Note: Descriptions are shown in the official language in which they were submitted.
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
DEVICES, SYSTEMS, AND METHODS FOR A VALVE REPLACEMENT
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority and benefit to: U.S. Provisional
Application No.
63/145,878, filed on February 2, 2021, entitled "Devices, Systems, and Methods
for a Self-
Adapting Valve Attachment"; International Application No. PCT/US/21/39451,
filed on June 28,
2021, entitled "Devices, Systems, and Methods for a Heart-Valve Annulus
Reinforcer";
International Application No. PCT/US21/51828, filed on September 23, 2021,
entitled "Devices,
Systems, and Methods for an Implantable Heart-Valve Adapter"; International
Application No.
PCT/U521/32817, filed on May 17, 2021, entitled "Devices, Systems, and Methods
for a
Collapsible and Expandable Replacement Heart Valve"; and International
Application No.
PCT/U521/38886, filed on June 24, 2021, entitled "Devices, Systems, and
Methods for a
Collapsible Replacement Heart Valve"¨the contents all of which are
incorporated herein by this
reference as though set forth in their entirety.
FIELD OF USE
[0002] The present disclosure relates generally to replacement heart-valve
technology, and
more specifically to devices, systems, and methods for a valve replacement
comprising a one-piece
system and a two-piece system. Characteristics of the discussed valve
replacement comprise high
flexibility, resiliency, conformality, and functionality as a replaceable
heart valve.
BACKGROUND
[0003] Heart-valve intervention, such as full open-heart surgery, is often
required to treat
diseases of one or more of the four heart valves (which work together to keep
blood properly
flowing through the heart). Replacement and/or repair of a heart valve is
often required when a
valve is "leaky" (e.g., there is valve regurgitation) or when a valve is
narrowed and does not open
properly (e.g., valve stenosis). Heart-valve replacement, such as mitral-valve
or tricuspid-valve
replacement, typically involves replacement of the heart's original (native)
valve with a
replacement mechanical and/or tissue (bioprosthetic) valve. Common problems
with the
replacement of valves and/or the frames carrying them include degradation of
the leaflets (valve-
like structure); breaking or failing frames, particularly with laser-cut
nitinol frames; and
undesirable changing in size of the native valve annulus. Replacement heart
valves pose additional
problems after they are implanted. For example, the replacement valve may move
or migrate after
1
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
it is placed in a desired location in the heart, or its location may not
permit proper directional flow
of blood through other parts of the organ, such as the outflow tract of the
left ventricle.
Replacement valves are also not readily retrievable, most often because such
removal can damage
the surrounding heart tissue. This can be particularly problematic, for
example, if the replacement
valve is not properly and accurately placed into position when it is implanted
in the native heart,
as well as when the replacement valve starts failing, which may occur soon or
years after initial
implantation. An additional problem is that typical replacement valves,
especially laser-cut valve
frames, are relatively stiff and inflexible, resulting in a valve that does
not flex with the dynamic
movements of the pumping heart. Such inflexible valves do not conform to such
dynamic
movements, which can cause trauma to the heart surfaces, cause breaks in the
frame itself,
otherwise cause or exacerbate problems during or after implantation.
[0004] Thus, what is needed are devices, systems, and methods for a valve
replacement that
enables compact and secure delivery into the heart and convenient control of
both the valve
replacement during implantation as well as the expansion and retraction of the
valve replacement
when being implanted or removed/replaced, preferably entirely via a catheter.
Also needed are
devices, systems, methods for ensuring proper directional flow of blood
through the heart during
and after a valve-replacement procedure.
[0005] Such devices, systems, and methods should provide the functionality
of a one-piece
system comprising both an adapter body with engaging mechanisms that secure to
the heart and a
valve assembly with leaflets that is positioned within the adapter body. Such
devices, systems, and
methods should also provide the functionality of a two-piece system comprising
an adapter body
and valve assembly that are compatible with each other yet wherein the valve
assembly may be
removable from the adapter body such that both can be delivered together or
separately and such
that the adapter body may remain implanted while the valve assembly may be
removed and
replaced.
SUMMARY OF THE DISCLOSURE
[0006] The following presents a simplified overview of the example
embodiments in order to
provide a basic understanding of some embodiments of the present disclosure.
This overview is
not an extensive overview of the example embodiments. It is intended to
neither identify key or
critical elements of the example embodiments nor delineate the scope of the
appended claims. Its
sole purpose is to present some concepts of the example embodiments in a
simplified form as a
2
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
prelude to the more detailed description that is presented herein below. It is
to be understood that
both the following general description and the following detailed description
are exemplary and
explanatory only and are not restrictive.
[0007] The present disclosure is directed to devices, systems, and method
for a valve
replacement that serves the purpose of anchoring, sealing, and controlling the
position of the
leaflets and sub-valvular structure. The replacement is highly flexible,
resilient, fatigue resistant,
and securable to the native valve tissue. And it is self-adapting, meaning, it
adapts to¨and in
addition, also supports¨the natural movement of the heart. In a preferred
embodiment, the valve
replacement comprises a collapsible adapter body that attaches to the native
valve tissue and
provides a sealing portion. The valve replacement comprises a frame optimized
for effective
sealing and fixation to the valve, wherein the design of the adapting frame is
anatomically inspired
and designed to maximize ventricular filling and minimize outflow tract
obstruction. The valve
replacement¨whether as a one- or two-piece system¨further comprises a valve
assembly,
wherein the valve assembly comprises leaflets and is compatible to reside
within the adapting
frame.
[0008] The present disclosure provides for a valve replacement that¨due to
its braided-wire
frame design¨is compressible to a smaller profile when compared to the prior
art, wherein the
smaller compressed profile allows for delivery via not only transapical
approaches but also
transfemoral and transseptal approaches. The two-piece system disclosed herein
allows for a
further lower profile because the adapting frame and the valve assembly may be
delivered as two
separate devices.
[0009] Still other advantages, embodiments, and features of the subject
disclosure will become
readily apparent to those of ordinary skill in the art from the following
description wherein there
is shown and described a preferred embodiment of the present disclosure,
simply by way of
illustration of one of the best modes best suited to carry out the subject
disclosure. As will be
realized, the present disclosure is capable of other different embodiments and
its several details
are capable of modifications in various obvious embodiments all without
departing from, or
limiting, the scope herein. Accordingly, the drawings and descriptions will be
regarded as
illustrative in nature and not as restrictive.
3
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The accompanying drawings, which are incorporated in and constitute
a part of this
specification, illustrate embodiments of the disclosure and together with the
general description of
the disclosure given above and the detailed description of the drawings given
below, serve to
explain the principles of the disclosure. In certain instances, details that
are not necessary for an
understanding of the disclosure or that render other details difficult to
perceive may have been
omitted.
[0011] Figure 1 generally illustrates an embodiment of a valve replacement
as disclosed herein.
[0012] Figures 2A-2C generally illustrate an embodiment of a valve
replacement as disclosed
herein.
[0013] Figure 3 generally illustrates an embodiment of a valve replacement
as disclosed herein.
[0014] Figure 4 generally illustrates an embodiment of a valve replacement
as disclosed herein.
[0015] Figure 5 generally illustrates an embodiment of a valve replacement
as disclosed herein.
[0016] Figures 6A and 6B generally illustrate embodiments of a valve
replacement as
disclosed herein.
[0017] Figures 7A-7D generally illustrate embodiments of a valve
replacement as disclosed
herein.
[0018] Figures 8A generally illustrates the helical functionality of the
human heart.
[0019] Figure 8B generally illustrate embodiments of a valve replacement as
disclosed herein.
[0020] Figure 9 generally illustrates an embodiment of a valve replacement
as disclosed herein.
