U.S. patent application number 17/832849 was filed with the patent office on 2022-09-22 for sinus-engaging valve fixation member.
The applicant listed for this patent is Medtronic, Inc.. Invention is credited to Raphael Benary, Ido Kilemnik, Yossi Tuval.
Application Number | 20220296368 17/832849 |
Document ID | / |
Family ID | 1000006379632 |
Filed Date | 2022-09-22 |
United States Patent
Application |
20220296368 |
Kind Code |
A1 |
Tuval; Yossi ; et
al. |
September 22, 2022 |
Sinus-Engaging Valve Fixation Member
Abstract
A prosthesis is provided for implantation at a native semilunar
valve of a native valve complex, the native valve complex having
three semilunar sinuses and three native commissures. The
prosthesis includes a valve prosthesis support, which comprises a
support structure comprising exactly three engagement arms that
meet one another at three respective junctures. The engagement arms
are shaped so as define three peak complexes at the three
respective junctures, and three trough complexes, each of which is
between two of the peak complexes. Upon implantation of the
prosthesis, each of the engagement arms is at least partially
disposed within a respective one of the semilunar sinuses, such
that each of the peak complexes is disposed distal to and in
rotational alignment with a respective one of the native
commissures, and each of the trough complexes is disposed at least
partially within the respective one of the semilunar sinuses.
Inventors: |
Tuval; Yossi; (Even Yehuda,
IL) ; Benary; Raphael; (Tel Aviv, IL) ;
Kilemnik; Ido; (Herzliya, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medtronic, Inc. |
Minneapolis |
MN |
US |
|
|
Family ID: |
1000006379632 |
Appl. No.: |
17/832849 |
Filed: |
June 6, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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17722324 |
Apr 16, 2022 |
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17832849 |
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17359112 |
Jun 25, 2021 |
11304802 |
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17722324 |
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17222926 |
Apr 5, 2021 |
11304801 |
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17359112 |
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16724358 |
Dec 22, 2019 |
11304800 |
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17222926 |
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15881853 |
Jan 29, 2018 |
10543077 |
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16724358 |
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15179483 |
Jun 10, 2016 |
9913714 |
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15881853 |
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14484387 |
Sep 12, 2014 |
9387071 |
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15179483 |
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12721789 |
Mar 11, 2010 |
8834564 |
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14484387 |
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11726893 |
Mar 23, 2007 |
8414643 |
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12721789 |
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60845728 |
Sep 19, 2006 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/2409 20130101;
A61F 2/24 20130101; A61F 2220/0075 20130101; A61F 2230/008
20130101; A61F 2230/0054 20130101; A61F 2220/0016 20130101; A61F
2/2412 20130101; A61F 2/91 20130101; A61F 2220/0058 20130101; A61F
2230/005 20130101; A61F 2/9522 20200501; A61F 2/2427 20130101; A61F
2/2418 20130101; A61F 2/2436 20130101; A61F 2220/005 20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1-12. (canceled)
13. A prosthetic valve comprising: an inner support structure
expandable from a compressed state to an expanded state; a valve
member positioned inside and coupled to the inner support
structure; and an outer support structure expandable from a
compressed state to an expanded state, the outer support structure
positioned around the inner support structure, a first end of the
outer support structure coupled to the inner support structure and
extending radially outward from the inner support structure such
that, in the expanded state, a space exists between the outer
support structure and the inner support structure, the outer
support structure comprising a tissue engagement portion disposed
radially outward of the inner support structure, the tissue
engagement portion configured to engage a native valve from within
the native valve.
14. The prosthetic valve of claim 13, wherein the native valve is a
mitral valve.
15. The prosthetic valve of claim 13, wherein the native valve is
an aortic valve.
16. The prosthetic valve of claim 13, wherein the native valve is a
tricuspid valve.
17. The prosthetic valve of claim 13, wherein the native valve is a
pulmonary valve.
18. The prosthetic valve of claim 13, wherein the inner support
structure is self-expanding.
19. The prosthetic valve of claim 13, wherein the outer support
structure is self-expanding.
20. The prosthetic valve of claim 13, wherein the tissue engagement
portion comprises one or more tissue piercing elements.
21. The prosthetic valve of claim 20, wherein the one or more
tissue piercing elements comprise barbs.
22. The prosthetic valve of claim 13, wherein at least a portion of
the outer support structure comprises a covering.
23. The prosthetic valve of claim 13, wherein at least a portion of
the inner support structure comprises a covering.
24. The prosthetic valve of claim 13, wherein the first end of the
outer support structure is coupled to a first end of the inner
support structure.
25. The prosthetic valve of claim 13, wherein a distal end of the
outer support structure is coupled to a distal end of the inner
support structure.
26. The prosthetic valve of claim 13, wherein the prosthetic valve
further comprises an upstream tissue engagement portion and a
downstream tissue engagement portion, wherein the upstream tissue
engagement portion is configured to engage an upstream surface of
the native valve, and wherein the downstream tissue engagement
portion is configured to engage a downstream surface of the native
valve.
27. The prosthetic valve of claim 13, wherein the outer support
member extends in a lengthwise direction of the inner support
member.
28. The prosthetic valve of claim 13, wherein the prosthetic valve
further comprises one or more arms configured to extend behind a
native leaflet.
29. The prosthetic valve of claim 13, wherein a second end of the
outer support structure is not coupled to the inner support
structure.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation-in-part of U.S.
application Ser. No. 11/726,893, filed Mar. 23, 2007, which claims
the benefit of U.S. Provisional Application 60/845,728, filed Sep.
19, 2006, entitled, "Fixation member for valve;" both of which are
assigned to the assignee of the present application and are
incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to prosthetic
devices for the treatment of body lumens, and specifically to a
valve prosthesis for such body lumens.
BACKGROUND OF THE INVENTION
[0003] PCT Publication WO 05/002466 to Schwammenthal et al., which
is assigned to the assignee of the present application and is
incorporated herein by reference, describes prosthetic devices for
treating aortic stenosis.
[0004] PCT Publication WO 06/070372 to Schwammenthal et al., which
is assigned to the assignee of the present application and is
incorporated herein by reference, describes a prosthetic device
having a single flow field therethrough, adapted for implantation
in a subject, and shaped so as to define a fluid inlet and a
diverging section, distal to the fluid inlet.
[0005] US Patent Application Publication 2006/0149360 to
Schwammenthal et al., which is assigned to the assignee of the
present application and is incorporated herein by reference,
describes a prosthetic device including a valve-orifice attachment
member attachable to a valve in a blood vessel and including a
fluid inlet, and a diverging member that extends from the fluid
inlet, the diverging member including a proximal end near the fluid
inlet and a distal end distanced from the proximal end. A distal
portion of the diverging member has a larger cross-sectional area
for fluid flow therethrough than a proximal portion thereof.
[0006] U.S. Pat. No. 6,730,118 to Spencer et al., which is
incorporated herein by reference, describes a valve prosthesis
device suitable for implantation in body ducts. The device
comprises a support stent, which comprises a deployable
construction adapted to be initially crimped in a narrow
configuration suitable for catheterization through the body duct to
a target location, and adapted to be deployed by exerting
substantially radial forces from within by means of a deployment
device to a deployed state in the target location; and a valve
assembly comprising a flexible conduit having an inlet end and an
outlet, made of pliant material attached to the support beams
providing collapsible slack portions of the conduit at the outlet.
The support stent is provided with a plurality of longitudinally
rigid support beams of fixed length. When flow is allowed to pass
through the valve prosthesis device from the inlet to the outlet,
the valve assembly is kept in an open position, whereas a reverse
flow is prevented as the collapsible slack portions of the valve
assembly collapse inwardly providing blockage to the reverse
flow.
[0007] U.S. Pat. No. 7,018,406 to Seguin et al., which is
incorporated herein by reference, describes a prosthetic valve
assembly for use in replacing a deficient native valve, comprising
a replacement valve supported on an expandable valve support. If
desired, one or more anchors may be used. The valve support, which
entirely supports the valve annulus, valve leaflets, and valve
commissure points, is configured to be collapsible for transluminal
delivery and expandable to contact the anatomical annulus of the
native valve when the assembly is properly positioned. The anchor
engages the lumen wall when expanded and prevents substantial
migration of the valve assembly when positioned in place. The
prosthetic valve assembly is compressible about a catheter, and
restrained from expanding by an outer sheath. The catheter may be
inserted inside a lumen within the body, such as the femoral
artery, and delivered to a desired location, such as the heart.
When the outer sheath is retracted, the prosthetic valve assembly
expands to an expanded position such that the valve and valve
support expand within the deficient native valve, and the anchor
engages the lumen wall.
[0008] U.S. Pat. No. 7,018,408 to Bailey et al., which is
incorporated herein by reference, describes prosthetic cardiac and
venous valves and a single catheter device, and minimally invasive
techniques for percutaneous and transluminal valvuloplasty and
prosthetic valve implantation. The device consists generally of a
stent body member, a graft, and valve flaps. The graft is
preferably a biocompatible, fatigue-resistant membrane which is
capable of endothelialization, and is attached to the stent body
member on at least portions of either or both the lumenal and
ablumenal surfaces of the stent body member by suturing to or
encapsulating stent struts. The valve leaflets are preferably
formed by sections of the graft material attached to the stent body
member. The stent body member is shaped to include the following
stent sections: proximal and distal anchors, a intermediate annular
stent section, and at least one valve arm or blood flow regulator
struts.
[0009] U.S. Pat. No. 6,458,153 and US Patent Application
Publication 2003/0023300 to Bailey et al., which are incorporated
herein by reference, describe prosthetic cardiac and venous valves
and a single catheter device, and minimally invasive techniques for
percutaneous and transluminial valvuloplasty and prosthetic valve
implantation.
[0010] US Patent Application Publication 2004/0186563 to Lobbi,
which is incorporated herein by reference, describes a prosthetic
heart valve having an internal support frame with a continuous,
undulating leaflet frame defined therein. The leaflet frame has
three cusp regions positioned at an inflow end intermediate three
commissure regions positioned at an outflow end thereof. The
leaflet frame may be cloth covered and flexible leaflets attached
thereto form occluding surfaces of the valve. The support frame
further includes three cusp positioners rigidly fixed with respect
to the leaflet frame and located at the outflow end of the support
frame intermediate each pair of adjacent commissure regions. The
valve is desirably compressible so as to be delivered in a
minimally invasive manner through a catheter to the site of
implantation. Upon expulsion from catheter, the valve expands into
contact with the surrounding native valve annulus and is anchored
in place without the use of sutures. In the aortic valve position,
the cusp positioners angle outward into contact with the sinus
cavities, and compress the native leaflets if they are not excised,
or the aortic wall if they are. The support frame may be formed
from a flat sheet of nitinol that is bent into a three-dimensional
configuration and heat set. A holder having spring-like arms
connected to inflow projections of the valve may be used to
deliver, reposition and re-collapse the valve, if necessary.
[0011] US Patent Application Publication 2003/0130729 to Paniagua
et al., which is incorporated herein by reference, describes a
percutaneously implantable replacement heart valve device and a
method of making same. The replacement heart valve device comprises
a stent member made of stainless steel or self-expanding nitinol,
and a biological tissue artificial valve means disposed within the
inner space of the stent member. An implantation and delivery
system has a central part which consists of a flexible hollow tube
catheter that allows a metallic wire guide to be advanced inside
it. The endovascular stented-valve is a glutaraldehyde fixed bovine
pericardium which has two or three cusps that open distally to
permit unidirectional blood flow.
[0012] US Patent Application Publication 2004/0236411 to Sarac et
al., which is incorporated herein by reference, describes a
prosthetic valve for replacing a cardiac valve, including an
expandable support member and at least two valve leaflets made of a
first layer of biological material selected from peritoneal tissue,
pleural tissue, or pericardial tissue. A second layer of biological
material is attached to the support member. The second layer is
also made from peritoneal tissue, pleural tissue, or pericardial
tissue. The second layer includes a radially inwardly facing
surface that defines a conduit for directing blood flow. The valve
leaflets extend across the conduit to permit unidirectional flow of
blood through the conduit.
[0013] US Patent Application Publication 2005/0075720 to Nguyen et
al., which is incorporated herein by reference, describes a method
and system for minimally invasive replacement of a valve. The
system includes a collapsible valve and anchoring structure,
devices and methods for expanding the valve anchoring structure,
adhesive means to seal the valve to the surrounding tissue, a
catheter-based valve sizing and delivery system, native valve
removal means, and a temporary valve and filter assembly to
facilitate removal of debris material. The valve assembly comprises
a valve and anchoring structure for the valve, dimensioned to fit
substantially within the valve sinus.
[0014] US Patent Application Publication 2006/0058872 to Salahieh
et al., which is incorporated herein by reference, describes an
apparatus for endovascularly replacing a patient's heart valve. In
some embodiments, the apparatus includes an expandable anchor
supporting a replacement valve, the anchor and replacement valve
being adapted for percutaneous delivery and deployment to replace
the patient's heart valve, the anchor having a braid having
atraumatic grasping elements adapted to grasp tissue in a vicinity
of the patient's heart valve.
[0015] US Patent Application Publication 2005/0137688 to Salahieh
et al., which is incorporated herein by reference, describes a
method for percutaneously replacing a heart valve of a patient. In
some embodiments the method includes the steps of percutaneously
delivering a replacement valve and an expandable anchor to a
vicinity of the heart valve in an unexpanded configuration;
expanding the anchor to a deployed configuration in which the
anchor contacts tissue at a first anchor site; repositioning the
anchor to a second anchor site; and deploying the anchor at the
second anchor site.
[0016] US Patent Application Publication 2005/0137690 to Salahieh
et al., which is incorporated herein by reference, describes
apparatus for endovascularly replacing a patient's heart valve,
including: a delivery catheter having a diameter of 21 french or
less; an expandable anchor disposed within the delivery catheter;
and a replacement valve disposed within the delivery catheter. The
invention also includes a method for endovascularly replacing a
heart valve of a patient. In some embodiments the method includes
the steps of: inserting a catheter having a diameter no more than
21 french into the patient; endovascularly delivering a replacement
valve and an expandable anchor to a vicinity of the heart valve
through the catheter; and deploying the anchor and the replacement
valve.
[0017] US Patent Application Publication 2005/0137691 to Salahieh
et al., which is incorporated herein by reference, describes
apparatus for endovascularly replacing a patient's heart valve,
including: a custom-designed anchor; and a replacement valve,
wherein the custom-designed anchor is adapted to engage native
leaflets of the heart valve, and wherein the anchor and the valve
are adapted for in vivo expansion and coupling to one another to
form composite apparatus that endovascularly replaces the heart
valve. The invention also includes a method for endovascularly
replacing a patient's heart valve. In some embodiments the method
includes the steps of: providing apparatus comprising an anchor
piece and a replacement valve piece; endovascularly delivering the
anchor piece to a vicinity of the heart valve in a collapsed
delivery configuration; expanding the anchor piece to a deployed
configuration; engaging at least one valve leaflet of the heart
valve with the anchor piece; endovascularly delivering the
replacement valve piece to the vicinity of the heart valve in a
collapsed delivery configuration; expanding the replacement valve
piece to a deployed configuration; and coupling the valve piece to
the anchor piece in vivo to form composite two-piece apparatus that
endovascularly replaces the patient's heart valve.
[0018] US Patent Application Publication 2005/0137695 to Salahieh
et al., which is incorporated herein by reference, describes
apparatus for endovascularly replacing a patient's heart valve,
including a replacement valve adapted to be delivered
endovascularly to a vicinity of the heart valve; an expandable
anchor adapted to be delivered endovascularly to the vicinity of
the heart valve; and a lock mechanism configured to maintain a
minimum amount of anchor expansion.
[0019] US Patent Application Publication 2005/0143809 to Salahieh
et al., which is incorporated herein by reference, describes
techniques for endovascularly replacing a heart valve of a patient.
One aspect described is a method including the steps of
endovascularly delivering a replacement valve and an expandable
anchor to a vicinity of the heart valve in an unexpanded
configuration; and applying an external non-hydraulically expanding
or non-pneumatically expanding actuation force on the anchor to
change the shape of the anchor, such as by applying proximally
and/or distally directed force on the anchor using a releasable
deployment tool to expand and contract the anchor or parts of the
anchor. Another aspect described includes an apparatus including a
replacement valve; an anchor; and a deployment tool comprising a
plurality of anchor actuation elements adapted to apply a
non-hydraulically expanding or non-pneumatically expanding
actuation force on the anchor to reshape the anchor.
[0020] US Patent Application Publication 2005/0182483 to Osborne et
al., which is incorporated herein by reference, describes a venous
valve prosthesis having a substantially non-expandable, valve
portion comprising a valve-closing mechanism, such as a pair of
opposing leaflets; and an anchoring portion, such as one or more
self-expanding frames or stents that are expandable to anchor the
prosthesis at the implantation site. In one embodiment, the rigid
valve portion includes a deposition of material such as pyrolitic
carbon to reduce the thrombogenicity of the blood-contacting
surfaces. The anchoring portions preferably include a covering,
such as a tubular construct of synthetic or collagen-derived
material (such as a bioremodelable ECM material), which attaches
about the support structure such that blood flow is directed
through the valve mechanism as it transitions from the larger
diameter anchoring portion to the intermediate, smaller-diameter
portion of the prosthesis. In another embodiment, the valve support
housing and valve-closing elements are delivered in a collapsed,
folded, and/or dissembled state sized for delivery, then
manipulated in situ to the second expanded configured following
deployment.
[0021] US Patent Application Publication 2005/0197695 to Stacchino
et al., which is incorporated herein by reference, describes a
cardiac-valve prosthesis adapted for percutaneous implantation. The
prosthesis includes an armature adapted for deployment in a
radially expanded implantation position, the armature including a
support portion and an anchor portion, which are substantially
axially coextensive with respect to one another. A set of leaflets
is coupled to the support portion. The leaflets can be deployed
with the armature in the implantation position. The leaflets
define, in the implantation position, a flow duct that is
selectably obstructable. The anchor portion can be deployed to
enable anchorage of the cardiac-valve prosthesis at an implantation
site.
[0022] US Patent Application Publication 2005/0240200 to Bergheim,
which is incorporated herein by reference, describes methods and
systems for introducing a delivery device in the heart at or near
the apex of the heart, wherein the methods include advancing the
prosthesis to a target site, and disengaging the prosthesis from
the delivery device at the target site for implantation.
Specifically, the valve replacement systems are described for
delivering a replacement heart valve to a target site in or near a
heart. The valve replacement system comprises a trocar or other
suitable device to penetrate the heart at or near the apex of the
heart, a delivery member that is movably disposed within the
trocar, and a replacement cardiac valve disposed on the delivery
member. The delivery member may further comprise mechanical or
inflatable expanding members to facilitate implantation of the
prosthetic valve at the target site.
[0023] US Patent Application Publication 2006/0025857 to Bergheim
et al., which is incorporated herein by reference, describes valve
prostheses adapted to be initially crimped in a narrow
configuration suitable for catheterization through body ducts to a
target location, and adapted to be deployed by exerting
substantially radial forces from within by means of a deployment
device to a deployed state in the target location.
[0024] US Patent Application Publication 2006/0025855 to Lashinski
et al., which is incorporated herein by reference, describes a
cardiovascular prosthetic valve comprising an inflatable body that
has at least a first inflatable chamber and a second inflatable
chamber that is not in fluid communication with the first
inflatable chamber. The inflatable body is configured to form, at
least in part, a generally annular ring. A valve is coupled to the
inflatable body. The valve is configured to permit flow in a first
axial direction and to inhibit flow in a second axial direction
opposite to the first axial direction. A first inflation port is in
communication with the first inflatable chamber. A second inflation
port in communication with the second inflatable chamber.
[0025] US Patent Application Publication 2006/0047338 to Jenson et
al., which is incorporated herein by reference, describes a cardiac
valve having a support frame having a first end member and a second
end member opposing the first end member in a substantially fixed
distance relationship, and a cover extending over the support frame
to allow for unidirectional flow of a liquid through the valve.
[0026] US Patent Application Publication 2006/0052867 to Revuelta
et al., which is incorporated herein by reference, describes a
method for functionally replacing a previously implanted prosthetic
heart valve. The method includes positioning a replacement
prosthetic heart valve within an internal region defined by the
previously implanted prosthetic heart valve. The replacement
prosthetic heart valve is then physically docked to the previously
implanted prosthetic heart valve. With this technique, the
previously implanted prosthetic heart valve serves as a platform
for securement of the replacement prosthetic heart valve to the
patient's native tissue.
[0027] US Patent Application Publication 2006/0074485 to
Realyvasquez, which is incorporated herein by reference, describes
methods and apparatus for valve repair or replacement. In one
embodiment, the apparatus is a valve delivery device comprising a
first apparatus and a second apparatus. The first apparatus
includes a heart valve support having a proximal portion and a
distal portion and a heart valve excisor slidably mounted on said
first apparatus. The second apparatus includes a fastener assembly
having a plurality of penetrating members mounted to extend outward
when the assembly assumes an expanded configuration; and a heart
valve prosthesis being releasably coupled to said second apparatus.
The first apparatus and second apparatus are sized and configured
for delivery to the heart through an opening formed in a femoral
blood vessel. The heart valve prosthesis support is movable along a
longitudinal axis of the device to engage tissue disposed between
the anvil and the valve prosthesis.
[0028] US Patent Application Publication 2006/0259136 to Nguyen et
al., which is incorporated herein by reference, describes a heart
valve prosthesis having a self-expanding multi-level frame that
supports a valve body comprising a skirt and plurality of coapting
leaflets. The frame transitions between a contracted delivery
configuration that enables percutaneous transluminal delivery, and
an expanded deployed configuration having an asymmetric hourglass
shape. The valve body skirt and leaflets are constructed so that
the center of coaptation may be selected to reduce horizontal
forces applied to the commissures of the valve, and to efficiently
distribute and transmit forces along the leaflets and to the frame.
Alternatively, the valve body may be used as a surgically
implantable replacement valve prosthesis.
[0029] U.S. Pat. No. 7,137,184 to Schreck, which is incorporated
herein by reference, describes methods for forming a support frame
for flexible leaflet heart valves from a starting blank include
converting a two-dimensional starting blank into the
three-dimensional support frame. The material may be superelastic,
such as NITINOL, and the method may include bending the 2-D blank
into the 3-D form and shape setting it. A merely elastic material
such as ELGILOY may be used and plastically deformed in stages,
possibly accompanied by annealing, to obtain the 3-D shape.
[0030] U.S. Pat. No. 6,558,418 to Carpentier et al., which is
incorporated herein by reference, describes a highly flexible
tissue-type heart valve is disclosed having a structural stent in a
generally cylindrical configuration with cusps and commissures that
are permitted to move radially. The stent commissures are
constructed so that the cusps are pivotably or flexibly coupled
together at the commissures to permit relative movement
therebetween. The stent may be cloth-covered and may be a single
element or may be made in three separate elements for a three cusp
valve, each element having a cusp portion and two commissure
portions; adjacent commissure portions for each pair of adjacent
stent element combining to form the stent commissures. If the stent
has separate elements their commissure portions may be pivotably or
flexible coupled, or may be designed to completely separate into
independent leaflets at bioresorbable couples. The cloth covering
may have an outwardly projecting flap that mates with valve
leaflets (e.g., pericardial leaflets) along the cusps and
commissures. A connecting band may be provided that follows the
cusps and commissures and extends outwardly. The valve is connected
to the natural tissue along the undulating connecting band using
conventional techniques, such as sutures.
[0031] U.S. Pat. No. 6,296,662 to Caffey, which is incorporated
herein by reference, describes heart valve prosthesis including a
heart valve formed of a flexible material. An elongated stent
member is provided in the valve and includes terminal ends. A
plurality of flexible post members are formed in the stent member.
Each post member includes a pair of opposite sides. A crimp collar
interconnects the terminal ends of the stent member. The crimp
collar is positioned between adjacent post members. A first radius
is formed in the stent member between the crimp collar and an
adjacent side of each adjacent post member. A plurality of second
radii are formed in the stent member between an opposite side of a
first one of the adjacent post members and an opposite side of a
second one of the adjacent post members. The second radii are
greater than each first radius.
