known catheters, tools and devices. Such
orientation may be accomplished by gross steering of the device to
the desired location and then refined steering of the device
components to achieve a desired result.
[0220] Gross steering may be accomplished by a number of methods. A
steerable guidewire may be used to introduce a guide catheter and
the prosthetic treatment device into the proper position. The guide
catheter may be introduced, for example, using a surgical cut down
or Seldinger access to the femoral artery in the patient's groin.
After placing a guidewire, the guide catheter may be introduced
over the guidewire to the desired position. Alternatively, a
shorter and differently shaped guide catheter could be introduced
through the other routes described above.
[0221] A guide catheter may be pre-shaped to provide a desired
orientation relative to the mitral valve. For access via the
trans-septal approach, the guide catheter may have a curved, angled
or other suitable shape at its tip to orient the distal end toward
the mitral valve from the location of the septal puncture through
which the guide catheter extends. For the retrograde approach, as
shown in FIGS. 7 and 8, guide catheter 4 may have a pre-shaped
J-tip which is configured so that it turns toward the mitral valve
MV after it is placed over the aortic arch AA and through the
aortic valve AV. As shown in FIG. 7, the guide catheter 4 may be
configured to extend down into the left ventricle LV and to assume
a J-shaped configuration so that the orientation of an
interventional tool or catheter is more closely aligned with the
axis of the mitral valve MV. In either case, a pre-shaped guide
catheter may be configured to be straightened for endovascular
delivery by means of a stylet or stiff guidewire which is passed
through a lumen of the guide catheter. The guide catheter might
also have pull-wires or other means to adjust its shape for more
fine steering adjustment.
Selected Embodiments of Prosthetic Heart Valve Devices and
Methods
[0222] Embodiments of the present technology as described herein
can be used to treat one or more of the valves of the heart as
described herein, and in particular embodiments, can be used for
treatment of the mitral valve. Introductory examples of prosthetic
heart valve devices, system components and associated methods in
accordance with embodiments of the present technology are described
in this section with reference to FIGS. 10A-56. It will be
appreciated that specific elements, substructures, advantages,
uses, and/or other features of the embodiments described with
reference to FIGS. 10A-56 can be suitably interchanged, substituted
or otherwise configured with one another and/or with the
embodiments described with reference to FIGS. 57A-71 in accordance
with additional embodiments of the present technology. Furthermore,
suitable elements of the embodiments described with reference to
FIGS. 10A-71 can be used as stand-alone and/or self-contained
devices.
[0223] Systems, devices and methods are provided herein for
percutaneous implantation of prosthetic heart valves in a heart of
a patient. In some embodiments, methods and devices are presented
for the treatment of valve disease by minimally invasive
implantation of artificial replacement heart valves. In one
embodiment, the artificial replacement valve can be a prosthetic
valve device suitable for implantation and replacement of a mitral
valve between the left atrium and left ventricle in the heart of a
patient. In another embodiment, the prosthetic valve device can be
suitable for implantation and replacement of another valve (e.g., a
bicuspid or tricuspid valve) in the heart of the patient. FIG. 10A
shows an isometric view of a prosthetic heart valve device 100 in
an expanded configuration 102 in accordance with an embodiment of
the present technology, and FIG. 10B is a schematic illustration of
a cross-sectional view of a heart depicting the left atrium, left
ventricle, and native mitral valve of the heart. FIG. 10B also
shows an embodiment of the expandable prosthetic valve device 100
implanted in the native mitral valve region of the heart.
[0224] As shown in FIG. 10A, the device 100 can include a flexible
anchoring member 110 at least partially surrounding and coupled to
an inner valve support 120. The device 100 can further include a
prosthetic valve 130 coupled to, mounted within, or otherwise
carried by the valve support 120. FIGS. 10C-10F are side,
perspective cut-away, top, and bottom views, respectively, of the
prosthetic heart valve device 100 in accordance with the present
technology. The device 100 can also include one or more sealing
members 140 and tissue engaging elements 170. For example, the
sealing member 140 can, in one embodiment, extend around an inner
wall 141 of the anchoring member 110 and/or around an exterior
surface 127 of the valve support 120 to prevent paravalvular (e.g.,
paraprosthetic) leaks between the device 100 and the native tissue
and/or between the anchoring member 110 and the valve support 120.
In another specific embodiment, and as shown in FIG. 10A, the
tissue engaging elements 170 can be spikes disposed on an upstream
perimeter 113 of the anchoring member 110 and extend in an upward
and/or radially outward direction to engage, and in some
embodiments, penetrate the native tissue to facilitate retention or
maintain position of the device in a desired implanted location.
The tissue engaging elements 170 may also be included around an
outer wall 142 of the anchoring member 110 and can extend outwardly
to engage and, in some embodiments, penetrate the native valve
leaflets or other adjacent tissue. Additionally, the valve support
120 can have a plurality of coupling features 180, such as eyelets,
around an upstream end 121 to facilitate loading, retention and
deployment of the device 100 within and from a delivery catheter
(not shown), as further described herein.
[0225] The prosthetic heart valve device 100 can be movable between
a delivery configuration (not shown), an expanded configuration 102
(FIG. 10A), and a deployed configuration 104 (FIG. 10B). In the
delivery configuration, the prosthetic heart valve device 100 has a
low profile suitable for delivery through small-diameter guide
catheters positioned in the heart via the trans-septal, retrograde,
or trans-apical approaches described herein. In some embodiments,
the delivery configuration of the prosthetic heart valve device 100
will preferably have an outer diameter no larger than about 8-10 mm
for trans-septal approaches, about 8-10 mm for retrograde
approaches, or about 8-12 mm for trans-apical approaches to the
mitral valve MV. As used herein, "expanded configuration" refers to
the configuration of the device when allowed to freely expand to an
unrestrained size without the presence of constraining or
distorting forces. "Deployed configuration," as used herein, refers
to the device once expanded at the native valve site and subject to
the constraining and distorting forces exerted by the native
anatomy.
[0226] Referring back to FIG. 3, "subannular," as used herein,
refers to a portion of the mitral valve MV that lies on or
downstream DN of the plane PO of the native orifice. As used
herein, the plane PO of the native valve orifice is a plane
generally perpendicular to the direction of blood flow through the
valve and which contains either or both the major axis MVA1 or the
minor axis MVA2 (FIG. 5C). Thus, a subannular surface of the mitral
valve MV is a tissue surface lying on the ventricular side of the
plane PO, and preferably one that faces generally downstream,
toward the left ventricle LV. The subannular surface may be
disposed on the annulus AN itself or the ventricular wall behind
the native leaflets LF, or it may comprise a surface of the native
leaflets LF, either inward-facing IF or outward-facing OF, which
lies below the plane PO. The subannular surface or subannular
tissue may thus comprise the annulus AN itself, the native leaflets
LF, leaflet/annulus connective tissue, the ventricular wall or
combinations thereof.
[0227] In operation, the prosthetic heart valve device 100 can be
intravascularly delivered to a desired location in the heart, such
as an intracardiac location near the mitral valve MV, while in the
delivery (e.g., collapsed) configuration within a delivery catheter
(not shown). Referring to FIG. 10B, the device 100 can be advanced
to a position within or downstream of the native annulus AN where
the device 100 can be released from the delivery catheter to
enlarge toward the expanded configuration 102 (FIG. 10A). The
device 100 will engage the native tissue at the desired location,
which will deform or otherwise alter the shape of the device 100
into the deployed configuration 104 (FIG. 10B). Once released from
the catheter, the device 100 can be positioned such that at least a
portion of the flexible anchoring member 110 engages a subannular
surface of the native valve so as to resist systolic forces and
prevent upstream migration of the device 100 (FIG. 10B). In the
embodiment illustrated in FIG. 10B, the upstream perimeter 113 of
the anchoring member 110 engages the inward-facing surfaces IF
(FIG. 3) of the native leaflets LF, which are pushed outwardly and
folded under the native annulus AN. The leaflets LF engage a
ventricular side of the annulus AN and are prevented from being
pushed further in the upstream direction, thus maintaining the
anchoring member 110 below the plane of the native valve annulus.
The tissue engaging elements 170 can penetrate the tissue of the
leaflets LF and/or the annulus AN to stabilize and firmly anchor
the device 100. In some embodiments, however, some portions of the
anchoring member 110 may extend above the annulus AN, with at least
some portions of the anchoring member 110 engaging tissue in a
subannular location to prevent migration of the device 100 toward
the left atrium LA. As shown in FIG. 10B, the leaflets LF can lie
in apposition against the outer wall 142 of the anchoring member
110 forming a blood-tight seal with the sealing member 140. The
tissue engaging elements 170 can apply pressure against or, in
another embodiment, penetrate the annulus AN or leaflets LF along
the outer wall 142 of the anchoring member 110 to further stabilize
the device 100 and prevent migration.
[0228] In accordance with aspects of the present technology, the
proximal or upper end of the anchoring member 110, while in a
deployed configuration 104, conforms to the irregularly-shaped
mitral annulus AN, effectively sealing the device 100 against the
native annulus AN to anchor the device and to prevent paravalvular
leaks. As described further herein, the anchoring member 110
mechanically isolates the valve support 120 from distorting forces
present in the heart such that the anchoring member 110 may adapt
and/or conform to native forces while the valve support 120
maintains its structural integrity. Accordingly, the anchoring
member 110 can be sufficiently flexible and resilient and/or
coupled to the valve support 120 in such a manner as to
mechanically isolate the valve support 120 from the forces exerted
upon the anchoring member 110 by the native anatomy. Alternatively,
or in addition to the above features, the valve support 120 may be
more rigid and/or have greater radial strength than the radial
strength of the anchoring member 110 so as to maintain its
cylindrical or other desired shape and to ensure proper opening and
closing of the prosthetic valve 130 housed within the valve support
structure 120. In some embodiments, the valve support 120 has a
radial strength of at least 100%, or in other embodiments at least
200%, and in further embodiments at least 300%, greater than a
radial strength of the anchoring member 110. In one embodiment, the
valve support 120 can have a radial strength of approximately 10 N
to about 12 N. Thus, if deformed from its unbiased shape by
exerting a radially compressive force against its circumference,
the valve support 120 can exhibit a hoop force which is about 2 to
about 20 times greater for a given degree of deformation than will
be exhibited by the anchoring member 110.
[0229] As illustrated in FIGS. 10A-10F, the anchoring member 110
has a downstream portion 111 and an upstream portion 112 opposite
the downstream portion 111 relative to a longitudinal axis 101 of
the device 100. The upstream portion 112 of the anchoring member
110 can be a generally outward oriented portion of the device 100,
as shown in FIG. 10D. In one embodiment the anchoring member 110
has a generally hyperboloidic shape, such as the shape of a
two-sheet hyperboloid. In another example, the downstream portion
111 can be substantially circular in cross-section while the
upstream portion 112 can be generally non-circular. In some
embodiments, the anchoring member 110 can include a series of
circumferentially positioned, resiliently deformable and flexible
longitudinal ribs 114 which, in some embodiments, are connected
circumferentially by deformable and/or flexible connectors 116.
Once deployed, at least a portion of the upstream ends of the
longitudinal ribs 114 engage a subannular surface of the native
valve (e.g., mitral valve). As described in more detail below,
certain embodiments of longitudinal ribs 114 are configured to
penetrate subannular tissue to anchor and further stabilize the
device 100.
[0230] Additionally, FIGS. 10A-10F also illustrate that the
longitudinal ribs 114 and/or circumferential connectors 116 may be
arranged in a variety of geometrical patterns. In the examples
shown in FIGS. 10A-10F, the connectors 116 are formed in a chevron
configuration. One of ordinary skill will recognize that
diamond-shaped patterns, sinusoidal configurations, closed cells,
open cells, or other circumferentially expandable configurations
are also possible. In some embodiments, the longitudinal ribs 114
may be divided along their length into multiple, separated segments
(not shown), e.g. where the connectors 116 interconnect with the
longitudinal ribs 114. The plurality of connectors 116 and ribs 114
can be formed from a deformable material or from a resilient or
shape memory material (e.g., Nitinol). In other embodiments, the
anchoring member 110 can comprise a mesh or woven construction in
addition to or in place of the longitudinal ribs 114 and/or
circumferential connectors 116. For example, the anchoring member
110 could include a tube or braided mesh formed from a plurality of
flexible wires or filaments arranged in a diamond pattern or other
configuration. In another example, a metal tube can be laser cut to
provide a desired rib or strut geometry. The diamond configuration
can, in some embodiments, provide column strength sufficient to
inhibit movement of the device 100 relative the annulus under the
force of systolic blood pressure against the valve 130 mounted in
the valve support 120. In a particular example, the anchoring
member 120 can be formed of a preshaped Nitinol tube having, for
example, a wall thickness of approximately 0.010 inches to about
0.030 inches.
[0231] FIGS. 11A-11H show several embodiments of valve supports 120
that can be used in embodiments of the prosthetic heart valve
device 100 shown in FIGS. 10A-10F. FIGS. 11A-11G are side and
isometric views of the valve support 120 shown in an expanded
configuration 102, and FIG. 11H is an isometric view of another
embodiment of a prosthetic heart valve device 100 disposed in an
expanded configuration 102 in accordance with the present
technology. Referring to FIGS. 10A-10F and 11A-11H together,
several embodiments of the valve support 120 can be generally
cylindrical having an upstream end 121 and a downstream end 123
formed around a longitudinal axis 101 with a circular, oval,
elliptical, kidney-shaped, D-shaped, or other suitable
cross-sectional shape configured to support a tricuspid or other
prosthetic valve 130. In some embodiments, the valve support 120
includes a plurality of posts 122 connected circumferentially by a
plurality of struts 124. The posts 122 and struts 124 can be
arranged in a variety of geometrical patterns that can expand and
provide sufficient resilience and column strength for maintaining
the integrity of the prosthetic valve 130. For example, the
plurality of posts 122 can extend longitudinally across multiple
rows of struts 124 to provide column strength to the valve support
120. However, in other embodiments, the valve support 120 can
include a metallic, polymeric, or fabric mesh or a woven
construction.
[0232] Generally, the plurality of posts 122 can extend along an
axial direction generally parallel to the longitudinal axis 101 and
the struts 124 can extend circumferentially around and transverse
to the longitudinal axis 101. The posts 122 can extend an entire
longitudinal height H.sub.1 of the valve support 120 (FIG. 11A), or
in another embodiment, the posts 122 can include a plurality of
independent and separate post segments (not shown) along the valve
support height H.sub.1. In one embodiment the height H.sub.1 can be
approximately 14 mm to about 17 mm. The struts 124 can form a
series of rings around the longitudinal axis 101, wherein each ring
has a circumferentially expandable geometry. In the example shown
in FIGS. 11A, 11D and 11H, the struts 124 are formed in a series of
zig-zags and arranged in pairs 180 degrees out of phase with each
other so as to form a series of diamonds. Alternative expandable
geometries can include sinusoidal patterns, chevron configurations
(FIG. 11B), closed cells (FIG. 11C), open cells, or other
expandable configurations. The plurality of struts 124 can attach
to the plurality of posts 122 so as to define a plurality of nodes
125 where the struts and posts intersect. The plurality of struts
124 and the plurality of posts 122 can be formed from a deformable
material or a resilient or shape memory material (e.g.,
Nitinol).
[0233] The anchoring member 110 and the valve support 120 may be
made of the same or, in some embodiments, different materials. In
some embodiments, both the anchoring member 110 and the valve
support 120 include a resilient biocompatible metal, such as
stainless steel, nickel cobalt or cobalt chromium alloys such as
MP35N, or nickel titanium alloys such as Nitinol. Superelastic
shape memory materials such as Nitinol can allow the device to be
collapsed into a very low profile delivery configuration suitable
for delivery through the vasculature via catheter, and allow
self-expansion to a deployed configuration suitably sized to
replace the target valve. In some embodiments, the anchoring member
110 and/or the valve support 120 can be laser cut from a single
metal tube into the desired geometry, creating a tubular scaffold
of interconnected struts. Anchoring member 110 may then be shaped
into a desired configuration, e.g. a flared, funnel-like or
hyperboloid shape, using known shape-setting techniques for such
materials.
[0234] As shown in FIGS. 11B-11E, the valve support 120 has an
interior surface 126 and an exterior surface 127, and the valve
support 120 is configured to receive or support the prosthetic
valve 130 within an interior lumen of the valve support 120 to
inhibit retrograde blood flow (e.g., blood flow from the left
ventricle into the left atrium). Accordingly, the valve support 120
can provide a scaffold to which prosthetic valve tissue can be
secured and provide a scaffold that has sufficient axial rigidity
to maintain a longitudinal position of the prosthetic valve 130
relative to the anchoring member 110. The valve support 120 can
further provide such a scaffold having radial rigidity to maintain
circularity (or other desired cross-sectional shape) to ensure that
leaflets 132 of the prosthetic valve 130 coapt or otherwise seal
when the device 100 is subject to external radial pressure. In one
embodiment, the valve support 120 can have a support region 145
along the longitudinal axis 101 that is configured to attach to the
prosthetic valve, or in other embodiments, be aligned with the
coaptation portion of the leaflets 132 (shown in FIG. 11B).
[0235] The valve 130 may comprise a temporary or permanent valve
adapted to block blood flow in the upstream direction and allow
blood flow in the downstream direction through the valve support
120. The valve 130 may also be a replacement valve configured to be
disposed in the valve support 120 after the device 100 is implanted
at the native mitral valve. The valve 130 can have a plurality of
leaflets 132, and may be formed of various flexible and impermeable
materials including PTFE, Dacron.RTM., pyrolytic carbon, or other
biocompatible materials or biologic tissue such as pericardial
tissue or xenograft valve tissue such as porcine heart tissue or
bovine pericardium. Other aspects of valve 130 are described
further below. The interior surface 126 within the lumen of the
valve support 120 can be covered at least partially by an
impermeable sealing member 140 to prevent blood flow from inside
the valve support 120 to the outside of the valve support 120,
where it could leak around the exterior of the valve support 120.
In another embodiment, the sealing member 140 may be affixed to the
exterior surface 127 of the valve support 120 and, in either
embodiment, may be integrally formed with or attached directly to
valve 130. In an additional embodiment, the sealing member 140 can
be applied on at least portions of both the interior surface 126
and the exterior surface 127 of the valve support 120.
[0236] As shown in FIGS. 11B-11H, the prosthetic valve 130 can be
sutured, riveted, glued, bonded, mechanically interlocked, or
otherwise fastened to posts 122 or commissural attachment
structures 128, which are configured to align with valve
commissures C. The posts 122 or commissural attachment structures
128 can include eyelets 129, loops, or other features formed
thereon to facilitate attachment of sutures or other fastening
means to facilitate attachment of the prosthetic valve 130. In one
embodiment, shown in FIG. 11B, the attachment structures 128 can be
integrated into the structural frame of the valve support 120 such
that the attachment structures 128 are distributed around the
circumference of the valve support 120 and function as posts 122.
In another embodiment, shown in FIG. 11D, the attachment structures
128 can be attachment pads formed on parts of the posts 122 (e.g.,
along an upper end of the posts 122). In the embodiments
illustrated in FIGS. 11E-11G, the valve support 120 includes
support bands 119 to which the attachment structures 128 are
incorporated. In one embodiment, the attachment structures 128 can
be integral with the support bands 119 (e.g., laser cut from a
single metal tube into the desired geometry, creating one or more
tubular support bands having interconnected struts with
longitudinal attachment structures). In other embodiments, the
support bands 119 can be separate component that are fastened to
the attachment structures 128. In a further embodiment, shown in
FIG. 11H, the attachment structures 128 can be separate structures
that can be coupled to posts 122, struts 124 or other components
along the interior surface 126 of the valve support 120.
[0237] As illustrated in FIG. 11C, the prosthetic valve 130 may
also be attached to the sealing member 140 or sleeve which is
attached to the interior surface 126 of the valve support 120, as
described above. Once attached, the prosthetic valve 130 can be
suitable to collapse or compress with the device 100 for loading
into a delivery catheter (not shown). In one embodiment, the
prosthetic valve 130 has a tri-leaflet configuration, although
various alternative valve configurations may be used, such as a
bi-leaflet configuration. The design of the prosthetic valve 130,
such as the selection of tri-leaflet vs. bi-leaflet configurations,
can be used to determine the suitable shape of the valve support
120. For example, for a tri-leaflet valve, the valve support 120
can have a circular cross-section, while for a bi-leaflet valve,
alternative cross-sectional shapes are possible such as oval or
D-shaped cross-sections. In particular examples, the valve support
can have a circular cross-sectional diameter of approximately 25 mm
to about 32 mm, such as 27 mm.
[0238] In some arrangements, the valve support 120 can have a
permanent prosthetic valve pre-mounted therein, or the valve
support 120 may be configured to receive a separate
catheter-delivered valve following implantation of the device 100
at the native mitral valve. In arrangements where a permanent or
replacement valve is desirable, the valve support 120 can further
include a temporary valve pre-mounted within the interior lumen. If
a period of time between placement of the device 100 and further
implantation of the permanent prosthetic valve is desirable, a
temporary valve sewn into or otherwise secured within the valve
support 120 can assure regulation of blood flow in the interim. For
example, temporary valves may be used for a period of about 15
minutes to several hours or up to a several days. Permanent or
replacement prosthetic valves may be implanted within a temporary
valve or may be implanted after the temporary valve has been
removed. Examples of pre-assembled, percutaneous prosthetic valves
include, e.g., the CoreValve ReValving.RTM. System from
Medtronic/Corevalve Inc. (Irvine, Calif., USA), or the
Edwards-Sapien.RTM. valve from Edwards Lifesciences (Irvine,
Calif., USA). If adapted to receive a separate catheter-delivered
valve, the valve support 120 may have features within its interior
lumen or on its upper or lower ends to engage and retain the
catheter-delivered valve therein, such as inwardly extending
ridges, bumps, prongs, or flaps. Additional details and embodiments
regarding the structure, delivery and attachment of prosthetic
valves, temporary valves and replacement valves suitable for use
with the prosthetic heart valve devices disclosed herein can be
found in International PCT Patent Application No.
PCT/US2012/043636, entitled "PROSTHETIC HEART VALVE DEVICES AND
ASSOCIATED SYSTEMS AND METHODS," filed Jun. 21, 2012, the entire
contents of which are incorporated herein by reference.
[0239] In some arrangements, the anchoring member 110 is defined by
a structure separate from the valve support 120. For example, the
anchoring member 110 can be a first or outer frame or skeleton and
the valve support 120 can be a second or inner frame or skeleton.
As such, the anchoring member 110 can at least partially surround
the valve support 120. In some embodiments, the downstream portion
111 of the anchoring member 110 can be coupled to the valve support
120 while the upstream portion 112 is not connected or coupled to
the valve support 120 in a manner that unduly influences the shape
of the valve support 120. For example, in some embodiments, the
upstream portion 112 of the anchoring member 110 can be configured
to engage and deform to the shape of the native tissue on or under
the annulus while the cross-sectional shape of the valve support
120 remains sufficiently stable. For example, the valve support 120
(e.g., at least at the upstream end 121) can be spaced radially
inward from the upstream portion 112 of the anchoring member 110
such that if the anchoring member 110 is deformed inwardly, at
least the upstream end 121 of the valve support 120 remains
substantially undeformed. As used herein, "substantially
undeformed" can refer to situations in which the valve support 120
is not engaged or deformed, or can refer to scenarios in which the
valve support 120 can deform slightly but the prosthetic valve 130
remains intact and competent (e.g., the leaflets 132 coapt
sufficiently to prevent retrograde blood flow). In such
arrangements, leaflets 132 of the prosthetic valve 130 can close
sufficiently even when the device 100 is under systolic pressures
or forces from the pumping action of the heart.
[0240] The longitudinal ribs 114 and/or circumferential connectors
116 can be less rigid than the posts 122 and/or struts 124 of the
valve support 120, allowing greater flexibility in the anchoring
member 110 and/or more stability to the shape and position of the
valve support 120. In some embodiments, the flexibility of the
anchoring member 110 can allow the anchoring member 110 to absorb
distorting forces as well as allow the device 100 to conform to the
irregular, non-circular shape of the native annulus (while leaving
the valve support 120 substantially unaffected), encouraging tissue
ingrowth and creating a seal to prevent leaks between the device
100 and the native tissue. In addition, the longitudinal ribs 114
and/or connectors 116 can be configured to press radially outward
against the native valve, ventricular and/or aortic structures so
as to anchor the device 100 in a desired position, as well as
maintain an upstream deployed circumference 150' larger than that
of the native annulus such that subannular positioning effectively
prevents upstream migration of the device 100 (described further
below in FIG. 14C). Furthermore, the longitudinal ribs 114 can have
sufficient resilience and column strength (e.g., axial stiffness)
to prevent longitudinal collapse or eversion of the anchoring
member 110 and/or the device 100 and to resist movement of the
device in an upstream direction.
[0241] By structurally separating the anchoring member 110 from the
valve support 120, the valve 130 and valve support 120 are
effectively mechanically isolated from the distorting forces
exerted on the anchoring member 110 by the native tissue, e.g.,
radially compressive forces exerted by the native annulus and/or
leaflets, longitudinal diastolic and systolic forces, hoop stress,
etc. For example, deformation of the anchoring member 110 by the
native tissue can change a cross-section of the anchoring member
110 (e.g., to a non-circular or non-symmetrical cross-section),
while the valve support 120 may be substantially undeformed. In one
embodiment, at least a portion of the valve support 120 can be
deformed by the radially compressive forces, for example, where the
anchoring member 110 is coupled to the valve support 120 (e.g., the
downstream end 123). However, the upstream end 121 of the valve
support 120 and/or the valve support region 145 (FIG. 11B) is
mechanically isolated from the anchoring member 110 and the
compressive forces such that at least the valve support region 145
can be substantially undeformed. Thus the valve support 120, and at
least the valve support region 145, can maintain a circular or
other desirable cross-section so that the valve remains stable
and/or competent. The flexibility of the longitudinal ribs 114 can
contribute to the absorption of the distorting forces, and also aid
in mechanically isolating the valve support 120 and valve 130 from
the anchoring member 110.
[0242] At an upstream end of the device 100 oriented toward the
left atrium, the valve support 120 can be configured to sit below,
even with, or above the uppermost terminal of the upstream portion
112 of the anchoring member 110. At a downstream end of the device
100 oriented toward and residing within the left ventricle, the
anchoring member 110 can be coupled to the valve support 120.
Alternatively, the anchoring member 110 can be coupled to the valve
support 120 anywhere along a length of the valve support 120. The
valve support 120 and anchoring member 110 may be coupled by a
variety of methods known in the art, e.g., suturing, soldering,
welding, staples, rivets or other fasteners, mechanical
interlocking, friction, interference fit, or any combination
thereof. In other embodiments, the valve support 120 and the
anchoring member 110 can be integrally formed with one another. In
yet another embodiment, a sleeve or other overlaying structure (not
shown) may be attached to both the anchoring member 110 and the
valve support 120 to interconnect the two structures.
[0243] FIGS. 12A-12C are side views of various longitudinal ribs
114 flexing in response to a distorting force F in accordance with
further embodiments of the present technology. The degree of
flexibility of individual longitudinal ribs 114 (and thus the
anchoring member 110) may be consistent among all ribs of an
anchoring member 110, or, alternatively, some ribs 114 may be more
flexible than other ribs 114 within the same anchoring member 110.
Likewise, a degree of flexibility of individual ribs 114 may be
consistent throughout an entire length of the rib 114 or the degree
of flexibility can vary along the length of each rib 114.
[0244] As shown FIGS. 12A-12C, the longitudinal ribs 114 (shown
individually as 114A-114C) may flex along their respective lengths
in response to distorting forces F that can be applied by the
surrounding tissue during or after implantation of the device 100.
In FIG. 12A, the rib 114A may flex downward to a position 75' or
upward to a position 75'' in response to an upward or downward
force F.sub.1, respectively. Similarly, in FIG. 12B, a rib 114B
with multiple distinct segments 85A, 85B, 85C may flex and/or
rotate inwardly/outwardly or side-to-side in response to a
laterally-directed force F.sub.2. The distinct segment 85A at the
end of the rib 114B may flex and/or rotate inwardly/outwardly or
side-to-side (e.g., to position 85A') in response to the laterally
directed force F.sub.2 separate from lower distinct segments 85B
and 85C. In other arrangements, the segment 85A may flex and/or
rotate (e.g., to position 85AB') with the distinct segment 85B or
with both segments 85B and 85C together (not shown). As shown in
FIG. 12C, the rib 114C having a generally linear shape when in a
relaxed state, may also flex and/or rotate inwardly/outwardly or
side-to-side (e.g., to positions 95' or 95'') in response to a
laterally-directed force F.sub.3, by bending to create a curved
shape, or in another embodiment not shown, by bending so as to
create two substantially linear segments.
[0245] Individual ribs 114 can also have a variety of shapes and be
placed in a variety of positions around a circumference of the
anchoring member 110. In some embodiments, the device 100 can
include a first and second plurality of ribs wherein the first
plurality of ribs have a characteristic different than the second
plurality of ribs. Various characteristics could include size of
the rib, rib shape, rib stiffness, extension angle and the number
of ribs within a given area of the anchoring member. In other
embodiments, the longitudinal ribs can be unevenly or evenly spaced
around an outer perimeter of the anchoring member,
[0246] The ribs 114 can be positioned around a circumference
oriented along the longitudinal axis 101 of the anchoring member
110 to create any number of overall cross-sectional geometries for
the anchoring member 110, e.g., circular, D-shaped, oval, kidney,
irregular, etc. FIG. 13A is a schematic, cross-sectional view of a
prosthetic heart valve device in accordance with another embodiment
of the present technology, and FIGS. 13B-13F are partial side views
of prosthetic heart valve devices illustrating a variety of
longitudinal rib configurations in accordance with additional
embodiments of the present technology. Referring to FIG. 13A, an
individual rib 114 can comprise a plurality of linear segments,
such as segments 85A and 85B. In the illustrated example, the rib
segment 85B is angled radially outwardly (e.g., angled away from
the longitudinal axis 101) by a first angle A.sub.1. The rib
segment 85B extends in an upstream direction from its point of
attachment to the valve support 120 at the downstream end of the
segment 85B, thereby giving the anchoring member 110 a conical or
flared shape, with a larger diameter D.sub.2 at the upstream
portion 112 and a smaller diameter D.sub.3 at the downstream
portion 111 of the anchoring member 110. In one embodiment, the
upper rib segment 85A can be angled at a steeper second angle
A.sub.2 relative to the longitudinal axis 101 than lower rib
segment 85B, resulting in a wider flared upstream portion 112A at
the upstream portion 112 of the anchoring member 110. In some
arrangements, the wider flared upstream portion 112A may enhance
sealing between the anchoring member 110 and the native tissue,
while the downstream portion 111 can provide a more rigid geometry
for resisting upstream movement of the device 100 when systolic
forces are exerted on the device 100. Alternatively, the rib 114
can be arcuate over all or a portion of its length, as shown in the
partial side view of FIG. 13B.
[0247] In yet other embodiments, as illustrated by FIGS. 13C-13F,
the rib 114 can have a more complex shape defined by multiple
distinct segments 85A, 85B, 85C, etc. For example, as shown in FIG.
13C, the rib 114 includes a linear rib segment 85C generally
parallel to the longitudinal axis 101 connected at its upstream end
to a linear and radially outwardly extending rib segment 85B, where
rib segment 85B is connected at its upstream end to a more vertical
rib segment 85A which is about parallel with the longitudinal axis
101. Referring to FIG. 13D, the rib 114 can include a linear rib
segment 85B generally parallel to longitudinal axis 101 and
connected at its upstream end to a linear and radially outwardly
extending rib segment 85A, which is generally perpendicular to
longitudinal axis 101. Referring to FIG. 13E, the rib 114 can
include a linear rib segment 85C generally parallel to the
longitudinal axis 101 and connected at its upstream end to a linear
and radially outwardly extending rib segment 85B which is generally
perpendicular to the longitudinal axis 101. The rib segment 85B can
further be connected at its most radially outward end to a vertical
rib segment 85C generally parallel with the longitudinal axis 101.
In reference to FIG. 13F, the rib 114 includes a linear segment 85D
generally parallel with the longitudinal axis 101 and connected at
its upstream end to a radially outwardly extending segment 85C
which is generally perpendicular to the longitudinal axis 101. The
rib segment 85C can further be connected at its most radially
outward end to a linear, vertical segment 85B generally parallel
with the longitudinal axis 101, and where 85B is connected at its
most radially outward end to a linear and radially inward extending
segment 85A.
[0248] In the embodiments illustrated in FIGS. 13C-13F, the ribs
114 can be coupled to the valve support 120 (e.g., coupled to posts
122) in a manner to enhance mechanical isolation of the valve
support 120. For example, the ribs 114 may be attached to the valve
support 120 near the downstream end of the ribs 114 such that a
substantial portion of each rib 114 upstream of the attachment
point is movable and deformable relative to the valve support 120,
thereby allowing the rib 120 to flex radially outward or
circumferentially back and forth relative to the valve support 120.
Additionally, one of ordinary skill in the art will recognize that
in any of the embodiments illustrated in FIGS. 13A-13F, any or all
of the rib segments may have a curvature, and any interconnections
of segments shown as angled may instead be curved. Accordingly, any
of these various geometries may be configured to allow the
anchoring member 110 to conform to the native anatomy, resist
migration of the device 100, and mechanically isolate the valve
support 120 and/or the prosthetic valve 130 contained therein from
forces exerted on the anchoring member 110 by the native
tissue.
[0249] The flexible characteristics of the individual ribs 114 can
allow for the flexibility and conformability of the anchoring
member 110 to engage and seal the device 100 against uneven and
uniquely-shaped native tissue. Additionally, the flexibility can
assist in creating a seal between the device 100 and the
surrounding anatomy. FIG. 14A is a schematic top view of a native
mitral valve MV illustrating the minor axis 50 and major axis 55,
and FIGS. 14B-14C are schematic top views of an anchoring member
110 in an expanded configuration 102 and in a deployed
configuration 104, respectively, overlaying the schematic of the
native mitral valve MV in accordance with an embodiment of the
present technology.
[0250] Referring to FIG. 14B, the upstream portion 112 (FIG. 10A)
of the anchoring member 110 can have an outer circumference 150
with a diameter D.sub.1 that is greater than the minor axis 50
(FIG. 14A) of the native annulus, and usually less than the major
axis 55 of the annulus, when the anchoring member 110 is in an
expanded configuration 102 (shown as dashed lines). In other
embodiments, the anchoring member 110 may have a diameter D.sub.1
at least as large as the distance between the native commissures C,
and may be as large as or even larger than the major axis 55 of the
native annulus. In some embodiments, the outer circumference 150 of
the anchoring member 110 has the diameter D.sub.1 which is
approximately 1.2 to 1.5 times the diameter (not shown) of the
valve support 120 (or the prosthetic valve 130), and can be as
large as 2.5 times the diameter of the valve support 120 (or the
prosthetic valve 130). While conventional valves must be
manufactured in multiple sizes to treat diseased valves of various
sizes, the valve support 120 and the prosthetic valve 130, in
accordance with aspects of the present technology, may be
manufactured in just a single diameter to fit a multitude of native
valve sizes. For example, the valve support 120 and the prosthetic
valve 130 do not need to engage and fit the native anatomy
precisely. In a specific example, the valve support 120 may have a
diameter (not shown) in the range of about 25 mm to about 32 mm for
adult human patients. Also in accordance with aspects of the
present technology, the anchoring member 110 may be provided in
multiple diameters to fit various native valve sizes, and may range
in diameter at an upstream end from about 28 mm to about 80 mm, or
in other embodiments, greater than 80 mm.
[0251] The top view of the anchoring member 110 shown in FIG. 14C
illustrates how flexibility and/or deformation of one or more
longitudinal ribs 114 and/or rib segments allows the anchoring
member 110 to distort relative to the expanded configuration 102,
as shown by the dashed lines, into a deployed configuration 104, as
shown by the bolded lines. As shown in FIG. 14C, the anchoring
member 110, when deployed or implanted at or under the mitral valve
annulus, can conform to the highly variable native mitral valve
tissue shape MV, as shown in the dotted lines, while the ribs 114
bend, twist, and stretch such that the overall shape of the
anchoring member 110 has a deployed (e.g., a generally more oval or
D-shaped, or other irregular shape) configuration 104 instead of a
fully expanded configuration 102. Referring to FIGS. 14B-14C
together, the anchoring member 110 covers the mitral valve
commissures C in the deployed configuration 104, whereas the
commissures C would be left unsealed or exposed in the more
circular expanded configuration 102, potentially allowing
paravalvular leaks. The anchoring member 110 could also be
pre-shaped to be in a generally oval or D-shape, or other shape,
when in an unbiased condition.
