U.S. patent application number 15/013341 was filed with the patent office on 2016-08-18 for integrated valve assembly and method of delivering and deploying an integrated valve assembly.
The applicant listed for this patent is Medtronic, Inc.. Invention is credited to Geoffrey Orth, Paul Rothstein, Jeffrey Sandstrom.
Application Number | 20160235525 15/013341 |
Document ID | / |
Family ID | 55442883 |
Filed Date | 2016-08-18 |
United States Patent
Application |
20160235525 |
Kind Code |
A1 |
Rothstein; Paul ; et
al. |
August 18, 2016 |
INTEGRATED VALVE ASSEMBLY AND METHOD OF DELIVERING AND DEPLOYING AN
INTEGRATED VALVE ASSEMBLY
Abstract
An integrated valve prosthesis includes an anchor stent, a
tether component, and a valve component. The anchor stent includes
a self-expanding tubular frame member configured to be deployed in
the annulus of an aortic valve or the aorta. The valve component
includes a valve frame and a prosthetic valve coupled to the valve
frame, and is configured to be deployed within the anchor stent.
The tether component includes a first end coupled to the anchor
stent and a second end coupled to the valve frame. In the delivery
configuration, the tether component extends in a first direction
from the anchor stent to the valve component, and in the deployed
configuration, the tether component extends in a second direction
from the anchor stent to the valve component. The second direction
is generally opposite the first direction. The tether component may
set the location of the valve component relative to the anchor
stent.
Inventors: |
Rothstein; Paul; (Elk River,
MN) ; Sandstrom; Jeffrey; (Scandia, MN) ;
Orth; Geoffrey; (Sebastopol, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medtronic, Inc. |
Minneapolis |
MN |
US |
|
|
Family ID: |
55442883 |
Appl. No.: |
15/013341 |
Filed: |
February 2, 2016 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
62115464 |
Feb 12, 2015 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/2418 20130101;
A61F 2250/006 20130101; A61F 2002/826 20130101; A61F 2002/828
20130101; A61F 2220/0008 20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. An integrated valve assembly having a radially compressed
delivery configuration and a radially expanded deployed
configuration, the valve prosthesis comprising: an anchor stent;
and a valve component including a valve frame and a prosthetic
valve coupled to the valve frame; and a tether component having a
first end coupled to the anchor stent and a second end coupled to
the valve component, wherein in the delivery configuration the
tether component extends in a first direction from the anchor stent
to the valve component, and in the deployed configuration the
tether component extends in a second direction from the anchor
stent to the valve component, wherein the second direction is
generally opposite the first direction.
2. The integrated valve assembly of claim 1, wherein the anchor
stent is configured to be deployed within the annulus of an aortic
valve.
3. The integrated valve assembly of claim 2, wherein in the
radially expanded deployed configuration, a proximal portion of the
valve frame is deployed within the anchor stent.
4. The integrated valve assembly of claim 2, wherein the tether
component is configured such that in the deployed configuration the
tether component is taut to set the location of the valve component
within the anchor stent.
5. The integrated valve assembly of claim 2, wherein the tether
component comprises a plurality of tethers, and wherein each tether
is an elongate element.
6. The integrated valve assembly of claim 5, further comprising a
tubular skirt coupled to an inner surface or outer surface of the
tethers.
7. The integrated valve assembly of claim 2, wherein the tether
component comprises a tubular skirt.
8. The integrated valve assembly of claim 7, wherein in the
deployed configuration, a portion of the tubular skirt is
configured to extend proximal of the anchor stent.
9. The integrated valve assembly of claim 8, wherein in the
deployed configuration, the portion of the tubular skirt extending
proximal of the anchor stent is configured to extend radially
outward to seal against tissue of the heart.
10. The integrated valve assembly of claim 1, wherein the anchor
stent is configured to be deployed in the aorta, and wherein a
proximal portion of the valve frame is configured to be deployed in
the annulus of the aortic valve.
11. The integrated valve assembly of claim 10, wherein the tether
component is configured such that in the deployed configuration the
tether is taut to set the location of the valve component within
the annulus of the aortic valve.
12. The integrated valve assembly of claim 11, wherein the tether
component comprises a plurality of tethers, further comprising a
tubular skirt coupling the tethers to the valve component.
13. The integrated valve assembly of claim 12, wherein in the
deployed configuration, the tubular skirt is configured to be
disposed between the valve frame and the annulus of the aortic
valve.
14. The integrated valve assembly of claim 11, wherein the anchor
stent further comprises a proximal arm component, extending from a
proximal end of the anchor stent, the proximal arm component
configured to be deployed in the sinuses of the aortic valve.
15. The integrated valve assembly of claim 14, wherein the proximal
arm component comprises three proximal arms with each proximal arm
configured to be deployed in one of the three aortic sinuses.
16. The integrated valve assembly of claim 14, wherein the proximal
arm component comprises a plurality of proximal arms and each
proximal arm comprises a wire loop with a first end of the wire
coupled to the proximal end of the anchor stent, the wire extending
proximally from the first end and bending back distally to a second
end of the wire coupled to the proximal end of the anchor stent
spaced from the first end.
17. The integrated valve assembly of claim 16, wherein the proximal
arm component comprises three proximal arms with each proximal arm
configured to be deployed in one of the three aortic sinuses.
18. A method of implanting an integrated valve assembly at a
location of a native valve comprising the steps of: advancing the
integrated valve assembly in a radially compressed delivery
configuration to the location of the native valve, wherein the
integrated valve assembly comprises an anchor stent, a valve
component including a valve frame and a prosthetic valve, and a
tether component having a first end coupled to the anchor stent and
a second end coupled to the valve component, wherein in the
radially compressed delivery configuration the tether component
extends in a first direction from the anchor stent to the valve
component; deploying the anchor stent from the radially compressed
configuration to a radially expanded configuration at a location
within an annulus of the native valve; advancing the valve
component in the delivery configuration in a second direction
opposite the first direction through at least a portion of the
anchor stent such that the tether component extends in the second
direction from the anchor stent to the valve component; and
deploying the valve component such that the valve frame expands
from the radially compressed delivery configuration to a radially
expanded configuration with a proximal portion of the valve frame
engaging an inner surface of the anchor stent.
19. The method of claim 18, wherein the step of advancing the valve
component in the delivery configuration through at least a portion
of the anchor stent comprises advancing the valve component until
the tether component becomes taught such that a length of the
tether sets a location for the deployed valve component.
20. The method of claim 18, wherein the tether component comprises
a plurality of tethers.
21. The method of claim 18, wherein the tether component comprises
a tubular skirt, the tubular skirt being configured such that the
step of advancing the valve component disposes the tubular skirt
between the anchor stent and the valve frame.