[0032] The following patents and patent application publication,
all of which are incorporated herein by reference, may be of
interest: [0033] U.S. Pat. No. 6,312,465 to Griffin et al. [0034]
U.S. Pat. No. 5,908,451 to Yeo [0035] U.S. Pat. No. 5,344,442 to
Deac [0036] U.S. Pat. No. 5,354,330 to Hanson [0037] US Patent
Application Publication 2004/0260389 to Case et al.
SUMMARY OF THE INVENTION
[0038] In some embodiments of the present invention, an aortic
valve prosthesis for treating a native stenosed valve comprises two
portions that are configured to axially sandwich a native valve
complex from the aortic (i.e., downstream) and left-ventricular
(i.e., upstream) sides thereof, and a collapsible valve that is
configured to be open during systole and closed during diastole.
The two portions typically include a collapsible inner support
structure that serves as a proximal (i.e., upstream) fixation
member, and a collapsible outer support structure that serves as a
distal (i.e., downstream) fixation member. The distal fixation
member is configured to be positioned in an ascending aorta of the
subject, and to apply, to an aortic side of the native valve
complex, a first axial force directed toward a left ventricle of
the subject. The proximal fixation member is configured to be
positioned at least partially on the left-ventricular side of the
aortic valve, typically extending at least partially into the left
ventricular outflow tract (LVOT), and to apply, to a
left-ventricular side of the aortic annulus (typically, at the top
of the left ventricle), a second axial force directed in a
downstream direction (i.e., toward the ascending aorta).
Application of the first and second forces couples the prosthesis
to the native valve.
[0039] In some embodiments of the present invention, the valve
prosthesis is configured to treat a native pulmonary valve.
[0040] For some applications, the distal fixation member is shaped
so as to define engagement arms that are configured to be
positioned distal to the native annulus, at least partially within
the aortic sinuses, and, for some applications, to apply the first
axial force. Typically, for these applications, the distal fixation
member is configured to apply the first axial force to the floors
of the aortic sinuses.
[0041] The valve prosthesis is configured to be placed in the
native stenosed valve using a minimally-invasive approach, such as
an endovascular or transapical approach. The valve prosthesis is
configured to be self-expanding and easy to position, and typically
does not require suturing to be held in place. The native valve
leaflets typically do not need to be opened to the maximal extent
possible, but rather only to the extent which allows insertion of
the narrowest part of the valve prosthesis, the diameter of which
is typically about 15-20 mm. Placement of the valve prosthesis is
thus accompanied by reduced risk of embolism of calcific or
thrombotic material dislodged from the valve and coronary occlusion
compared to many conventional valve prosthesis implantation
procedures.
[0042] Unlike some valve prostheses known in the art, the valve
prosthesis of some embodiments of the present invention does not
rely for fixation on high forces applied outwardly radially against
the native valve. Typically, a ratio of (a) the first or second
axial force applied by the valve prosthesis to (b) the radial force
applied outwardly by the valve prosthesis against the native valve
is greater than 1.5:1, e.g., greater than 3:1 or greater than 6:1.
For some applications, the valve prosthesis applies a radial force
of less than 0.5 pounds (0.23 kilogram-force) outwardly against the
native valve, such as less than 0.3 pounds (0.14 kgf), or less than
0.1 pounds (0.045 kgf). For some applications, the valve prosthesis
is configured to apply the first axial force with a force of at
least 40 g during diastole, and the second axial force with a force
of at least 1 g (e.g., at least 5 g) during systole. For some
applications, the valve prosthesis is configured to apply the first
axial force with a force of no more than 1700 g during
diastole.
[0043] In other embodiments, the valve prosthesis applies a force
outwardly radially against the native valve that is sufficient to
aid with fixation of the prosthesis, or sufficient to fixate the
prosthesis.
[0044] In some embodiments of the present invention, the valve
prosthesis applies such outwardly radial forces only to the extent
necessary to allow insertion of the prosthesis through the native
valve, but not sufficiently to fully open the native leaflets to
the maximum extent possible. This level of radial force
application, typically in conjunction with the distal fixation
member placed upon the aortic side of the native valve leaflets,
prevents pushing of the native valve leaflets against the coronary
ostia. Additionally, the configuration of the valve prosthesis
generally reduces or eliminates leakage around the prosthetic
valve, by avoiding damage to the native leaflets. Such damage is
avoided because the valve prosthesis typically does not fully open,
fold over, or crimp the native leaflets. Instead, the valve
prosthesis gently envelops the leaflets between the distal fixation
member (e.g., the engagement arms thereof) and the proximal
fixation member. Such damage to the native leaflets is also avoided
because the valve prosthesis typically does not apply substantial
axial force to the native valve commissures. Furthermore, for
applications in which the valve prosthesis comprises a bulging
proximal skirt, as described hereinbelow, the skirt generally helps
reduce leakage around the prosthetic valve.
[0045] Typically, the valve prosthesis does not apply an axial
force to the tips of the native valve leaflets that would result in
shortening of the length of the leaflets, or forced bending,
crimping, or folding over of the leaflets. Given the complex
composition of the leaflets (fibrous tissue, soft atheroma, and
calcifications), such compression might result in the application
of shear forces to the leaflets, which might dislodge material and
cause an embolism.
[0046] Although the valve prosthesis is generally described herein
with respect to treating a native aortic valve, in some embodiments
the valve prosthesis is used to treat a native pulmonary valve
(i.e., the other semilunar valve in the heart), or another native
valve of the body, with appropriate modifications to the valve
prosthesis.
[0047] As used herein, including in the claims, the "native valve
complex" includes the native semilunar valve leaflets, the annulus
of the valve, the subvalvular tissue on the ventricular side, and
the lower half of the semilunar sinuses.
[0048] There is therefore provided, in accordance with an
embodiment of the present invention, apparatus including a
prosthesis for implantation at a native semilunar valve of a native
valve complex of a subject, the native valve complex having three
semilunar sinuses and three native commissures, the prosthesis
including a valve prosthesis support, which includes a support
structure including exactly three engagement arms that meet one
another at three respective junctures,
[0049] wherein the engagement arms are shaped so as define three
peak complexes at the three respective junctures, and three trough
complexes, each of which is between two of the peak complexes,
and
[0050] wherein upon implantation of the prosthesis, each of the
engagement arms is at least partially disposed within a respective
one of the semilunar sinuses, such that each of the peak complexes
is disposed distal to and in rotational alignment with a respective
one of the native commissures, and each of the trough complexes is
disposed at least partially within the respective one of the
semilunar sinuses.
[0051] In an embodiment, the native semilunar valve includes a
native aortic valve of the subject, the semilunar sinuses include
respective aortic sinuses, and upon implantation of the prosthesis,
each of the engagement arms is disposed at least partially within
the respective one of the aortic sinuses.
[0052] In an embodiment, the native semilunar valve includes a
native pulmonary valve of the subject, the semilunar sinuses
include respective pulmonary sinuses, and upon implantation of the
prosthesis, each of the engagement arms is disposed at least
partially within the respective one of the pulmonary sinuses.
[0053] In an embodiment, the engagement arms are shaped such that
each of the peak complexes includes exactly one peak at its
respective one of the junctures. In an embodiment, the engagement
arms are shaped such that each of the trough complexes includes
exactly one trough.
[0054] For some applications, the engagement arms are shaped so as
to define exactly one trough between each two of the peak
complexes. Alternatively, the engagement arms are shaped so as to
define a plurality of troughs between each two of the peak
complexes.
[0055] In an embodiment, the engagement arms are configured to
touch respective transitions between the respective semilunar
sinuses and respective native leaflet roots of the native valve
complex, upon implantation of the prosthesis.
[0056] In an embodiment, the prosthesis is configured such that,
during implantation of the prosthesis, the peak complexes
self-align with the respective native commissures.
[0057] For some applications, upon implantation of the prosthesis,
each of the peak complexes is disposed in the rotational alignment
with the respective one of the native commissures with a rotational
offset. Alternatively, upon implantation of the prosthesis, each of
the peak complexes is disposed in the rotational alignment with the
respective one of the native commissures without a rotational
offset.
[0058] In an embodiment, the valve prosthesis support, upon
implantation of the prosthesis, does not press upon the native
commissures of the native semilunar valve. Alternatively, the peak
complexes, upon implantation of the prosthesis, touch the
respective native commissures of the native semilunar valve at the
respective junctures of the engagement arms.
[0059] For some applications, the prosthesis is configured to apply
a radial force of less than 0.5 pounds outwardly against the native
semilunar valve.
[0060] In an embodiment, the prosthesis is configured such that any
radial force applied by the prosthesis outwardly against the native
semilunar valve is insufficient by itself to chronically maintain
the prosthesis in position with respect to the native valve complex
under conditions of normal cardiac motion.
[0061] In an embodiment, the prosthesis is configured, upon
implantation thereof, to embrace, such as gently embrace, without
squeezing, leaflets of the native semilunar valve.
[0062] For some applications, the prosthesis is configured, upon
implantation thereof, such that the engagement arms apply a force
to distal sides of the leaflets of the native semilunar valve while
the engagement arms are generally parallel to the distal sides of
the leaflets.
[0063] In an embodiment, the valve prosthesis support is configured
such that, upon implantation of the prosthesis, the valve
prosthesis support does not fold over leaflets of the native
semilunar valve. In an embodiment, the valve prosthesis support is
configured such that, upon implantation of the prosthesis, the
valve prosthesis support does not push leaflets of the native
semilunar valve towards respective semilunar sinus floors of the
native valve complex. In an embodiment, the prosthesis is
configured to less than fully open leaflets of the native valve
complex when the prosthesis is implanted at the native valve
complex. In an embodiment, the valve prosthesis support is
configured to elevate leaflets of the native semilunar valve from
within the semilunar sinuses upon implantation of the
prosthesis.
[0064] In an embodiment, the prosthesis is configured such that,
upon implantation at the native valve complex, the engagement arms
are aligned by rotation with respective ones of the semilunar
sinuses.
[0065] In an embodiment, each of the engagement arms includes at
least one extension element that extends from the engagement arm,
which at least one extension element is configured to engage a
sinus floor of the respective one of the semilunar sinuses upon
implantation of the prosthesis.
[0066] In an embodiment, each of the engagement arms is configured
to engage a respective one of the semilunar sinuses upon
implantation of the prosthesis. For some applications, each of the
engagement arms is configured to firmly engage the respective one
of the semilunar sinuses upon implantation of the prosthesis.
[0067] In an embodiment, the valve prosthesis support is configured
not to apply a force to leaflets of the native semilunar valve
sufficient to hold the prosthesis in place.
[0068] For some applications, each of the engagement arms is shaped
so as to define at least one extension element that extends from
the engagement arm, and each of the engagement arms and its
respective at least one extension element are configured such that
the engagement arm engages, via the at least one extension element,
a sinus floor of the respective one of the semilunar sinuses upon
implantation of the prosthesis.
[0069] For some applications, each of the engagement arms is shaped
to define a length, parallel to a longitudinal axis of the
prosthesis, between (a) at least one of the junctures and (b) a
contact point of one of the engagement arms that meets at the
juncture with a sinus floor of the respective one of the semilunar
sinuses upon implantation of the prosthesis, which length is
greater than 6 mm.
[0070] In an embodiment, the prosthesis includes a prosthetic valve
including one or more prosthetic leaflets, at least a portion of
each of the prosthetic leaflets is configured to assume a closed
position during diastole and an open position during systole, and
the at least a portion is not directly coupled to any of the
engagement arms. For some applications, the prosthetic valve is
coupled to the support structure such that at least 50% of an axial
length of the prosthetic leaflets is distal to native valve
leaflets of the native semilunar valve, upon implantation of the
prosthesis. For some applications, the prosthetic valve includes a
collapsible pliant material, configured to assume the open and
closed positions. For some applications, the valve prosthesis
support and the prosthetic valve are configured to define a single
flow field through the valve prosthesis support and the prosthetic
valve. Alternatively, the valve prosthesis support and the
prosthetic valve are configured to define a plurality of flow
fields through the valve prosthesis support and the prosthetic
valve.
[0071] In an embodiment, the support structure includes exactly
three commissural posts, to which the junctures of the engagement
arms are respectively attached. For some applications, upon
implantation of the prosthesis, the commissural posts are
rotationally aligned with respective ones of the native
commissures.
[0072] In an embodiment, the engagement arms are shaped so as to
flare out laterally to an angle with respect to a central axis of
the prosthesis. In an embodiment, the engagement arms conform to a
shape of a semilunar root of the native valve complex when the
engagement arms are flared out. In an embodiment, the engagement
arms are shaped so as to curve outwards laterally. In an
embodiment, a shape of at least one of the engagement arms is
generally characterized by a function z''(r)>=0, where z is a
height of any given point on the at least one engagement arm
measured along a longitudinal axis of the prosthesis, and r is a
distance from the longitudinal axis to the given point. For some
applications, the shape is generally characterized by the function
z''(r)>0.
[0073] In an embodiment, the support structure is configured to
serve as a distal fixation member, the valve prosthesis support
includes a proximal fixation member, and the proximal fixation
member and the engagement arms of the distal fixation member are
configured to axially sandwich the native valve complex from
ventricular and downstream sides thereof, respectively, upon
implantation of the prosthesis.
[0074] In an embodiment, the engagement arms are configured to be
disposed, during an implantation procedure, at least partially
within the respective ones of the semilunar sinuses before the
proximal fixation member is positioned at least partially on the
ventricular side of the native valve complex, such that the arms
prevent leaflets of the native valve complex from opening more than
a predetermined desired amount, the opening being because of force
applied by the proximal fixation member to the leaflets.
[0075] In an embodiment, the proximal fixation member is configured
to be positioned at least partially in a ventricle of the subject
upon implantation of the prosthesis.
[0076] In an embodiment, the proximal fixation member is shaped so
as to define at least one barb configured to apply a barb force to
the ventricular side of the native valve complex. For some
applications, the at least one barb is configured to pierce the
ventricular side of the native valve complex. Alternatively, the at
least one barb is configured to protrude into tissue of the
ventricular side of the native valve complex, without piercing the
tissue. In an embodiment, the distal fixation member is shaped so
as to define at least one mating barb, and the at least one barb of
the proximal fixation member is configured to engage the at least
one mating barb, so as to help hold the prosthesis in place.
[0077] In an embodiment, the proximal and distal fixation members
are collapsible. For some applications, the distal fixation member
is configured to be positioned, during an implantation procedure,
in a downstream artery while collapsed, and to be expanded before
the proximal fixation member is positioned at least partially on
the ventricular side of the native valve complex, the downstream
artery selected from the group consisting of: an ascending aorta,
and a pulmonary trunk. For some applications, the apparatus
includes at least one tube selected from the group consisting of:
an overtube and a trocar, and the proximal and distal fixation
members are configured to be stored in the selected tube while
collapsed, and to expand upon being deployed from the selected
tube.
[0078] In an embodiment, the proximal fixation member includes an
inner support structure, and the distal fixation member includes an
outer support structure that is placed partially over the inner
support structure. For some applications, the inner and outer
support structures are configured to be coupled to one another
during an implantation procedure.
[0079] In an embodiment, the outer support structure is shaped so
as to define a plurality of distal diverging strut supports, from
which the engagement arms extend radially outward. In an
embodiment, the prosthesis is configured such that, upon
implantation at the native valve complex, the strut supports are
aligned with the respective native commissures. In an embodiment,
the inner support structure is shaped so as to define a plurality
of distal diverging inner struts.
[0080] In an embodiment, the inner support structure is shaped so
as to define a bulging proximal skirt, a proximal portion of which
is configured to apply an axial force directed toward a downstream
artery selected from the group consisting of: an ascending aorta,
and a pulmonary trunk. For some applications, the prosthesis
includes a graft covering that covers at least a portion of the
skirt.
[0081] In an embodiment, the inner support structure is shaped so
as to define a plurality of distal diverging inner struts, and the
skirt extends from the inner struts.
[0082] In an embodiment, the outer support structure is shaped so
as to define a plurality of distal diverging strut supports, from
which the engagement arms extend radially outward, and each of the
strut supports is positioned over a respective one of the inner
struts.
[0083] In an embodiment, the engagement arms are positioned over a
portion of the skirt.
[0084] In an embodiment, the prosthesis includes a valve including
a collapsible pliant material, configured to assume a closed
position during diastole and an open position during systole, and
the pliant material includes a plurality of segments, at least two
of which are coupled together by one of the strut supports and its
respective one of the inner struts.
[0085] There is further provided, in accordance with an embodiment
of the present invention, apparatus including a prosthesis for
implantation at a native aortic valve of a native valve complex of
a subject, the native valve complex having exactly two aortic
sinuses and two native commissures, the prosthesis including a
valve prosthesis support, which includes a support structure
including exactly two engagement arms that meet one another at two
respective junctures,
[0086] wherein the engagement arms are shaped so as define two peak
complexes at the two respective junctures, and two trough
complexes, each of which is between the peak complexes, and
[0087] wherein upon implantation of the prosthesis, each of the
engagement arms is at least partially disposed within a respective
one of the aortic sinuses, such that each of the peak complexes is
disposed distal to and in rotational alignment with a respective
one of the native commissures, and each of the trough complexes is
disposed at least partially within the respective one of the aortic
sinuses.
[0088] In an embodiment, the engagement arms are shaped such that
each of the peak complexes includes exactly one peak at its
respective one of the junctures. In an embodiment, the engagement
arms are shaped such that each of the trough complexes includes
exactly one trough.
[0089] In an embodiment, each of the engagement arms is configured
to engage a respective one of the aortic sinuses upon implantation
of the prosthesis.
[0090] There is still further provided, in accordance with an
embodiment of the present invention, apparatus including a
prosthesis for implantation at a native semilunar valve of a native
valve complex of a subject, the prosthesis including:
[0091] a prosthetic valve including one or more prosthetic leaflets
configured to assume a closed position during diastole and an open
position during systole; and
[0092] a valve prosthesis support, coupled to the prosthetic valve,
and configured to engage one or more semilunar sinuses of the
native semilunar valve site, such that at least 50% of an axial
length of the prosthetic leaflets is distal to native valve
leaflets of the native semilunar valve.
[0093] In an embodiment, the native semilunar valve includes a
native aortic valve, the semilunar sinuses include respective
aortic sinuses, and the valve prosthetic support is configured to
engage the one or more aortic sinuses. In an embodiment, the native
semilunar valve includes a native pulmonary valve, the semilunar
sinuses include respective pulmonary sinuses, and the valve
prosthetic support is configured to engage the one or more
pulmonary sinuses.
[0094] There is yet further provided, in accordance with an
embodiment of the present invention, a method for implanting a
prosthesis at a native semilunar valve of a native valve complex of
a subject, the native valve complex having three semilunar sinuses
and three native commissures, the method including:
[0095] providing the prosthesis including a valve prosthesis
support, which valve prosthesis support includes a support
structure including exactly three engagement arms that meet one
another at three respective junctures, and the engagement arms are
shaped so as define three peak complexes at the three respective
junctures, and three trough complexes, each of which is between two
of the peak complexes; and
[0096] implanting the prosthesis such that each of the engagement
arms is at least partially disposed within a respective one of the
semilunar sinuses, each of the peak complexes is disposed distal to
and in rotational alignment with a respective one of the native
commissures, and each of the trough complexes is disposed at least
partially within the respective one of the semilunar sinuses.
[0097] In an embodiment, the native semilunar valve includes a
native aortic valve of the subject, the semilunar sinuses include
respective aortic sinuses, and implanting includes implanting the
prosthesis such that each of the engagement arms is disposed at
least partially within the respective one of the aortic
sinuses.
[0098] In an embodiment, the native semilunar valve includes a
native pulmonary valve of the subject, the semilunar sinuses
include respective pulmonary sinuses, and implanting includes
implanting the prosthesis such that each of the engagement arms is
disposed at least partially within the respective one of the
pulmonary sinuses.
[0099] In an embodiment, the prosthesis is configured such that,
during implantation of the prosthesis, the peak complexes
self-align with the respective native commissures.
[0100] In an embodiment, implanting includes implanting the
prosthesis such that the prosthesis embraces, such as gently
embraces, without squeezing, leaflets of the native semilunar
valve. In an embodiment, implanting includes implanting the
prosthesis such that the valve prosthesis support does not fold
over leaflets of the native semilunar valve.
[0101] In an embodiment, implanting includes implanting the
prosthesis such that the engagement arms touch respective floors of
the respective semilunar sinuses.
[0102] In an embodiment, implanting includes causing the prosthesis
to self-align with respect to the native semilunar valve site by
gently rotating the prosthesis.
[0103] In an embodiment, the support structure is configured to
serve as a distal fixation member, the valve prosthesis support
includes a proximal fixation member, and implanting includes
implanting the prosthesis such that the proximal fixation member
and the engagement arms of the distal fixation member axially
sandwich the native valve complex from ventricular and downstream
sides thereof, respectively.
[0104] In an embodiment, implanting includes:
[0105] positioning the distal fixation member in a downstream
artery while the distal fixation member is collapsed;
[0106] expanding the distal fixation member; and
[0107] thereafter, positioning the proximal fixation member at
least partially on the ventricular side of the native valve
complex, the downstream artery selected from the group consisting
of: an ascending aorta, and a pulmonary trunk.
[0108] In an embodiment, implanting includes:
[0109] storing the proximal and distal fixation members in at least
one tube selected from the group consisting of: an overtube and a
trocar, while the proximal and distal fixation members are
collapsed; and
[0110] deploying the proximal and distal fixation members from the
selected tube such that the proximal and distal fixation members
expand.
[0111] In an embodiment, the proximal fixation member includes an
inner support structure, the distal fixation member includes an
outer support structure that is placed partially over the inner
support structure, and implanting includes configuring the inner
and outer support structures to one another during the
implanting.
[0112] There is additionally provided, in accordance with an
embodiment of the present invention, a method for implanting a
prosthesis at a native aortic valve of a native valve complex of a
subject, the native valve complex having exactly two aortic sinuses
and two native commissures, the method including:
[0113] providing the prosthesis including a valve prosthesis
support, which valve prosthesis support includes a support
structure including exactly two engagement arms that meet one
another at two respective junctures, and the engagement arms are
shaped so as define two peak complexes at the two respective
junctures, and two trough complexes, each of which is between the
peak complexes; and
[0114] implanting the prosthesis such that each of the engagement
arms is at least partially disposed within a respective one of the
aortic sinuses, each of the peak complexes is disposed distal to
and in rotational alignment with a respective one of the native
commissures, and each of the trough complexes is disposed at least
partially within the respective one of the aortic sinuses.
[0115] There is still additionally provided, in accordance with an
embodiment of the present invention, a method for implanting a
prosthesis at a native semilunar valve of a native valve complex of
a subject, the method including:
[0116] providing the prosthesis including a prosthetic valve
including one or more prosthetic leaflets configured to assume a
closed position during diastole and an open position during
systole, and a valve prosthesis support, coupled to the prosthetic
valve; and
[0117] implanting the prosthesis such that the valve prosthesis
support engages one or more semilunar sinuses of the native
semilunar valve site, such that at least 50% of an axial length of
the prosthetic leaflets is distal to native valve leaflets of the
native semilunar valve.
[0118] In an embodiment, the native semilunar valve includes a
native aortic valve, and implanting the prosthesis includes
implanting the prosthesis such that the valve prosthesis support
engages the one or more semilunar sinuses of the native aortic
valve.
[0119] In an embodiment, the native semilunar valve includes a
native pulmonary valve, and implanting the prosthesis includes
implanting the prosthesis such that the valve prosthesis support
engages the one or more semilunar sinuses of the native pulmonary
valve.
[0120] In an embodiment, implanting the prosthesis includes
implanting the prosthesis such that the prosthesis leaflets do not
engage the semilunar sinuses.
[0121] In an embodiment, implanting the prosthesis includes causing
the prosthesis to self-align with respect to the native semilunar
valve site by gently rotating the prosthesis.
[0122] There is yet additionally provided, in accordance with an
embodiment of the present invention, a method, including:
[0123] placing a semilunar valve prosthesis at a native semilunar
valve site, which prosthesis includes a prosthetic valve including
one or more prosthetic leaflets configured to assume a closed
position during diastole and an open position during systole;
and
[0124] engaging a portion of the semilunar valve prosthesis, other
than the prosthetic leaflets, with one or more semilunar sinuses of
the native semilunar valve site, such that at least 50% of an axial
length of the prosthetic leaflets is distal to native valve
leaflets of a native semilunar valve of the native semilunar valve
site.
