U.S. patent application number 16/196143 was filed with the patent office on 2019-03-21 for heart and peripheral vascular valve replacement in conjunction with a support ring.
The applicant listed for this patent is VALCARE, INC.. Invention is credited to Jeffrey DUMONTELLE, Avi EFTEL, Samuel M. SHAOLIAN, Nadav YELLIN.
Application Number | 20190083239 16/196143 |
Document ID | / |
Family ID | 51934245 |
Filed Date | 2019-03-21 |
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United States Patent
Application |
20190083239 |
Kind Code |
A1 |
SHAOLIAN; Samuel M. ; et
al. |
March 21, 2019 |
HEART AND PERIPHERAL VASCULAR VALVE REPLACEMENT IN CONJUNCTION WITH
A SUPPORT RING
Abstract
An implantable valve replacement system for a cardiovascular
valve may include an adjustable stabilizing ring. The stabilizing
ring may be composed of a body member that is transitionable from
an elongate insertion geometry to an annular operable geometry. The
stabilizing ring may further include a plurality of anchors
deployable in the annular operable geometry to engage the annulus
of the cardiovascular valve. The ring may be used in conjunction
with an implantable valve frame. The valve frame may be located
within the ring and the ring, in turn, may be stabilized through
the anchors engaging the valve annulus. The valve replacement
system may be applied by engaging the ring in its annular operable
geometry with the valve annulus through the anchors. The valve
frame may be inserted through the opening of the ring, thereby
forming a stabilizing mechanical contact between the frame and the
annulus.
Inventors: |
SHAOLIAN; Samuel M.;
(Newport Beach, CA) ; YELLIN; Nadav; (Ramat Gan,
IL) ; EFTEL; Avi; (Tel Aviv, IL) ; DUMONTELLE;
Jeffrey; (Irvine, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
VALCARE, INC. |
Newport Beach |
CA |
US |
|
|
Family ID: |
51934245 |
Appl. No.: |
16/196143 |
Filed: |
November 20, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14893131 |
Nov 23, 2015 |
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PCT/US2014/039454 |
May 23, 2014 |
|
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16196143 |
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61827531 |
May 24, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/2448 20130101;
A61F 2230/0004 20130101; A61F 2220/0016 20130101; A61F 2230/0006
20130101; A61F 2/2418 20130101; A61F 2/2409 20130101; A61F 2/2466
20130101; A61F 2230/0008 20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. An implantable valve system comprising: an adjustable
stabilizing ring comprising: a body member that is transitionable
from an elongate insertion geometry to an annular operable
geometry, and a plurality of anchors deployable in the annular
operable geometry to engage the annulus of a cardiovascular valve;
and an implantable valve frame in mechanical communication with the
adjustable stabilizing ring, wherein the elongate insertion
geometry is configured to allow percutaneous passage of the
stabilizing ring, via a catheter, to a position adjacent to an
annulus of the cardiovascular valve, and wherein the annular
operable geometry has a closed state to conform to the annulus of
the cardiovascular valve.
2. The implantable valve system of claim 1, wherein the implantable
valve frame comprises one, two, or three valve leaflets.
3. The implantable valve system of claim 1, wherein the adjustable
stabilizing ring, the implantable valve frame, or both are coated
with a pliable material.
4. The implantable valve system of claim 3, wherein the pliable
material is a polymer.
5. The implantable valve system of claim 3, wherein the pliable
material is a polyester.
6. The implantable valve system of claim 1, wherein the implantable
valve frame comprises a first support element, a second support
element, and at least one bridging element extending from the first
support element to the second support element.
7. The implantable valve system of claim 6, wherein the implantable
valve frame further comprises one, two, or three valve leaflets at
least partially secured to the first support element, the second
support element, the at least one bridging element, or any
combination thereof.
8. The implantable valve system of claim 6, wherein the at least
one bridging element comprises a continuous surface having a first
end and a second end, wherein the first end is in physical contact
with an entirety of the first support element and the second end is
in physical contact with an entirety of the second support
element.
9. The implantable valve system of claim 6, wherein the at least
one bridging element comprises a collapsible material.
10. The implantable valve system of claim 6, wherein the at least
one bridging element comprises a woven material.
11. The implantable valve system of claim 6, wherein the at least
one bridging element comprises a plurality of independent bridging
elements.
12. The implantable valve system of claim 6, wherein the at least
one bridging element extends radially inwards towards a central
axis of the implantable valve frame.
13. The implantable valve system of claim 6, wherein at least a
portion of an exterior surface of the at least one bridging element
is in mechanical communication with the adjustable stabilizing
ring.
14. The implantable valve system of claim 6, wherein the
implantable valve frame comprises at least one ring anchor
configured to stabilize the implantable valve frame in mechanical
communication with the adjustable stabilizing ring.
15. The implantable valve system of claim 14, wherein the at least
one ring anchor is in mechanical communication with the at least
one bridging element.
16. The implantable valve system of claim 1, wherein the
implantable valve frame comprises a woven structure.
17. The implantable valve system of claim 1, wherein the
implantable valve frame comprises a plurality of elements disposed
in a criss-cross arrangement.
18. The implantable valve system of claim 1, wherein the
implantable valve frame comprises at least a portion of a
stent.
19. The implantable valve system of claim 1, wherein the
implantable valve frame is rigid or semi-rigid.
20. The implantable valve system of claim 1, wherein the
implantable valve frame is at least partially collapsible.
21. The implantable valve system of claim 20, wherein the
implantable valve frame is configured to be delivered via a
catheter in an at least partially collapsed state.
22. The implantable valve system of claim 20, wherein the at least
partially collapsible implantable valve frame is expandable.
23. The implantable valve system of claim 22, wherein the at least
partially collapsible implantable valve frame is
self-expandable.
24. The implantable valve system of claim 22, wherein the at least
partially collapsible implantable valve frame is configured to
expand under the actions of an expansion device.
25. The implantable valve system of claim 1, wherein the
implantable valve frame comprises one or more of a memory metal, a
nickel titanium alloy, a stainless steel alloy, and a cobalt-chrome
alloy.
26. The implantable valve system of claim 1, wherein the adjustable
stabilizing ring in the annular operable geometry is rigid or
semi-rigid in the closed state.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. application Ser.
No. 14/893,131, entitled "HEART AND PERIPHERAL VASCULAR VALVE
REPLACEMENT IN CONJUNCTION WITH A SUPPORT RING," filed Nov. 23,
2015, which is a U.S. national stage filing under 35 U.S.C. .sctn.
371 of International Application No. PCT/US2014/039454 entitled
"HEART AND PERIPHERAL VASCULAR VALVE REPLACEMENT IN CONJUNCTION
WITH A SUPPORT RING," filed May 23, 2014, which claims benefit of
and priority to U.S. Provisional Patent Application No. 61/827,531,
entitled "HEART AND PERIPHERAL VASCULAR VALVE REPLACEMENT IN
CONJUNCTION WITH A SUPPORT RING," filed May 24, 2013, the
disclosures of which are incorporated herein by reference in their
entirety.
BACKGROUND
[0002] There are four valves in the heart that serve to direct
blood flow through the two sides of the heart. On the left
(systemic) side of the heart are the mitral valve, located between
the left atrium and the left ventricle, and the aortic valve,
located between the left ventricle and the aorta. These two valves
may direct oxygenated blood from the lungs through the left side of
the heart and into the aorta for distribution to the body. On the
right (pulmonary) side of the heart are the tricuspid valve,
located between the right atrium and the right ventricle, and the
pulmonary valve, located between the right ventricle and the
pulmonary artery. These two valves may direct de-oxygenated blood
from the body through the right side of the heart and into the
pulmonary artery for distribution to the lungs, where the blood
becomes re-oxygenated. The cardiac valves are composed of moveable
features, generally described as leaflets or cusps. The mitral
valve has two leaflets, and the tricuspid valve has three leaflets.
The aortic and pulmonary heart valves have leaflets that are shaped
somewhat like half-moons and are typically described as cusps. Each
of the aortic valve and the pulmonary valve has three cusps.
[0003] Other valves, such as venous valves, may be present in the
vascular system to aid in directing the flow of blood through the
body. Such peripheral vascular values typically have a single
leaflet structure and act as gates to prevent blood from flowing
backward. For example, as a leg muscle contracts, the venous
vessels may be compressed, and the blood may be pushed through a
valve. As the muscle relaxes, the blood may be prevented from
flowing backwards as the valve closes. The one-way venous valves
may ensure that the blood flows in one direction back towards the
heart.
[0004] All heart and vascular valves are passive structures that
simply open and close in response to differential pressures on
either side of the valve. They do not, in general, expend energy
and do not perform any active contractile function. The
cardiovascular valves may exhibit abnormal anatomy and function as
a result of congenital or acquired valve disease. Congenital valve
abnormalities may be well-tolerated for many years only to develop
a life-threatening problem in an elderly patient. Alternatively,
such abnormalities may be so severe that emergency surgery may be
required in-utero or within the first few hours of life. Acquired
valve disease may result from such causes as rheumatic fever,
degenerative disorders of the valve tissue, bacterial or fungal
infections, and trauma.