22. The method of claim 21, wherein the step of advancing the valve
component causes the tubular skirt to fold such that a portion of
the skirt extends proximal of the anchor stent and wherein the step
of deploying the valve component causes the portion of the tubular
skirt extending proximal of the anchor stent to extend radially
outward to seal the skirt against tissue of the heart.
23. A method of implanting an integrated valve assembly at a
location of a native valve comprising the steps of: advancing the
integrated valve assembly in a radially compressed configuration
into the aorta, wherein the integrated valve assembly comprises an
anchor stent, a valve component including a valve frame and a
prosthetic valve, and a tether component having a first end coupled
to the anchor stent and a second end coupled to the valve
component, wherein in the delivery configuration the tether
component extends in a first direction from the anchor stent to the
valve component; deploying the anchor stent from the radially
compressed configuration to a radially expanded configuration at a
location within the aorta; advancing the valve component in the
delivery configuration in a second direction opposite the first
direction through the anchor stent until the tether component
becomes taut; deploying the valve component such that the valve
frame expands from the radially compressed configuration to a
radially expanded deployed configuration with a first portion of
the valve frame engaging the aortic valve.
24. The method of claim 23, wherein the tether component comprises
a plurality of tethers.
25. The method of claim 23, wherein a length of the tether
component is configured such that the step advancing the valve
component until the tether becomes taut causes at least a portion
of the valve component to be disposed within an annulus of the
aortic valve.
26. The method of claim 24, wherein the tether component comprises
a tubular skirt disposed adjacent the valve component such that the
step of advancing the valve component and deploying the anchor
component disposes the tubular skirt between the valve component
and the annulus of the aortic valve.
27. The method of claim 23, wherein the anchor stent further
comprises a proximal arm component extending from a proximal end of
the anchor stent, wherein the step of deploying the anchor stent
comprises deploying the proximal arm component in a sinus of the
aortic valve.
28. The method of claim 27, wherein the proximal arm component
comprises a plurality of proximal arms and the step of deploying
the anchor stent comprises deploying each proximal arm in one of
the three aortic sinuses.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority under 35 U.S.C. 119(e) to
the benefit of the filing date of U.S. Provisional Application No.
62/115,464 filed Feb. 12, 2015, the contents of which are
incorporated herein by reference in their entirety.
FIELD OF THE INVENTION
[0002] Embodiments hereof relate to heart valve prostheses and
methods for intraluminally deploying heart valve prostheses, and in
particular, to an integrated heart valve prosthesis including an
anchor stent connected to a valve component and methods of
intraluminally delivering and deploying the integrated valve
prosthesis.
BACKGROUND OF THE INVENTION
[0003] Heart valves, such as the mitral, tricuspid, aortic, and
pulmonary valves, are sometimes damaged by disease or by aging,
resulting in problems with the proper functioning of the valve.
Heart valve problems generally take one of two forms: stenosis in
which a valve does not open completely or the opening is too small,
resulting in restricted blood flow; or insufficiency in which blood
leaks backward across a valve when it should be closed.
[0004] Heart valve replacement has become a routine surgical
procedure for patients suffering from valve regurgitation or
stenotic calcification of the leaflets. Conventionally, the vast
majority of valve replacements entail full sternotomy in placing
the patient on cardiopulmonary bypass. Traditional open surgery
inflicts significant patient trauma and discomfort, requires
extensive recuperation times, and may result in life-threatening
complications.
[0005] To address these concerns, efforts have been made to perform
cardiac valve replacements using minimally-invasive techniques. In
these methods, laparascopic instruments are employed to make small
openings through the patient's ribs to provide access to the heart.
While considerable effort has been devoted to such techniques,
widespread acceptance has been limited by the clinician's ability
to access only certain regions of the heart using laparascopic
instruments.
[0006] Still other efforts have been focused upon percutaneous
transcatheter (or transluminal) delivery of replacement cardiac
valves to solve the problems presented by traditional open surgery
and minimally-invasive surgical methods. In such methods, a valve
prosthesis is compacted for delivery in a catheter and then
advanced, for example through an opening in the femoral artery and
through the descending aorta to the heart, where the prosthesis is
then deployed in the valve annulus (e.g., the aortic valve
annulus).
[0007] Various types and configurations of prosthetic heart valves
are used in percutaneous valve procedures to replace diseased
natural human heart valves. The actual shape and configuration of
any particular prosthetic heart valve is dependent to some extent
upon the valve being replaced (i.e., mitral valve, tricuspid valve,
aortic valve, or pulmonary valve). In general, prosthetic heart
valve designs attempt to replicate the function of the valve being
replaced and thus will include valve leaflet-like structures used
with either bioprostheses or mechanical heart valve prostheses. If
bioprostheses are selected, the replacement valves may include a
valved vein segment or pericardial manufactured tissue valve that
is mounted in some manner within an expandable stent frame to make
a valved stent. In order to prepare such a valve for percutaneous
implantation, one type of valved stent can be initially provided in
an expanded or uncrimped condition, then crimped or compressed
around a balloon portion of a catheter until it is close to the
diameter of the catheter. In other percutaneous implantation
systems, the stent frame of the valved stent can be made of a
self-expanding material. With these systems, the valved stent is
crimped down to a desired size and held in that compressed state
within a sheath, for example. Retracting the sheath from this
valved stent allows the stent to expand to a larger diameter, such
as when the valved stent is in a desired position within a
patient.
[0008] While some problems of traditional open-heart surgery are
overcome by percutaneous transcatheter (transluminal) methods,
there are still risks associated with the method including patient
prosthetic mismatch (PPM), para-valvular leakage, and conductance
disorders. Many of these potential risks are thought to be
aggravated by improper valve placement.
[0009] Patient prosthetic mismatch (PPM) is when an effective
prosthetic valve area is less than that of a normal human valve.
Despite technical efforts to optimize valve prostheses, their
rheological properties are not comparable with those of native
human valves and aortic stenosis will occur in a normally
functioning prosthesis that is too small for the patient. Patient
prosthetic mismatch is associated with decreased regression of left
ventricular hypertrophy, reduced coronary flow reserve, increased
incidence of congestive heart failure, diminished functional
capacity, and increased risk of early and late mortality.
Implantation of a prosthetic heart valve at an inaccurate depth is
thought to increase the incidence and severity of patient
prosthetic mismatch.
[0010] Para-valvular leakage (PVL) is leakage around an implanted
prosthetic valve. The effects of para-valvular leakage on patients
range from small PVL resulting in valve inefficiency and
intravascular hemolysis causing anemia, to large PVL resulting in
risk of heart failure and endocarditis. Often, sealing material is
secured to the inside or outside of the stent frame to reduce the
incidence of PVL, but the sealing material increases overall
diameter (crossing profile) of the radially collapsed stent which
limits crimping and may limit access through some vessels.