[0125] In an embodiment, the native semilunar valve site includes a
native aortic valve site, the semilunar sinuses include respective
aortic sinuses, the semilunar valve prosthesis includes an aortic
valve prosthesis, placing includes placing the aortic valve
prosthesis at the native aortic valve site, and engaging includes
engaging the portion of the aortic valve prosthesis with the one or
more aortic sinuses.
[0126] In an embodiment, the native semilunar valve site includes a
native pulmonary valve site, the semilunar sinuses include
respective pulmonary sinuses, the semilunar valve prosthesis
includes a pulmonary valve prosthesis, placing includes placing the
pulmonary valve prosthesis at the native pulmonary valve site, and
engaging includes engaging the portion of the pulmonary valve
prosthesis with the one or more pulmonary sinuses.
[0127] In an embodiment, engaging includes causing the semilunar
valve prosthesis to self-align with respect to the native semilunar
valve site by gently rotating the semilunar valve prosthesis.
[0128] There is also provided, in accordance with an embodiment of
the present invention, apparatus including a prosthesis for
implantation at a native semilunar valve of a native valve complex
of a subject, the native valve complex having semilunar sinuses,
the prosthesis including a valve prosthesis support, which includes
a support structure including at least two engagement arms,
[0129] wherein, upon implantation of the prosthesis, each of the
engagement arms is at least partially disposed within a respective
one of the semilunar sinuses, and
[0130] wherein a shape of at least one of the engagement arms is
generally characterized by a function z''(r)>=0, where z is a
height of any given point on the at least one engagement arm
measured along a longitudinal axis of the prosthesis, and r is a
distance from the longitudinal axis to the given point.
[0131] For some applications, the shape is generally characterized
by the function z''(r)>0.
[0132] In an embodiment, the native semilunar valve includes a
native aortic valve of the subject, the semilunar sinuses include
respective aortic sinuses, and, upon implantation of the
prosthesis, each of the engagement arms is disposed at least
partially within the respective one of the aortic sinuses.
[0133] In an embodiment, the native semilunar valve includes a
native pulmonary valve of the subject, the semilunar sinuses
include respective pulmonary sinuses, and, upon implantation of the
prosthesis, each of the engagement arms is at least partially
disposed within the respective one of the pulmonary sinuses.
[0134] For some applications, each of the engagement arms includes
at least one extension element that extends from the engagement
arm, which at least one extension element is configured to engage a
sinus floor of the respective one of the semilunar sinuses upon
implantation of the prosthesis.
[0135] In an embodiment, the support structure includes exactly
three engagement arms.
[0136] In an embodiment, the prosthesis is configured, upon
implantation thereof, to embrace, such as gently embrace, without
squeezing, leaflets of the native semilunar valve. In an
embodiment, the valve prosthesis support is configured such that,
upon implantation of the prosthesis, the valve prosthesis support
does not fold over leaflets of the native semilunar valve.
[0137] In an embodiment, the support structure is configured to
serve as a distal fixation member, the valve prosthesis support
includes a proximal fixation member, and the proximal fixation
member and the engagement arms of the distal fixation member are
configured to axially sandwich the native valve complex from
ventricular and downstream sides thereof, respectively, upon
implantation of the prosthesis.
[0138] In an embodiment, each of the engagement arms is configured
to engage a respective one of the semilunar sinuses upon
implantation of the prosthesis.
[0139] For some applications, each of the engagement arms is shaped
so as to define at least one extension element that extends from
the engagement arm, and each of the engagement arms and its
respective at least one extension element are configured such that
the engagement arm engages, via the at least one extension element,
a sinus floor of the respective one of the semilunar sinuses upon
implantation of the prosthesis.
[0140] For some applications, each of the engagement arms is shaped
to define a length, parallel to a longitudinal axis of the
prosthesis, between (a) at least one of the junctures and (b) a
contact point of one of the engagement arms that meets at the
juncture with a sinus floor of the respective one of the semilunar
sinuses upon implantation of the prosthesis, which length is
greater than 6 mm.
[0141] In an embodiment, the prosthesis includes a prosthetic valve
including one or more prosthetic leaflets, at least a portion of
each of the prosthetic leaflets is configured to assume a closed
position during diastole and an open position during systole, and
the at least a portion is not directly coupled to any of the
engagement arms. For some applications, the prosthetic valve is
coupled to the support structure such that at least 50% of an axial
length of the prosthetic leaflets is distal to native valve
leaflets of the native semilunar valve, upon implantation of the
prosthesis.
[0142] In an embodiment, the engagement arms are configured to
touch respective floors of the respective semilunar sinuses, upon
implantation of the prosthesis.
[0143] In an embodiment, the engagement arms are configured to
firmly engage the respective semilunar sinuses, upon implantation
of the prosthesis.
[0144] There is further provided, in accordance with an embodiment
of the present invention, apparatus including a prosthesis for
implantation at a native semilunar valve of a native valve complex
of a subject, the native valve complex having semilunar sinuses,
the prosthesis including a valve prosthesis support, which includes
a support structure including at least two engagement arms,
[0145] wherein, upon implantation of the prosthesis, each of the
engagement arms is at least partially disposed within a respective
one of the semilunar sinuses, and
[0146] wherein a shape of at least one of the engagement arms is
generally upwardly concave.
[0147] There is still further provided, in accordance with an
embodiment of the present invention, a method for implanting a
prosthesis at a native semilunar valve of a native valve complex of
a subject, the native valve complex having semilunar sinuses, the
method including:
[0148] providing the prosthesis including a valve prosthesis
support, which valve prosthesis support includes a support
structure including at least two engagement arms, and a shape of at
least one of the engagement arms is generally characterized by a
function z''(r)>=0, where z is a height of any given point on
the at least one engagement arm measured along a longitudinal axis
of the prosthesis, and r is a distance from the longitudinal axis
to the given point; and
[0149] implanting the prosthesis such that each of the engagement
arms is at least partially disposed within a respective one of the
semilunar sinuses.
[0150] In an embodiment, implanting includes implanting the
prosthesis such that each of the engagement arms is configured to
engage a respective one of the semilunar sinuses.
[0151] There is yet further provided, in accordance with an
embodiment of the present invention, a method for implanting a
prosthesis at a native semilunar valve of a native valve complex of
a subject, the native valve complex having semilunar sinuses, the
method including:
[0152] providing the prosthesis including a valve prosthesis
support, which valve prosthesis support includes a support
structure including at least two engagement arms, and a shape of at
least one of the engagement arms is generally upwardly concave;
and
[0153] implanting the prosthesis such that each of the engagement
arms is at least partially disposed within a respective one of the
semilunar sinuses.
[0154] There is additionally provided, in accordance with an
embodiment of the present invention, a method including:
[0155] providing a semilunar valve prosthesis; and
[0156] implanting the prosthesis without using any imaging
techniques.
[0157] In an embodiment, providing the semilunar valve prosthesis
includes providing an aortic valve prosthesis. In an embodiment,
providing the semilunar valve prosthesis includes providing a
pulmonary valve prosthesis.
[0158] In an embodiment, implanting includes: placing the
prosthesis at a semilunar valve site; and causing the prosthesis to
self-align with respect to the site by gently rotating the
prosthesis.
[0159] In an embodiment, implanting the prosthesis includes
determining a correct rotational disposition of the prosthesis with
respect to a semilunar valve site based on tactile feedback.
[0160] There is still additionally provided, in accordance with an
embodiment of the present invention, a method including:
[0161] providing a semilunar valve prosthesis;
[0162] placing the prosthesis in a body of a subject; and
[0163] determining a correct rotational disposition of the
prosthesis with respect to a semilunar valve site based on tactile
feedback.
[0164] In an embodiment, providing the semilunar valve prosthesis
includes providing an aortic valve prosthesis. In an embodiment,
providing the semilunar valve prosthesis includes providing a
pulmonary valve prosthesis.
[0165] In an embodiment, placing the prosthesis includes placing
the prosthesis without using any imaging techniques.
[0166] There is yet additionally provided, in accordance with an
embodiment of the present invention, a method including:
[0167] placing a semilunar valve prosthesis at a native semilunar
valve site; and
[0168] causing the prosthesis to self-align with respect to the
site by gently rotating the valve prosthesis.
[0169] In an embodiment, the semilunar valve prosthesis includes an
aortic valve prosthesis, the native semilunar valve site includes a
native aortic valve site, and placing includes placing the aortic
valve prosthesis at the native aortic valve site. In an embodiment,
the semilunar valve prosthesis includes a pulmonary valve
prosthesis, the native semilunar valve site includes a native
pulmonary valve site, and placing includes placing the pulmonary
valve prosthesis at the native pulmonary valve site.
[0170] In an embodiment, causing the prosthesis to self-align
includes moving the prosthesis in an axial direction defined with
respect to an axis of a downstream artery, while gently rotating
the prosthesis, the downstream artery selected from the group
consisting of: an ascending aorta, and a pulmonary trunk.
[0171] In an embodiment, gently rotating the prosthesis includes
moving the prosthesis in a proximal direction such that contact of
the prosthesis with tissue of the native semilunar valve site
causes the rotating.
[0172] In an embodiment, placing the prosthesis and causing the
prosthesis to self-align include placing the prosthesis and causing
the prosthesis to self-align without using any imaging
techniques.
[0173] In an embodiment, causing the prosthesis to self-align
includes verifying that the prosthesis is properly aligned with
respect to the semilunar valve site by attempting to rotate the
prosthesis with respect to the semilunar valve site.
[0174] In an embodiment, the prosthesis is shaped so as to define
one or more proximal engagement arms that are configured to be
positioned at least partially within respective semilunar sinuses
of the native semilunar valve site, and causing the prosthesis to
self-align includes causing the engagement arms to self-align with
respect to the respective semilunar sinuses.
[0175] In an embodiment, gently rotating the prosthesis includes
moving the prosthesis in a proximal direction such that contact of
one or more of the engagement arms with tissue of the native
semilunar valve site causes the rotating.
[0176] In an embodiment, causing the prosthesis to self-align
includes verifying that the engagement arms are properly placed
with respect to the semilunar valve site by attempting to rotate
the engagement arms with respect to the semilunar valve site.
[0177] There is also provided, in accordance with an embodiment of
the present invention, a method, including:
[0178] placing a semilunar valve prosthesis at a native semilunar
valve site, the prosthesis shaped so as to define one or more
proximal engagement arms;
[0179] attempting to position the engagement arms at least
partially within respective semilunar sinuses of the native
semilunar valve site; and
[0180] verifying that the engagement arms are properly placed with
respect to the semilunar valve site by attempting to rotate the
engagement arms with respect to the semilunar valve site.
[0181] In an embodiment, the semilunar valve prosthesis includes an
aortic valve prosthesis, the native semilunar valve site includes a
native aortic valve site, and placing includes placing the aortic
valve prosthesis at the native aortic valve site.
[0182] In an embodiment, the semilunar valve prosthesis includes a
pulmonary valve prosthesis, the native semilunar valve site
includes a native pulmonary valve site, and placing includes
placing the pulmonary valve prosthesis at the native pulmonary
valve site.
[0183] There is further provided, in accordance with an embodiment
of the present invention, apparatus including a prosthesis for
implantation at a native semilunar valve of a native valve complex
of a subject, the prosthesis including a support structure, which
is configured such that a correct rotational disposition of the
prosthesis with respect to the native semilunar valve can be
determined based on tactile feedback.
[0184] There is still further provided, in accordance with an
embodiment of the present invention, apparatus including a
prosthesis for implantation at a native semilunar valve of a native
valve complex of a subject, the native valve complex having
semilunar sinuses and native commissures, the prosthesis
including:
[0185] a distal fixation member, configured to be positioned in a
downstream artery of the subject selected from the group consisting
of: an ascending aorta, and a pulmonary trunk, and shaped so as to
define exactly three proximal engagement arms that are configured
to be positioned at least partially within respective ones of the
semilunar sinuses, and, in combination, to apply, to tissue that
defines the semilunar sinuses, a first axial force directed toward
a ventricle of the subject; and
[0186] a proximal fixation member coupled to the distal fixation
member, the proximal fixation member configured to be positioned at
least partially on a ventricular side of the native semilunar
valve, and to apply, to the ventricular side of the native valve
complex, a second axial force directed toward the downstream
artery, such that application of the first and second forces
couples the prosthesis to the native valve complex.
[0187] In an embodiment, the native semilunar valve includes a
native aortic valve, and the downstream artery includes the
ascending aorta, the semilunar sinuses include respective aortic
sinuses, and the distal fixation member is configured to be
positioned in the ascending aorta, and the proximal engagement arms
are configured to be positioned at least partially within the
respective aortic sinuses.
[0188] In an embodiment, the native semilunar valve includes a
native pulmonary valve, and the downstream artery includes the
pulmonary trunk, and the semilunar sinuses include respective
pulmonary sinuses, and the distal fixation member is configured to
be positioned in the pulmonary trunk, and the proximal engagement
arms are configured to be positioned at least partially within the
respective pulmonary sinuses.
[0189] In an embodiment, the distal and proximal fixation members
are configured to couple the prosthesis to the native valve complex
by axially sandwiching the native valve complex from a downstream
side and the ventricular side thereof, upon implantation of the
prosthesis.
[0190] In an embodiment, the distal fixation member does not press
upon the native commissures upon implantation of the
prosthesis.
[0191] In an embodiment, the prosthesis is configured to apply a
radial force of less than 0.5 pounds outwardly against the native
semilunar valve. In an embodiment, the prosthesis is configured to
apply the first axial force with a force of at least 40 g during
diastole. In an embodiment, the prosthesis is configured to apply
the second axial force with a force of at least 1 g during
systole.
[0192] In an embodiment, the prosthesis is configured such that any
radial force applied by the prosthesis outwardly against the native
semilunar valve is insufficient by itself to chronically maintain
the prosthesis in position with respect to the native valve complex
under conditions of normal cardiac motion.
[0193] In an embodiment, the prosthesis is configured, upon
implantation thereof, to embrace, such as gently embrace, without
squeezing, leaflets of the native semilunar valve.
[0194] In an embodiment, the distal fixation member is configured
to be positioned in the downstream artery during an implantation
procedure before the proximal fixation member is positioned at
least partially on the ventricular side of the native valve
complex.
[0195] In an embodiment, the distal fixation member is configured
such that it does not fold over leaflets of the native semilunar
valve upon implantation of the prosthesis. In an embodiment, the
distal fixation member is configured such that it does not push
leaflets of the native semilunar valve towards semilunar sinus
floors of the native valve complex upon implantation of the
prosthesis.
[0196] In an embodiment, each of the proximal engagement arms is
shaped so as define at least one trough that is configured to be
positioned at least partially within a respective one of the
semilunar sinuses.
[0197] In an embodiment, the three engagement arms meet one another
at three respective junctures, the engagement arms are shaped so as
define three peak complexes at the three respective junctures, and
three trough complexes, each of which is between two of the peak
complexes, and upon implantation of the prosthesis, at least a
portion of each of the peak complexes is disposed distal to and in
rotational alignment with a respective one of the native
commissures, and each of the trough complexes is disposed at least
partially within the respective one of the semilunar sinuses.
[0198] In an embodiment, the engagement arms are configured to be
positioned, during an implantation procedure, at least partially
within the respective ones of the semilunar sinuses before the
proximal fixation member is positioned at least partially on the
ventricular side of the native valve complex, such that the
engagement arms prevent leaflets of the native valve complex from
opening more than a predetermined desired amount, the opening being
because of force applied by the proximal fixation member to the
leaflets.
[0199] In an embodiment, the proximal fixation member is configured
to be positioned at least partially in a ventricle of the subject
upon implantation of the prosthesis.
[0200] In an embodiment, the prosthesis is configured to apply the
first axial force such that a ratio of (a) the first axial force to
(b) a radial force applied outwardly by the prosthesis against the
native semilunar valve is greater than 1.5:1.
[0201] In an embodiment, the prosthesis is configured to less than
fully open leaflets of the native valve complex when the prosthesis
is implanted at the native semilunar valve complex.
[0202] In an embodiment, the distal fixation member is configured
to elevate leaflets of the native semilunar valve from within the
semilunar sinuses upon implantation of the prosthesis.
[0203] In an embodiment, the distal fixation member is configured
to apply the first axial force to respective roots of one or more
leaflets of the native valve complex. In an embodiment, the distal
fixation member is configured to apply the first axial force to
respective transitions between respective semilunar sinus floors
and one or more leaflets of the native valve complex.
[0204] In an embodiment, the prosthesis is configured to apply the
first axial force such that the ratio is greater than 3:1, such as
greater than 6:1.
[0205] In an embodiment, the prosthesis is configured to apply the
second axial force such that a ratio of (a) the second axial force
to (b) a radial force applied outwardly by the prosthesis against
the native semilunar valve is greater than 1.5:1, such as greater
than 3:1, e.g., greater than 6:1.
[0206] In an embodiment, the prosthesis includes a prosthetic valve
configured to assume a closed position during diastole and an open
position during systole. In an embodiment, the prosthetic valve
includes a collapsible pliant material, configured to assume the
open and closed positions.
[0207] In an embodiment, the distal and proximal fixation members
and the prosthetic valve are configured to define a single flow
field through the distal and proximal fixation members and the
prosthetic valve. Alternatively, the distal and proximal fixation
members and the prosthetic valve are configured to define a
plurality of flow fields through the distal and proximal fixation
members and the prosthetic valve.
[0208] In an embodiment, the prosthetic valve includes one or more
prosthetic leaflets, and the prosthetic valve is coupled to the
prosthesis such that at least 50% of an axial length of the
prosthetic leaflets is distal to native valve leaflets of the
native semilunar valve upon implantation of the prosthesis.
[0209] In an embodiment, the distal fixation member is configured
to apply the first axial force to one or more semilunar sinus
floors of the native valve complex.
[0210] In an embodiment, the distal fixation member is configured
not to apply force to leaflets of the native semilunar valve.
[0211] In an embodiment, the proximal fixation member is shaped so
as to define at least one barb configured to apply a barb force to
the ventricular side of the native valve complex. For some
applications, the at least one barb is configured to pierce the
ventricular side of the native valve complex. Alternatively, the at
least one barb is configured to protrude into tissue of the
ventricular side of the native value complex, without piercing the
tissue. For some applications, the distal fixation member is shaped
so as to define at least one mating barb, and the at least one barb
of the proximal fixation member is configured to engage the at
least one mating barb, so as to help hold the prosthesis in
place.
[0212] In an embodiment, the proximal and distal fixation members
are collapsible. For some applications, the distal fixation member
is configured to be positioned, during an implantation procedure,
in the downstream artery while collapsed, and to be expanded before
the proximal fixation member is positioned at least partially on
the ventricular side of the native valve complex. For some
applications, the apparatus includes at least one tube selected
from the group consisting of: an overtube and a trocar, and the
proximal and distal fixation members are configured to be stored in
the selected tube while collapsed, and to expand upon being
deployed from the selected tube.
[0213] In an embodiment, the proximal fixation member includes an
inner support structure, and the distal fixation member includes an
outer support structure that is placed partially over the inner
support structure.
[0214] In an embodiment, the outer support structure is shaped so
as to define exactly three distal diverging strut supports, from
which respective ones of the proximal engagement arms extend
radially outward.
[0215] In an embodiment, the prosthesis is configured such that,
upon implantation at the native valve complex, the engagement arms
are aligned by rotation with respective ones of the semilunar
sinuses.
[0216] In an embodiment, the prosthesis is configured such that,
upon implantation at the native valve complex, the strut supports
are aligned with respective ones of the native commissures.
[0217] In an embodiment, the prosthesis is configured such that the
engagement arms self-align themselves by rotation during
implantation of the prosthesis at the native valve complex.
[0218] In an embodiment, the inner support structure is shaped so
as to define a plurality of distal diverging inner struts.
[0219] In an embodiment, the inner support structure is shaped so
as to define a bulging proximal skirt, a proximal portion of which
is configured to apply the second axial force.
[0220] In an embodiment, the prosthesis includes a graft covering
that covers at least a portion of the skirt.
[0221] In an embodiment, the inner support structure is shaped so
as to define a plurality of distal diverging inner struts, and the
skirt extends from the inner struts.
[0222] In an embodiment, the outer support structure is shaped so
as to define exactly three distal diverging strut supports, from
which respective ones of the proximal engagement arms extend
radially outward, and each of the strut supports is positioned over
a respective one of the inner struts.
[0223] In an embodiment, the engagement arms are positioned over a
portion of the skirt.
[0224] In an embodiment, the prosthesis includes a valve including
a collapsible pliant material, configured to assume a closed
position during diastole and an open position during systole, and
the pliant material includes a plurality of segments, at least two
of which are coupled together by one of the strut supports and its
respective one of the inner struts.
[0225] There is yet further provided, in accordance with an
embodiment of the present invention, apparatus including a
prosthesis for implantation at a native semilunar valve of a native
valve complex of a subject, the prosthesis including:
[0226] a distal fixation member, configured to be positioned in a
downstream artery of the subject selected from the group consisting
of: an ascending aorta, and a pulmonary trunk, and to apply, to
tissue that defines one or more semilunar sinuses of the native
valve complex, a first axial force directed toward a ventricle of
the subject; and
[0227] a proximal fixation member coupled to the distal fixation
member, the proximal fixation member configured to be positioned at
least partially on a ventricular side of the native semilunar
valve, and to apply, to the ventricular side of the native valve
complex, a second axial force directed toward the downstream
artery, such that application of the first and second forces
couples the prosthesis to the native valve complex.
[0228] In an embodiment, the native semilunar valve includes a
native aortic valve, the downstream artery includes the ascending
aorta, the semilunar sinuses include respective aortic sinuses, and
the distal fixation member is configured to be positioned in the
ascending aorta, and to apply the first axial force to the tissue
that defines the one or more aortic sinuses.
[0229] In an embodiment, the native semilunar valve includes a
native pulmonary valve, the downstream artery includes the
pulmonary trunk, the semilunar sinuses include respective pulmonary
sinuses, and the distal fixation member is configured to be
positioned in the pulmonary trunk, and to apply the first axial
force to the tissue that defines the one or more pulmonary
sinuses.
[0230] In an embodiment, the distal and proximal fixation members
are configured to couple the prosthesis to the native valve complex
by axially sandwiching the native valve complex from a downstream
side and the ventricular side thereof, upon implantation of the
prosthesis.
[0231] In an embodiment, the distal fixation member does not press
upon native valve commissures of the native semilunar valve upon
implantation of the prosthesis.
[0232] In an embodiment, the prosthesis is configured to apply a
radial force of less than 0.5 pounds outwardly against the native
semilunar valve. In an embodiment, the prosthesis is configured to
apply the first axial force with a force of at least 40 g during
diastole. In an embodiment, the prosthesis is configured to apply
the second axial force with a force of at least 1 g during
systole.
[0233] In an embodiment, the prosthesis is configured such that any
radial force applied by the prosthesis outwardly against the native
semilunar valve is insufficient by itself to chronically maintain
the prosthesis in position with respect to the native valve complex
under conditions of normal cardiac motion.
[0234] In an embodiment, the prosthesis is configured, upon
implantation thereof, to embrace, such as gently embrace, without
squeezing, leaflets of the native semilunar valve.
[0235] In an embodiment, the distal fixation member is configured
to be positioned in the downstream artery during an implantation
procedure before the proximal fixation member is positioned at
least partially on the ventricular side of the native valve
complex.
[0236] In an embodiment, the distal fixation member is configured
such that it does not fold over leaflets of the native semilunar
valve upon implantation of the prosthesis. In an embodiment, the
distal fixation member is configured such that it does not push
leaflets of the native semilunar valve towards semilunar sinus
floors of the native valve complex upon implantation of the
prosthesis. In an embodiment, the prosthesis is configured to less
than fully open leaflets of the native valve complex when the
prosthesis is implanted at the native valve complex.
[0237] In an embodiment, the distal fixation member is configured
to apply the first axial force to respective roots of one or more
leaflets of the native valve complex. In an embodiment, the distal
fixation member is configured to apply the first axial force to
respective transitions between respective semilunar sinus floors
and one or more leaflets of the native valve complex.
[0238] In an embodiment, the proximal fixation member is configured
to be positioned at least partially in a ventricle of the subject
upon implantation of the prosthesis.