[0252] FIG. 15 is an isometric view of an embodiment of the
prosthetic heart valve device 100 illustrated in a deployed
configuration 104 in accordance with an embodiment of the present
technology. FIG. 15 illustrates the device 100 having a plurality
of ribs 114, wherein a first set of ribs 160 can be configured to
bend inwards or compress toward the center longitudinal axis 101 of
the device 100 and a second set of ribs 162 can be configured to
bend outwards or flex in response to an distorting forces present
in a subannular space of the native valve. As a result, the outer
circumference 150 of the anchoring member 110 may distort from a
more circular shape in the expanded configuration 102, as shown by
the dashed line, to a generally more oval or D-shape in the
expanded configuration 104, as shown by the solid line, thus
conforming to the shape of the native anatomy. In a further
arrangement, the upstream portion 112 of the anchoring member 110
may be sized slightly larger than the subannular space into which
it is deployed, such that the anchoring member 110 is compressed to
a slightly smaller diameter in its deployed configuration 104. This
may cause a slight relaxation of the sealing member 142, such that
sealing member sections between adjacent ribs 114 are sufficiently
slack to billow or curve inwards or outwards to form a slack
section Bi, as shown in FIG. 15. Such billowing can be desirable in
some arrangements because the curvature of the relaxed sleeve
segment Bi can engage and conform to the mitral leaflet tissue,
thereby enhancing a seal formed between the device 100 and the
native tissue.
[0253] As shown in FIG. 15, the unbiased, expanded configuration of
the valve support 120, which in the illustrated embodiment is
circular in cross-section, remains substantially unaffected while
the anchoring member 110 conforms to the non-circular shape of the
native mitral valve annulus MV. Accordingly, the valve support 120
is mechanically isolated from these forces and maintains its
structural shape and integrity. The mechanical isolation of the
valve support 120 from the anchoring member 110 may be attributed
to several aspects of the prosthetic heart valve device 100. For
example, the relative high flexibility of the anchoring member 110
compared with the lower flexibility of the valve support 120 allows
the anchoring member 110 to deform significantly when deployed and
when in operation (e.g., conform to the shape and motion of the
anatomy under ventricular systole forces) while the valve support
120 remains substantially undeformed (e.g., generally circular) in
these same conditions. Additionally, radial spacing between the
anchoring member 110 and the valve support 120, particularly at the
upstream portion/upstream end where the anchoring member 110
engages the native annulus and/or subannular tissue, allows the
anchoring member 110 to be deformed inwardly a substantial amount
without engaging the valve support 110. Further, the anchoring
member 110 can be coupled to the valve support 120 at a location
(e.g. the downstream portion 111 of the anchoring member 110) which
is spaced apart longitudinally a substantial distance from the
location (e.g., the upstream portion 112 of the anchoring member
110) at which the anchoring member 110 engages the native annulus,
allowing the ribs 114 of the anchoring member 110 to absorb much of
the distorting forces exerted upon it rather than transmitting
those forces directly to the valve support 120. Moreover, the
coupling mechanisms employed to attach the anchoring member 110 to
the valve support 120 can be configured (e.g., to be flexible or
moveable) so as to reduce the transmission of forces from the
anchoring member 110 to the valve support 120 (discussed in more
detail herein).
[0254] In many embodiments, the anchoring member 110 can have
sufficient flexibility such that the anchoring member 110 conforms
to the native mitral annulus when in the deployed configuration 104
(FIGS. 14C and 15); however, the anchoring member 110 can be
configured to remain biased towards its expanded configuration 102
(e.g., FIGS. 10A and 14B) such that, when in the deployed
configuration 104, the anchoring member 110 pushes radially
outwards against the native annulus, leaflets, and/or ventricular
walls just below the annulus. In some arrangements, the radial
force generated by the biased anchoring member shape may be
sufficient to deform the native anatomy such that the minor axis 50
(FIG. 14A) of the native valve is increased slightly, and/or the
shape of the annulus is otherwise altered. Such radial force can
enhance anchoring of the device 100 to resist movement toward the
atrium when the valve 130 is closed during ventricular systole as
well as movement toward the ventricle when the valve 130 is open.
Furthermore, the resulting compression fit between the anchoring
member 110 and leaflets and/or ventricular walls or other
structures helps create a long-term bond between the tissue and the
device 100 by encouraging tissue ingrowth and encapsulation.
[0255] FIGS. 16A-17C illustrate a prosthetic heart valve device 100
configured in accordance with additional embodiments of the present
disclosure. FIGS. 16A-16C include a top view and first and second
side views of a prosthetic heart valve device 100 illustrated in an
expanded configuration 102 that includes features generally similar
to the features of the prosthetic heart valve device 100 described
above with reference FIGS. 10A-15. For example, the device 100
includes the valve support 120 and the prosthetic valve 130 housed
within an interior lumen of the valve support 120. However, in the
embodiment shown in FIGS. 16A-16C, the device 100 includes an
anchoring member 210 having an oval or D-shaped upstream perimeter
213 and a plurality of elevations around a circumference 250 of the
anchoring member 210 such that the anchoring member 210 is suitable
for engaging and conforming with tissue in the subannular region of
the mitral valve.
[0256] Referring to FIGS. 16A-16C together, the device 100 can
include the flexible anchoring member 210 at least partially
surrounding and coupled to the valve support 120 at a downstream
portion 211 of the anchoring member 210. The device 100 can also
include one or more sealing members 140 extending around an inner
wall 241 of the anchoring member 210 and/or around the exterior
surface 127 or the interior surface 126 of the valve support 120 to
prevent paravalvular leaks between the device 100 and the native
tissue and/or between the anchoring member 210 and the valve
support 120. In one embodiment, the sealing member 140 can wrap
around and/or cover the upstream perimeter 213 of the anchoring
member 210. For example, the sealing member 140 can be sewn,
sutured, or adhered to a wall 241, 242 and have an extended portion
(not shown) that folds over the upstream perimeter 213. In one
embodiment, the sealing member 140 can be adhered to an opposite
wall (e.g., extend from the inner wall 241 to cover the upstream
perimeter 213 and attached to an upper portion of the outer wall
242). However, in other embodiments, the sealing member 140 can
have a longer free edge (not shown) left unattached. The free edge
of the sealing member 140 can be suitable in some arrangements to
inhibit blood flow between the upper perimeter 213 and the native
tissue.
[0257] As illustrated in FIGS. 16B-16C, the anchoring member 210
has the downstream portion 211 and an upstream portion 212 opposite
the downstream portion 111 along a longitudinal axis 201 of the
device 100. Similar to the anchoring member 110 of device 100 (FIG.
10A), the upstream portion 212 of the anchoring member 210 can be a
generally outward oriented portion of the device 100. In some
embodiments, the anchoring member 110 can include of a series of
circumferentially positioned, resiliently deformable and flexible
ribs 214 which can be in a crisscross pattern around the
circumference 250 of the anchoring member 210 to form a diamond
pattern. In one embodiment, the ribs 214 can be flexible wires or
filaments arranged in a diamond pattern or configuration. The
diamond configuration, in some embodiments, provides hoop strength
sufficient to provide a frictional attachment to the native annulus
and leaflet tissue to inhibit movement of the device 100 relative
the annulus under the force of systolic blood pressure against the
valve 130 mounted in the valve support 120. In a particular
example, the anchoring member 120 can be formed of a preshaped
Nitinol tube having, for example, a wall thickness of approximately
0.010 inches to about 0.030 inches. The diamond pattern or
configuration can, for example, include one or more rows of
diamonds, and in some embodiments, between approximately 12 and
approximately 36 columns of diamonds around the circumference 250
of the anchoring member 210.
[0258] In some embodiments, the upstream perimeter 213 of the
anchoring member 210 does not lie in a single plane. For example,
the ribs 214 can have variable lengths and/or be off-set from each
other at variable angles such that a distance (e.g., elevation)
between a downstream perimeter 215 and the upstream perimeter 213
can vary around the circumference 250. For example, the upstream
perimeter 213 can form a rim having a plurality of peaks 251 and
valleys 252 (FIG. 16B) for adapting to the shape of the native
mitral valve (see FIG. 5C). As used herein, "peaks" and "valleys"
do not refer to diamond peaks and diamond valleys of a diamond
pattern formed by the plurality of ribs 214, but refers to portions
of the upstream perimeter 213 having an undulating shape formed by
changes in elevation with respect to the downstream perimeter 215.
In one embodiment, the distance between the downstream perimeter
215 and the upstream perimeter (e.g., elevation) can vary from
about 6 mm to about 20 mm, and in another embodiment, between about
9 mm and about 12 mm.
[0259] In one embodiment, the upstream perimeter 213 of the
anchoring member 210 can have two peaks 251 that are separated by
two valleys 252. In some embodiments, a first peak can have a
different shape or elevation than that of a second peak. In other
embodiments, the shape of a valley 252 can be different than a
shape of an inverted peak 251. Accordingly, the peaks 251 and
valleys 252 can be asymmetrically positioned and shaped around the
circumference 250 of the anchoring member 210. In various
arrangements, the valleys 252 can be configured for positioning
along commissural regions of the native annulus, and the peaks 251
can be configured for positioning along leaflet regions of the
native annulus. In one embodiment, the peaks 251 can have apices
configured to be positioned near midpoint regions of the leaflets.
The anchoring member might also be circumferentially symmetric when
in the unconstrained position, but form the aforementioned "peaks
and valleys" when deployed in a non-circular annulus, so that the
more radially expanded portions, typically corresponding to the
commissures, are lower than the less expanded areas, near the
centers of the leaflets. Such an effect might be facilitated by the
specific geometry of the ribs and diamond patterns of the anchoring
member.
[0260] Referring to FIGS. 17A-17C, one specific example of the
anchoring member 210 can have a first elevation E.sub.1 between the
downstream perimeter 215 and the upstream perimeter 213 of
approximately 7 mm to about 8 mm at first and second regions 253,
254 of the anchoring member. The first and second regions 253, 254
are configured to align with the first and second commissures
(e.g., anterolateral commissure AC and posteromedial commissure PC,
FIG. 5A) of the native mitral valve. The anchoring member 210 can
also have a second elevation E.sub.2 between the downstream
perimeter 215 and the upstream perimeter 213 of approximately 9 mm
to about 11 mm at a third region 255 of the anchoring member 210,
wherein the third region 255 is configured to align with an
anterior leaflet AL (FIG. 5A) of the native mitral valve. The
anchoring member 210 can further have a third elevation E.sub.3
between the downstream perimeter 215 and the upstream perimeter 213
of approximately 12 mm to about 13 mm at a fourth region 256 of the
anchoring member 210 opposite the third region 255, wherein the
fourth region 256 is configured to align with a posterior leaflet
PL (FIG. 5A) of the native mitral valve. One of ordinary skill in
the art will recognize that the elevations E.sub.1, E.sub.2 and
E.sub.3 can have other measurements, and in some embodiments, the
elevations E.sub.1, E.sub.2 and E.sub.3 can be different from one
another or the same.
[0261] Additionally, the upstream perimeter 213 can form a rim
having a generally oval or D-shape, or other irregular shape for
adapting to the shape of the native mitral valve. For example, and
referring to FIG. 17A, the upstream perimeter 213 of the anchoring
member 210 can have a major perimeter diameter D.sub.m1 and a minor
perimeter diameter D.sub.m2 perpendicular to the major perimeter
diameter D.sub.m1. In one embodiment, the major perimeter diameter
D.sub.m1 is greater than the long axis MVA1 of the native mitral
valve (shown in FIG. 5C) when the device 100 is in the expanded
configuration 102 (FIG. 17A). In another embodiment, the major
perimeter diameter D.sub.m1 is less than the long axis MVA1 when
the device 100 is in the expanded configuration 102. In such
embodiments, the device 100 can be configured to have a major
perimeter diameter D.sub.m1 that is greater than the long axis MVA1
when the device is in the deployed configuration (e.g., when
engaging the tissue on or under the native annulus, see FIG. 16E).
Further, the minor perimeter diameter D.sub.m2 can be greater than
the short axis MVA2 of the native mitral valve (shown in FIG. 5C)
when the device 100 is in the expanded configuration 102 (FIG.
17A), or alternatively in the deployed configuration (FIG. 16E). In
one embodiment, the major perimeter diameter D.sub.m1 and/or minor
perimeter diameter D.sub.m2 can be approximately 2 mm to
approximately 22 mm, or in another embodiment, approximately 8 mm
to approximately 15 mm greater than the long axis MVA1 and/or the
short axis MVA2, respectively, of the native mitral valve. In some
embodiments, the major perimeter diameter can be approximately 45
mm to about 60 mm and the minor perimeter diameter can be
approximately 40 mm to about 55 mm.
[0262] Again referring to FIG. 16C, the upstream portion 212 of the
anchoring member 210 can be radially separated from the valve
support 120 by a gap 257. In one embodiment, the gap 257 is greater
on an anterior leaflet facing side of the device 100 (e.g., along
the third region 255) than on a posterior leaflet-facing side of
the device 100 (e.g., along the fourth region 256).
[0263] Referring back to FIGS. 16A and 16C, the valve support 120
can be oriented along the first longitudinal axis 101 and the
anchoring member 210 can be oriented along the second longitudinal
axis 201. The second longitudinal axis 201 can be off-set from the
first longitudinal axis 101. "Off-set" can refer to an arrangement
where the axes 101, 201 are parallel but separated such that the
gap 257 can vary around the circumference 250 (FIG. 16C). FIG. 16D
shows another embodiment in which "off-set" can refer to an
arrangement wherein the second axis 201 can be angled from the
first axis 101 (e.g., the first and second 101, 201 axes are
non-collinear or non-parallel) such that the anchoring member 210
is generally tilted with respect to the valve support 120. In one
embodiment, the second longitudinal axis 201 is disposed at a tilt
angle A.sub.TL between 15.degree. and 45.degree. relative to the
first longitudinal axis 101.
[0264] In additional embodiments, and as shown in more detail in
FIG. 18, the first and second regions 253 and 254 of the upstream
perimeter 213 can extend further from the longitudinal axis 201
than the third 255 and fourth regions 256. For example, the
anchoring member 210 can have a generally conical body (shown in
dotted lines) and have upstream rim extensions 258 in the first and
second regions 253 and 254. In some embodiments, the third region
255 of the upstream perimeter 213 can extend further from the
longitudinal axis 201 than the fourth region 256. In some
arrangements, the third region 255 can have a size and shape that
allows the anchoring member 210 to engage the inward facing surface
of the anterior leaflet without substantially obstructing the left
ventricular outflow tract (LVOT).
[0265] Referring to FIGS. 17A-17C together, the valve support 120
can be oriented along the longitudinal axis 101, and the upstream
portion 212 of the anchoring member 210 can flare outward from the
longitudinal axis 101 by a taper angle A.sub.T. In embodiments
where the ribs 214 are generally curved outward from the downstream
portion 211 to the upstream portion 212 (rather than linear), the
taper angle A.sub.T can continuously change between the downstream
portion and the upstream portion. In some embodiments, the taper
angle A.sub.T can be the same around the circumference 250 of the
upstream portion 212 of the anchoring member 210; however, in other
embodiments, the taper angle A.sub.T can vary around the
circumference 250. For example, the anchoring member 210 can have a
first taper angle A.sub.T1 at the first and second regions 253 and
254 (FIG. 17B) which can be configured to align with the
anterolateral commissure AC and posteromedial commissure PC (see
FIG. 5C), respectively. The anchoring member 210 can further have a
second taper angle A.sub.T2 at the third region 255 which can be
configured to align with the anterior leaflet, and a third taper
angle A.sub.T3 at the fourth region 256 which can be configured to
align with the posterior leaflet (FIG. 17C). In one embodiment, the
taper angle can be approximately 30.degree. to about 75.degree.,
and in another embodiment, between approximately 40.degree. and
about 60.degree..
[0266] One important aspect of having asymmetric rib lengths for
the anchoring members is that different lengths might mean that one
side or segment of the anchoring member is exposed from the
delivery system before the others, allowing the physician deploying
the device to optimize the orientation of the device prior to full
deployment.
[0267] These variations in shaping of the anchoring member can
serve several functions. One is to ensure a better fit with the
native valve annulus. Another is to optimize the bending load on
each rib and section of the anchoring member in the deployed
position, in part to minimize long-term fatigue stresses on the
ribs. A third reason is to ensure that the anchoring member, when
deployed in the mitral annulus, does not impart asymmetric forces
on the valve support member. A fifth is to reduce the force of the
deployed device against the anterior leaflet, so the leaflet isn't
excessively displaced towards the aortic valve. By making sure that
the middle of the anterior leaflet is less radially expanded, the
radius of curvature of the circumference of the anchoring member
will be higher in that area, and per Laplace's law, the radial
force of that area will be lower.
[0268] FIG. 16E is a schematic top view of a native mitral valve in
the heart viewed from the left atrium and showing the prosthetic
treatment device 100 of FIG. 16A-16C implanted at the native mitral
valve MV in accordance with an embodiment of the present
technology. Once deployed, and as illustrated in FIG. 16E, at least
a portion of the upstream ends of the ribs 214 (shown in FIGS.
16B-16C) engage a subannular surface of the native valve (e.g.,
mitral valve). As described in more detail below, certain
embodiments of ribs 114 or 214 are configured to penetrate
subannular tissue to anchor and further stabilize the devices
100.
[0269] Although the anchoring member 210 is deformable in response
to distorting forces exerted by the native anatomy, the valve
support 120 can have sufficient rigidity to maintain a circular or
other original cross-sectional shape, thus ensuring proper
functioning of the prosthetic valve leaflets 132 when opening and
closing. Such mechanical isolation from the anchoring member 210
may be achieved by the valve support 120 having sufficient rigidity
to resist deformation while anchoring member 210 is deformed, and
by selecting a location and means for coupling the valve support
120 to the anchoring member 210 so as to mitigate the transmission
of forces through the anchoring member 210 to the valve support 120
or the prosthetic valve 130 contained therein. For example, the
valve support 120 may be coupled to the anchoring member 210 only
at the downstream end 123 of the valve support 120, which is
separated from the upstream end 121 where the anchoring member 210
engages the annulus. On the upstream end 121, the valve support 120
may be completely unconnected to and spaced radially apart from the
anchoring member 210 by the gap 257 to allow deformation of the
anchoring member 210 without impacting the shape of valve support
120 (see FIGS. 16A-16C where the prosthetic valve 130 is located).
Thus, forces exerted on the anchoring member 210 by the annulus can
be absorbed by the flexible ribs 214 of the anchoring member 210 to
mitigate transmission of such forces to the downstream end 123 of
valve support 120.
[0270] In some embodiments, it may be desirable to limit a distance
the device 100 extends downstream of the annulus into the left
ventricle (e.g., to limit obstruction of the left ventricle outflow
tract (LVOT)). Accordingly, some embodiments of the device 100 can
include anchoring members 210 having a relatively low overall
elevation (e.g., elevations E.sub.1, E.sub.2 and E.sub.3, FIGS.
17B-17C), such that the anchoring member 210 does not extend into
or obstruct the LVOT. As shown in the side view of FIG. 16B, for
example, the anchoring member 110 can have a low overall elevation
E.sub.L (e.g., the distance between the upstream perimeter 213 and
the downstream perimeter 215 of the anchoring member 210) with
respect to a height H.sub.V of the valve support 120. In such
embodiments, the upstream perimeter 213 of the anchoring member 110
may be just below, adjacent to, or positioned within the annulus of
the native mitral valve while the downstream perimeter 215 of the
anchoring member 210 is configured to extend minimally into the
left ventricle below the native mitral valve annulus when the
device 100 is implanted. In some arrangements, the valve support
120 can be coupled to anchoring member 210 so as to also minimize
protrusion into the left ventricle, and in some embodiments, may
extend upwardly through the plane of the native annulus into the
left atrium.
Additional Components and Features Suitable for Use with the
Prosthetic Heart Valve Devices
[0271] Additional components and features that are suitable for use
with the prosthetic heart valve devices (e.g., devices 100
described above) are described herein. It will be recognized by one
of ordinary skill in the art that while certain components and
features are described with respect to a particular device (e.g.,
device 100), the components and features can also be suitable for
use with or incorporated with other devices as described further
herein.
[0272] As discussed above with respect to FIG. 10A, some
embodiments of the prosthetic heart valve device 100 can include a
sealing member 140 that extends around portions of the anchoring
member 110 and/or the valve support 120. For example, the
embodiment illustrated in FIG. 10A has a sealing member 140 around
the inner wall 141 of the anchoring member 110 and around an
exterior surface 127 of the valve support 120 to prevent
paravalvular leaks both between the device 100 and the anatomy but
also through components of the device 100.
[0273] FIGS. 19A-19C are isometric, side and top views,
respectively, of a prosthetic heart valve device 100 having a
sealing member 140 in accordance with a further embodiment of the
present technology. Referring to FIGS. 19A-19C together, the device
100 includes a sealing member 140, such as a skirt 144. The skirt
144 can be disposed on the outer wall 142 or disposed on the inner
wall 141 and at least partially over the upstream perimeter 113 of
the anchoring member 110. Accordingly, the skirt 144 can be fixed
and/or coupled to any surface of the anchoring member 110. The
skirt 144 can also overlay an interior surface 126 (shown in FIG.
19A) and/or exterior surface 127 of the valve support 120.
Variations of the skirt 144 and/or other sealing members 140 can be
configured to (1) create a blood flow-inhibiting seal between the
anchoring member 110 and the native tissue, (2) block blood flow
through the walls 141, 142 of the anchoring member 110 and/or
through the surfaces 126, 127 of the valve support 120, and (3)
block blood flow through the space between the valve support 120
and the anchoring member 110. In some embodiments, the sealing
member 140 can be configured to promote in-growth of adjacent
tissue. The sealing member 140 can help to seal between the
anchoring member 110 and the valve support 120, as well as between
the device 100 and the surrounding anatomy such that blood flow is
restricted to flowing through the prosthetic valve 130 from the
left atrium to the left ventricle. Additionally, the sealing member
140 can provide circumferential support for the anchoring member
110 when in the expanded configuration 102 (FIGS. 10A, 16A and 19A)
or deployed configuration 104 (FIGS. 10B and 16B). In some
embodiments, the sealing member 140 may further serve to attach the
anchoring member 110 to the valve support 120. For example, the
skirt 144 can be coupled to the inner wall 141 of the anchoring
member 110 and integrally formed with or otherwise attached to the
sealing member 140 that is coupled to the valve support 120. In
other embodiments, the sealing member 140 can be used to couple the
valve support 120 to the prosthetic valve 130 housed in the
interior of the valve support 120. Sealing members 140, such as
skirts 144, can be coupled to the anchoring member 110 and/or valve
support 120 with sutures, rivets or other known mechanical
fasteners. In other embodiments, adhesives, glues and other bonding
materials can be used to couple the sealing members to components
of the device 100.
[0274] FIG. 20A is an isometric view of a prosthetic heart valve
device 100 without a sealing member 140, and FIGS. 20B-20E are
isometric views of prosthetic heart valve devices 100 having
sealing members 140 in accordance with additional embodiments of
the present technology. For example, FIGS. 20B-20C show embodiments
of the device 100 in which the sealing member 140 is a sleeve 146.
The sleeve 146 can include an impermeable sealing material that is
cylindrical and configured to fit within or over various frame or
skeleton structures of the device 100 as further described below.
In FIG. 20B the sleeve 146 is on the exterior surface 127 of the
valve support 120, whereas in FIG. 20C, the sleeve 146 is also
disposed on the inner wall 141 of the anchoring member 110 and on
the exterior surface 127 of the valve support 120. FIG. 20D
illustrates an embodiment of the device 100 in which the sleeve 146
is disposed on the outer wall 142 of the anchoring member 110 and
on the exterior surface 127 of the valve support 120. Referring to
FIG. 20E, the device 100 can also incorporate the sleeve 146 on
both the outer wall 142 and inner wall 141 of the anchoring member
110 as well as on the exterior surface 127 of the valve support
120.
[0275] One of ordinary skill in the art will recognize that the
sealing members 140, such as the skirts 144 and sleeves 146 shown
in FIGS. 19A-20E, can fully cover the walls 141, 142 or surfaces
126,127, or in other embodiments, at least partially cover the
walls 141, 142, and/or the surfaces 126, 127 of the anchoring
member 110 and the valve support 120, respectively. Any combination
of sealing members 140 is contemplated. Additionally, the sealing
member 140 can comprise a single continuous sheet of fluid
impervious material (e.g., for covering the inner surface 141 of
the anchoring member 110 and the exterior surface 127 of the valve
support 120), which could create a seal between the anchoring
member 110 and the valve support 120. In various embodiments, the
sealing member 140, such as the skirt 144 or sleeve 146, can
comprise a fabric or other flexible and biocompatible material such
as Dacron.RTM., ePTFE, bovine pericardium, or other suitable
flexible material to integrate with tissue and minimize
paravalvular leaks. In other embodiments, the sealing member 140
can include a polymer, thermoplastic polymer, polyester,
Gore-tex.RTM., a synthetic fiber, a natural fiber or polyethylene
terephthalate (PET). The valve 130 may also be attached to the
sealing member 140 or integrally formed with the sealing member
140.
[0276] In a further embodiment, shown in FIGS. 21A-21F, the valve
support 120 may comprise a tubular member 148 of fabric, polymer,
or pericardium with little or no metallic or other structural
support. Referring to FIGS. 21A-21B, the tubular member 148 may be
a thicker and more rigid portion of a sleeve 146 which is capable
of retaining its shape and has sufficient strength to resist radial
and axially tensile forces during systole, and axial compressive
forces during diastole. The leaflets 132 of the prosthetic valve
130 may be integrally formed with, sewn or otherwise attached to
the tubular member 148. In one embodiment, the tubular member 148
can be integrally formed with an outer portion 146A of the sleeve
146 that extends around the anchoring member 110 (shown in FIG.
21A), or in another embodiment, the tubular member 148 can be a
separate and/or thicker member which is sewn, bonded, or otherwise
fastened to the sleeve 146 in a blood-tight manner. The tubular
member 148 can optionally include reinforcing members to give it
greater strength and to help it retain a desirable shape suitable
for operating the valve 130. For example, a series of relatively
stiff longitudinal struts 190 of metal or polymer can be coupled to
or embedded within the walls of tubular member 148 (FIG. 21C),
and/or a wire coil 192 may extend around or be embedded within
walls of the tubular member 148 (FIG. 21D). In a further
embodiment, a series of tethers 194 can be coupled between the
outer portion 146A of the sleeve 146 and tubular member 148 (FIG.
21E). In one arrangement, the tethers 194 can extend at a
downstream angle from the upstream portion 112 of the anchoring
member 110 so as to inhibit collapse or structural compromise of
the tubular member 148 during atrial systole. In yet another
embodiment, a plurality of vertical septa 196 may be interconnected
between the anchoring member 110 (and/or a sealing member 140
coupled to the inner wall 141 of the anchoring member 110) and the
tubular member 148 (FIG. 21F). The plurality of vertical septa 196
coupled between the anchoring member 110 and the valve support 120
can be a flexible fabric or polymer, and in some embodiments, can
be the same material used for the sleeve 146. The septa 196, which
can be collapsed with the anchoring member 110 to a low profile
delivery configuration (not shown) can also constrain the outward
deflection of the ribs 114 when the device 100 is in the expanded
configuration 102.
[0277] As described herein, the anchoring member 110 can be a
structure or component separate from the valve support 120. In one
embodiment, the anchoring member 110 can be coupled to the valve
support 120 at, for example, a downstream end 123 of the valve
support 120, while the upstream portion of the anchoring member 110
can remain uncoupled to the valve support 120 and/or other
otherwise be mechanically isolated from the valve support 120. The
anchoring member 110 can be coupled to the valve support 120 using
a variety of mechanisms, including flexible, or non-rigid, coupling
mechanisms. FIGS. 22A-22G and 22I-22K are enlarged side views of
various mechanisms of coupling the valve support 120 to the
anchoring member 110 that allow relative movement between the
downstream portions or the anchoring member 110 and the valve
support 120 or otherwise provide mechanical isolation of the valve
support 120 from the anchoring member 110 in accordance with
additional embodiments of the present technology.
[0278] FIGS. 22A-22B illustrate a downstream end 326 of a rib 114
of the anchoring member 110 coupled to a post 122 of the valve
support 120. In a first embodiment, the rib 114 can be coupled to
the post 122 by a suture, wire or other suitable filament 310 which
is wrapped around the adjacent elements and tied (FIG. 22B). In
some embodiments, either or both the rib 114 and the post 122 may
have a feature to which the filament 310 may be secured, such as a
through-hole 312 (FIG. 22C), a loop or eyelet 314 (FIG. 22D), or a
groove 316 configured to retain the filament 310 therein and
inhibit sliding along the rib 114 or post 122.
[0279] In another embodiment shown in FIG. 22F, the rib 114 can be
coupled to the post 122 by a rivet, screw, pin, or other fastener
318 which passes through aligned holes 319 in the rib 114 and the
post 122. Alternatively, and as shown in FIGS. 22G-22H, the post
122 may have a cavity 320 in its outer wall configured to receive a
downstream end 326 of rib 144, and the two elements 114, 122 can be
fastened together by a filament or fastener 322. In this
arrangement, a substantial portion of the systolic force exerted on
the valve support 110 can be translated directly to the rib 114
because the downstream end of the rib 114 engages the floor of the
cavity 320, thereby relieving the suture or fastener 322 from
having to resist such force.
[0280] In further embodiments shown in FIGS. 22I-22J, a downstream
end 326 of the rib 114 passes through a passage 324 formed through
the post 122. The downstream end 326 is then secured to post 122 by
a fastener 328 or a filament like those described above.
Additionally, because the rib 114 is held within the passage 324,
the systolic loads exerted on the valve support 120 can be
translated directly to the ribs 114 rather than to the fastener
328. In yet another embodiment shown in FIG. 22K, a downstream end
330 of the post 122 is formed radially outward in a hook or
J-shape, forming a channel 332 in which a downstream end 326 of the
rib 114 can be received. The ends 330, 326 of the two elements may
be secured by a fastener 334 passing through holes 319 in the rib
114 and the post 122. Systolic loads applied to the post 122 can be
translated directly to the rib 114 via channel 332, relieving
fastener 334 from bearing a substantial portion of the load.
[0281] FIGS. 23A-23B illustrate further embodiments of mechanisms
suitable for coupling the anchoring member 110 to the valve support
120. In the embodiments shown in FIGS. 23A-23B, circumferential
connectors 116 of the anchoring member 110 are coupled to the
struts 124 of the valve support 120. For example, in FIG. 23A, the
connectors 116 are formed so as to have an hourglass-shaped portion
336 forming a waist 338 and an enlarged connector head 340 forming
a connector cell 341. Struts 124 similarly have an enlarged strut
head 346 forming a strut cell 347. The hourglass portion 336 of the
connector 116 can be configured to pass through the strut cell 347
such that the strut head 346 extends around the waist 338 of the
connector 116. The connector head 340 can be sufficiently large
that it is prevented from being released from the strut cell 347.
Further, due to the diverging angles of connector segments 116A,
116B, the strut head 346 can be prevented from sliding upward
relative to the connector head 340. In such arrangements, systolic
loads exerted in the upward direction on the valve support 120 can
be translated through the struts 124 to the connectors 116, which
in turn translate these forces to the ribs 114 which are driven
into the native anatomy to anchor the device 100 in place.
[0282] In FIG. 23B, the connectors 116 can be formed so as to have
a loop portion 348 extending downwardly which is nested in a
concave portion 350 formed in the strut 124. The loop portion 348
can be fastened to the concave portion 350 in various ways, e.g. by
a suture 352 wrapped around each member 348, 350. In this
arrangement, systolic loads applied to valve support 120 in the
upstream direction can be transferred through the concave portion
350 to loop portions 348 of the anchoring member 110.
[0283] In other embodiments, the anchoring member 110, or selected
components thereof, can be integrally formed with the valve support
120. As shown in FIG. 24A, the ribs 114 of the anchoring member 110
can be integrally formed with posts 122 of the valve support 120
with a U-shaped bridge member 356 interconnecting each rib 114 to
respectively aligned posts 122. The ribs 114 may be
circumferentially interconnected by expandable connectors 116
formed integrally therewith. Alternatively, in the embodiment shown
in FIG. 24A, a plurality of separate bands or wires 358 extend
around the circumference 150 of the anchoring member 110 and are
each slideably coupled to the ribs 114, e.g. by extending through a
hole 360 formed in each individual rib 114. The flexible bands or
wires 358 permit ribs 114 to be collapsed inwardly to a low-profile
delivery configuration (not shown), while limiting the outward
deflection of the ribs 114 when in the expanded configuration 102.
Alternatively, a tether 361 of wire or suture may be coupled
between the individual ribs 114 and the posts 122 (shown in FIG.
24B) to limit the outward deflection of the ribs 114 when in the
expanded configuration 102.
[0284] In further embodiments, a sleeve 146 may be secured to the
ribs 114 in a manner which limits the outward deflection of the
ribs 114 when the device 100 is in the expanded configuration
(shown in FIG. 24C). The sleeve 146 may, for example, extend around
the outer side of each rib 114 as shown in FIG. 24C to constrain it
from expanding outwardly beyond a predetermined limit Optionally,
the sleeve 146 may further include a horizontal septum 359
extending between an inner portion 146B of the sleeve 146 that
extends around the valve support 120 and an outer portion 146A of
the sleeve 146 that extends around the anchoring member 110. The
horizontal septum 359 can more rigidly constrain the outward
flexion of the ribs 114. In some embodiments, the septum 359 can
also seal the annular cavity 163 formed by the septum 359 between
the inner portion 146B and the outer portion 146A to limit blood
flow into this cavity 163 and minimizing clot formation therein.
Alternatively, openings (not shown) may be formed in the sleeve 146
downstream of the septum 359 which can permit blood to flow into
the enclosed cavity 163 to form a region of clot, thereby limiting
the deflection of the ribs 114 and making the device more rigid and
securely anchored. The septum 359, which can be a flexible fabric,
polymeric, or pericardial material, can be located at the upstream
end of the device 100 as shown, or at a location spaced further
downstream from the upstream end 121 of the valve support 120. In a
further embodiment shown in FIG. 24D, each individual rib 114 can
be constrained within a passage 364 formed in the sleeve 146 by
suturing or bonding two layers of sleeve fabric together. In the
expanded configuration 102, the movement of the ribs 114 can be
limited relative to the sleeve 146.
[0285] FIG. 25A is a partial cross-sectional view of a prosthetic
heart valve device 100 having an anchoring member 110 and a valve
support 120, and FIG. 25B is an enlarged view of the designated box
shown in FIG. 25A in accordance with an embodiment of the present
technology. As shown in FIGS. 25A and 25B, there can be a gap 108
between the valve support 120 and lower portion 111 of the
anchoring member 110. If the gap 108 exists, the gap 108 can be
protected by a sleeve 146 to prevent blood from leaking between the
anchoring member 110 and the valve support 120 in either an
upstream or downstream direction.
[0286] FIGS. 26A-26D are schematic cross-sectional views of
prosthetic heart valve devices 100 having atrial retainers 410 and
implanted at a native mitral valve MV in accordance with various
embodiments of the present technology. FIGS. 26A-26C show several
embodiments of the device 100 in which the device 100 includes an
atrial retainer 410 configured to engage a supra-annular surface of
the annulus AN or other tissue within the left atrium to assist the
native leaflets in preventing downstream migration of the device
100 into the left ventricle. In these arrangements, the annulus AN
can be sandwiched between a top circumference 150 of the anchoring
member 110 and a bottom surface of the atrial retainer 410.
[0287] As shown in FIG. 26A, one embodiment of the device 100 can
include the atrial retainer 410 coupled to or integrally formed
with the inner valve support 120. The atrial retainer 410 can
extend upstream through the annulus AN and into a supra-annular
space within the atrium and engage the supra-annular surface or
other atrial tissue with an outwardly extending flange 420. In
another embodiment shown in FIG. 26B, the atrial retainer 410 can
comprise a plurality of fingers 412 which may be formed integrally
with or otherwise coupled to the valve support 120 (e.g. comprising
upward extensions of posts 122 or upward extensions of the
anchoring member 110). The fingers 212 can be generally uncovered
or exposed within the left atrium as illustrated in FIG. 26B;
however, in another embodiment, the fingers 412 can be covered with
a sealing member (not shown) or other covering of fabric, polymeric
sheet, or pericardial tissue extending around the outside or inside
surfaces of the fingers 412 to form a conical shape to help seal
the device 100 with the native tissue on the atrial side of the
annulus AN and to help funnel blood into the prosthetic valve 130
(FIG. 10A). The fingers 412 may also include circumferential struts
(not shown) interconnecting the fingers 412 to limit lateral
deflection and enhance the stiffness of the fingers. The fingers
412 can include a resilient shape memory material (e.g., Nitinol)
such that the fingers can be straightened and deflected inwardly
for delivery and be released to an unbiased, radially projecting
outward position in the expanded configuration 102 as shown. For
example, the fingers 412 can have finger tips 414 biased outwardly
and, in some arrangements, in the downstream direction in the
expanded configuration 102. During delivery to a desired position
within the native mitral valve MV, the device 100 can be unsheathed
in the distal or downstream direction (discussed in more detail
below), such that the fingers 412 are first released to engage the
atrial side of the valve annulus AN. This indexes the position of
the device 100 relative to the native valve to ensure that the
anchoring member 110 is positioned on the ventricular side of the
native annulus AN but not overextended into the ventricle when it
is unsheathed and expanded.