Implantation of a prosthetic heart valve at an inaccurate depth is
also thought to increase the incidence and severity of
para-valvular leakage.
[0011] Conductance disorder is the abnormal progression of
electrical impulses through the heart causing the heart to beat in
an irregular fashion. The abnormal impulses may exhibit themselves
as a mismatch of the electrical signals between sides or top to
bottom and may cause symptoms from headaches, dizziness, and
arrhythmia to cardiac arrest. Valve prostheses implanted too deep
are thought to be more prone to inducing conduction disorders.
[0012] There is a need for devices and methods that allow for
reduced crossing profile of a percutaneous transcatheter
(transluminal) delivery of replacement heart valves while also
providing sealing material to reduce para-valvular leakage (PVL).
There is also a need for devices and methods to accurately locate
and deploy valve prostheses to minimize para-valvular leakage
(PVL), patient prosthesis mismatch (PPM), and conductance disorders
in patients undergoing transcatheter valve implantation
procedures.
BRIEF SUMMARY OF THE INVENTION
[0013] Embodiments hereof are related to an integrated valve
assembly including an anchor stent, a tether component, and a valve
component sequentially arranged within a delivery device. The
anchor stent includes a self-expanding tubular frame member
configured to be deployed in the annulus of an aortic valve. The
valve component includes a valve frame configured to be deployed
within the tubular frame member of the anchor stent such that the
valve frame engages with the attachment members of the tubular
frame member and a prosthetic valve coupled to the valve frame. The
tether component is a plurality of tethers with a first end of the
tether component coupled to the anchor frame and a second end of
the tether component coupled to the valve frame. In the delivery
configuration, the tether component extends in a first direction
from the anchor stent to the valve component, and in the deployed
configuration, the tether component extends in a second direction
from the anchor stent to the valve component. The second direction
is generally opposite the first direction.
[0014] Embodiments hereof are also directed to a method of
implanting an integrated valve assembly at a location of a native
heart valve. In an embodiment, the integrated valve assembly
including an anchor stent, a valve component, and a tether
component having a first end coupled to the anchor stent and a
second end coupled to the valve component, is advanced in a
delivery system in a radially compressed configuration into the
annulus of a heart valve. The anchor stent includes a tubular frame
member. The anchor stent is deployed in the annulus of the heart
valve such that the tubular frame member expands from the radially
compressed configuration to a radially expanded configuration
engaging an inner wall surface of the annulus. Next, the tether
component is exposed from the delivery system. The delivery system
is advanced through the lumen of the anchor stent, effectively
flipping the direction of the tether component. Accordingly,
whereas the tether component in the delivery system initially
extends in a first direction from the anchor stent towards the
valve component, once flipped, the tether component extends in a
second direction generally opposite from the first direction from
the anchor stent towards the valve component. The delivery device
is advanced until the tether component is taut. Tautness of the
tether component correctly positions the valve component for
deployment within the anchor stent. The valve component is then
deployed. The valve component includes a valve frame and a
prosthetic valve coupled to the valve frame. The valve component is
deployed at the native aortic valve such that the valve frame
expands from a radially compressed configuration to a radially
expanded configuration with a proximal portion of the valve frame
engaging an inner surface of the anchor stent.
[0015] In another embodiment, an integrated valve assembly includes
an anchor stent, a valve component, a tether component, and a
skirt. The tether component includes a first end coupled to the
anchor stent, and a second end coupled to the skirt. The skirt has
a first end coupled to the tether component and a second end
coupled to the valve component. The integrated valve assembly is
advanced in a radially compressed configuration into the aorta. The
anchor stent includes a tubular frame member and a proximal arm
component extending from a proximal end of the tubular frame
member. The proximal arm component is deployed such that the
proximal arm component expands from a radially compressed
configuration to the radially expanded configuration engaging the
inner wall surface of the aortic sinuses. The anchor stent is
advanced until the proximal arm component bottoms at the nadir of
the aortic valve leaflets. The anchor stent is deployed in the
aorta near the sinotubular junction such that the tubular frame
member expands from the radially compressed configuration to a
radially expanded configuration engaging an inner wall surface of
the ascending aorta. The tether component and skirt are released
from the delivery system. The delivery system with the valve
component disposed therein is advanced through the lumen of the
anchor stent, effectively flipping the direction of the tethers and
skirt. Accordingly, whereas the tether component and the skirt
initially extend in a first direction from the anchor stent towards
the valve component, once flipped, the tethers and skirt extend in
a second, and generally opposite direction from the anchor stent
towards the valve component. The delivery system is advanced until
the tether component and the skirt are taut. Tautness of the tether
component and the skirt correctly positions the valve component for
deployment within the annulus of the native valve. The valve
component includes a valve frame and a prosthetic valve coupled to
the valve frame. The valve component is deployed at the native
aortic valve such that the valve frame expands from a radially
compressed configuration to a radially expanded configuration with
a proximal portion of the valve frame engaging the native aortic
annulus and a distal portion of the valve frame engaging an inner
surface of the anchor stent.
BRIEF DESCRIPTION OF DRAWINGS
[0016] The foregoing and other features and advantages of the
invention will be apparent from the following description of
embodiments hereof as illustrated in the accompanying drawings. The
accompanying drawings, which are incorporated herein and form a
part of the specification, further serve to explain the principles
of the invention and to enable a person skilled in the pertinent
art to make and use the invention. The drawings are not to
scale.
[0017] FIG. 1 is a schematic illustration of a prior art stented
valve prosthesis.
[0018] FIG. 2 is a schematic illustration of the prior art stented
valve prosthesis of FIG. 1.
[0019] FIG. 3 is a schematic illustration of an integrated
prosthesis assembly in accordance with an embodiment hereof.
[0020] FIGS. 3A and 3B are a schematic cross-sectional
illustrations of embodiments of an anchor stent with filler
material on an inside surface or outside surface thereof.
[0021] FIG. 4 is a schematic illustration of an integrated
prosthesis assembly in accordance with another embodiment
hereof.
[0022] FIGS. 5-11, and 11A are schematic illustrations of an
embodiment of a method for delivering and deploying the integrated
prosthesis assembly of FIG. 3 at an aortic valve with the anchor
stent deployed in the annulus.
[0023] FIG. 12 is a schematic illustration of the integrated valve
prosthesis assembly of FIG. 4 deployed at an aortic valve according
to the method of FIGS. 5-11A.
[0024] FIG. 13 is a schematic illustration of the integrated valve
prosthesis assembly of FIG. 4 deployed at an aortic valve with the
skirt component everted.