[0239] In an embodiment, the prosthesis is configured to apply the
first axial force such that a ratio of (a) the first axial force to
(b) a radial force applied outwardly by the prosthesis against the
native semilunar valve is greater than 1.5:1, such as greater than
3:1, e.g., greater than 6:1.
[0240] In an embodiment, the prosthesis is configured to apply the
second axial force such that a ratio of (a) the second axial force
to (b) a radial force applied outwardly by the prosthesis against
the native semilunar valve is greater than 1.5:1, such as greater
than 3:1, e.g., greater than 6:1.
[0241] In an embodiment, the prosthesis includes a prosthetic valve
configured to assume a closed position during diastole and an open
position during systole. In an embodiment, the prosthetic valve
includes a collapsible pliant material, configured to assume the
open and closed positions.
[0242] In an embodiment, the distal and proximal fixation members
and the prosthetic valve are configured to define a single flow
field through the distal and proximal fixation members and the
prosthetic valve. Alternatively, the distal and proximal fixation
members and the prosthetic valve are configured to define a
plurality of flow fields through the distal and proximal fixation
members and the prosthetic valve.
[0243] In an embodiment, the prosthetic valve includes one or more
prosthetic leaflets, and the prosthetic valve is coupled to the
prosthesis such that at least 50% of an axial length of the
prosthetic leaflets is distal to native valve leaflets of the
native semilunar valve upon implantation of the prosthesis.
[0244] In an embodiment, the distal fixation member is configured
to apply the first axial force to one or more semilunar sinus
floors of the native valve complex.
[0245] In an embodiment, the distal fixation member is configured
not to apply force to leaflets of the native semilunar valve.
[0246] In an embodiment, the distal fixation member is shaped so as
to define one or more proximal engagement arms that are configured
to be positioned at least partially within respective ones of the
semilunar sinuses, and, in combination, to apply the first axial
force.
[0247] In an embodiment, the distal fixation member is shaped so as
to define exactly three proximal engagement arms.
[0248] In an embodiment, each of the proximal engagement arms is
shaped so as define at least one trough that is configured to be
positioned at least partially within a respective one of the
semilunar sinuses.
[0249] In an embodiment, the three engagement arms meet one another
at three respective junctures, the engagement arms are shaped so as
define three peak complexes at the three respective junctures, and
three trough complexes, each of which is between two of the peak
complexes, and upon implantation of the prosthesis, at least a
portion of each of the peaks is disposed distal to and in
rotational alignment with a respective native commissure of the
native semilunar valve, and each of the trough complexes is
disposed at least partially within the respective one of the
semilunar sinuses.
[0250] In an embodiment, the distal fixation member is shaped so as
to define exactly two proximal engagement arms.
[0251] In an embodiment, the engagement arms are configured to be
positioned, during an implantation procedure, at least partially
within the respective ones of the semilunar sinuses before the
proximal fixation member is positioned at least partially on the
ventricular side of the native valve complex, such that the
engagement arms prevent leaflets of the native valve complex from
opening more than a predetermined desired amount, the opening being
because of force applied by the proximal fixation member to the
leaflets.
[0252] In an embodiment, the proximal fixation member is shaped so
as to define at least one barb configured to apply a barb force to
the ventricular side of the native valve complex. For some
applications, the at least one barb is configured to pierce the
ventricular side of the native valve complex. Alternatively, the at
least one barb is configured to protrude into tissue of the
ventricular side of the native value complex, without piercing the
tissue. For some applications, the distal fixation member is shaped
so as to define at least one mating barb, and the at least one barb
of the proximal fixation member is configured to engage the at
least one mating barb, so as to help hold the prosthesis in
place.
[0253] In an embodiment, the proximal and distal fixation members
are collapsible. For some applications, the distal fixation member
is configured to be positioned, during an implantation procedure,
in the downstream artery while collapsed, and to be expanded before
the proximal fixation member is positioned at least partially on
the ventricular side of the native valve complex. For some
applications, the apparatus includes at least one tube selected
from the group consisting of: an overtube and a trocar, and the
proximal and distal fixation members are configured to be stored in
the selected tube while collapsed, and to expand upon being
deployed from the selected tube.
[0254] In an embodiment, the proximal fixation member includes an
inner support structure, and the distal fixation member includes an
outer support structure that is placed partially over the inner
support structure.
[0255] In an embodiment, the outer support structure is shaped so
as to define a plurality of distal diverging strut supports, from
which a plurality of proximal engagement arms extend radially
outward.
[0256] In an embodiment, the prosthesis is configured such that,
upon implantation at the native valve complex, the engagement arms
are aligned by rotation with respective ones of the semilunar
sinuses.
[0257] In an embodiment, the prosthesis is configured such that,
upon implantation at the native valve complex, the strut supports
are aligned with respective commissures of the native valve
complex.
[0258] In an embodiment, the prosthesis is configured such that the
engagement arms self-align themselves by rotation during
implantation of the prosthesis at the native valve complex.
[0259] In an embodiment, the inner support structure is shaped so
as to define a plurality of distal diverging inner struts.
[0260] In an embodiment, the inner support structure is shaped so
as to define a bulging proximal skirt, a proximal portion of which
is configured to apply the second axial force. For some
applications, the prosthesis includes a graft covering that covers
at least a portion of the skirt.
[0261] In an embodiment, the inner support structure is shaped so
as to define a plurality of distal diverging inner struts, and the
skirt extends from the inner struts.
[0262] In an embodiment, the outer support structure is shaped so
as to define a plurality of distal diverging strut supports, from
which a plurality of proximal engagement arms extend radially
outward, and each of the strut supports is positioned over a
respective one of the inner struts.
[0263] In an embodiment, the engagement arms are positioned over a
portion of the skirt.
[0264] In an embodiment, the prosthesis includes a valve including
a collapsible pliant material, configured to assume a closed
position during diastole and an open position during systole, and
the pliant material includes a plurality of segments, at least two
of which are coupled together by one of the strut supports and its
respective one of the inner struts.
[0265] There is additionally provided, in accordance with an
embodiment of the present invention, apparatus including a
prosthesis for implantation at a native semilunar valve of a native
valve complex of a subject, the prosthesis including:
[0266] a distal fixation member, configured to be positioned in a
downstream artery of the subject selected from the group consisting
of: an ascending aorta, and a pulmonary trunk, and to apply, to
native commissures of the native semilunar valve, a first axial
force directed toward a ventricle of the subject, without applying
any force to native leaflets of the native semilunar valve, and the
distal fixation member is configured to rotationally align with the
native semilunar valve; and
[0267] a proximal fixation member coupled to the distal fixation
member, the proximal fixation member configured to be positioned at
least partially on a ventricular side of the native valve complex,
and to apply a second axial force directed toward the downstream
artery, such that application of the first and second forces
couples the prosthesis to the native valve complex by axially
sandwiching the native valve complex from a downstream side and the
ventricular side thereof, upon implantation of the prosthesis.
[0268] In an embodiment, the native semilunar valve includes a
native aortic valve, the downstream artery includes the ascending
aorta, and the distal fixation member is configured to be
positioned in the ascending aorta, and to apply the first axial
force to the native commissures of the native aortic valve.
[0269] In an embodiment, the native semilunar valve includes a
native pulmonary valve, the downstream artery includes the
pulmonary trunk, and the distal fixation member is configured to be
positioned in the pulmonary trunk, and to apply the first axial
force to the native commissures of the native pulmonary valve.
[0270] In an embodiment, the distal fixation member is configured
to rotationally self-align with the native semilunar valve.
[0271] In an embodiment, the distal fixation member includes one or
more engagement arms that are positioned at least partially within
respective semilunar sinuses of the native valve complex, upon
implantation of the prosthesis.
[0272] In an embodiment, the engagement arms are configured to
apply respective forces to respective floors of the semilunar
sinuses, upon implantation of the prosthesis.
[0273] In an embodiment, the engagement arms are configured not to
apply any force to floors of the semilunar sinuses, upon
implantation of the prosthesis.
[0274] There is still additionally provided, in accordance with an
embodiment of the present invention, apparatus including a
prosthesis for implantation at a native semilunar valve of a native
valve complex of a subject, the prosthesis including:
[0275] a distal fixation member, configured to be positioned in a
downstream artery of the subject selected from the group consisting
of: an ascending aorta, and a pulmonary trunk, and to apply a first
axial force directed toward a ventricle of the subject; and
[0276] a proximal fixation member coupled to the distal fixation
member, the proximal fixation member configured to be positioned at
least partially on a ventricular side of the native valve complex,
and to apply a second axial force directed toward the downstream
artery, such that application of the first and second forces
couples the prosthesis to the native valve complex by axially
sandwiching the native valve complex from a downstream side and the
ventricular side thereof,
[0277] wherein the prosthesis is configured to apply a radial force
of less than 0.5 pounds outwardly against the native semilunar
valve.
[0278] In an embodiment, the native semilunar valve includes a
native aortic valve, the downstream artery includes the ascending
aorta, and the distal fixation member is configured to be
positioned in the ascending aorta.
[0279] In an embodiment, the native semilunar valve includes a
native pulmonary valve, the downstream artery includes the
pulmonary trunk, and the distal fixation member is configured to be
positioned in the pulmonary trunk.
[0280] In an embodiment, the distal fixation member does not press
upon native valve commissures of the native semilunar valve upon
implantation of the prosthesis.
[0281] In an embodiment, the prosthesis is configured to apply the
first axial force such that a ratio of (a) the first axial force to
(b) the radial force is greater than 1.5:1. In an embodiment, the
prosthesis is configured to apply the second axial force such that
a ratio of (a) the second axial force to (b) the radial force is
greater than 1.5:1. In an embodiment, the prosthesis is configured
to apply the first axial force with a force of at least 40 g during
diastole. In an embodiment, the prosthesis is configured to apply
the second axial force with a force of at least 1 g during
systole.
[0282] In an embodiment, the prosthesis is configured such that any
radial force applied by the prosthesis outwardly against the native
semilunar valve is insufficient by itself to chronically maintain
the prosthesis in position with respect to the native valve complex
under conditions of normal cardiac motion.
[0283] In an embodiment, the prosthesis is configured, upon
implantation thereof, to embrace, such as gently embrace, without
squeezing, leaflets of the native semilunar valve. In an
embodiment, the distal fixation member is configured such that it
does not fold over leaflets of the native semilunar valve upon
implantation of the prosthesis. In an embodiment, the prosthesis is
configured to less than fully open leaflets of the native valve
complex when the prosthesis is implanted at the native valve
complex.
[0284] In an embodiment, the proximal fixation member is configured
to be positioned at least partially in a ventricle of the subject
upon implantation of the prosthesis.
[0285] In an embodiment, the prosthesis includes a valve configured
to assume a closed position during diastole and an open position
during systole. In an embodiment, the valve includes a collapsible
pliant material, configured to assume the open and closed
positions.
[0286] In an embodiment, the distal and proximal fixation members
and the valve are configured to define a single flow field through
the distal and proximal fixation members and the valve.
Alternatively, the distal and proximal fixation members and the
valve are configured to define a plurality of flow fields through
the distal and proximal fixation members and the valve.
[0287] In an embodiment, the valve includes one or more prosthetic
leaflets, and the valve is coupled to the prosthesis such that at
least 50% of an axial length of the prosthetic leaflets is distal
to native valve leaflets of the native semilunar valve upon
implantation of the prosthesis.
[0288] In an embodiment, the proximal fixation member is shaped so
as to define at least one barb configured to apply a barb force to
the ventricular side of the native valve complex. For some
applications, the at least one barb is configured to pierce the
ventricular side of the native valve complex. Alternatively, the at
least one barb is configured to protrude into tissue of the
ventricular side of the native valve complex, without piercing the
tissue. For some applications, the distal fixation member is shaped
so as to define at least one mating barb, and the at least one barb
of the proximal fixation member is configured to engage the at
least one mating barb, so as to help hold the prosthesis in
place.
[0289] In an embodiment, the proximal and distal fixation members
are collapsible. For some applications, the distal fixation member
is configured to be positioned, during an implantation procedure,
in the downstream artery while collapsed, and to be expanded before
the proximal fixation member is positioned at least partially on
the ventricular side of the native valve complex. For some
applications, the apparatus includes at least one tube selected
from the group consisting of: an overtube and a trocar, and the
proximal and distal fixation members are configured to be stored in
the selected tube while collapsed, and to expand upon being
deployed from the selected tube.
[0290] In an embodiment, the proximal fixation member includes an
inner support structure, and the distal fixation member includes an
outer support structure that is placed partially over the inner
support structure.
[0291] In an embodiment, the outer support structure is shaped so
as to define a plurality of distal diverging strut supports, from
which a plurality of proximal engagement arms extend radially
outward.
[0292] In an embodiment, the inner support structure is shaped so
as to define a plurality of distal diverging inner struts.
[0293] In an embodiment, the inner support structure is shaped so
as to define a bulging proximal skirt, a proximal portion of which
is configured to apply the second axial force. For some
applications, the prosthesis includes a graft covering that covers
at least a portion of the skirt.
[0294] In an embodiment, the inner support structure is shaped so
as to define a plurality of distal diverging inner struts, and the
skirt extends from the inner struts.
[0295] In an embodiment, the outer support structure is shaped so
as to define a plurality of distal diverging strut supports, from
which a plurality of proximal engagement arms extend radially
outward, and each of the strut supports is positioned over a
respective one of the inner struts.
[0296] In an embodiment, the engagement arms are positioned over a
portion of the skirt.
[0297] In an embodiment, the prosthesis includes a valve including
a collapsible pliant material, configured to assume a closed
position during diastole and an open position during systole, and
the pliant material includes a plurality of segments, at least two
of which are coupled together by one of the strut supports and its
respective one of the inner struts.
[0298] There is yet additionally provided, in accordance with an
embodiment of the present invention, a method for implanting a
valve prosthesis at a native semilunar valve of a native valve
complex of a subject, the method including:
[0299] providing a distal fixation member of the valve prosthesis
coupled to a proximal fixation member of the valve prosthesis,
which distal fixation member is shaped so as to define exactly
three proximal engagement arms;
[0300] positioning the distal fixation member in a downstream
artery of the subject selected from the group consisting of: an
ascending aorta, and a pulmonary trunk, such that the three
proximal engagement arms are positioned at least partially within
respective semilunar sinuses of the native valve complex, and, in
combination, apply, to tissue that defines the semilunar sinuses, a
first axial force directed toward a ventricle of the subject;
and
[0301] positioning the proximal fixation member at least partially
on a ventricular side of the native semilunar valve, such that the
proximal fixation member applies, to the ventricular side of the
native valve complex, a second axial force directed toward the
downstream artery, such that application of the first and second
forces couples the prosthesis to the native valve complex.
[0302] In an embodiment, the native semilunar valve includes a
native aortic valve, the downstream artery includes the ascending
aorta, and positioning the distal fixation member includes
positioning the distal fixation member in the ascending aorta.
[0303] In an embodiment, the native semilunar valve includes a
native pulmonary valve, the downstream artery includes the
pulmonary trunk, and positioning the distal fixation member
includes positioning the distal fixation member in the pulmonary
trunk.
[0304] In an embodiment, providing includes coupling the distal
fixation member to the proximal fixation member before positioning
the distal fixation member and before positioning the proximal
fixation member.
[0305] In an embodiment, providing includes coupling the distal
fixation member to the proximal fixation member after performing at
least one action selected from the group consisting of: positioning
the distal fixation member, and positioning the proximal fixation
member.
[0306] In an embodiment, the distal fixation member and the
proximal fixation member are fabricated as one integrated
structure, and providing the distal fixation member coupled to the
proximal fixation member includes providing the distal fixation
member and the proximal fixation member that are fabricated as one
integrated structure.
[0307] In an embodiment, positioning the distal and proximal
fixation members includes positioning the engagement arms at least
partially within the respective ones of the semilunar sinuses
before positioning the proximal fixation member at least partially
on the ventricular side of the native valve complex, such that the
engagement arms prevent leaflets of the native valve complex from
opening more than a predetermined desired amount, the opening being
because of force applied by the proximal fixation member to the
leaflets.
[0308] There is also provided, in accordance with an embodiment of
the present invention, a method for implanting a valve prosthesis
at a native semilunar valve of a native valve complex of a subject,
the method including:
[0309] providing a distal fixation member of the valve prosthesis
coupled to a proximal fixation member of the valve prosthesis;
[0310] positioning the distal fixation member in a downstream
artery of the subject selected from the group consisting of: an
ascending aorta, and a pulmonary trunk, such that the distal
fixation member applies, to a downstream side of the native valve
complex, a first axial force directed toward a ventricle of the
subject; and
[0311] positioning the proximal fixation member at least partially
on a ventricular side of the native semilunar valve, such that the
proximal fixation member applies, to a ventricular side of the
native semilunar valve, a second axial force directed toward the
downstream artery, such that application of the first and second
forces couples the prosthesis to the native semilunar valve.
[0312] In an embodiment, the native semilunar valve includes a
native aortic valve, the downstream artery includes the ascending
aorta, and positioning the distal fixation member includes
positioning the distal fixation member in the ascending aorta.
[0313] In an embodiment, the native semilunar valve includes a
native pulmonary valve, the downstream artery includes the
pulmonary trunk, and positioning the distal fixation member
includes positioning the distal fixation member in the pulmonary
trunk.
[0314] In an embodiment, providing includes coupling the distal
fixation member to the proximal fixation member before positioning
the distal fixation member and before positioning the proximal
fixation member.
[0315] In an embodiment, providing includes coupling the distal
fixation member to the proximal fixation member after performing at
least one action selected from the group consisting of: positioning
the distal fixation member, and positioning the proximal fixation
member.
[0316] In an embodiment, the distal fixation member and the
proximal fixation member are fabricated as one integrated
structure, and providing the distal fixation member coupled to the
proximal fixation member includes providing the distal fixation
member and the proximal fixation member that are fabricated as one
integrated structure.
[0317] In an embodiment, positioning the distal and proximal
fixation members includes positioning the distal fixation member in
the downstream artery before positioning the proximal fixation
member at least partially on the ventricular side of the native
semilunar valve.
[0318] In an embodiment, the prosthesis includes a prosthetic
valve, and positioning the distal fixation member includes
positioning the distal fixation member such that the valve assumes
a closed position during diastole and an open position during
systole.
[0319] In an embodiment, positioning the distal fixation member
includes positioning the distal fixation member such that it limits
an extent of opening of leaflets of the native valve complex.
[0320] In an embodiment, positioning the proximal and distal
fixation members includes:
[0321] collapsing the proximal and distal fixation members;
[0322] inserting the proximal and distal fixation members, while
collapsed, in the ventricle and the downstream artery,
respectively; and
[0323] expanding the proximal and distal fixation members in the
ventricle and the downstream artery, respectively.
[0324] In an embodiment, positioning the distal fixation member
includes positioning the distal fixation member in the downstream
artery while collapsed, and expanding the distal fixation member
before positioning the proximal fixation member at least partially
on the ventricular side of the native semilunar valve.
[0325] In an embodiment, inserting the proximal and distal fixation
members includes storing the proximal and distal fixation members
while collapsed in at least one tube selected from the group
consisting of: an overtube and a trocar, and expanding the proximal
and distal fixation members includes deploying the proximal and
distal fixation members from the selected tube.
[0326] In an embodiment, the native semilunar valve includes a
native aortic valve, the downstream artery includes the ascending
aorta, and inserting the proximal and distal fixation members
includes inserting the selected tube through an apex of a heart of
the subject, and advancing the selected tube through the ventricle
until a distal end of the selected tube passes the native semilunar
valve.
[0327] In an embodiment, the native semilunar valve includes a
native aortic valve, the downstream artery includes the ascending
aorta, and inserting the proximal and distal fixation members
includes inserting the selected tube using a transaortic
approach.
[0328] In an embodiment, the native semilunar valve includes a
native pulmonary valve, the downstream artery includes the
pulmonary trunk, the ventricle includes a right ventricle, and
inserting the proximal and distal fixation members includes
inserting the selected tube through a free wall of the right
ventricle, and advancing the selected tube through the right
ventricle past a right ventricular outflow tract of the heart until
a distal end of the selected tube passes the native pulmonary
valve.
[0329] In an embodiment, the proximal fixation member includes an
inner support structure, the distal fixation member includes an
outer support structure that is placed partially over the inner
support structure, and positioning the proximal and distal fixation
members includes positioning the inner and outer support
structures, respectively.
[0330] In an embodiment, the outer support structure is shaped so
as to define a plurality of distal diverging strut supports, from
which a plurality of proximal engagement arms extend radially
outward, and positioning the outer support structure includes
rotationally aligning the engagement arms with respective ones of
the semilunar sinuses.
[0331] In an embodiment, positioning the outer support structure
includes rotationally aligning the strut supports with respective
commissures of the native valve complex.
[0332] In an embodiment, aligning the engagement arms and the strut
supports includes moving the outer support structure in a proximal
direction, such that the engagement arms self-align with the
respective ones of the semilunar sinuses.
[0333] There is further provided, in accordance with an embodiment
of the present invention, a method for implanting a valve
prosthesis at a native semilunar valve of a native valve complex of
a subject, the method including:
[0334] providing a distal fixation member of the valve prosthesis
coupled to a proximal fixation member of the valve prosthesis;
[0335] positioning the distal fixation member in a downstream
artery of the subject selected from the group consisting of: an
ascending aorta, and a pulmonary trunk, such that the distal
fixation member applies, to native commissures of the native
semilunar valve, a first axial force directed toward a ventricle of
the subject, without applying any force to native leaflets of the
native semilunar valve;
[0336] causing the distal fixation member to rotationally align
with the native semilunar valve by gently rotating the valve
prosthesis; and
[0337] positioning the proximal fixation member at least partially
on a ventricular side of the native valve complex, such that the
proximal fixation member applies a second axial force directed
toward the downstream artery, such that application of the first
and second forces couples the prosthesis to the native valve
complex by axially sandwiching the native valve complex from a
downstream side and the ventricular side thereof.
[0338] In an embodiment, the native semilunar valve includes a
native aortic valve, the downstream artery includes the ascending
aorta, and positioning the distal fixation member includes
positioning the distal fixation member in the ascending aorta.
[0339] In an embodiment, the native semilunar valve includes a
native pulmonary valve, the downstream artery includes the
pulmonary trunk, and positioning the distal fixation member
includes positioning the distal fixation member in the pulmonary
trunk.
[0340] In an embodiment, causing the distal fixation member to
align includes causing the distal fixation member to rotationally
self-align with the native semilunar valve.
[0341] In an embodiment, providing includes coupling the distal
fixation member to the proximal fixation member before positioning
the distal fixation member and before positioning the proximal
fixation member.
[0342] In an embodiment, providing includes coupling the distal
fixation member to the proximal fixation member after performing at
least one action selected from the group consisting of: positioning
the distal fixation member, and positioning the proximal fixation
member.
[0343] In an embodiment, the distal fixation member and the
proximal fixation member are fabricated as one integrated
structure, and providing the distal fixation member coupled to the
proximal fixation member includes providing the distal fixation
member and the proximal fixation member that are fabricated as one
integrated structure.
[0344] There is still further provided, in accordance with an
embodiment of the present invention, a method for implanting a
valve prosthesis at a native semilunar valve of a native valve
complex of a subject, the method including:
[0345] providing a distal fixation member of the valve prosthesis
coupled to a proximal fixation member of the valve prosthesis;
[0346] positioning the distal fixation member in a downstream
artery of the subject selected from the group consisting of: an
ascending aorta, and a pulmonary trunk, such that the distal
fixation member applies a first axial force directed toward a
ventricle of the subject; and
[0347] positioning the proximal fixation member at least partially
on a ventricular side of the native valve complex, such that the
proximal fixation member applies a second axial force directed
toward the downstream artery, such that application of the first
and second forces couples the prosthesis to the native valve
complex by axially sandwiching the native valve complex from a
downstream side and the ventricular side thereof, and the
prosthesis applies a radial force of less than 0.5 pounds outwardly
against the native semilunar valve.
[0348] In an embodiment, the native semilunar valve includes a
native aortic valve, the downstream artery includes the ascending
aorta, and positioning the distal fixation member includes
positioning the distal fixation member in the ascending aorta.
[0349] In an embodiment, the native semilunar valve includes a
native pulmonary valve, the downstream artery includes the
pulmonary trunk, and positioning the distal fixation member
includes positioning the distal fixation member in the pulmonary
trunk.