[0021] Figures 10A and 10B generally illustrate embodiments of a valve
replacement as
disclosed herein.
[0022] Figures 11A and 11B generally illustrate embodiments of a valve
replacement as
disclosed herein.
[0023] Figures 12A-12E generally illustrate embodiments of a valve
replacement as disclosed
herein.
[0024] Figures 13A-13D generally illustrate embodiments of a valve
replacement as disclosed
herein.
[0025] Figures 14A-14E generally illustrate embodiments of a valve
replacement as disclosed
herein.
4
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
[0026] Figures 15A and 15B generally illustrate embodiments of a valve
replacement as
disclosed herein.
[0027] Figures 16A and 16D generally illustrate embodiments of a valve
replacement as
disclosed herein.
[0028] Figures 17A-17D generally illustrate embodiments of a valve
replacement as disclosed
herein.
[0029] Figures 18A and 18B generally illustrate embodiments of a valve
replacement as
disclosed herein.
[0030] Figure 19A and 19B generally illustrate embodiments of a valve
replacement as
disclosed herein.
[0031] Figure 20 generally illustrates an embodiment of a valve replacement
as disclosed
herein.
DETAILED DESCRIPTION OF EMBODIMENTS
[0032] Before the present systems and methods are disclosed and described,
it is to be
understood that the systems and methods are not limited to specific methods,
specific components,
or to particular implementations. It is also to be understood that the
terminology used herein is for
the purpose of describing particular embodiments only and is not intended to
be limiting. Various
embodiments are described with reference to the drawings. In the following
description, for
purposes of explanation, numerous specific details are set forth in order to
provide a thorough
understanding of one or more embodiments. It may be evident, however, that the
various
embodiments may be practiced without these specific details. In other
instances, well-known
structures and devices are shown in block diagram form to facilitate
describing these embodiments.
[0033] Figure 1 generally illustrates an embodiment of a valve replacement
as disclosed herein.
Figure 1 discloses a valve replacement ("Valve Replacement") 100 implanted in
a malfunctioning
mitral valve. The Valve Replacement, however, is not limited to compatibility
with only the mitral
valve and may be also implanted in the tricuspid valve. In a preferred
embodiment, the Valve
Replacement comprises a braided, collapsible frame and a braided valve-and-
leaflet assembly that
together serve to provide a sealing portion.
[0034] As set forth herein, the compatibility of the collapsible frame and
leaflet assembly may
be performed in various embodiments. In one embodiment, the Valve Replacement
may comprise
the frame and valve assembly as a two-piece apparatus (referred to herein for
ease of reference as
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
the "Two-Piece System"). In another embodiment, the Valve Replacement may
comprise the
frame and valve assembly as a one-piece apparatus (referred to herein for ease
of reference as the
"One-Piece System"). Regardless of the embodiments, the Valve Replacement may
further
comprise attachments and additional features for catheter delivery,
positioning, partial
deployment, and retrieval.
[0035] Two-Piece Valve Replacement Overview
[0036] Figures 2A-2C generally illustrate an embodiment of a valve
replacement as disclosed
herein. Figures 2A-2C disclose embodiments of a Two-Piece System. As shown in
Figure 2A, the
Two-Piece System comprises a heart-valve frame 200 (referred to herein for
ease of reference as
the "Adapter") and a heart-valve assembly 250 (referred to herein for ease of
reference as the
"Valve Assembly"). In one embodiment, the Adapter 200 comprises an opening 205
that is
compatible with the Valve Assembly 250. The Adapter 200 further comprises a
sealing skirt 210
at the top, a body portion 215, and one or more anchors 220 extending out from
the bottom of the
body portion 215. In an embodiment, the Valve Assembly 250 comprises a leaflet-
structure
component 255 that enables blood flow through the Valve Assembly 250.
[0037] Figure 2C discloses the Valve Replacement as a Two-Piece System
wherein the Adapter
200 and the Valve Assembly 250 are cooperatively sized and configured
together. The Adapter
200 and the Valve Assembly 250 may fit as a single unit and be compressed to
be inserted into a
heart catheter for delivery to a target valve, i.e., in an as-connected form
where the two portions
are mechanically linked together. This configuration advantageously allows the
delivery and
control of both portions of the Valve Replacement.
[0038] The Adapter 200 and the Valve Assembly 250 may also be carried in a
delivery catheter
in an unconnected form where the two portions are not mechanically linked
together. This
configuration advantageously allows the delivery catheter to independently
control each of the
portions and can also increase the flexibility and torsion characteristics of
the delivery catheter
containing the two portions, which can be advantageous both while conveying
the delivery catheter
to through the patient's body, the vasculature, the desired target, and while
delivering the
replacement valve at/to the target. In such embodiments, the Adapter 200 and
the Valve Assembly
250, as separately delivered portions, may both be further compressed,
enabling a low profile that
is conducive to delivery via blood vessels that may not be sufficiently
healthy or wide in size so
as to allow delivery of both portions as a single unit.
6
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
[0039] One-Piece Valve Replacement Overview
[0040] Figure 3 generally illustrates an embodiment of a valve replacement
as disclosed herein.
Figure 3 discloses an embodiment of a One-Piece System 300, comprising an
opening 305 for
blood flow, a sealing skirt 310, and a leaflet structure 315. Though not shown
in Figure 3, the One-
Piece System 300 further comprises a body below the sealing skirt 310 that is
similar to the body
of the Adapter 200 in Figures 2A-2C and may further comprise anchors similar
to anchors of the
Adapter 200 in Figures 2A-2C. In one embodiment, the One-Piece System 300 may
function as a
permanent implant.
[0041] Whether as a One- or Two-Piece System, the Valve Replacement allows
for valve-in-
valve placement, wherein embodiments of the valve-in-valve placement comprise
replacing
existing leaflets and valve assemblies without a reduction in area (such as by
placing new material
over existing material), and without compromising the functionality of the
implanted Valve
Replacement.
[0042] Braided Structures
[0043] The braided structures disclosed herein are applicable to the One-
Piece System and to
the Adapter and the Valve Assembly of the Two-Piece System. Thus, though
various embodiments
of braided structures may be shown in relation to the Adapter and the Valve
Assembly, it should
be understood that such embodiments are also in relation to the One-Piece
System.
[0044] Figure 4 generally illustrates an embodiment of a valve replacement
as disclosed herein.
Figure 4 discloses the braided wire frame of an Adapter 400 and the braided
wire frame of a Valve
Assembly 450. The braided wire frame allows the Adapter 400 and the Valve
Assembly 450 to be
compressed, which, when released may expand in size. Similarly, the One-Piece
System may also
be compressed and expanded. The braided wire frame design thus enables the
Valve Replacement
to be compressed to a small diameter¨such as 4mm to 6mm¨such that it may be
delivered in a
catheter. The braiding of the wire and overlapping with other wires also
reduces or eliminates
fracturing of the wire because of the decreased stress on the frame. The
braiding also enables
various-sized wires to be used.
[0045] The braided wire frame of the One-Piece System, the Adapter 400, and
Valve Assembly
450 may comprise various wire embodiments, such as a single wire, two or more
wires (for
example, grafted or welded together), and a wire spliced of multiple wires.
The wire(s) making up
7
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
the One-Piece System and the Two-Piece System may be constructed of varying
material, such as
nitinol, which has shape-memory characteristics, and vary in dimensions, such
as in diameter size.