[0005] Since the cardiovascular valves are passive structures,
valve failure modes can be classified into two categories:
stenosis, in which a valve does not open properly; and
insufficiency (also called regurgitation), in which a valve does
not close properly. Stenosis and insufficiency may occur at the
same time in the same valve or in different valves. Both of these
abnormalities may increase the workload placed on the heart as well
as other organs of the body, such as the liver and kidneys. In
particular, the severity of this increased stress on the heart, and
the heart's ability to adapt to it, may determine whether an
abnormal valve can be repaired or if valve removal and/or
replacement is warranted.
SUMMARY
[0006] In an embodiment, an implantable valve system may include an
adjustable stabilizing ring having a body member that is
transitionable from an elongate insertion geometry to an annular
operable geometry, and a plurality of anchors deployable in the
annular operable geometry to engage the annulus of the
cardiovascular valve. The elongate insertion geometry of the body
member may be configured to allow percutaneous passage of the
stabilizing ring, via a catheter, to a position adjacent to an
annulus of a cardiovascular valve. The annular operable geometry of
the body member may have a closed state to conform to the annulus
of the cardiovascular valve. The implantable valve system may
further include an implantable valve frame in mechanical
communication with the adjustable stabilizing ring.
[0007] In an embodiment, a platform to stabilize an implantable
valve frame may include an adjustable stabilizing ring having a
body member that is transitionable from an elongate insertion
geometry to an annular operable geometry, and a plurality of
anchors deployable in the annular operable geometry to engage the
annulus of the cardiovascular valve. The elongate insertion
geometry of the body member may be configured to allow percutaneous
passage of the stabilizing ring, via a catheter, to a position
adjacent to an annulus of a cardiovascular valve. The annular
operable geometry of the body member may have a closed state to
conform to the annulus of the cardiovascular valve. The adjustable
stabilizing ring in the closed state of the annular operable
geometry may be configured to receive and stabilize the implantable
valve frame at a position proximal to the annulus of the
cardiovascular valve.
[0008] In an embodiment, a method of stabilizing a replacement of a
cardiovascular valve may include inserting a distal end of a
catheter comprising a delivery system into a cardiovascular valve,
guiding, via the delivery system, an adjustable stabilizing ring in
an elongate geometry from a proximal end of the catheter to the
distal end of the catheter such that the adjustable stabilizing
ring transitions to an annular operable geometry upon exiting the
distal end of the catheter, deploying a number of anchors from the
adjustable stabilizing ring to engage an annulus of the
cardiovascular valve, guiding an implantable valve frame including
the replacement of the cardiovascular valve through the
cardiovascular valve and through a center of the adjustable
stabilizing ring, and engaging at least a portion of the
implantable valve frame with the adjustable stabilizing ring,
thereby stabilizing a position of the implantable valve frame with
respect to the cardiovascular valve.
[0009] In an embodiment, a method of replacing a cardiovascular
valve may include inserting a distal end of a catheter comprising
at least one delivery system into a cardiovascular valve, guiding,
via the at least one delivery system, an implantable valve frame
having the replacement of the cardiovascular valve through the
cardiovascular valve, expanding the implantable valve frame,
guiding, via the at least one delivery system, an adjustable
stabilizing ring in an elongate geometry through the implantable
valve frame and the replacement of the cardiovascular valve such
that the adjustable stabilizing ring transitions to an annular
operable geometry around an exterior of the implantable valve frame
upon exiting the distal end of the catheter, engaging at least a
portion of the implantable valve frame with the adjustable
stabilizing ring, and deploying a number of anchors from the
adjustable stabilizing ring to engage an annulus of the
cardiovascular valve.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1A depicts a perspective view of an illustrative
adjustable annuloplasty ring in an annular (D-shaped) operable
geometry and a contracted state according to an embodiment.
[0011] FIG. 1B depicts a perspective view of an illustrative
adjustable annuloplasty ring in an expanded state according to an
embodiment.
[0012] FIG. 1C depicts a schematic diagram of an illustrative
cutting pattern used for laser processing a hypotube of an
adjustable annuloplasty ring according to an embodiment.
[0013] FIG. 2A depicts a schematic diagram of a perspective view of
a second illustrative adjustable annuloplasty ring in an annular
(D-shaped) operable geometry and a contracted state according to an
embodiment.
[0014] FIG. 2B depicts a schematic diagram of a perspective view of
an illustrative adjustable annuloplasty ring in an expanded state
according to an embodiment.
[0015] FIG. 3A depicts a schematic diagram of a perspective view of
a second illustrative adjustable annuloplasty ring in an annular
(D-shaped) operable geometry and in an expanded state according to
an embodiment.
[0016] FIG. 3B depicts a schematic diagram of a perspective view of
a second illustrative adjustable annuloplasty ring in a contracted
state according to an embodiment.
[0017] FIGS. 4A and 4B depict a perspective view and a
cross-sectional view, respectively, of an illustrative stepped
connector of an adjustable annuloplasty ring according to an
embodiment.
[0018] FIG. 5A depicts a schematic diagram illustrating a side view
of an internal anchor ribbon including a plurality of curved
anchors according to an embodiment.
[0019] FIG. 5B depicts a schematic diagram of a top view of
illustrative anchors cut into an internal anchor ribbon in an
elongate insertion geometry according to an embodiment.
[0020] FIG. 5C depicts a schematic diagram of a side view of an
illustrative internal anchor ribbon in an elongate insertion
geometry and a plurality of anchors in a curled or curved deployed
configuration according to an embodiment.
[0021] FIG. 5D depicts a schematic diagram of a top view of an
illustrative internal glide ribbon in an elongate insertion
geometry according to an embodiment.
[0022] FIG. 5E depicts a schematic diagram of a side view of an
illustrative internal glide ribbon according to an embodiment.
[0023] FIGS. 5F and 5G depict a front view and a side view,
respectively, of a tube-like polymeric element according to an
embodiment.
[0024] FIGS. 5H, 5I, and 5J depict a top view, a first side view,
and a second side view, respectively, of a polymeric element
according to an embodiment.
[0025] FIGS. 6A and 6B depict schematic diagrams of cross-sectional
side views of an annuloplasty ring before (FIG. 6A) and after (FIG.
6B) deployment of a plurality of anchors according to an
embodiment.
[0026] FIG. 6C depicts a schematic diagram of a side view of
various segments of illustrative internal anchors according to an
embodiment.
[0027] FIG. 7 depicts a schematic diagram of a side view of an
illustrative internal anchor member including linear anchors
according to an embodiment.
[0028] FIG. 8A depicts a schematic diagram of an illustrative
trans-septal approach for endovascular delivery of an annuloplasty
ring to the mitral valve of a heart according to an embodiment.
[0029] FIG. 8B depicts a schematic diagram of an illustrative
retrograde approach of an annuloplasty ring to the mitral valve of
a heart according to an embodiment.
[0030] FIG. 8C depicts a schematic diagram of an illustrative
trans-apical approach of an annuloplasty ring to the mitral valve
of a heart according to an embodiment.
[0031] FIG. 9A depicts a flow diagram of a first illustrative
method of placing an annuloplasty ring at a target valve according
to an embodiment.
[0032] FIG. 9B depicts a flow diagram of a second illustrative
method of placing an annuloplasty ring at a target valve according
to an embodiment.
[0033] FIGS. 9C, 9D, 9E, and 9F depict schematic diagrams of
transcatheter delivery of an annuloplasty ring from a delivery
system according to various embodiments.
[0034] FIG. 10 depicts a schematic diagram of a perspective,
partial cross-sectional view of a heart during an expansion of an
adjustable annuloplasty ring using a balloon expansion tool,
preparatory to affixation to the annulus of the mitral valve
according to an embodiment.
[0035] FIG. 11 depicts a schematic diagram of a perspective,
partial cross-sectional view of the heart during an expansion of an
adjustable annuloplasty ring using a cage or basket expansion tool,
preparatory to affixation to the annulus of the mitral valve
according to an embodiment.
[0036] FIGS. 12A and 12B depict perspective views of a stabilizer
of a percutaneous annuloplasty system according to an
embodiment.
[0037] FIGS. 12C and 12D depict a stabilizer including a balloon,
according to an embodiment.
[0038] FIG. 12E depicts a schematic diagram that demonstrates how
holes in the arms of a stabilizer may be used to help guide sutures
that are exiting the ring according to an embodiment.
[0039] FIGS. 13A, 13B, 13C, and 13D depict perspective views of a
stabilizer of a percutaneous annuloplasty system according to an
embodiment.
[0040] FIGS. 13E-13G depict a perspective view, a side view, and a
top view, respectively, of an illustrative annuloplasty ring having
strats according to an embodiment.
[0041] FIGS. 13H and 13I depict a top view and a detailed view,
respectively, of an engagement of an annuloplasty ring having
strats with a stabilizer according to an embodiment.
[0042] FIGS. 14A and 14B depict perspective views of a stabilizer
of a percutaneous annuloplasty system according to an
embodiment.