[0025] FIG. 14 is a schematic illustration of an integrated valve
assembly in accordance with another embodiment hereof.
[0026] FIG. 14A is a schematic illustration of an anchor stent of
the integrated valve assembly of FIG. 14.
[0027] FIG. 15 is a schematic illustration of a distal portion of a
delivery device with the integrated valve assembly of FIG. 14
disposed therein.
[0028] FIGS. 16-23 are schematic illustrations of an embodiment of
a method for delivering and deploying the integrated valve assembly
of FIG. 14 at an aortic valve with the anchor stent deployed in the
aorta.
DETAILED DESCRIPTION OF THE INVENTION
[0029] Specific embodiments of the present invention are now
described with reference to the figures, wherein like reference
numbers indicate identical or functionally similar elements. The
terms "distal" and "proximal" when used in the following
description to refer to a catheter or delivery system are with
respect to a position or direction relative to the treating
clinician. Thus, "distal" and "distally" refer to positions distant
from or in a direction away from the clinician and "proximal" and
"proximally" refer to positions near or in a direction toward the
clinician. When the terms "distal" and "proximal" are used in the
following description to refer to a device to be implanted into a
vessel, such as an anchor stent or valve component, they are used
with reference to the direction of blood flow from the heart. Thus,
"distal" and "distally" refer to positions in a downstream
direction with respect to the direction of blood flow and
"proximal" and "proximally" refer to positions in an upstream
direction with respect to the direction of blood flow.
[0030] FIGS. 1 and 2 show an exemplary conventional valve
prosthesis similar to the Medtronic CoreValve.RTM. transcatheter
aortic valve replacement valve prosthesis and as described in U.S.
Patent Application Publication No. 2011/0172765 to Nguyen et al.
(hereinafter "the '765 publication"), which is incorporated by
reference herein in its entirety. As shown in FIGS. 1 and 2, valve
prosthesis 100 includes an expandable frame 102 having a valve body
104 affixed to its interior surface, e.g., by sutures. Frame 102
preferably comprises a self-expanding structure formed by laser
cutting or etching a metal alloy tube comprising, for example,
stainless steel or a shape memory material such as nickel titanium.
The frame has an expanded deployed configuration which is impressed
upon the metal alloy tube using techniques known in the art. Valve
body 104 preferably comprises individual leaflets assembled to a
skirt, where all of the components are formed from a natural or
man-made material, including but not limited to, mammalian tissue,
such as porcine, equine or bovine pericardium, or a synthetic or
polymeric material.
[0031] Frame 102 in the exemplary embodiment includes an outflow
section 106, an inflow section 110, and a constriction region 108
between the inflow and outflow sections. Frame 102 may comprise a
plurality of cells having sizes that vary along the length of the
prosthesis. When configured as a replacement for an aortic valve,
inflow section 110 extends into and anchors within the aortic
annulus of a patient's left ventricle and outflow section 106 is
positioned in the patient's ascending aorta. Frame 102 also may
include eyelets 130 for use in loading the heart valve prosthesis
100 into a delivery catheter.
[0032] Valve body 104 may include a skirt 121 affixed to frame 102,
and leaflets 112, 114, 116. Leaflets 112, 114, 116 may be attached
along their bases to skirt 121, for example, using sutures or a
suitable biocompatible adhesive. Adjoining pairs of leaflets are
attached to one another at their lateral ends to form commissures
124, 126, 128, with free edges 118, 120, 122 of the leaflets
forming coaptation edges that meet in an area of coaptation, as
described in the '765 application and shown in FIG. 2 hereof.
[0033] The following detailed description is merely exemplary in
nature and is not intended to limit the invention or the
application and uses of the invention. Although the description of
the invention is in the context of transcatheter aortic valve
implantation, the invention may also be used in any other body
passageways where it is deemed useful. Furthermore, there is no
intention to be bound by any expressed or implied theory presented
in the preceding technical field, background, brief summary or the
following detailed description.
[0034] Embodiments hereof are related to an integrated valve
assembly including an anchor stent, a tether component, and a valve
component assembled and connected together outside the human body.
The tether component may be a plurality of tethers, a cylindrical
skirt or a combination of thereof.
[0035] In an embodiment shown in FIG. 3, an integrated valve
assembly 300 includes an anchor stent 210, a tether component 301
and a valve component 240. Valve component 240 is sized and shaped
to fit within a lumen of anchor stent 210, and anchor stent 210 is
designed to deploy within the annulus of a heart valve, as
described in more detail below.
[0036] Anchor stent 210 includes a frame 212 having a proximal end
216 and a distal end 214, as shown in FIG. 3. Frame 212 is a
generally tubular configuration having a lumen 213. Frame 212 is a
stent structure as is known in the art. Frame 212 may be self
expanding or may be balloon expandable. Generally, frame 212
includes a first, radially compressed configuration for delivery
and a second, radially expanded or deployed configuration when
deployed at the desired site. In the radially expanded
configuration, frame 212 may have a diameter in the range of 23 to
29 millimeters for use in the aortic annulus. However, it is
recognized that frame 212 may have a smaller or larger expanded
diameter depending on the application. Further, the unrestrained
expanded diameter of self-expanding frames, such as frame 212, is
generally about 2-5 millimeters larger than the diameter of the
location in which the frame is to be installed, in order to create
opposing radial forces between the outward radial force of the
frame against an inward resisting force of the vessel.
[0037] Anchor stent 210 may include a filler material 211 on an
outside 213 surface of anchor stent 210, as shown in FIG. 3A, or
the inside surface 215 of anchor stent 210, as shown in FIG. 3B, or
both surfaces (not shown). Filler material 211 may be any
anti-para-valvular leakage material suitable for the purposes
described herein, such as, but not limited to, polyethylene
terephthalate (PET), tissue (including porcine or bovine
pericardium), or other biocompatible materials. The material may be
woven or knitted. Filler material 211 may be secured to anchor
stent 210 by methods such as, but not limited to, adhesives,
sutures, laser or ultrasonic welding, or any other methods suitable
for the purposes described herein.
[0038] Tether component 301 includes a plurality of tethers 302 as
shown in FIG. 3. The embodiment of FIG. 3 shows three (3) tethers
302, however, it is understood that more or fewer tethers 302 may
be provided depending on the specific requirements of the
components, devices, and procedures being utilized. Tether
component 301 has a first end 304 coupled to anchor stent 210, a
second end 306 coupled to valve component 240, and a length that
provides proper location placement of valve component 240 at the
implantation site, as described in greater detail below. Tethers
302 are elongated members such as wires or sutures and may be
constructed of materials such as, but not limited to, stainless
steel, Nitinol, nylon, polybutester, polypropylene, silk, and
polyester or other materials suitable for the purposes described
herein. Tethers 302 may be connected to anchor frame 212 and valve
frame 242 by methods such as, but not limited to fusing, welding,
sutures or otherwise tied.