[0046] By integrating diverse wire thicknesses and braiding designs, the
Valve Replacement
conforms with various densities and characteristics (i.e., radial force and
expansion) of the heart's
anatomy. In this, the braided frame enables the Valve Replacement to have a
flexible and
conformable performance, wherein the Valve Replacement self-adapts and moves
with the heart
while being forgiving to anatomical anomalies¨similar to the heart's helical
structure, as will be
disclosed herein. The braided frame also facilitates placement of the Valve
Replacement,
maximizes its seal, and prevents migration with an integrated and optimized
anchoring system.
The braided frame geometry of the Valve Replacement allows for diverse
application, such as
being customizable to mitral and tricuspid anatomies; allows for fewer sizes
to be needed to treat
most disease states; promotes rapid prototyping; allows incorporation of
various design features;
promotes quicker design advancement with rapid evaluation and optimization of
features; and is
scalable using conventional processes. The braiding structure also allows for
more degrees of
freedom and opportunities for the wires to be in various positions.
[0047] An embodiment of fabricating the braided wire frame comprises
oversizing the braided
wire frame in relation to heart valve, which allows for more radial force for
the same amount of
material and geometry, thus allowing the frame to open up more fully and
function better.
Furthermore, it decreases the manufacturing tolerances involved in
manufacturing the Valve
Replacement. Oversizing the braided frame biases the wire frame structure so
that there is less
motion between the wires as they are predisposed with elastic strain energy to
conform and adapt
with greater radial force. As a result, the valves have higher degree of
consistency and the
manufacturing tolerances associated with attaching the leaflets, for example,
is greatly improved.
[0048] In one embodiment, the braided frame is wrapped and shape set such
that it has enough
radial force to self-expand and be opened up to desired radial capacity while
still being configured
to fit within a catheter.
[0049] Embodiments of the Valve Replacement may range in diameter from 25mm to
more
than 55pm. In one embodiment, the wire frame is oversized, which comprises
braiding the wire
frame on a mandrel that is 25.4mm in diameter (or 28.0mm or 32.0mm, depending
on the desired
valve size) and shape-setting it by treating it in 505 degree C salt/sand
bath. The frame is then
removed from the initial mandrel and stretched over a 29.0mm mandrel (or
31.0mm or 33.0mm,
8
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
e.g., for larger valves) and shape-set again. Temporary strings (or other
similar methods known to
one skilled in the art) are then run through the loops and tied using a 25.4mm
mandrel as a reference
diameter for the valve frame. This compresses the frame by spring loading the
loops (though other
embodiments may comprise other structures beyond loops, such as simple
apices). The braided
Valve Replacement may thus be shape set at a larger diameter and then
constrained to a smaller
diameter and held with string until fabric is sewn onto the frame. In another
manufacturing
embodiment, the wire frame repeats a braid pattern over its length three times
while wrapping five
times around a circle.
[0050] Embodiments of the Valve Replacement may comprise compatibility with
various-size
catheters, such as 26F, 28F, 30F, 32F, and 34F.
[0051] Figure 5 generally illustrates an embodiment of a valve replacement
as disclosed herein.
As shown in Figure 5, an Adapter 510 may be compatible with a human heart 505,
wherein
embodiments of achieving coaptation comprise sealing and anchoring by
adjustment of the over-
and-under pattern of the braid to realize separable sections of the braid that
can behave
independently. The Adapter 510 may be constructed of varying material and vary
in dimensions.
In one embodiment, the Adapter 510 may be made up of a nitinol wire braid of
one or more wires
with different diameters. When released the Adapter may expand in size (e.g.,
the body expanding
to 25mm or greater in diameter and the sealing skirt expanding anywhere from
40mm to 70mm in
diameter).
[0052] The Valve Replacement may comprise other types of wire, such as
stainless steel, cobalt
chrome, and other types of implant metals. In other embodiments, the Valve
Replacement may
comprise polymer materials, such as biocompatible plastics and fiber-
reinforced polymer. Some
embodiments may comprise drawn-filled tubing (outside material NiTi and inside
material some
higher radiopaque material) for the Valve Replacement or portions of the Valve
Replacement (e.g.,
anchors, or features desired to be seen under fluoroscopy). The Valve
Replacement or portions of
it may be made of hollow tubing. Additionally, flat wire or other cross
sections of wire may be
chosen for portions of the Valve Replacement, such as to provide
tailored/increased stiffness for
anchors.
[0053] Flanges and Anchors of the Braided Wire Frame
[0054] The Adapter is designed to preserve native ventricular filling by
orienting flow into the
ventricle in such a way as to limit turbulence and maximize efficient flow,
such as towards the
9
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
ventricle wall, between the papillary muscles, or otherwise oriented towards
the apex of the
ventricle ("virtual apex").
[0055] The Adapter is also designed to be anatomically customized with
patient and disease
state-specific sizing. Sizing may be based on anatomical data, for example:
Using a sizing tool to
determine Adapter diameter and flange length, while also optimizing valve
orientation for both
ventricle outflow consideration and ventricular efficiency. In the example,
parameters of the sizing
tool are fed to the parametric device model, which automatically creates the
pattern for the shape-
set tooling.
[0056] Figure 6A generally illustrates an embodiment of a valve replacement
as disclosed
herein. As shown in Figure 6A, the Adapter may comprise an Adapter body 605
and one or more
atrial flanges 610. In one embodiment wherein the Adapter is applied to a
valve, such as a mitral
valve, the circumference of the atrial flange 610 is separated into one-third
613 and two-thirds 616.
The one-third portion 613 of the atrial flange 620 engages with the fibrous
aorta-mitral curtain and
is formed at an angle that prevents the valve being pulled into the LVOT. This
feature also
maximizes sealing during systole. The two-thirds portion 616 of the atrial
flange 620 engages the
muscular wall and is formed at an angle that pulls the valve away from the
LVOT and directs flow
towards the apex of the ventricle, between the papillary muscles, or towards
the ventricle wall. In
other embodiments, the Adapter body and atrial flange function similarly or
identically when
applied to the tricuspid valve.
[0057] Figure 6B generally illustrates an embodiment of a valve replacement
as disclosed
herein. As shown in Figure 6B, the Adapter may comprise valve and retainers
615 within the inner
frame of the Adapter body. The Adapter may also comprise sub-valvular anchors
620 for leaflet
management. In one embodiment, the sub-valvular anchors 620 are made up of one
or more of the
following: anterior leaflet anchor 625, trigone anchor 630, and posterior
leaflet anchors 645. For
example, the Adapter may comprise a single anterior leaflet anchor 625, two
trigone anchors 630,
and three posterior leaflet anchors 645. The anchors may be configured to be
biased in an upward
direction so as to be radially overlapping in relation to the Adapter body.
[0058] Figure 7A generally illustrates an embodiment of a valve replacement
as disclosed
herein. Figure 7A shows an embodiment of a wire braid frame that the Adapter
is comprised of.
The wire braid frame may comprise a 24-point braid pattern, with double
posterior leaflet anchors
705, wherein the double posterior leaflet anchors 705 are used to maintain
symmetry and
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
additionally provide twice the structural anchoring. The wire braid frame may
also comprise dual
stabilization anchors 710. Also shown is that the wire braid frame may have
the anchor locations
available in 15-degree increments.
[0059] The anchors may be, in some embodiments, an extension of the tubular
braided frame
and extend out from the outflow end to function as an engagement attachment.
In other
embodiments, the wire braid frame of an Adapter may have anchors that are
grafted, welded, or
fused on. For example, Figure 7A shows the combination of a larger gage wire
(0.0175"-0.02")
(represented by the stabilization anchors 710) and smaller gage wire (0.012-
0.0175") (represented
by the posterior leaflet anchors 705 and further represented by additional
wires 715) by means of
a joining operation at the interface between the varying-size wires. The
connection interface may
be a weld or a weld with a support tube.