[0043] FIG. 15A depicts a perspective view of a proximal end of a
handle of a percutaneous annuloplasty system according to an
embodiment.
[0044] FIG. 15B depicts a cross-sectional view of the proximal end
of a handle of a percutaneous annuloplasty system according to an
embodiment.
[0045] FIGS. 16A and 16B depict diagrams of perspective views of an
illustrative delivery system of a percutaneous annuloplasty system
according to an embodiment.
[0046] FIGS. 17A and 17B depict illustrative examples of a full
assembly of the ring, stabilizer and distal end of the catheter as
configured in a target site after deployment of the ring from the
catheter according to an embodiment.
[0047] FIGS. 18A and 18B depict illustrative longitudinal
cross-sectional views of a catheter connecting the distal end of
the delivery system of FIG. 17A to the proximal end of the delivery
system of FIG. 16A or 16B according to an embodiment.
[0048] FIGS. 19A, 19B, and 19C depict illustrative examples of the
proximal side of a delivery system which functions as a handle
according to an embodiment.
[0049] FIG. 20A depicts a perspective view of an illustrative
example of an adjustable valve support ring in an extended state
according to an embodiment.
[0050] FIG. 20B depicts a perspective view of an illustrative
example of an adjustable valve support ring in a closed geometry
according to an embodiment.
[0051] FIG. 20C depicts a perspective view of an illustrative
example of an adjustable valve support ring in a closed geometry
with extended anchors according to an embodiment.
[0052] FIG. 21A depicts an isometric view of an illustrative
example of an angled D-shaped cylindrical valve frame according to
an embodiment.
[0053] FIG. 21B depicts an isometric view of an illustrative
example of an angled cylindrical valve frame according to an
embodiment.
[0054] FIG. 21C depicts a side view of the D-shaped valve frame
depicted in FIG. 21A or the cylindrical valve frame depicted in
FIG. 21B according to an embodiment.
[0055] FIG. 21D depicts an isometric view of an illustrative
example of a straight D-shaped valve frame according to an
embodiment.
[0056] FIG. 21E depicts a side view of the straight D-shaped valve
frame depicted in FIG. 21D according to an embodiment.
[0057] FIG. 21F depicts an isometric view of an illustrative
example of a straight cylindrical valve frame further depicting
support elements and a continuous bridging element surface
according to an embodiment.
[0058] FIG. 21G depicts an isometric view of an illustrative
example of a straight cylindrical valve frame further depicting
support elements and a plurality of independent bridging elements
according to an embodiment.
[0059] FIG. 21H depicts an illustrative example of an adjustable
stabilizing ring according to an embodiment.
[0060] FIG. 22A depicts a top view of an illustrative example of an
angled D-shaped cylindrical valve frame including an exemplary
bi-leaflet valve according to an embodiment.
[0061] FIG. 22B depicts a top view of an illustrative example of an
angled cylindrical valve frame including an exemplary tri-leaflet
valve according to an embodiment.
[0062] FIG. 22C depicts a top view of an illustrative example of a
straight D-shaped cylindrical valve frame including an exemplary
bi-leaflet valve according to an embodiment.
[0063] FIG. 23A depicts a perspective view of an illustrative
example of an implantable valve system including an adjustable
valve support ring in a closed geometry with extended anchors and
an angled D-shaped cylindrical valve frame including an exemplary
bi-leaflet valve according to an embodiment.
[0064] FIG. 23B depicts a top view of the implantable valve system
depicted in FIG. 23A.
[0065] FIG. 23C depicts a perspective view of an illustrative
example of an implantable valve system including an adjustable
valve support ring in a closed geometry with extended anchors and
an angled cylindrical valve frame including an exemplary
tri-leaflet valve according to an embodiment.
[0066] FIG. 23D depicts a top view of the implantable valve system
depicted in FIG. 23C.
[0067] FIG. 24A depicts an isometric view of an illustrative
example of an angled D-shaped cylindrical valve frame having
attachment anchors for a support ring according to an
embodiment.
[0068] FIG. 24B depicts an isometric view of an illustrative
example of an implantable valve system including an adjustable
valve support ring in a closed geometry with extended anchors
secured to an angled D-shaped cylindrical valve frame having
attachment anchors according to an embodiment.
[0069] FIG. 25 depicts a flow diagram of an illustrative method of
stabilizing a replacement cardiovascular valve according to an
embodiment.
[0070] FIG. 26 depicts a flow diagram of an illustrative method of
replacing a cardiovascular valve according to an embodiment.
DETAILED DESCRIPTION
[0071] The valve structures in the heart and vascular system are
not composed of rigid tissues but have some natural compliance. The
natural compliance of a valve may aid in its natural functional
performance. However, if the valve is diseased, the compliance may
change significantly, and the function of the valve may be
compromised. If the natural tissue structure surrounding the valve
is weak, supplemental support of the surrounding tissue may be
highly desirable. If the valve structure is not badly compromised,
the supplemental support alone may be sufficient to restore the
valve's normal function. However, supplemental support alone may
not be sufficient to restore a valve's normal function, and the
diseased valve may require replacement with a prosthesis.
[0072] Minimally invasive or percutaneous valve replacement surgery
or valve function replacement is well known in the art and a number
of surgical options are available. However, the currently available
valve replacement procedures may be difficult to employ for valve
implantation in some areas of the heart (e.g. mitral valve,
tricuspid valve) or in peripheral (e.g. venous) vasculature where
the tissue is naturally highly compliant or highly compliant due to
disease. While the rigid frames used to support the flexible
leaflets in replacement valves may be able to hold the replacement
prosthetic valve in position acutely, it is difficult for them to
remain in place over a long period of time due to the dynamic and
compliant nature of the surrounding tissue. Therefore, there is a
need for an improvement to allow the prosthetic valve to be
implanted within these more highly compliant structures. Through
the use of a separate minimally or percutaneously delivered support
ring, which may be delivered and secured to the surrounding tissue
or annulus thereby reinforcing it, a replacement prosthetic valve
could then be implanted within the support ring and remain in
position to provide the long-term benefit it is designed for.
[0073] A rigid or semi-rigid support ring may be delivered to the
valve area via small bore delivery systems or catheters using
percutaneous methods. Such a support ring may be external to the
replacement valve and could provide the support needed for the
replacement prosthetic valve. The use of such a support ring may
allow the replacement valve to remain permanently or
semi-permanently in place.
[0074] A support ring that can be used in conjunction with a
prosthetic valve may be fabricated from a biocompatible, durable,
non-thrombogenic, sterilizable, material and may further exhibit
advantageous hemodynamic performance. As cardiovascular procedures
become minimally invasive, a support ring or structure that can be
delivered using percutaneous procedures and secured to allow for
secondary implantation of a prosthetic valve is needed.
[0075] The following terms shall have, for the purposes of this
application, the respective meanings set forth below.
[0076] A "heart valve" refers to any valve of a heart. In some
embodiments, the heart may be a human heart. In other embodiments,
the valve may be a non-human heart. The heart valves include
atrioventricular valves (mitral valve and tricuspid valve) and
semilunar valves (aortic valve and pulmonary valve). As used
herein, the term "valve" is used to denote a heart valve, except
where explicitly stated otherwise. Various portions of the heart,
including the valves, may contain one or more fibrous rings
therearound. Such a fibrous ring is commonly known (and used
herein) as an "annulus."
[0077] A "patient" refers to any human or non-human individual. The
patient is generally any patient that has been diagnosed or will be
diagnosed with a valve-related disorder, such as, for example, a
heart valve-related disorder. In some embodiments, the patient may
be an individual that would benefit from the apparatuses, systems,
and methods described herein.
[0078] As used herein, "percutaneous" refers to a procedure that
uses incisions through the skin of the abdomen for access to a
surgical site, such as, for example, a patient's heart. Thus, as
used herein, percutaneous surgery and laparoscopic surgery are
mutually exclusive. In the preferred embodiment, the methods
described herein are performed percutaneously, although
laparoscopic methods are contemplated. As used herein, a
percutaneous procedure may be a minimally invasive procedure or a
highly invasive procedure. A percutaneous procedure may also
include a trans-septal approach, a trans-apical approach, or a
trans atrial approach.
[0079] The systems and methods described herein may generally be
used to facilitate repair of a heart valve through percutaneous
trans-catheter delivery and fixation of an annuloplasty ring to the
heart valve. The embodiments of stabilizers and delivery systems
can be configured in elongated insertion geometries that can be
inserted into a catheter tube and deployed to an operable geometry
providing a 3D geometry that corresponds to and attaches to an
annuloplasty ring connected to a catheter delivery system.
[0080] FIG. 1A depicts a schematic diagram of a perspective view of
an illustrative adjustable annuloplasty ring, generally designated
100, according to an embodiment. As shown in FIG. 1A, the
annuloplasty ring 100 may be in an annular (D-shaped) operable
geometry in a contracted state. FIG. 1B depicts a schematic diagram
of a perspective view of the adjustable annuloplasty ring 100 of
FIG. 1A when in an expanded state. The annuloplasty ring 100 may be
configured to enable percutaneous, transcatheter annuloplasty to
repair a heart valve. The annuloplasty ring 100 may be fastened,
percutaneously, to the annulus of a target heart valve while in the
expanded state and reduced to the contracted state to decrease an
A-P distance of the target valve and thereby improve leaflet
coaptation of the target valve and reduce regurgitation through the
target valve.