[0039] Valve component 240 includes a frame 242 and a prosthetic
valve 250. Frame 242 is a generally tubular configuration having a
proximal end 246, a distal end 244, and a lumen 243 there between.
Frame 242 is a stent structure as is known in the art, and may be
self-expanding or balloon expandable. Generally, frame 242 includes
a first, radially compressed configuration for delivery and a
second, radially expanded or deployed configuration when deployed
at the desired site. In the radially expanded configuration, frame
242 may have a diameter in the range of 23 to 31 millimeters.
However, it is recognized that frame 242 may have a smaller or
larger expanded diameter depending on the application. Further, the
unrestrained expanded diameter of self-expanding frames, such as
frame 242, is generally about 2-5 millimeters larger than the
diameter of the location in which the frame is to be installed, in
order to create opposing radial forces between the outward radial
force of the frame against an inward resisting force of the vessel.
In the embodiment shown, distal end 244 has a larger expanded
diameter than proximal end 246, similar to valve prosthesis 100
shown in FIGS. 1-2. However, frame 242 is not limited to such a
configuration, and instead may have proximal and distal ends with
similar expanded diameters. Further, frame 242 may have a smaller
or larger expanded diameter depending on the application. Valve
component 240 is configured to be disposed such that prosthetic
valve 250 is disposed approximately at the location of the native
aortic valve.
[0040] As explained briefly above and in more detail below,
integrated valve assembly 300 includes anchor stent 210, tether
component 301, and valve component 240. Anchor stent 210 is
configured to be disposed in the annulus of the aortic valve. Valve
component 240 is configured to be disposed such that prosthetic
valve 250 is disposed approximately at the location of the native
aortic valve with proximal end 246 of frame 242 separating the
valve leaflets of the native aortic valve. Proximal end 246 of
frame 242 extends into lumen 213 of frame 212 of anchor stent 210
and is held in place by the outward radial force of frame 242 and
frictional forces between frame 242 of valve component 240 and
frame 212 of anchor stent 210. Further, an inner surface of frame
212 and/or an outer surface of frame 242 may include locking
features such as barbs, anti-migration tabs or other devices known
to those skilled in the art to interconnect with anchor frame 212
and/or filler material 211
[0041] FIG. 4 shows another embodiment of an integrated valve
assembly 320 including anchor stent 210, a tether component 321
comprising a cylindrical skirt 322, and a valve component 240.
Anchor stent 210 and valve component 240 may be as described above
with respect to the embodiment of FIG. 3. Skirt 322 has a first end
324 coupled to anchor stent 210, a second end 326 coupled to valve
component 240, and a length that provides proper placement of valve
component 240 at the implantation site, as described in greater
detail below. Skirt 322 is a cylindrical tube constructed of cloth
or fabric material. The fabric may comprise any suitable material
including, but not limited to, woven polyester such as polyethylene
terephthalate, polytetrafluoroethylene (PTFE), tissue (such as
porcine or bovine pericardium, or other biocompatible materials.
Skirt 322 is secured to anchor frame 212 and valve frame 242 in a
manner such as, but not limited to sutures, laser or ultrasonic
welding, or other methods suitable for the purposes disclosed
herein.
[0042] While embodiments of FIGS. 3 and 4 provide possible
configurations for a tether component, they are not meant to limit
the component to these configurations, and other materials, shapes,
and combinations of skirts and/or tethers may be utilized. For
example, and not by way of limitation, a skirt may be attached to
an inside surface or outside surface of the tethers, or the tethers
and the skirt may be connected sequentially. For example, and not
by way of limitation, the tethers may be attached to the anchor
stent and to the skirt with the skirt attached to the tethers and
to the valve component.
[0043] FIGS. 5-11 and 11A schematically represent a method of
delivering and deploying an integrated valve assembly in accordance
with an embodiment hereof. FIGS. 5-11A describe the method with
respect to integrated valve assembly 300 of FIG. 3. FIGS. 5-11A are
not drawn to scale regarding relative lengths of anchor stent 210
and valve component 240.
[0044] FIG. 5 shows a guidewire 502 advanced distally, i.e., away
from the clinician, through the aorta 400 into the aortic sinuses
412 in the region of the aortic valve 414. Guidewire 502 may be
introduced through an opening or arteriotomy through the wall of
femoral artery in the groin region of the patient by methods known
to those skilled in the art, such as, but not limited to, the
Seldinger technique. Guidewire 502 is advanced into the descending
(or abdominal) aorta 406, the aortic arch 404, and the ascending
aorta 402, as shown in FIG. 5. FIG. 5 also shows three branch
arteries emanating from aortic arch 404. In particular, the
innominate or brachiocephalic artery 416, the left common carotid
artery 418, and the left subclavian artery 420 emanate from aortic
arch 404. The brachiocephalic artery 416 branches into the right
common carotid artery and the right subclavian artery. Although
FIGS. 5-11A show a retrograde percutaneous femoral procedure, it is
not meant to limit the method of use and other procedural methods
may be used. For example, and not by way of limitation, retrograde
percutaneous implantation via subclavian/axillary routes, direct
apical puncture, and the use of direct aortic access via either
ministernotomy or right anterior thoracotomy may also be used.
[0045] FIG. 6 shows a delivery system 500 for delivering integrated
valve assembly 300 being advanced distally, i.e., away from the
clinician, over guidewire 502 to a location in the annulus 415 of
aortic valve 414. Delivery system 500 may be any suitable delivery
system for delivering stents and/or stent grafts. In the embodiment
shown schematically, anchor stent 210 is a self-expanding stent,
tether component 301 is a plurality of tethers, and valve frame 242
of valve component 240 is a self-expanding stent. Accordingly,
delivery system 500 generally includes an inner or guidewire shaft
508 which includes a guidewire lumen for receiving guidewire 502. A
proximal end of guidewire 502 may be backloaded into the guidewire
lumen of inner shaft 508 through a distal opening in inner shaft
508. Delivery system 500 may be an over-the-wire type catheter, or
a rapid exchange catheter, or other catheter devices. Delivery
system 500 further generally may include a distal tip 501, an outer
sheath 504 that maintains anchor stent 210 and valve component 240
in the radially compressed or delivery configuration during
intraluminal delivery through the vasculature, as shown in FIG. 6
and may also include a pusher or stopper 506, and other features.
Delivery system 500 and/or anchor stent 210 may also include, for
example, radiopaque markers such that the clinician may determine
when delivery system 500 and/or anchor stent 210 is in the proper
location for deployment.