[0060] Embodiments of welding used may be in relation to the material that
the Valve
Replacement is comprised of. In an embodiment of the anchors comprising a
hollow tubing
(hypotube) material, the inside diameter of the hypotube mates perfectly with
the diameter of the
wire so that a helical weld pattern may be used to join the anchor to the
frame. There, the ends of
the hypotube may be chamfered so as to present a smooth transition with the
attached wire.
Radiopaque wire may be inserted inside the hypotube and positioned to be at
the peaks of the
anchors (such embodiment provides optimal fluoroscopic visualization).
[0061] Figures 7B and 7C generally illustrate embodiments of a valve
replacement as
disclosed herein. In one embodiment, as shown in Figure 7B, a Valve
Replacement may comprise
an atrial sealing skirt 705, a frame body 710, and a stabilization anchor 715
that are covered in a
fabric for the purpose of flow sealing and/or encouraging (e.g., influencing
either promoting or
inhibiting) tissue growth after implantation. The embodiment may further
comprise a clip 720 that
is not covered in a fabric. Figure 7C shows a Valve Replacement comprising
posterior leaflet
anchors 725 and clips 720.
[0062] Figure 7D generally illustrates an embodiment of a valve replacement
as disclosed
herein. Figure 7D shows an embodiment of the Valve Replacement comprising a
clip component
for the purpose of improving delivery control, via secure attachment of the
Valve Replacement to
a delivery catheter, and for the purpose of improving the efficiency and
efficacy of leaflet
attachment. Figure 7D shows a flat-pattern schematic of a wire frame with a
clip 735, wherein the
clip 735 may be a looped portion of the wire frame extending out from the main
body of the wire
11
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
frame. In some embodiments, a clip 735 may be positioned at two or more
separate locations
around the circumference of the Valve Replacement. In other embodiments, clips
735 be shape set
180 degrees such that they can provide for a hook shape to clip onto the
native valve leaflets. For
example, once the Valve Replacement is released from a delivery system, the
clips 735 may attach
onto the native valve leaflets, providing securement of the Valve Replacement.
[0063] Various embodiments of the Valve Replacement may comprise various
quantities of
anchors. For example, one embodiment may comprise six anchors whereas another
may comprise
three anchors. In a preferred embodiment comprising three anchors, applicable
to the mitral valve,
the Valve Replacement comprises a 150 angle between the P1 and P3 anchors
with the P2 anchor
being symmetric between the P1/P3 anchors. In a preferred embodiment
comprising three anchors,
applicable to the tricuspid valve, the Valve Replacement comprises a uniform
120 /120 /120
spacing of the anchors.
[0064] The anchors may be made of the same wire as the braided frame or
different wire¨
whether it be different in material and size. This provides a novel aspect:
The ability to have thicker
and/or more durable wire for the anchors allows for the anchors¨which are
required to attach to
the valve tissue and maintain the Valve Replacement in place¨to be stronger
and/or firm, without
comprising the flexibility of the body frame. This enables the Valve
Replacement to remain firmly
and securely positioned within the heart valve while still allowing the Valve
Replacement to move
and function in accordance with the heart's natural movements.
[0065] Another novel aspect is the synchronization between the flanges and
the anchors. Once
implanted, the flanges provide a downward force on the heart tissue as the
anchors provide an
upward force. These two forces exerted by the Valve Replacement further secure
it in place without
comprising the fluidity of the braided body frame or the functionality of the
leaflets.
[0066] Helical Braided Design
[0067] The novel helical-braided designs of embodiments of the Valve
Replacement
purposefully leverage the natural helical movements of a beating human heart
so as to balance
both flexibility and strength. Studies of the human heart reveal that the
mechanisms of ejection
and suction are from a helical design of muscles in a "coil within a coil"
formation, which are
responsible for clockwise and counterclockwise rotation and functional
activity. More specifically,
the underlying anatomy of the human heart comprises a helical braid having a
transverse basal
12
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
loop of muscle for contraction that overlies an oblique helix that is
responsible for ejection and
suction within the heart.
[0068] The disclosed braided helical design is configured to put less
stress on the individual
components of the Valve Replacement because the Valve Replacement moves with
the heart, i.e.,
the leaflets and anchors and other components have less stress and the Valve
Replacement migrates
less because its natural helical movement with the heart keeps it in in place.
[0069] Figure 8A generally illustrates the helical functionality of the
human heart. As shown
in Figure 8A, the twisting and untwisting motions within the heart are created
by inner helical
spirals within the descending and ascending apical loop muscle segments, with
the heart having a
natural clockwise torsion/contraction for ejection and a natural
counterclockwise
loosening/lengthening for suction. In heart disease, the natural helix of the
heart becomes
architecturally altered in shape.
[0070] Figure 8B generally illustrates an embodiment of a valve replacement
as disclosed
herein. As shown in Figure 8B, an embodiment of the Valve Replacement
comprises a helical
braided design that mimics and reinforces the normal helical and elliptical
formation of the heart
and its twisting/turning motions. In one embodiment, the helical braided
design comprises a design
wherein the braided wires resemble a frame that is constantly turning in one
direction as it is
compressed and/or elongated around an open center. Both the One-Piece System
and the Adapter
and Valve Assembly of the Two-Piece System may comprise the helical braided
design. A normal
heart develops ejection and suction as a functional consequence of the
contraction integrity of the
apical ellipse. The braided helical design of the Valve Replacement maximizes
shortening and
lengthening of the heart muscles, thereby reinforcing the desired apical
ellipse of a healthy heart
movement.
[0071] For example, as the human heart muscles compress and descend, the
braided helical
wires of the Valve Replacement¨rather than be stiff¨also compress and descend
with the heart
muscles, thereby reinforcing a natural spiral compression and descension of
the heart muscle
surrounding the braided wires. With the braided helical design, the Valve
Replacement conforms
to and reinforces the natural movement of the heart. The braided helical
design of the Valve
Replacement produces a twisting spiral coil that develops torsion in a
clockwise direction. And as
the human-heart muscles lengthen and fill, the braided helical design
reinforces a natural spiral
13
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
lengthening and filling of the braided wires with the surrounding heart
muscle, resulting in an
untwisting spiral coil within the adapter or valve that develops an ejection
force.
[0072] The novel braided helical design is significant for treating heart
valves. By comprising
a braided helical design, embodiments of the Valve Replacement reinforce the
natural helical
movement of the heart and more naturally adapt and sits within the desired
valve area. For
example, embodiments of the Valve Replacement will tend to remain in the
desired mitral or
tricuspid valve area because the braided helical design will move (contract,
twist and shorten and
untwist and lengthen) with the natural movements of the heart. This allows for
the Valve
Replacement to self-correct and seat within the valve area in a natural state,
thus conforming to
the heart's natural movements and encouraging central vortex flow.
[0073] The novel braided helical design thus facilitates a natural heart
movement. In one
embodiment, the Valve Replacement is held in place by the combined efforts of
the flange and
anchors, with the helical braided portion being in between the flange and
anchors. The helical
braided portion twists back and forth with the heart's natural movement,
enabling a pumping-and-
squeezing motion. The twisting motion, when the heart pumps, encourages flow
of liquid through
the Valve Replacement, thus allowing for better flow dynamics.
[0074] Material Covering
[0075] In some embodiments, different materials are prepared prior to
assembling into a
continuous covering. In other embodiments, material may be added and receive a
modification
treatment post-assembly that is applied to only specific locations on the
Valve Replacement.
[0076] Figure 9 generally illustrates an embodiment of a valve replacement
as disclosed herein.