[0081] Referring collectively to FIGS. 1A and 1B, the annuloplasty
ring 100 may include a body member 101 having a plurality of
regions 102a, 102b, 102c (collectively 102), biasing elements 103a,
103b (collectively 103), a plurality of anchors 104, a ring closure
lock 106, and a pivot 108. In FIGS. 1A and 1B, as well as in other
embodiments disclosed herein, the body member 101, including the
plurality of regions 102, may be arranged in a "D-shape" in the
operable geometry. The D-shaped annuloplasty ring 100 may have a
particular geometrical ratio that is in conformance (or approximate
conformance) with the anatomical geometry of the human mitral valve
annulus. For example, in certain embodiments, the ratio of the A-P
distance to the commissure-commissure (C-C) distance of the
annuloplasty ring 100 when implanted (for example, in the
contracted state) may be about 0.55 to about 0.80, including about
0.55, about 0.60, about 0.65, about 0.70, about 0.75, about 0.80,
or any value or range between any two of these values (including
endpoints). In a particular embodiment, the implanted ratio of the
A-P distance to the C-C distance may be about 0.73.
[0082] Although the illustrated embodiment of an annuloplasty ring
100 of FIGS. 1A and 1B is a D-shaped operable geometry, those
having ordinary skill in the art will recognize that other
annular-shaped operable geometries may also be used without
departing from the present disclosure. For example, circular or
oval operable geometries may be used.
[0083] In some embodiments, the body member 101 may include a
hollow hypotube (or outer hollow member). The hypotube may be cut
from, for example, a tube to form the plurality of regions 102. The
cuts may define a shape and/or characteristics of the body member
101. For example, laser cuts may define the plurality of regions
102 (and define how the plurality of regions interact), anchor
windows 110, and/or the biasing elements 103.
[0084] In various embodiments, the body member 101 may include a
shape memory (such as, for example, nitinol) hypotube into which a
plurality of cuts and/or segments may be laser cut to define a
size, a shape, and/or characteristics of the plurality of regions
102. The shape memory hypotube may be heat set to a "memorized"
annular shape (such as, for example, the D-shaped operable
geometry). The shape memory hypotube may be superelastic such that
applying sufficient stress may place the body member 101, including
the plurality of regions 102, into an elongate insertion geometry
and releasing the stress allows the body member 101, including the
plurality of regions 102, to resume the D-shaped operable geometry.
In some embodiments, laser cuts may define a flexibility of the
body member 101. For example, the laser cuts may allow the body
member 101 to be flexible when the annuloplasty ring 100 is in an
elongate insertion geometry (as described herein) and/or rigid when
the annuloplasty ring is in the operable geometry.
[0085] In addition to the operable geometry shown in FIGS. 1A and
1B, the body member 101 may transitionable from an elongate
insertion geometry (see, for example, FIG. 9C) to the annular
operable geometry shown in FIGS. 1A and 1B. The elongate insertion
geometry may allow the annuloplasty ring 100 to be inserted into
and passed through a catheter for percutaneous passage into the
heart of a patient, as described in greater detail herein. A
transition from an elongate insertion geometry to an annular
operable geometry is illustrated in FIGS. 9C-9F, and discussed
herein with reference to the same.
[0086] Once in an annular operable geometry as shown in FIGS. 1A
and 1B, the annuloplasty ring 100 may have a contracted state as
shown in FIG. 1A and an expanded state as shown in FIG. 1B. The
biasing elements 103 may be configured to expand to increase the
A-P distance of the annuloplasty ring 100 to an expanded state. The
A-P distance AP1 of the contracted state of FIG. 1A is enlarged by
a distance d such that the A-P distance AP2 of the expanded state
FIG. 1B is larger (AP2=AP1+d). Expansion of the biasing elements
103 may allow the body member 101 to be expanded to an expanded
state. In situ in the heart, expansion of the body member 101 to
the expanded state may enlarge the annuloplasty ring 100 to a size
conforming, or approximately conforming, to an annulus of a target
heart valve to be repaired. Expansion of the body member 101 may be
accomplished by an expansion tool, such as a balloon, a cage, or
another tool such as is shown in FIGS. 10, 11, 12A-12E, 13A-13D,
and 14A-14B, and described herein with reference to the same. In
the illustrated embodiment of FIGS. 1A and 1B, a biasing element
103a disposed between a first posterior region 102a and an anterior
region 102c and a biasing element 103b disposed between a second
posterior region 102b and the anterior region 102c may enable a
desired expansion from the contracted state shown in FIG. 1A to the
expanded state shown in FIG. 1B.
[0087] The expanded state of FIG. 1B may be such that the
annuloplasty ring 100 is disposed in abutment with, or in intimate
contact with, the annulus of the target valve. Disposing the
annuloplasty ring 100 in intimate contact with the annulus may
enhance an anchoring process in which the plurality of anchors 104
are deployed to fasten the annuloplasty ring 100 to the annulus.
Once the annuloplasty ring 100 is fastened to the annulus, it may
be contracted from the expanded state of FIG. 1B back to the
contracted state of FIG. 1A to reduce a diameter of the annulus of
the target valve.
[0088] Contraction of the annuloplasty ring 100 from the expanded
state to the contracted state may decrease the A-P distance of the
annuloplasty ring and, with the plurality of anchors 104 securing
the annuloplasty ring to the annulus, may also decrease an A-P
distance of the target valve to improve leaflet coaptation and
reduce regurgitation through the target valve. In the illustrated
embodiment of FIGS. 1A and 1B, contraction of the annuloplasty ring
100 from the expanded state to the contracted state may be
accomplished by the biasing elements 103. The biasing elements 103
may bias the annuloplasty ring 100 toward the contracted state such
that expansion of the annuloplasty ring to the expanded state
stores potential energy in the biasing elements 103. Releasing the
biasing elements 103 (such as, for example, releasing or otherwise
removing an expansion tool and/or expansion force) may release the
stored potential energy, thereby forcing movement of the first
posterior region 102a and the second posterior region 102b of the
body member 101 toward the anterior region 102c of the body member
to decrease the A-P distance of the annuloplasty ring 100 to the
contracted state. In other words, the biasing elements 103, upon
release, may actively transition the annuloplasty ring 100 from the
expanded state to the contracted state.
[0089] A typical range for change of the A-P distance d (between
the expanded state and the contracted state) may be about 3 mm to
about 8 mm, including about 3 mm, about 3.5 mm, about 4 mm, about
4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 6.5 mm, about 7
mm, about 7.5 mm, about 8 mm, or any value or range between any two
of these values (including endpoints). In some embodiments, the
range of d may depend on the overall size of the annuloplasty ring
100. For example, for a final geometry of the annuloplasty ring 100
that is 26 mm, a change distance d of about 3 mm may be desired. As
another example, for a final geometry of the annuloplasty ring 100
that is 36 mm, a change distance d of about 5 mm may be
desired.
[0090] The biasing elements 103 of the illustrated annuloplasty
ring 100 of FIGS. 1A and 1B may be a spiral cut or helical portion
of the body member 101 that is laser cut into the body member. The
spiral cut or helical portion, because it is cut into the body
member 101, is a biasing element 103 that is integral to the body
member. The spiral cut portion of the body member 101, as shown in
FIG. 1B, may form or otherwise define a spiral shape configured to
expand to allow the anterior region 102c to move away from the
first posterior region 102a and from the second posterior region
102b, thereby increasing the A-P distance of the annuloplasty ring
100. Also, the spiral cut or helical portion of the body member 101
may be biased toward a relaxed position, or the contracted state as
shown in FIG. 1A, such that expansion of the spiral cut or helical
portion stores potential energy and release of an expansion force
results in a release of potential energy and contraction toward the
contracted state.
[0091] In some embodiments, other integral biasing elements 103 may
be used. For example, a diamond cut pattern cut into the body
member 101 may allow desired expansion and biasing toward the
contracted state. In another embodiment, a corrugated pattern (such
as, for example, folds) may be formed in the body member 101. The
corrugated pattern may allow desired expansion to increase the A-P
distance of the annuloplasty ring 100 and may be biased toward the
contracted state.
[0092] In addition to integral biasing elements 103 (formed
integrally in the body member 101 of the annuloplasty ring 100),
other biasing elements 103 may be used that are not integral to the
body member. For example, FIGS. 2A and 2B illustrate an embodiment
in which the biasing element 203 is a spring and not integral to
the body member 201, as described herein. In still other
embodiments, the biasing element 203 may include a nonintegral
biasing component (such as, for example, a spring) to complement or
enhance operation of an integrally formed biasing element.