[0046] Once delivery system 500 has been advanced to the desired
location, such as when proximal end 216 of anchor stent is
generally aligned with annulus 415, outer sheath 504 is retracted
proximally, i.e., towards the clinician, as shown in FIG. 7. As
outer sheath 504 is retracted, anchor frame 212 of anchor stent 210
expands radially outward, engaging the inner wall of annulus 415 of
aortic valve 414, as shown in FIG. 7.
[0047] Outer sheath 504 is further retracted proximally, i.e.,
towards the clinician, to deploy tether component 301 from outer
sheath 504. In other words, sheath 504 is retracted such that
tether component 301 is no longer constrained by sheath 504. FIG. 7
shows tethers 302 deployed distal of anchor stent 210 and extending
in a first direction 520 from anchor stent 210 toward valve frame
242.
[0048] With outer sheath 504 retracted such that anchor stent 210
is deployed at the annulus 415 and tethers 302 are released from
outer sheath 504, delivery system 500 is advanced distally, i.e.,
away from the clinician, through lumen 213 of anchor frame 212,
pulling tethers 302 into lumen 213, effectively flipping the
direction of tethers 302. Accordingly, whereas tethers 302 in FIG.
7 extend in a first direction 520 from anchor stent 210 towards
valve component 240, tethers 302 in FIGS. 8-9 extend in a second
direction 522 from anchor stent 210 towards valve component 240.
Second direction 522 is generally opposite first direction 520. The
term "generally opposite" with respect to directions described
herein and terms similar thereto, as used herein, is not so narrow
as to mean 180 degrees difference in direction. Instead, the term
"generally opposite" with respect to direction means that a
component includes a vector component in the first direction, the
direction which is generally opposite includes a vector component
in the opposite direction. Thus, the tethers 302 in the first
direction 520 may be within 45 degrees of the first direction 520
and the second, generally opposite direction may be within 135
degrees to 225 degrees of the first direction 520. With delivery
system 500 advanced into lumen 213 of anchor stent 210, tethers 302
reside within lumen 213 of anchor frame 212. Delivery system 500 is
advanced until tethers 302 are taut. Tautness of tethers 302
correctly positions valve component 240 for deployment within
anchor stent 210, as shown in FIGS. 8-9. Anchor stent 210 is shown
with dotted lines for clarity of illustration in FIGS. 8-11A.
[0049] With tethers 302 taut and valve component 240 in proper
alignment with anchor stent 210, sheath 504 is further retracted
proximally, i.e., towards the clinician, and valve component 240 is
deployed and expands radially outward, engaging the inner wall of
the anchor frame 212 and sinotubular junction 413, as shown in
FIGS. 10-11A. With integrated valve prosthesis assembly 300 fully
deployed, delivery system 500 and guidewire 502 may be retracted
proximally, i.e., towards the clinician, and removed in a manner
consistent with current procedures know to those in the art.
Integrated valve prosthesis 300 remains in the fully deployed
configuration as shown in a close-up view of FIG. 11A.
[0050] While FIGS. 7-11A show the embodiment of FIG. 3 with tether
component 301 as a plurality of tethers 302, the method above would
be equally applicable to the embodiment of FIG. 4 with skirt 322.
FIG. 12 shows integrated valve prosthesis 320 including skirt 322
deployed by the method as described with respect to FIGS.
5-11A.
[0051] In another embodiment, integrated valve prosthesis 320 of
FIG. 4 may be deployed such that skirt 322 everts and is folded
proximal of anchor stent 210, as shown in FIG. 13. In such an
embodiment, rather than the tautness of skirt 322 locating valve
component 240, valve component 240 may be located by conventional
methods such as, but not limited to, x-ray fluoroscopy, ultrasound
imaging, electromagnetic tracking, or other methods suitable for
the purposes disclosed herein. In order to deploy skirt 322 as
shown in FIG. 13, the steps shown in FIGS. 5-7 are as described
with respect to those figures. After skirt 322 is deployed as shown
in FIG. 7 with respect to tethers 302, delivery system 500 is
advanced distally. However, due to the length of skirt 322,
delivery system 500 and skirt 322 extend through and beyond anchor
stent 210. Delivery system 500 is then retracted such that proximal
end 246 of valve component 240 is disposed within anchor stent 210
and skirt 322 folds as shown in FIG. 13. The remaining steps for
deploying valve component 240 are as described with respect to
FIGS. 10-11.
[0052] The close-up views described above show lateral gaps between
the different parts which are disposed adjacent to each other.
These gaps are shown for clarity such that the different parts of
the integrated valve prosthesis and the heart valve may be seen. It
is understood than many of these parts will abut directly against
each other due to the radially outward forces of anchor stent 210
and valve frame 242.
[0053] FIG. 14 shows schematically another embodiment of an
integrated valve assembly 600 including an anchor stent 610, a
plurality of tethers 602, a skirt 608, and a valve component 640.
Valve component 640 is sized and shaped to fit within a lumen of
anchor stent 610, and anchor stent 610 is designed to deploy in the
aorta, as described in more detail below.
[0054] Anchor stent 610 includes a frame 612 having a proximal end
616 and a distal end 614, and a proximal arm component 620
extending proximally from proximal end 616 of frame 612, as shown
in FIG. 14. Frame 612 is a generally tubular stent structure having
a lumen 613, as described previously. Frame 612 may be
self-expanding or may be balloon expandable. Generally, frame 612
includes a first, radially compressed configuration for delivery
and a second, radially expanded or deployed configuration when
deployed at the desired site. In the radially expanded
configuration, frame 612 may have a diameter in the range of 23 to
31 millimeters. However, the expanded diameter may be a smaller or
larger depending on the application. Further, as known those
skilled in the art, the unrestrained expanded diameter of
self-expanding frames, such as frame 612, is generally about 2-5
millimeters larger than the diameter of the vessel in which the
frame is to be installed, in order to create opposing radial forces
between the outward radial force of the frame against an inward
resisting force of the vessel.
[0055] Proximal arm component 620 extends proximally from proximal
end 616 of frame 612. In the embodiment shown in FIG. 14, proximal
arm component 620 includes a first arm 622, a second arm 624, and a
third arm 626. In the embodiment shown in FIG. 14, each arm 622,
624, 626 is in the form of a wire loop with first and second ends
of the wire attached to frame 612. In particular, first arm 622
includes first and second ends attached to frame 612 at connections
632, 633 respectively, as shown in FIG. 14A. Similarly, second arm
624 includes first and second ends attached to frame 612 at
connections 628, 629, respectively, and third arm 626 includes
first and second ends attached to frame 612 at connections 630,
631, respectively. Connections 628, 629, 630, 631, 632, 633 may be
formed by the material of the arms and frame 612 fused or welded
together. Alternatively, the connections may be mechanical
connections such as, but not limited to, sutured or otherwise tied,
a crimp connector to crimp ends of the arms to frame 612, or other
suitable connections. Proximal arm component 620 includes a
radially compressed configuration for delivery to the treatment
site and a radially expanded or deployed configuration. In the
radially expanded configuration, proximal arm component has a
diameter in the range of 29 to 39 mm. However, the diameter may be
smaller or larger depending on the application. As shown in FIG.