[0350] In an embodiment, providing includes coupling the distal
fixation member to the proximal fixation member before positioning
the distal fixation member and before positioning the proximal
fixation member.
[0351] In an embodiment, providing includes coupling the distal
fixation member to the proximal fixation member after performing at
least one action selected from the group consisting of: positioning
the distal fixation member, and positioning the proximal fixation
member.
[0352] In an embodiment, the distal fixation member and the
proximal fixation member are fabricated as one integrated
structure, and providing the distal fixation member coupled to the
proximal fixation member includes providing the distal fixation
member and the proximal fixation member that are fabricated as one
integrated structure.
[0353] There is yet further provided, in accordance with an
embodiment of the present invention, apparatus including a
prosthesis for implantation at a native semilunar valve of a native
valve complex of a subject, the prosthesis including:
[0354] a distal fixation member, configured to be positioned in a
downstream artery of the subject selected from the group consisting
of: an ascending aorta, and a pulmonary trunk, and to apply a first
axial force directed toward a ventricle of the subject; and
[0355] a proximal fixation member coupled to the distal fixation
member, the proximal fixation member configured to be positioned at
least partially on a ventricular side of the native valve complex,
and to apply a second axial force directed toward the downstream
artery, such that application of the first and second forces
couples the prosthesis to the native valve complex by axially
sandwiching the native valve complex from a downstream side and the
ventricular side thereof,
[0356] wherein the prosthesis is configured to apply the first
axial force such that a ratio of (a) the first axial force to (b) a
radial force applied outwardly by the prosthesis against the native
semilunar valve is greater than 1.5:1.
[0357] In an embodiment, the native semilunar valve includes a
native aortic valve, the downstream artery includes the ascending
aorta, and the distal fixation member is configured to be
positioned in the ascending aorta.
[0358] In an embodiment, the native semilunar valve includes a
native pulmonary valve, the downstream artery includes the
pulmonary trunk, and the distal fixation member is configured to be
positioned in the pulmonary trunk.
[0359] In an embodiment, the prosthesis is configured such that the
radial force is less than 0.5 pounds. In an embodiment, the distal
fixation member does not press upon native valve commissures of the
native semilunar valve upon implantation of the prosthesis. In an
embodiment, the prosthesis is configured to apply the first axial
force with a force of at least 40 g during diastole.
[0360] In an embodiment, the prosthesis is configured such that any
radial force applied by the prosthesis outwardly against the native
semilunar valve is insufficient by itself to chronically maintain
the prosthesis in position with respect to the native valve complex
under conditions of normal cardiac motion.
[0361] In an embodiment, the prosthesis is configured, upon
implantation thereof, to embrace, such as gently embrace, without
squeezing, leaflets of the native semilunar valve.
[0362] In an embodiment, the distal fixation member is configured
such that it does not fold over leaflets of the native semilunar
valve upon implantation of the prosthesis. In an embodiment, the
prosthesis is configured to less than fully open leaflets of the
native valve complex when the prosthesis is implanted at the native
valve complex.
[0363] In an embodiment, the proximal fixation member is configured
to be positioned at least partially in a ventricle of the subject
upon implantation of the prosthesis.
[0364] In an embodiment, the prosthesis is configured to apply the
first axial force such that the ratio is greater than 3:1, such as
greater than 6:1.
[0365] In an embodiment, the prosthesis includes a valve configured
to assume a closed position during diastole and an open position
during systole.
[0366] In an embodiment, the valve includes a collapsible pliant
material, configured to assume the open and closed positions.
[0367] In an embodiment, the distal and proximal fixation members
and the valve are configured to define a single flow field through
the distal and proximal fixation members and the valve.
[0368] In an embodiment, the distal and proximal fixation members
and the valve are configured to define a plurality of flow fields
through the distal and proximal fixation members and the valve.
[0369] In an embodiment, the valve includes one or more prosthetic
leaflets, and the valve is coupled to the prosthesis such that at
least 50% of an axial length of the prosthetic leaflets is distal
to native valve leaflets of the native semilunar valve upon
implantation of the prosthesis.
[0370] In an embodiment, the proximal fixation member is shaped so
as to define at least one barb configured to apply a barb force to
the ventricular side of the native valve complex. For some
applications, the at least one barb is configured to pierce the
ventricular side of the native valve complex. Alternatively, the at
least one barb is configured to protrude into tissue of the
ventricular side of the native valve complex, without piercing the
tissue. For some applications, the distal fixation member is shaped
so as to define at least one mating barb, and the at least one barb
of the proximal fixation member is configured to engage the at
least one mating barb, so as to help hold the prosthesis in
place.
[0371] In an embodiment, the proximal and distal fixation members
are collapsible. For some applications, the distal fixation member
is configured to be positioned, during an implantation procedure,
in the downstream artery while collapsed, and to be expanded before
the proximal fixation member is positioned at least partially on
the ventricular side of the native valve complex. For some
applications, the apparatus includes at least one tube selected
from the group consisting of: an overtube and a trocar, and the
proximal and distal fixation members are configured to be stored in
the selected tube while collapsed, and to expand upon being
deployed from the selected tube.
[0372] In an embodiment, the proximal fixation member includes an
inner support structure, and the distal fixation member includes an
outer support structure that is placed partially over the inner
support structure.
[0373] In an embodiment, the outer support structure is shaped so
as to define a plurality of distal diverging strut supports, from
which a plurality of proximal engagement arms extend radially
outward.
[0374] In an embodiment, the inner support structure is shaped so
as to define a plurality of distal diverging inner struts.
[0375] In an embodiment, the inner support structure is shaped so
as to define a bulging proximal skirt, a proximal portion of which
is configured to apply the second axial force.
[0376] For some applications, the prosthesis includes a graft
covering that covers at least a portion of the skirt.
[0377] In an embodiment, the inner support structure is shaped so
as to define a plurality of distal diverging inner struts, and the
skirt extends from the inner struts.
[0378] In an embodiment, the outer support structure is shaped so
as to define a plurality of distal diverging strut supports, from
which a plurality of proximal engagement arms extend radially
outward, and each of the strut supports is positioned over a
respective one of the inner struts.
[0379] In an embodiment, the engagement arms are positioned over a
portion of the skirt.
[0380] In an embodiment, the prosthesis includes a valve including
a collapsible pliant material, configured to assume a closed
position during diastole and an open position during systole, and
the pliant material includes a plurality of segments, at least two
of which are coupled together by one of the strut supports and its
respective one of the inner struts.
[0381] There is additionally provided, in accordance with an
embodiment of the present invention, apparatus including a
prosthesis for implantation at a native semilunar valve of a native
valve complex of a subject, the prosthesis including:
[0382] a distal fixation member, configured to be positioned in a
downstream artery of the subject selected from the group consisting
of: an ascending aorta, and a pulmonary trunk, and to apply a first
axial force directed toward a ventricle of the subject; and
[0383] a proximal fixation member coupled to the distal fixation
member, the proximal fixation member configured to be positioned at
least partially on a ventricular side of the native valve complex,
and to apply a second axial force directed toward the downstream
artery, such that application of the first and second forces
couples the prosthesis to the native valve complex by axially
sandwiching the native valve complex from a downstream side and the
ventricular side thereof,
[0384] wherein the prosthesis is configured such that any radial
force applied by the prosthesis outwardly against the native
semilunar valve is insufficient by itself to chronically maintain
the prosthesis in position with respect to the native valve complex
under conditions of normal cardiac motion.
[0385] In an embodiment, the native semilunar valve includes a
native aortic valve, the downstream artery includes the ascending
aorta, and the distal fixation member is configured to be
positioned in the ascending aorta.
[0386] In an embodiment, the native semilunar valve includes a
native pulmonary valve, the downstream artery includes the
pulmonary trunk, and the distal fixation member is configured to be
positioned in the pulmonary trunk.
[0387] In an embodiment, the prosthesis is configured to apply the
first axial force such that a ratio of (a) the first axial force to
(b) the radial force is greater than 1.5:1. In an embodiment, the
prosthesis is configured to apply the second axial force such that
a ratio of (a) the second axial force to (b) the radial force is
greater than 1.5:1. In an embodiment, the prosthesis is configured
such that the radial force is less than 0.5 pounds.
[0388] In an embodiment, the distal fixation member does not press
upon native valve commissures of the native semilunar valve upon
implantation of the prosthesis.
[0389] In an embodiment, the prosthesis is configured to apply the
first axial force with a force of at least 40 g during diastole. In
an embodiment, the prosthesis is configured to apply the second
axial force with a force of at least 1 g during systole.
[0390] In an embodiment, the prosthesis is configured, upon
implantation thereof, to embrace, such as gently embrace, without
squeezing, leaflets of the native semilunar valve. In an
embodiment, the distal fixation member is configured such that it
does not fold over leaflets of the native semilunar valve upon
implantation of the prosthesis. In an embodiment, the prosthesis is
configured to less than fully open leaflets of the native valve
complex when the prosthesis is implanted at the native valve
complex.
[0391] In an embodiment, the prosthesis includes a valve configured
to assume a closed position during diastole and an open position
during systole. In an embodiment, the valve includes a collapsible
pliant material, configured to assume the open and closed
positions.
[0392] In an embodiment, the distal and proximal fixation members
and the valve are configured to define a single flow field through
the distal and proximal fixation members and the valve. For some
applications, the distal and proximal fixation members and the
valve are configured to define a plurality of flow fields through
the distal and proximal fixation members and the valve.
[0393] In an embodiment, the valve includes one or more prosthetic
leaflets, and the valve is coupled to the prosthesis such that at
least 50% of an axial length of the prosthetic leaflets is distal
to native valve leaflets of the native semilunar valve upon
implantation of the prosthesis.
[0394] There is also provided, in accordance with an embodiment of
the present invention, a method for implanting a valve prosthesis
at a native semilunar valve of a native valve complex of a subject,
the method including:
[0395] providing a distal fixation member of the valve prosthesis
coupled to a proximal fixation member of the valve prosthesis;
[0396] positioning the distal fixation member in a downstream
artery of the subject selected from the group consisting of: an
ascending aorta, and a pulmonary trunk, such that the distal
fixation member applies a first axial force directed toward a
ventricle of the subject, such that a ratio of (a) the first axial
force to (b) a radial force applied outwardly by the prosthesis
against the native semilunar valve is greater than 1.5:1; and
[0397] positioning the proximal fixation member at least partially
on a ventricular side of the native valve complex, such that the
proximal fixation member applies a second axial force directed
toward the downstream artery, and application of the first and
second forces couples the prosthesis to the native valve complex by
axially sandwiching the native valve complex from a downstream side
and the ventricular side thereof.
[0398] In an embodiment, the native semilunar valve includes a
native aortic valve, the downstream artery includes the ascending
aorta, and positioning the distal fixation member includes
positioning the distal fixation member in the ascending aorta.
[0399] In an embodiment, the native semilunar valve includes a
native pulmonary valve, the downstream artery includes the
pulmonary trunk, and positioning the distal fixation member
includes positioning the distal fixation member in the pulmonary
trunk.
[0400] In an embodiment, providing includes coupling the distal
fixation member to the proximal fixation member before positioning
the distal fixation member and before positioning the proximal
fixation member.
[0401] In an embodiment, providing includes coupling the distal
fixation member to the proximal fixation member after performing at
least one action selected from the group consisting of: positioning
the distal fixation member, and positioning the proximal fixation
member.
[0402] In an embodiment, the distal fixation member and the
proximal fixation member are fabricated as one integrated
structure, and providing the distal fixation member coupled to the
proximal fixation member includes providing the distal fixation
member and the proximal fixation member that are fabricated as one
integrated structure.
[0403] There is still additionally provided, in accordance with an
embodiment of the present invention, a method for implanting a
valve prosthesis at a native semilunar valve of a native valve
complex of a subject, the method including:
[0404] providing a distal fixation member of the valve prosthesis
coupled to a proximal fixation member of the valve prosthesis;
[0405] positioning the distal fixation member in a downstream
artery of the subject selected from the group consisting of: an
ascending aorta, and a pulmonary trunk, such that the distal
fixation member applies a first axial force directed toward a
ventricle of the subject; and
[0406] positioning the proximal fixation member at least partially
on a ventricular side of the native valve complex, such that the
proximal fixation member applies a second axial force directed
toward the downstream artery, and application of the first and
second forces couples the prosthesis to the native valve complex by
axially sandwiching the native valve complex from a downstream side
and the ventricular side thereof,
[0407] wherein positioning the distal and proximal fixation members
includes positioning the distal and proximal fixation members such
that any radial force applied by the prosthesis outwardly against
the native semilunar valve is insufficient by itself to chronically
maintain the prosthesis in position with respect to the native
valve complex under conditions of normal cardiac motion.
[0408] In an embodiment, the native semilunar valve includes a
native aortic valve, the downstream artery includes the ascending
aorta, and positioning the distal fixation member includes
positioning the distal fixation member in the ascending aorta.
[0409] In an embodiment, the native semilunar valve includes a
native pulmonary valve, the downstream artery includes the
pulmonary trunk, and positioning the distal fixation member
includes positioning the distal fixation member in the pulmonary
trunk.
[0410] In an embodiment, providing includes coupling the distal
fixation member to the proximal fixation member before positioning
the distal fixation member and before positioning the proximal
fixation member.
[0411] In an embodiment, providing includes coupling the distal
fixation member to the proximal fixation member after performing at
least one action selected from the group consisting of: positioning
the distal fixation member, and positioning the proximal fixation
member.
[0412] In an embodiment, the distal fixation member and the
proximal fixation member which are fabricated as one integrated
structure, and providing the distal fixation member coupled to the
proximal fixation member includes providing the distal fixation
member and the proximal fixation member that are fabricated as one
integrated structure.
[0413] There is yet additionally provided, in accordance with an
embodiment of the present invention, apparatus including a
prosthesis for implantation at a native semilunar valve of a native
valve complex of a subject, the prosthesis including:
[0414] a distal fixation member, configured to be positioned in a
downstream artery of the subject selected from the group consisting
of: an ascending aorta, and a pulmonary trunk, and to apply a first
axial force directed toward a ventricle of the subject; and
[0415] a proximal fixation member coupled to the distal fixation
member, the proximal fixation member configured to be positioned at
least partially on a ventricular side of the native valve complex,
and to apply a second axial force directed toward the downstream
artery, such that application of the first and second forces
couples the prosthesis to the native valve complex by axially
sandwiching the native valve complex from a downstream side and the
ventricular side thereof,
[0416] wherein the prosthesis is configured, upon implantation
thereof, to embrace, without squeezing, leaflets of the native
semilunar valve.
[0417] In an embodiment, the prosthesis is configured, upon
implantation thereof, to gently embrace, without squeezing, the
leaflets of the native semilunar valve.
[0418] In an embodiment, the native semilunar valve includes a
native aortic valve, the downstream artery includes the ascending
aorta, and the distal fixation member is configured to be
positioned in the ascending aorta.
[0419] In an embodiment, the native semilunar valve includes a
native pulmonary valve, the downstream artery includes the
pulmonary trunk, and the distal fixation member is configured to be
positioned in the pulmonary trunk.
[0420] In an embodiment, the prosthesis is configured such that any
radial force applied by the prosthesis outwardly against the native
semilunar valve is insufficient by itself to chronically maintain
the prosthesis in position with respect to the native valve complex
under conditions of normal cardiac motion.
[0421] In an embodiment, the prosthesis is configured to apply the
first axial force such that a ratio of (a) the first axial force to
(b) a radial force applied outwardly by the prosthesis against the
native semilunar valve is greater than 1.5:1. In an embodiment, the
prosthesis is configured to apply the second axial force such that
a ratio of (a) the second axial force to (b) a radial force applied
outwardly by the prosthesis against the native semilunar valve is
greater than 1.5:1.
[0422] In an embodiment, the prosthesis is configured to apply a
radial force of less than 0.5 pounds outwardly against the native
semilunar valve.
[0423] In an embodiment, the distal fixation member does not press
upon native valve commissures of the native semilunar valve upon
implantation of the prosthesis.
[0424] In an embodiment, the prosthesis is configured to apply the
first axial force with a force of at least 40 g during diastole. In
an embodiment, the prosthesis is configured to apply the second
axial force with a force of at least 1 g during systole.
[0425] In an embodiment, the prosthesis is configured such that any
radial force applied by the prosthesis outwardly against the native
semilunar valve is insufficient by itself to chronically maintain
the prosthesis in position with respect to the native valve complex
under conditions of normal cardiac motion.
[0426] In an embodiment, the distal fixation member is configured
such that it does not fold over leaflets of the native semilunar
valve upon implantation of the prosthesis. In an embodiment, the
prosthesis is configured to less than fully open leaflets of the
native valve complex when the prosthesis is implanted at the native
valve complex.
[0427] In an embodiment, the prosthesis includes a valve configured
to assume a closed position during diastole and an open position
during systole. In an embodiment, the valve includes a collapsible
pliant material, configured to assume the open and closed
positions.
[0428] In an embodiment, the distal and proximal fixation members
and the valve are configured to define a single flow field through
the distal and proximal fixation members and the valve.
Alternatively, the distal and proximal fixation members and the
valve are configured to define a plurality of flow fields through
the distal and proximal fixation members and the valve.
[0429] In an embodiment, the valve includes one or more prosthetic
leaflets, and the valve is coupled to the prosthesis such that at
least 50% of an axial length of the prosthetic leaflets is distal
to native valve leaflets of the native semilunar valve upon
implantation of the prosthesis.
[0430] There is also provided, in accordance with an embodiment of
the present invention, apparatus including a valve prosthesis for
implantation at a native semilunar valve of a subject, the
prosthesis including:
[0431] one or more distal fixation members, which are configured to
be coupled without suturing to the native semilunar valve such that
the members prevent opening of native leaflets of the native
semilunar valve to their maximum diameter; and
[0432] a pliant material coupled to at least one of the distal
fixation members, the pliant material having a closed position and
an open position.
[0433] In an embodiment, the native semilunar valve includes a
native aortic valve, and the one or more distal fixation members
are configured to be coupled with suturing to the native aortic
valve. In an embodiment, the native semilunar valve includes a
native pulmonary valve, and the one or more distal fixation members
are configured to be coupled with suturing to the native pulmonary
valve.
[0434] In an embodiment, the one or more distal fixation members
are configured to define a maximum extent of opening of the native
leaflets.
[0435] In an embodiment, the one or more distal fixation members
include at least two distal fixation members, and the at least two
distal fixation members are configured such that upon implantation
of the prosthesis, at least a portion of the native leaflets is
positioned between the at least two distal fixation members.
[0436] There is further provided, in accordance with an embodiment
of the present invention, a method for implanting a valve
prosthesis at a native semilunar valve of a native valve complex of
a subject, the method including:
[0437] providing a distal fixation member of the valve prosthesis
coupled to a proximal fixation member of the valve prosthesis;
[0438] positioning the distal fixation member in a downstream
artery of the subject selected from the group consisting of: an
ascending aorta, and a pulmonary trunk, such that the distal
fixation member applies a first axial force directed toward a
ventricle of the subject; and
[0439] positioning the proximal fixation member at least partially
on a ventricular side of the native valve complex, such that the
proximal fixation member applies a second axial force directed
toward the downstream artery, and application of the first and
second forces couples the prosthesis to the native valve complex by
axially sandwiching the native valve complex from a downstream side
and the ventricular side thereof,
[0440] wherein positioning the distal and proximal fixation members
includes positioning the distal and proximal fixation members such
that the valve prosthesis embraces, without squeezing, leaflets of
the native semilunar valve.
[0441] In an embodiment, the native semilunar valve includes a
native aortic valve, the downstream artery includes the ascending
aorta, and positioning the distal fixation member includes
positioning the distal fixation member in the ascending aorta. In
an embodiment, the native semilunar valve includes a native
pulmonary valve, the downstream artery includes the pulmonary
trunk, and positioning the distal fixation member includes
positioning the distal fixation member in the pulmonary trunk.
[0442] In an embodiment, positioning the distal and proximal
fixation members includes positioning the distal and proximal
fixation members such that the valve prosthesis gently embraces,
without squeezing, the leaflets of the native semilunar valve.
[0443] There is still further provided, in accordance with an
embodiment of the present invention, a method for implanting a
valve prosthesis at a native semilunar valve of a subject, the
method including:
[0444] positioning one or more distal fixation members of the valve
prosthesis in a vicinity of the native semilunar valve, and a
pliant material coupled to at least one of the distal fixation
members has a closed position and an open position; and
[0445] without suturing, coupling the one or more distal fixation
members to the native semilunar valve such that the distal fixation
members prevent opening of native leaflets of the native semilunar
valve to their maximum diameter.
[0446] In an embodiment, the native semilunar valve includes a
native aortic valve, and positioning includes positioning the one
or more distal fixation members in the vicinity of the native
aortic valve.
[0447] In an embodiment, the native semilunar valve includes a
native pulmonary valve, and positioning includes positioning the
one or more distal fixation members in the vicinity of the native
pulmonary valve.
[0448] In an embodiment, positioning the one or more distal
fixation members includes positioning the one or more distal
fixation members to define a maximum extent of opening of the
native leaflets.
[0449] In an embodiment, the one or more distal fixation members
include at least two distal fixation members, and positioning
includes positioning the at least two distal fixation members such
that at least a portion of the native leaflets are positioned
between the at least two distal fixation members.
[0450] There is further provided, in accordance with an embodiment
of the present invention, apparatus including a prosthesis for
implantation at a stenosed native aortic valve of a native valve
complex of a subject, the prosthesis including:
[0451] a distal fixation member, configured to be positioned in an
ascending aorta of the subject, and to apply, to an aortic side of
the native valve complex, a first axial force directed toward a
left ventricle of the subject; and
[0452] a proximal fixation member coupled to the distal fixation
member, the proximal fixation member configured to be positioned at
least partially on a left-ventricular side of the native aortic
valve, and to apply, to a left-ventricular side of the aortic
annulus, a second axial force directed toward the ascending aorta,
such that application of the first and second forces couples the
prosthesis to the native valve complex.
[0453] In an embodiment, the distal fixation member is configured
to be positioned in the ascending aorta during an implantation
procedure before the proximal fixation member is positioned at
least partially on the left-ventricular side of the native aortic
valve.
[0454] In an embodiment, the distal fixation member is configured
such that it does not crimp, fold, or compress leaflets of the
native aortic valve upon implantation of the prosthesis.
[0455] In an embodiment, the distal fixation member is configured
such that it does not push leaflets of the native aortic valve
towards aortic sinus floors of the native valve complex upon
implantation of the prosthesis.
[0456] In an embodiment, the prosthesis includes a valve configured
to assume a closed position during diastole and an open position
during systole.
[0457] In an embodiment, the valve includes a collapsible pliant
material, configured to assume the open and closed positions.
[0458] In an embodiment, the distal and proximal fixation members
and the valve are configured to define a single flow field through
the distal and proximal fixation members and the valve.
[0459] In an embodiment, the distal and proximal fixation members
and the valve are configured to define a plurality of flow fields
through the distal and proximal fixation members and the valve.
[0460] In an embodiment, the prosthesis is configured to not fully
open leaflets of the native valve complex when the prosthesis is
implanted at the native aortic valve complex.
[0461] In an embodiment, the distal fixation member is configured
to be positioned within one or more aortic sinuses of the native
valve complex upon implantation of the prosthesis.
[0462] In an embodiment, the distal fixation member is configured
to elevate leaflets of the native aortic valve from within the one
or more aortic sinuses upon implantation of the prosthesis.
[0463] In an embodiment, the distal fixation member is configured
to apply the first axial force to respective roots of one or more
leaflets of the native valve complex.
[0464] In an embodiment, the distal fixation member is configured
to apply the first axial force to respective transitions between
respective aortic sinus floors and one or more leaflets of the
native valve complex.
[0465] In an embodiment, the distal fixation member is configured
to apply the first axial force to one or more aortic sinus floors
of the native valve complex.
[0466] In an embodiment, the distal fixation member is shaped so as
to define one or more proximal engagement arms that are configured
to be positioned within respective ones of the aortic sinuses, and,
in combination, to apply the first axial force.
[0467] In an embodiment, the arms are configured to be positioned,
during an implantation procedure, within the respective ones of the
aortic sinuses before the proximal fixation member is positioned at
least partially on the left-ventricular side of the native aortic
valve, such that the arms prevent leaflets of the native valve
complex from opening more than a predetermined desired amount
because of force applied by the proximal fixation member to the
leaflets.