[0093] Referring back to FIGS. 1A and 1B, the plurality of anchors
104, as noted above, may be configured to secure the annuloplasty
ring 100 to the annulus of the heart valve. In some embodiments,
the anchors 104 may be barbs. As used herein, the terms "anchor"
and "barb" may be used interchangeably. In certain embodiments, the
anchors 104 are sufficient such that additional suturing of the
annuloplasty ring 100 to the valve annulus is not needed. As shown
in FIG. 1A, the anchors 104 may be within the body member 101 in an
insertion geometry. As shown in FIG. 1B, the anchors 104 may be
curved in the illustrated deployed configuration. The anchors 104
in other embodiments may include other shapes, such as linear or
helical deployed configurations. In certain embodiments, the
anchors 104 may include a shape memory material (such as, for
example, nitinol) that is heat set to a deployed configuration
(such as, for example, a curved configuration, a linear
configuration, or a helical configuration). Those with ordinary
skill in the art will recognize that combinations of different
deployed anchor configurations may also be used without departing
from the scope of the present disclosure.
[0094] The anchors 104 may be superelastic such that applying
sufficient stress places the anchors into an introduction
configuration and releasing the stress allows the anchors to resume
their respective deployed configurations. In certain embodiments,
the anchors 104 may lay flat against the body member 101 in the
introduction configuration during insertion of the annuloplasty
ring 100 through the catheter. As described in greater detail
herein, in other embodiments, the anchors 104 may be retracted
inside the hollow body member 101 of the annuloplasty ring 100 in
the introduction configuration during insertion of the annuloplasty
ring 100 through the catheter. In such embodiments, the anchors 104
may be selectively deployed at a desired time (such as, for
example, after the annuloplasty ring 100 is properly positioned
against, or in abutment with, the annulus of the heart valve). In
certain embodiments, the superelastic property of the anchors 104
may be used to self-propel the anchors into the annulus of the
heart valve. The anchors 104 may be configured to be deployed from
within the body member 101 through the anchor windows 110.
[0095] The ring closure lock 106 may be used to secure two open
ends of the annuloplasty ring 100 to form a closed ring of the
operable geometry. In certain embodiments, the ring closure lock
106 may include a female snap and a male snap. As discussed in
greater detail herein, the annuloplasty ring 100 may be "snap
locked" using wires or sutures to pull a male snap into a female
snap. The ring closure lock 106 of the illustrated annuloplasty
ring 100 of FIGS. 1A and 1B may be disposed at a posterior side of
the annuloplasty ring. The ring closure lock 106 may allow an
angled coupling of the two ends, such as, for example, at an apex
of a curved side of a D-shaped annular operable geometry.
[0096] The pivot 108 may be used to automatically rotate the
annuloplasty ring 100 after it exits the catheter within the heart
to align the plane of the annuloplasty ring 100 (in the annular
operable geometry) with the plane of the heart valve. The
annuloplasty ring 100 may be pushed from the catheter in a
direction that is substantially perpendicular to the plane of the
heart valve (such as, for example, parallel to the general
direction of blood flow through the valve). Upon exiting the
catheter, the annuloplasty ring 100 may be rotated at or about the
pivot 108 to allow proper positioning of the annuloplasty ring 100
against the annulus. With the annuloplasty ring 100 properly
oriented in alignment with the plane of the heart valve, the
annuloplasty ring 100 may be expanded to the expanded state. For
example, an expansion tool may be be used to expand the
annuloplasty ring 100, as shown in FIGS. 10, 11, 12A-12E, 13A-13D,
and 14A-14B and described in greater detail herein. The
annuloplasty ring 100 in the expanded state may be pressed against
the valve annulus before deploying the anchors 104, and an act of
deploying the anchors may drive the anchors into the adjacent
tissue. A positioning tool may facilitate expansion and/or proper
positioning/orientation of the annuloplasty ring 100 against the
heart valve annulus. A stabilizer, such as a tri-pod tool or a
bi-pod tool, shown for example in FIGS. 12A-12E, 13A-13D, and
14A-14B and described in greater detail herein, may be used to
position the annuloplasty ring 100 in abutment against the annulus
of the target heart valve, or otherwise in intimate contact with
the annulus of the target heart valve. In addition, fluoroscopy,
ultrasound, and/or other imaging techniques may be used to assist
in proper positioning of the annuloplasty ring 100 against the
heart valve annulus.
[0097] Although not shown in FIGS. 1A and 1B, certain ring
embodiments may include a selectively adjustable member for
changing the size and/or shape of the annuloplasty ring 100
postoperatively to compensate for changes in the size of the heart
and/or the treated heart valve. An illustrative example of an
adjustable member may be a member made of a material that can be
adjusted via the application of energy, such as, for example RF
energy, light energy, or thermal energy.
[0098] FIG. 1C depicts a schematic diagram of an illustrative
cutting pattern, generally designated 116, used for laser
processing a hypotube to form a body member 101 of an adjustable
annuloplasty ring 100 according to an embodiment. The pattern 116
may enable a hypotube or outer tube (also referred to herein as an
"outer hollow member") to be cut for use as a body member 101 of an
annuloplasty ring 100 according to an embodiment. The cutting
pattern 116 may correspond to the entire body member 101 as if the
body member were cut along a longitudinal axis and unrolled. The
cutting pattern 116 may enable cutting the hypotube to form the
plurality of regions 102 and the integral biasing 101 elements 103.
The cutting pattern 116 shown in FIG. 1C may define the
configuration of the plurality of regions 102 and how the regions
102 interact with adjacent regions as the body member 101
transitions from the elongate insertion geometry shown to the
annular operable geometry.
[0099] The cutting pattern 116 may also enable cutting the hypotube
to form one or more holes 120, 121 at each end to allow one or more
pins (not shown) to couple male and/or female components of the
ring closure lock 106 to respective ends of the body member 101.
The cutting pattern 116 may also enable cutting the hypotube to
form anchor windows 110 through which the plurality of anchors 104
may be deployed.
[0100] FIG. 2A depicts a schematic diagram of a perspective view of
an illustrative adjustable annuloplasty ring, generally designated
200, according to an embodiment. The annuloplasty ring 200 may be
in an annular (D-shaped) operable geometry and a contracted state.
FIG. 2B depicts a schematic diagram of a perspective view of an
illustrative adjustable annuloplasty ring 200 in an expanded state.
The annuloplasty ring 200 may be configured to enable percutaneous,
transcatheter annuloplasty to repair a heart valve.
[0101] Referring collectively to FIGS. 2A and 2B, the annuloplasty
ring 200 may include a body member 201 having a plurality of
regions 202a, 202b, 202c (collectively 202), biasing elements 203a,
203b (collectively 203), a plurality of anchors 204, a ring closure
lock 206, and a pivot 208. The body member 201 may be a "D-shape"
in the operable geometry, but those having ordinary skill in the
art will recognize that other annular-shaped operable geometries
may also be used without departing from the scope of the present
disclosure. For example, circular or oval operable geometries may
be used. Different from the annuloplasty ring 100 of FIGS. 1A-1B,
the ring closure lock 206 may be disposed on the anterior side of
the annuloplasty ring 200 (rather than the posterior side).
[0102] In addition to the operable geometry shown in FIGS. 2A and
2B, the body member 201 may be transitionable from an elongate
insertion geometry (see, for example, FIG. 9C) to the annular
operable geometry shown in FIGS. 2A and 2B. The elongate insertion
geometry may allow the annuloplasty ring 200 to be inserted into
and passed through a catheter for percutaneous passage of the
annuloplasty ring into the heart of a patient. A transition from an
elongate insertion geometry to an annular operable geometry is
illustrated in FIGS. 9C-9F, and discussed herein with reference to
the same.
[0103] Once in an annular operable geometry, the annuloplasty ring
200 may have a contracted state as shown in FIG. 2A and an expanded
state as shown in FIG. 2B. The biasing elements 203 may be
configured to allow expansion of the body member 201 to increase
the A-P distance of the annuloplasty ring 200 to an expanded state.
In situ within the heart, expansion of the body member 201 to the
expanded state may enlarge the annuloplasty ring 200 to a size
conforming, or approximately conforming, to an annulus of a target
heart valve to be repaired. Expansion of the body member 201 may be
accomplished by an expansion tool, such as a balloon, a cage, or
another expansion tool, such as is shown in FIGS. 10, 11, 12A-12E,
13A-13D, and 14A-14B, and described in greater detail herein. In
the illustrated embodiment of FIGS. 2A and 2B, a biasing element
203a disposed between a first anterior region 202a and a posterior
region 202c and a biasing element 203b disposed between a second
anterior region 202b and the posterior region 202c may enable a
desired expansion from the contracted state shown in FIG. 2A to the
expanded state shown in FIG. 2B.
[0104] The expanded state of FIG. 2B may be such that the
annuloplasty ring 200 is disposed in abutment with, or in intimate
contact with, the annulus of the target valve. Disposing the
annuloplasty ring 200 in intimate contact with the annulus may
enhance an anchoring process in which the plurality of anchors 204
is deployed to fasten the annuloplasty ring 200 to the annulus.