As shown in Figure 9, tissue attachment and ingrowth may be promoted in an
area that is desired
to become anchored to the tissue, while cellular interaction can be limited to
simple
endothelialization or no response at all, to allow disturbance of part of the
device at a later date
without risk of tissue or thrombus embolization. Put simply, the varying
material used may be
either conducive or non-conducive to chemical bonding. For example, in a
preferred embodiment,
the materials in contact between the inner portion of the Adapter and the
outer portion of the Valve
Assembly do not bond, so as to allow for movement of both portions; whereas
the material on the
outside of the Adapter bonds with human tissue. Thus, depending on the
location, materials may
be used such that cellular growth is inhibited or promoted.
14
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
[0077] Figure 9 further illustrates how the Valve Replacement may be
encased, either
completely or partially, in a continuous material covering to elicit the type
of physiological
response that is desired as well as the mechanical behavior. Though the
covering is continuous¨
as in there are no material gaps at the transitions of physical features¨the
materials may be
modified locally in areas of the device to behave differently. For example,
the material covering
one side of the flange may deliberately be nonporous to facilitate sealing
while the material on the
other side of the flange may be a knit that facilitates tissue ingrowth for
anchoring. Alternatively,
the flange could be alternating rings of nonporous and ingrowth material on
both sides of the
flange. These techniques can be applied to any surface of the device.
[0078] Material differences range from being entirely different
materials¨natural tissue or
synthetic fabric¨to physical and chemical surface modification, to obtain the
desired mechanical
and biocompatible properties. These modifications can include but are not
limited to coating,
etching, mechanically biasing, ion infusion, various deposition techniques,
and
oxidizing/nitriding/carbiding. Modifications may be used in any combination to
achieve the
desired result.
[0079] Figures 10A and 10B generally illustrate embodiments of a valve
replacement as
disclosed herein. As shown in Figures 10A and 10B, an embodiment of the Valve
Replacement
may comprise a continuous piece of material around the outside of the frame. A
continuous seal
may be configured from the material (such as fabric) extending from an inflow
edge of the Valve
Replacement to the extrados of the body of the Valve Replacement. A strip of
ingrowth fabric may
be sewn around the inflow edge of the Valve Replacement, with a non-porous
coating forming a
continuous seal extending into the ventricle.
[0080] The continuous surface of the fabric may be locally influenced and
characterized for
modulating or even contradicting properties, such as coating with medical
polymer in locations
where no tissue attachment is desired, hydrogels where space-filling or latent
actions are desired,
or a hydrophilic tissue adhesive. The continuous material structure of the
fabric may be
voluminous in nature, filling space and adapting the round heart valve to the
asymmetrical shape
of the valve annulus. Combined with other attachment methods, an embodiment of
the mitral-
valve adapter fabricated with this method aids in engagement and attachment of
the leaflet tissue
and other sub-valvular structures. The partially porous fabric provides an
improved seal for a
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
replacement valve, enabling accommodation to irregular shaped anatomy through
the compliance
of the fabric.
[0081] In other embodiments, the Valve Replacement may be fabricated using
a constraint to
hold the Valve Replacement at a specific dimension while attaching material to
influence device
performance. A fabrication technique is disclosed, which acts to influence the
disposition of a
braided wire frame¨removing the inherent freedom of movement and
unpredictability that is
present between relative members of the frame structure when in a load-free
state. This technique
involves restraining the radial expansion of the frame with a constraint, such
as feeding some
number of sutures through or around the structure to hold it at a specific
dimension other than its
unrestrained, "free" dimension. In subsequent fabrication steps, the structure
is incorporated into
an assembly that adopts this new configuration and considers this to be the
final dimension. When
the constraints are removed from the braided frame, this braided frame tries
to recover to its
original "free" dimension¨applying additional radial force to the surrounding
structure while
being constrained to the desired dimension.
[0082] The degree of radial force transmitted to the fabric material from
the frame can be
adjusted as required to achieve the optimal combination or performance
properties. In particular,
the strain energy density of the structure can be more uniform. A greater
stiffness is achieved
(resulting in a better seal) with less material, resulting in a more low-
profile structure. The suture
finally provides a biasing of the structure toward a desirable diameter and
height for the valve
structure.
[0083] To expand the concept further, structures that possess features
described herein may be
co-deployed singularly or with a connected design, so as to engage both the
mitral and the aortic
valve apparatus and/or annulus. The intent is to influence the leaflets of
both valves, as well as the
angulation of the valves relative to one another, to ensure the most effective
management of flow
through the ventricle and maximizing the efficiency of the outflow tract.
[0084] In some embodiments, the Valve Replacement is covered in a material
that wraps
around the frame in a continuous manner. Embodiments of the material are
fabric and animal
tissue. By using materials that can be locally modified to change
characteristics such as porosity
and surface roughness, a certain level of control over cellular interaction on
the various parts of
the device can be achieved. In other embodiments, the Adapter body and atrial
flange may be
16
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
covered in fabric for the purpose of flow sealing and/or influencing (e.g.,
either promoting or
inhibiting) tissue growth after implantation.
[0085] The material used further assists with the loading and deployment of
the Valve
Replacement. For example, the material may promote the Valve Replacement to
function as a re-
valve system, wherein a tubular braided fabric tube (coated with a polymer to
decrease porosity to
blood) surrounds the frame and constrains the diameter. This tube is sewn onto
the frame,
sometimes in conjunction with a leaflet panel, so that the strings can be
removed and what remains
is a pretensioned frame constrained by the fabric.
[0086] Sewing Methods and Belt Loops
[0087] Figures 11A and 11B generally illustrate embodiments of a valve
replacement as
disclosed herein. More specifically, Figures 11A and 11B show various
embodiments of the
fabrication of material for the Valve Replacement, focused on the Two-Piece
System.
[0088] Figure 11A shows an aran flange 1105, a secant flange 1110, a secant
outer cuff 1115,
and an aran inner cuff 1120 of the Valve Replacement. The aran flange 1105
comprises a circular
top piece, wherein it may further comprise a coating to reduce fluid
permeability. The secant flange
1110 comprises a circular bottom piece that stretches to allow expansion of
the Valve Replacement
when deployed. The secant outer cuff 1115 comprises a cross-stich that
attaches the ends to create
a tube-like shape. The aran inner cuff 1120 comprises a running or cross-
stitch that attaches the
ends to create a tube shape, wherein the fabric of the aran inner cuff 1120
has limited elasticity
and either stitch maintains integrity of the aran inner cuff 1120.
[0089] In one embodiment, the secant flange 1110 and the secant outer cuff
1115 may be
combined, either by cross-stitching or other method know to one skilled in the
art, to form a secant
bottom piece. The flange may be stitched furthest away from any anchor slots.
The formed secant
bottom piece may be positioned onto the bottom of the Adapter or the One-Piece
System, wherein
the shape-set thread around the body of the frame is cut and wrap-stitch is
used to close or secure
the anchor slots.
[0090] In another embodiment, the aran inner cuff 1120 may be attached to
the inner opening
of the aran flange 1105 to form an aran top piece. The aran top piece may be
slide over the top of
the Adapter or the One-Piece System after which the fabric is wrap-stitched
closest to the frame.
[0091] In another embodiment, the secant bottom piece and the aran top
piece may be
connected, such as by wrap stitching at the bottom of the frame to connect the
aran top piece to
17
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
the secant bottom piece. For this, the fabric of the aran flange 1105 and the
secant flange 1110
may be smoothed and held in place (such as with sewing clips) and connected
around the wire
flange (such as with a running stitch), wherein the border of the flange may
be circular and not
rigid. The excess fabric may be trimmed, and additional stitch may be added
around the flange and
each wire flange tip. Additional stitching may be performed along the wires to
secure the fabrics
together and keep flush against the wire flange. The stitching may be done to
the second crossing
of wires, followed to the next wire, and then up towards the tip of the wire
flange. This process
may be continued around the flange and repeated on the next set of wires.