14, in the radially expanded configuration, arms 622, 624, and 626
flare outwardly from proximal end 616 of frame 612. Although
proximal arm component 620 has been shown as having three arms with
connections approximately equally spaced around the circumference
of frame 612, more or fewer arms may be utilized, and the arms need
not be equally spaced around the circumference of frame 612.
[0056] The embodiment of FIG. 14 shows three (3) tethers 602,
however, it is understood that more or fewer tethers 602 may be
provided depending on the specific requirements of the components,
devices and procedures being utilized. Tethers 602 have a first end
604 coupled to anchor stent 610, a second end 606 coupled to skirt
608, and a length that provides proper location placement of valve
component 640 at the implantation site, as described in greater
detail below. Tethers 602 are elongated members such as wires or
sutures and may be constructed of materials such as, but not
limited to, stainless steel, Nitinol, nylon, polybutester,
polypropylene, silk, and polyester or other materials suitable for
the purposes described herein. Skirt 608 includes a first end 609
connected to tethers 602 and a second end 607 connected to valve
component 640. In the embodiment shown, skirt 608 is a cylindrical
tube constructed of cloth or fabric material. The fabric may
comprise any suitable material including, but not limited to, woven
polyester such as polyethylene terephthalate,
polytetrafluoroethylene (PTFE), or other biocompatible material.
Tethers 602 may be connected to anchor stent 610 by tying, fusion,
or other connectors that permit tethers 602 to move as described
below. Similarly, skirt 608 may be attached to valve component 640
using sutures or other connectors that permit skirt 608 to move
relative to valve component 640, as described below. Tethers 602
may be attached to skirt 608 be tying or suturing tethers 602 to
skirt 608, or by other connectors suitable for the purposes
described herein. Additionally, the tethers 602 may be tied at a
first end 604 coupled to anchor stent 610, tied to a second point
on the end 606 of the skirt 608, and tied to a third point 607 on
valve component 640.
[0057] While the embodiment of FIG. 14 provides a possible
configuration for tethers 602 and skirt 608, it is not meant to
limit the component to this configuration, and other materials,
shapes and combinations of skirts and/or tethers may be utilized
depending on the application.
[0058] Valve component 640 includes a frame 642 and a prosthetic
valve 650. Frame 642 is a generally tubular configuration having a
proximal end 646, a distal end 644, and a lumen 643 there between.
Frame 642 may be a stent structure as is known in the art. Frame
642 may be self-expanding or may be balloon expandable. Generally,
frame 642 includes a first, radially compressed configuration for
delivery and a second, radially expanded or deployed configuration
when deployed at the desired site. In the radially expanded
configuration, frame 642 may have a diameter in the range of 23 to
31 millimeters. In the embodiment shown in FIG. 14, distal end 644
and proximal end 646 of frame 642 have different diameters, similar
to valve prosthesis 100 shown in FIG. 1. However, distal end 644
and proximal end 646 may instead have similar expanded diameters.
Further, the diameter may be larger or smaller than the range
provided above depending on the application. Valve component 640 is
configured to be disposed such that prosthetic valve 650 is
disposed approximately at the location of the native aortic
valve.
[0059] As explained briefly above and in more detail below,
integrated valve assembly 600 includes anchor stent 610, tethers
602, skirt 608, and valve component 640. Anchor stent 610 is
configured to be disposed in the aorta, with proximal arm component
620 extending into the aortic root or aortic sinuses. Valve
component 640 is configured to be disposed such that prosthetic
valve 650 is disposed approximately at the location of the native
aortic valve with proximal end 646 of frame 642 separating the
valve leaflets of the native aortic valve. Distal end 644 of frame
642 extends into lumen 613 of frame 612 of anchor stent 610 and is
held in place by the outward radial force of frame 642 and
frictional forces between frame 642 of valve component and frame
612 of anchor stent 610. Further, an inner surface of frame 612
and/or an outer surface of frame 642 may include locking features
such as barbs, anti-migration tabs or other devices known to the
art to interconnect with anchor frame 612. For example, and not by
way of limitation, barbs 611 shown in FIG. 14A may extend from an
inner surface of anchor stent 610. Further, proximal arm component
620 provides support for anchor stent 610 within the aortic
sinuses, as described in more detail below.
[0060] FIGS. 15-23 schematically represent a method of delivering
and deploying integrated valve assembly 600 in accordance with an
embodiment hereof. FIGS. 15-23 are not drawn to scale.
[0061] FIG. 15 shows a distal portion of an exemplary delivery
system 700 to deliver and deploy integrated valve prosthesis 600.
Delivery system 700 may be similar to other delivery devices for
delivery and deployment of valve prostheses. Accordingly, the
proximal portion of delivery system 700 is not described herein,
but may included features such as handles and knobs to advance
delivery system 700, retract sheath 704, and release valve
component 640 from hub 705. Delivery system 700 may include, among
other features, an inner or guidewire shaft 708 which includes a
guidewire lumen for receiving a guidewire 702, a distal tip 701, an
outer sheath 704 defining a capsule 703, and a hub 705. A proximal
end of guidewire 702 may be backloaded into the guidewire lumen of
inner shaft 708 through a distal opening tip 701. Delivery system
700 may be an over-the-wire type catheter, or a rapid exchange
catheter, or other known catheter devices. Outer sheath 704
maintains anchor stent 610 and valve component 640 in the radially
compressed or delivery configuration during intraluminal delivery
through the vasculature, as shown in FIG. 15. Hub 705 may include
grooves or other features to mate with tabs 641 disposed at a
distal end of valve component 640. Hub 705 and tabs 641 may be
features as described, for example and not by way of limitation, in
U.S. Patent Application Publication Nos. 2011/0264203; 201/0251675;
2011/0098805; 2010/0049313; and 2009/0287290; and in U.S. Pat. Nos.
8,398,708; 8,052,732; and 6,267,783, each of which is incorporated
by reference herein in its entirety. However, delivery system 700
may include different features to retain and subsequently release
valve component 640. Further, delivery system 700 may alternatively
include a pusher or stopper as described above with respect to
delivery system 500. Delivery system 700 may also include other
features known to those skilled in the art. Delivery system 700
and/or anchor stent 610 may also include, for example, radiopaque
markers such that the clinician may determine when delivery system
700 and/or anchor stent 610 is in the proper location for
deployment.