[0105] Once the annuloplasty ring 200 is fastened to the annulus,
it may be contracted from the expanded state of FIG. 2B back to the
contracted state of FIG. 2A to reduce a diameter of the annulus of
the target valve. Contraction of the annuloplasty ring 200 may
include the first and second anterior regions 202a, 202b of the
body member 201 moving in a telescopic manner into the posterior
region 202c as the biasing members 203 force movement of the first
and second anterior regions of the body member toward the posterior
region. Contraction of the annuloplasty ring 200 from the expanded
state to the contracted state may decrease the A-P distance of the
annuloplasty ring and, with the plurality of anchors 204 securing
the annuloplasty ring to the annulus, may also decrease the A-P
distance of the target valve to improve leaflet coaptation and
reduce regurgitation through the target valve.
[0106] In the illustrated embodiment of FIGS. 2A and 2B,
contraction of the annuloplasty ring 200 from the expanded state to
the contracted state may be accomplished by the biasing elements
203. The biasing elements 203 may bias the annuloplasty ring 200
toward the contracted state such that expansion of the annuloplasty
ring 200 to the expanded state stores potential energy in the
biasing elements. Releasing the biasing elements 203 (for example,
releasing or otherwise removing an expansion tool and/or expansion
force) releases the stored potential energy and thereby forces
movement of the first anterior region 202a and the second anterior
region 202b of the body member 201 toward the anterior region 202c
of the body member to decrease the A-P distance of the annuloplasty
ring 200 to the contracted state. In other words, the biasing
elements 203, upon release, may actively transition the
annuloplasty ring 200 from an expanded state to the contracted
state.
[0107] The biasing elements 203 of the illustrated annuloplasty
ring 200 of FIGS. 2A and 2B may include springs or another similar
element that is nonintegral to the body member. The springs of the
biasing elements 203 may allow the anterior regions 202a, 202b to
move away from the first posterior region 202c, thereby increasing
the A-P distance of the annuloplasty ring 200.
[0108] The A-P distance AP1 of the contracted state of FIG. 2A may
be enlarged a distance d upon expansion of the annuloplasty ring
200 such that the A-P distance AP2 of the expanded state FIG. 2B is
larger (AP2=AP1+d). The springs of the biasing elements 203 may be
biased toward a relaxed position, or the contracted state as shown
in FIG. 2A, such that expansion of the springs stores potential
energy and release of the springs results in a release of potential
energy and contraction toward the contracted state.
[0109] In various embodiments, the plurality of anchors 204 may be
configured to secure the annuloplasty ring 200 to the annulus of
the heart valve. In FIGS. 2A and 2B, the anchors 204 may be curved
in the illustrated deployed configuration. The anchors 204 in other
embodiments may include other shapes, such as, for example, linear
or helical deployed configurations. In certain embodiments, the
anchors 204 may include a shape memory material (such as, for
example, nitinol) that is heat set to a deployed configuration (for
example, curved configuration, linear configuration, or helical
configuration). Those with ordinary skill in the art will recognize
that combinations of different deployed anchor configurations may
also be used without departing from the scope of the present
disclosure.
[0110] The anchors 204 may be superelastic such that applying
sufficient stress places the anchors into an introduction
configuration and releasing the stress allows the anchors to resume
their respective deployed configurations. In certain embodiments,
the anchors 204 may lay flat against the body member 201 in the
introduction configuration during insertion of the annuloplasty
ring 200 through the catheter. As discussed below, in other
embodiments, the anchors 204 may retract inside a hollow body
member 201 of the annuloplasty ring 200 in the introduction
configuration during insertion of the annuloplasty ring through the
catheter. In such embodiments, the anchors 204 may be selectively
deployed at a desired time (for example, after the annuloplasty
ring 200 is properly positioned against, or in abutment with, the
annulus of the heart valve). In certain embodiments, the
superelastic property of the anchors 204 may be used to self-propel
the anchors into the annulus of the heart valve.
[0111] The ring closure lock 206 may be used to secure two open
ends of the annuloplasty ring 200 to form a closed ring of the
operable geometry. Different from the annuloplasty ring 100 of
FIGS. 1A-1B, the ring closure lock 206 may be disposed on the
anterior side of the annuloplasty ring 200 (rather than the
posterior side). In certain embodiments, the ring closure lock 206
may include a female snap and a male snap. The annuloplasty ring
100 may be "snap locked" using wires or sutures to pull a male snap
into a female snap.
[0112] The pivot 208 may facilitate rotation of the annuloplasty
ring 200 after it exits the catheter within the heart to align the
plane of the annuloplasty ring (in the annular operable geometry)
with the plane of the heart valve, as previously described
herein.
[0113] FIG. 3A depicts a schematic diagram of a perspective view of
an illustrative adjustable annuloplasty ring 300 according to
another embodiment. The annuloplasty ring 300 may be in an annular
(D-shaped) operable geometry and an expanded state. FIG. 3B depicts
a schematic diagram of a perspective view of the adjustable
annuloplasty ring 300 of FIG. 3A in a contracted state. The
annuloplasty ring 300 may be configured to enable percutaneous,
transcatheter annuloplasty to repair a heart valve.
[0114] Referring collectively to FIGS. 3A and 3B, the annuloplasty
ring 300 may include a body member 301 having a plurality of
regions 302a, 302b, 302c (collectively 302), a plurality of anchors
304, a ring closure lock 306, and a pivot 308, similar to
previously described embodiments. The annuloplasty ring 300 may be
transitionable from an elongate insertion geometry (see, for
example, FIG. 9C) to the annular operable geometry shown in FIGS.
3A and 3B. The elongate insertion geometry may allow the
annuloplasty ring 300 to be inserted into and passed through a
catheter for percutaneous passage of the annuloplasty ring into the
heart of a patient, as illustrated in FIGS. 9C-9F and discussed in
greater detail herein.
[0115] The plurality of regions 302 of the illustrated annuloplasty
ring 300 of FIGS. 3A and 3B may be separate, individual segments.
The segments 302 may be coupled together by stepped connectors
330a, 330b (collectively 330) in the annular operable geometry. The
stepped connectors 330 may be configured to enable the body member
301 to be adjustable to decrease the A-P distance of the
annuloplasty ring 300 from an expanded state as shown in FIG. 3A to
a contracted state as shown in FIG. 3B. The stepped connectors 330
may initially couple the posterior segment 302c to each of a first
anterior segment 302a and a second anterior segment 302b in the
expanded state of FIG. 3A, conforming, or approximately conforming,
to an annulus of a target heart valve to be repaired. The expanded
state of FIG. 3A may be such that the annuloplasty ring 300 is
disposed in abutment with, or in intimate contact with, the annulus
of the target valve, thereby enhancing an anchoring process in
which the plurality of anchors 304 are deployed to fasten the
annuloplasty ring to the annulus.
[0116] Once the annuloplasty ring 300 is fastened to the annulus,
it may be contracted from the expanded state of FIG. 3A to the
contracted state of FIG. 3B to reduce a diameter of the annulus of
the target valve. Contraction of the annuloplasty ring 300 may
include the stepped connectors 330 moving in a telescopic manner
into the posterior region 302c as the first and second anterior
regions 302a, 302b of the body member 301 move toward the posterior
region. Contraction of the annuloplasty ring 300 from the expanded
state to the contracted state may decrease the A-P distance of the
annuloplasty ring and, with the plurality of anchors 304 securing
the annuloplasty ring 300 to the annulus, may also decrease an A-P
distance of the target valve to improve leaflet coaptation and
reduce regurgitation through the target valve. The stepped
connectors 330 may allow for multiple degrees of adjustment. For
example a stepped connector having two engagement steps (see
engagement steps 402 in FIGS. 4A and 4B) may allow two degrees of
adjustment, as discussed in greater detail herein.
[0117] In the illustrated embodiment of FIGS. 3A and 3B,
contraction of the annuloplasty ring 300 from the expanded state to
the contracted state may be accomplished percutaneously through use
of sutures or wires to force the posterior segment 302c toward the
first and second anterior segments 302a, 302b and vice versa.
[0118] In certain embodiments, a biasing element (not shown in
FIGS. 3A and 3B) may bias the annuloplasty ring 300 toward the
contracted state and aid in contraction of the annuloplasty ring
300 from the expanded state to the contracted state. In other
embodiments, a biasing element may enable expansion from an initial
state to an expanded state, and a stepped connector 330 may operate
to ensure expansion from the contracted state is restricted.
[0119] Different from the embodiments of FIGS. 1A-1C and 2A-2B, the
annuloplasty ring 300 of FIGS. 3A and 3B may initially be in an
expanded state upon transition to the annular operable geometry. In
other words, the initial A-P distance AP1 of the annuloplasty ring
300 may be sufficient to conform or substantially conform to the
A-P distance of a target valve. The A-P distance AP1 of the
expanded state of FIG. 3A may be decreased a distance d upon
contraction of the annuloplasty ring 300 such that the A-P distance
AP2 of the contracted state FIG. 3B is smaller (AP2=AP1-d). The
decrease of the A-P distance, with the anchors fastening the
annuloplasty ring 300 to the annulus of the valve, may decrease the
A-P distance of the target valve to improve leaflet coaptation of
the target valve and reduce regurgitation through the target
valve.