[0092] In one embodiment of the secant outer cuff 1115, the secant outer
cuff 1115 may be
folded in half and secured together (such as with a sewing clip), after which
a blanket stitch may
be performed around the edges. The blanket stitch allows the secant outer cuff
1115 to retain its
shape without sinching the fabric. The secant outer cuff 1115 may be turned
inside out and placed
over the anchor wire, after which the secant outer cuff 1115 is secured to the
front and back of the
anchor wire (such as with a running stitch). In this, the seam of the stitch
(used to close the anchor
slots) may be caught between the front and back fabric of the secant outer
cuff 1115 to secure it to
the Adapter or One-Piece System. The running stitch may encompass the front of
the secant outer
cuff 1115, the seam, and the back of the secant outer cuff 1115 along the base
of the anchor wire.
Once the secant outer cuff 1115 is secured at the base, a stitch may be
continued along the anchor
wire to keep the secant outer cuff 1115 from slipping or sliding on the
anchor. Fabric may be
slightly caught, wherein it is not loose enough to leave excess fabric but not
tight enough to affect
the shape of the wire.
[0093] Figure 11B shows an aran inner valve cuff 1125 and an aran outer
valve cuff 1130. In
one embodiment, leaflets may be connected to the aran inner valve cuff 1125,
such as along a strip
of fabric with a double running stitch along the belly of the leaflet, wherein
the stitches are uniform
across the leaflets to allow for proper valve opening and closing. The leaflet
tabs may be exposed,
such as by laser-cutting with slots at the top of the aran inner valve cuff
1125 (wherein a strip of
the aran inner valve cuff 1125 may be folded in half, making sure that
leaflets are aligned on top
of each other; and wherein the ends of the aran inner valve cuff 1125 may be
attached to the
junction of the belly and tabs with a double running stitch). Following the
exposure of the leaflet
tabs, the aran inner valve cuff 1125 may be placed inside the Valve Assembly
frame, the tabs may
18
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
be pulled through commissure wires and laid flat between the leaflets and the
aran inner valve cuff
1125.
[0094] In one embodiment, the ends of the aran outer valve cuff 1130 may be
connected and
the aran outer valve cuff 1130 slide over the outside of the Valve Assembly
frame.
[0095] In another embodiment, the arran inner valve cuff 1125 and the aran
outer valve cuff
1130 may be connected together. After placing the arran inner valve cuff 1125
on the inside of the
Valve Assembly frame and the aran outer valve cuff 1130 on the outside of the
Valve Assembly
frame, the two parts may be connected to the bottom of the frame (such as by
tacking down both
parts with a square knot) directly below commissure wires and the parts may be
stitched along the
bottom of the frame. Following a commissure attachment, which is set forth in
the following
paragraph, both portions may be combined by sewing through the frame and the
top of the Valve
Assembly frame may be stitched. Additional steps may comprise, along the upper
perimeter of the
valve, stitching around the wires travelling from the commissures downwards
and away from the
peaks so as to create a z-shaped pattern. In this, the stitches may connect
the inner fabric behind
the leaflet and the aran outer valve cuff 1130.
[0096] In an embodiment of a commissure attachment, leaflet tabs are fed
through the
commissures, wherein each tab folds towards its own leaflet and is wrapped
around the
commissure wires. The ends of the tabs may be held together against the entry
of the tabs and
secured together, such as with running stitches vertically and on the inside
of the Valve Assembly.
Stitching may continue in front and around the commissure, such as for 3-4
times, and entering
and existing at the location of the running stitch. Stitches may be
perpendicular, comprising of
embodiments such as a running stitch along the y-axis and a wrap stitch along
the x-axis.
[0097] In other embodiments of the fabrication of material for the Valve
Replacement wherein
the focus is on the One-Piece System, a fabric for the secant portions
comprises a stretchy and
semi-transparent fabric; wherein the secant outer cuff 1115 and secant flange
1110 are sewn
together to create the outer piece. Cross stitch may be used to connect the
edges of the secant outer
cuff 1115 and to connect the secant outer cuff 1115 to the secant flange 1110.
[0098] In a separate embodiment, a fabric for the aran portions comprises
an inflexible and
opaquer fabric where the coating is visible; wherein the aran inner cuff 1120
and aran flange 1105
are sewn together to create the inner piece. A running stitch may be used to
connect the edges of
19
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
the aran inner cuff 1120 and a cross stitch is used to connect the aran inner
cuff 1120 to the aran
flange 1105.
[0099] For these embodiments focused on the One-Piece System, an aran inner
valve cuff may
be created, wherein leaflets are attached to the aran inner cuff 1120 and
wherein leaflet tabs are
placed through slots of the aran inner cuff 1120 where the junction of the
aran inner cuff 1120 and
tabs meet, with the leaflets held in place, such as with sewing clips. Using a
double running stitch,
the belly's edge of each leaflet is sewed to the aran inner cuff 1120. The
tabs and top edge of the
leaflet(s) are flushed and level with one another and the running stitch on
each belly of the leaflet(s)
is level and uniform. (Inconsistent stitches can lead to a defective valve.)
After the leaflets are
attached to the aran inner cuff 1120, the aran inner cuff 1120 is folded in
half, keeping leaflets
level and held in place. A double running stitch may then be sewn directly
down from the junction
of the leaflet tabs, continuing away from the leaflets with a running stitch
back up towards the
junction of the leaflet tabs. (The running stitch should be away from the
leaflet belly.) Following
these steps, the aran inner valve cuff should create a tube.
[00100] An aran set may be created by connecting the aran inner valve cuff
from above to the
aran flange 1105, such as with a cross stitch, wherein leaflets are away from
the seam.
[00101] Once the aran set is created, it may be connected to the secant set
(the secant flange
1110 and secant outer cuff 1115 previously sewn together) by using a running
stitch through the
frame (between the double running stitch of the leaflet belly) and following
the belly stitch of the
leaflet(s) to secure both sets together. The tabs are then secured through the
commissures and wrap
stitch is used to connect the secant set to the aran set at the base of the
frame. The deployment
apertures are created, by cutting the fabric, before finishing the wrap
stitch. Once connected, a beta
stitch is incorporated on the flange and anchors cuff placements.
[00102] Figures 12A-12E generally illustrate embodiments of a valve
replacement as disclosed
herein. More specifically, Figures 12A-12E illustrate deployment belt loops
commonly used for
the Two-Piece System. The deployment belt loops may comprise one or more sets
of loops.
[00103] In a preferred embodiment, the Adapter comprises seven belt loops at
the base of the
body of the Adapter, wherein there are belt loops on either side of three
anchors and one belt loop
at a vertical seam. The Adapter further comprises five belt loops at the
horizontal seam between
the body and the flange, wherein the five belt loops are located at cross
wires on the same plane
as one another. Hidden belt loops may be found behind the long anchors (P1/P3
anchors). The
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
Adapter also comprises four belt loops along the flange, located at the
crossed wires to the left and
right of the long anchors. Additionally, the Adapter comprises two belt loops
at the tips of the long
anchors. Though in a preferred embodiment the anchor-tip belt loops comprise
three loops and all
other belt loops comprise two loops, it should be known that the belt loops
are not limited to a
specific number of loops.
[00104] Figure 12A shows the belt loops in relation to the P1 and P3 anchors.
The Adapter
comprises one or more belt loops 1205 behind (i.e., on the body and hidden
from view unless the
anchor is lifted up) the P1 and/or P3 anchor 1220 and along the horizontal
seam 1210. And the
Adapter comprises and one or more belt loops 1215 to the left and right of the
P1 and/or P3 anchor
1220.