[0288] The atrial retainer 410 may alternatively be an extension of
the anchoring member 110. In one embodiment shown in FIG. 26C, the
atrial retainer 410 can include a plurality of atrial loops 416,
which, although depicted in a more vertical plane, may
alternatively lie in a plane more parallel to the plane of the
native annulus AN, and which extend upstream through the annulus
AN, then extend radially outwardly to engage a supra-annular
surface. The loops 416, which may comprise extensions of one or
more ribs 114 of the anchoring member 110, can include a resilient
shape-memory metal (e.g., Nitinol) or other material that may be
compressed into a low profile shape for delivery then released to
expand to the radially-extended configuration shown in FIG. 26C.
Similar to the device 100 of FIG. 26C, FIG. 26D is also a
cross-sectional view of a prosthetic heart valve device 100 that
includes an atrial retainer 410 formed by an extension of the
anchoring member 110. As shown in FIG. 26D, the atrial retainer 410
can include a cylindrical portion 418 which extends upwardly from
the anchoring member 110 through the native annulus AN, with a
flange 420 at the proximal region which extends over the atrial
side of the native annulus AN to engage the supra-annular surface.
The flange 420 can include a resilient shape memory material (e.g.,
Nitinol) that can be collapsed for delivery and expand when
deployed at the native mitral valve MV. The cylindrical portion 418
and flange 420 may be integrally formed with the anchoring member
110, e.g. comprised of extensions of the ribs 114, or in another
embodiment, can be coupled to one or more portions of the anchoring
member 110 and/or the valve support 120.
[0289] In other embodiments, the prosthetic heart valve device 100
can include atrial extending features that assist in retaining the
device 100 in a desired location within the native mitral valve,
but do not substantially engage atrial or supra-annular tissue. For
example, FIG. 27 is a side view of an anchoring member 110 having a
vertical portion 422 at the upstream end 424 for engaging the
annulus AN in accordance with another embodiment of the present
technology. The anchoring member 110 can include the lower portion
111 and the upper flared portion 112 which is positionable in a
subannular location between the leaflets LF and downstream of the
annulus AN. The upstream portion 112 can be expandable to a
dimension that is larger than a corresponding dimension of the
subannular tissue and/or inward facing leaflets LF. The vertical
portion 422 can be fitted within the annulus orifice so as to
engage the annulus AN around an entire upstream circumference 150
of the anchoring member 110. The vertical portion 422 can be
expandable to a dimension that is larger than a corresponding
dimension of the annulus AN such that radial expansion of the
vertical portion 422 presses outwardly against the native tissue to
assist retaining the device in the desired location with the native
mitral valve. Optionally, the anchoring member 110 can also include
a plurality of tissue engaging elements 170, such as spikes. In one
embodiment, the spikes (shown here as tissue engaging elements 170)
can be distributed around the circumference 150 of the upper
portion 112 of the anchoring member 110 and oriented such that the
spikes can penetrate tissue in a subannular location and can be
configured to help the anchoring member 110 resist movement in
either an upstream or downstream direction.
Prosthetic Heart Valve Devices Having Stabilizing Members
[0290] FIG. 28 illustrates one embodiment of the prosthetic heart
valve device 100 in an expanded configuration 102 that further
comprises one or more stabilizing members 501 to help stabilize the
device 100 at the native valve site and, in some embodiments,
prevent tilting or lateral migration, or to inhibit upstream or
downstream migration of the device 100. In some embodiments, the
stabilizing members 501 may comprise one or more arms 510 extending
from a lower or downstream portion 111 of the anchoring member 110.
The arms 510 are configured to engage the native tissue, e.g. the
valve leaflets, subannular tissue, or ventricular wall, either
inside or outside the native leaflets, depending on the
configuration.
[0291] FIG. 29 is an enlarged schematic, side view of a prosthetic
heart valve device having an extended arm in accordance with an
embodiment of the present technology. As shown in FIG. 29, an
individual arm 510 may comprise an arm body 512, an arm extension
514, and an arm tip 516. The arm body 512 has an arm body length
L.sub.1 and may connect to a post 511 at a first joint 508. The
post 511 can be a valve support post 122, an anchoring member rib
114, and/or another feature of the device 100 (e.g., strut 124 or
connector 116). A first arm angle A.sub.A1 is formed by the
intersection of the axes of post 511 and the arm body 512; the
first arm angle A.sub.A1 selected such that the arm 512 is
positionable so that the tip 516 can engage the native tissue at a
desired location, e.g. the subannular tissue or ventricular wall
behind the native leaflets. FIGS. 30A-30C are enlarged partial side
views of a prosthetic heart valve device 100 having arms 510
coupled to the device at various angles with respect to a
longitudinal axis 101 of the device in accordance with further
embodiments of the present technology. In one embodiment, the first
arm angle A.sub.A1 can be about 10.degree. to about 45.degree.. In
other embodiments, the first arm angle A.sub.A1 can be an obtuse
angle (FIG. 30A), generally perpendicular or approximately a
90.degree. angle (FIG. 30B), or an acute angle (FIG. 30C).
[0292] Referring back to FIG. 29, the arm body 512 can connect to
the arm extension 514 at a distal end of the arm body 512. The arm
extension 514 can have an arm extension length L.sub.2 which can be
selected or optimized for penetrating a desired distance into the
native tissue, such as about 0.5-2 mm. The arm extension 514 can
extend from the arm body 212 at second arm angle A.sub.A2. The
second arm angle A.sub.A2 can be formed by the intersection between
the arm extension 514 and arm body 512 and be selected to provide
the desired angle of engagement with the native tissue, such as
about 100.degree. to about 135.degree.. In other embodiments, the
arm extension 514 may be parallel or collinear with the arm body
512 (not shown), or may be eliminated entirely. The arm extension
514 terminates at the arm tip 516. In embodiments without an arm
extension 514, the arm tip 516 can be the most distal portion of
the arm body 512 (not shown).
[0293] The arm 510 may have an arm height H.sub.A1 extending from
the first joint 508 to the most distal reaching point of the arm,
which could be the arm tip 516 (shown in FIG. 29) along an axis
parallel to the longitudinal axis 101 of the device 100. The arm
height H.sub.A1 can be selected or optimized such that the arm tip
516 engages a desired location in the subannular anatomy when the
device 100 is in a desired longitudinal position relative to the
native mitral valve (e.g., when the anchoring member 110 is in
engagement with the subannular tissue). The arm height H.sub.A1
will depend upon of the overall height of the anchoring member 110
and/or valve support 120 as well as the location of the joint 508.
FIGS. 31A-31C are enlarged, partial side views of prosthetic heart
valve devices having arms 510 of various lengths (L.sub.1+L.sub.2),
and accordingly having variable heights H.sub.A1. As shown, the arm
height H.sub.A1 may be greater than the overall height H.sub.D1 of
the anchoring member 110 (represented by rib 114) or valve support
(FIG. 31A), be intermediate between the respective heights
H.sub.D1, H.sub.V1 of the anchoring member 110 (represented by rib
114) and the valve support 120 (represented by post 122) (FIG.
31B), or be less than the overall height H.sub.D1 of both the
anchoring member 110 (represented by rib 114) and the valve support
120 (FIG. 31C).
[0294] Additional details and embodiments regarding the structure
and attachment of arms or other stabilizing members suitable for
use with the device 100 can be found in International PCT Patent
Application No. PCT/US2012/043636, entitled "PROSTHETIC HEART VALVE
DEVICES AND ASSOCIATED SYSTEMS AND METHODS," filed Jun. 21, 2012,
the entire contents of which are incorporated herein by
reference.
[0295] FIGS. 32A, 32B, 32C, and 32D are cross-sectional views of a
heart with an implanted prosthetic heart valve device 100 having
arms 510a disposed on an inward-facing surface of the leaflets LF,
and FIGS. 32A-1, 32B-1, 32C-1 and 32D-1 are enlarged views of the
arms 510a engaging the inward-facing surface of the leaflets as
shown in FIGS. 32A, 32B, 32C and 32D, respectively. The embodiments
of prosthetic heart valve devices 100 illustrated in FIGS.
32A-32D-1 have arms 510a configured to expand to a position
radially inside the leaflets LF, radially outside the leaflets LF,
or a combination of inside and outside the leaflets LF. For
example, FIGS. 32A and 32A-1, show arms 510a expanding and engaging
an inward surface of the leaflets LF and show the arms 510a
partially piercing the leaflets LF. In another example illustrated
in FIGS. 32B and 32B-1, the arms 510a may fully penetrate the
leaflets LF. In a further example, the device 100 can incorporate
arms 510a that 1) completely penetrate the leaflets LF and 2)
partially pierce subannular tissue (FIGS. 32C and 32C-1). Referring
to FIGS. 32D and 32D-1, the device 100 can be configured to
incorporate arms 510a that fully penetrate both the leaflets LF and
the annular tissue of the mitral valve MV.
[0296] FIGS. 33A-33C are schematic views illustrating various
embodiments of tissue engaging elements 170 for use with prosthetic
heart valve devices 100 in accordance with the present technology.
Tissue engaging elements 170 can include any feature that engaged
tissue in an atraumatic manner, such as a blunt element, or which
partially pierces or fully penetrates cardiac tissue, such as a
barb or spike. As used herein, "tissue engaging" refers to an
element 170 which exerts a force on the tissue T but does not
necessarily pierce the tissue T, such as being atraumatic to the
tissue T, as shown in FIG. 33A. As used herein, "partially
piercing" refers to a tissue engaging feature 170 which at least
partially penetrates the tissue T but does not break through an
opposite surface S, as shown in FIG. 33B. As used herein, "fully
piercing" refers to a tissue engaging feature 170 which can both
enter and exit the tissue T, as shown in FIG. 33C. "Piercing" alone
may refer to either partial or full piercing. Tissue engaging
elements 170 may take the form of spikes, barbs, or any structure
known in art capable of piercing cardiac tissue, or alternatively,
any blunt or atraumatic feature configured to apply pressure on the
cardiac tissue without piercing the tissue. Further details on
positioning of such elements is described herein.
[0297] FIGS. 34A, 34B and 34C are cross-sectional views of a heart
with an implanted prosthetic heart valve device 100 having arms
510a with tissue engaging elements 170 disposed on an inward-facing
surface of the leaflets LF, and FIGS. 34A-1, 34B-1 and 34C-1 are
enlarged views of the arms 510a engaging the inward-facing surface
of the leaflets LF as shown in FIGS. 34A, 34B and 34C,
respectively. As illustrated in FIGS. 34A-34C-1, tissue engaging
elements 170 can be incorporated on and extend from the arms 510a
in either a downstream direction (FIGS. 34A and 34A-1), upstream
direction (FIGS. 34B and 34B-1), or in both the downstream and
upstream directions (FIGS. 34C and 34C-1). In other embodiments,
the tissue engaging elements 170 can be incorporated on and extend
from the components of the anchoring member 110 and/or the valve
support 120 in either or both the upstream and downstream
directions.
[0298] FIGS. 35A-35C are side views showing prosthetic heart valve
devices 100 implanted at a mitral valve MV (illustrated in
cross-section) in a deployed configuration 104, wherein the devices
have arms 510b for engaging an outward-facing surface of the native
leaflets LF in accordance with various embodiments of the present
technology. FIG. 35A shows an embodiment of the device 100 that
includes arms 510b configured to extend from the downstream end of
the device 100 (e.g., the ventricular end of a device implanted at
a native mitral valve downstream of the leaflets) to reach behind
the leaflets LF such that the leaflets LF are effectively
sandwiched between the arms 510b and the outer wall 142 of the
anchoring member 110. In another embodiment, and as shown in FIG.
35B, the arms 510b may cause leaflets LF to fold upon themselves in
the space between the arms 510b and the outer wall 142 of the
anchoring member 110. In a further embodiment illustrated in FIG.
35C, the arms 510b can also include the tissue engaging elements
170. FIG. 35C-1 is an enlarged view of the arm 510b having tissue
engaging elements 170 for engaging the outward-facing surface of
the leaflets LF as shown in FIG. 35C. As shown in FIG. 35C-1, the
arms 510b configured to engage an outside-facing surface of the
native leaflets LF may include tissue engaging elements 170 on an
inside surface of the arms 510b such that they are oriented toward
the leaflet tissue.
[0299] In accordance with another embodiment of the present
technology, FIG. 36A is a side view showing a prosthetic heart
valve device 100 implanted at a mitral valve MV (illustrated in
cross-section). The device shown in FIG. 36A has arms 510b for
engaging an outward-facing surface of the native leaflets LF and
arms 510a for engaging an inward-facing surface of the native
leaflets LF. Inside/outside arms 510a, 510b may further comprise
tissue engaging elements 170 on a radially inside surface or
radially outside surface of the arms 510a, 510b, respectively, for
engaging or piercing the leaflet tissue. The arrangement of
inside/outside arms 510a, 510b around a circumference of the device
100 can alternate in a pre-designed pattern. For example, inside
arms 510a can alternate with outside arms 510b as shown in FIG.
36B, or alternatively, arms 510a, 510b may extend radially outward
and/or radially inward randomly or at irregular intervals,
depending on placement of the device 100 and with respect to
alignment with the native posterior and anterior leaflets.
[0300] FIGS. 37A-37D are enlarged side views of additional
embodiments of arms 510 suitable for use with a prosthetic heart
valve device 100 in accordance with the present technology. For
example, in FIGS. 37A-37D, the arms 510 can have a similar overall
profile as a profile of the anchoring member 110. The anchoring
member 110 can include ribs having varying shapes, sizes and/or
outwardly or inwardly oriented rib segments 85 for forming the
overall anchoring member profile. Accordingly, the arms 510 can
also have varying shapes, sizes and/or outwardly or inwardly
oriented arm segments that mimic the anchoring member 110 profile.
In some arrangements, the embodiments shown in FIGS. 37A-37D are
configured to clamp leaflets LF and/or the annulus AN tissue
between the arms 510 and the ribs 114 so as to conform the leaflet
tissue to the shape of the anchoring device 110 for enhanced
sealing and anchoring of the device. For example, FIG. 37A
illustrates one embodiment in which arm extensions 514 and/or arm
bodies 512 may partially mimic the shape of the ribs 114 and/or rib
segments 85, and FIG. 37B illustrates another embodiment in which
arm extensions 514 and/or arm bodies 512 more closely follow the
shape of the ribs 114. Embodiments encompassed by FIGS. 37A-37B can
apply to outward surface engaging arms 510b and/or inward surface
engaging arms 510a. Additionally, as shown in FIGS. 37A-37B, the
arm extensions 514 can extend radially outwardly so as to be
generally parallel with an upstream segment 85A of the rib 114. The
arm extension 514 can be configured to extend partially along the
length of the rib 114 and/or rib segments 85 (FIGS. 37A and 37C) or
fully along the length of the rib 114 and/or rib segments 85. In
FIG. 37D, the arms 510 have second arm extensions 518 connected to
an upstream portion of the first arm extension 514 and extending
outwardly so as to be generally parallel to a second rib segment
85B and third rib segment 85A.
[0301] In some embodiments, the prosthetic heart valve device 100
may incorporate a plurality of arms 510 around a circumference of
the device 100; however, in other embodiments, the device may
include the plurality of arms in groupings (e.g., first and second
groupings so as to engage the posterior and anterior leaflets,
respectively). Additionally, the arms 510 may extend from the
anchoring member 110 and/or valve support 120 independently of
other components including other arms 510, such as shown in FIG.
38A. In other embodiments and as shown in FIG. 38B, the device 100
may further include at least one first arm 510x interconnected with
at least one second arm 510y by interconnecting arm struts 520. The
arm struts 520 can be configured to be circumferentially expandable
and may connect all arms 510 (e.g., arm 510x and 510y) or one or
more groups of arms 510. In some embodiments, the arm struts 520
can limit the outward extension of the arms 510x, 510y away from
the device 100.
[0302] In accordance with aspects of the present technology, the
arms 510 can be coupled to and/or extend from components of the
device 100 symmetrically and/or asymmetrically around the
circumference 150 of the device 100. FIGS. 39A-39D are schematic
top views of arm location patterns with respect to the ribs 114 of
the anchoring member 110 (e.g., as shown in FIG. 38A). The arms 510
can be interspersed with ribs 114 (FIGS. 39A and 39C), in the same
radial plane as the ribs 114 of the anchoring member 110 (FIG.
39B), or both interspersed and in plane with the ribs 114 (FIG.
39D). Further, the arms 510 may be configured to extend outside the
expanded outer circumference 150 of the anchoring member 110 (FIG.
39B), inside the expanded outer circumference 150 of the anchoring
member 110 (FIG. 39A), extend to the same outer circumference 150
of the anchoring member 110 (FIG. 39C), or a combination of these
configurations (FIG. 39D).
[0303] In the above-described embodiments, the arms 510 may be
configured to engage tissue independently of the deployment of
anchoring member 110. For example, delivery catheters suitable for
the delivery of the prosthetic heart valve devices 100 may be
equipped with separate mechanisms operable to deploy the arms 510
and the anchoring members 110 individually or otherwise
independently of each other. In this way, the anchoring member 110
may be first released into engagement with the native tissue so
that the position of device 100 may be assessed and adjusted by the
operator until the desired final position has been attained.
Following deployment and positioning of the anchoring member 110,
the arms 510 can be released to engage the tissue. Such deployment
systems and methods are useful when the arms 510 are equipped with
tissue engaging elements 170 which, once deployed, may prohibit any
repositioning of the device 100. In some embodiments, the anchoring
member 110 will be equipped with atraumatic tissue engagement
elements 170 which do not penetrate tissue or inhibit device
relocation once the anchoring member 110 has been deployed.
Accordingly, some embodiments of the device 100 may be
repositionable even with the anchoring member 110 expanded so long
as the arms 510 are constrained in an undeployed configuration,
with the device 100 becoming permanently anchored only when the
arms 510 are released.
[0304] Alternatively or in addition to tissue engaging elements 170
present on the arms 510 as described above, tissue engaging
elements 170 may be present on other components of the device 100.
FIGS. 40A-40E are side views of prosthetic heart valve devices 100
having tissue engaging elements 170 on varying structures of the
device 100 in accordance with additional embodiments of the present
technology. For example, tissue engaging elements 170 can be
incorporated on the ribs 114 of the anchoring member 110. FIG. 40A
shows tissue engaging elements 170 incorporated on the upper rib
segment 85A, and FIG. 40B shows the tissue engaging elements 170
incorporated on lower rib segment 85B. FIG. 40C illustrates an
embodiment of the device having the tissue engaging elements 170
along the entire rib 114. The tissue engaging elements 170 are
shown in FIGS. 40A-40C schematically, but one of ordinary skill in
the art will recognize that the elements can be any of a variety of
tissue engaging elements 170 described herein (e.g., atraumatic,
partially piercing, fully penetrating, etc.), or in other
embodiments, a combination of different types of tissue engaging
elements 170. Additionally, the tissue engaging elements 170 are
shown oriented in an upstream direction (e.g., to inhibit upstream
migration of the device 100); however, in other embodiments, the
tissue engaging elements 170 can be oriented in a downstream
direction (e.g., to inhibit downstream migration of the device
100), or in a combination of downstream and upstream oriented
directions. The tissue engaging elements 170 can be incorporated
symmetrically around a circumference of the device 100, or in other
embodiments, the tissue engaging elements 170 can be incorporated
asymmetrically. For example, in some embodiments, the tissue
engaging elements 170 can be present on a side of the device 100
aligned with the posterior leaflet, but be absent or have a
different arrangement on a side of the device 100 aligned with the
anterior leaflet such that the wall separating the aortic valve
from the left ventricle will not be affected by the tissue engaging
elements 170.
[0305] FIG. 40D illustrates an embodiment of the device 100 having
tissue engaging elements 170, such as spikes on an upstream tip 175
of the rib 114, wherein the spikes can be configured to fully or
partially penetrate subannular tissue when the device 100 is
deployed on or under the annulus of the mitral valve. In some
embodiments, the tissue engaging elements 170 (e.g., spikes) can
include barbs 176 or other features for retaining the tissue
engaging elements 170 (e.g., spikes) in the tissue. In other
embodiments, the tissue engaging elements 170 (e.g., spikes) can be
blunt so as to engage but not penetrate the subannular tissue.
FIGS. 40E-40G are enlarged side views of tissue engaging elements
170 (e.g., spikes) suitable for use on upstream tips 175 of the
ribs 114. Devices 100 having tissue engaging elements 170 on the
upstream tips 175 can also incorporate features for limiting the
distance of penetration into the tissue. For example, the upstream
tip 175 can have a hilt 177 formed a short distance, e.g. 1-5 mm,
proximal to the tip of each tissue engaging element 170 to limit
the distance to which the tissue engaging element 170 can penetrate
the subannular tissue (FIG. 40E). Alternatively, as shown in FIG.
40F, the depth penetration of the tissue engaging element 170 into
the tissue can be limited by positioning connectors 116 a desired
distance from the tips of the tissue engaging element 170. In a
further embodiment shown in FIG. 40G, a sealing member 140 may be
attached to the ribs 114 such that the upstream edge 178 of the
sealing member 140 can limit the depth of penetration of the tissue
engaging element 170. In order to prevent slippage of the sealing
member 140 downward, an attachment feature such as a hole 173
configured to receive a suture may be formed in the rib 114 at the
desired distance from its upstream tip 175 to which the sealing
member 140 can be firmly secured.
[0306] Alternatively, tissue engaging elements 170, such as bumps,
ridges, or other protrusions configured to exert frictional forces
on cardiac tissue, may be also present on one or more valve support
struts 124, valve support posts 122, and/or other components (e.g.,
sealing members 140). These tissue engaging elements 170 can be
disposed on an outer portion of these features and can be
configured to extend outwardly to engage the native leaflets and to
stabilize and firmly anchor the device 100 in the desired location.
Alternatively, ridges, scales, bristles, or other features having
directionality may be formed on the surface of the ribs 114,
connectors 116, or sealing member 140 to allow movement relative to
native tissue in one direction, while limiting movement in the
opposite direction.
[0307] The tissue engaging elements 170 on the anchoring member 110
can be barbs, spikes, or other retention features configured to
have a delayed deployment so as to allow the device to be
repositioned or removed for a period of time until these elements
become fully deployed. For example, the tissue engaging element 170
may be constructed of a shape memory material (e.g., Nitinol) which
is preshaped in a deployed configuration and adapted to retain the
tissue engaging element 170 in the native tissue. The tissue
engaging element 170 may be deformed into a contracted
configuration which permits removal from tissue, and retained in
this shape by a bioerodible material or adhesive. Once immersed in
tissue, this material can erode over a period of time (e.g., 10
minutes-2 hours) allowing the tissue engaging element 170 to return
to its unbiased deployed shape which will assist in retaining the
tissue engaging element 170 in the tissue.
[0308] Several examples of such delayed, deployable tissue engaging
elements 170 are shown in FIGS. 40I-40T. In the embodiment of FIG.
40I, the tissue engaging element 170 comprises a shape memory alloy
shaft 450 laser cut so as to have a diamond-shaped window 451 near
its distal tip 452, which can be sharp enough to penetrate tissue.
The shape set so that window 451 is biased toward being open in an
expanded configuration as shown in FIG. 40I. Prior to delivery of
the device, window 451 may be pinched closed and a bioerodible glue
455 may be injected into window 451 to hold it in a closed
configuration as shown in FIG. 40J. Upon deployment of the device,
the distal tip 452 can penetrate the native tissue, e.g. valve
leaflet or annulus, as shown in FIG. 40K. The glue 455 within
window 451 maintains it in a closed configuration for a period of
time to allow the operator to reposition or remove the device if
necessary. If left in position, the glue 455 erodes, allowing the
window 451 to reopen into the expanded configuration which will
retain the tissue engaging element 170 in the tissue as shown in
FIG. 40L.
[0309] In the embodiment shown in FIGS. 40M-40P, the tissue
engaging element 170 comprises an arrowhead-shaped tip 453 having
two or more wings 454 biased to be angled radially outward and
pointing in a proximal direction as shown in FIG. 40M. A
bioerodible glue or coating 455 is applied over the arrowhead tip
453 to hold the wings 454 in a radially contracted configuration as
shown in FIG. 40N. In the contracted configuration, the device 100
is deployed such that the tissue engaging element 170 pierces the
native tissue as shown in FIG. 40O. The bioerodible coating 455
then erodes gradually until it allows the wings 454 to return to
the laterally expanded configuration shown in FIG. 40P, thus
retaining the tissue engaging element 170 in the tissue.
[0310] A further embodiment is shown in FIGS. 40Q-40T. In this
embodiment, the tissue engaging element 170 comprises a helical tip
456 in an unbiased state. A bioerodible coating 455 may be used to
retain the helical tip 456 in a straightened configuration as shown
in FIG. 40R. The tissue engaging element 170 can penetrate the
tissue in the contracted configuration, and when the bioerodible
coating 455 erodes sufficiently to allow the helical tip 456 to
return to its deployed configuration, the tissue engaging element
170 can be retained in the tissue.
[0311] The prosthetic heart valve device 100 can also be configured
to have additional tissue engaging elements 170 for engaging the
annulus. For example, FIG. 41 is an isometric view of a prosthetic
heart valve device 100 having a plurality of annulus engaging
elements 179 in accordance with a further embodiment of the present
technology. The annulus engaging elements 179 can be a C-shaped
hook feature or other shape that allows the element 179 to engage
tissue on the annulus, as well as a portion of supra-annular tissue
and subannular tissue. As shown, the annulus engaging elements 179
can be symmetrically (shown in FIG. 41) or asymmetrically
interspersed around the upstream perimeter of the anchoring member
110 and coupled to ribs 114, connectors 116 (not shown), or to a
sealing member 140. The annulus engaging elements 179 may also be
coupled to the anchoring member 110 at other locations downstream
of the upstream perimeter 113, or in other embodiments to a portion
of the valve support 120 that extends through at least the annulus
plane PO (FIG. 3). Additionally, the annulus engaging elements 179
may be blunt (e.g., for pressing but not penetrating into the
annular tissue), or they may be sharp for penetrating the annulus
tissue on either or both of the supra-annular or subannular
surfaces. The annulus engaging element 179 can be suitable for both
positioning the device 100 in the desired location (e.g., with
anchoring member 110 below the annulus), as well as to inhibit
movement of the device in either an upstream or downstream
direction.
[0312] In another embodiment shown in FIGS. 42A-42B, a prosthetic
heart valve device 100 can have tissue engaging elements 372
deployable from a plurality of tubular ribs 314. Referring to FIG.
42A, the prosthetic heart valve device 100 can have an anchoring
member 110 having a plurality of tubular ribs 314 configured to
retain a plurality of deployable tissue engaging elements 372. FIG.
42B is an enlarged view of the tubular rib 314 and a deployable
tissue engaging element 372 retained within a lumen 316 of the rib
314 and shown before deployment of the element 372. The tissue
engaging element 372 can comprise a shape memory material (e.g.,
Nitinol) configured to deploy to a preformed shape upon release of
the tissue engaging element 372 from the inner lumen 316 of the rib
314. Release of the tissue engaging element 372 can be achieved by
engaging a proximal end 374 of the tissue engaging element 372. For
example, the proximal end 374 can be engaged during the deployment
of the device 100 to release the tissue engaging element 372 after
the anchoring member 110 is positioned at the desired location
below the annulus AN. The tubular rib 314 can include a U-shaped
deflector 318 and a pivot point 320 configured to guide the tissue
engaging element 372 distally through a distal opening 315 of the
rib 314. As illustrated in dotted lines in FIG. 42B, engagement of
the proximal end 374 of element 372 will encourage a distal end 376
of the tissue engaging element 372 from the distal opening 315 of
the tubular rib 314 to penetrate adjacent subannular tissue. Once
deployed and after exiting an opposing surface S, such as the
supra-annular surface, the tissue engaging element 372 can
transition into its preformed shape, such as a curled shape 378
that can resist retraction of the distal end 376 from the
tissue.
[0313] In accordance with another embodiment of the prosthetic
treatment device 100, tissue engaging elements 170 can be
incorporated into sealing members 140 (e.g., sleeve 146). FIGS.
43A-43B are an isometric view and an enlarged detail view of a
prosthetic heart valve device 100 having a sealing member 140
configured with tissue engaging elements 170. Referring to FIGS.
43A-43B together, the tissue engaging elements 170 can comprise
metallic or polymeric wires 274 or fibers, rigid and sharp enough
to penetrate tissue, which are woven into or otherwise coupled to
sealing member 140 materials. The sealing member 140 can then be
attached to outer and/or inner walls 141, 142 of the anchoring
member 110 and/or interior and/or exterior surfaces 126, 127 of the
valve support 120 such that tissue engaging elements 170 extend
radially outward from the sealing member 140 to engage the adjacent
leaflets or other tissue.
[0314] Tissue engaging elements 170 may alternatively comprise an
array of relatively short barbs, points, rods, tines, or similar
protrusions configured to frictionally engage the tissue, or dent
or slightly penetrate the surface of the tissue, to inhibit motion
of the anchoring member 110 relative to the native leaflets or
annulus. These tissue engaging elements, in exemplary embodiments,
may be polymeric or metallic, about 0.2-5 mm in length, about
0.1-0.5 mm in diameter, flexible enough to deflect slightly in
engagement with tissue, and distributed over the surface of the
sealing member 140 in densities of 4-100 per square centimeter. The
tissue engaging elements 170 may be integrally formed with the
material of the sealing member 140, woven into such material, or
formed in or mounted to a flexible sheet which is bonded, riveted,
or otherwise fastened to the sealing member 140. The tissue
engaging elements 170 may be angled, curved, or bent so as to point
preferentially in a non-perpendicular direction, preferably in an
upstream direction, to impart higher retention force against
movement in the upstream direction while allowing movement more
easily in the downstream direction. In some embodiments, the tissue
engaging elements may be composed of a bioerodible material that
lasts, following implantation, a sufficient time to allow tissue
ingrowth or encapsulation to retain the device 100 in position. The
tissue engaging elements 170, and/or the material of sealing member
140, may also be coated with a permanent or temporary
friction-enhancing coating or adhesive that enhances retention at
least until the device has been encapsulated in tissue sufficiently
to prevent movement.
[0315] FIGS. 44A-44F are enlarged side views of embodiments of
additional tissue engaging elements that can be incorporated on
various device structures (referred collectively as "ST"), such
struts, connectors, posts, arms, and/or ribs which may be
incorporated into device features, such as the anchoring member 110
or valve support 120. For example, the additional tissue engaging
elements may comprise one or more cut-out protrusions 350 (FIGS.
44A and 44B) in place of or in addition to tissue engaging elements
170. In a collapsed or straightened configuration, as shown by the
side view of FIG. 44C, cut-out protrusion 350 maintains low relief
relative to the surface of structure ST to maintain a low profile
during delivery. As the device 100 expands and structure ST changes
to its deployed configuration (e.g. a curvature as shown in FIG.
44D), the protrusion separates from the ST to a higher relief. The
protrusion 350 may also be configured to grab subannular tissue,
pulling the cut-out protrusions even farther away from structure
ST. The device structures ST may also be shaped to include sharp
protrusions 352 along one or more of its edges or faces, as
illustrated in FIG. 44E, or may also include pointed scale-like
protrusions 354, as shown in FIG. 44F.
[0316] In addition to the stabilizing members 501 described above,
the prosthetic heart valve devices described herein (e.g., devices
100) may also include support features such as tethers 360 and
sealing member septa 370 for stabilizing the anchoring member 110
and/or the valve support 120, and/or for spreading pressure
gradient loads evenly over a greater area of the device 100 (e.g.,
during ventricular systole). Referring to FIG. 45A, one example of
the device 100 can incorporate a plurality of tethers 360 at least
loosely coupling the upper portion 112 of the anchoring member 110
to the upstream end 121 of the valve support 120. In one
embodiment, the tethers 360 can include a single suture that is run
continuously around the circumference 150 of the anchoring member
110. In another embodiment, the device 100 can include several
sutures of discreet lengths tied between the anchoring member 110
and the valve support 120. In one embodiment the tethers can be a
suture comprising polytetrafluoroethylene (PTFE). Generally, the
tethers 360 assist in distributing forces evenly along the
anchoring member 110 without deforming the valve support 120 or
compromising the closure of the prosthetic valve 130. In some
arrangements, the tethers 360 can assist in limiting radial
expansion of the upstream portion. Accordingly, even with the
incorporation of the tethers 360, the valve support 120 remains
mechanically isolated from at least the upstream portion of the
anchoring member 110.
[0317] FIG. 45B shows another example of a stabilizing member 501
suitable to stabilize the anchoring member 110 and/or the valve
support 120, and/or for spreading pressure gradient loads evenly
over a greater area of the device 100 (e.g., during ventricular
systole). As shown in FIG. 45B, the device 100 can include a
plurality of sealing member septa 370 extending between the
anchoring member 110 and the valve support 120. In the illustrated
embodiment, the septa 370 can be extensions of the sealing member
material configured to span between a sealing member 140, such as a
skirt 144, coupled to the inner wall 141 of the anchoring member
110 and a sealing member 140, such as a sleeve 146, coupled to an
interior or exterior surface 126, 127 of the valve support 120.
Accordingly, the septa 370 can be formed of fabric or other
flexible and biocompatible materials such as Dacron.RTM., ePTFE,
bovine pericardium, or other suitable materials. Similar to the
embodiment illustrated in FIG. 45A, the septa 370 can assist in
distributing forces evenly along the anchoring member 110 without
deforming the valve support 120 or otherwise compromising the
closure of the prosthetic valve 130. In some arrangements, the
septa 370 can assist in preventing the device 100 from everting
during ventricular systole. Accordingly, even with the
incorporation of the septa 370, the valve support 120 is
mechanically isolated from at least the upstream portion of the
anchoring member 110.
[0318] Each of the elements and members of the device 100 may be
made from any number of suitable biocompatible materials, e.g.,
stainless steel, nickel titanium alloys such as Nitinol.TM., cobalt
chromium alloys such as MP35N, other alloys such as ELGILOY.RTM.
(Elgin, Ill.), various polymers, pyrolytic carbon, silicone,
polytetrafluoroethylene (PTFE), or any number of other materials or
combination of materials depending upon the desired results. The
arm members 510, sealing member 140, sleeves 146, anchoring member
110 and/or valve support 120 or other elements of device 100 may
also be coated or covered with a material that promotes tissue
in-growth (e.g., Dacron.RTM., PTFE, etc.)
Delivery Systems
[0319] FIGS. 46A-46D illustrate one embodiment of a delivery system
10 suitable for delivery of the prosthetic heart valve devices
disclosed herein. As used in reference to the delivery system,
"distal" refers to a position having a distance farther from a
handle of the delivery system 10 along the longitudinal axis of the
system 10, and "proximal" refers to a position having a distance
closer to the handle of the delivery system 10 along the
longitudinal axis of the system 10.
[0320] FIG. 46A illustrates one embodiment of the delivery system
10 which may be used to deliver and deploy the embodiments of the
prosthetic heart valve device 100 disclosed herein through the
vasculature and to the heart of a patient. The delivery system 10
may optionally include a guiding catheter GC having a handle 12
coupled to a delivery shaft 16, which in one embodiment is 34 F or
less, and in another embodiment, 28 F or less in diameter. The
guiding catheter GC may be steerable or preshaped in a
configuration suitable for the particular approach to the target
valve. The delivery catheter 18 is placed through a hemostasis
valve HV on the proximal end of guiding catheter GC and includes a
flexible tubular outer shaft 19 extending to a delivery sheath 20
in which the device 100 is positioned in a collapsed or delivery
configuration 106. A flexible inner shaft 28 is positioned
slideably within outer shaft 19 and extends through the device 100
to a nosecone 21 at the distal end. The inner shaft 28 has a
guidewire lumen through which a guidewire 24 may be slideably
positioned. The device 100 is coupled to the inner shaft 28 and is
releasable from the inner shaft 28 by release wires 30, as more
fully described below. The delivery sheath 20 can protect and
secure the device 100 in its collapsed configuration 106 during
delivery. The outer shaft 20 is coupled to a retraction mechanism
23 on the handle 14 of the delivery catheter 18. Various retraction
mechanisms 23 may be used, such as an axially-slidable lever, a
rotatable rack and pinion gear, or other known mechanisms. In this
way, the outer shaft 20 may be retracted relative to the inner
shaft 28 to release (e.g., deploy) the device 100 from the sheath
20.
[0321] FIG. 46B shows the distal end of the delivery catheter 18
with the sheath 20 cut away to illustrate the coupling of the
device 100 to the inner shaft 28. A plurality of locking fingers 32
are coupled to the nose cone 21 and extend proximally through the
interior of the valve support 120 of the device 100. As shown in
FIG. 46C, a selected number of posts 122 of the valve support 120
have a coupling element 61 comprising a tab 34 cut out from each
post 122 at a proximal end thereof. The tab 34 may be deflected
inwardly from the post 122 as shown in FIG. 46B and is configured
to extend through a window 42 in the locking finger 32 as shown in
FIG. 46D. The release wires 30 pass through the holes 40 in the
tabs 34, which prevents the tabs 34 from being withdrawn from the
windows 42 to secure the device 100 to the inner shaft 28. The
pull-wires 30 can be sandwiched tightly between the tabs 34 and the
locking fingers 32, such that friction temporarily prevents the
pull-wire 30 from slipping in a proximal or distal direction. In
this way, the sheath 20 may be retracted relative to the device 100
to permit expansion of the device 100 while the inner shaft 28
maintains the longitudinal position of the device 100 relative to
the anatomy. The pull-wires 30 may extend proximally to the handle
14, for example, in between the inner shaft 28 and the outer shaft
19 or within one or more designated lumens. A suitable mechanism
(not shown) on the handle 14 can allow the operator to retract the
release wires 30 in a proximal direction until they are disengaged
from the tabs 34. Accordingly, the device 100 can be released from
the locking fingers 32 and expand for deployment at the target
site.