[0468] In an embodiment, the proximal fixation member is configured
to be positioned at least partially in a left ventricle of the
subject upon implantation of the prosthesis.
[0469] In an embodiment, the proximal fixation member is shaped so
as to define at least one barb configured to apply a barb force to
the left-ventricular side of the aortic annulus.
[0470] In an embodiment, the at least one barb is configured to
pierce the left-ventricular side of the aortic annulus.
[0471] In an embodiment, the at least one barb is configured to
protrude into tissue of the left-ventricular side of the aortic
annulus, without piercing the tissue.
[0472] In an embodiment, the distal fixation member is shaped so as
to define at least one mating barb, and the at least one barb of
the proximal fixation member is configured to engage the at least
one mating barb, so as to help hold the prosthesis in place.
[0473] In an embodiment, the proximal and distal fixation members
are collapsible.
[0474] In an embodiment, the distal fixation member is configured
to be positioned, during an implantation procedure, in the
ascending aorta while collapsed, and to be expanded before the
proximal fixation member is positioned at least partially on the
left-ventricular side of the native aortic valve.
[0475] In an embodiment, the apparatus includes at least one tube
selected from the group consisting of: an overtube and a trocar,
and the proximal and distal fixation members are configured to be
stored in the selected tube while collapsed, and to expand upon
being deployed from the selected tube.
[0476] In an embodiment, the proximal fixation member includes an
inner support structure, and the distal fixation member includes an
outer support structure that is placed partially over the inner
support structure.
[0477] In an embodiment, the outer support structure is shaped so
as to define a plurality of distal diverging strut supports, from
which a plurality of proximal engagement arms extend radially
outward.
[0478] In an embodiment, the prosthesis is configured such that,
upon implantation at the native valve complex, the engagement arms
are aligned by rotation with respective ones of aortic sinuses of
the native valve complex.
[0479] In an embodiment, the prosthesis is configured such that,
upon implantation at the native valve complex, the strut supports
are aligned with respective commissures of the native valve
complex.
[0480] In an embodiment, the prosthesis is configured such that the
engagement arms self-align themselves by rotation during
implantation of the prosthesis at the native valve complex.
[0481] In an embodiment, the inner support structure is shaped so
as to define a plurality of distal diverging inner struts.
[0482] In an embodiment, the inner support structure is shaped so
as to define a bulging proximal skirt, a proximal portion of which
is configured to apply the second axial force.
[0483] In an embodiment, the prosthesis includes a graft covering
that covers at least a portion of the skirt.
[0484] In an embodiment, the inner support structure is shaped so
as to define a plurality of distal diverging inner struts, and the
skirt extends from the inner struts.
[0485] In an embodiment, the outer support structure is shaped so
as to define a plurality of distal diverging strut supports, from
which a plurality of proximal engagement arms extend radially
outward, and each of the strut supports is positioned over a
respective one of the inner struts.
[0486] In an embodiment, the engagement arms are positioned over a
portion of the skirt.
[0487] In an embodiment, the membrane includes a plurality of
segments, at least two of which are coupled together by one of the
strut supports and its respective one of the inner struts.
[0488] There is further provided, in accordance with an embodiment
of the invention, apparatus including a valve prosthesis for
implantation at a stenosed native aortic valve of a subject, the
prosthesis including:
[0489] one or more fixation members, which are configured to be
coupled without suturing to the native aortic valve such that the
members do not open native leaflets of the native aortic valve to
their maximum diameter; and
[0490] a membrane coupled to at least one of the fixation members,
the membrane having a closed position and an open position.
[0491] There is still further provided, in accordance with an
embodiment of the invention, a method for treating a stenosed
native aortic valve of a native valve complex of a subject, the
method including:
[0492] positioning a distal fixation member of a valve prosthesis
in an ascending aorta of the subject, such that the distal fixation
member applies, to an aortic side of the native valve complex, a
first axial force directed toward a left ventricle of the subject;
and
[0493] positioning a proximal fixation member of the prosthesis at
least partially on a left-ventricular side of the native aortic
valve, such that the proximal fixation member applies, to a
left-ventricular side of the aortic annulus, a second axial force
directed toward the ascending aorta, such that application of the
first and second forces couples the prosthesis to the native
valve.
[0494] In an embodiment, positioning the distal and proximal
fixation members includes positioning the distal fixation member in
the ascending aorta before positioning the proximal fixation member
at least partially on the left-ventricular side of the native
aortic valve.
[0495] In an embodiment, positioning the distal fixation member
includes positioning the distal fixation member such that it does
not crimp, fold, or compress leaflets of the native aortic
valve.
[0496] In an embodiment, positioning the distal fixation member
includes positioning the distal fixation member such that it does
not push leaflets of the native aortic valve towards aortic sinus
floors of the native valve complex.
[0497] In an embodiment, the prosthesis includes a valve, and
positioning the distal fixation member includes positioning the
distal fixation member such that the valve assumes a closed
position during diastole and an open position during systole.
[0498] In an embodiment, the valve includes a collapsible pliant
material, and positioning the distal fixation member includes
positioning the distal fixation member such that the pliant
material assumes the open and closed positions.
[0499] In an embodiment, positioning the distal and proximal
fixation members and the valve includes positioning the distal and
proximal fixation members and the valve such that the distal and
proximal fixation members and the valve define a single flow field
through the distal and proximal fixation members and the valve.
[0500] In an embodiment, positioning the distal and proximal
fixation members and the valve includes positioning the distal and
proximal fixation members and the valve such that the distal and
proximal fixation members and the valve define a plurality of flow
fields through the distal and proximal fixation members and the
valve.
[0501] In an embodiment, positioning the distal fixation member
includes positioning the distal fixation member such that it does
not fully open leaflets of the native valve complex.
[0502] In an embodiment, positioning the distal fixation member
includes positioning the distal fixation member within one or more
aortic sinuses of the native valve complex.
[0503] In an embodiment, positioning the distal fixation member
includes positioning the distal fixation member such that it
elevates leaflets of the native aortic valve from within the one or
more aortic sinuses.
[0504] In an embodiment, positioning the distal fixation member
includes positioning the distal fixation member such that the
distal fixation member applies the first axial force to respective
roots of one or more leaflets of the native valve complex.
[0505] In an embodiment, positioning the distal fixation member
includes positioning the distal fixation member such that the
distal fixation member applies the first axial force to respective
transitions between respective aortic sinus floors and one or more
leaflets of the native valve complex.
[0506] In an embodiment, positioning the distal fixation member
includes positioning the distal fixation member such that the
distal fixation member applies the first axial force to one or more
aortic sinus floors of the native valve complex.
[0507] In an embodiment, the distal fixation member is shaped so as
to define one or more proximal engagement arms, and positioning the
distal fixation member includes positioning the engagement arms
within respective ones of the aortic sinuses, such that the
engagement arms apply the first axial force.
[0508] In an embodiment, positioning the arms includes positioning
the arms before positioning the proximal fixation member, such that
the arms prevent leaflets of the native valve complex from opening
more than a predetermined desired amount because of force applied
by the proximal fixation member to the leaflets.
[0509] In an embodiment, positioning the proximal fixation member
includes positioning the proximal fixation member at least
partially in a left ventricle of the subject.
[0510] In an embodiment, the proximal fixation member is shaped so
as to define at least one barb, and positioning the proximal
fixation member includes positioning the proximal fixation member
applies a barb force to the left-ventricular side of the aortic
annulus.
[0511] In an embodiment, positioning the proximal fixation member
includes positioning the proximal fixation member such that the at
least one barb pierces the left-ventricular side of the aortic
annulus.
[0512] In an embodiment, positioning the proximal fixation member
includes positioning the proximal fixation member such that the at
least one barb protrudes into tissue of the left-ventricular side
of the aortic annulus, without piercing the tissue.
[0513] In an embodiment, the distal fixation member is shaped so as
to define at least one mating barb, and positioning the proximal
and distal fixation members includes engaging the at least one barb
by the at least one mating barb, so as to help hold the prosthesis
in place.
[0514] In an embodiment, positioning the proximal and distal
fixation members includes:
[0515] collapsing the proximal and distal fixation members;
[0516] inserting the proximal and distal fixation members, while
collapsed, in the left ventricle and the ascending aorta,
respectively; and
[0517] expanding the proximal and distal fixation members in the
left ventricle and the ascending aorta, respectively.
[0518] In an embodiment, positioning the distal fixation member
includes positioning the distal fixation member in the ascending
aorta while collapsed, and expanding the distal fixation member
before positioning the proximal fixation member at least partially
on the left-ventricular side of the native aortic valve.
[0519] In an embodiment, inserting the proximal and distal fixation
members includes storing the proximal and distal fixation members
while collapsed in at least one tube selected from the group
consisting of: an overtube and a trocar, and expanding the proximal
and distal fixation members includes deploying the proximal and
distal fixation members from the selected tube.
[0520] In an embodiment, inserting the proximal and distal fixation
members includes inserting the selected tube through an apex of a
heart of the subject, and advancing the selected tube through the
left ventricle until a distal end of the selected tube passes the
native aortic valve.
[0521] In an embodiment, inserting the proximal and distal fixation
members includes inserting the selected tube using a transaortic
approach.
[0522] In an embodiment, the proximal fixation member includes an
inner support structure, the distal fixation member includes an
outer support structure that is placed partially over the inner
support structure, and positioning the proximal and distal fixation
members includes positioning the inner and outer support
structures, respectively.
[0523] In an embodiment, the outer support structure is shaped so
as to define a plurality of distal diverging strut supports, from
which a plurality of proximal engagement arms extend radially
outward, and positioning the outer support structure includes
rotationally aligning the engagement arms with respective ones of
the aortic sinuses.
[0524] In an embodiment, positioning the outer support structure
includes rotationally aligning the strut supports with respective
commissures of the native valve complex.
[0525] In an embodiment, aligning the engagement arms and the strut
supports includes moving the outer support structure in a proximal
direction, such that the engagement arms self-align with the
respective ones of the aortic sinuses.
[0526] In an embodiment, the inner support structure is shaped so
as to define a bulging proximal skirt, and positioning the inner
support structure includes positioning the inner support structure
such that a proximal portion of the skirt applies the second axial
force.
[0527] In an embodiment, the prosthesis includes a graft covering
that covers at least a portion of the skirt, and positioning the
inner support structure includes positioning the inner support
structure including the graft covering.
[0528] In an embodiment, the inner support structure is shaped so
as to define a plurality of distal diverging inner struts, the
skirt extends from the inner struts, and positioning the inner
support structure includes positioning the inner support structure
that is shaped so as to define the plurality of distal diverging
inner struts.
[0529] In an embodiment, the outer support structure is shaped so
as to define a plurality of distal diverging strut supports, from
which a plurality of proximal engagement arms extend radially
outward, each of the strut supports is positioned over a respective
one of the inner struts, and positioning the outer support
structure includes positioning the outer support structure that is
shaped so as to define the plurality of distal diverging strut
supports.
[0530] In an embodiment, the engagement arms are positioned over a
portion of the skirt, and positioning the outer support structure
includes positioning the outer support structure including the
engagement arms positioned over the portion of the skirt.
[0531] There is yet further provided, in accordance with an
embodiment of the invention, a method for treating a stenosed
native aortic valve of a subject, the method including:
[0532] positioning one or more fixation members of a valve
prosthesis in a vicinity of the native aortic valve, and a membrane
coupled to at least one of the fixation members has a closed
position and an open position; and
[0533] without suturing, coupling the one or more fixation members
to the native aortic valve such that the fixation members do not
open native leaflets of the native aortic valve to their maximum
diameter.
[0534] In some embodiments of the present invention, a fixation
mechanism is provided for implanting a stent-based valve prosthesis
for treating a native stenosed valve, such as an aortic valve. The
fixation mechanism typically enables accurate positioning of the
prosthesis in the native valve orifice in a guided self-aligning
procedure, as well as safe and secure deployment and fixation.
[0535] In some embodiments of the present invention, the fixation
mechanism includes one or more of the following components and/or
features:
[0536] a distal (i.e., downstream) fixation member, which typically
includes a fixation frame. When the valve prosthesis is in a
collapsed position, the fixation frame is pressed against a body of
the valve prosthesis by insertion into an outer sheath (i.e., an
overtube);
[0537] the downstream fixation frame is shaped so as to define
aortic sinus fixation arms, a number of which is typically equal to
the number of aortic sinuses of the native valve;
[0538] the arms are configured to flare out laterally, when
released from the outer sheath, to an angle with respect to a
central axis of the prosthesis. Typically, the angle is precisely
predefined by the design of the downstream fixation frame and arms,
said angle open in the upstream direction. For some applications,
the arms are shaped so as to curve outwards laterally;
[0539] upon deployment at the bottom of the aortic sinuses, the
downstream fixation arms exert force largely or substantially only
in the direction of the left ventricle (i.e., an axial force), and
exert little or substantially no force in the radial direction;
[0540] the downstream fixation arms engage with the downstream side
of the native valve leaflets, but not with the upstream side of the
native valve leaflets. As a result: (a) the arms limit the opening
motion of the native valve leaflets to the above-mentioned angle
(which is typically predefined), and (b) the configuration of the
arms enables the sequential entrapment of the native valve
leaflets, first, from the downstream side by the fixation arms,
and, second, from the upstream side, by a proximal (i.e., upstream)
fixation member, thereby sandwiching the leaflets at the
above-mentioned angle (which is typically predefined) without
crimping, folding over, or bending the native leaflets;
[0541] the downstream fixation arms engage with an upstream portion
of the valve prosthesis to form a locking mechanism, which, for
some applications, includes barbs; and/or
[0542] divergent commissural struts which encompass at their distal
end an area larger than the native aortic orifice, so that the
struts help resist migration of the valve prosthesis in an upstream
direction (i.e., towards the left ventricle), and contribute to
exerting and enhancing axial force in an upstream direction in a
manner that increases with their outward angulation and the
downstream (aortic) pressure.
[0543] In some embodiments of the present invention, the valve
prosthesis is implanted using a transapical implantation procedure.
An introducer overtube or trocar is inserted into the left
ventricular apex using a Seldinger technique. Through this trocar,
a delivery catheter onto which the collapsed valve prosthesis
(covered by a sheath) is mounted, is advanced into the ascending
aorta. Withdrawal of the sheath causes the fixation arms to flare
out laterally to an angle which is typically predetermined by
design, and to open in an upstream direction.
[0544] Gentle withdrawal and rotation of the delivery catheter,
onto which the prosthesis with the flared-out arms is mounted,
causes the arms to slide into the aortic sinuses, until the arms
reach the bottom (anatomic inferior portion) of the sinuses. This
rotational alignment occurs because the three-dimensional geometry
of the downstream fixation frame, including the extended aortic
sinus fixation arms, conforms to the three-dimensional geometry of
the aortic valve and aortic root. In this position, the fixation
arms engage with the downstream side of the native valve leaflets,
and not with the upstream side of the native valve leaflets. Such
engagement limits the opening motion of the native valve leaflets
to the above-mentioned angle (which is typically predefined), so
that the native leaflets are not pushed against the coronary
arteries upon device release. In addition, such engagement provides
the proper conditions for sequentially entrapping the native valve
leaflets first from the downstream side (by the fixation arms), and
subsequently from the upstream side (by the bottom of the valve
prosthesis), thereby sandwiching the leaflets at the angle (which
is typically predefined), without crimping, folding over, or
bending the native leaflets.
[0545] Once the proper position of the arms at the bottom of the
aortic sinuses is verified, the correct position for complete
device release is automatically achieved. The proper position may
be verified, for example, by (a) sensing an elastic resistance in
the axial direction, and sensing that the device is rotationally
locked in place, and/or (b) using imaging techniques such as
fluoroscopy and/or ultrasound. Release of the device from the
delivery catheter causes a lower inflow portion of the prosthesis
to unfold and press against the upstream side of the native
leaflets, thereby engaging with the upstream fixation arms in the
aortic sinuses. The upstream fixation arms serve as counterparts to
the lower inflow portion of the prosthesis in a mechanism that
locks the native leaflets and the surrounding periannular tissue
for fixation.
[0546] Device migration in the upstream direction (into the left
ventricle) is prevented by (a) the aortic sinus fixation arms,
which exert axial pressure against the bottom of the sinuses, and
(b) the outwardly directed angulation of the
longitudinally-oriented commissural struts of the prosthesis. The
angulation of the struts not only prevents migration into the left
ventricle by itself, but, during systole, also by exerting leverage
on the aortic sinus fixation arms, which is a function of the
degree of the angle and aortic pressure. Migration of the device in
a downstream direction is prevented by the inflow part of the
device pressing against the periannular tissue surrounding the
upstream side of the valve leaflets, and by the inflow part of the
device engaging with the fixation arms in a locking mechanism,
which, for some applications, includes the use of barbs placed at
the inflow section of the device in an upstream direction against
the fixation arms.
[0547] In other embodiments of the present invention, the valve
prosthesis is implanted using another implantation technique, such
as an antegrade transseptal technique, or a retrograde
endovascular-percutaneous technique.
[0548] The present invention will be more fully understood from the
following detailed description of embodiments thereof, taken
together with the drawings, in which:
BRIEF DESCRIPTION OF THE DRAWINGS
[0549] FIG. 1 is a schematic illustration of a fully-assembled
valve prosthesis, in accordance with an embodiment of the present
invention;
[0550] FIG. 2A is a schematic illustration of a collapsible outer
support structure of the prosthesis of FIG. 1 prior to assembly
with an inner support structure of the prosthesis, in accordance
with an embodiment of the present invention;
[0551] FIG. 2B is a schematic illustration of the collapsible inner
support structure prior to assembly with the outer support
structure of the prosthesis of FIG. 1, in accordance with an
embodiment of the present invention;
[0552] FIGS. 2C and 2D are schematic illustrations of alternative
configurations of a portion of the prosthesis of FIG. 1, in
accordance with respective embodiments of the present
invention;
[0553] FIG. 2E is a schematic illustration of another configuration
of a collapsible outer support structure of the prosthesis of FIG.
1 prior to assembly with an inner support structure of the
prosthesis, in accordance with an embodiment of the present
invention;
[0554] FIGS. 3A-E are schematic illustrations of additional
configurations of the outer support structure of FIG. 2A, in
accordance with respective embodiments of the present
invention;
[0555] FIG. 3F is a schematic illustration of an additional
configuration of the outer support structure of FIG. 2A, in
accordance with an embodiment of the present invention;
[0556] FIG. 3G is a schematic illustration of a fully-assembled
valve prosthesis that includes inner engagement arms of the
configuration of FIG. 3F, in accordance with an embodiment of the
present invention;
[0557] FIGS. 4A-C are schematic illustrations of configurations for
coupling a pliant material to inner struts of the inner support
structure of FIG. 2B and strut supports of the outer support
structure of FIG. 2A, in accordance with respective embodiment of
the present invention;
[0558] FIGS. 4D and 4E are side-view schematic illustrations of
configurations for coupling the pliant material of FIGS. 4A-C to a
graft covering, in accordance with respective embodiments of the
present invention;
[0559] FIGS. 5A-C, 6A-B, 7A-E, and 8A illustrate apparatus and a
method for implanting the valve prosthesis of FIG. 1 in a native
stenosed valve of a heart, in accordance with respective
embodiments of the present invention;
[0560] FIGS. 8B-C illustrate the prosthesis of FIG. 1 in situ, in
accordance with respective embodiments of the present
invention;
[0561] FIGS. 9A-G schematically illustrate a transaortic approach
for implanting the valve prosthesis of FIG. 1, in accordance with
an embodiment of the present invention;
[0562] FIGS. 10A and 10B show the valve prosthesis of FIG. 1 in
open (systolic) and closed (diastolic) positions, respectively, in
accordance with an embodiment of the present invention;
[0563] FIGS. 11A-D illustrate several configurations for axially
coupling the valve prosthesis of FIG. 1 to the aortic annulus, in
accordance with respective embodiments of the present
invention;
[0564] FIGS. 12A-G illustrate a holding device for holding the
valve prosthesis of FIG. 1 prior to the implantation of the
prosthesis, in accordance with an embodiment of the present
invention;
[0565] FIGS. 13A-D illustrate the loading of the valve prosthesis
of FIG. 1 into a tube from the holding device of FIGS. 12A-G, in
accordance with an embodiment of the present invention;
[0566] FIG. 14 is a schematic illustration of a valve prosthesis
placed in a pulmonary valve, in accordance with an embodiment of
the present invention;
[0567] FIG. 15 is a schematic anatomical illustration showing the
location of a native valve complex, in accordance with an
embodiment of the present invention;
[0568] FIGS. 16A-H schematically illustrate another transapical
technique for implanting the prosthesis of FIG. 1, in accordance
with an embodiment of the present invention;
[0569] FIG. 17 is a schematic illustration showing a shape of
engagement arms of an outer support structure of the prosthesis of
FIG. 1, in accordance with an embodiment of the present
invention;
[0570] FIG. 18 is a schematic illustration of an assembled valve
prosthesis support structure, in accordance with an alternative
embodiment presented herein;
[0571] FIG. 19A is a schematic illustration of a collapsible outer
support structure of the valve prosthesis support structure of FIG.
18, prior to assembly with the inner support structure of FIG. 19B,
in accordance with an embodiment presented herein; and
[0572] FIG. 19B is a schematic illustration of a collapsible inner
support structure of the valve prosthesis support structure of FIG.
18, prior to assembly with the outer support structure of FIG. 19A,
in accordance with an embodiment of the present invention.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0573] FIG. 1 is a schematic illustration of a fully-assembled
valve prosthesis 10, in accordance with an embodiment of the
present invention. Valve prosthesis 10 comprises a collapsible
inner support structure 12 that serves as a proximal fixation
member, and a collapsible outer support structure 14 that serves as
a distal fixation member. Outer and inner support structures 14 and
12 may be initially formed separately and then joined together, as
shown, or may be formed as one integrated structure, i.e., not
formed separately and then joined together. For some applications,
outer and inner support structures 14 and 12 are joined together
prior to implantation of prosthesis 10 (during a manufacturing
process, or by a healthcare worker prior to implantation), while
for other applications, the outer and inner support structures are
coupled to one another during an implantation procedure. For some
applications, outer support structure 14 is constructed from a
plurality of separate pieces, which are joined to inner support
structure 12 using standard manufacturing means, such as welding,
gluing, or suturing (configuration not shown), such that the
functionality of outer support structure 14 is attained.
[0574] Valve prosthesis 10 is configured to be placed in a native
diseased valve of a subject, such as a native stenotic aortic or
pulmonary valve, using a minimally-invasive approach, such as a
beating heart transapical procedure, such as described hereinbelow
with reference to FIGS. 5A-8A or with reference to FIGS. 16A-H, or
a retrograde transaortic procedure, such as described hereinbelow
with reference to FIGS. 9A-G. As used in the present application,
including in the claims, a "native semilunar valve" is to be
understood as including: (a) native semilunar valves that include
their native leaflets, and (b) native semilunar valves, the native
leaflets of which have been surgically excised or are otherwise
absent.
[0575] Reference is made to FIG. 2A, which is a schematic
illustration of collapsible outer support structure 14 prior to
assembly with inner support structure 12, in accordance with an
embodiment of the present invention. Outer support structure 14 is
shaped so as to define a plurality of distal diverging strut
supports 20, from which a plurality of proximal engagement arms 22
extend radially outward in a proximal direction. Typically, the
engagement arms have a shape that is generally upwardly concave,
such as described hereinbelow with reference to FIG. 17.
[0576] Although three strut supports 20 and engagement arms 22 are
shown in the figures, for some applications valve prosthesis 10
comprises fewer or more supports and/or arms, such as two supports
and two arms. It is noted that approximately 90% of humans have
exactly three aortic sinuses. The three supports and/or arms
provided in most embodiments correspond to these three aortic
sinuses. For implantation in the approximately 10% of patients that
have exactly two aortic sinuses, prosthesis 10 typically includes
exactly two supports and/or arms.
[0577] Engagement arms 22 are typically configured to be at least
partially disposed within aortic sinuses of the subject, and, for
some applications, to engage and/or rest against floors of the
aortic sinuses, and to apply an axial force directed toward a left
ventricle of the subject. Engagement arms 22 meet one another at
respective junctures 24. For applications in which each of
engagements arms 22 is fabricated as a separate piece, the
engagement arms are mechanically engaged to one another where they
meet at respective junctures 24. For some applications, engagement
arms 22 meet one another without actually touching one another, and
instead meet via an area defined at each respective juncture 24.