[0120] FIGS. 4A and 4B depict a perspective view and a
cross-sectional view, respectively, of a male component 400 of a
stepped connector 330 of an adjustable annuloplasty ring 300
according to an embodiment. A corresponding female component (not
shown) may be configured to receive the male component 400 to form
the stepped connector 330. The stepped connector 330 may include
two engagement steps 402a, 402b (collectively 402) to allow two
degrees of adjustment and/or gradual adjustment. As shown in FIG.
4B, a cable 404 or suture may couple to the male component 400 of
the stepped connector 330. The cable 404 or suture may enable a
force to move the male component 400 in a telescopic manner into a
female component of the stepped connector 330. Contraction of the
annuloplasty ring 300 until engagement of a first engagement step
402a within the female component may secure the annuloplasty ring
in a partial contracted state. Further contraction of the
annuloplasty ring 300 to engagement of a second engagement step
402b within the female component may secure the annuloplasty ring
in the contracted state. In this manner, the stepped connector 330
may enable two degrees of adjustment (and for gradual adjustment)
of the A-P distance of the annuloplasty ring.
[0121] FIG. 5A depicts a schematic diagram illustrating a side view
of an illustrative internal anchor ribbon 500 including the curved
anchors 104 shown in FIGS. 1A and 1B according to an embodiment. In
certain embodiments, deployment of the anchors 104 may be
accomplished using an internal anchor member, such as anchor ribbon
500, that is selectively movable within a hollow tube of the body
member 101 (FIG. 1A). The curved anchors 104 may be affixed (for
example, laser welded) to the internal anchor ribbon 500 or
directly cut into the internal anchor ribbon. Like the anchors 104,
the internal anchor ribbon 500 may include a superelastic shape
memory material (such as, for example, nitinol). The shape memory
of the anchor ribbon 500 may be heat set to the same memorized
annular shape as the plurality of regions 102 of the body member
101 in the contracted state of the annular operable geometry, as
shown in FIG. 1A.
[0122] The internal anchor ribbon 500 may be slidable (for example,
using wires or sutures accessible through the catheter) in the
hollow body member 101 of the annuloplasty ring 100. To reduce
friction between the internal anchor ribbon 500 and the body member
101, certain ring embodiments may include an internal glide ribbon
510. The internal glide ribbon 510 may include a low-friction
material (for example, as a coating or covering) such as
polytetrafluoroethylene (PTFE) or other polymer. In addition, or in
other embodiments, the internal glide ribbon 510 may include a
superelastic shape memory material (such as, for example, nitinol)
that is heat set to the same memorized annular shape as the body
member 101. Thus, in particular embodiments, three D-shaped
superelastic members (the outer tube of the body member 101, the
internal anchor ribbon 500, and the internal glide ribbon 510) may
be included, which may cooperate to increase the rigidity of the
annuloplasty ring 100.
[0123] In various embodiments, as shown in FIGS. 5F and 5G, the
internal anchor ribbon may be a tube-like polymeric element 502
having a curved wall 503 and an opening 504 therethrough. In some
embodiments, the polymeric element 502 may be located inside the
ring 101 (FIGS. 1A and 1B) such that the anchors 104 (FIGS. 5A-5C)
slide inside the ring. The general shape and/or pattern of the
polymeric element 502 is not limited by this disclosure, and may
generally be any pattern that allows for movement of the anchors
104 (FIGS. 5A-5C) inside the ring 101 (FIGS. 1A and 1B), as
described herein. For example, FIGS. 5H, 5I, and 5J depict a top
view, a first side view, and a second side view, respectively, of
an illustrative pattern for a polymeric element 502. The polymeric
material 502 may generally be made of any material now known or
later developed to reduce friction and facilitate sliding of the
anchors 104 (FIGS. 5A-5C) within the ring. Illustrative materials
may include, but are not limited to, polytetrafluoroethylene
(PTFE), fluorinated ethylene propylene (FEP), polyether block amide
(PEBA), and/or the like. In addition, the polymeric element 502 may
be constructed by any method now known or later developed,
including, but not limited to, an extrusion method, an injection
molding method, a machining method, and/or the like.
[0124] FIG. 5B depicts a schematic diagram of a top view of the
anchors 104 cut into the internal anchor ribbon 500 shown in FIG.
5A in the elongate insertion geometry according to an embodiment.
In some embodiments, a laser may be used to cut the anchors 104
along a first side 512, a second side 514 (for example, in a
pointed or tip shape), and a third side 516, while leaving a fourth
side 518 of the anchor 104 uncut and attached to the internal
anchor ribbon 500. After cutting, the anchors 104 may be heat set
to the desired memorized shape for the deployed configuration. For
example, FIG. 5C depicts a schematic diagram of a side view of the
internal anchor ribbon 500 in the elongate insertion geometry and
the anchors 104 in a curled or curved deployed configuration
according to an embodiment. The amount of curvature in the deployed
configuration of the anchors 104 may depend on the particular
application. In the example shown in FIG. 5C, the anchors 104 may
fold back on themselves such that the prong or tip 520 points
parallel to or away from the internal anchor ribbon 500. FIG. 5D
depicts a schematic diagram of a top view of the internal glide
ribbon 510, and FIG. 5E depicts a schematic diagram of a side view
of the internal glide ribbon 510, in the elongate insertion
geometry according to an embodiment.
[0125] FIGS. 6A and 6B depict schematics of cross-sectional side
views of an annuloplasty ring 600 before (FIG. 6A) and after (FIG.
6B) deployment of the anchors 104 shown in FIGS. 5A-5C according to
an embodiment. For illustrative purposes, the annuloplasty ring 600
in FIGS. 6A and 6B is shown in an elongate insertion geometry.
Those having ordinary skill in the art will recognize, however,
that the anchors 104 may generally be deployed when the
annuloplasty ring 600 is in the annular operable geometry without
departing from the scope of the present disclosure.
[0126] The illustrated annuloplasty ring 600 may include an outer
tube 610 (for example, formed by the body member 101 shown in FIG.
1) including a plurality of anchor deployment windows 612. During
the manufacturing of the annuloplasty ring 600, and before the
annuloplasty ring is loaded into the catheter, the internal anchor
ribbon 500 and the internal glide ribbon 510 may be inserted into
the outer tube 610 in a position where the anchors 104 are
prevented from exiting through the windows 612. As shown in FIG.
6A, inserting the internal anchor ribbon 500 into the outer tube
610 may prevent the anchors from assuming their fully curved
deployed configuration.
[0127] For deploying the anchors 104, the internal anchor ribbon
500 may include (or may be attached to) a hook or loop 614 for
engaging a wire or suture 616 that may be pulled by a user through
the catheter (for example, in the direction of arrow 618 in FIG.
6A) to move the tip of each anchor 104 to a corresponding window
612. In particular embodiments, the anchors 104 and windows 612 may
be arranged such that the tip of each anchor 104 reaches its
respective window 612 at substantially the same time as the other
anchor/window pairs. As shown in FIG. 6B, once the tips of the
anchors 104 reach the respective windows 612, the superelasticity
of the anchors may propel the internal anchor ribbon 500 in the
opposite direction (as indicated by arrow 620) as the anchors
spring out the windows (as indicated by arrow 622) to resume their
curved configurations. As the anchors 104 drive through the windows
612 the anchors may drive into surrounding tissue (for example, the
heart valve annulus). The superelasticity of the anchors 104 may
allow the anchors to be self-propelled into the tissue adjacent or
proximate to the annuloplasty ring 600.
[0128] In some embodiments, as shown in FIG. 6C, the anchors 104
may be divided into a plurality of segments 650a, 650b, 650c. While
FIG. 6C depicts 3 segments, those having ordinary skill in the art
will recognize that any number of segments may be used without
departing from the scope of the present disclosure. For example,
the anchors 104 may be divided into 2 segments, 3 segments, 4
segments, 5 segments, 6 segments, or more. Dividing the anchors 104
into a plurality of segments 650a, 650b, 650c may allow for
actuation of one or more of the segments at a time such that the
actuated segment deploys its respective anchor(s) 104 while the
remaining anchors remain non-deployed. In some embodiments, various
segments 650a, 650b, 650c may be actuated sequentially. In other
embodiments, various segments 650a, 650b, 650c may be actuated
simultaneously. In some embodiments, various segments 650a, 650b,
650c may be actuated based upon which anchors 104 an operator
desires to deploy, which may be based upon positioning and location
of the annuloplasty ring. In some embodiments, the segments 650a,
650b, 650c may be arranged in a plurality of zones. For example, a
posterior side may be a first zone having a first plurality of
segments and an anterior side may be a second zone having a second
plurality of segments. Thus, the anterior zone may be deployed
separately from the posterior zone, or at substantially the same
time.