[0062] As described previously with respect to FIG. 5, a guidewire
702 is advanced distally, i.e., away from the clinician, through
the aorta 400 into the aortic sinuses 412 in the region of the
aortic valve 414. Guidewire 702 may be introduced through an
opening or arteriotomy through the wall of femoral artery in the
groin region of the patient by methods known to those skilled in
the art, such as, but not limited to, the Seldinger technique.
Guidewire 702 is advanced into the descending (or abdominal) aorta
406, the aortic arch 404, and the ascending aorta 402. Although
FIGS. 15-23 show a retrograde percutaneous femoral procedure, it is
not meant to limit the method of use and other procedural methods
may be used. For example, and not by way of limitation, retrograde
percutaneous implantation via subclavian/axillary routes, direct
apical puncture, and the use of direct aortic access via either
ministernotomy or right anterior thoracotomy may also be used.
[0063] Delivery system 700 is advanced over guidewire 702, as shown
in FIG. 16. Once delivery system 700 has been advanced to the
desired location, such as when proximal end 616 of anchor stent is
generally aligned with the sinotubular junction 413, outer sheath
704 is retracted proximally, i.e., towards the clinician, as shown
in FIG. 17. As outer sheath 704 is retracted, proximal arm
component 620 expands radially outward, as shown in FIG. 17.
Delivery system 700 is then advanced distally, i.e., away from
clinician, until proximal arm component 620 bottoms at the nadir of
the aortic valve leaflets 117, as shown in FIG. 18.
[0064] Next, anchor stent 610 is deployed in the aorta near the
sinotubular junction 413 by further retracting proximally, i.e.,
towards the clinician, outer sheath 704 such that tubular frame
member 612 expands from the radially compressed configuration to a
radially expanded configuration engaging an inner wall surface of
the ascending aorta, as shown in FIG. 19.
[0065] Although proximal arm component 620 is shown in FIGS. 18-23
as having arms 622, 624, 626 extending to an area near the base of
leaflets 414, those skilled in the art would recognize that arms
622, 624, 626 may be shorter such that they engage the sinuses 412
at a location nearer to sinotubular junction 413 than shown in
FIGS. 18-23.
[0066] As can be seen in FIG. 19, proximal arm component 620 is in
the radially expanded configuration such that it flares outwardly
from frame 612 and engages the aortic sinuses 412, and frame 612 is
in the radially expanded configuration such that it engages the
inner wall of the ascending aorta 402.
[0067] Outer sheath 704 is further retracted proximally, i.e.,
towards the clinician, to deploy tethers 602 and skirt 608 from
outer sheath 704, as shown in FIG. 20. As shown in FIG. 20, tethers
602 and skirt 608 are disposed distal of anchor stent 610 and are
not constrained by sheath 704. Tip 701 may then be retracted to
near the distal end of sheath 704, as shown in FIG. 20.
[0068] With outer sheath 704 retracted such that anchor stent 610
is deployed in the aorta 400 and tethers 602 and skirt 608 are
released from outer sheath 704, delivery system 700 is advanced
distally, i.e., away from the clinician, through lumen 613 of
anchor frame 612, pulling skirt 608 and tethers 602 through lumen
613, effectively flipping the direction of tethers 602 and skirt
608. Accordingly, whereas tethers 602 and skirt 608 in FIGS. 19-20
extend in a first direction 720 from anchor stent 610 towards valve
component 640, tethers 602 and skirt 608 in FIGS. 21-23 extend in a
second direction 722 from anchor stent 610 towards valve component
640. Second direction 722 is generally opposite first direction
720. The term "generally opposite" with respect to directions
described herein and terms similar thereto, as used herein, is not
so narrow as to mean 180 degrees difference in direction. Instead,
the term "generally opposite" with respect to direction means that
a component includes a vector component in the first direction, the
direction which is generally opposite includes a vector component
in the opposite direction. Thus, the tethers 602 and skirt 608 in
the first direction 720 may be within 45 degrees of the first
direction 720 and the second, generally opposite direction 722 may
be within 135 degrees to 225 degrees of the first direction 720.
Delivery system 700 is advanced distally, i.e., away from the
clinician, until tethers 602 and skirt 608 are taut. Tautness of
tethers 602 and skirt 608 correctly positions valve component 640
for deployment at desired location, such as near the native aortic
valve leaflets 414 and proximal end 646 of frame 642 being
generally aligned with the aortic annulus 415, as shown in FIG.
21
[0069] Sheath 704 is then further retracted proximally, i.e.,
towards the clinician, to deploy frame 642 of valve component 640.
Frame 642 expands radially outward to the radially expanded or
deployed configuration, as shown in FIGS. 22-23. As frame 642
expands, frame 642 separates the leaflets of native valve 414, as
shown in FIGS. 22-23. Proximal end 646 of frame 642 engages the
inner wall of the annulus 415, with skirt 608 disposed between
frame 642 and the annulus 415. Dist end 644 of frame 642 engages an
inner surface of anchor frame 612, as shown in FIGS. 22-23.
[0070] With integrated valve prosthesis 600 fully deployed,
delivery system 700 and guidewire 702 may be retracted proximally,
i.e., towards the clinician, and removed in a manner consistent
with current procedures know to those knowledgeable in the art.
Integrated valve prosthesis 600 remains in the fully deployed
configuration as shown in FIG. 23. FIGS. 16-23 show lateral gaps
between the different parts which are disposed adjacent to each
other. These gaps are shown for clarity such that the different
parts of the integrated valve prosthesis and the heart valve may be
seen. It is understood than many of these parts will abut directly
against each other due to the radially outward forces of anchor
stent 610 and valve frame 642.
[0071] Although some examples of advantages have been described
above, these are non-limiting in that other advantages of the
integrated valve assembly 300/320/600 would be apparent to those
skilled in the art.
[0072] It will also be understood that each feature of each
embodiment discussed herein, and of each reference cited herein,
can be used in combination with the features of any other
embodiment. All patents and publications discussed herein are
incorporated by reference herein in their entirety.
[0073] While various embodiments according to the present invention
have been described above, it should be understood that they have
been presented by way of illustration and example only, and not
limitation. It will be apparent to persons skilled in the relevant
art that various changes in form and detail can be made therein
without departing from the spirit and scope of the invention. Thus,
the breadth and scope of the present invention should not be
limited by any of the above-described exemplary embodiments, but
should be defined only in accordance with the appended claims and
their equivalents. It will also be understood that each feature of
each embodiment discussed herein, and of each reference cited
herein, can be used in combination with the features of any other
embodiment
* * * * *