[0322] FIGS. 47A-47D are schematic, cross-sectional side views of a
heart H showing a trans-septal or antegrade approach for delivering
and deploying a prosthetic heart valve device 100. As shown in FIG.
47A, a guidewire 24 may be advanced intravascularly using any
number of techniques, e.g., through the inferior vena cava IVC or
superior vena cava SVC, through the inter-atrial septum IAS and
into the right atrium RA. The guiding catheter GC may be advanced
along the guidewire 24 and into the right atrium RA until reaching
the anterior side of the atrial septum AS, as shown in FIG. 47B. At
this point, the guidewire 24 may be exchanged for the needle 25,
which is used to penetrate through the inter-atrial septum IAS
(FIG. 47C). The guiding catheter GC may then be advanced over the
needle 25 into the left atrium LA, as shown in FIG. 47D. The
guiding catheter GC may have a pre-shaped or steerable distal end
to shape or steer the guiding catheter GC such that it will direct
the delivery catheter 18 (FIG. 46A) toward the mitral valve.
[0323] As an alternative to the trans-septal approach, the mitral
valve may also be accessed directly through an incision in the left
atrium. Access to the heart may be obtained through an intercostal
incision in the chest without removing ribs, and a guiding catheter
may be placed into the left atrium through an atrial incision
sealed with a purse-string suture. A delivery catheter may then be
advanced through the guiding catheter to the mitral valve.
Alternatively, the delivery catheter may be placed directly through
an atrial incision without the use of a guiding catheter.
[0324] FIGS. 48A-48C are cross-sectional views of the heart
illustrating a method of implanting a prosthetic heart valve device
100 using a trans-septal approach. Referring to FIGS. 48A-48C
together, the distal end 21 of the delivery catheter 18 may be
advanced into proximity to the mitral valve MV. Optionally, and as
shown in FIG. 48A, a guidewire GW may be used over which catheter
18 may be slideably advanced over a guidewire GW. The sheath 20 of
the delivery catheter 18, which contains the device 100 in a
collapsed configuration 106, is advanced through the mitral valve
annulus AN between native leaflets LF, as shown in FIG. 48A.
Referring to FIG. 48B, the sheath 20 is then pulled back proximally
relative to the distal nose cone 27 allowing the device 100 to
expand such that anchoring member 110 pushes the leaflets LF
outwardly to fold beneath the mitral valve annulus AN. The tips of
the ribs 114 engage and may penetrate into or through the leaflet
tissue to further engage the tissue of the annulus AN. After the
sheath 20 has been removed and the device 100 allowed to expand,
the delivery system can still be connected to the device 100 (e.g.,
system eyelets, not shown, are connected to the device eyelets 180,
shown in FIG. 10A) so that the operator can further control the
placement of the device 100 in the expanded configuration 102. For
example, the device 100 may be expanded upstream or downstream of
the target location then pushed downstream or upstream,
respectively, into the desired target location before releasing the
device 100 from delivery system 10. Once the device 100 is
positioned at the target site, the pull-wires 30 (FIGS. 46A-46B)
may be retracted in a proximal direction, to detach the device 100
in the deployed configuration 104 from the delivery catheter 18.
The delivery catheter 18 can then be removed as shown in FIG. 48C.
Alternatively, the device 100 may not be connected to the delivery
system 10 such that the device 100 deploys and is fully released
from the delivery system 10.
[0325] FIGS. 49A and 49B illustrate another variation for
delivering and deploying one or more prosthetic heart valve devices
100 using a retrograde approach to the mitral valve via the aorta
and left ventricle. In this example, the guidewire GW may be
advanced intravascularly from a femoral or radial artery or through
direct aortic puncture through the aorta AO and aortic valve AV,
and into the left ventricle LV of the heart H (FIG. 49A). A guiding
catheter GC, or alternatively, the delivery catheter 18, may be
advanced along the guidewire GW until the distal end is positioned
within the left ventricle in proximity to the mitral valve MV, as
shown in FIGS. 49A and 49B. In many arrangements, the guiding
catheter GC and/or the delivery catheter 18 will have a steering
mechanism or a pre-shaped distal tip allowing it to be steered
around the 180.degree. turn from the aortic valve AV to the mitral
valve MV. The distal end of the delivery catheter 18 may optionally
be advanced at least partially through the mitral valve MV into the
left atrium LA.
[0326] FIGS. 50A-50B illustrate delivery of the device 100 in the
collapsed configuration 106 to the mitral valve MV in a
trans-apical approach. Referring to FIG. 50A, the delivery catheter
18 is advanced through a guiding catheter GC that has been inserted
into the left ventricle of the heart through a puncture in the left
ventricle wall at or near the apex of the heart. The catheter can
be sealed by a purse-string suture. Alternatively, the delivery
catheter 18 may be placed directly through a purse-string-sealed
trans-apical incision without a guiding catheter. The sheath 20 and
the device 100 (e.g., in the collapsed configuration 106) within
the sheath 20 are advanced through the mitral annulus AN between
native leaflets LF as shown in FIG. 50A. Referring to FIG. 50B, the
sheath 20 is pulled proximally such that the device 100 expands to
the expanded and/or deployed configurations 102, 104. The delivery
system 10 can remain connected to the device 100 (e.g., system
eyelets, not shown, are connected to the device eyelets 180, FIG.
10A) after removing the sheath 20 so that the operator can control
the placement of the device 100 while in the expanded configuration
102. The pull-wires 30 may be retracted in a proximal direction to
release the device 100 from the delivery system 10, allowing the
delivery system 10 to be removed and the device to be fully
implanted at the mitral valve MV in the deployed configuration 104.
In one embodiment, the device 100 may be expanded upstream or
downstream of the desired target location then pulled or pushed
downstream or upstream, respectively, into the target location
before releasing the device 100 from delivery system 10.
Alternatively, the device 100 may not be connected to the delivery
system 10 such that the device 100 deploys and is fully released
from the delivery system 10.
[0327] FIGS. 51A-51B are partial side views of a delivery system 10
wherein a prosthetic heart valve device 100 is mounted on an
expandable balloon 300 of a delivery catheter 18 in accordance with
another embodiment of the present technology. Referring to FIGS.
51A and 51B together, the device 100 can be mounted on an
expandable balloon 300 of a delivery catheter while in a collapsed
configuration 106 and delivered to the desired location at or near
a native mitral valve (FIG. 51A). When the device 100 is released
from the sheath 20 (FIGS. 46A-46B), the device 100 can be expanded
to its expanded configuration 102 by inflation of the balloon 300
(FIG. 51B). When using a balloon 300 with the delivery system 10,
the device 100 can be advanced from the delivery shaft 16 to
initially position the device 100 in a target location. The balloon
300 can be inflated to fully expand the device 100. The position of
the device 100 relative to the mitral valve may then be adjusted
using the device locking hub to position the device into desired
implantation site (e.g., just below the annulus of the native
mitral valve). In another embodiment, the balloon 300 can initially
be partially inflated to partially expand the device 100 in the
left atrium. The delivery system 10 can then be adjusted to push or
pull (depending on the approach) the partially expanded heart valve
device 100 into the implantation site, after which the device 100
can be fully expanded to its functional size. In other alternative
methods, the anchoring member 110 is a self-expanding construct
which is first released from a sheath 20 (FIGS. 46A-46B) at the
target site to engage the native anatomy, while the valve support
120 is a balloon-expandable element mounted on a balloon 300 which
is then expanded to fully deploy the valve support 120 after the
anchoring member 110 has been released.
[0328] In still further embodiments, the valve support 120 of
device 100 may be configured to be axially movable or detachable
from the anchoring member 110. In such arrangements, the two
components 110, 120 may be loaded in an axially separated
configuration within the delivery system 10, thereby reducing the
overall profile of the system 10. After delivery to the target
valve site, the components 110, 120 can be assembled together.
FIGS. 52A-52D show an embodiment of assembling the valve support
120 and anchoring member 110 in the heart. As shown in FIG. 52A,
the delivery catheter 380 is advanced into the left atrium via a
guiding catheter GC placed through the inter-atrial septum or the
atrial wall. The delivery catheter 380 has a split sheath 382, 384
comprising a distal nose cone 382 and a proximal capsule 384. The
delivery catheter 380 is advanced through the native valve MV until
the nose cone 382 is positioned distally of the native annulus AN
(FIG. 52A). The nose cone 382 is then advanced further distally
while maintaining the position of the remainder of the delivery
catheter 380 thereby releasing the anchoring member 110 from the
nose cone 382 (FIG. 52B). The anchoring member 110 self-expands
outward, engaging the native leaflets LF and folding them outward
beneath the native annulus AN, as shown in FIG. 52B. The upstream
tips of ribs 114 (FIG. 52B) engage the subannular tissue to anchor
the device 100 in position. The sealing member 140 is fixed around
the perimeter 113 of the anchoring member 110 and has a connecting
portion 386 extending into the proximal capsule 384 where it is
fixed to the valve support 120, which is still constrained within
the proximal capsule 384. The delivery catheter 380 is then
advanced so as to position the proximal capsule 384 within the
anchoring member 110 as shown in FIG. 52C. By advancing the
catheter 380 until the sealing member 140 becomes taught, the
proper positioning may be attained. The proximal capsule 384 is
then retracted relative to the nose cone 382 to release the valve
support 120 from the proximal capsule 384. The valve support 120
can self-expand into engagement with the downstream end of
anchoring member 110 to couple the two components together. The
delivery catheter 380 may then be withdrawn from the patient.
[0329] FIGS. 53A-53H show various mechanisms that may be used for
coupling the valve support 120 to the anchoring member 110 in the
process shown in FIGS. 52A-52D. For example, as shown in FIG. 53A,
the valve support 120 may include a circumferential ridge or detent
388 near its downstream end that engages in a groove 390 in the
anchoring member 110 to inhibit detachment of the two components.
Alternatively, valve support 120 may have a hook 392 formed at the
downstream end of each post 122 which is configured to extend
around a downstream end of anchoring member 110, e.g. around either
the downstream tip of rib 114 or connectors 116, as shown in FIGS.
53B-53C. For example, the hook 392 may be configured to flex
inwardly when it engages the inner surface of the rib 114 as the
valve support 120 is advanced, and be configured to resiliently
recoil to its outward configuration when extended beyond the
downstream end of the rib 114, as shown in FIG. 53C. Optionally, a
depth-limiting feature such as a stub 394 may extend outwardly from
the valve support 120 which is configured to engage a complementary
feature such as a bump or ridge 396 on the anchoring member 110 to
prevent insertion of the valve support 120 beyond a predetermined
depth.
[0330] In a further embodiment shown in FIGS. 53D-53F, the valve
support 120 may have a coupling element 398 on its outer surface
configured to slideably couple to the anchoring member 110. In a
first configuration, the coupling element 398 comprises a loop 40O,
shown in FIG. 53E, through which a vertical guide member 402 on the
anchoring member 110 may slide. The anchoring member 110 may have a
plurality of such guide members 402 extending upwardly from its
downstream end at locations spaced around its circumference. A bump
404 may be formed near the downstream end of each guide member 402
over which the loop 400 may slide to inhibit the valve support 120
from sliding back in the upstream direction (FIG. 53D). In an
alternative configuration, shown in FIG. 53F, the guide member 402
has a vertical slot 406 into which a radially extending pin 408 on
the valve support 120 can extend. The pin 408 may slide to the
downstream end of the slot 406 where it may be urged through a
waist 411, which prevents the pin 408 from sliding back in the
upstream direction.
[0331] In a further embodiment shown in FIGS. 53G-53H, coupling
elements 398 on the valve support 120 are configured to slideably
receive the ribs 114, which themselves perform a similar function
as the guide members 402 (described with respect to FIGS. 53D-53F).
As shown in FIG. 53G, coupling of the ribs 114 to the valve support
120 helps restrain the ribs 114 in a radially compact configuration
when the valve support 120 slides axially upward relative to the
anchoring member 110. In the arrangement shown in FIGS. 53GG-53H,
the delivery of the device 100 may not require the need for a
separate sheath to constrain the ribs 114 during the delivery. As
shown in FIG. 53H, the valve support 120 may slide in the
downstream direction relative to the anchoring member 110 until the
ribs 114 assume their radially outward configuration. As with guide
members 402, each rib 114 may have a bump 412 formed near its
downstream end past which coupling element 398 may be urged, but
which then inhibits valve support 120 from sliding in the upstream
direction (FIG. 53H).
[0332] FIGS. 54A-55C illustrate a delivery catheter 400 of a
delivery system 40 in accordance with additional embodiments of the
present technology. FIG. 54A is a cross-sectional side view of the
delivery system 40 for the prosthetic heart valve device 100 and
FIG. 54B is a partial cross-sectional side view of a distal portion
of the delivery system 40 shown in FIG. 54A. As shown in FIGS. 54A
and 54B, the delivery catheter 400 comprises a sheath 402 having an
outer wall 403 and a closed distal nose 406 defining a blind
annular cavity 408. An inner wall 405 extends proximally to the
proximal end of the catheter (not shown), thus forming a tubular
catheter shaft 407 defining an inner lumen extending axially
therethrough in which a guidewire GW may be slideably positioned. A
piston 412 is slideably disposed in the cavity 408 and has an
O-ring 413 around its circumference to create a fluid seal with the
wall of the cavity 408. A tubular piston shaft 414 extends
proximally from piston 412 and is slideably mounted over the
catheter shaft 407. The piston shaft 414 is oversized relative to
the catheter shaft 407 so as to define a fluid lumen 416 which is
in communication with the cavity 408. The device 26 is retained in
its radially collapsed delivery configuration within cavity 408,
with piston shaft 414 and catheter shaft 407 extending through the
interior of the valve support 120 (shown in FIGS. 55A-55C).
Preferably, the device 100 is releasably coupled to piston 412 by,
for example, pins (not shown) extending radially outwardly from
piston shaft 414.
[0333] The sheath 402 may have features that limit its travel. For
example, a wire (not shown) may tether the protective sheath to a
handle on the proximal end of catheter 400. The wire may be
attached to an adjustable stop on the handle, allowing the length
of piston travel to be adjusted. When fluid is injected into cavity
408, piston 412 will travel until this stop is reached. In this
manner, the deployment progression can be controlled.
[0334] To ease the retraction of sheath 402 through the valve of
the device 100 following deployment, a tapered feature may advance
to abut the proximal end of the sheath 402 (see FIG. 56).
Alternatively, piston 412 may have a taper or soft bumper material
affixed directly to the back of piston 412 facing in the proximal
direction. In this way the proximal side of the piston would itself
provide an atraumatic leading surface to ease retraction of the
sheath 402 through the valve support 120.
[0335] Features intended to control and smooth the deployment of
device 100 can be incorporated. For example, a common problem
during deployment of self-expanding stents is a tendency of the
deployed device to "pop" or jump forward or backward as the final
elements exit the deployment device. Features to prevent the sheath
402 from being thrust forward by the expanding skeletons of the
device 100 may be important in order to prevent accidental damage
to the ventricle or other tissue. Such features may incorporate
stops or tethers within the deployment system designed to retain
the position of the sheath 402 relative to the deployed device 100.
For example, the proximal edge of the sheath 402 could be swaged
slightly inward to prevent the piston from exiting the sheath and
to precisely locate the taper or bumper features described above to
ease withdrawal of the system through the deployed valve.
Alternatively or additionally, a spring mechanism (not shown) could
be built into the delivery system 40 so that when the last features
of the device 100 leave the sheath 402, the sheath actively
retracts slightly into the downstream end of the newly deployed
device 100.
[0336] The operation of the delivery catheter 400 is illustrated in
FIGS. 55A-55C. The delivery catheter 400 is positioned at the
target valve site using one of the approaches described elsewhere
herein. The delivery catheter 400 is particularly well suited to
placement through the native valve from the upstream direction. The
catheter 400 is advanced until the sheath 402 is positioned
downstream of the native annulus (FIG. 55A). Fluid can then be
injected through fluid lumen 416 into the cavity 408, distal to the
piston 412 (FIG. 55B). This drives the sheath 402 distally,
releasing the device 100 from the cavity 408 (FIG. 55C). The
delivery catheter 400 and the device 100 may remain in a stationary
longitudinal position relative to the native valve while the device
100 is deployed, thereby increasing the precision of deployment. In
addition, the device 100 may be deployed in a slow and controlled
manner, avoiding sudden and uncontrolled jumps of the device 100.
Further, such hydraulic actuation allows the sheath 402 to be moved
in incremental steps to only partially deploy the device 100,
allowing the operator to assess its position relative to the native
valve and reposition as needed before complete deployment.
[0337] In one embodiment, the piston 412 can be hydraulically
actuated, however, in another embodiment, the piston 412 could be
operated by manual retraction of the piston shaft 414 or
advancement of the sheath 402. The delivery catheter 400 may be
equipped with a handle on its proximal end having a retraction
mechanism coupled to the piston shaft 414 and/or catheter shaft
407. Such a mechanism may use gears or pulleys to provide a
mechanical advantage to reduce the force required to retract the
piston or advance the sheath.
[0338] The delivery catheters in accordance with aspects of the
present technology may further be configured to be reversible, to
allow the device 100 to be retracted back in to the catheter 400
after a full or partial deployment. One embodiment of such a
catheter is illustrated in FIG. 56, wherein the delivery catheter
400 of FIGS. 54A-55C is adapted to retract the device 100 back into
the sheath 402 after being fully or partially deployed therefrom.
The piston 412 has at least a first pulley 420 coupled thereto,
while distal nose 406 has at least a second pulley 422 coupled
thereto. A plurality of additional pulleys 423 may also be provided
at locations around the circumference of the piston 412 for
additional mechanical assistance. A cable 424, which may comprise a
length of wire or suture, extends through the fluid lumen 416 and
cavity 408, passes around first and second pulleys 420, 422 and any
additional pulleys 423, and is secured to piston 412. The device
100 can be releasably coupled to the piston shaft 414 by a
plurality of pins 426 extending radially from the piston shaft 414
into engagement with the device 100, preferably near a downstream
end 428 thereof.
[0339] To deploy the device 100, the delivery catheter 400 of FIG.
56 operates similarly as described above in connection with FIGS.
55A-55C; however, in an additional embodiment and before the
downstream end 428 has been fully released from the sheath 402, the
operator can checks the location of the device 100. Upon
deployment, the upstream end 430 of the device 100 will expand
toward its expanded configuration. An operator can view, using
ultrasound, fluoroscopy, MRI, or other means, the position and
shape of the deployed device 100 in the native tissue. Following
positioning, the sheath 402 may be further advanced relative to the
piston 412 to fully deploy the device 100 from the sheath 402,
whereupon the downstream end 428 fully expands and pins 426 are
disengaged from device 100. In situations where the operator
desires to recover the device 100 back into the sheath 402 for
repositioning or other reasons, the cable 424 is pulled so as to
move the piston 412 in the distal direction relative to the sheath
402. The pins 426 pull the device 100 with the piston 412 back into
the sheath 402 and the device 100 is collapsed as it is pulled in
the sheath 402. The delivery catheter 400 may then be repositioned
and the device redeployed.
[0340] In one embodiment, the prosthetic heart valve device 100 may
be specifically designed for a specific approach or delivery method
to reach the mitral valve, or in another embodiment, the device 100
may be designed to be interchangeable among the approaches or
delivery methods.
Additional Embodiments of Prosthetic Heart Valve Devices, Delivery
Systems and Methods
[0341] FIGS. 57A-57E are isometric views of prosthetic heart valve
devices 600 shown in an expanded configuration 602 and configured
in accordance with additional embodiments of the present
technology. The prosthetic heart valve devices 600 include features
generally similar to the features of the prosthetic heart valve
device 100 described above with reference to FIGS. 10A-56. For
example, the prosthetic heart valve device 600 includes the valve
support 120 configured to support a prosthetic valve 130 and an
anchoring member 610 coupled to the valve support 120 in a manner
that mechanically isolates the valve support 120 from forces
exerted upon the anchoring member 610 when implanted at the native
mitral valve. However, in the embodiments shown in FIGS. 57A-57E,
an upstream region 612 of the anchoring member 610 is coupled to
the valve support 120 such that a downstream region 611 of the
anchoring member 610 is configured to engage native tissue on or
downstream of the annulus so as to prevent migration of the device
600 in the upstream direction.
[0342] FIGS. 57A and 57B illustrate embodiments of the device 600
wherein the anchoring member 610 includes a plurality of
longitudinal ribs 614 coupled to the upstream end 121 of the valve
support 120 and extending in a downstream to distal direction. As
shown in FIG. 57A, the ribs 614 can project radially outward away
from the longitudinal axis 101 at the downstream region 611 of the
anchoring member 610 such that the downstream region 611 is flared
outward for engaging subannular tissue below the mitral annulus.
FIG. 57B illustrates an embodiment of the device 600 having an
anchoring member 610 with an upward-facing lip 617 at the
downstream region. In this embodiment, the ribs 614 can be formed
such that the downstream region is generally flared outwardly from
the longitudinal axis 101 but the tips 615 of the ribs 614 reorient
to point in an upstream direction at the lip 617. The lip 617 may
assist the anchoring member 610 in engaging subannular tissue and
can be configured to include tissue engaging elements (not shown)
as described above with respect to device 100. The anchoring member
610 can also be coupled to the valve support 120 at a position
desirable for positioning the valve support 120 and prosthetic
valve 130 within the native valve. For example, FIG. 57C
illustrates an embodiment of the device 600 in which the anchoring
member 610 can be coupled to the valve support 120 at a location
downstream from the upstream end 121.
[0343] Referring to FIGS. 57A-57C together, the anchoring member
610 can have a first cross-sectional dimension D.sub.C1 at the
upstream region 612 that is less than a second cross-sectional
dimension D.sub.C2 at the downstream region 611. Additionally, the
valve support 120 is radially separated from the downstream region
611 of the anchoring member 610 such that when the device 600 is
deployed, the downstream region 611 can deform inwardly without
deforming the upstream portion of the valve support 120.
Additionally, the anchoring member 610 can have a generally oval or
D-shape, or other irregular shape such as those described above
with respect to FIGS. 16A-17C, while the valve support 120 can be
generally cylindrical in shape. In such embodiments, the second
cross-sectional dimension D.sub.C2 can be greater than a
corresponding cross-sectional dimension (e.g., MVA1 or MVA2) of the
annulus of the native mitral valve (FIG. 5C).
[0344] FIG. 57D illustrates yet another embodiment of the device
600 in an expanded configuration 602. As shown, the valve support
120 can include a flange 620 at the downstream end 123 of the valve
support 120. The flange 620 can extend radially outward from the
longitudinal axis 101 at the downstream end 123 to radially engage
subannular tissue. The anchoring member 610 can include a plurality
of ribs 614 coupled to the upstream end 121 of the valve support
120 and extending radially outward in the downstream direction to
attach to an outer rim 622 of the flange 620. The anchoring member
610 can be configured to engage subannular tissue, such as
inward-facing surfaces of the leaflets. In this embodiment, the
ribs 614 can be flexible such that deformation of the anchoring
member 610 between the coupling at the upstream region 612 and the
coupling to the flange 620 at the lower region 611 will not
substantially deform the valve support 120 wherein a prosthetic
valve is connected.
[0345] FIG. 57E is a schematic cross-sectional view of the
prosthetic heart valve device 600 of FIG. 57A implanted at a native
mitral valve MV in accordance with an embodiment of the present
technology. As shown, the flared downstream region 611 of the
anchoring member 610 can engage the subannular tissue, e.g.,
inward-facing surfaces of the leaflets LF, a subannular surface,
etc. The ribs 614 can incorporate tissue engaging elements 170 on
the rib tips 615 for penetrating and/or partially penetrating the
tissue. Further, the anchoring member 610 can expand radially
outward to seal (not shown) against the tissue to prevent migration
of the device 600 in the upstream or downstream direction and/or to
prevent paravalvular leaks between the tissue and the device 600.
Accordingly, the device 600 can incorporate one or more sealing
members 140 as described above with respect to device 100.
Additionally, the device 600 can also include an atrial extension
member or atrial retainer 410 (shown in dotted lines) as described
above with respect to the device 100. The atrial retainer, if
present, can be configured to engage tissue above the annulus AN
such as a supra-annular surface or some other tissue in the left
atrium LA to inhibit downstream migration of the device (e.g.,
during atrial systole).
[0346] FIGS. 58A-58D are cross-sectional views of a heart showing a
method of delivering a prosthetic heart valve device 600 to a
native mitral valve MV in the heart using a trans-apical approach
in accordance with another embodiment of the present technology.
Referring to FIG. 58A, the delivery catheter 18 is advanced through
guiding catheter (not shown) which enters the left ventricle LV of
the heart through a puncture in the left ventricle wall at or near
the apex of the heart and is sealed by a purse-string suture.
Alternatively, the delivery catheter 18 may be placed directly
through a purse-string-sealed trans-apical incision without a
guiding catheter. The sheath 20, containing a collapsed device 600,
606 (shown in FIG. 58B), is advanced through the mitral annulus AN
between native leaflets LF as shown in FIG. 58A. Referring to FIGS.
58B-58D together, the sheath 20 is pulled proximally to allow the
device 600 to expand to the expanded and/or deployed configurations
602, 604 (FIGS. 58C and 58D).
[0347] Although the sheath 20 can be retracted and the device 600
allowed to expand, the delivery system can remain connected to the
device 600 (e.g., system eyelets, not shown, are connected to the
device eyelets, not shown) such that the operator can control the
placement of the device 600 while in the expanded configuration 602
(FIGS. 58C and 58D). For example, as the sheath 20 is disengaged
from the device 600, the upstream region 612 of the anchoring
member 610 can remain collapsed within the sheath preventing the
anchoring member 610 from fully expanding (FIG. 58C). During this
phase of the delivery, the position of the device 600 within the
mitral valve area can be adjusted or altered. After the device 600
is located at the target site, the sheath 20 can be fully removed
from the device 600 and the anchoring member 610 of the device 600
can expand outwardly at the downstream region 611 to engage
subannular tissue, such as the leaflets LF, and to retain the
device 600 in the desired target location. The pull-wires (not
shown) may be retracted in a proximal direction to release the
device 600 from the delivery system, allowing the delivery system
to be removed and the device to be fully implanted at the mitral
valve MV in the deployed configuration 104. Alternatively, the
device 600 may be expanded upstream or downstream of the desired
target location then pulled or pushed downstream or upstream,
respectively, into the target location before releasing the device
600 from delivery system.
[0348] FIGS. 59A-59C are isometric views of prosthetic heart valve
devices 700 shown in an expanded configuration 702, and FIG. 59D is
a schematic cross-sectional view of the prosthetic heart valve
device 700 implanted at a native mitral valve configured in
accordance with further embodiments of the present technology. The
prosthetic heart valve devices 700 include features generally
similar to the features of the prosthetic heart valve devices 100
and 600 described above with reference to FIGS. 10A-58D. For
example, the prosthetic heart valve device 700 includes the valve
support 120 configured to support a prosthetic valve 130 and a
first anchoring member 610 coupled to the valve support 120 in a
manner that mechanically isolates the valve support 120 from forces
exerted upon the first anchoring member 610 when implanted at the
native mitral valve. Particularly, the upstream region 612 of the
first anchoring member 610 is coupled to the valve support 120 and
the downstream region 611 of the first anchoring member 610 is
configured to flare outwardly to engage native tissue on or
downstream of the annulus so as to prevent migration of the device
600 in the upstream direction. However, in the embodiments shown in
FIGS. 59A-59D, the device 700 also includes a second anchoring
member 710 having a downstream region 711 coupled to the valve
support 120, and an upstream region 712 extending radially outward
in the upstream direction. Accordingly, the device 700 includes
both the first and second anchoring members 610 and 710 for
engaging tissue on or under the annulus of the mitral valve.
[0349] Referring to FIGS. 59A-59D together, the first anchoring
member 610 can have the first cross-sectional dimension D.sub.C1 at
the upstream region 612 that is less than the second
cross-sectional dimension D.sub.C2 at the downstream region 611.
The second anchoring member 710 can have a third cross-sectional
dimension D.sub.C3 at the upstream region 712 that is greater than
a fourth cross-sectional dimension D.sub.C4 at the downstream
region 711. In some embodiments, the third cross-sectional
dimension D.sub.C3 is less than the second cross-sectional
dimension D.sub.C2 such that the second anchoring member 710 can be
partially surrounded by the first anchoring member 610 (FIG. 59A).
In such an embodiment, the upstream region 712 can apply radial
outward pressure against an inner wall (not shown) of the first
anchoring member 610 and further support the fixation of the first
anchoring member 610 to the tissue on or under the annulus. In
another embodiment shown in FIG. 59B, the third cross-sectional
dimension D.sub.C3 can be approximately the same as the second
cross-sectional dimension D.sub.C2 such that the first and second
anchoring members 610, 710 meet at a flared junction 740. In one
embodiment, the first and second anchoring members 610 and 710 can
be coupled at the flared junction 740; however, in other
embodiments, the first and second anchoring members 610 and 710 are
not coupled. FIG. 59C shows another embodiment of the device 700
wherein the downstream region 615 of the first anchoring member 610
is separated from the upstream region 713 of the second anchoring
member 710 by a gap 750. In one embodiment, the device 700 shown in
FIG. 59C can be implanted at the native heart valve such that the
first anchoring member 610 can engage supra-annular tissue or other
cardiac tissue upstream of the annulus and the second anchoring
member 710 can engage subannular tissue or other cardiac tissue
downstream of the annulus such that the annulus is retained or
captured within the gap 750.
[0350] In a further embodiment illustrated in FIG. 59D, the third
cross-sectional dimension D.sub.C3 is greater than the second
cross-sectional dimension D.sub.C2 such that the second anchoring
member 710 can partially surround the first anchoring member 610.
In such an embodiment, the downstream region 611 of the first
anchoring member 610 can apply radial outward pressure against an
inner wall 741 of the second anchoring member 710 and further
support the fixation of the second anchoring member 710 to the
tissue on or under the annulus AN.
[0351] Additionally, the valve support 120 can be radially
separated from the downstream region 611 of the first anchoring
member 610 as well as the upstream region 712 of the second
anchoring member 710 such that when the device 700 is deployed, the
downstream region 611 and/or the upstream region 712 can deform
inwardly without substantially deforming the valve support 120 or
without deforming a support region 734 of the valve support 120
supporting the prosthetic valve 130. Additionally, the first and
second anchoring members 610, 710 can have a generally oval or
D-shape, or other irregular shape such as those described above
with respect to FIGS. 16A-17C, while the valve support 120 can be
generally cylindrical in shape. Moreover, additional features may
be incorporated on the device 700, such as sealing membranes 140
and tissue engaging elements 170 as described above with respect to
the device 100.
[0352] FIGS. 60A-60B are cross-sectional side views of a distal end
of a delivery catheter 18 for delivering the prosthetic heart valve
device 700 of FIG. 59C to a native mitral valve in the heart in
accordance with another embodiment of the present technology. As
shown in FIGS. 60A-60B the prosthetic heart valve device 700 is
collapsed into a delivery configuration 706 and retained within a
two portion delivery sheath 70 at the distal end of the catheter 18
(FIG. 60A). Upon delivery of the distal end of the catheter 18 to
the desired location at or near a native mitral valve, the device
700 can be released from the two portion sheath 70 by retracting an
upper portion 72 in a distal direction and/or retracting a lower
portion 74 in a proximal direction (shown with arrows in FIG. 60A)
thereby separating the sheath and exposing the collapsed device 700
from within the sheath 70. In one embodiment, the device 700 can
self-expand to its expanded configuration 702 following retraction
of the sheath 70 (FIG. 60B). As illustrated in FIG. 60B, when the
sheath 70 is retracted in both the proximal and distal directions,
the first and second anchoring members 610, 710 can self-expand
outwardly to engage the native tissue. When using a balloon 300 to
expand the support valve 120, the balloon 300 can be inflated to
fully expand the device 700.
[0353] FIG. 61 illustrates a prosthetic heart valve device 800
configured in accordance with another embodiment of the present
technology. FIG. 61 is a side view of the device 800 that includes
features generally similar to the features of the prosthetic heart
valve devices 100, 600, 700 described above with reference to FIGS.
10A-60B. For example, the device 800 includes a support valve 120
having upstream and downstream ends 121, 123 and an interior in
which a valve (not shown) may be coupled. The device also includes
first and second anchoring members 810 and 850. The first anchoring
member 810 has a first flared upstream portion 812 and a first
downstream portion 811 that is coupled to an outer or exterior
surface 127 of the valve support 120. The first flared upstream
portion 812 can be mechanically isolated from the valve support
120. Additionally, the first flared upstream portion 812 can be
configured to engage supra-annular tissue of the native mitral
valve. The second anchoring member 850 can be configured to at
least partially surround the first anchoring member 810 and to have
a second flared upstream portion 852 for engaging the subannular
tissue of the native mitral valve. The second anchoring member 850
can also have a second downstream portion 851 coupled to the outer
surface 127 of the valve support 120 in a manner that mechanically
isolates the valve support 120 from at least the second upstream
portion 852.
[0354] As shown in FIG. 61, the first anchoring member 810 can have
a plurality of first longitudinal ribs 814 and the second anchoring
member 850 can have a plurality of second longitudinal ribs 854. In
one embodiment, each of the individual first ribs 814 are longer
than each of the individual second ribs 854 such that the first
anchoring member 810 has a height H.sub.AM1 greater than a height
H.sub.AM2 of the second anchoring member 850. Accordingly, the
height H.sub.AM2 can be selected to orient the second anchoring
member 850 to engage subannular tissue, while the height H.sub.AM1
can be selected to orient the first anchoring member 810 to extend
through the mitral valve from the left ventricle to engage
supra-annular tissue in the left atrium.
[0355] FIG. 61 illustrates one embodiment of the device 800 that
can include a lower ring 808 on which the ribs 814, 854 can be
interconnected. The lower ring 808 can allow the ribs 814, 854 to
expand radially outward away from the valve support 120 at the
upstream portions 812, 852. The device 800 can also include a first
upper ring member 816 coupled to the plurality of first
longitudinal ribs 814. The first upper ring member 816 can be
shaped and or patterned to have a downward oriented rim 818 for
engaging supra-annular tissue. The device can further include a
second upper ring member 856 coupled to the plurality of second
longitudinal ribs 854. The second upper ring member 856 can be
shaped and or patterned to have an upward oriented rim 858 for
engaging subannular tissue.
[0356] FIGS. 62A-62C are partial cross-sectional side views of a
distal end of a delivery system 10 showing delivery of the
prosthetic heart valve device 800 of FIG. 61 at a mitral valve MV
in accordance with another embodiment of the present technology.
The device 800 can be retained in a collapsed configuration 806
within a sheath 20 of the delivery system (FIG. 62A). When the
distal end of the delivery system engages the target location, the
sheath 20 can be retracted proximally from the device 800, thereby
releasing the features of the device 800 to expand into the
expanded configuration 102 (FIGS. 62B-62C). As shown in FIG. 62B,
the second anchoring member 850 can be released first from the
retracting sheath 20 and the upward oriented rim 858 of the second
upper ring member 856 can be positioned to engage the subannular
tissue. The sheath 20 can prevent the first anchoring member 810
from disengaging from the delivery system 10 and/or moving outside
the sheath 20 until the rim 858 of the second anchoring member 850
is moved into position to engage the subannular tissue. Referring
to FIG. 62C, a plunger 11 can engage the first anchoring member 810
(as shown by downward arrow in FIG. 62B) and/or the sheath 20 can
be disengaged/retracted (shown by upward arrow in FIG. 62C) from
the first anchoring member 810 thereby allowing the second
anchoring member 850 to move radially outward to the expanded
configuration 802. The downward oriented rim 818 of the first upper
ring member 816 can be positioned to engage the supra-annular
tissue (FIG. 62C). Once deployed, the rings 816, 856 can sandwich
the annulus AN of the mitral valve and inhibit movement of the
device 800 in both upstream and downstream directions.
[0357] FIG. 63 is an isometric side view of a prosthetic heart
valve device 900 in accordance with a further embodiment of the
present technology. The device 900 includes features generally
similar to the features of the prosthetic heart valve devices 100,
600, 700 and 800 described above with reference to FIGS. 10A-62C.