[00105] Figure 12B shows the belt loops in between the P1 1235 and P2 anchors
1240. Belt
loops 1225 along the horizontal seam 1210 are at the same plane. The Adapter
further comprises
belt loops 1230 to the side of the P1 anchor 1235 and the P2 anchor 1240,
wherein the belt loops
1230 are also approximately at the same plane.
[00106] Figure 12C shows the belt loops in between the P1 1235 and P3 anchors
1260. One belt
loop 1245 is at the junction of the horizontal 1210 and vertical seam 1250 and
one belt loop 1255
is at the bottom of the vertical seam 1250.
[00107] Figure 12D shows the belt loops in between the P2 1240 and P3 anchors
1260. The belt
loops 1265 along the horizontal seam 1210 are at the same plane. Because the
P3 anchor 1260 is
slightly higher, the belt loop 1270 near the P3 anchor 1260 is adjusted to a
height approximate to
the P3 anchor 1260. The belt loop 1230 is in a position in relation to the
location of the P2 anchor
1240. In a preferred embodiment, the anchors are biased towards the flange. In
other embodiments,
the anchors may be perpendicular to the body.
[00108] Figure 12E shows anchor loops in relation to the P1 and/or P3 anchors.
In one
embodiment, the anchor loops comprise double loops 1275 positioned at the
crossing wires on the
flange to the left and right of the P1 and/or P3 anchor 1220, and the anchor
loops further comprise
a triple loop 1280 at the tip of the P1 and/or P3 anchor 1220.
[00109] Figures 13A-13D generally illustrate embodiments of a valve
replacement as disclosed
herein. Figures 13A-13D illustrate deployment belt loops commonly used for the
One-Piece
System. The deployment belt loops may comprise one or more sets of loops.
21
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
[00110] In a preferred embodiment, the One-Piece System comprises seven belt
loops, wherein
the belt loops on the adapter body of the One-Piece System are double loops
and the belt loops
located on a horizontal seam are at the crossed wires along the same plane.
[00111] Figure 13A shows belt loops in between the P1 1305 and P3 anchors
1310. Three belt
loops 1315 are located along the horizontal seam 1320 with one belt loop
located at the junction
of where the horizontal 1320 and vertical seams 1325 meet and located in line
with a commissure
wire. The two other belt loops are located just outside of the P1 1305 and P3
anchors 1310.
[00112] Figure 13B shows belt loops in between the P2 anchor 1330 and either
the P1 1305 or
P3 anchor 1310. Two loops 1335 are located along the horizontal seam and
secured at the same
plane of the crossed wires outside the P2 anchor 1330 and the long anchor
(P1/P3 anchor).
[00113] Figure 13C shows the belt loops 1340 of the long anchor, wherein the
belt loops 1340
are located on either side of the long anchor. Figure 13D shows the belt loops
1345 of the P2
anchor 1330, wherein the belt loops 1345 are located on either side of the P2
anchor 1330.
[00114] Figures 13E and 13F show an embodiment of the location of deployment
apertures,
wherein the deployment apertures 1350 are located directly below each long
anchor and are located
on either side 1355 of the P2 anchor 1330.
[00115] Figures 13G and 13H show another embodiment of the location of
deployment apertures
1375. In this embodiment, fabric is removed (e.g., in a triangular shape) two
peaks away 1360
from the commissures 1365 so as to expose the wire peak. A wrap stitch 1370 is
placed around the
perimeter of the frame so as to catch wires around the exposed peaks.
[00116] Engagement Structures
[00117] Figure 14A generally illustrates an embodiment of a valve replacement
as disclosed
herein. In an embodiment, as shown in Figure 14A, the Adapter or the One-Piece
System
comprises a body 1405 and an atrial sealing skirt 1410. The Adapter body 1405
and sealing skirt
1410 may be constructed of varying material and vary in dimensions. For
example, the Adapter
body 1405 and sealing skirt 1410 may be made up of a wire braid of one or more
wires with
different diameters. The wire may be made of material such as nitinol and
designed to be
compressed to a small diameter¨such as 4mm to 6mm¨to be delivered in a
catheter. When
released the Adapter body 1405 and sealing skirt 1410 may expand in size (i.e.
the body expanding
to 25mm or greater in diameter and the sealing skirt expanding anywhere from
40mm to 70mm in
diameter).
22
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
[00118] The exterior surface of the Adapter body 1405 may also be covered with
a multitude of
small, short barbs 1415. The barbs 1415 may be used to engage the leaflet or
annulus of a
malfunctioning cardiac valve, such as a mitral valve. The barbs 1415 may be
made up of basic,
short wires and/or may also have an extra barb-component, like a fishhook
barb, to fixably retain
the annular tissue.
[00119] The Adapter body 1405 may also have one or more hooks 1420 or 1425
(more or less
in number than the barbs 1415) varying in size, that can hook under the native
valve tissue. These
larger hooks may or may not have fishhook barbs. The larger hooks may have a
spring-like
function that engage with the native valve tissue and prevent it from moving.
[00120] In a preferred embodiment, the sealing skirt 1410 may be connected to
a catheter,
wherein the Adapter Attachment is sequentially released from the catheter once
the Adapter body
1405 is released and engaged with annual tissue. The sealing skirt 1410 may be
designed to flex
downward, toward, or even past the plane defining the joint between the
Adapter body 1405 and
the sealing skirt 1410¨so as to be radially overlapping with the Adapter body
1405. The multitude
of barbs 1415 on the Adapter body 1405 would work together to ensure the
Adapter body 1405 is
strongly engaged in the native annulus and resists the downward pressure of
the sealing skirt 1410,
such that the sealing skirt 1410 would create a strong seal against the atrial
tissue surrounding the
native valve annulus.
[00121] Figures 14B-14E generally illustrate embodiments of a valve
replacement as disclosed
herein. In these figures, the sealing skirt is not shown for ease of
illustration. As shown in Figure
14B, the Adapter body 1405 is designed with a braid of varying weave densities
and/or wire
diameters, and/or combined with releasable mechanisms such that the Adapter
body initially has
a round cross-section. The Adapter body 1405 has barbs 1415 designed to engage
a native valve
leaflet 1450. Once the barbs 1410 are engaged, the anchoring/attaching
functionalities of the
Adapter Attachment cause it to conform to a "D-shape" or other asymmetrical
shape¨keeping the
Adapter body 1405 cylindrical or otherwise specifically shaped to receive the
valve structure. This
accommodation and conformity is achieved via the different weave, wire
diameters, or mechanism
enabling such. As shown in Figure 14C, the change in shape creates a sharper
curve radius to make
the D-shape. The change from a circular cross-section to a D-shape cross-
section may pull the
leaflet, which can be useful, for example, in a mitral valve where an implant
such as the Adapter
body may cause outflow tract obstruction. Figures 14D and 14E disclose an
oblique view of the
23
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
structure and mechanism corresponding with Figures 14B and 14C. Embodiments
disclosed in
Figures 14B-14E may also comprise the sealing skirt and other features
described in previous
drawings.
[00122] Figures 15A and 15B generally illustrate embodiments of a valve
replacement as
disclosed herein. Figure 15A discloses an embodiment of the Valve Replacement
implanted in a
malfunctioning mitral valve, with the body 1505 deployed in the mitral valve
and the sealing skirt
1510 deployed against the floor of the left atrium. In this embodiment, the
Adapter body 1505 is
oriented at a slight angle (i.e., from 10-30 degrees relative to the plane of
the skirt), such that when
deployed, the Adapter body 1505 is biased towards the posterior leaflet 1515.