Typically, the engagement arms are configured to define respective
peaks at junctures 24 (or peak complexes, as described hereinbelow
with reference to FIG. 3E), and respective troughs 26 between each
two of the peaks (or trough complexes, as described hereinbelow
with reference to FIG. 3E).
[0578] Outer support structure 14 comprises a suitable material
that allows mechanical deformations associated with crimping and
expansion of valve prosthesis 10, such as, but not limited to,
nitinol or a stainless steel alloy (e.g., AISI 316). Outer support
structure 14 is fabricated from a single piece or from a plurality
of parts that are coupled together (e.g., by suturing). For some
applications, placement of engagement arms 22 within the aortic
sinuses prevents "device migration," i.e., undesired retrograde
movement of valve prosthesis 10 that may result from fluid forces
applied to the valve. For some applications, engagement arms 22 are
coated with a flexible material (e.g., polyester, biocompatible,
synthetic, and/or pericardium).
[0579] Strut supports 20 and engagement arms 22 may be formed as
one integrated structure (as shown), or, alternatively, may be
initially formed separately and then joined to one another. For
example, the strut support and arms may be mechanically interlocked
or sutured together, or coupled by other means. Typically, the
strut support and arms are joined prior to implantation.
[0580] Reference is made to FIG. 2B, which is a schematic
illustration of collapsible inner support structure 12 prior to
assembly with outer support structure 14, in accordance with an
embodiment of the present invention. For some applications, inner
support structure 12 is shaped so as to define a plurality of
distal diverging inner struts 30, and a bulging proximal skirt 32
that extends from the struts. A proximal portion 34 of proximal
skirt 32 is configured to engage a left ventricular outflow tract
(LVOT) of the subject and/or periannular tissue at the top of the
left ventricle. A relatively narrow throat section 36 of proximal
skirt 32 is configured to be positioned at a valvular annulus of
the subject, and to engage the native valve leaflets. Inner support
structure 12 comprises, for example, nitinol, a stainless steel
alloy, another metal, or another biocompatible material.
[0581] Reference is again made to FIG. 1. Inner and outer support
structures 12 and 14 are assembled together by placing outer
support structure 14 over inner support structure 12, such that
outer strut supports 20 are aligned with, and typically support,
respective inner struts 30, and engagement arms 22 are placed over
a portion of proximal skirt 32. Inner struts 30 and outer strut
supports 20 together function as commissural posts.
[0582] Typically, such assembly is performed prior to implantation
of prosthesis 10, such as during manufacture of the prosthesis;
alternatively, such assembly is performed in vivo during an
implantation procedure, or prior to implantation by a healthcare
worker.
[0583] Valve prosthesis 10 typically comprises a prosthetic distal
valve 104, which typically comprises a pliant material 105 coupled
to strut supports 20 and/or inner struts 30. Pliant material 105 of
valve 104 is configured to collapse inwardly (i.e., towards a
longitudinal axis of valve prosthesis 10) during diastole, in order
to inhibit retrograde blood flow, and to open outwardly during
systole, to allow blood flow through the prosthesis. For some
applications, when in an open position, valve 104 assumes a
diverging shape that causes blood to flow therethrough with
pressure recovery at a distal outlet of the valve, for example
using techniques described in one or more of the above-mentioned
patent application publications to Schwammenthal et al. For other
applications, the shape of the valve does not cause such pressure
recovery. For example, an angle between the pliant material 105 and
a central longitudinal axis of prosthesis 10 may be too great to
cause pressure recovery. In this latter case, the large angle may
serve exclusively, or at least in part, to help provide axial
fixation of prosthesis 10 to the native valve complex. Regardless
of whether pressure recovery is achieved, the angle between pliant
material 105 and the central longitudinal axis of prosthesis 10
typically inhibits migration of the device in an upstream
direction.
[0584] Pliant material 105 comprises a flexible supple material,
such as an inert biological material, e.g., pericardium sheet or
any medically safe elastomer, such as, but not limited to,
polyester, polymer, a metallic material/alloy, polyurethane, latex,
or synthetic rubber. For some applications, pliant material 105 is
coupled to strut supports 20 and/or inner struts 30 by sewing, such
as described hereinbelow with reference to FIG. 4. For example,
pliant material 105 may be sewn onto outer diverging strut supports
20. Valve 104 comprises a single piece or multiple pieces of pliant
material 105 (e.g., leaflets) joined together to give a desired
shape, typically a distally diverging shape. For some applications,
the pliant material and support structures are coupled to one
another in a single-step procedure (e.g., by sewing all the pieces
together); alternatively, the pliant material and support
structures are coupled to one another in a plurality of sequential
steps.
[0585] Typically, valve prosthesis 10 further comprises a graft
covering 106 which is coupled to proximal skirt 32, such as by
sewing the covering within the skirt (configuration shown in FIG.
1) or around the skirt (configuration not shown). Inner support
structure 12 thus defines a central structured body for flow
passage that proximally terminates in a flared inlet (proximal
skirt 32) that is configured to be seated within an LVOT
immediately below an aortic annulus/aortic valve. For some
applications, graft covering 106 is coupled at one or more sites to
pliant material 105.
[0586] FIGS. 2C and 2D are schematic illustrations of alternative
configurations of a portion of valve prosthesis 10, in accordance
with respective embodiments of the present invention. In these
configurations, inner support structure 12 and outer support
structure 14 are replaced by an element 38, which is shaped so as
to define first and second portions 40 and 42. First portions 40
serve as support structures, each of which functionally corresponds
to a pair of strut support 20 and inner strut 30, described
hereinabove with reference to FIGS. 2A and 2B. Pliant material 105
is coupled to support structures 40. Second portions 42 are bent in
a proximal direction, such that proximal portions of the second
portions define respective engagement arms 22.
[0587] In the configuration shown in FIG. 2C, two second portions
42 extend from the distal end of each first portion 40. In the
configuration shown in FIG. 2D, element 38 is shaped so as to
define two shoulders 44 that extend laterally from each first
portion 40. A single second portion 42 extends from each of
shoulders 44.
[0588] Reference is again made to FIG. 1. In an embodiment of the
present invention, inner support structure 12 is shaped so as to
define one or more barbs 120, which are configured to pierce or
protrude into the ventricular side of the aortic annulus, as
described hereinbelow with reference to FIGS. 7A-E. For some
applications, one or more of inner struts 30 is shaped so as to
define a respective barb, while for other applications, another
element of valve prosthesis 10 is shaped so as to define the one or
more barbs, such as proximal skirt 32. For some applications, barbs
120 are oriented parallel to a longitudinal axis of valve
prosthesis 10, while for other applications, barbs 120 are oriented
to form an angle with respect to the longitudinal axis, such as
between about -20 degrees (i.e., slanted towards a central axis of
the native valve) and about +89 degrees (i.e., slanted away from
the central axis of the native valve), such as between about -5 and
about +30 degrees. For some applications, barbs 120 are set at the
desired angle by heat-setting.
[0589] Reference is made to FIG. 2E, which is a schematic
illustration of another configuration of collapsible outer support
structure 14 prior to assembly with inner support structure 12, in
accordance with an embodiment of the present invention. Inter-strut
support elements 17 are coupled between adjacent ones of distal
diverging strut supports 20, and typically serve to help maintain a
desired distance between each of strut supports 20. For example, if
a force is applied that would bring closer or separate two of the
strut supports, the inter-strut support element between the strut
supports would tend to reduce such a deformation. For some
applications, one or more of support elements 17 is shaped so as to
define a kink or curved section 19, which deforms slightly in
response to force applied to element 17.
[0590] Reference is made to FIGS. 3A-E, which are schematic
illustrations of additional configurations of outer support
structure 14, in accordance with respective embodiments of the
present invention. In the configurations shown in FIGS. 3A-B, outer
support structure 14 is shaped so as to define one or more native
valve support elements 122. These support elements apply pressure
to an outer (downstream) surface of the native valve when
engagement arms 22 are positioned in the aortic sinuses, so as to
hold the native leaflets in place against proximal skirt 32. In the
configuration shown in FIG. 3A, the area defined by engagement arms
22 and support elements 122 is open, while in the configuration
shown in FIG. 3B, a covering 124 is provided in this area. The
covering generally may help capture calcific, thrombotic, or other
material which might be dislodged from the native valve or the
surrounding tissue, and may comprise, for example, polyester. In
the configuration shown in FIG. 3C, covering 124 is provided
without support elements 122.
[0591] In the configuration shown in FIG. 3D, each of engagement
arms 22 comprises or is shaped so as to define at least one
extension element 23 that extends from the engagement arm. The
engagement arms and extension elements are configured such that the
engagement arms engage and/or rest against the floors of the aortic
sinuses via the extension elements. For some applications, such as
shown in FIG. 3D, exactly one extension element 23 extends from
each of engagement arms 22, while for other applications, more than
one extension element 23 extends from each engagement arm
(configuration not shown). Although engagement arms 22 are shown in
FIG. 3D as curving down toward the sinus floors, for some
applications the engagement arms are shaped so as to remain above
the native commissures (for example, the engagement arms
collectively may be annular in shape), or to curve down less than
is shown in FIG. 3D.
[0592] In the configuration shown in FIG. 3E, each of engagement
arms 22 is shaped so as to define a plurality of troughs 25 and
local peaks 27, rather than a single trough 26, as shown in FIG.
2A. In addition, each of engagement arms 22 is shaped so as to
define a plurality of peaks 29 and local troughs 31, rather than a
single peak at each of junctures 24, as shown in FIG. 2A. (Outer
support structure 14 may include both, only one of, or neither of
the features described in the preceding two sentences.) As used in
the present application, including in the claims, a "trough
complex" means a portion of an engagement arm that extends
downwards between respective "peak complexes." Each "trough
complex" includes n local troughs 25 and n-1 local peaks 29, where
n is greater than or equal to one. Each "peak complex" includes m
local peaks 29 and m-1 local troughs 31, where m is greater than or
equal to one. It is noted that the portion of a peak complex that
is at a juncture may define a local trough (configuration not
shown). In addition, although the peak and trough complexes shown
in FIG. 3E are generally symmetrical, non-symmetrical arrangements
are also within the scope of the present invention.
[0593] For some applications, respective extension elements 23,
described hereinabove with reference to FIG. 3D, extend from one or
more of the troughs of a trough complex, and/or from elsewhere
along the trough complex.
[0594] FIG. 3F is a schematic illustration of an additional
configuration of outer support structure 14, in accordance with an
embodiment of the present invention. In this embodiment, outer
support structure 14, in addition to defining proximal engagement
arms 22, is shaped so as to define a plurality of inner engagement
arms 33. The inner engagement arms are configured to pass through
the valvular annulus. Typically, troughs 35 of inner engagement
arms 33 are configured to engage the LVOT and/or periannular tissue
at the top of the left ventricle. For some applications, each of
inner engagement arms 33 is shaped so as to define one or more
barbs 37, which are configured to pierce or protrude into the
ventricular side of the aortic annulus. Typically, during an
implantation procedure, inner engagement arms 33 are released from
an overtube, trocar, or catheter prior to the release of proximal
skirt 32 therefrom, such as described hereinbelow with reference to
FIGS. 7A-C, 9A-G, and 16A-H. The fixation provided by inner
engagement arms 33 holds prosthesis 10 in place until the
implantation procedure is complete, such that blood flow against
skirt 32 does not dislodge the prosthesis during the implantation
procedure.
[0595] FIG. 3G is a schematic illustration of a fully-assembled
valve prosthesis that includes inner engagement arms 33 of FIG. 3F,
in accordance with an embodiment of the present invention. FIG. 7E,
described hereinbelow, shows prosthesis 10 in situ having the
configuration shown in FIG. 3F.
[0596] For some applications, the features shown in one or more of
FIGS. 2A-B and 3A-G are combined. For example, valve support
elements 122 and/or covering 124 may be provided for arms 22 of
FIG. 3E. Other such combinations of features are within the scope
of the present invention.
[0597] Reference is now made to FIGS. 4A-C, which are schematic
illustrations of configurations for coupling pliant material 105 to
inner struts 30 of inner support structure 12 and to strut supports
20 of outer support structure 14, in accordance with respective
embodiments of the present invention.
[0598] In the configuration shown in FIG. 4A, valve 104 comprises a
plurality of segments of pliant material 105, pairs of which are
coupled together at respective interfaces between one of inner
struts 30 and one of strut supports 20. Inner strut 30 is shaped so
as to define an elongated slit 130. During manufacture of valve
prosthesis 10, edges of two pieces of pliant material 105 are
inserted through slit 130 such that a portion of each of the pieces
of pliant material is sandwiched between inner strut 30 and strut
support 20. The inner strut and strut support are tightly coupled
together, such as by passing one or more sutures 132 through holes
134 defined by inner strut 30 and strut support 20. Sutures 132
typically couple the strut and strut support together such that
pliant material 105 is supported on both sides thereof, thereby
forming a strain relief which reduces stresses on the leaflets of
valve 104 at the sutures. The relatively large surface areas of
inner strut 30 and strut support 20 distribute the stress applied
at pliant material 105, so that this stress is not applied
primarily around holes 134. Typically, the edges of slit 130 are
rounded in order to avoid damage to pliant material 105.
[0599] In the configuration shown in FIGS. 4B-C, portions 136 of
graft covering 106 (including, optionally, pericardium or any
suitable supple synthetic or biological material) are inserted
through slit 130, between the edges of the slit and the two pieces
of pliant material. The portions of the graft covering reduce
friction between the pliant material and inner strut 30. As can be
seen in FIG. 4C, portions 136 of graft covering 106 are typically
integral with the rest of graft covering 106 (which is sewn to
skirt 32). Graft covering 106 (including, optionally, pericardium
or any suitable supple synthetic or biological material) is thus
shaped so as to define distally protruding portions 136.
[0600] FIGS. 4D and 4E are side-view schematic illustrations of two
configurations for coupling pliant material 105 to graft covering
106, and reducing leaflet stress during valve opening (FIG. 4D) or
valve closure (FIG. 4E), in accordance with respective embodiments
of the present invention. In both of these configurations, graft
covering 106 is sewn to a cord 107, such that a portion of pliant
material 105 is held between the cord and the graft covering. Cord
107 passes through a hole 108 (FIG. 4C) passing through or near one
of the commissural posts (configuration not shown).
[0601] Reference is now made to FIGS. 5A-8A, which illustrate
apparatus and a method for implanting valve prosthesis 10 in a
native stenosed valve 140 of a heart 142, in accordance with
respective embodiments of the present invention.
[0602] FIGS. 5A-C illustrate an overtube or trocar 150 and the
initial steps of the implantation method, in accordance with
respective embodiments of the present invention. Overtube or trocar
150 is placed over a dilator 154. As shown in FIG. 5A, overtube or
trocar 150 is typically inserted through an apex 156 of heart 142,
and advanced into a left ventricle 157 where its motion is
terminated, or through left ventricle 157 until the distal end of
dilator 154 passes native aortic valve leaflets 158. For example,
apex 156 may be punctured using a standard Seldinger technique, and
a guidewire may be advanced into an ascending aorta 160.
Optionally, native aortic valve 140 is partially dilated to about
15-20 mm (e.g., about 16 mm), typically using a standard
valvuloplasty balloon catheter. (In contrast, full dilation would
be achieved utilizing dilation of 20 mm or more.) Overtube or
trocar 150 is advanced into the ascending aorta. Overtube or trocar
150 is pushed beyond aortic valve 140 such that the distal end of
overtube or trocar 150 is located above the highest point of native
aortic valve 140. Dilator 154 is removed while overtube or trocar
150 remains in place with its distal end located above aortic valve
140, as shown in FIG. 5B. It is to be understood that the procedure
may be modified so that overtube or trocar 150 is placed within the
left ventricle and remains within the left ventricle throughout the
entire implantation procedure. Valve prosthesis 10 is advanced
through the distal end of overtube or trocar 150 into ascending
aorta 160 distal to native leaflets 158, as shown in FIG. 5C.
Typically, to facilitate this advancement, prior to the
implantation procedure valve prosthesis 10 is loaded into a
delivery tube 202, such as described hereinbelow with reference to
FIGS. 12A-13D. During the implantation procedure, delivery tube 202
is advanced through overtube or trocar 150, thereby advancing the
valve prosthesis through the overtube or trocar.
[0603] FIGS. 6A-B show an implantation of valve prosthesis 10 in
ascending aorta 160, in accordance with an embodiment of the
present invention. As mentioned above with reference to FIGS. 5A-C,
the distal end of overtube or trocar 150 is positioned past native
valve leaflets 158. The distal end of valve prosthesis 10 is
advanced out of overtube or trocar 150 until engagement arms 22
exit overtube or trocar 150 and snap or spring open, as shown in
FIG. 6A. Overtube or trocar 150 is gently pulled back until
engagement arms 22 are brought into aortic sinuses 164. For some
applications, overtube or trocar 150 and/or valve prosthesis 10 are
gently rotated as indicated by arrows 166 in order to align
engagement arms 22 with respective aortic sinuses 164. Although not
typically necessary, fluoroscopic, ultrasound, or other surgical
imaging techniques may be used to aid in this positioning. Overtube
or trocar 150 and valve prosthesis 10 are pulled back slightly,
such that engagement arms 22 are positioned within respective
aortic sinuses 164, as shown in FIG. 6B. (Although engagement arms
22 are shown in FIG. 6B as being in contact with the sinus floors,
for some applications the engagement arms do not come in contact
with the sinus floors, such as described hereinbelow with reference
to FIG. 7B.) Typically, valve prosthesis 10 is configured such that
when engagement arms 22 are placed properly within aortic sinuses
164, outer strut supports 20 are aligned with commissures 170 (see,
for example, FIG. 8A), thus preventing any possible obstruction of
coronary ostia 116 by valve prosthesis 10. At this point in the
implantation procedure, the distal end of valve prosthesis 10 is
free of overtube or trocar 150, and the proximal end of prosthesis
10 remains in overtube or trocar 150.
[0604] For some applications, the use of imaging techniques is not
necessary. The careful pulling back of valve prosthesis 10, without
application of excessive force, generally causes each of engagement
arms 22 to automatically self-align with a respective aortic sinus
164, because outer support structure 14, particularly engagement
arms 22, generally matches the three-dimensional shape of aortic
valve 140. If one of engagement arms 22 comes in contact with a
commissure 170 during the careful pulling back of the prosthesis,
the arm slides down the slope of the leaflet into the aortic sinus.
Typically, arms 22 are evenly distributed around valve prosthesis
10 with a separation of 120 degrees between arms, such that all
three arms naturally fall into place in respective sinuses upon
even just one of the engagement arms achieving proper alignment
with a sinus. This natural alignment generally occurs even if the
sinuses themselves are not perfectly distributed at 120 degrees
from one another.
[0605] This alignment process generally ensures positioning of the
prosthetic leaflets within the aortic sinuses, thus exposing the
prosthetic leaflets to natural blood vortex formation in the aortic
sinuses, which contributes to early closure of the prosthetic
leaflets, thus reducing closing volume (i.e., leakage through the
prosthetic leaflets before fully closing), as well as promoting
low-impact closure of the prosthetic leaflets, which typically
reduces leaflet wear.
[0606] For some applications, a correct rotational disposition of
the prosthesis with respect to the aortic valve site is determined
by the surgeon based on tactile feedback.
[0607] Reference is now made to FIGS. 7A-E, which illustrate valve
prosthesis 10 in situ upon completion of the implantation
procedure, in accordance with respective embodiments of the present
invention. After valve prosthesis 10 is placed properly within
native stenosed valve 140, as described hereinabove with reference
to FIGS. 5A-6B, the proximal end of valve prosthesis 10 is released
from overtube or trocar 150, by withdrawing overtube or trocar 150.
Proximal skirt 32 snaps or springs open to at least partially
engage, with its proximal portion 34, the left-ventricular side of
native valve 140, including at least a portion of an inner surface
of an LVOT 180. As a result, valve prosthesis 10 forms an axial
engagement system above and below native valve annulus 182 of
native valve 140, which axially sandwiches a native valve complex
(as defined hereinbelow with reference to FIG. 15) from the aortic
and left-ventricular sides thereof. Native valve leaflets 158 are
captured between proximal skirt 32 and engagement arms 22,
typically without applying force along the longitudinal axis of the
leaflets, in order to avoid shortening of the length of the
leaflets, or forced bending, crimping, or folding over of the
leaflets. For some applications, barbs 120, if provided, pierce
aortic annulus 182 on the left-ventricular side of native valve
140, while for other applications, the barbs are blunt, in which
case they generally protrude into the tissue of the aortic annulus,
without piercing the tissue. For some applications, support
structure 14 is configured to elevate native valve leaflets 158
from within the aortic sinuses.
[0608] In the embodiment shown in FIG. 7A, upon the completion of
the implantation of prosthesis 10, engagement arms 22 are
positioned within aortic sinuses 164, such that the ends of the
engagement arms touch the floors of the sinuses. Although the ends
of the engagement arms are shown touching approximately the radial
center of the floors of the sinuses, for some applications, the
ends of the engagement arms touch the floors further from leaflets
158 or closer to the leaflets, or touch the body of the leaflets,
the roots of the leaflets, or the transition between the sinuses
and the leaflet roots. Alternatively, the engagement arms are
shorter, such as shown in FIG. 7B, such that they do not reach the
floors of the sinuses. Further alternatively, for some applications
prosthesis 10 does not comprise arms 22, as shown in FIG. 7C.
[0609] In the embodiment shown in FIG. 7D, prosthesis 10 has been
implanted after the native valve leaflets have been excised, in
accordance with an embodiment of the present invention.
[0610] The embodiment illustrated in FIG. 7E shows valve prosthesis
10 in situ having the configuration of outer support structure 14
described hereinabove with reference to FIG. 3F.
[0611] For some applications, barbs 120 are coated or otherwise
provided with a surface property for enhancing their attachment to
tissue of aortic annulus 182. Graft covering 106 of proximal skirt
32 also helps prevent regurgitation and device migration.
[0612] For some applications, the positioning of arms 22 prior to
the opening of proximal skirt 32 prevents native valve leaflets 158
from opening more than a predetermined desired amount. The support
provided by arms 22 to the valve leaflets limits the subsequent
opening of the leaflets by the proximal skirt. The desired amount
of opening is determined at least in part by the angle between arms
22 and a central longitudinal axis of the prosthesis (shown, for
example, as angle .theta. in FIG. 7A). Typically, the angle is
between about 1 and about 89 degrees, such as between about 10 and
about 60 degrees, such as 25 degrees, or between about 25 and about
65 degrees. Typically, the angle is predetermined. For some
applications, the fixation members of prosthesis 10 are configured
to prevent opening of the native leaflets to their maximum
diameter.
[0613] Reference is again made to FIG. 7A. For some applications,
prosthetic distal valve 104 is coupled to strut supports 20 and/or
inner struts 30 of prosthesis 10 (see, for example, FIG. 1), such
that at least 50% of an axial length of the prosthetic leaflets is
distal to native valve leaflets 158. In other words, if prosthetic
distal valve 104 has an axial length L1, a portion L2 of length L1
that is distal to leaflets 158 is greater than a portion L3 of
length L1 that is proximal to leaflets 158.
[0614] FIG. 8A shows valve prosthesis 10 in situ upon completion of
the implantation procedure, as viewed from ascending aorta 160,
upon placement of engagement arms 22 within respective aortic
sinuses 164, in accordance with an embodiment of the present
invention. In this embodiment, engagement arms 22 are positioned
within aortic sinuses 164, such that the ends of the engagement
arms touch the floors of the sinuses, for example as described
hereinabove with reference to FIG. 7A.
[0615] FIG. 8B shows valve prosthesis 10 in situ upon completion of
the implantation procedure, in accordance with an embodiment of the
present invention. In this embodiment, junctures 24 between pairs
of engagement arms 22 ride above respective native commissures 170,
without impinging on the commissures (i.e., touching or pushing the
commissures). In other words, there is a gap between each of
junctures 24 and its respective native commissure 170. Engagement
arms 22 are positioned within aortic sinuses 164, such that the
ends of the engagement arms touch the floors of the sinuses. In
this embodiment, the number of engagement arms 22 is typically
equal to the number of aortic sinuses 164 of the native valve, and
the engagement arms are radially separated by approximately equal
angles. The three-dimensional shape of engagement arms 22 causes
the ends of the engagement arms to find the lowest point of reach
within the floors of the sinuses, thereby enabling self-alignment
of prosthesis 10 with the native aortic valve site and commissures
170.