For example, the device 900 includes a support valve 120 having
upstream and downstream ends 121, 123 and an interior in which a
valve (not shown) may be coupled. The device 900 includes an
anchoring member 910 that has a flared upstream portion 912 and a
downstream portion 911 coupled to the valve support 120. However,
the device 900 also includes upper and lower rings 950, 952 and a
plurality of flexible annulus engaging elements 970 distributed
around a circumference 980 of the anchoring member 910 and
configured to couple the upper ring 950 to the lower ring 952. The
flexible annulus engaging elements 970 can have a shape such as a
C-shape or U-shape that is oriented to have an open portion outward
from the device 900 such that the native annulus AN can be engaged
in recesses 971 of the annulus engaging elements 970. The annulus
engaging elements 970 can also include points 972, 973 for engaging
and potentially piercing supra-annular and subannular tissue,
respectively. The annulus engaging elements 970 can be suitably
flexible to bend in a manner that brings the points 972, 973 close
together for securing the device 900 to the annulus AN when the
device 900 is deployed.
[0358] FIGS. 64A-64B illustrate a method for deploying the device
900 at the native mitral valve. Referring to FIGS. 63 and 64A-64B
together, the annulus engaging elements 970 can be generally
relaxed or have a wide recess 971 in an open state 903. As such,
the upper ring 950 can rest above the lower ring 952 a first
distance D.sub.R1 when the elements 970 are in the open state 903.
The device 900 can also include a plurality of pull-wires 974 that
are slideably engaged with the upper ring 950 (e.g., through holes
975) and secured to the lower ring 952. When the wires 974 are
pulled in an upward or upstream direction, the lower ring 952 moves
in an upward/upstream direction toward the upper ring 950. As the
lower ring 952 approaches the upper ring 950, the annulus engaging
elements 970 can bend such that the points 972, 973 are brought
closer together and/or engage or pierce the annulus tissue (FIG.
64B). Accordingly, when the device 900 is in the deployed state
904, the upper ring 950 can be held by the pull-wires 974 at a
second distance D.sub.R2 above the lower ring 952, wherein the
second distance D.sub.R2 is less than the first distance
D.sub.R1.
[0359] FIGS. 64C-64D show an alternative arrangement of the
pull-wires 974 in which the wires 974 are secured to the upper ring
950 and are slideably engaged with the lower ring 952 (e.g.,
through holes 976). The pull-wires 974 can also be slideably
engaged with the upper ring 950 (e.g., such as through holes 975)
such that the pull-wires can be pulled in an upward direction to
bring the rings 950, 952 closer together in the deployed state
904.
[0360] FIG. 65A is an isometric side view of a prosthetic heart
valve device 1000 in accordance with a further embodiment of the
present technology. The device 1000 includes features generally
similar to the features of the prosthetic heart valve devices 100,
600, 700, 800 and 900 described above with reference to FIGS.
10A-64D. For example, the device 1000 includes a support valve 120
having upstream and downstream ends 121, 123 and an interior 134 in
which a valve 130 may be coupled. However, the device 1000 includes
an inflatable anchoring member 1010 coupled to and at least
partially surrounding the valve support 120. The inflatable
anchoring member 1010 can be configured to inflate/expand upon
deployment and engage native tissue at the desired target location.
As shown in FIG. 65A, the inflatable anchoring member 1010 can have
one or more fillable chambers 1014 for receiving a fill substance
such as a solution (e.g., saline or other liquid) or gas (e.g.,
helium, CO.sub.2 or other gas) following implantation of the device
1000. In other embodiments, the fillable chambers 1014 can be
filled with a hardening material (e.g., epoxy, cement, or other
resin).
[0361] In one embodiment, the fillable chambers 1014 and/or the
anchoring member 1010 can be formed of polytetrafluoroethylene
(PTFE), urethane, or other expandable polymer or biocompatible
material. The fillable chambers 1014 can have a predetermined shape
such that the fillable chambers 1014, when inflated, form fixation
elements 1015 for engaging the native anatomy. For example, the
fixation elements 1015 can include a supra-annular flange 1016 for
engaging a surface of the annulus AN within the left atrium LA. The
elements 1015 may also include subannular flanges 1018 for engaging
subannular tissue and/or arms 1020 for engaging leaflets LF (e.g.,
behind leaflets). Accordingly, the chambers 1014 can be
incorporated or shaped such that the anchoring member 1010 engages
supra-annular tissue, subannular tissue, leaflets or other tissue
at or near the mitral valve MV while mechanically isolating the
valve support 120 from distorting diastolic and systolic forces
generated in the heart and particularly radial forces exerted on
the device 1000 at or near the native mitral valve. For example,
following deployment, the inflatable anchoring member 1010 can
absorb pulsatile loading and other forces generated against the
device 1000 such that deformation of the anchoring member 1010 does
not substantially deform the valve support 120.
[0362] FIG. 65B is a partial cross-sectional side view of a distal
end of a delivery system 10 suitable for delivery of the prosthetic
heart valve device 1000 of FIG. 65A in accordance with another
embodiment of the present technology. As shown in FIG. 65B, the
delivery system 10 can include a delivery catheter 18 configured to
retain the device 1000 in a collapsed configuration 1006. In the
collapsed configuration 1006, the inflatable anchoring member 1010
is deflated. The delivery system 10 can also include a fill tube 90
suitable to deliver the fill substance when the device 1000 is in
position and ready for deployment. Referring to FIGS. 65A-65B
together, and in one embodiment, the inflatable anchoring member
1010 can be partially filled with the fill substance such that the
position of the device 1000 at the implant site can be adjusted to
align the fixation elements 1015 with the native tissue features
before fully expanding and/or inflating the anchoring member 1010
to hold the device 1000 in place at the target location.
[0363] FIGS. 66A-66D are cross-sectional views of prosthetic heart
valve devices 1100 having fillable chambers 1114 in accordance with
additional embodiments of the present technology. Similar to the
device 1000 discussed with respect to FIGS. 65A-65B, the devices
1100 include features such as the valve support 120 having an
interior 134 in which a valve 130 is coupled and include an
expandable anchoring member 1110 coupled to the valve support 120
in a manner that mechanically isolates the valve support 120 from
forces exerted upon the anchoring member 1110 when implanted at the
native mitral valve. The anchoring member 1110 can be coupled to
the valve support 120 such that an upstream region 1112 of the
anchoring member 1110 is configured to engage native tissue on or
downstream of the annulus so as to prevent migration of the device
1100 in the upstream direction. In the embodiments shown in FIGS.
66A-66D, the devices 1100 can also include one or more fillable
chambers 1114 configured to expand and/or inflate in an outward
direction to support an outward expansion of the anchoring member
1100 (FIGS. 66A, 66C-66D), or to engage native tissue (FIG. 66B).
In one embodiment, the fillable chambers 1114 and/or the anchoring
member 1010 can be formed of polytetrafluoroethylene (PTFE),
urethane, or other expandable polymer or biocompatible material.
The fillable chambers 1114 can have a predetermined shape such that
the fillable chambers 1114, when inflated, form fixation elements
for engaging the native anatomy (as shown in FIG. 66B) or for
engaging the anchoring member 1110 (as shown in FIGS. 66A, 66C and
66D).
[0364] Referring to FIG. 66A, the fillable chamber 1114 can be
chambers 1114 created with a space between the valve support 120
and the anchoring member 1110. Following expansion of the device
1100, the fillable chambers 1114 can be filled with a fill
substance such as a solution (e.g., saline or other liquid) or gas
(e.g., helium, CO.sub.2 or other gas). In other embodiments, the
fillable chambers 1114 can be filled with a hardening material
(e.g., epoxy, cement, or other resin). In other embodiments, the
fillable chambers 1114 can be a separate component of the device
1100, such a ring-shaped chamber 1150 coupled to an outer surface
1142 of the anchoring member 1110 (FIG. 66B) or to an inner surface
1141 of the anchoring member 1110 or to an exterior surface 127 of
the support valve 120. In FIGS. 66C-66D, for example, the
ring-shaped chamber 1150 can provide additional support to the
anchoring member 1110 such that inward deformation is counteracted
by the presence of the ring-shaped chamber 1150. Additionally, as
shown in FIG. 66D, the fillable chamber 114 can be a ring-shaped
chamber 1150 that deforms the anchoring member 1110 in an outward
direction against the native tissue.
[0365] In accordance with another aspect of the present technology,
FIGS. 67A-67B illustrates other embodiments of a prosthetic heart
valve device 1200. Referring to FIGS. 67A-67B together, the device
1200 can include a radially expandable anchoring member 1210
configured to engage native tissue on or downstream of the annulus,
and a support valve 120 and/or a prosthetic valve 130 coupled to an
interior portion 1234 of the anchoring member 1210. The anchoring
member 1210 can have a first longitudinal length L.sub.L1 on a
posterior leaflet-facing side 1222 of the anchoring member 1210 and
have a second longitudinal length L.sub.L2 on an anterior
leaflet-facing side 1224 of the anchoring member 1210. As shown in
FIG. 67A, the first length L.sub.L1 is greater than the second
length L.sub.L2 such that occlusion of a left ventricle outflow
tract (LVOT) is limited. Accordingly, in one embodiment, the
posterior leaflet-facing side 1222 can provide suitable fixation
and support for the anchoring member 1210 by engaging the thicker
ventricular wall and tissue on the posterior leaflet side of the
mitral valve. Concurrently, the shorter anterior leaflet-facing
side 1224 of the anchoring member 1210 can have sufficient sealing
and conformability to engage the anterior leaflet and/or subannular
tissue aligned with the anterior leaflet of the native valve.
[0366] Optionally, the device 1200 can also include one or more
stabilizing elements such as an arm 1250 coupled to the anchoring
member 1210 for engaging a leaflet and/or a subannular surface. In
FIG. 67A, the arm 1250 can be coupled to a downstream end 1223 of
the anchoring member 1210 on the posterior leaflet-facing side 1222
of the anchoring member 1210 and be configured to extend behind the
posterior leaflet. In one embodiment, the arm 1250 can be
configured to sandwich the posterior leaflet between the arm 1250
and the anchoring member 1210.
[0367] In FIG. 67B, the device 1200 can include first and second
arms (individually identified as 1250a and 1250b) coupled to the
anchoring member 1210 for engaging leaflets and/or subannular
surfaces. For example, the first arm 1250a can be coupled to the
downstream end 1223 at the anterior leaflet-facing side 1224 of the
anchoring member 1210 with extension 1251a and can be configured to
further extend behind the anterior leaflet. The second arm 1250b
can be coupled to the downstream end 1223 of the posterior
leaflet-facing side 1222 of the anchoring member 1210 with
extension 1251b and be configured to extend behind the posterior
leaflet. In the illustrated embodiment, the extensions 1251a and
1251b can vary with respect to each other and be selected based on
the anatomy of the target tissue. In other embodiments, not shown,
the arm 1250 and or the anchoring member 1210 can include tissue
engaging elements as described above with respect to device 100 for
further positioning and stabilizing of the device 1200 at the
desired target location. One of ordinary skill will recognize that
the valve support 120 can also be uneven or have sides having
different lengths such that the valve support will not
substantially occlude the left ventricle outflow tract (LVOT).
[0368] FIGS. 68A-68B are side views of prosthetic heart valve
devices 1300 shown in an expanded configuration 1302 and configured
in accordance with an additional embodiment of the present
technology. The prosthetic heart valve devices 1300 include
features generally similar to the features of the prosthetic heart
valve device 100 described above with reference to FIGS. 10A-56.
For example, the prosthetic heart valve device 1300 includes the
valve support 120 configured to support a prosthetic valve 130 and
an anchoring member 110 coupled to the valve support 120 in a
manner that mechanically isolates the valve support 120 from forces
exerted upon the anchoring member 110 when implanted at the native
mitral valve. However, in the embodiments shown in FIGS. 68A-68B,
the device 1300 also includes a positioning element 1350 configured
to adjust or maintain a desired position of the device 1300 within
or near the native mitral valve (e.g., away from the LVOT). The
positioning element 1350 can be coupled to the downstream portion
111 of the anchoring member 110 (as shown in FIGS. 68A-68B), the
upstream portion 112 of the anchoring member 110, or to the valve
support 120, at an element connection point 1352 and extend outward
from the element connection point 1352 to engage ventricular tissue
at a desired location. In one embodiment, the positioning element
1350 can extend outward from the device 1300 in a direction
approximately transverse to the longitudinal axis 101. In other
embodiments, not shown, the positioning element 1350 can extend
outwardly from the device 1300 at an obtuse or an acute angle
relative to the longitudinal axis 101 for engaging the ventricular
tissue at the desired location.
[0369] In the embodiment shown in FIG. 68A, the positioning element
1350 can include a positioning arm 1354 and a tissue engaging
portion 1356 coupled to the distal arm end 1358 of the positioning
arm 1354. The positioning arm 1354 and tissue engaging portion 1356
together can extend a desired positioning distance D.sub.P1 away
from the element connection point 1352 on the device 1300 (e.g.,
from the anchoring member 110) such that the distal end 1360 of the
positioning element 1350 can engage ventricular tissue, such as a
ventricular wall. In some embodiments, the positioning distance
D.sub.P1 can be selected to be greater than a distance between the
implanted device 1300 and the ventricular tissue such that the
positioning element 1350, after engaging the ventricular tissue,
extends the distance between the implant device 1300 and the
ventricular tissue. In this way, the device 1300 can be positioned,
aligned and maintained in an alternate position within or near the
mitral valve.
[0370] The tissue engaging portion 1356 can be configured to
contact the ventricular tissue, or other tissue (e.g., annular
tissue, leaflet tissue, etc.), in an atraumatic manner such that
the tissue engaging portion 1356 does not penetrate or pierce the
tissue. In one embodiment, the tissue engaging portion 1356 can be
resilient and/or be formed of a shape memory material (e.g.,
Nitinol) that can be partially deformed when engaging tissue. For
example, the tissue engaging portion 1356 can be configured to
absorb forces generated by the ventricular tissue (e.g.,
ventricular wall) during e.g., systole, without translating
movement or altering a desired position of the device 1300 with
respect to the native mitral valve. In other embodiments, the
distal end 1360 of the positioning element 1350 can have other
shapes or configurations that penetrate the ventricular tissue. The
device 1300 can include one or more positioning elements 1350
disposed around the device 1300 for positioning and/or maintaining
a desired position of the device 1300 with respect to native
anatomy. For example, it may be desirable to increase the distance
between the device 1300 and the left ventricular outflow tract
(LVOT), and a positioning element 1350 can be configured to engage
ventricular tissue to push or encourage the device 1300 a selected
distance away from the LVOT.
[0371] In the embodiment shown in FIG. 68B, the positioning element
1350 can include a looped tissue engaging portion 1358 coupled to
the device 1300 at the connection point 1352. The looped tissue
engaging portion 1358 can extend the desired positioning distance
D.sub.P1 away from the element connection point 1352 on the device
1300 (e.g., from the anchoring member 110) such that the distal end
1360 of the looped tissue engaging portion 1358 can engage
ventricular tissue, such as a ventricular wall. The looped tissue
engaging portion 1358 can be configured to absorb radially
contracting forces or other forces generated and transmitted by the
ventricular tissue (e.g., within the left ventricle) such that they
are not transmitted to or can change the position of the device
1300 with respect to the native heart valve. Accordingly, the
device 1300 can be positioned, aligned and maintained in an
alternate position within or near the mitral valve.
[0372] In another embodiment, not shown, a positioning structure,
separate from the prosthetic heart valve device 100, can be
implanted or otherwise positioned in the left ventricle (e.g., at
or near the LVOT) and which can be configured to engage portions of
the device 100, such as the anchoring member 110. Accordingly, such
a positioning structure can be provided to prevent the device 100
from obstructing or partially obstructing the LVOT. In one
embodiment, not shown, the positioning structure could be a
stent-like cylinder or cage that expands into engagement with the
ventricular wall and keeps the LVOT clear to allow blood to flow
freely from the left ventricle through the aortic valve. In one
example, the positioning structure could be delivered by catheter
that is inserted through the aorta and the aortic valve into the
left ventricle, or through the apex or the left atrium via the same
delivery catheter used for delivering and implanting the device
100.
[0373] FIGS. 69A-69E are cross-sectional and side views of
prosthetic heart valve devices 1400 shown in an expanded
configuration 1402 and configured in accordance with an additional
embodiment of the present technology. The prosthetic heart valve
devices 1400 include features generally similar to the features of
the prosthetic heart valve devices 100, 600 described above with
reference to FIGS. 10A-57E. For example, the prosthetic heart valve
devices 1400 include the valve support 120 configured to support a
prosthetic valve 130 and an anchoring member 110 or 610 coupled to
the valve support 120 in a manner that mechanically isolates the
valve support 120 from forces exerted upon the anchoring member 110
when implanted at the native mitral valve. However, in the
embodiments shown in FIGS. 69A-69E, the devices 1400 also includes
a an expandable tissue-engaging ring 1450 coupled to a tissue
engaging portion of the anchoring member 110 and configured to
provide additional contact surface for engaging native tissue at or
near the annulus of the heart valve.
[0374] In one embodiment, shown in FIGS. 69A-69B, the expandable
tissue-engaging ring 1450 can be coupled to an upstream perimeter
113 of the anchoring member 110 and have a tissue-engaging surface
1452 facing in an outward direction relative to the device 1400. In
some embodiments, the tissue-engaging surface 1452 can have
tissue-engaging elements 170 for engaging and/or piercing the
tissue. In another embodiment, shown in FIG. 69C, the expandable
tissue-engaging ring 1450 can be coupled to a downstream perimeter
115 of the anchoring member 1410 and have a tissue-engaging surface
1452 facing in an outward direction relative to the device 1400. In
another embodiment shown in FIG. 69D, the expandable
tissue-engaging ring 1450 may include a plurality of fibrous
elements 1454 (e.g., fiber elements) that can be configured to
encourage tissue ingrowth, thrombus and/or be configured to provide
a seal between the anchoring member 110 and the tissue. In various
arrangements, the expandable tissue-engaging ring 1450 can expand
and contract between various deployment and delivery
configurations.
[0375] FIG. 69E shows another embodiment of the prosthetic heart
valve device 1400 having the expandable tissue-engaging ring 1450.
In this embodiment, the device 1400 can have a valve support 120
coupled to a first anchoring member 110 and a second anchoring
member. In one embodiment, the first anchoring member 110 can be
coupled to the valve support 120 at the downstream end 123 and
extends outward and in an upstream direction. The second anchoring
member 1410 can be coupled to the valve support 120 at the upstream
end 121 and extend outward and in a downstream direction. The
expandable tissue-engaging ring 1450 can be coupled to the distal
portions of the first and second anchoring members 110, 1410 and
have the tissue-engaging surface 1452 facing in an outward
direction relative to the device 1500 for engaging tissue at or
near the annulus AN or leaflets LF. In a particular example, the
expandable tissue-engaging ring 1450 can have a first end 1460
coupled to an upstream end 1461 of the first anchoring member 110.
The expandable tissue-engaging ring 1450 can also have a second end
1470 coupled to a downstream end 1471 of the second anchoring
member 1410. The tissue-engaging surface 1452 may also include
tissue engaging elements 170 for engaging and/or piercing the
tissue at the target location.
[0376] Referring to FIGS. 69A-69E together, the outward radial
force of the expandable tissue-engaging ring 1450 against the
tissue and supported by the anchoring members 110 and/or 1410 can
prevent the device 1400 from migrating in an upstream direction.
Additionally, the expandable tissue-engaging ring 1450 along with
at least the portions of the anchoring members 110 and/or 1410 that
are uncoupled from the valve support 120 can effectively
mechanically isolate the valve support 120 and the valve 130 from
compromising radially compressive forces exerted on the device 1400
from the heart valve tissue.
[0377] FIG. 70 is a cross-sectional side view of another prosthetic
heart valve device 1500 configured in accordance with an embodiment
of the present technology. The device 1500 can also include
features as described above including a valve support 120 and a
prosthetic valve 130 retained within the valve support 120. The
device 1500 can also include a plurality of anchoring members
(individually identified as 110a-c). The anchoring members 110a-c
can be coupled at respective downstream perimeters 115a-c to the
valve support 120 and be separated by gaps 1515 such that
respective upstream perimeter 113a-c can engage cardiac tissue at
variable target locations at the native valve. Optionally, the
device 1500 can also include the expandable tissue-engaging ring
1450 (FIGS. 69A-D) such as those having tissue engaging features
170 for further engaging tissue at the native valve. In one
embodiment, the expandable tissue-engaging ring 1450 can be coupled
to the upstream perimeter of more than one anchoring member (e.g.,
the upstream perimeters 113b and 113c of anchoring members 110b and
110c). However, in other arrangements, the device 1500 will not
have the expandable tissue-engaging ring 1450.
[0378] FIG. 71 is a cross-sectional side view of yet another
prosthetic heart valve device 1600 configured in accordance with an
embodiment of the present technology. The device 1600 can also
include features as described above including a valve support 120
and a prosthetic valve 130 retained within the valve support 120.
The device 1500 can also include the anchoring member 110. However,
the device 1600 can also include an expandable retainer 1610 for
further engaging tissue at or near the native valve annulus. In one
embodiment, the retainer 1610 can be an extension of upstream end
121 of the valve support 120, however, in another embodiment, the
retainer 1610 can include a separate expandable feature coupled to
the upstream end 121 of the valve support. In some arrangements,
the retainer 1610 can be mechanically isolated from the valve
support 120 such that forces generated at the native valve are
absorbed or otherwise translated by the retainer 1610. In this
manner, the retainer 1610 may be deformed by radial forces exerted
on the retainer 1610 while the valve support remains substantially
undeformed.
[0379] In one embodiment, as shown, the anchoring member 110 can be
configured to engage the retainer 1610; however, in other
embodiments, the anchoring member 110 can be positioned differently
such that the anchoring member 110 contacts tissue different than
that of the retainer 1610. For example, the anchoring member 110
may extend outside a radius (not shown) of the retainer to contact
subannular tissue. Additional details and embodiments regarding the
structure, delivery and attachment of retainers 1610 suitable for
use with the prosthetic heart valve devices disclosed herein can be
found in International PCT Patent Application No. PCT/US2012/61215,
(Attorney Docket NO. 82829-8005WO00), entitled "DEVICES, SYSTEMS
AND METHODS FOR HEART VALVE REPLACEMENT," filed Oct. 19, 2012, the
entire contents of which are incorporated herein by reference.
[0380] FIG. 72 is an isometric view of a prosthetic heart valve
device 1700 in accordance with another embodiment of the present
technology. The device 1700 can include an anchoring member 110, a
valve support 120 positioned radially within at least a portion of
the anchoring member 110, and a prosthetic valve 130 retained
within the valve support 120. The device 1700 can further include a
first sealing member portion 140a coupled to an inner wall of the
anchoring member 110 and a second sealing member portion 140b
coupled to the inner wall of the valve support 120. In other
embodiments, the first sealing member portion 140a can be coupled
to the outer wall of the anchoring member 110 and/or the second
sealing member portion 140b can be coupled to the outer wall of the
valve support 120. The first and second sealing member portions
140a and 140b can be integral portions of a single sealing member,
or the first and second sealing member portions 140a and 140b can
be separate sealing members that are attached independently to the
anchoring member 110 and the valve support 120. The first and
second sealing member portions 140a and 140b will in any event
together form a sealed bather between the valve support 120 and the
anchoring member 110 to inhibit or prevent blood from flowing
outside of the valve support 120 as blood flows from the atrium to
ventricle or vice versa. As with several embodiments described
above, an upstream portion 121 of the valve support 120 is spaced
radially inward from the anchoring member 110, and a downstream
portion 123 of the valve support 120 is coupled to the anchoring
member 110.
[0381] FIG. 73 is a side view of the prosthetic heart valve device
1700, and FIG. 74 is a bottom isometric view of the prosthetic
heart valve device 1700. The anchoring member 110 can include a
fixation portion 1710 configured to securely fix the anchoring
member 110 to tissue at a native heart valve, an integration region
1720 configured to integrate the anchoring member 110 with the
valve support 120, and a lateral portion 1730 between the fixation
portion 1710 and the integration region 1720. The fixation portion
1710, integration region 1720, and lateral portion 1730 can be
formed by a plurality of structural elements 1711 that can extend
from the fixation portion 1710 to the integration region 1720. The
integration region 1720 and the lateral region 1730 can
collectively or individually define a connection structure that
positions and controls the fixation portion 1710 relative to the
valve support 120. The structural elements 1711 can be shaped and
connected to form diamond-shaped or other structural configurations
that provide the desired strength and flexion. The structural
elements 1711 can be struts or other structural features formed
from metal, polymers, or other suitable materials that can
self-expand or be expanded by a balloon or other mechanical
expander.
[0382] Several embodiments of the fixation portion 1710 can be a
generally cylindrical fixation ring having an outwardly facing
engagement surface 1712, which may be a large, generally
cylindrical surface for engaging tissue at or near the annulus of a
native valve. For example, the outer surface of the fixation
portion 1710 can extend in a direction P-P that is at least
substantially parallel to a longitudinal axis L-L, or the fixation
portion 1710 can be inclined to converge from the lateral portion
1730 toward the longitudinal axis L-L such that all or a portion of
the fixation ring is tapered in the upstream direction. For
example, the fixation portion 1710 can be inclined inwardly (arrow
I) toward the longitudinal axis L-L in the upstream direction at an
angle of 0 to -30.degree. relative to the longitudinal axis L-L. In
other embodiments, the fixation portion 1710 can be inclined
outwardly (arrow O) from the longitudinal axis L-L by an angle of 0
to 45.degree. to increase the outward radial force. In several
embodiments, the fixation portion 1710 can be parallel to an
outwardly facing surface of the valve support 120.
[0383] Several embodiments of the anchoring member 110 are
configured to press the engagement surface 1712 against tissue at
an implant site on or below a native annulus of the native heart
valve when the orientation of the fixation portion 1710 is at least
generally parallel to the longitudinal axis L-L or tapered inwardly
in the upstream direction. The fixation portion 1710 may have such
a configuration in an unbiased state before implantation, or it may
assume this inwardly tapered configuration through deformation
imposed by engagement with tissue at the implant site. For example,
the fixation portion 1710 can be deflectable through a range of
angles relative to the longitudinal axis L-L such that upon
engagement with the tissue the fixation portion 1710 moves from an
unbiased state to the implanted orientation in which it is
orientated at least substantially parallel to or tapered in the
upstream direction toward the longitudinal axis L-L. As explained
in more detail below, the large, generally cylindrical area of the
outer surface of the fixation portion 1710 and the orientation of
the fixation portion 1710 in a direction P-P provide good fixation
to the annulus and subannular tissue of a native mitral valve or
other heart valve. In several embodiments, the fixation portion can
have a height (H.sub.f) of 10 mm-20 mm.
[0384] The fixation portion 1710 of the anchoring member 110 may
have different regions of radial stiffness along the P-P axis.
These regions can conform to and exert an outward radial force on
the surrounding anatomy to provide fixation and sealing. In one
example, the radial stiffness may be greater in the region of the
fixation portion that is downstream of the annulus and lesser in
the region that is in contact with and upstream of the annulus.
This combination would provide a region downstream of the annulus
that resists compression and ensures that the device maintains its
fixation with respect to the anatomy when subjected to a systolic
pressure gradient and a region at the annulus that allows some
compression (preventing dilation of the annulus), but maintains
sufficient radial outward force to keep the fixation portion in
contact with the anatomy to provide sealing between the device and
the anatomy.
[0385] Radial stiffness may be controlled by the design of the
structural elements of the attachment portion 1720 and/or the
lateral portion 1730, the taper angle or curve between these
regions and the fixation portion 1710, or a combination of those
properties. The design of the structural elements 1711 of the
fixation portion 1710 may have different properties (wall
thickness, width, length, angle, etc.) along with the P-P axis to
provide regions of different radial stiffness. Additionally, the
fixation portion 1710 can have a first flexibility and the
integration region 1720 and/or the lateral portion 1730 can have a
second flexibility different than the first flexibility. The
fixation portion 1710 can itself have a downstream region with a
first flexibility and an upstream region with a second flexibility
different than the first flexibility.
[0386] The fixation portion 1710 can further include a plurality of
tissue engaging elements 170 configured to penetrate into the
annulus and/or subannular tissue. The prosthetic heart valve device
is preferably anchored solely by the engagement of fixation portion
1710 with the native tissue, which resists the high forces of blood
against the device during ventricular systole. Other means of
anchoring, such as tissue-engaging arms or tethers coupled to the
native tissue, are not required. Thus, the tissue engaging elements
170 are configured to engage the native tissue to reliably resist
movement of the device without fully penetrating or perforating the
leaflets or heart wall tissue, or otherwise causing undue trauma as
the heart beats. Because the upstream forces during ventricular
systole are so high, the tissue engaging elements 170 will
preferably project at least in the upstream direction to inhibit
movement of anchoring member 110 in the upstream direction relative
to the native tissue. Smaller forces are exerted on the device in
the downstream direction during diastole, so in some cases
downstream-projecting tissue engaging elements may also be
desirable (e.g., project superiorly in the case of a mitral valve).
In one embodiment, the fixation portion 1710 can include an upper
row 171a of tissue engaging elements that project superiorly and
inferiorly, a second row 171b of tissue engaging elements that also
extend superiorly and inferiorly, and a third row 171c of tissue
engaging elements that extend superiorly. The tissue engaging
elements 170 can be barbs, tines, pins, or other elements that
penetrate into or otherwise grip the tissue of the native annulus
and/or native subannular tissue. In several embodiments, the tissue
engaging elements 170 project radially outward from the structural
elements 1711 of the fixation portion 1710 by a distance of
approximately 0.5-5 millimeters.
[0387] The integration region 1720 of the anchoring member 110 can
be formed from the lower portions of the structural elements 1711.
In the embodiment illustrated in FIGS. 73 and 74, the integration
region 1720 has a plurality of diamond-shaped structures 1722 and
vertical members 1724. In the illustrated embodiment, each of the
vertical members 1724 can include a portion of two of the
structural elements 1711. In several embodiments, the anchoring
member 110 and the valve support 120 are made from separate struts,
and the integration region 1720 is an attachment portion or
fastening portion of the anchoring member 110 that is attached to
the valve support 120. For example, when the anchoring member 110
and the valve support 120 are separate components, the integration
region 1720 can be an attachment portion including a plurality of
connecting points 1726 where the integration region 1720 is coupled
to the valve support 120. In one embodiment, the integration region
1720 of the anchoring member 110 can be connected to the valve
support 120 at a plurality of connecting points 1726 (e.g., 12)
using Nitinol rivets. In other embodiments, threads, adhesives,
solder, laser welding, metal bolts or other mechanical features, or
other types of fasteners can be used to secure the valve support
120 to the integration region 1720. The integration region 1720 can
thus be a fastening portion.
[0388] In other embodiments, the anchoring member 110 and the valve
support 120 are integrally formed together from common struts, or a
number of struts can be integrally formed with both the anchoring
member 110 and the valve support 120. In these embodiments, the
integration region 1720 is the structure that transitions from the
anchoring member 110 to the valve support 120 without otherwise
being fastened together. For example, the integration region 1720
can be a curved or otherwise bent portion of such struts between a
cylindrically shaped valve support 120 and the portion of the
anchoring member 110 that projects away from the valve support
120.
[0389] The lateral portion 1730 extends between the upper region of
the integration region 1720 and the lower region of the fixation
portion 1710 in the embodiment shown in FIGS. 72-74. The lateral
portion 1730, for example, extends laterally outward from the
integration region 1720 to the fixation portion 1710. In one
embodiment, the lateral portion 1720 includes a plurality of
connectors 1732 having lateral sections 1733 (FIG. 74) formed from
a portion of the structural elements 1711. The lateral sections
1733 of the connectors 1732 extend laterally, which in several
embodiments is a direction transverse to the longitudinal axis L-L
in an outwardly straight, conical, curved, or outwardly angled
(e.g., flared) configuration. Additionally, "traverse direction"
includes any non-parallel direction relative to the longitudinal
axis L-L. The connectors 1732 can have a first transition zone 1734
that curves from the orientation of the fixation portion 1710,
which is generally parallel to or canted inwardly toward the
longitudinal axis L-L, to the lateral sections 1733 of the
connectors 1732 that are transverse to the longitudinal axis L-L.
In many embodiments the lateral sections 1733 of the connectors
1732 are nearly perpendicular or perpendicular to the longitudinal
axis L-L. The connectors 1732 can also have second transition zone
1736 that curves from the lateral sections 1733 of the connectors
1732 to the orientation of the integration region 1720 that extends
at least generally parallel to the longitudinal axis L-L (FIG. 73).
In the embodiment shown in FIG. 73, the first transition zone 1734
is an inward and/or superior bend at an angle of approximately
60.degree.-160.degree. (e.g., approximately 90.degree.) from the
lateral sections 1733 to the orientation of the engagement surface
1712 of the fixation portion 1710. The second transitional zone
1736 can be a downward and/or inferior bend at an angle in the
range of 75.degree.-160.degree. (e.g., approximately 90.degree.)
from the lateral sections 1733 of the connectors 1732 to the
integration region 1720. The smaller angles result in an S-Shape;
the larger angles result in a tapered transition as shown in FIG.
75. The first transition zone 1734 can thus be a concave curve with
respect to the longitudinal axis L-L, and similarly the second
transition zone 1736 can be a convex curve with respect to the
longitudinal axis L-L. The curves of the first transition zone 1734
and the second transitional zone 1736 enable the fixation portion
1710 to present a large engagement surface 1712 to contact the
annulus and leaflets of the native heart valve to provide good
fixation of the device 1700. The connectors 1732 also enable the
fixation portion 1710 to flex based on the shape of the native
annulus and the contraction of the left ventricle without
transmitting the full forces of such flexure of the fixation
portion 1710 to the upstream portion 121 of the valve support 120
where the prosthetic valve 130 is attached. The device 1700
accordingly provides enhanced fixation to the native tissue and
sufficient mechanical isolation between the fixation portion 1710
and the upstream portion 121 of the valve support 120 such that the
prosthetic leaves of the prosthetic valve 130 maintain sufficient
contact with each other to inhibit backflow after the anchoring
member 110 has been implanted at a native mitral valve and during
left ventricular contraction.
[0390] In several embodiments, as explained above, the integration
region 1720 and the lateral portion 1730 can individually or
collectively define a connecting structure that interconnects the
anchoring member 110 and valve support 120. The connecting
structure can comprise a plurality of struts that each have an
inner end connected to or integral with the valve support 120 and
an outer end connected to or integral with the anchoring member
110. For example, the connecting structure can be a flared portion
that flares outwardly from the valve support 120 in the upstream
direction, and in selected embodiments the connecting structure can
be configured to be disposed entirely downstream of the native
annulus when the anchoring member is at the implant site. The
connecting structure can have an upstream end connected to the
anchoring member such that the upstream end is positioned below the
native annulus when the anchoring member is at the implant
site.
[0391] The anchoring member 110 can thus include the fixation
portion 1710 and the connection structure 1720/1730, and the
connection structure 1720/1730 can have an inner end connected to
the valve support 120, an outer end connected to the fixation
portion 1710, and an intermediate portion between the inner end and
the outer end which flares outwardly from the valve support 120.
The intermediate portion, for example, can flare outwardly in an
upstream direction.
[0392] The fixation portion 1710 can have a skirt covering an
inward-facing surface of the fixation portion 1710, and in
additional embodiments the skirt can further cover an inward-facing
side of the connecting structure. Additionally, the device 1700 can
further include a tubular valve cover extending around the valve
support, and the skirt can be attached to the tubular valve cover.
In additional embodiments, the valve cover is disposed on an inward
facing surface of the valve support.
[0393] FIG. 75 is a side view of another embodiment of the
prosthetic heart valve device 1700, and FIG. 76 is a bottom view of
the prosthetic heart valve device 1700 shown in FIG. 75. In this
embodiment, the connectors 1732 of the lateral portion 1730 are
defined by laterally extending portions of individual structural
elements 1711 that extend between the fixation portion 1710 and the
integration region 1720. Referring to FIG. 76, each connector 1732
includes a single one of the structural elements 1711 as opposed to
two structural elements 1711 as shown in FIGS. 72-74. Additionally,
the connectors 1732 are inclined at a non-perpendicular angle with
respect to the longitudinal axis L-L of the device 1700. The
connectors 1732 nonetheless each include a first transition 1734
bending from the connectors 1732 to the fixation portion 1710, and
a second transition zone 1736 bending from the connectors 1732 to
the integration region 1720.
[0394] FIG. 77 is a side view of the prosthetic heart valve device
1700 in accordance with another embodiment of the present
technology. In this embodiment, the device 1700 wraps a portion of
the first sealing member portion 140a around a rim 1714 of the
fixation portion 1710 of the anchoring member 110. The section of
the first sealing portion 140a wrapped over the rim 1714 provides
an atraumatic edge to protect the roof of the left atrium during
implantation and use.
[0395] FIG. 78 is an isometric view of the prosthetic heart valve
device 1700 in accordance with yet another embodiment of the
present technology. In this embodiment, the material of the second
sealing portion 140b on the inside of the valve stent 120 has
openings 142a-142c spaced apart from each other around the
perimeter of the valve support 120. The openings 142a-142c are
spaced between the commissures where the prosthetic valve 130 is
attached to the second sealing portion 140b. In operation, the open
areas 142a-142c are expected to decrease static blood volume on the
atrial side of the device 1700 to reduce fibrin and thrombus
deposition and to provide better flow dynamics.