[00123] Deployment as disclosed in Figure 15A ensures good engagement of barbs
into the
posterior leaflet but not necessarily the anterior leaflet. The system may be
designed to normally
be in this geometric condition but be mechanically expandable by design so
that it can expand to
engage the anterior leaflet, then released back to the normal position after
the barbs and/or hooks
engage the anterior leaflet. This forces the anterior leaflet towards the
posterior leaflet and away
from the LVOT, ensuring it is not obstructed post procedure. Also shown are
the delivery catheter
1520 and a guidewire 1525.
[00124] In another embodiment, the body of the Valve Replacement may be used
to engage the
leaflets with the barbs, wherein the body expands to a diameter larger than
the diameter at
deployment to ensure engagement with the leaflets. As the device is further
deployed, the diameter
of the engaged portion reduces to a final configuration¨symmetrical or
asymmetrical¨thereby
pulling the leaflets towards the device and away from the LVOT.
[00125] Figure 15B generally illustrates an embodiment of an Adapter
attachment as disclosed
herein. Figure 15B discloses a final configuration of an Adapter in its
original position after
release, wherein the anterior leaflet is drawn and held towards the posterior
leaflet, ensuring no
obstruction of the LVOT.
[00126] Figures 16A and 16D generally illustrate embodiments of a valve
replacement as
disclosed herein. Figure 16A shows a top view of a Valve Replacement and
Figure 16B shows a
bottom view of the Valve Replacement. As shown in Figures 16A and 16B, the
inflow end of the
Valve Replacement may comprise anchor retracting chords coming through the
flow portion and
anchor to the underside of a flange. These sutures permit control of the
anchors by pulling and
releasing the chords. Alternatively, the sutures may be releasably attached to
a delivery system to
24
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
provide similar manipulation of the anchors. Figure 16B further discloses the
chords attached to
the anchors. Figures 16C-16D show attachment configurations for a collapsible
flange.
[00127] Figures 17A-17D generally illustrate embodiments of a valve
replacement as disclosed
herein. Figures 17A-17D show the attachment configurations for collapsible
anchors and clips and
further disclose a close-up view of a suture pattern that is used to collapse
and control the anchors
from all angles of the Valve Replacement. In these embodiments, a delivery
component, such as
one comprising one or more suture lines, is connected on a first to the
engagement attachment,
wherein the one or more suture lines connects on a second end to a controlling
mechanism.
[00128] Valve Assembly
[00129] Figures 18A and 18B generally illustrate embodiments of a valve
replacement as
disclosed herein. As shown in Figures 18A and 18B, an embodiment of the Valve
Replacement
may be fabricated using a constraint to hold an Adapter frame at a specific
dimension while
attaching material to influence device performance. A fabrication technique is
disclosed, which
acts to influence the disposition of a braided wire frame¨removing the
inherent freedom of
movement and unpredictability that is present between relative members of the
frame structure
when in a load-free state. This technique involves restraining the radial
expansion of the frame
with a constraint, such as feeding some number of sutures through or around
the structure to hold
it at a specific dimension other than its unrestrained, "free" dimension. In
subsequent fabrication
steps, the structure is incorporated into an assembly that adopts this new
configuration and
considers this to be the final dimension. When the constraints are removed
from the braided frame,
this braided frame tries to recover to its original "free" dimension¨applying
additional radial force
to the surrounding structure while being constrained to the desired dimension.
[00130] The degree of radial force transmitted to the fabric material from the
frame can be
adjusted as required to achieve the optimal combination or performance
properties. In particular,
the strain energy density of the structure can be more uniform. A greater
stiffness is achieved
(resulting in a better seal) with less material, resulting in a more low-
profile structure. The suture
finally provides a biasing of the structure toward a desirable diameter and
height for the valve
structure.
[00131] Figure 19A and 19B generally illustrate embodiments of a valve
replacement as
disclosed herein. Figure 19A generally illustrates an embodiment of a Valve
Assembly wherein
leaflets 1905 are assembled to each other and/or to the frame by sewing. The
leaflets are joined at
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
commissure seams 1910 and then sewn, welded or otherwise attached to the
commissure posts as
well as to other points on the frame such as wires or wire intersections, or
to materials attached to
the frame, for example the leaflets being attached to a cuff, which cuff is
then attached to the frame.
Once the assembly is complete, the leaflets work in concert to close on the
outflow (distal side
when being implanted into leaflets a mitral valve) when fluid pressure is
increased distally, so that
the leaflets close or co-apt work in a Y pattern 1920.
[00132] As shown in Figure 19B, a Valve Assembly 1930 comprises a braided
frame a cuff
covering 1935 on the outside. This cuff over the complete outer frame may
serve as an extended
sealing zone. A belly stitch 1940 may be sewn to the frame whereas a bellows
stitch 1945 is not
sewn to the frame. In this embodiment, the distal leaflet ends 1950 are shown
coapting so as to
close the valve in a loose Y-shape. In some embodiments, the valve co-apt area
may comprise
some "looseness" so as to ensure sufficient and effective contact among all
three leaflets and
ensure complete closing of the valve. Leaflets may be constructed of tissue
such as porcine
pericardium or other materials known to the art. In some cases, valves or
parts of valves excised
from animals may be sewn into the disclosed frame structure.
[00133] Figure 20 generally illustrates an embodiment of a valve replacement
as disclosed
herein. Figure 20 shows a bottom perspective view of the One-Piece System
comprising a braided
wire frame making up a flange 2005, an adapter body 2010, tabs 2015 compatible
with leaflets,
and leaflets 2020.
[00134] Other embodiments may include combinations and sub-combinations of
features
described or shown in the several figures, including for example, embodiments
that are equivalent
to providing or applying a feature in a different order than in a described
embodiment, extracting
an individual feature from one embodiment and inserting such feature into
another embodiment;
removing one or more features from an embodiment; or both removing one or more
features from
an embodiment and adding one or more features extracted from one or more other
embodiments,
while providing the advantages of the features incorporated in such
combinations and sub-
combinations. As used in this paragraph, "feature" or "features" can refer to
structures and/or
functions of an apparatus, article of manufacture or system, and/or the steps,
acts, or modalities of
a method.
[00135] References throughout this specification to "one embodiment," "an
embodiment," "an
example embodiment," etc., indicate that the embodiment described may include
a particular
26
CA 03210770 2023-08-03
WO 2022/170129 PCT/US2022/015360
feature, structure, or characteristic, but every embodiment may not
necessarily include that
particular feature, structure, or characteristic. Moreover, such phrases are
not necessarily referring
to the same embodiment. Further, when a particular feature, structure, or
characteristic is described
in connection with one embodiment, it will be within the knowledge of one
skilled in the art to
affect such feature, structure, or characteristic in connection with other
embodiments whether or
not explicitly described.
[00136] Unless the context clearly indicates otherwise (1) the word "and"
indicates the
conjunctive; (2) the word "or" indicates the disjunctive; (3) when the article
is phrased in the
disjunctive, followed by the words "or both," both the conjunctive and
disjunctive are intended;
and (4) the word "and" or "or" between the last two items in a series applies
to the entire series.
[00137] Where a group is expressed using the term "one or more" followed by a
plural noun,
any further use of that noun to refer to one or more members of the group
shall indicate both the
singular and the plural form of the noun. For example, a group expressed as
having "one or more
members" followed by a reference to "the members" of the group shall mean "the
member" if there
is only one member of the group.
[00138] The term "a" or "an" entity refers to one or more of that entity. As
such, the terms "a"
(or "an"), "one or more" and "at least one" can be used interchangeably
herein. It is also to be noted
that the terms "comprising", "including", and "having" can be used
interchangeably.
27