[0616] A length L (parallel to a longitudinal axis of prosthesis
10) between (a) each juncture 24 and (b) the contact point of
respective engagement arm 22 to the sinus floor is typically
greater than about 6 mm, e.g., greater than about 10 mm, or than
about 13 mm. For some applications, length L is between about 10
and about 18 mm, e.g., about 13 mm.
[0617] In typical human subjects, the native valve complex has
three native commissures 170, which define respective commissural
high points, and three respective sinus low points. Prosthesis 10
is configured to match these high and low points. Such matching
enables axial anchoring, without forced bending, crimping, or
folding over of the leaflets, and without impinging on the
commissures. In this way, prosthesis 10 embraces the leaflets,
rather than squeezing them.
[0618] For some applications, engagement arms 22 are generally
aligned with the native leaflets, thereby avoiding local
deformation, and distributing force over a larger contiguous area
of the leaflet surface.
[0619] FIG. 8C shows valve prosthesis 10 in situ upon completion of
the implantation procedure, in accordance with an embodiment of the
present invention. In this embodiment, junctures 24 between pairs
of engagement arms 22 ride above respective native commissures 170,
impinging on the commissures (i.e., touching or pushing the
commissures). Engagement arms 22 are positioned within aortic
sinuses 164, such that the ends of the engagement arms do not reach
the floors of the sinuses (such as described hereinabove with
reference to FIG. 7B). The three-dimensional shape of junctures 24
causes the junctures to align with commissures 170, thereby
enabling self-alignment of prosthesis 10 with the native aortic
valve site and commissures 170. In an embodiment (not shown),
junctures 24 apply axial force to (i.e., push) the commissures, and
engagement arms 22 apply axial force to aortic sinuses 164.
[0620] Reference is made to FIGS. 9A-G, which schematically
illustrate a retrograde transaortic approach for implanting valve
prosthesis 10, in accordance with an embodiment of the present
invention. Prior to the implantation procedure, prosthesis 10 is
positioned in a retrograde delivery catheter 250, as shown in FIG.
9G. A retrograde delivery catheter tube 251 of catheter 250 holds
engagement arms 22, and a delivery catheter cap 252 holds proximal
skirt 32.
[0621] The implantation procedure begins with the transaortic
insertion of a guidewire 190 into left ventricle 157, as shown in
FIG. 9A. Optionally, stenotic aortic valve 140 is partially dilated
to about 15-20 mm (e.g., about 16 mm), typically using a standard
valvuloplasty balloon catheter. (In contrast, full dilation would
be achieved by using a balloon catheter with a diameter of 20 mm or
more.) Retrograde delivery catheter 250 is advanced over guidewire
190 into ascending aorta 160 towards native aortic valve 140, as
shown in FIG. 9A. As shown in FIG. 9B, retrograde delivery catheter
250 is advanced over guidewire 190 until delivery catheter cap 252
passes through native aortic valve 140 partially into left
ventricle 157. As also shown in FIG. 9B, retrograde delivery
catheter tube 251 is pulled back (in the direction indicated by an
arrow 255), while a device stopper 254 (shown in FIG. 9G) prevents
valve prosthesis 10 within tube 251 from being pulled back with
tube 251, so that engagement arms 22 are released and flare out
laterally into the sinuses. At this stage of the implantation
procedure, proximal skirt 32 of prosthesis 10 remains in delivery
catheter cap 252.
[0622] As shown in FIG. 9C, at the next step of the implantation
procedure, delivery catheter cap 252 is pushed in the direction of
the apex of the heart (as shown by an arrow 257), using a
retrograde delivery catheter cap shaft 253 that passes through tube
251 and prosthesis 10. This advancing of cap 252 frees proximal
skirt 32 to snap or spring open, and engage the inner surface of
LVOT 180. Barbs 120, if provided, pierce or protrude into the
aortic annulus on the left-ventricular side of the native valve.
Retrograde delivery catheter tube 251 is further pulled back until
the rest of valve prosthesis 10 is released from the tube, as shown
in FIG. 9D.
[0623] Retrograde delivery catheter tube 251 is again advanced over
shaft 253 toward the apex of the heart, until tube 251 rejoins cap
252, as shown in FIG. 9E. Retrograde delivery catheter 250 and
guidewire 190 are withdrawn from left ventricle 157, and then from
ascending aorta 160, leaving prosthesis 10 in place, as shown in
FIG. 9F.
[0624] FIGS. 10A and 10B show valve prosthesis 10 in open
(systolic) and closed (diastolic) positions, respectively, in
accordance with an embodiment of the present invention. For clarity
of illustration, the surrounding anatomy is not shown in the
figure.
[0625] Collapsible pliant material 105 of valve 104 opens during
systole and closes during diastole, because of the fluid forces
applied thereto by the blood flow and the pressure difference
between the left ventricle and the aorta. Alternatively, valve 104
comprises one or more rigid components, such as rigid leaflets, for
example as described in U.S. Pat. No. 6,312,465 to Griffin et al.
or U.S. Pat. No. 5,908,451 to Yeo, both of which are incorporated
herein by reference. Although prosthesis 10, including valve 104,
is shown in the figures as defining a single flow field
therethrough, for some applications the prosthesis and valve are
configured so as to define a plurality of flow fields therethrough,
such as shown in several figures of the '451 patent to Yeo (e.g.,
FIGS. 1-3 thereof).
[0626] Reference is made to FIGS. 11A-D, which illustrate several
configurations for axially coupling valve prosthesis 10 to aortic
annulus 182, in accordance with respective embodiments of the
present invention. For clarity of illustration, these figures show
a spread view of the native valve, viewed from a central axis of
the native valve, with native aortic valve leaflets 158 cut
longitudinally and pulled to the sides.
[0627] In the configuration shown in FIG. 11A, proximal skirt 32 of
valve prosthesis 10 is shaped so as to define a single barb 120 for
each leaflet 158, such that the barbs are generally centered with
respect to the leaflets and engagement arms 22. In the
configuration shown in FIG. 11B, the proximal skirt is shaped so as
to define a pair of barbs 120 for each leaflet 158.
[0628] In the configuration shown in FIG. 11C, each engagement arm
22 comprises at least one proximal spike 192, which typically
protrudes from a most proximal region of the engagement arm (i.e.,
the portion of the engagement arm closest to the apex of the
heart). Spikes 192 penetrate aortic annulus 182 from the aortic
side, until the spikes exit the annulus on the left-ventricular
side, and engage respective barbs 120 on the left-ventricular
side.
[0629] In the configuration shown in FIG. 11D, barbs 120 penetrate
aortic annulus 182 from the left-ventricular side thereof, until
the barbs exit the annulus on the aortic side, and are coupled to
respective engagement arms 22 in respective sinuses. For example,
the ends of the barbs may be shaped as hooks, in order to hook
around proximal regions of engagement arms 22.
[0630] Reference is made to FIGS. 12A-G, which illustrate a holding
device 200 for holding valve prosthesis 10 prior to the
implantation of the prosthesis, in accordance with an embodiment of
the present invention. Valve prosthesis 10 is loaded into delivery
tube 202 from holding device 200, as is described hereinbelow with
reference to FIGS. 13A-D. During an implantation procedure,
delivery tube 202 is advanced into an overtube or trocar, such as
overtube or trocar 150, described hereinabove with reference to
FIGS. 5A-C.
[0631] FIGS. 12A and 12B illustrate outer and sectional views,
respectively, of holding device 200, in accordance with an
embodiment of the present invention. For some applications, holding
device 200 is shaped so as to define a conical portion 204 and a
tubular portion 206. Holding device 200 comprises, for example,
plastic.
[0632] FIG. 12C shows valve prosthesis 10 loaded in holding device
200, in accordance with an embodiment of the present invention. The
proximal end of valve prosthesis 10 is typically fully compressed
within tubular portion 206, while collapsible pliant material 105
is in at least a partially open position within conical portion
204, so as not to deform the typically delicate material of the
valve. The proximal end of the prosthesis is optionally coupled to
a device holder 208.
[0633] FIGS. 12D and 12E show a configuration of device holder 208,
in accordance with an embodiment of the present invention. In this
configuration, device holder 208 is shaped so as to define one or
more female coupling openings 209, to which corresponding male
coupling members 218 of valve prosthesis 10 are releasably coupled.
For example, proximal portion 34 of proximal skirt 32 (FIGS. 1 and
2B) may be shaped so as to define male coupling members 218. (For
clarity of illustration, proximal skirt 32 is not shown in FIG.
12E.) For some applications, the genders of the coupling elements
are reversed.
[0634] FIG. 12F illustrates holding device 200 in storage in a jar
210 containing a preservation fluid 212 such as glutaraldehyde
solution. For some applications, holding device 200 is held upright
by a holder 214. The contents of the holding device 200 are
typically kept in preservation fluid 212 at all times, and jar 210
is sealed by a cover 216.
[0635] FIG. 12G illustrates the removal of holding device 200 from
storage jar 210 prior to loading valve prosthesis 10 into delivery
tube 202, in accordance with an embodiment of the present
invention. Holding device 200 and its contents are typically washed
prior to loading.
[0636] Reference is now made to FIGS. 13A-D, which illustrate the
loading of valve prosthesis 10 into delivery tube 202 from holding
device 200, in accordance with an embodiment of the present
invention. As shown in FIG. 13A, a distal end of a central delivery
shaft 222 includes a device holder connector 220. Device holder
connector 220 is removably coupled to device holder 208, which is
coupled (e.g., fixed) to valve prosthesis 10. For example, device
holder connector 220 and device holder 208 may comprise mating,
screw-threaded male and female connectors.
[0637] As shown in FIG. 13B, retraction, to the right in the
figure, of central delivery shaft 222 pulls valve prosthesis 10,
which is at least partially compressed, into delivery tube 202. As
shown in FIG. 13C, valve prosthesis 10 is pulled into delivery tube
202. Valve prosthesis 10 is placed in delivery tube 202 such that
engagement arms 22 extend from delivery tube 202, and thus are free
to flare outwards radially, as shown in FIG. 13D. (The engagement
arms are constrained from flaring outwards during the initial steps
of an implantation procedure by an overtube or trocar into which
delivery tube 202 is inserted, such as overtube or trocar 150,
described hereinabove with reference to FIGS. 5A-C.)
[0638] Although valve prosthesis 10 has been generally described
herein as being implantable in an aortic valve, in some embodiments
of the present invention the valve prosthesis is configured to be
placed in another cardiac valve, such as a mitral valve, tricuspid
valve, or pulmonary valve (such as described hereinbelow with
reference to FIG. 14), or in a venous valve. As used herein,
including in the claims, "proximal" and "upstream" mean the side of
the native or prosthetic valve closer to incoming blood flow, and
"distal" and "downstream" mean the side of the native or prosthetic
valve closer to outgoing blood flow.
[0639] Reference is made to FIG. 14, which is a schematic
illustration of a fully-assembled valve prosthesis 300 placed in a
pulmonary valve 310, in accordance with an embodiment of the
present invention. Valve prosthesis 300 is generally similar to
valve prosthesis 10, described herein with reference to FIGS. 1-13D
and 16A-17, with appropriate modifications, such as size, for
placement in pulmonary valve 310. Valve prosthesis 300 comprises
two portions that are configured to axially sandwich the native
pulmonary valve complex from right-ventricular 312 and pulmonary
trunk 314 sides thereof.
[0640] Reference is made to FIG. 15, which is a schematic
anatomical illustration showing the location of a native valve
complex, in accordance with an embodiment of the present invention.
As used herein, including in the claims, the "native valve complex"
includes the area demarcated by a box 320, which includes native
aortic valve leaflets 158, native valve annulus 182, subvalvular
tissue 322 on the left-ventricular side, and the lower half of the
aortic sinuses 164 (i.e., up to the top of box 320).
[0641] Reference is made to FIGS. 16A-H, which schematically
illustrate another transapical technique for implanting valve
prosthesis 10 (in addition to the transapical approach described
hereinabove with reference to FIGS. 5A-8A), in accordance with an
embodiment of the present invention. Prior to the implantation
procedure, prosthesis 10 is positioned in a transapical delivery
catheter 350, as shown in FIG. 16H. A transapical delivery tube 351
of catheter 350 holds proximal skirt 32, and a transapical delivery
cap 352 holds the distal end of the valve.
[0642] The implantation procedure begins with insertion of catheter
350 through an apex of the heart, into left ventricle 157. For
example, the apex may be punctured using a standard Seldinger
technique. A guidewire 390 is advanced through catheter 350 into
ascending aorta 160, as shown in FIG. 16A. Optionally, aortic valve
140 is partially dilated to about 15-20 mm (e.g., about 16 mm),
typically using a standard valvuloplasty balloon catheter.
[0643] Catheter 350 is advanced over guidewire 390 through native
aortic valve 140, into ascending aorta 160. Delivery cap 352 is
advanced further into the ascending aorta, by pushing with delivery
cap shaft 353. The advancement of the delivery cap releases
engagement arms 22, which flare out laterally, as shown in FIG.
16B. Catheter 350 is withdrawn towards the ventricle, thereby
positioning engagement arms 22 in the sinuses, as shown in FIG.
16C. (Although engagement arms 22 are shown in FIG. 16C as being in
contact with the sinus floors, for some applications the engagement
arms do not come in contact with the sinus floors, such as
described hereinabove with reference to FIG. 7B.) At this stage of
the implantation procedure, proximal skirt 32 remains in tube
351.
[0644] Alternatively, catheter 350 is placed within an overtube
(not shown), similar to overtube or trocar 150 (FIGS. 5A-6B), and
in such a configuration the engagement arms may be released either
by pulling back of the overtube, or by the pushing forward of
delivery end cap 352.
[0645] At the next step of the implantation procedure, tube 351 is
withdrawn in the direction of the apex of the heart. Delivery cap
shaft 353 prevents cap 352 from being withdrawn with tube 351 (FIG.
16H). As a result, proximal skirt 32 is freed from tube 351 to snap
or spring open, and engage the inner surface of LVOT 180. Barbs
120, if provided, pierce or protrude into the aortic annulus on the
left-ventricular side of the native valve. It is noted that cap 352
remains in place until after proximal skirt 32 opens. Blood flow
thus cannot wash the skirt downstream during the implantation
procedure.
[0646] Cap 352 is advanced further into the ascending aorta by
pushing on delivery cap shaft 353, thereby releasing the rest of
valve prosthesis 10 from cap 352, as shown in FIG. 16E. Delivery
tube 351 is advanced over shaft 353 through aortic valve 140, until
tube 351 rejoins cap 352, as shown in FIG. 16F. Delivery catheter
350 is withdrawn into the left ventricle, as shown in FIG. 16G, and
then from the heart, along with guidewire 390. Prosthesis 10 is
left in place, completing the implantation procedure.
[0647] Reference is made to FIG. 17, which is a schematic
illustration showing a shape of engagement arms 22, in accordance
with an embodiment of the present invention. In the figure, outer
support structure 14 is shown placed on an abstract geometric form
400 for clarity of illustration of the shape of the structure. As
can be seen, in this embodiment engagement arms 22 have a shape
that is generally upwardly concave (except at the junctures), i.e.,
concave in a downstream direction. In mathematical terms, this
shape can be characterized by the function z''(r)>0, where z is
the height at any given point on one of engagement arms 22 (e.g.,
point P), and r is the distance from the z-axis to the given point.
(It is understood that the arms may be shaped so as to include one
or more relatively short sections that are upwardly convex (i.e.,
z''(r)<0), but that the general shape of the arms is upwardly
concave.)
[0648] For some applications, engagement arms 22 are shaped such
that at least a portion of the arms is parallel to the longitudinal
axis of outer support structure 14.
[0649] In en embodiment, the shape of the arms is characterized by
the function z''(r)<=0, i.e., the general shapes of the arms is
not upwardly concave.
[0650] As used herein, including in the claims, the "ascending
aorta" includes the aortic root (sinuses) and the tubular portion
above the root.
[0651] Although valve prostheses 10 and 300 have been described
herein as comprising a valve, for some applications the prostheses
do not comprise valves.
[0652] FIG. 18 is a schematic illustration of an assembled valve
prosthesis support structure 1800, in accordance with an
alternative embodiment presented herein. Assembled valve prosthesis
support structure 1800 comprises a collapsible inner support
structure 1812, which serves as a proximal fixation member, and a
collapsible outer support structure 1814, which serves as a distal
fixation member.
[0653] FIG. 19A is a schematic illustration of collapsible outer
support structure 1814. FIG. 19B is a schematic illustration of
collapsible inner support structure 1812. Outer and inner support
structures 1814 and 1812 may be initially formed separately and
then joined together, as shown in FIG. 18, or may be formed as one
integrated structure. In one embodiment, outer and inner support
structures 1814 and 1812 are joined together prior to implantation
of the prosthesis (e.g., during a manufacturing process, or by a
healthcare worker prior to implantation). In another embodiment,
the outer and inner support structures 1814 and 1812 are coupled to
one another during an implantation procedure. In one embodiment,
outer support structure 1814 is constructed from a plurality of
separate pieces, which are joined to inner support structure 1812
using standard manufacturing means, such as welding, gluing, or
suturing, such that the functionality of outer support structure
1814 is attained.
[0654] Assembled valve prosthesis support structure 1800 is
configured to include a valve prosthesis as described above with
respect to FIG. 1. The support structure 1800 and valve prosthesis
is configured to be placed in a native diseased valve of a subject,
such as a native stenotic aortic or pulmonary valve, using a
minimally-invasive approach, such as a beating heart transapical
procedure, such as described with reference to FIGS. 5A-8A, or with
reference to FIGS. 16A-H, or a retrograde transaortic procedure,
such as described with reference to FIGS. 9A-G.
[0655] As shown in FIG. 19A, outer support structure 1814 is shaped
so as to define a plurality of distal strut supports 1820, from
which a plurality of proximal engagement arms 1822 extend radially
outward in a proximal direction. Strut supports 1820 and engagement
arms 1822 may be formed as one integrated structure (as shown), or,
alternatively, may be initially formed separately and then joined
to one another. For example, the strut supports 1820 and engagement
arms 1822 may be mechanically interlocked, sutured, or coupled by
other means. Typically, the strut support 1820 and engagement arms
1822 are joined prior to implantation.
[0656] Typically, engagement arms 1822 have a shape that is
generally upwardly concave, such as described with reference to
FIG. 17. Engagement arms 1822 are typically configured to be at
least partially disposed within the aortic sinuses of the subject,
to engage and/or rest against floors of the aortic sinuses, and/or
to apply an axial force directed toward the left ventricle of the
subject. Placement of engagement arms 1822 within the aortic
sinuses prevents "device migration," i.e., undesired retrograde
(towards the left ventricle) movement of the valve prosthesis that
may result from fluid forces applied to the valve. Engagement arms
1822 meet one another at respective junctures 1824. In one
embodiment, engagement arms 1822 are fabricated as separate pieces
and are mechanically engaged to one another at respective junctures
1824. In another embodiment, engagement arms 1822 meet via an area
defined at each respective juncture 1824, and thus do not actually
touch one another. Typically, the engagement arms are configured to
define respective peaks at junctures 1824, and respective troughs
1826 between each two of the peaks.
[0657] Outer support structure 1814 is typically formed of a
suitable material that allows mechanical deformations associated
with crimping and expansion of a valve prosthesis. For example,
outer support structure 1814 may be formed of nitinol or a
stainless steel alloy (e.g., AISI 316). In one embodiment, outer
support structure 1814 is fabricated from a single piece. In
another embodiment, outer support structure 1814 is formed of a
plurality of pieces that are coupled together. In one embodiment,
engagement arms 1822 are coated with a flexible material (e.g.,
polyester, other synthetic material, pericardium, and/or other
biological material).
[0658] With reference to FIG. 19B, inner support structure 1812 is
shaped so as to define a plurality of distal inner strut supports
1830. In one embodiment, inner support structure 1812 is sutured to
outer support structure 1814 at respective strut supports 1820 and
1830.
[0659] Sutures between inner and outer support structures 1812 and
1814 allow for movement and compliance between the inner and outer
support structures. Inner support structure 1812 also includes a
proximal skirt 1832 that extends from the struts. A proximal
portion 1834 of proximal skirt 1832 is provided in a bulging
configuration to engage the left ventricular outflow tract (LVOT)
of the subject and/or periannular tissue at the top of the left
ventricle. A relatively narrow throat portion 1836 of proximal
skirt 1832 is configured to be positioned at a valvular annulus of
the subject. A flared distal portion 1837 of proximal skirt 1832 is
configured to flare outward so as to engage the inner surface of
the native valve leaflets. The flared distal portion 1837 preserves
prosthesis leaflet integrity and prolongs overall valve durability
by avoiding contact between the prosthesis leaflets and inner
support structure 1812 when the prosthesis leaflets are open. Inner
support structure 1812 may be formed of materials such as: nitinol,
stainless steel alloys, other metals or metal alloys, or
biocompatible materials.
[0660] In the embodiment shown in FIG. 18, support structure 1800
has been designed to provide a more accommodating fit within
bulkier, calcified native valve commissures. For example, a
distance 1841 is created between engagement arms 1822 of outer
support structure 1814. In one embodiment, distance 1841 is between
about 0.5 millimeters (mm) to about 8 mm; alternatively between
about 1 mm to about 6 mm, or between about 3 mm and about 5 mm.
Distance 1841 allows for the accommodation of bulkier, calcified
commissures, and allows support structure 1800 to sit lower in the
aortic root even in the face of moderate-heavy calcification. A
distance 1843 is also created between each respective trough 1826
of each engagement arm 1822 and skirt portion 1832 of inner support
structure 1812. Distance 1843 allows for the accommodation of
bulkier, calcified native valve leaflets. In one embodiment,
distance 1843 is between about 1 mm to about 14 mm; alternatively
between about 2 mm to about 10 mm, or between about 3 mm to about 8
mm, or between about 4 mm to about 6 mm. More specifically,
depending on the size of the prosthesis, distance 1843 is between
about 1 mm and about 10 mm; alternatively between about 1 mm to
about 12 mm, or between about 1 mm to about 14 mm; alternatively,
between about 2 mm and about 9 mm, or between about 2 mm to about
10 mm; alternatively between about 3 mm to about 8 mm;
alternatively between about 4 mm to about 6 mm. The design of
support structure 1800 provides a frame that can conform to the
patient-specific anatomy, including variability in calcium loads,
while maintaining the correct position of the support structure,
and therefore ensuring proper valve function. The design of support
structure 1800 also ensures stable implantation and localization of
the valve prosthesis, and proper sealing between the prosthesis and
the native valve against perivalvular leaks.
[0661] The scope of the present invention includes embodiments
described in the following applications, which are assigned to the
assignee of the present application and are incorporated herein by
reference. In an embodiment, techniques and apparatus described in
one or more of the following applications are combined with
techniques and apparatus described herein:
[0662] U.S. patent application Ser. No. 11/024,908, filed Dec. 30,
2004, entitled, "Fluid flow prosthetic device," which published as
US Patent Application Publication 2006/0149360;
[0663] International Patent Application PCT/IL2005/001399, filed
Dec. 29, 2005, entitled, "Fluid flow prosthetic device," which
published as PCT Publication WO 06/070372; and/or
[0664] International Patent Application PCT/IL2004/000601, filed
Jul. 6, 2004, entitled, "Implantable prosthetic devices
particularly for transarterial delivery in the treatment of aortic
stenosis, and methods of implanting such devices," which published
as PCT Publication WO 05/002466, and U.S. patent application Ser.
No. 10/563,384, filed Apr. 20, 2006, in the national stage thereof,
which published as US Patent Application Publication
2006/0259134.
[0665] It will be appreciated by persons skilled in the art that
the present invention is not limited to what has been particularly
shown and described hereinabove. Rather, the scope of the present
invention includes both combinations and subcombinations of the
various features described hereinabove, as well as variations and
modifications thereof that are not in the prior art, which would
occur to persons skilled in the art upon reading the foregoing
description.
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