[0396] FIGS. 79A and 79B are partial cross-sectional views of a
heart (H) and side views of an embodiment of the prosthetic heart
valve device 1700 showing an embodiment of a method for implanting
the prosthetic heart valve device 1700 in accordance with the
present technology. Referring to FIG. 79A, the device 1700 is
attached to a delivery device 1800 (shown schematically) and
inserted into the heart (H) via a transapical approach in a
low-profile configuration (not shown). The device 1700 is inserted
superiorly (arrow S) through the native mitral valve (MV). The
fixation portion 1710 of the device 1700 can be positioned in the
left atrium (LA) at this stage of the procedure, and then relative
movement between an outer member 1810 and an inner member 1820 of
the delivery device 1800 can release the fixation portion 1710 from
the delivery device 1800. The fixation portion 1710 can then
self-expand or be expanded using a balloon or other mechanical
expander to a partially deployed state in which the integration
region 1720 remains attached to the delivery device 1800. In the
partially deployed state shown in FIG. 79A, the fixation portion
can have a diameter that is larger than the opening defined by the
annulus (AN) of the mitral valve (MV). In selected embodiments, the
outer diameter of the fixation portion 1710 of the device 1700 can
be between approximately 38 mm and 56 mm depending on the size and
shape of the native annulus (AN) of the mitral valve (MV). It will
be appreciated that other sizes can be used depending on the
specific anatomy of a patient.
[0397] FIG. 79B illustrates the prosthetic heart valve device 1700
after it has been positioned at a desired location with respect to
the annulus (AN) of the native mitral valve (MV). The device 1700
reaches the position shown in FIG. 79B by moving the delivery
device 1800 (FIG. 79A) inferiorly (arrow W) until the fixation
portion 1710 contacts and fixedly engages the annulus (AN). In some
embodiments, the rim 1714 of the fixation portion 1710 can project
slightly superior of the annulus (AN). The rim 1714 can accordingly
be positioned approximately 1-5 mm above the native annulus (AN) at
the anterior leaflet (AL) side of the atrium (LA) in such
embodiments. In other embodiments, the rim 1714 of the fixation
portion 1710 can be positioned at or below the upper rim of the
annulus (AN) such that the fixation portion 1710 contacts at least
the annulus (AN) and potentially a portion of the anterior leaflet
(AL) and/or the posterior leaflet (PL) of the mitral valve (ML). In
still other embodiments, the rim 1714 of the fixation portion 1710
can be positioned at a subannular (SA) location underneath the
annulus (AN) (not shown in FIG. 79B). After the device 1700 is
positioned at a desired location relative to the annulus (AN) of
the mitral valve (MV), the delivery device 1800 (FIG. 79A) is
withdrawn inferiorly (arrow W in FIG. 79A) and removed from the
patient.
[0398] In the embodiment shown in FIG. 79B, the device 1700 is
implanted such that the rim 1714 is approximately 1-5 mm above the
native annulus (AN). Since the diameter of the fixation portion
1710 in the expanded configuration is greater than that of the
native annulus (AN), the outer surface of the fixation portion 1710
and the tissue engaging members 170 securely hold the anchoring
member 110 with respect to the mitral valve (MV).
[0399] FIG. 79C is an anatomical cross-section view of a heart (H)
showing the device 1700 implanted at a location slightly lower than
the position shown in FIG. 79B such that the rim 1714 of the
fixation portion 1710 pushes outward under a portion (AN1) of the
native annulus (AN). The device 1700 can also be implanted lower
than the elevation shown in FIG. 79C. For example, the rim 1714 of
the fixation portion 1710 can be positioned at an elevation E-E at
the bottom of the annulus (AN) or even at the subannular space
(SA). In all of these embodiments, the portion of the native
annulus (AN) over the rim 1714 further restricts the device 1700
from moving upwardly into the left atrium (LA) during ventricular
systole.
[0400] FIG. 79D is a schematic view showing an aspect of implanting
the device 1700 as shown above in FIG. 79B or 79C, or in many other
applications as well. Referring to FIG. 79D, the
outwardly-projecting portion of the anchoring member 110 that
extends from the valve support 120 to the fixation portion 1710,
which can be the laterally curved connection structure 1730a in
FIG. 79D, is preferably located entirely downstream of the native
annulus (AN) as shown in FIGS. 79B and 79C. For example, the
transition zone 1734 between the connecting structure 1730a and the
fixation portion 1710 can be located inferiorly of the lower
portion (LMV) of the mitral valve annulus (AN) to urge or drive the
downstream end of fixation portion 1710 outwardly below the annulus
(AN). This allows the anchoring member 110 to engage tissue on the
downstream surface of the native annulus so that that upstream
forces against the prosthetic device 1700 during ventricular
systole are resisted by both the resulting upward force against the
annulus (AN) as well as the outward pressure of the fixation
portion 1710 against the annulus (AN), friction between the
fixation portion 1710 and the annulus (AN), and the engagement of
tissue engaging elements 170 with the native tissue.
[0401] The anchoring member 110 and the valve support 120 can be
configured such that the downstream end of the valve support 120 is
disposed not more than 26 mm downstream of the native annulus (AN).
Additionally, the fixation portion 1710 can be configured such that
the engagement surface has a width (e.g., height) of at least about
10-20 mm. The connecting structure can additionally have a height
(H.sub.i in FIG. 73) of not more than about 0-15 mm downstream from
the end at the valve support 120 to the outer end at the fixation
portion 1710. The total height (H.sub.t FIG. 73) of the device 1700
can be approximately 16-26 mm.
[0402] The large contact area of the engagement surface 1712 (FIG.
73) that faces the tissue located at or near the annulus (AN)
provides exceptionally good fixation to hold the device 1700 at a
desired location, and the tissue engaging elements 170 around the
fixation portion 1710 further enhance the fixation of the device
1700 to the region of the annulus (AN). The transverse orientation
of the connectors 1732 further provides significant outward support
of the fixation portion 1710 to exert a sufficient outward force
against the annulus (AN), yet the orientation and configuration of
the connectors 1732 in combination with attaching the valve support
(not shown in FIG. 79B) to the terminus of the integration region
1720 isolates the upstream portion of the valve support from forces
exerted by the fixation portion 1710 to accommodate for the
irregular shapes and motion of the mitral valve (MV) after
implantation. Also, as noted above, the anchoring member further
secures the device 1700 to the anatomy by compressing upwardly
against the bottom or lower portion of the native annulus (AN) in
combination with the friction and radial hoop force exerted by the
fixation portion 1710 and the tissue engaging elements as described
above with reference to FIGS. 79B-79D. Tests of the device 1700
further show that tissue grows in and around the fixation portion
1710, which further secures the device 1700 to the desired location
relative to the annulus (AN).
[0403] FIGS. 80A-80P are schematic cross-sectional views and FIG.
80Q is an isometric view of several additional embodiments of
prosthetic heart valve devices 1700 in accordance with the present
technology. Like reference numbers refer to similar or identical
components in FIGS. 72-80Q. The embodiment of the device 1700
illustrated in FIG. 80A represents several of the embodiments
described above with reference to FIGS. 72-79D. In this embodiment,
the connectors 1732 extend at an angle .alpha. of
30.degree.-90.degree. with respect to the longitudinal dimension
L-L of the device 1700. As the angle .alpha. approaches 90 degrees,
the loads from the fixation portion 1710 to the valve support 120
increase relative to angles that are less than 90 degrees. As such,
a greater taper (e.g., lower angle .alpha.) reduces the loads
transmitted to the valve support 120 and the prosthetic valve
130.
[0404] FIG. 80B illustrates an embodiment of the device 1700 in
which the connectors 1732 have an S-shape. One advantage of having
S-shaped connectors 1732 is that the valve support 120 can be
shortened to mitigate the extent that the device 1700 protrudes
into the left ventricle and interrupts flow through the LVOT. As
noted above, the lower end of the device 1700 can interfere with
the flow through the LVOT during ventricular contraction.
[0405] FIG. 80C illustrates an embodiment of the device 1700 in
which the anchoring member 110 is inverted such that the fixation
portion 1710 is located around the downstream portion 123 of the
valve support 120 and the integration region 1720 is attached to
the upstream portion 121 of the valve support 120. This embodiment
of the device 1700 positions the valve support 120 further into the
left atrium as opposed to the left ventricle.
[0406] FIG. 80D illustrates an embodiment of the device 1700 in
which the fixation portion 1710 is orientated downwardly to be
positioned at the elevation of the downstream portion of the valve
support 1720. This embodiment is expected to inhibit loads from
being transmitted from the fixation portion 1710 to the valve
support 120, and it also positions the valve support 120 to reduce
the valve support 120 from protruding into the left ventricle.
[0407] FIG. 80E illustrates an embodiment of the device 1700 in
which the valve support 120 is offset relative to different areas
of the fixation portion 1710. In this device, the anchoring member
110 can include first connectors 1732a between the fixation portion
1710 and the valve support 120 at one side of the device 1700, and
second connectors 1732b between the valve support 120 and the
fixation portion 1710 at another side of the device 1700. The first
connectors 1732a can be shorter than the second connectors 1732b
such that the valve support 120 is closer to the fixation portion
1710 at the one side of the device compared to another side of the
device. The embodiment of the device 1700 illustrated in FIG. 80E
may advantageously position the valve support 120 and prosthetic
valve 130 further away from the LVOT to mitigate interference with
blood flow during ventricular contraction. Additionally, the
embodiment of the device 1700 shown in FIG. 80E is expected to
provide a more uniform load distribution to accommodate for the
non-circular shape and saddle profile of the mitral valve
annulus.
[0408] FIG. 80F illustrates an embodiment of the device 1700 in
which the integration region 1720 of the anchoring member 110 is
attached to an intermediate portion of the valve support 120 as
opposed to the end of the valve support 120. The embodiment of the
device 1700 illustrated in FIG. 80F may reduce the interaction
between the fixation portion 1710 and valve function.
[0409] FIG. 80G illustrates another embodiment of the device 1700
in which the valve support 120 has commissural attachment
structures 128 that have extensions 1728 that project radially
inwardly from the downstream end of the commissural attachment
structures. The extensions 1728 can converge inwardly at a desired
angle toward the central axis of the device 1700. In one
embodiment, the angle of the extensions 1728 maintains an
appropriate minimum required bend radius so that the extensions
1728 can be linearized to minimize valve diameter during placement.
The integration region 1720 of the anchoring member 110 can be
attached to the extensions 1728. The embodiment of the device 1700
illustrated in FIG. 80G is expected to increase the minimum
required bend radius for the connectors 1732, and reduce the height
of the fixation portion 1710 for a given taper angle. The inward
extensions 1728 might also provide an advantageous attachment point
for the commissures of the valve tissue. By moving this attachment
point further into the ventricle and further towards the centerline
of the valve, the overall stresses on the valve tissue will be
reduced. If the free edges of the valve leaflets are slightly
shorter than the commissures, they will not touch these extensions
1728 in the open position. Therefore blood flow will not be
impeded, and the leaflets will not be damaged by repeatedly
touching the extensions.
[0410] FIG. 80H is a cross-sectional view of another embodiment of
the prosthetic heart valve 1700 in accordance with the present
technology. In this embodiment, the lateral portion 1730 has a
continuously outwardly flared shape from the downstream end 123 of
the valve support 120, and the integration region 1720 is at the
terminus of the lateral portion 1730 where the anchoring member 110
is attached to the valve support 120. The first transition zone
1732 of the lateral portion 1730 bends superiorly from the lateral
portion 1730 to the orientation of the fixation portion 1710 such
that the fixation portion 1710 is configured to face the tissue of
a native mitral valve. This embodiment thus shows a flared
laterally extending lateral portion 1730.
[0411] FIG. 80I is a cross-sectional view of another embodiment of
the prosthetic heart valve 1700 in accordance with the present
technology. In this embodiment, the lateral portion 1730 has an
outwardly projecting conical shape from the downstream end 123 of
the valve support 120, and the integration region 1720 is at the
terminus of the lateral portion 1730 where the anchoring member 110
is attached to the valve support 120. The first transition zone
1732 of the lateral portion 1730 bends superiorly from the lateral
portion 1730 to the orientation of the fixation portion 1710 such
that the fixation portion 1710 is configured to face the tissue of
a native mitral valve. This embodiment thus shows a conical
laterally extending lateral portion 1730.
[0412] FIG. 80J is a cross-sectional view of another embodiment of
the prosthetic heart valve 1700 in accordance with the present
technology. In this embodiment, the lateral portion 1730 has arms
that are slightly convex when viewed from the downstream end, or
concave when viewed from the upstream end. In this embodiment, the
systolic blood pressure against the valve and valve support imparts
a compressive column loading on each of the arms. Due to the
slightly bent shape of the arms, this imparts a slight bending load
on the arms in the downstream direction. At the same time, the
systolic blood pressure against the arms themselves and the
attached sealing portions imparts a slight bending load on the arms
in the upstream direction. By optimizing the curvature of the arms,
the net bending load on the arms due to blood pressure can be
minimized or eliminated.
[0413] FIG. 80K is a cross-sectional view of another embodiment of
the prosthetic heart valve 1700 in accordance with the present
technology. In this embodiment, the lateral portion 1730 has a
continuously outwardly flared shape from a location at or near the
upstream end 121 of the valve support 120, and the integration
region 1720 is at the peak of the lateral portion 1730 where the
anchoring member 110 is attached to the valve support 120. The
first transition zone 1732 of the lateral portion 1730 bends from
the lateral portion 1730 to the orientation of the fixation portion
1710 such that the fixation portion 1710 is configured to face the
tissue of a native mitral valve. This embodiment thus shows an
inverted flared laterally extending lateral portion 1730. Lateral
portion 1730 may be integrally formed with fixation portion 1710,
or it may be a separate structure that is attached to fixation
portion 1710 by welding or other suitable means. In the latter
case, the transition zone 1732 may bend either upwardly so that the
tip of lateral portion 1730 points in an upstream direction, or
downwardly so the tip of lateral portion 1730 points in a
downstream direction.
[0414] FIGS. 80L and 80M are cross-sectional views of additional
embodiments of the prosthetic heart valve 1700 in accordance with
the present technology. In these embodiments, the lateral portion
1730 extends radially from a mid-section 118 of the valve support
120 (FIG. 80L) or from the upstream end 121 of the valve support
120 (FIG. 80M). In other embodiments lateral portion 1730 may
extend radially from a point at or near the downstream end of valve
support 120. Referring to FIGS. 80L and 80M, the lateral portions
1730 can be have a serpentine or zig-zag cross-section and/or other
configuration that is radially compressible or deflectable to
permit radial movement of the fixation portion 1710 toward and away
from the valve support 120, and that is resilient so as to bias the
fixation portion 1710 radially away from the valve support 120.
[0415] FIG. 80N is a cross-sectional view of another embodiment of
the prosthetic heart valve 1700 in which the anchoring member 110
is inverted such that the fixation portion 1710 is located around
the downstream portion 123 of the valve support 120 and the
integration region 1720 is attached to the upstream portion 121 of
the valve support 120. In this embodiment, the lateral portion 1730
has a continuously outwardly flared shape from a point at or near
the upstream end 121 of the valve support 120. This embodiment of
the device 1700 positions the valve support 120 further into the
left atrium as opposed to the left ventricle.
[0416] FIG. 80O is a cross-sectional view of another embodiment of
the heart valve 1700 in which the fixation portion 1710 of the
anchoring member 110 is located around the mid-section 118 of the
valve support 120. In this embodiment, the anchoring member 110 is
attached to the valve support by a first lateral portion 1730a
having a continuously outwardly flared shape from a point at or
near the upstream end 121 of the valve support 120, and by a second
lateral portion 1730b having a continuously outwardly flared shape
from a point at or near the downstream end 123 of the valve support
120.
[0417] FIG. 80P is a cross-sectional view of another embodiment of
the heart valve 1700 in which the fixation portion 1710 of the
anchoring member 110 is proportioned to be substantially
coextensive with the valve support 120 in the axial or longitudinal
direction. In this embodiment, the anchoring member 110 is attached
to the valve support 120 by a first lateral portion 1730a extending
from the integration region 1720 located at the mid-section 118 of
the valve support 118 and by a second lateral portion 1730b
extending from the integration region 1720 at the mid-section 118.
The first and second lateral portions 1730a, 1730b may be
integrally formed with each other and/or with the fixation portion
1710.
[0418] FIG. 80Q is an isometric view of another embodiment of the
prosthetic heart valve device 1700 in accordance with the present
technology. In this embodiment, the fixation portion 1710 includes
an extension 1713 that extends downstream from the first transition
zone 1734. The extension 1713 can be formed by extensions of
selected structural elements 1711 that project downstream beyond
the area where the transition zone 1734 comes into the fixation
portion 1710. The extension 1713 increases the height of the
fixation portion 1710, and it further enhances sealing and ingrowth
at the downstream portion of the fixation portion 1710. For
example, the extension 1713 can enhance the ingrowth at the
ventricular portion of the fixation portion 1710 of a mitral valve
device.
[0419] FIG. 81A is a cross-sectional view schematically showing a
prosthetic heart valve device 1900 in accordance with another
embodiment of the present technology. The device 1900 can include
an anchoring member 110, valve support 120, and prosthetic valve
130. The device 1900 can further include a compartment 1910
attached to one or both of the anchoring member 110 and the valve
support 120. The compartment 1910 can be configured to fit between
the anchoring member 110 and the valve support 120. The compartment
1920 can extend around only a portion of the circumference of the
anchoring member 110, or the compartment 1910 can extend around the
entire inner circumference of the anchoring member 110. The
compartment 1910 can further include a second portion 1910a that
projects towards the left atrium to provide more space for packing
into a low-profile configuration.
[0420] In one embodiment, the compartment 1910 is made from a
fabric, mesh, braid, porous material, or other suitable material
that can contain a material 1920. The fabric, mesh, or other
material might be optimized on one end to minimize blood flow
through it during the initial period after implantation, while the
other end might be more open to allow more aggressive tissue
ingrowth and even vascularization of the compartment 1910. The
material 1920, for example, can be a time-released agent that
inhibits or prevents clotting (e.g., clopidogrel or aspirin), a
healing agent (ascorbic acid), or other agents that promote tissue
and growth. The material 1920 can alternatively include structural
filler elements, such as small spheres, random intermeshed fibers,
foam, swellable hydrogels, etc., either in lieu of or in addition
to anti-clotting and healing agents. These small spheres, fiber,
foam etc. might be optimized for their compressibility. In this way
the structural filler elements can provide structural support
between the anchoring member 110 and the valve support 120 without
transmitting fully forces from the anchoring member 110 to the
valve support 120. The compartment 1910 can be attached to the
anchoring member 110 or the valve support 120 by fasteners 1930,
such as clasps, threaded ties, or other suitable fasteners. The
material 1920 might be introduced into the device after the device
has been deployed into the patient, for example via a tube which
extends from the compartment 1910 to the proximal end of the
delivery system. Once the compartment 1910 has been filled with
material 1920, the tube can be pulled out of compartment 1910, with
a self-sealing valve preventing leakage of material 1920 from the
compartment.
[0421] FIG. 81B is a top view of the prosthetic heart valve device
1900 illustrating an embodiment in which the compartment 1910 has a
plurality of separate cells 1912 (identified individually as cells
1912a-1912g). Each of the cells 1912 can include the same material
1920 (FIG. 81A), or a number of the cells can include different
materials 1920. For example, cells 1912a, 1912c, 1912e, and 1912g
can include an anticlotting agent, and cells 1912b, 1912d, and
1912f can include a healing agent to promote healing of connective
tissues.
[0422] FIG. 82A is an isometric view of a prosthetic heart valve
device 2000 in accordance with another embodiment of the present
technology, and FIG. 82B is a cross-sectional view of the device
2000 along line 20B-20B in FIG. 20A. The device 2000 can include an
anchoring member 110 having a frame and a plurality of tissue
engaging elements 170 similar to the fixation portion 1710 of the
devices 1700 described above. The device 2000 can further include
one or more fibers or webs 2010 that flexibly couple the anchoring
member 110 to the valve support 120. The webs 2010, for example,
can be a fabric, mesh, braid, sheet, or other material formed form
a textile, polymer, metal, natural fiber, or other suitable
materials. These webs might have a variety of orientations.
[0423] Referring to FIG. 82B, the web 2010 can include a first
portion 2012 at the upstream end of the valve support 120, a second
portion 2014 at the downstream end of the valve support 120, and
side portions 2016 attached to the anchoring member 110 and the
valve support 120 by fasteners 2020. The web 2010 illustrated in
FIG. 82B can form an enclosed compartment 2018 that can be filled
with a material such as a time-release agent and/or filler elements
as described above. The fasteners 2020 can be sutures, other
threaded ties, clasps, rivets or other suitable fastening means.
Additional fibers or webs might extend from the downstream end of
the anchoring member to the upstream end of the valve support, from
the upstream end of the anchoring member to the downstream end of
the valve support, or in other directions. Alternatively, vertical
radially-oriented planar webs may extend from the anchoring member
to the valve support.
[0424] The device 2000 illustrated in FIGS. 82A and 82B may provide
very good force isolation between the anchoring member 110 and the
valve support 120 because there is no metal-to-metal interface and
the suture-type fasteners 2020 add further stability and
potentially better fatigue life. The device 2000 has the potential
for further improving fatigue life because of the robust materials
that can be used for the web 2010 (e.g., Kevlar.RTM., a trademark
of E. I. du Pont de Nemours and Company) and the flexibility of the
web 2010.
[0425] FIG. 83 is a schematic cross-sectional view of the device
2000 in accordance with another embodiment of the present
technology. In this embodiment, the web 2010 has a top portion
between the upstream ends of the anchoring member 110 and the valve
support 120, and the side portions are connected to the anchoring
member 110 and the valve support 120 by fasteners 2020. The device
2000 in this embodiment further includes tethers 2040 attached to
the downstream end of the anchoring member 110 and to an
intermediate area of the valve support 120.
[0426] FIGS. 84A-84C are schematic cross-sectional views
illustrating an aspect of several embodiments of the prosthetic
heart valve devices 1700, 1900 and 2000 in accordance with the
present technology. Referring to FIG. 84A, the device 1700 can have
a fully expanded state in which the fixation portion 1710 extends
from the lateral portion 1730 (e.g., connecting structure) by an
angel of 45.degree. outwardly away from the longitudinal axis of
the device 1700 to an angle of -30.degree. inwardly toward the
longitudinal axis of the device. The fixation portion 1710 extends
approximately parallel to the longitudinal axis of the device in
the embodiment shown in FIG. 84A. The device 1700 can have such a
fully expanded state outside of the body or after the device 1700
has been implanted at a native valve. The fixation portion 1710,
however, can flex or otherwise deform upon implantation such that
the fixation portion 1710 at least partially adapts to the shape of
the native valve location and deflects (arrow D) inwardly or
outwardly to also at least partially adapt to the angular
orientation of tissue at the native valve location. FIG. 84B, for
example, shows deflection of the fixation portion 1710 inwardly to
adapt to the angle of the tissue at the underside of the native
annulus (AN), and FIG. 84C shows deflection of the fixation portion
1710 outwardly to adapt to the angle of the tissue on the other
side of the native annulus (AN). Such double conformability
enhances the fixation of the device to the native tissue.
Additionally, the fixation portion 1710 need not deflect with
respect to the lateral portion 1730 at a mid-section of the
fixation portion 1710 as shown in solid lines in FIG. 84A, but
rather the fixation portion 1710 can deflect around areas that are
at or near the ends of the fixation portion as shown by the
transition areas of lateral sections 1730' and 1730'' shown in
broken lines in FIG. 84A.
[0427] FIGS. 85A-85C are side views illustrating selected
embodiments of the deflection of the fixation portion 1710 relative
to the lateral portion 1730. Referring to FIG. 85A, the fixation
portion 1710 can be connected to the outer end of the lateral
portion 1730 by a hinge 1737. In the embodiment shown in FIG. 85B,
the fixation portion 1710 deflects about the first transition zone
1734 where the lateral portion 1730 bends to the fixation portion
1710. FIG. 85C shows an embodiment in which the fixation portion
1710 is attached to the lateral portion 1730 by mechanical
fasteners 1738, such as pins, bolts, rivets, or other fasteners. In
any of these embodiments, the fixation member can pivot, rotate,
flex or otherwise deflect to an inward orientation 1710' or to an
outward orientation 1710'' depending on the tissue at the implant
site.
[0428] FIGS. 86A-107B illustrate prosthetic heart valve devices
2100 having extension members 2110 in accordance with additional
embodiments of the present technology. Similar to the devices
discussed above with respect to FIGS. 10A-85C, the devices 2100
include features such as the valve support 120 (e.g., FIG. 86B)
having an interior 134 in which a prosthetic valve 130 (e.g., FIG.
86B) is coupled and an expandable anchoring member 110 (e.g.,
fixation member having a tubular fixation frame) coupled to the
valve support 120 in a manner that mechanically isolates the valve
support 120 from forces exerted upon the anchoring member 110 when
implanted. FIG. 86A is a side view and FIG. 86B is an isometric
view of the device 2100 that includes features generally similar to
the features of the prosthetic heart valve device 1700 described
above with reference to FIGS. 72-85C. Similar to the device 1700,
the anchoring member 110 can be coupled to the valve support 120
such that a fixation portion 1710 of the anchoring member 110 is
configured to engage native tissue on or downstream of the annulus
so as to prevent migration of the device 2100 in the upstream
direction.
[0429] In the embodiment illustrated in FIGS. 86A and 86B, the
device 2100 also includes an extension member 2110 extending from
the anchoring member 110 (e.g., from the fixation portion 1710 of
the anchoring member 110). The extension member 2110 can be a brim,
flange, shoulder or expansion ring projecting from or tethered to
the fixation portion 1710 of the anchoring member 110. In one
embodiment, the extension member 2110 is configured to be
positioned and to engage tissue upstream of the native annulus
while the anchoring member 110 is configured to engage tissue at or
near the annulus or leaflets. In some arrangements, the extension
member 2110 is a self-expanding retainer configured to engage
tissue in the upstream heart chamber (e.g., left atrium) to (a)
align and position the device 2100 within the native valve region
such that the device 2100 is accurately seated within the native
valve to ensure proper engagement and retention by the surrounding
tissue; and/or (b) assist in visualization and detection of device
position relative to the anatomy during implantation by deflecting,
deforming, or otherwise moving in response to engagement with
native tissue in a manner that can be visualized using fluoroscopy,
echocardiography, or other visualization methods; and/or (c)
inhibit the device 2100 from moving in a downstream direction
during operative use as a prosthetic valve in the heart of a
patient.
[0430] Referring to FIG. 86A, the extension member 2110 can have an
outer circumference 2112 with a cross-sectional transverse
dimension D.sub.4 that is greater than the cross-sectional
transverse dimension D1 of the outer circumference 150 of the
upstream portion 112 (e.g., fixation portion 1710) of the anchoring
member 110 when the device 2100 is in the expanded configuration
2102. In other embodiments, the extension member 2110 may have a
cross-sectional transverse dimension D.sub.4 at least as large or
even larger that the major axis 55 of the native annulus (FIG.
14A). In some embodiments, the outer circumference 2112 of the
extension member 2110 has a cross-sectional transverse dimension
D.sub.4 that is greater than the supra-annular surface such that
the extension member 2110 is deflected by the walls of the atrium
in an upstream direction when the extension member 2110 is deployed
above the annulus. In some embodiments, the cross-sectional
transverse dimension D.sub.4 of the extension member 2110 can be
approximately 1.2 to 3 times the cross-sectional dimension D.sub.1
of the fixation portion 1710 of the anchoring member 110 when in a
fully expanded, undeformed condition. In a specific example, the
extension member 2110 in a fully expanded, unbiased, undeformed
condition, may have a transverse dimension D.sub.4 in the range of
about 40 mm to about 150 mm, or about 40 mm to about 80 mm, for
adult human patients. In some embodiments, extension member 2110
may be non-circular in a transverse/horizontal plane (e.g. oval or
D-shaped) and in such embodiments may have a major diameter in a
range of about 40 to about 150 mm, preferably about 40 to about 80
mm, the major diameter being about 1.2 to 2 times its minor
diameter. Also in accordance with aspects of the present
technology, the extension member 2110 may be provided in multiple
transverse dimensions and/or shapes to fit various native valve
sizes allowing a surgeon to select the appropriate size and shape
for each patient.
[0431] In some embodiments the extension member 2110 can be
configured to align the device 2100 relative to the native annulus
by engaging the tissue upstream of the native annulus. As the
device is delivered to the target site via a delivery catheter (not
shown), and as described in more detail below, the extension member
2110 expands within the atrial chamber before the anchoring 110
member and valve support 120 are released from the delivery
catheter at or near the annulus. In these embodiments, the
extension member 2110 can be rested on or pulled down against the
supra-annular surface before the remainder of the device 2100
(e.g., anchoring member 110 and valve support 120) is released from
a delivery device. The total height (H.sub.t FIG. 86A) of the
device 2100 and/or the fixation height (H.sub.f FIG. 86A) of the
fixation portion 1710 can be configured such that when the
extension member 2110 is engaging the supra-annular surface, the
fixation portion 1710 is properly aligned longitudinally with
respect to the native valve such that the fixation portion 1710
engages the desired annular and/or leaflet tissue. In other
embodiments, the extension member 2110 is configured to deflect or
deform when it engages the atrial walls or supra-annular surface
while the remainder of the device 2100 is advanced in a downstream
direction. The degree of deflection or deformation is correlated
with the longitudinal position of the fixation portion 1710
relative to the native annulus such that, by visualizing the
extension member 2110 using fluoroscopy, echocardiography, or other
means, the position of the device 2100 may be accurately determined
prior to full deployment.
[0432] The extension member 2110 can be, in some examples, an
extension of material either directly or indirectly coupled to the
upstream portion 112 (e.g., upper rim or upstream perimeter 113) of
the anchoring member 110 and which projects in a non-coaxial (or
transverse) direction relative to the anchoring member 110 when the
device 2100 is in an expanded configuration 2102. In a deployed
configuration 2104 (see, e.g., FIG. 89B) at a native mitral valve,
the extension member 2110 can extend upstream through the annulus
AN and into a supra-annular space within the atrium and engage the
supra-annular surface or other atrial tissue with an outwardly
extending flange or brim 2120.
[0433] The extension member 2110 may include the brim 2120
comprising a covering or sheet of material, such as a flexible
fabric, ring, disk, or web (e.g., a weave, braid or grating of
fabric, shape-memory polymeric material, and/or shape-memory
metal). In one embodiment, and as shown in FIGS. 86A and 86B, the
brim 2120 can include a sheet of flexible material coupled to the
anchoring member 110 near the upstream end or portion 112 and
extends radially outward from the anchoring member 110. In one
example, the device 2100 can include a first sealing member portion
140a (FIG. 86B) coupled to a wall of the anchoring member 110
(e.g., inner wall) and a second sealing member portion 140b coupled
to a wall of the valve support 120 (e.g., inner wall, outer wall).
As described above with respect to the device 1700 illustrated in
FIG. 72, the first and second sealing member portions 140a and 140b
can be integral portions of a single sealing member or can be
separate sealing members that are attached independently to the
anchoring member 120 and the valve support 120. Likewise, in one
embodiment, the brim 2120 can have an inner edge 2122 that is
coupled to the first sealing member portion 140a. For example, the
brim 2120 and the first sealing member portion 140a can be a
continuous sheet of material. In another example, the brim 2120 and
the first sealing member portion 140a can be coupled using an
attachment means, such as stitching, sutures, rivets, adhesive or
other mechanical coupling fasteners or features known in the art.
In such embodiments, the brim 2120 and the first sealing member
portion 140a may be formed of the same material or different
materials. In a particular example, the first sealing member
portion 140a and the brim 2120 can be formed of an impermeable
material for preventing perivascular leaks between the device 2100
and the adjacent tissue and/or to promote in-growth of tissue of
adjacent tissue (e.g., Dacron.RTM. or tissue such as pericardium).
In another example, the brim 2120 can be formed of a different
material having a desired flexion or shape-memory feature (e.g.,
shape-memory metal), or a combination of metal, fabric, tissue
and/or other materials.
[0434] The extension member 2110 may further include tissue
engaging elements 170a, such as barbs, bumps, tines, rods or
similar structures, integrated therewith, or bonded or otherwise
attached thereto, similar to those optionally included on the
sealing member 140 as described above in connection with FIG.
43A-43B. These tissue engaging elements 170a may be configured to
engage atrial wall or supra-annular tissue to inhibit movement of
the device 2100 in a downstream direction (toward the ventricle).
The tissue engaging elements 170a may be non-penetrating or may
penetrate the tissue surface slightly to inhibit movement. In
exemplary embodiments, the tissue engaging elements can be oriented
to point preferentially in a downstream direction to have higher
retention force against movement in the downstream direction than
in the upstream direction. Alternatively or additionally, the
outer, tissue-facing surface of the extension member 2110 may be
coated with a permanent or temporary adhesive or other material to
enhance friction and/or to adhere to the native tissue, at least
until tissue in-growth has occurred sufficiently to inhibit device
movement.
[0435] In some embodiments, the extension member 2110 can also
include a support structure 2130 coupled to or, in other
embodiments, integral with the brim 2120 (FIG. 86B). The support
structure 2130 can provide the extension member 2110 with
additional rigidity as the extension member 2110 extends radially
out from the anchoring member 110 when the device 2100 is in the
expanded configuration 2102. In several arrangements, the support
structure 2130 can be a stiffening member formed from metal and/or
a polymeric material that is sewn, sutured, or adhered to the brim
2120. In some embodiments, the support structure 2130 can include a
resilient metal or polymer mesh, ring or series of rings coupled to
or otherwise integrated into a portion of the brim 2120. In certain
embodiments, the support structure 2130 can be formed from a
deformable material or a resilient or shape memory material (e.g.,
Nitinol). In other embodiments, the support structure 2130 can
include one or more stiffening members, such as wires 2132 or
struts that are secured to the outer surface or positioned within
the material of the brim 2120 (FIG. 86B).
[0436] In one embodiment, the support structure 2130 can be
separate from the frame 2109 and/or the anchoring member 110. For
example, FIG. 86B illustrates an embodiment in which the support
structure 2130 includes wires 2132 (e.g., a plurality of struts)
formed in a crisscrossing serpentine configuration that form a
continuous ring around the extension member 2110 and in which the
wires 2132 are not in direct contact with the frame 2109. In this
embodiment, the extension member 2110 is connected to the anchoring
member 110 (e.g., at the fixation portion 1710) by the material of
the brim 2120 (e.g. fabric or tissue). In some embodiments, the
extension member 2110 (including the brim 2120 and any support
structure 2130) is connected to the anchoring member 110 only by
fabric, suture, or other highly flexible, non-metal elements.
Accordingly, in this embodiment, the wires 2132 are structurally
independent from the anchoring member 110 such that the support
structure 2130 is indirectly coupled to the frame 2109 by the brim
2120 (e.g., fabric, material, etc.). As such, the support structure
2130, in an undeformed or unbiased condition, is spaced apart from
the frame 2109 of the anchoring member 110 and is mechanically
isolated from the frame 2109. While the embodiment illustrated in
FIG. 86B illustrates a generally concentric arrangement of the
wires forming a crisscrossing serpentine pattern (e.g., zig-zag
pattern, diamond pattern), other arrangements and patterns (e.g.,
serpentine, wavy, radial arms, square, etc.) can also be formed to
provide a desired rigidity to the extension member 2110, and as
described below with respect to FIGS. 87A-107B.
[0437] In a further embodiment, and as illustrated in FIGS. 87A and
87B, the support structure 2130 can be integral with the frame 2109
(e.g., Nitinol frame) of the anchoring member 110. FIGS. 87A and
87B are side and top views, respectively, of a device 2100 having
an extension member 2110 that includes a support structure 2130
formed from an extension of the frame 2109. For example, the
support structure 2130 includes integral wires 2134 (e.g., struts)
extending from the structural elements 2111 of the frame 2109 into
the brim 2120 (FIG. 87A, dotted lines). As illustrated in FIG. 87B,
the integral wires 2134 can be arranged in a pattern (e.g., a
combination of straight, outwardly projecting struts 2134a and
triangular-oriented struts 2134b) for providing a desired
combination of rigidity and flexibility about the brim 2120. In
some embodiments, the integral wires 2134 connecting the support
structure 2130 to the frame 2109, due to their number, dimensions,
geometrical arrangement, or other aspect, are individually or
collectively substantially more flexible than the structural
elements of the frame 2109 so that the extension member 2109 is
comparatively easily deflected or deformed when it engages native
tissue. For example, the number of integral wires 2134
interconnecting extension member 2110 to frame 2109 around the
circumference of the device 2100 may be substantially fewer than
the number of structural elements 2111 around the
circumference.
[0438] In another embodiment, the support structure 2130 can be
connected to the frame 2109 at one or more connection points using
rivets, (e.g. Nitinol rivets), threads, adhesives, solder, laser
welding, metal bolts or other mechanical features, or other types
of fasteners can be used to secure the support structure 2130 to
the frame 2109 of the anchoring member 110. In some arrangements,
the support structure 2130 can be coupled to the frame 2109 with a
plurality of flexible connecting members (not shown) that are
substantially less rigid than the frame 2109. In this embodiment,
the flexibility of the extension member 2110 can allow the
extension member 2110 to distort without distorting the anchoring
member 110 and/or the valve support 110. Various aspects of this
arrangement can allow the extension member 2110 to be conformable
and, in some embodiments, more atraumatic to the supra-annular
tissue and atrial wall. In some embodiments, the wires 2132 or
struts can have a rigidity or stiffness that is less than the
rigidity of stiffness of the structural elements 2111 of the frame
2109. In these embodiments, the extension member 2110 may be
deformed by the surrounding supra-annular tissue and/or atrial
walls without transmitting forces to the more rigid frame structure
of the anchoring member 110.
[0439] FIGS. 88A-88C are cross-sectional views of a heart showing a
method of delivering a prosthetic heart valve device 2100 to a
native mitral valve MV in the heart using a trans-apical approach
in accordance with another embodiment of the present technology.
Referring to FIG. 88A, the delivery catheter 18 is advanced through
guiding catheter (not shown) which enters the left ventricle LV of
the heart through a puncture in the left ventricle wall at or near
the apex of the heart and is sealed by a purse-string suture.
Alternatively, the delivery catheter 18 may be placed directly
through a purse-string-sealed trans-apical incision without a
guiding catheter. The sheath 20, which contains a collapsed device
2100 in a radially contracted delivery configuration 2106, is
advanced through the mitral annulus AN between native leaflets LF
as shown in FIG. 88A. The valve support 120, the anchoring member
110 and the extension member 2110 (e.g., brim, flange, shoulder,
expansion ring, etc.) have a low profile configured for delivery
through the delivery catheter 18 positioned at or near the native
mitral valve when in the delivery configuration 2106. Referring to
FIGS. 88B-88C together, once the device is positioned so that the
extension member 2110 is located in the atrium, the sheath 20 is
pulled proximally to allow the device 2100 to expand to the
radially expanded and/or deployed configurations 2102, 2104 (FIGS.
88B and 88C).
[0440] As with other devices disclosed herein, retraction of the
sheath 20 allows the device 2100 to expand while the delivery
system remains connected to the device 2100 (e.g., system eyelets,
not shown, are connected to the device eyelets, not shown). In this
manner, an operator can control the placement of the device 2100
while at least portions of the device 2100 (e.g., the extension
member 2110, upstream portion 112 of the anchoring member 110) are
in the expanded configuration 2102 (FIGS. 88B and 88C). For
example, as the sheath 20 is disengaged from the device 2100, the
extension member 2110 can expand within the left atrium while the
upstream region 112 of the anchoring member 110 is retained within
the sheath 20 (FIG. 88B). During this phase of the delivery, the
position of the device 2100 within the mitral valve area can be
adjusted or altered.
[0441] In one embodiment, the extension member 2110 can have an
indicator portion 2116 (FIGS. 88C and 89B) that can be visualized
during device implantation to determine the position of the device
2100 relative to the native annulus. In one embodiment, deflection
of the indicator portion 2116 caused by engagement of the extension
member 2110 with a wall of the left atrium (e.g., when treating the
mitral valve) can be visualized to accurately determine the
position of the device 2100 relative to the native annulus. In some
arrangements, the indicator portion 2116 preferably deflects about
an axis generally parallel to a plane containing the native
annulus. In another arrangement, the indicator portion 2116 forms
an angle with a plane containing the native annulus, wherein the
angle increases as the indicator portion 2116 is deflected. In a
particular positioning and deployment step, the extension member
2110 can be placed such that the indicator portion 2116 forms a
first angle with the plane during the visualization step and then
the device 2100 is moved such that the indicator portion 2116 forms
a second angle with the plane less than the first angle before the
anchoring member 110 is deployed. Because the position of the
fixation portion 1710 (FIG. 86A) relative to the extension member
2110 is known for a given degree of deflection, the position of the
fixation portion 1710 relative to the native annulus can be
determined based upon degree of deflection (i.e. second angle) of
the extension member 2110. The indicator portion 2116, for example,
can include a radiopaque material coupled to or integrated with the
brim 2120 and/or the support structure 2130, and the radiopaque
material can visualized using fluoroscopy.
[0442] In another example, the indicator portion 2116 can include
an echogenic material that is visualized using ultrasound. The
indicator portion may include, in a further embodiment, one or more
metallic members. In some embodiments, the device 2100 can also
include gas (e.g. CO.sub.2) pockets or chambers (not shown) within
or associated with the extension member 2110 that enhance
echocardiographic visibility. For example, the extension member
2110 can be made of closed cell foam or other material with trapped
gas pockets. In another embodiment, the extension member 2110
(e.g., the support structure 2130) can include a platinum core wire
for enhancing fluoroscopic visibility. The platinum core wire can
be removable such that once the device 2100 is properly positioned
and implanted, the platinum core wire can be removed to avoid a
galvanic response with NiTi wires.
[0443] After the device 2100 is located at the target site, the
sheath 20 can be fully removed from the device 2100 and the
anchoring member 110 of the device 2100 can expand outwardly to
engage subannular tissue, such as the leaflets LF, and to retain
the device 2100 in the desired target location. Following
positioning and deployment of the device 2100 where the extension
member 2110 is positioned and conformed to tissue above the annulus
and the anchoring member 110 is engaging the annular and/or
subannular tissue, the pull-wires (not shown) may be retracted in a
proximal direction to release the device 2100 from the delivery
system. The delivery system can then be removed to thereby fully
implant the device 2100 at the mitral valve MV in the deployed
configuration 2104. Alternatively, the device 2100 may be expanded
upstream or downstream of the desired target location then pulled
or pushed downstream or upstream, respectively, into the target
location before releasing the device 2100 from delivery system.
[0444] FIGS. 89A and 89B are schematic top views of a native mitral
valve in the heart viewed from the left atrium and showing the
prosthetic treatment device of FIGS. 86A and 86B implanted at the
native mitral valve in accordance with an embodiment of the present
technology. During deployment, the device 2100 is configured to
transition from a radially contracted delivery configuration (FIG.
88A) to an unbiased/expanded configuration 2102 (FIG. 89A) in which
the extension member 2110 expands radially outward from the
anchoring member 110 (e.g., the upstream perimeter 113 and/or the
fixation portion 1710) over the supra-annular surface of the native
valve and/or the atrial wall surrounding the native valve. Prior to
completely releasing the device 2100 from the delivery catheter,
the catheter may be moved in a downstream direction (toward the
ventricle) to position the fixation portion at the desired location
relative to the native annulus (FIGS. 88B-88C). In doing so, the
outer portion of the extension member 2110 may be deflected upward
and radially inward due to contact with the atrial tissue (FIGS.
88C and 89B). This deflection can be visualized using fluoroscopy
and/or echocardiography, thereby indicating to the practitioner the
longitudinal position of the device 2100. As illustrated in FIG.
89B, the device 2100 can assume a final deployed configuration 2104
in which at least a portion of the extension member 2110 engages
and is at least partially deformed by a supra-annular surface or
tissue above the native valve (e.g., an atrial wall).
[0445] In many embodiments, the extension member 2110 can have
sufficient flexibility such that the extension member 2110 conforms
to supra-annular and atrial wall anatomy when in the deployed
configuration 2104 (FIG. 89B). Accordingly, during implantation at
a native valve (e.g., native mitral valve), the extension member
2110 can be deformed or deflected by the native tissue from its
bias toward the expanded configuration 2102 to the deployed
configuration 2104 in which it extends further in an upstream
direction (FIG. 89B). Although the extension member 2110 is
deflectable in an upstream direction (FIG. 89B), the extension
member 2110 is resiliently biased to return to the unbiased
configuration (FIGS. 86A-87B and 89A) where it to radially extends
and pushes downward against the supra-annular surface. This bias
contributes to the retention of the extension member 2110 in the
atrium (e.g., resist movement toward the left ventricle under axial
compressive forces during diastole and/or atrial contraction) and
the maintenance of the positioning of the device 2100 with respect
to the native valve annulus. Furthermore, the resulting compression
fit between the extension member 2110 and the supra-annular surface
and/or atrial walls or other structures helps create a long-term
bond between the tissue and the device 2100 by encouraging tissue
ingrowth (e.g., into the brim 2120) and encapsulation.
[0446] The flexible characteristics of the structural elements 2111
of the frame 2109 (FIG. 86A) having the first sealing member
portion 140a and the support structure 2130 and brim 2120 can allow
for the flexibility and conformability of the anchoring member 110
and extension member 2110, respectively, to engage and seal the
device 2100 against uneven and uniquely-shaped native tissue at the
native mitral valve. Although the extension member 2110 and the
anchoring member 110 are deformable in response to forces exerted
by the native anatomy, the valve support 120 can be substantially
isolated from such deformation and/or can have sufficient rigidity
to maintain a circular or other original cross-sectional shape,
thus ensuring proper coaptation of the leaflets of the prosthetic
valve 130 when implanted. The mechanical isolation of the
prosthetic valve 130 from the forces exerted by the native tissue
may be achieved by the independent deformability of the portion of
the anchoring member 110 that is spaced apart from the valve
support 102 as well as the independent deformability and atrial
positioning of the extension member 2110.
[0447] As described above, mechanical isolation of the valve
support 120 from the anchoring member 110 may be attributed to
several aspects of the prosthetic heart valve devices disclosed
herein. Some of these aspects can include, but not be limited to,
(a) the relative high flexibility of the anchoring member 110, or
flexibility of the transverse elements connecting the fixation
portion 1710 of the anchoring member 110 to the valve support 120,
compared with the lower flexibility of the valve support 120; (b)
radial spacing between the anchoring member 110 and the valve
support 120, particularly in some embodiments, at the upstream
portion/upstream end where the anchoring member 110 engages the
native annulus and/or subannular tissue; and (c) the coupling
mechanisms employed to attach the anchoring member 110 to the valve
support 120 (e.g. connection structure 1720/1730, FIG. 73) can be
configured (e.g., to be flexible, compressible, or moveable) so as
to reduce the transmission of forces from the anchoring member 110
to the valve support 120.
[0448] In the device 2100, the anchoring member 110 can also be
mechanically isolated from the extension member 2110. When deployed
at a native mitral valve, the extension member 2110 is more
substantially influenced by anatomical tissue forces of the atrium
and by atrial diastolic forces, whereas the anchoring member 110 is
more substantially influenced by anatomical tissue forces at or
near (e.g., below) the annulus and/or by ventricular systolic
forces. The device 2100 is configured to conform to the shape and
motion of the anatomy under these separate forces by mechanically
isolating the anchoring member 110 from the extension member 2110
as well as from the valve support 120. In one embodiment, the
extension member 2110 can have a relative high flexibility compared
to the flexibility of the anchoring member 110 and/or the valve
support 120 such that the extension member 2110 can deform
significantly when deployed and in when in operation without
substantially affecting the deformation of the anchoring member
110. In another embodiment, the extension member 2110 can have a
deformable portion 2114 (FIG. 89A) that is mechanically isolated
from the anchoring member 110 such that the deformable portion 2114
is radially and/or longitudinally deformable without substantially
deforming the anchoring member 110. The extension member 2110 can
also be coupled to the anchoring member 110 in a manner and at a
location (e.g., upper rim or upstream perimeter 113) that allows
for deformability of the extension member 2110 without
substantially affecting the shape of the anchoring member 110 or
the valve support 120. Moreover, the coupling mechanisms employed
to attach the extension member 2110 to the anchoring member 110 can
be configured (e.g., to be flexible or moveable) so as to reduce
the transmission of forces from the extension member 2110 to the
anchoring member 110 or vice versa.
[0449] FIGS. 90A-90F are schematic illustrations showing how the
prosthetic heart valve device mechanically isolates the valve
support 120 from the forces exerted by the native tissue in
accordance with additional embodiments of the present technology.
Reference to forces exerted by the native tissue can include, in
some examples, the diastolic and systolic forces generated in the
beating heart, or in other examples, can include forces exerted by
anatomical differences in the native valve that can vary patient to
patient. In one embodiment, shown in FIG. 90A, lateral forces
F.sub.H1 exerted on the device 2100 are absorbed by the anchoring
member 110 and/or the extension member 2110, such that the valve
support 120 is not deformed by the forces F.sub.H1. In this
embodiment, the device 2100 can have a central longitudinal axis
L-L and the lateral forces F.sub.H1 can deform or otherwise move
the anchoring member 110 and extension member 2110 into different
laterally offset positions relative to the axis L-L, while the
valve support 120 does not substantially move with respect to the
axis L-L. The extension member 2110 is also mechanically isolated
from the anchoring member 110 such that the anchoring member 110
can be moved a first distance DIS.sub.1 in a direction transverse
to longitudinal axis L-L and the extension member 2110 can move a
second distance DIS.sub.1 in the transverse direction that is
greater than, equal to or, in another embodiment, less than the
distance DIS.sub.1. In some cases, all three elements (anchoring
member 110, extension member 2110, and valve support 120) can be in
three different offset positions in the transverse direction
relative to axis L-L.
[0450] In another embodiment, multiple moment forces F.sub.A1 and
F.sub.A2 exerted on the device 2100 from the native tissue can also
be absorbed by the anchoring member 110 and/or the extension member
2110 (FIG. 90B). For example, the moment forces F.sub.A1, F.sub.A2
exerted by the native tissue can independently alter the
positioning (e.g., X-Y positioning, rotational positioning, etc.)
with respect to the central longitudinal axis of the anchoring
member 110, extension member 2110 and valve support 120 such that
each element is at a different angle relative to the longitudinal
axis L-L. As illustrated in FIG. 90B, the extension member 2110 can
deform, tilt, or move angularly independently of the deformation or
angle of the anchoring member 110, and vice versa.
[0451] In a further embodiment, the anchoring member 110 and
extension member 2110 can undergo relative shape changes with
respect to the expanded configuration 2102 (e.g., FIGS. 86A and
86B) when forces transmitted from the surrounding tissue are
absorbed by the anchoring member 110 and the extension member 2110.
In the examples illustrated in FIGS. 90C-90E, transverse
compressive forces, can be absorbed by portions of the anchoring
member 110 and/or the extension member 2110, such that the device
2100 is positioned and retained at the native valve site and so
that the valve support 120 remains substantially un-deformed under
the same conditions. In one embodiment, absorption of transverse
compressive forces F.sub.H2 and F.sub.H3 by the anchoring member
110 can cause the upstream portion 112 of the anchoring member 110
to deform inwardly without or less deformation of the extension
member 2110 under the same and/or different applied forces (FIG.
90C). Alternatively, the downstream end of the extension member
2110 may be deformed in the transverse direction without or with
less deformation of the upstream end of the anchoring member
110.
[0452] In other embodiments, as illustrated in FIGS. 90D and 90E,
forces can change the shape of the extension member 2110 in the
horizontal plane into a shape that is different than the shape of
the anchoring member 110 resulting from the same or different
forces. For example, the extension member 2110 can be subjected to
different horizontal forces F.sub.H4 and F.sub.H5 (e.g., within the
atrium) than the forces F.sub.H2 and F.sub.H3 (e.g., at the annulus
or downstream of the annulus) exerted on the anchoring member 110
(FIG. 90D). As a result, extension member 2110 may be ovalized with
its major axis in a first direction, while anchoring member 110 is
ovalized with its major axis in a second direction transverse to
the first direction. FIG. 90E illustrates another embodiment in
which lateral forces F.sub.H2, F.sub.H3, F.sub.H4 and F.sub.H5 are
absorbed by the extension member 2110 and the anchoring member 110
such that the extension member 2110 is deformed into a D-shape,
while the anchoring member 110 has a different shape--e.g.
circular, oval, or a non-aligned D-shape--in the horizontal
plane.
[0453] FIG. 90F illustrates an embodiment in which the anchoring
member 110 and extension member 2110 undergo relative shape changes
in the expanded configuration 2102 when longitudinal forces
F.sub.L1 and F.sub.L2 transmitted from the surrounding tissue are
absorbed by the anchoring member 110 and the extension member 2110.
In this embodiment, longitudinal mechanical forces F.sub.L1 and
F.sub.L2 can cause distortion of the extension member 2110 and the
anchoring member 110, such that these elements have side profiles
with different shapes along a transverse axis T-T of the device
2100. For example, extension member 2110 may have a saddle shape
corresponding to the shape of the supra-annular surface of the
native valve, while anchoring member 110 remains substantially
cylindrical or is deformed into a different shape, e.g. with an
arched side profile.
[0454] FIG. 91A is an isometric illustration of another device 2100
having an extension member 2110 in accordance with the present
technology. The extension member 2110 shown in FIG. 91A includes
the brim 2120 formed of fabric or another suitable material,
wherein the brim material 2124 has structure features such as folds
2125 in the fabric that are at least in part configured to provide
the support structure 2130 of the extension member 2110. The folds
2125 can be sewn, sutured, secured with adhesive, or formed using
other mechanical features such as staples. The folds 2125 in the
brim material 2124 can be patterned or positioned for desired
strength, rigidity and/or flexibility. For example, folds 2125 can
have concentric, radial, zig-zag, serpentine, diamond, square or
other patterns in the brim 2120. Optionally, one or more structural
elements (e.g., metal wires, plastic elements, etc.) can be sewn or
attached to the brim 2120 and/or placed within the fold(s) 2125 to
provided added structure.
[0455] FIG. 91B is a cross-sectional view of the folds 2125 in the
extension member 2110 shown in FIG. 91A. The folds 2125 can be sewn
or secured portions of the brim material 2124 arranged in a
spaced-apart manner circumferentially, radially or in another
pattern about the brim 2120. Some folds 2125a do not have
additional elements incorporated, while other folds 2125b may have
structural elements such as wires 2132 positioned within the fold
2125b (FIG. 91B). In some embodiments, the structural elements or
other elements can be radiopaque to assist visualization of the
device during and post implantation at the native valve. The device
2100 illustrated in FIGS. 91A and 91B, provides a compliant, easily
compressible, and atraumatic extension member 2110 that does not
apply or transmit deforming forces to the anchoring member 110 or
the valve support 120.
[0456] FIGS. 92-95B are schematic top views of several additional
embodiments of prosthetic heart valve devices 2100 in accordance
with the present technology. Like reference numbers refer to
similar or identical components in FIGS. 86A-95B. The embodiment of
the device 2100 illustrated in FIG. 92 represents several of the
embodiments described above with reference to FIGS. 86A-91B. In
this embodiment, the extension member 2110 includes a support
structure 2130 including a wire 2132 forming a series of loops 2135
positioned circumferentially around the brim 2120. The loops 2135
may provide increased resilience in the brim 2120 while still
providing sufficient flexibility for the extension member 2110 to
be deflected in an upstream direction. Moreover, the loops 2135 may
provide a support structure 2130 that atraumatically engages
tissue.
[0457] FIG. 93 illustrates an embodiment of the device 2100 in
which the support structure 2130 includes a plurality of wavy,
concentric wires 2132 positioned circumferentially around the brim
2120. FIG. 94 illustrates an embodiment of the device 2100 in which
the support structure 2130 includes a spiral/helical formed wire
2132, 2136 positioned circumferentially around the brim 2120. While
the illustrated embodiment of FIG. 94 includes a single wire 2132
formed in a concentric spiral/helical pattern, other wires (not
shown) could be included to form the spiral/helical pattern or
another pattern (e.g., a double helix, double spiral, etc.). The
support structures 2130 illustrated in FIGS. 93 and 94 can provide
axial strength while maintaining sufficient flexibility to conform
and deflect relative to the anchoring member 110 about an axis
transverse to the direction of blood flow through the prosthetic
valve 130.
[0458] FIGS. 95A and 95B illustrate additional embodiments of the
device 2100 in which the support structure 2130 includes a
plurality of spirally projecting spokes 2136 connected to or
otherwise integral with the frame 2109 of the anchoring member 110
and extending radially toward the outer circumference 2112 of the
extension member 2110. The spokes 2136 can have an atraumatic tip
2137 and/or tissue engaging portion such that the supra-annular
tissue and/or atrial wall is undamaged during deployment or
engagement by the extension member 2110. In some embodiments the
atraumatic tip 2137 can be a looped portion 2137a at the end of the
spoke 2136 (FIG. 95A). In other embodiments, the atraumatic tip
2137 can be a bent portion 2137b.
[0459] FIGS. 96A-96C illustrate another embodiment of the device
2100 having a support structure 2130 with atraumatic features. As
shown in FIGS. 96A and 96B, the device 2100 includes a rounded or
curvilinear extension member 2110 having a plurality of resilient
coils 2138 coupled to the brim 2120. In one embodiment, the
extension member 2110 shown in FIG. 96A is configured to conform to
the native anatomy without inducing trauma. The extension member
2110 can also enhance self-alignment of the device 2100 (e.g.,
mitigate tilting relative to the annulus). For example, the
extension member 2110 can counteract against forces that would
cause the device 2100 to tilt during systole. Further, one or more
components of the extension member 2110 can be used to visualize
the shape of the extension member 2110 and thereby detect or locate
the device 2100 during deployment.
[0460] The coils 2138 can extend from the frame 2109 of the
anchoring member 110 toward the outer circumference 2112 of the
extension member 2110 (FIG. 96B), or in another embodiment, the
coils 2138 can be spaced apart from the frame 2109. In one
embodiment, the coils 2138 are deflectable in at least an upward
direction, but are biased toward a radially outward orientation
with a rounded, downward oriented end 2139. In one embodiment, the
coils 2138 can wound from Nitinol (NiTi), polyether ether ketone
(PEEK) polymer, stainless steel or other suitable materials. In
various embodiments, the coils 2138 include shape-memory metal. In
a further embodiment, the extension member 2110 can include the
brim 2120 formed from a fabric, woven material, knitted material,
mesh or web made from polyester or other flexible materials (FIG.
96C). In yet a further embodiment, the brim 2120 can be formed from
a web, mesh, knitted material or other woven material made from
NiTi, stainless steel, (PEEK) polymer, or other suitable materials
that can be used to form the brim 2120 alone or in combination with
another material (e.g., integrated into the weave of) that is used
to form the brim 2120. As shown in FIGS. 96A-96C, the extension
member 2110 can be shaped to provide sealing between the native
tissue and the device 2100 when the valve is closed and under
pressure during ventricular systole. The extension member of FIGS.
96A-96C can also promote bio-integration of tissue into the
material of the brim 2120, which can then promote long-term sealing
of the device 2100 to the native tissue.
[0461] FIGS. 97A and 97B illustrate a further embodiment of the
device 2100 in which the extension member 2110 includes a
discontinuous brim 2120 around the upstream perimeter 113 of the
anchoring member 110 in accordance with the present technology.
FIGS. 97A and 97B are top and isometric views of a device 2100
having an extension member 2110 that includes a plurality of
discreet extending petals 2140 or protrusions extending from the
frame 2109 of the anchoring member 110. The petals 2140 can include
wires 2132 or struts radially extending from the frame 2109 to form
a plurality of spaced apart triangular-shaped petals 2140 around
the upstream perimeter 113 of the anchoring member 110. The wires
2132 can be covered with fabric or other brim material 2124 in a
continuous or discontinuous (FIGS. 97A and 97B) manner to define
the brim 2120. The petals 2140 are mechanically isolated from each
other petal 2140 and each petal 2140 is configured to be deflected
and/or deformed independently of each other petal 2140 to provide
enhanced conformity to the native tissue.
[0462] FIGS. 98A-98C illustrate additional embodiments of the
device 2100 in which the extension member 2110 includes a plurality
of petals 2140 radially extending from the frame 2109 of the
anchoring member 110. For example, FIG. 98A illustrates a device
2100 having a plurality of circular-shaped wires 2141 forming
individual petals 2140. The circular-shaped wires 2141 can be
flexibly connected via a plurality of connectors 2142 to the frame
2109 around the upstream perimeter 113 of the anchoring member 110.
Additionally, the circular-shaped wires 2141 can be covered or
otherwise attached to brim material 2124 for forming the brim 2120
(see FIGS. 98B and 98C). In one embodiment, the extension member
2110 includes a fabric or other material over and/or under the
circular-shaped wires 2141 and extending beyond the circular-shaped
wires 2141 to form a continuous brim 2120 (FIG. 98B). FIG. 98C
illustrates another embodiment in which the circular-shaped wires
are adhered to discreet portions of brim material 2124 to form
spaced apart circular-shaped petals 2140 around the upstream
perimeter 113 of the anchoring member 110. In this example, each
petal 2140 can be mechanically isolated from each adjacent petal
2140 and such that the petals 2140 can be deflected and/or deformed
independently of each other petal 2140 to provide the extension
member 2110 enhanced conformity to the surrounding native tissue.
In further embodiments, the petals 2140 can be connected or hinged
to adjacent petals 2140 (FIG. 98B) with links 2143 or other
fasteners to provide some cohesive movement within the brim 2120
while still allowing more freedom for conformity of unique tissue
anatomy engaged by the extension member 2110.
[0463] FIG. 99 illustrates an additional embodiment of the device
2100 having an extension member 2110 formed of a polymeric sheet
2118 or other panel. In various arrangements, the polymeric sheet
2118 can provide sufficient strength or/or rigidity such that the
extension member 2110 does not need support wires and/or can allow
for fewer wires or smaller wires to be used to form a support
structure (not shown). To provide flexibility to the extension
member 2110, certain embodiments of the polymeric sheet 2118
include a plurality of holes 2119 through the polymeric sheet
material. The holes 2119 can be selected for density, size and/or
position on the polymeric sheet 2118 can be varied to increase
and/or decrease flexibility of selected regions the extension
member 2110. For example, FIG. 99 illustrates an embodiment of the
device 2100 in which holes 2119 are placed in the polymeric sheet
2118 at greater density toward the outer circumference 2112 when
compared to the density at an inner portion 2113 of the polymeric
sheet 2118. In this example, the flexibility of the extension
member 2110 is greater towards the outer circumference 2112 than at
the inner portion 2113 allowing the region at or near the outer
circumference 2112 to more readily deform and conform to the native
tissue. In some embodiments, not shown, the density and/or size of
the holes 2119 can be unevenly distributed across the polymeric
sheet 2118 to form a non-uniform extension member 2110. For
example, it may be desirable to provide greater flexibility (e.g.,
greater density of holes 2118) on the side engaging the anterior
leaflet than on the side engaging the posterior leaflet such that
the device 2100 will not substantially occlude the LVOT.
[0464] FIGS. 100A and 100B illustrate another embodiment of the
device 2100 having an extension member 2110 with variable
flexibility during and following implantation in accordance with
the present technology. FIG. 100A illustrates the expanded device
2100, 2102 after release from a delivery catheter 18, and FIG. 100B
is a schematic top view of the device 2100. Referring to FIGS. 100A
and 100B together, the support structure 2130 can include a
combination of wires having variable stiffness (e.g., flexibility).
For example, the support structure 2130 can include flexible wires
2144 (e.g., thin, floppy) and include relatively stiffer wires 2145
that are less flexible than the flexible wires 2144. The stiffer
wires 2145 may also have higher radiopacity than the flexible wires
2144 so as to facilitate enhanced visualization during device
placement. In some embodiments, the stiffer wires 2145 can be
positioned within pockets or sleeves 2146 within or attached to the
brim 2120 such that the stiffer wires 2145 can be removable during
or after implantation of the device 2100. The sleeves 2146 may be
oriented such the stiffer wires 2145 provide radial support to the
extension member 2110 during deployment and implantation (FIG.
100B); however other orientations and arrangements are also
possible. As shown in FIG. 100A, the stiffer wires 2145 can remain
connected to the delivery catheter 18. After placement of the
extension member 2110 upstream of the native valve, the stiffer
wires 2145 can be removed from the sleeves 2146 and retracted
through the deliver catheter 18. In some embodiments, all the
stiffer wires 2145 can be removed, however, in other arrangements,
a portion of the stiffer wires 2145 or select stiffer wires can
remain within the extension member 2110 following implantation. The
flexible wires 2144 can remain coupled to the brim 2120 to provide
an atraumatic support structure 2130 having increased flexibility
once implanted.
[0465] FIG. 101 illustrates an embodiment of the device 2100 in
which the support structure 2130 includes one or more inflatable
chambers 2147 within the brim 2120 that can be inflated with fluid
to provide radial stiffness to the extension member 2110. The brim
material 2124 can be a fabric, polymer or other material, for
example, that provides the inflatable chambers 2147 (e.g., internal
channels). One or more independent or interconnected inflatable
chambers 2147 can be arranged in a continuous ring around the
extension member 2110, or in other arrangements (e.g., radially
extending arms, zig-zags, etc.) In one embodiment, the chambers
2147 are fillable with fluid (e.g., saline, CO.sub.2, air, gel,
contrast agent, etc.) via a port 2148 provided on the brim 2120
either before, during, or after deployment of the device 2100. In
one embodiment, the chambers 2147 can be at least partially filled
during deployment and the volume of the internal fluid can be
adjusted after deployment of the extension member 2110 and/or the
device 2100 to provide a desired degree of flexibility. In various
embodiments, the chambers 2147 can be inflated temporarily,
permanently, or be deflated before the release of the device 2100
from the delivery catheter (not shown). In one embodiment, the
extension member 2110 has radial stiffness only when inflated. The
extension member 2110 can be structurally independent from the
anchoring member 110, for example, attached via the brim material
2124 or via flexible connectors (not shown). In some embodiments,
the inflation chambers 2147 may provide improved visibility by
contrast echocardiography if the chambers 2147 are filled with a
gas (e.g., CO.sub.2) or other material more visible by
echocardiogram.
[0466] FIG. 102 illustrates an embodiment of the device 2100 in
which the extension member 2110 can include multiple layers 2150 of
brim materials 2124 and/or support structures 2130. Although, for
purposes of clarity, layers 2150 are shown separated in FIG. 102,
layers 2150 are preferably stacked in contact with each other
without intervening spaces In a particular example, multiple layers
2150 of woven fabric of polymeric sheets with one or more layers of
wires 2132 can provide the extension member 2110 with a selectable
degree of compliance or conformity to the native tissue. Individual
layers 2150 of brim materials 2124 can be formed of the same
materials or a combination of materials. Likewise, the support
structure 2130 can include layers of wires 2132 having the same or
different arrangements on the layers 2150 of brim materials 2124.
The wires 2132 can also include a combination of flexible wires
(e.g., smaller, less stiff) and stiffer wires. Accordingly the
multiple layers 2150 may include wires 2132 having different wire
diameters, geometries, overall size and stiffness. In another
embodiment, the layers 2150 can provide the extension member 2110
with an asymmetric degree of flexibility. In one example, the lower
layers 2151 (e.g., closer to the ventricle) can be more stiff
(e.g., less flexible) than the upper layers 2152 that contact
atrial chamber tissue. In another example, the extension member
2110 can have an asymmetric degree of flexibility between the side
engaging the anterior leaflet (e.g., greater flexibility) and the
sides engaging the posterior leaflet or commissures (e.g., less
flexibility) such that the device 2100 will not substantially
occlude the LVOT. In a further embodiment, the extension member
2110 can also include radiopaque markers 160 (e.g., metallic
strips, rings) placed on or between the layers 2150 to assist in
visualization of the device 2100 during and after implantation.
[0467] FIG. 103 illustrates an embodiment of the device 2100 having
a funnel-shaped extension member 2110 extending from the anchoring
member 110 in shape that diverges outwardly in an upstream
direction. In one embodiment, the extension member 2110 can include
an inverted funnel-shaped brim 2126 or tube that includes the brim
material 2124 (e.g., fabric) coupled to the anchoring member 110
and/or integral with the first sealing member portion 140a. In
another embodiment, the extension member 2110 can include the
inverted funnel-shaped brim 2126 further supported by support
structure comprising struts or wires (not shown).
[0468] FIGS. 104A and 104B illustrate an embodiment of the device
2100 in which the anchoring member 110 includes a plurality of
upstream extending lobes 2170 and the extension member 2110
positioned beneath (e.g., downstream) the lobes 2170. In one
embodiment, the lobes 2170 can be spaced apart radial struts 2171
(FIG. 104A), or in another embodiment, the lobes 2170 can be spaced
apart loops 2172 (FIG. 104B). The lobes 2170 can be pre-shaped and
connected to or integral with the frame 2109 of the anchoring
member 110. In one embodiment, the lobes 2170 can include metal or
other material visible by fluoroscopy or echocardiogram imaging
systems (not shown) for visualizing the placement of the device
2100.
[0469] Referring to FIGS. 104A and 104B together, the lobes 2170
can define the expected final deployed position of the extension
member 2110. As such, the lobes 2170 may limit deflection of the
extension member as the device 2100 is pulled (e.g., moved
downstream) into position. Alternatively or additionally, the lobes
2170 may provide a reference marker, visible using fluoroscopy,
relative to which the degree of deflection of the extension member
2110 that may be assessed. As illustrated in FIGS. 104A and 104B,
the angle .alpha. is the angle between the radially extended
extension member 2110 and the lobes 2170. When the angle .alpha. is
small, the extension member 2110 extends more longitudinally (e.g.,
low-profile), and the angle .alpha. increases as the extension
member 2110 extends outwardly. Visualizing the angle .alpha. during
deployment and implantation of the device 2100 can allow a
practitioner to better visualize the position of the device 2100
relative to the native valve anatomy before the anchoring member
110 and valve support with prosthetic valve (not shown) is deployed
from the delivery catheter (not shown). For example, in operation,
the extension member 2110 can be at least partially deployed from
the delivery catheter (not shown) such that the angle .alpha.
becomes large (e.g., full extension). The device 2100 can then be
pulled/pushed downstream through the native annulus. As the device
2100 is pulled/pushed downstream, the extension member 2110 is
deflected by the native tissue inwardly thereby decreasing the
angle .alpha.. Visualization of the decreasing angle .alpha. can
allow the practitioner to see the extent of the inward deflection
as the device 2100 is implanted and, as such, ensure correct
positioning of the device at the native valve.
[0470] FIG. 105 illustrates an embodiment of the device 2100 in
which the extension member 2110 includes an expansion ring 2153
separate from the anchoring member 110 in accordance with the
present technology. The expansion ring 2153 can be flexibly coupled
to the anchoring member 110 by one or more tethers 2154 or other
lines (e.g., sutures, fabric material etc.) spanning a desired
distance between the expansion ring 2153 and the upstream perimeter
113 of the anchoring member 110. In one embodiment, the expansion
ring 2153 may be formed of a wire frame or metal mesh. In another
embodiment, the expansion ring 2153 may be a cylindrical stent
connected to the upstream perimeter 113 and/or the frame 2109 of
the anchoring member 110 by the tethers 2154. In certain
embodiments, a cover or other material can be coupled to the
expansion ring 2153. In various arrangements, the expansion ring
2153 is structurally independent (e.g., mechanically isolated) from
the anchoring member 110 and can also provide a device delivery
positioning aid to ensure the proper position of the anchoring
member 110 before deployment.
[0471] FIGS. 106A and 106B illustrate embodiments of the device
2100 wherein the extension member 2110 is attached to or otherwise
extends from a portion of the valve support 120 (e.g., at a
location downstream from the upstream portion 112 of the anchoring
member 110). In some embodiments this may allow for higher
placement of the device 2100 within the native annulus (not shown).
In the embodiments shown in FIGS. 106A and 106B, the extension
member 2110 can be connected and/or attached (e.g., via stitching,
sutures, rivets, adhesive or other mechanical coupling fasteners or
features known in the art) to the valve support frame 136 and/or to
the second sealing member portion 140b coupled to the valve support
frame 136 at an upstream end 121 (FIG. 106B) or at an intermediate
portion 2155. As illustrated in FIGS. 106A and 106B, and in certain
embodiments, the extension member 2110 may also, or alternatively,
be attached and/or sealed to the anchoring member 110 at the
upstream portion 112 to provide a cover over the gap 2108 between
the anchor member 110 and the valve support 120 (e.g., inner
skeleton). The extension member 2110 may include a brim material
2124 that is impervious to blood or, alternatively, may contain
holes to allow fluid to easily pass into the gap 2108. Or the
extension member 2110 could have holes (not shown) with flap valves
(not shown) or other suitable one-way valves to allow blood or
fluid flow only into the gap 2108 where the fluid becomes trapped
in the space between the anchoring member 110 and the valve support
120, thus "inflating" the space to add additional radial
rigidity.
[0472] FIGS. 107A and 107B illustrate an embodiment of the device
2100 having a separate extension member 2180 that is a separately
deployable component in accordance with the present technology. The
separate extension member 2180 can have a brim 2120 and support
structure (not shown) similar to the extension members 2110
described above. In other arrangements (not shown), the separate
extension member 2180 can include a support structure (e.g.,
spiral-shaped wire) that is delivered above the annulus (not
shown). Additionally, the separate extension member 2180 can also
include one or more docking features 2182 (e.g., hooks, latches,
barbs, pins, etc.) configured to engage the anchoring member 110
(e.g., at corresponding hooks, on frame 2109, etc.). In one
embodiment, the separate extension member 2180 can be delivered by
delivery catheter 18 to the native valve NV before delivering the
anchoring member 110 carrying the prosthetic valve (FIG. 107A) to
the target site. In some embodiments, the separate extension member
2180 can engage the supra-annular surface above the annulus A when
deployed. Following deployment of the separate extension member
2180, the anchoring member 110 and valve support 120 can be
released from the delivery catheter 18 to engage and be retained by
the separate extension member 2180 in proper position within the
native valve NV (FIG. 107B). In one embodiment, the separate
extension member 2180 can remain implanted at the native valve NV;
however, in other embodiments, the separate extension member 2180
can be removed after the prosthetic valve device 2100 is implanted.
In other arrangements, the separate extension member 2180 and the
anchoring member 110 can be delivered as a single component and the
valve support 120 carrying the prosthetic valve can be delivered
separately.
[0473] Referring back to FIGS. 86A-107B, and in the case of mitral
valve replacement, the device 2100 is delivered in a low-profile
delivery configuration 2106 such that the extension member 2110 is
positioned in the left atrium and the anchoring member 110 (e.g.,
fixation portion 1710) is positioned at the native valve annulus.
The device 2100 is partially deployed such that the extension
member 2110 is release from the delivery catheter 18 and allowed to
expand radially while the anchoring member 110 is retained in the
delivery catheter 18. In many of the foregoing embodiments, the
extension member 2110 readily folds relative to the anchoring
member 110. As such, the device 2100 is then drawn toward the left
ventricle which causes the extension member 2110 to fold inwardly.
The extension member 2110 exerts a force that properly aligns the
anchoring member 110 with the native valve annulus, and the
relative position between the extension member 2110 and the
anchoring member 110 can be readily visualized through known
imaging techniques to enable the practitioner to accurately
position the device 2100 relative to the native valve
structure.
[0474] Additionally, as discussed above, the extension member 2110
can have many different embodiments including a brim 2120 or
shoulder that extends from the anchoring member 110, or an
expansion ring 2153 that is coupled to the anchoring member 110 by
at least one line (e.g., tether 2154). The brims 2120, shoulders,
and/or rings are configured to expand to have a larger diameter
than the anchoring member 110 and to flex, flap, and/or fold
relative to the anchoring member 110. The extension member 2110 is
accordingly configured to enhance the positioning,
orientation/alignment, and visualization of the device 2100
relative to the native valve anatomy. In some embodiments, but not
necessarily all, the extension member 2110 can provide additional
fixation and sealing of the device 2100.
Additional Embodiments
[0475] Features of the prosthetic heart valve device components
described above and illustrated in FIGS. 10A-107B can be modified
to form additional embodiments configured in accordance with the
present technology. For example, the prosthetic heart valve device
1100 illustrated in FIGS. 65A-65B without flared anchoring members
can include anchoring members that are coupled to the valve support
or other feature and are configured to extend radially outward to
engage subannular tissue. Similarly, the prosthetic heart valve
devices described above and illustrated in FIGS. 57A-71 can include
features such as sealing members as well as stabilizing features
such as arms and tissue engaging elements.
[0476] Features of the prosthetic heart valve device components
described above also can be interchanged to form additional
embodiments of the present technology. For example, the anchoring
member 1210 of the prosthetic heart valve device 1200 illustrated
in FIG. 67A can be incorporated into the prosthetic heart valve
device 600 shown in FIGS. 57A-57C. Additionally, many features of
the prosthetic heart valve devices 1700, 1900, 2000 and 2100
described above with reference to FIGS. 72-107B can be used with
the prosthetic heart valve devices described above with reference
to FIGS. 10-71A, and vice versa. In a particular embodiment,
extension members 2110 shown in FIGS. 86A-107B can be incorporated,
for example, in the device 100 (FIG. 10A).
[0477] The following Examples are illustrative of several
embodiments of the present technology.
EXAMPLES
[0478] 1. A prosthetic heart valve device, comprising: [0479] a
valve support having an upstream region and a downstream region
relative to blood flow through a native heart valve of a human
heart, the upstream region being configured to support a prosthetic
valve, the prosthetic valve having a plurality of leaflets and
having an undeformed shape in which the leaflets coapt sufficiently
to prevent backflow through the prosthetic valve; [0480] an
anchoring member having a longitudinal dimension and including a
tissue fixation portion, an integration region coupled to the valve
support, and a plurality of lateral connectors between the tissue
fixation portion and the integration region, wherein the tissue
fixation portion is configured to (a) engage tissue at an implant
site located at and/or downstream of a native annulus of the native
heart valve and (b) be at least partially deformable into a
non-circular shape to adapt to a shape of the tissue at the implant
site in a deployed state, and [0481] wherein the lateral connectors
have a lateral section extending in a transverse direction relative
to the longitudinal dimension of the anchoring member and at least
a first transition zone that bends in a direction different than
the transverse direction such that the tissue fixation portion
faces the tissue at the implant site in the deployed state; and
wherein the tissue fixation portion of the anchoring member is
mechanically isolated from the upstream region of the valve support
such that the upstream region of the valve support maintains the
undeformed shape if the anchoring member has deformed in the
non-circular shape.
[0482] 2. A prosthetic heart valve device, comprising: [0483] an
anchoring member having a longitudinal dimension and including a
tissue fixation portion having a first cross-sectional dimension in
a deployed state, an integration region having a second
cross-sectional dimension in the deployed state less than the first
cross-sectional dimension, and a lateral portion between the tissue
fixation portion and the integration region, wherein-- [0484] the
tissue fixation portion is configured to (a) engage tissue located
at and/or downstream of a native annulus of a heart valve in a
human and (b) be at least partially deformable into a non-circular
shape to adapt to a shape of the tissue engaged by the tissue
fixation portion in a deployed state, and [0485] the lateral
portion extends in a direction transverse with respect to the
longitudinal dimension of the anchoring member and has at least a
first transition zone that bends from the transverse direction to
the tissue fixation portion such that the tissue fixation portion
is configured to face the native annulus in the deployed state; and
[0486] a valve support having a first region and a second region,
the first region having a cross-sectional shape in the deployed
state configured to support a prosthetic valve such that prosthetic
leaflets of the prosthetic valve contact each other in the deployed
state, and the second region of the valve support being coupled to
the fixation portion of the anchoring member.
[0487] 3. The prosthetic heart valve device of any of examples 1-2,
wherein the connectors or lateral portion further include a second
transition zone that bends from the lateral section or lateral
portion to the integration region.
[0488] 4. The prosthetic heart valve device of any of examples 1-3,
wherein the anchoring member has a first end at the tissue fixation
portion and a second end at the integration region, and wherein the
first transition zone bends from the lateral section or lateral
portion toward the first end of the anchoring member and second
transition zone bends from the lateral section or lateral portion
toward the second end of the anchoring member.
[0489] 5. The prosthetic heart valve device of any of examples 1-4,
wherein the connectors or lateral portion further include a second
transition zone, and wherein the first transition zone bends
superiorly and the second transition zone bends inferiorly relative
to the heart.
[0490] 6. The prosthetic heart valve device of any of examples 1-5,
wherein the first transition zone has a concave curvature with
respect to the longitudinal dimension of the anchoring member.
[0491] 7. The prosthetic heart valve device of example 6, wherein
the connectors further comprise a second transition zone that bends
from the lateral section or lateral portion to the integration
region, and wherein the second transition zone has a convex
curvature with respect to the longitudinal dimension of the
anchoring member.
[0492] 8. The prosthetic heart valve device of any of examples 1-7,
wherein the tissue fixation portion extends at least substantially
parallel to the longitudinal dimension of the anchoring member.
[0493] 9. The prosthetic heart valve device of any of examples 1-8
wherein the longitudinal dimension is a central longitudinal axis
of the anchoring member, and the tissue fixation portion extends at
angle inclined inwardly toward the central longitudinal axis.
[0494] 10. The prosthetic heart valve device of any of examples
1-9, wherein the tissue fixation portion comprises a ring having
right cylindrical shape and a plurality of barbs projecting from
the ring.
[0495] 11. The prosthetic heart valve device of any of examples
1-10, wherein the tissue fixation portion has a height of 10-20 mm
and a generally flat outer surface along the height.
[0496] 12. The prosthetic heart valve device of any of examples
1-11, wherein the anchoring member has a first end at the tissue
fixation portion and a second end at the integration region, and
the second end of the anchoring member is connected to the
downstream region of the valve support.
[0497] 13. The prosthetic heart valve device of any of examples
1-11, wherein the anchoring member has a first end at the tissue
fixation portion and a second end at the integration region, and
the second end of the anchoring member is connected to the upstream
region of the valve support.
[0498] 14. The prosthetic heart valve device of any of examples
1-13, further comprising a compartment between the anchoring member
and the valve support, and a material in the compartment.
[0499] 15. The prosthetic heart valve device of example 14, wherein
the compartment comprises a fabric container attached to the
anchoring member and/or the valve support, and the material
includes at least one of an anti-clotting agent and/or a healing
agent.
[0500] 16. The prosthetic heart valve device of any of examples
1-15, wherein the lateral portion comprises an outwardly flared
section, and the fixation portion extends at least substantially
parallel to the longitudinal dimension of the anchoring member.
[0501] 17. The prosthetic heart valve device of any of examples
1-15, wherein the lateral portion comprises an outwardly extending
conical section, and the fixation portion extends at least
substantially parallel to the longitudinal dimension of the
anchoring member.
[0502] 18. A device for implantation at a native mitral valve, the
native mitral valve having a non-circular annulus and leaflets,
comprising: [0503] a valve support having a first region configured
to be attached to a prosthetic valve with a plurality of prosthetic
leaflets and a second region; [0504] an anchoring member having a
longitudinal dimension and including a first portion configured to
contact tissue at the non-circular annulus and a second portion
having a lateral portion between the first portion and the valve
support; [0505] wherein the second portion of the anchoring member
is attached to the second region of the valve support while in a
low-profile configuration in which the anchoring member and the
valve support are configured to pass through vasculature of a
human; [0506] wherein the lateral portion is transverse to the
longitudinal dimension; and [0507] wherein the anchoring member and
the valve support are configured to move from the low-profile
configuration to an expanded configuration in which the first
portion of the anchoring member at least partially adapts to the
non-circular annulus of the native mitral valve and the first
region of the valve support is spaced inwardly from the first
portion of the anchoring member relative to the longitudinal
dimension of the anchoring member such that a shape of the first
region of the valve support is at least partially independent of a
shape of the first portion of the anchoring member.
[0508] 19. The device of example 18, wherein the first portion of
the anchoring member comprises a tissue fixation portion and the
second portion of the anchoring member comprises an integration
region.
[0509] 20. The device of any of examples 18-19, wherein the lateral
portion comprises a plurality of lateral connectors, and individual
connectors include a lateral section extending in a transverse
direction relative to the longitudinal dimension of the anchoring
member and at least a first transition zone that bends in a
direction different than the transverse direction such that the
first portion or the tissue fixation portion of the anchoring
member faces tissue at the implant site in the deployed state.
[0510] 21. The device of any of examples 18-20, wherein the
connectors or lateral portion further include a second transition
zone that bends from the lateral section or lateral portion to the
valve support.
[0511] 22. The device of any of examples 18-21, wherein the first
portion or the tissue fixation portion of the anchoring member
extends at least substantially parallel to the longitudinal
dimension of the anchoring member.
[0512] 23. The prosthetic heart valve device of any of examples
18-21 wherein the longitudinal dimension is a central longitudinal
axis of the anchoring member, and the first portion or the tissue
fixation portion of the anchoring member extends at angle inclined
inwardly toward the central longitudinal axis.
[0513] 24. The prosthetic heart valve device of any of examples
18-23, wherein the first portion or the tissue fixation portion of
the anchoring member comprises a ring having right cylindrical
shape and a plurality of barbs projecting from the ring.
[0514] 25. The prosthetic heart valve device of any of examples
18-24, wherein the anchoring member has a first end at the first
portion or the tissue fixation portion and a second end at the
second portion or the integration region, and the second end of the
anchoring member is connected to a downstream region of the valve
support.
[0515] 26. The prosthetic heart valve device of any of examples
18-24, wherein the anchoring member has a first end at the first
portion or the tissue fixation portion and a second end at the
second portion or the integration region, and the second end of the
anchoring member is connected to an upstream region of the valve
support.
[0516] 27. The prosthetic heart valve device of any of examples
18-26, further comprising a compartment between the anchoring
member and the valve support, and a material in the
compartment.
[0517] 28. The prosthetic heart valve device of any of examples 27,
wherein the compartment comprises a fabric container attached to
the anchoring member and/or the valve support, and the material
includes at least one of an anti-clotting agent and/or a healing
agent.
[0518] 29. The prosthetic heart valve device of any of examples
18-28, wherein the lateral portion comprises an outwardly flared
section, and the first portion or the fixation portion of the
anchoring member extends at least substantially parallel to the
longitudinal dimension of the anchoring member.
[0519] 30. The prosthetic heart valve device of any of examples
18-28, wherein the lateral portion comprises an outwardly extending
conical section, and the first portion or the fixation portion of
the anchoring member extends at least substantially parallel to the
longitudinal dimension of the anchoring member.
[0520] 31. A method for operating of a prosthetic heart valve
wherein the prosthetic heart valve device including an anchoring
member and a valve support coupled to the anchoring member in a
heart of a human, and wherein the anchoring member has a tissue
fixation portion, an integration region attached to the valve
support, and a lateral portion between the tissue fixation portion
and the integration region, and wherein the method comprises:
[0521] expanding the anchoring member and the valve support such
that a tissue fixation portion has a size and shape that is spaced
apart from the valve support; [0522] moving the anchoring member
and the valve support such that the tissue fixation portion deforms
to a non-circular shape; and [0523] wherein a support region of the
valve support is mechanically isolated from the tissue fixation
portion of the anchoring member such that the support region of the
valve support has a predetermined cross-sectional shape that
supports a prosthetic valve so that prosthetic leaflets of the
prosthetic valve contact each other sufficiently to inhibit
backflow through the prosthetic valve.
[0524] 32. The method of example 31, wherein the tissue fixation
portion of the anchoring member comprises a right cylinder having
an outer surface that extends at least substantially parallel to a
longitudinal axis of the anchoring member.
[0525] 33. The method of any of examples 31-32, wherein the lateral
portion has a lateral section that extends transverse with respect
to the valve support or the longitudinal axis of the anchoring
member and at least a first transition zone having a first bend
from the lateral section to the tissue fixation portion.
[0526] 34. The method of example 32, wherein the lateral portion
further includes a second transition zone having a second bend from
the lateral section to the integration region.
[0527] 35. The method of any of examples 33 and 34, wherein the
lateral portion projects outwardly from the integration region and
the first bend is angled superiorly from the lateral portion.
[0528] 36. The method of any of examples 33 and 34, wherein the
lateral portion projects outwardly from the integration region and
the first bend is angled inferiorly from the lateral portion.
[0529] 37. A method for replacement of a native heart valve having
an annulus and leaflets coupled to the annulus, the method
comprising: [0530] positioning a prosthetic heart valve device
including an anchoring member and a valve support at a native
mitral valve location in a heart of the patient, wherein the
anchoring member has a first portion and a second portion, and the
valve support has a first region and a second region; and [0531]
expanding the anchoring member and the valve support while the
second portion of the anchoring member is coupled to the second
region of the valve support such that the first portion of the
anchoring member engages tissue on or downstream of the annulus and
at least partially adapts to a shape of the annulus at the native
mitral valve location; [0532] wherein, upon expansion, the first
region of the valve support is spaced inwardly apart from the first
portion of the anchoring member and the first region of the valve
support holds a prosthetic valve having prosthetic leaflets such
that the prosthetic leaflets contact each other sufficiently to
inhibit backflow through the prosthetic valve after the first
portion of the anchoring member has adapted to the shape of the
annulus of the native mitral valve.
[0533] 38. A prosthetic heart valve device, comprising: [0534] a
valve support having an upstream region and a downstream region
relative to blood flow through a native heart valve of a human
heart, the upstream region being configured to support a prosthetic
valve, the prosthetic valve having a plurality of leaflets and
having an undeformed shape in which the leaflets coapt sufficiently
to prevent backflow through the prosthetic valve; [0535] an
anchoring member including an outwardly-facing engagement surface
configured to engage tissue at an implant site on or below a native
annulus of the native heart valve and extend in an upstream
direction at an angle generally parallel to a longitudinal axis of
the anchoring member or tapering inwardly in the upstream
direction, the fixation portion being deformable into a
non-circular shape to adapt to a shape of the tissue at the implant
site in a deployed state; and [0536] a connection structure
interconnecting the anchoring member to the valve support; [0537]
wherein the tissue fixation portion of the anchoring member is
mechanically isolated from the upstream region of the valve support
such that the upstream region of the valve support maintains the
undeformed shape if the anchoring member has deformed into the
non-circular shape.
[0538] 39. The prosthetic heart valve device of example 38 wherein
the connection structure comprises a plurality of struts each
having an inner end connected to the valve support and an outer end
connected to the anchoring member.
[0539] 40. The prosthetic heart valve device of any of examples
38-39 wherein the connection structure has a flared portion that
flares outwardly in the upstream direction.
[0540] 41. The prosthetic heart valve of example 40 wherein the
connection structure is configured such that the flared portion is
disposed entirely downstream of the native annulus when the
anchoring member is at the implant site.
[0541] 42. Prosthetic heart valve device of any of examples 38-41
wherein the connection structure has an upstream end connected to
the anchoring member, the upstream end being configured for
positioning below the native annulus when the anchoring member is
at the implant site.
[0542] 43. The prosthetic heart valve device of any of examples
38-42 further comprising a plurality of barbs on the fixation
surface, the barbs pointing in the upstream direction and
configured to engage the tissue to resist upstream movement of the
anchoring member relative to the native annulus.
[0543] 44. The prosthetic heart valve device of any of examples
38-43 wherein the fixation surface is deflectable through a range
of angles relative to the longitudinal axis such that upon
engagement with the tissue the fixation surface is movable from an
unbiased orientation to an implanted orientation.
[0544] 45. The prosthetic heart valve device of example 44 wherein
the fixation surface is deflectable through a range of angles
relative to the connecting structure.
[0545] 46. The prosthetic heart valve device of any of examples
38-45 wherein the fixation portion has a first flexibility and the
connecting structure has a second flexibility different than the
first flexibility.
[0546] 47. The prosthetic heart valve device of any of examples
38-45 wherein the fixation portion has a downstream region with a
first flexibility and an upstream region with a second flexibility
different than the first flexibility.
[0547] 48. The prosthetic heart valve device of any of examples
38-47 wherein the fixation portion comprises a skirt covering an
inward-facing surface thereof.
[0548] 49. The prosthetic heart valve device of example 48 wherein
the skirt further covers an inward-facing side of the connecting
structure.
[0549] 50. The prosthetic heart valve device of example 48 further
comprising a tubular valve cover extending around the valve
support, the skirt being attached to the valve cover so as to
inhibit blood flow therebetween
[0550] 51. The prosthetic heart valve device of example 50 wherein
the valve cover is disposed on an inward facing surface of the
valve support.
[0551] 52. The prosthetic heart valve device of any of examples
38-51 wherein the fixation surface is disposed at an angle
generally parallel to an outwardly facing surface of the valve
support in an unbiased condition.
[0552] 53. The prosthetic heart valve device of any of examples
38-52 wherein the valve support has a downstream end, the anchoring
member being configured such that the downstream end is disposed no
more than 16 mm downstream of the native annulus when the
engagement surface is at the implant site.
[0553] 54. The prosthetic heart valve device of any of examples
38-53 wherein the fixation surface has a width in a direction
parallel to the longitudinal axis of at least about 10-20 mm.
[0554] 55. The prosthetic heart valve device of 38-54 wherein the
connecting structure extends a distance parallel to the
longitudinal axis of less than about 15 mm from the inner end to
the outer end.
[0555] 56. A prosthetic heart valve device, comprising:
[0556] a valve support having an upstream region and a downstream
region relative to blood flow through a native heart valve of a
human heart, the upstream region being configured to support a
prosthetic valve, the prosthetic valve having a plurality of
leaflets and having an undeformed shape in which the leaflets coapt
sufficiently to prevent backflow through the prosthetic valve;
and
[0557] an anchoring member including a connection structure and a
fixation portion, the connection structure having an inner end
connected to the valve support, an outer end connected to the
fixation portion, and an intermediate portion between the inner end
and the outer end which flares outwardly in an upstream direction,
the fixation portion having an outwardly-facing engagement surface
configured to engage tissue at an implant site on or below a native
annulus of the native heart valve with the flared portion of the
connection structure disposed entirely downstream of the native
annulus, the engagement surface extending in an upstream direction
at an angle generally parallel to a longitudinal axis of the
anchoring member or tapering inwardly in the upstream direction,
the fixation portion being deformable into a non-circular shape to
adapt to a shape of the tissue at the implant site in a deployed
state;
[0558] wherein the fixation portion of the anchoring member is
mechanically isolated from the upstream region of the valve support
such that the upstream region of the valve support maintains the
undeformed shape if the anchoring member has deformed into the
non-circular shape.
[0559] 57. A prosthetic heart valve device, comprising:
[0560] a valve support having an upstream region and a downstream
region relative to blood flow through a native heart valve of a
human heart, the upstream region being configured to support a
prosthetic valve, the prosthetic valve having a plurality of
leaflets and having an undeformed shape in which the leaflets coapt
sufficiently to prevent backflow through the prosthetic valve;
and
[0561] an anchoring member including a connection structure and a
fixation portion, the connection structure having an inner end
connected to the valve support and an outer end connected to the
fixation portion, the fixation portion having an outwardly-facing
engagement surface configured to engage tissue at an implant site
on or below a native annulus of the native heart valve, the
anchoring member having a downstream region with a first
flexibility and an upstream region with a second flexibility
different than the first flexibility, the fixation portion being
deformable into a non-circular shape to adapt to a shape of the
tissue at the implant site in a deployed state;
[0562] wherein the fixation portion of the anchoring member is
mechanically isolated from the upstream region of the valve support
such that the upstream region of the valve support maintains the
undeformed shape if the anchoring member has deformed into the
non-circular shape.
[0563] 58. The prosthetic heart valve device of example 57 wherein
the upstream region is in the fixation portion and the downstream
region is in the connecting structure.
[0564] 59. The prosthetic heart valve device of example 57 wherein
the upstream region is in an upstream portion of the fixation
portion and the downstream region is in a downstream portion of the
fixation portion.
[0565] 60. A prosthetic heart valve device comprising: [0566] an
anchoring member having a tubular fixation frame with an inlet end
and an outlet end; [0567] a tubular valve support having a first
portion coupled to the anchoring member and a second portion
mechanically isolated from the anchoring member such that the inlet
end of the anchoring member is radially deformable without
substantially deforming the second portion; [0568] a valve coupled
to the valve support and having at least one leaflet movable from a
closed position in which blood flow is blocked through the valve
support and an open position in which blood flow is allowed through
the valve support in a downstream direction; and [0569] an
extension member coupled to the fixation frame and extending
radially outward therefrom, at least a deformable portion of the
extension member being mechanically isolated from the anchoring
member such that the deformable portion of the extension member is
radially deformable without substantially deforming the anchoring
member.
[0570] 61. The prosthetic heart valve device of example 60 wherein
the extension member includes a brim comprised of a sheet of
flexible material coupled to the fixation frame and extending
radially outward therefrom, and a support structure coupled to the
brim, wherein the support structure is more rigid than the
brim.
[0571] 62. A prosthetic heart valve device comprising: [0572] an
anchoring member having a connection structure and a radially
expandable fixation frame, wherein the connection structure has a
first end coupled to the fixation frame, a second end coupled to a
valve support and a lateral portion that spaces the fixation frame
apart from the valve support; [0573] a valve coupled to the valve
support and having at least one leaflet movable from a closed
position in which blood flow is blocked through the interior and an
open position in which blood flow is allowed through an interior in
a flow direction from an inlet end toward an outlet end; and [0574]
an extension member comprising: [0575] a brim comprised of a sheet
of flexible material coupled to the fixation frame and extending
radially outward therefrom; and [0576] a support structure coupled
to the brim, the support structure being more rigid than the brim;
[0577] wherein the extension member is deflectable relative to the
fixation frame about an axis transverse to the flow direction and
the fixation frame is configured to deform at least partially
independently of the valve support.
[0578] 63. The prosthetic heart valve device of any of examples 61
and 62 wherein the support structure is resilient and is more
flexible than the fixation frame.
[0579] 64. The prosthetic heart valve device of any of examples
60-63 wherein the valve support comprises a generally cylindrical
valve frame formed around a longitudinal axis extending between the
inlet and outlet ends.
[0580] 65. The prosthetic heart valve device of example 64 wherein
the valve frame has an upper extremity and a lower extremity, and
the anchoring member is coupled to the lower extremity of the valve
frame.
[0581] 66. The prosthetic heart valve device of example 65 further
comprising a plurality of connecting members interconnecting the
lower extremity of the valve frame and the anchoring member.
[0582] 67. The prosthetic heart valve device of example 65 wherein
an upstream end of the anchoring member is radially spaced apart
from the upper extremity of the valve frame such that the upstream
end of the anchoring member is radially deformable without
substantially deforming the upper extremity of the valve frame.
[0583] 68. The prosthetic heart valve device of any of examples
61-63 wherein the anchoring member comprises a cover of a flexible
material coupled to the fixation frame and surrounding an interior
thereof.
[0584] 69. The prosthetic heart valve device of example 68 wherein
the brim has an inner edge attached to a circumference of the
cover.
[0585] 70. The prosthetic heart valve device of example 68 wherein
the brim and the cover comprise a continuous sheet of material.
[0586] 71. The prosthetic heart valve device of any of examples 61
and 62 wherein the support structure comprises a plurality of
struts.
[0587] 72. The prosthetic heart valve device of example 71 wherein
the struts are not directly connected to the fixation frame.
[0588] 73. The prosthetic heart valve device of example 71 wherein
the struts are spaced apart from the fixation frame.
[0589] 74. The prosthetic heart valve device of example 71 wherein
the struts are coupled directly to the fixation frame.
[0590] 75. The prosthetic heart valve of any of examples 60-62
wherein the extension member has an unbiased configuration in which
it extends radially outward from the anchoring member and is
deflectable to a deflected configuration in which it extends
further in an upstream direction, the extension member being
resiliently biased to return to the unbiased configuration.
[0591] 76. The prosthetic heart valve device of example 71 wherein
the struts extend in a radial direction away from the fixation
frame.
[0592] 77. The prosthetic heart valve device of example 71 wherein
the struts form a continuous ring around extension member.
[0593] 78. The prosthetic heart valve device of example 77 wherein
the struts form a wavy, zig-zag or diamond pattern around the
extension member.
[0594] 79. The prosthetic heart valve device of example 71 wherein
the struts are sewn to the brim.
[0595] 80. The prosthetic heart valve device of any of examples
60-63 wherein the extension member comprises a plurality of
discreet petals extending from an upstream end of the anchoring
member.
[0596] 81. The prosthetic heart valve device of any of examples
60-63 wherein in a deployed state the fixation frame is configured
to engage tissue downstream of a native annulus of a heart valve
and the extension member is configured to engage tissue upstream of
the native annulus.
[0597] 82. The prosthetic heart valve device of example 81 wherein
the extension member is configured align the heart valve device
relative to the native annulus by engaging the tissue upstream of
the native annulus.
[0598] 83. The prosthetic heart valve device of any of examples
61-63 wherein the support structure comprises a resilient metal or
polymer mesh.
[0599] 84. The prosthetic heart valve device of any of examples
61-63 wherein the support structure is coupled to the fixation
frame by a plurality of flexible connecting members, the connecting
members being substantially less rigid than the fixation frame.
[0600] 85. The prosthetic heart valve device of any of examples
61-63 wherein the extension member is coupled to the anchoring
member only by the brim.
[0601] 86. A prosthetic heart valve device comprising: [0602] an
anchoring member having a tubular fixation frame with an interior
and having an upstream end and a downstream end; [0603] a valve
coupled to the anchoring member and having at least one leaflet
movable from a closed position in which blood flow is blocked
through the interior and an open position in which blood flow is
allowed through the interior in a flow direction from the upstream
end toward the downstream end; and [0604] an extension member
comprising: [0605] a brim comprised of a sheet of flexible material
coupled to the anchoring member near the upstream end thereof and
extending radially outward therefrom; and [0606] a resilient
support structure coupled to the brim and being structurally
independent of the fixation frame; [0607] wherein the extension
member is radially deformable without substantially deforming the
anchoring member.
[0608] 87. A method of replacing a native heart valve comprising:
[0609] positioning a prosthesis in a first heart chamber upstream
of a native annulus with a delivery device, the prosthesis being in
a collapsed configuration; [0610] deploying an extension member of
the prosthesis in the first heart chamber so that the extension
member at least partially expands into an expanded shape while an
anchoring member of the prosthesis remains at least partially
collapsed; [0611] moving the prosthesis to cause an indicator
portion of the extension member to deflect by engagement with a
wall of the first heart chamber surrounding the native heart valve;
[0612] visualizing the indicator portion of the extension member to
determine a position of the prosthesis relative to a native annulus
based on the deflection of the indicator portion; and [0613]
deploying the anchoring member of the prosthesis such that it
expands into engagement with heart tissue downstream of the native
annulus so as to anchor the prosthesis in place.
[0614] 88. The method of example 87 wherein the indicator portion
comprises a radiopaque material, the indicator portion being
visualized using fluoroscopy.
[0615] 89. The method of example 87 wherein the indicator portion
comprises an echogenic material, the indicator portion being
visualized using ultrasound.
[0616] 90. The method of example 87 wherein the indicator portion
comprises one or more metallic members.
[0617] 91. The method of example 87 wherein the indicator portion
deflects about an axis generally parallel to a plane containing the
native annulus.
[0618] 92. The method of example 87 wherein the indicator portion
forms an angle with a plane containing the native annulus, the
angle increasing as the indicator portion is deflected.
[0619] 93. The method of example 92 wherein the indicator portion
forms a first angle with the plane during the visualization step,
further comprising moving the prosthesis after the visualization
step such that the indicator portion forms a second angle with the
plane less than the first angle before the anchoring member is
deployed.
[0620] 94. A method of replacing a native heart valve comprising:
[0621] positioning a prosthesis in a first heart chamber upstream
of a native annulus with a delivery device, the prosthesis being in
a collapsed configuration; [0622] deploying an extension member of
the prosthesis in the first heart chamber so that the extension
member at least partially expands into an expanded shape while an
anchoring member of the prosthesis remains at least partially
collapsed; [0623] deploying the anchoring member of the prosthesis
such that it expands into engagement with heart tissue downstream
of the native annulus so as to anchor the prosthesis in place; and
[0624] allowing the extension member to radially deform to a
greater extent than any deformation of the anchoring member.
[0625] 95. The method of example 94 further comprising expanding a
tubular valve support coupled to the anchoring member, the valve
support having a valve coupled thereto.
[0626] 96. The method of example 95 wherein the valve support has a
lower extremity coupled to a downstream end of the anchoring member
and an upper extremity which is mechanically isolated from an
upstream end of the anchoring member.
[0627] 97. The method of example 96 further comprising allowing the
anchoring member to radially deform without substantially deforming
the second end of the valve support.
[0628] 98. The method of example 94 wherein the extension member is
coupled to the anchoring member by a flexible coupling member, the
coupling member being substantially less rigid than the anchoring
member.
[0629] 99. The method of example 98 wherein the coupling member is
fabric.
[0630] 100. A prosthetic heart valve device comprising: [0631] an
anchoring member having a radially expandable frame with an
interior and having an upstream end and a downstream end, wherein
the upstream end includes a tissue fixation portion configured to
engage tissue located at and/or downstream of a native annulus of a
heart valve in a subject and configured to be at least partially
deformable to conform to a shape of the tissue; [0632] a valve
positioned relative to the anchoring member and having at least one
leaflet movable from a closed position in which blood flow is
blocked through the interior and an open position in which blood
flow is allowed through the interior in a flow direction from the
upstream end toward the downstream end, wherein the valve is spaced
inwardly apart from the tissue fixation portion of the anchoring
member such that the valve remains competent when the tissue
fixation portion is deformed to conform to the shape of the tissue;
and [0633] an extension member flexibly coupled to the anchoring
member proximate the upstream end of the expandable frame, wherein
the extension member extends longitudinally along the flow
direction in a low-profile configuration and is biased to project
laterally relative to the flow direction in a deployed
configuration, the extension member being configured to deform
relative to the expandable frame in the deployed configuration.
[0634] 101. The prosthetic heart valve device of example 100
wherein the extension member comprises a brim projecting from the
upstream end of the frame.
[0635] 102. The prosthetic heart valve device of example 100
wherein the extension member comprises a shoulder.
[0636] 103. The prosthetic heart valve device of example 100
wherein the extension member comprises an expansion ring separate
from the anchoring member, and the device further includes a tether
attached to the expansion ring and the anchoring member.
[0637] 104. The prosthetic heart valve device of any of examples
101, 102 and 103 wherein the brim comprises a cover.
[0638] 105. The prosthetic heart valve device of example 104
wherein the cover comprises a web material.
[0639] 106. The prosthetic heart valve device of example 105
wherein the web comprises a woven, braided and/or grating of
flexible material.
[0640] 107. The prosthetic heart valve device of any of examples
105 and 106 wherein the web comprises a shape-memory polymeric
material, a shape-memory metal, and/or a fabric.
[0641] 108. The prosthetic heart valve device of any of examples
101-107 wherein the extension member further comprises a support
structure attached to the brim.
[0642] 109. The prosthetic heart valve device of example 108
wherein the support structure comprises a stiffening member more
rigid than the brim.
[0643] 110. The prosthetic heart valve device of example 109
wherein the stiffening member comprises a scaffold formed from a
polymeric material and/or a metal.
[0644] 111. The prosthetic heart valve device of example 110
wherein the scaffold has a serpentine, zig-zag, diamond pattern,
and/or square pattern.
[0645] 112. The prosthetic heart valve device of example 111
wherein the scaffold comprises a continuous strut.
[0646] 113. The prosthetic heart valve device of example 111
wherein the scaffold comprises a plurality of struts that are
connected together.
[0647] 114. The prosthetic heart valve device of any of examples
108-113 wherein the support member is spaced apart from the
expandable frame such that support member is only indirectly
coupled to the anchoring member by the brim.
[0648] 115. The prosthetic heart valve device of examples 108-113
wherein the support member is mechanically isolated from the
expandable frame.
[0649] 116. The prosthetic heart valve device of example 115
wherein the support member is spaced apart from the frame of the
anchoring member and indirectly coupled to the anchoring member by
the brim.
[0650] 117. The prosthetic heart valve device of any of examples
108-113 wherein the support member is directly connected to the
expandable frame.
[0651] 118. A method of replacing a native heart valve comprising:
[0652] positioning a prosthesis in a first heart chamber upstream
of a native annulus with a delivery device, the prosthesis being in
a collapsed configuration; [0653] deploying an extension member of
the prosthesis in the first heart chamber so that the extension
member at least partially expands into an expanded shape while a
fixation member of the prosthesis remains at least partially
collapsed; [0654] moving the prosthesis in a downstream direction
such that the expanded extension member folds at least partially
inwardly and positions the fixation member at a desired location
relative to the native valve annulus; and [0655] deploying the
fixation member of the prosthesis such that it expands into
engagement with heart tissue downstream of the native annulus so as
to anchor the prosthesis in place.
[0656] 119. The method of example 118, further comprising
visualizing via an imaging modality the extension member folding
inwardly while moving the prosthesis downstream.
[0657] 120. The method of any of examples 118 and 119, wherein the
extension member causes the fixation member to align with the
native valve annulus.
[0658] 121. The method of any of examples 118-120 wherein the
extension member is configured for tissue ingrowth such that the
extension member provides additional fixation and sealing over
time.
CONCLUSION
[0659] The above detailed descriptions of embodiments of the
technology are not intended to be exhaustive or to limit the
technology to the precise form disclosed above. Although specific
embodiments of, and examples for, the technology are described
above for illustrative purposes, various equivalent modifications
are possible within the scope of the technology as those skilled in
the relevant art will recognize. For example, while steps are
presented in a given order, alternative embodiments may perform
steps in a different order. The various embodiments described
herein may also be combined to provide further embodiments.
[0660] From the foregoing, it will be appreciated that specific
embodiments of the technology have been described herein for
purposes of illustration, but well-known structures and functions
have not been shown or described in detail to avoid unnecessarily
obscuring the description of the embodiments of the technology.
Where the context permits, singular or plural terms may also
include the plural or singular term, respectively.
[0661] Moreover, unless the word "or" is expressly limited to mean
only a single item exclusive from the other items in reference to a
list of two or more items, then the use of "or" in such a list is
to be interpreted as including (a) any single item in the list, (b)
all of the items in the list, or (c) any combination of the items
in the list. Additionally, the term "comprising" is used throughout
to mean including at least the recited feature(s) such that any
greater number of the same feature and/or additional types of other
features are not precluded. It will also be appreciated that
specific embodiments have been described herein for purposes of
illustration, but that various modifications may be made without
deviating from the technology. Further, while advantages associated
with certain embodiments of the technology have been described in
the context of those embodiments, other embodiments may also
exhibit such advantages, and not all embodiments need necessarily
exhibit such advantages to fall within the scope of the technology.
Accordingly, the disclosure and associated technology can encompass
other embodiments not expressly shown or described herein.
* * * * *