[0129] FIG. 7 depicts a simplified schematic diagram of a side view
of an illustrative internal anchor member (or members) 700
including linear anchors 710 according to an embodiment. The linear
anchors 710 may be affixed (for example, laser welded) to the
internal anchor member 700. In the embodiment shown in FIG. 7,
however, the internal anchor member 700 and linear anchors 710 may
be cut from a single superelastic shape memory (such as, for
example, nitinol) hypotube. FIG. 7, for example, shows remaining
tubular portions 712 after the hypotube is cut to form prongs 714
of the linear anchors 710. The remaining tubular portions 712 may
facilitate sliding (for example, using wires or sutures accessible
through the catheter) the internal anchor member 700 coaxially
within the hollow tube of the annuloplasty ring (for example,
within the annuloplasty ring 600 shown in FIGS. 6A and 6B).
[0130] The internal anchor member 700 may be heat set to the same
memorized annular shape as the annuloplasty ring 600. The anchor
prongs 714 may be heat set to protrude outward through windows cut
in the annuloplasty ring 600. Barbs 716 may be laser welded to the
prongs 714 to form the linear anchors 710. The linear anchors 710
may be retracted/deployed by sliding the internal anchor member 700
within the annuloplasty ring 600.
[0131] As described herein, the annuloplasty ring may be configured
for percutaneous transcatheter delivery and fixation to heart
valves. The annuloplasty ring may be delivered through a catheter
to the mitral valve, for example, using a trans-septal approach, a
retrograde approach, or a trans-apical approach. For example, FIG.
8A depicts a schematic diagram of an illustrative trans-septal
approach for endovascular delivery of an annuloplasty ring (not
shown) to the mitral valve 810 of a heart 800 according to an
embodiment. For illustrative purposes, a partial cross-section of
the heart 800 is illustrated to show the right atrium RA, right
ventricle RV, left atrium LA, and left ventricle LV. For clarity,
certain features (for example, papillary muscles and chordae
tendineae) are not shown. In the trans-septal approach shown in
FIG. 8A, the left atrium LA may be approached by advancement of a
catheter 812 through the inferior vena cava 814, into the right
atrium RA, across the interatrial septum 816, and into the left
atrium LA. The annuloplasty ring may be delivered through the
catheter 812 into the atrium and anchored to the annulus of the
mitral valve 810.
[0132] As shown in FIG. 8A, the catheter 812 may be delivered
percutaneously into the heart 800. A guiding sheath (not shown) may
be placed in the vasculature system of the patient and used to
guide the catheter 812 and its distal end 818 to a desired
deployment site. In some embodiments, a guide wire (not shown) may
be used to gain access through the superior or inferior vena cava
814, for example, through groin access for delivery through the
inferior vena cava 814. The guiding sheath may be advanced over the
guide wire and into the inferior vena cava 814 shown in FIG. 8A.
The catheter 812 may be passed through the right atrium RA and
toward the interatrial septum 816. Once the distal end 818 of the
catheter 812 is positioned proximate to the interatrial septum 816,
a needle or piercing member (not shown) is advanced through the
catheter 812 and used to puncture the fossa ovalis or other portion
of the interatrial septum 816. In some embodiments, the catheter
812 may be dimensioned and sized to pass through the fossa ovalis
without requiring a puncturing device. That is, the catheter 812
may pass through the natural anatomical structure of the fossa
ovalis into the left atrium LA.
[0133] Similarly, any chamber (LV, RV, LA, RA) of the heart 800 may
be approached through the inferior vena cava 814. For example, the
right ventricle RV may be approached through the inferior vena cava
814, into the right atrium RA, and through the tricuspid valve 820.
A variety of other endovascular approaches may also be used.
[0134] FIG. 8B depicts a schematic diagram of an illustrative
retrograde approach of an annuloplasty ring (not shown) to the
mitral valve 810 of a heart 800 according to another embodiment. In
FIG. 8B, a femoral approach is shown wherein the delivery catheter
812 may be advanced through the aorta 822 and the aortic valve 824.
Typically, the catheter 812 may be advanced through a sheath
positioned within the femoral artery (not shown). Under fluoroscopy
or other methods of guidance, the distal end of the catheter 812
may be guided within the left ventricle LV and turned (for example,
as shown with a "U-turn" 826) within the left ventricle LV so as to
pass through the leaflets of the mitral valve 810 and into the left
atrium LA. After verification of the appropriate positioning of the
catheter 812, a guide wire (not shown) may be inserted through the
catheter 812 into the left atrium LA, which may be used to guide
one or more other catheters into the left atrium LA for delivering
and anchoring the annuloplasty ring to the annulus of the mitral
valve 810.
[0135] FIG. 8C depicts a schematic diagram of an illustrative
trans-apical approach of an annuloplasty ring (not shown) to the
mitral valve 810 of a heart 800 according to another embodiment. As
shown in FIG. 8C, the catheter 812 may pass through the apex 830 of
the heart 800, through the left ventricle LV, through the leaflets
of the mitral valve 810, and into the left atrium LA. The
annuloplasty ring may be delivered through the catheter 812 into
the left atrium LA and anchored to the annulus of the mitral valve
810. In an embodiment, a needle or trocar may be used to puncture
through the apex 830 to create a small opening through which a
guide wire (not shown) can be inserted through the left ventricle
LV into the left atrium LA. The guide wire may be used to guide
successively larger and stiffer catheters so as to gradually
increase the size of the opening in the apex 830 of the heart
800.
[0136] Additionally, an annuloplasty ring may be applied to the
mitral valve via a trans-atrial approach, in which a catheter is
introduced into the left atrium in a direct approach from the right
atrium (not shown).
[0137] FIG. 9A depicts a flow diagram of a first illustrative
method of placing an annuloplasty ring at a target valve according
to an embodiment. The method may include inserting 960 a distal end
of a catheter into a target tissue, such as the heart. The method
of insertion 960 is not limited by this disclosure and may be any
method, particularly methods described herein with respect to FIGS.
8A-8C. The annuloplasty ring may be inserted 962 in the proximal
end of the catheter and advanced 964 through the catheter and out
of the distal end such that it is placed at the location of the
target tissue. In some embodiments, advancing 964 may include
guiding the annuloplasty via the delivery system described herein.
When the annuloplasty ring is inserted 962 and advanced 964, it may
be in an elongate insertion geometry, as described in greater
detail herein. As the ring advances 964 out of the catheter, it may
be allowed 966 to transition to an annular operable geometry, as
described in greater detail herein. In some embodiments, advancing
964 and/or allowing 966 the annuloplasty ring may include
manipulating a ring closure knob located on a deployment handle, as
described in greater detail herein.
[0138] The ends of the annuloplasty ring may be drawn 968 together,
such as, for example, by pulling a first suture connected to the
annuloplasty ring through the catheter. In some embodiments, the
ends may be drawn 968 together via manipulating a ring closure knob
located on a deployment handle, as described in greater detail
herein. In some embodiments, a ring closure lock may lock the two
ends of the ring together once they have been sufficiently drawn
968 together. In some embodiments, drawing 968 the ends together
may further include manipulating a ring snap knob on a deployment
handle to cause the ends to snap together, as described in greater
detail herein.
[0139] In various embodiments, a determination 970 may be made as
to whether the ring is sufficiently oriented. In some embodiments,
orientation of the ring may be based on the positioning and/or
location of the catheter, the location and/or positioning of the
target tissue, the shape of the ring, and/or the like. If
orientation of the ring is necessary, the ring may be oriented 972.
Orienting 972 may include, for example, rotating the ring, the
catheter, and/or various other components described herein. In some
embodiments, orienting 972 may include automatically rotating the
ring to change a plane of the ring from a first orientation that is
parallel to the catheter to a second orientation that is parallel
to a plane of the annulus. In some embodiments, orienting 972 the
annuloplasty ring may be completed via the stabilizer portion, such
as by manipulating a stabilizer knob on a deployment handle, as
described in greater detail herein.
[0140] In various embodiments, a determination 974 may be made as
to whether the ring is sufficiently expanded. In some embodiments,
expansion of the ring may be based on the construction of the ring,
as described in greater detail herein. Thus, in some embodiments,
expansion may not occur, particularly in embodiments where the ring
is not expandable, as described in greater detail herein. If
expansion of the ring is necessary, the ring may be expanded 976.
Expansion of the ring may be completed by manipulating one or more
sutures, as described in greater detail herein. In some
embodiments, expanding 976 the ring may be completed via an
expansion tool, such as, for example, by manipulating an expansion
tool knob on a deployment handle, as described in greater detail
herein. In some embodiments, a percutaneously,
transcatheter-operated expansion tool may be actuated to expand 976
the annuloplasty ring in the annular operable geometry to an
expanded state to thereby increase an A-P distance of the
annuloplasty ring. Expansion of the annuloplasty ring may include
expanding a biasing element of the annuloplasty ring.
[0141] In various embodiments, a determination 978 may be made as
to whether the ring is contacting the annulus. The determination
978 may be necessary, for example, to ensure proper placement of
the ring adjacent to the annulus. In some embodiments, the ring may
be pressed 980 against the annulus. Pressing 980 may include
positioning the annuloplasty ring in abutment or similar relatively
intimate contact with an annulus of a target valve to enhance a
process of fastening the annuloplasty ring to the annulus. The
method may include manipulating a stabilizer, such as via a
stabilizer knob, as described in greater detail herein. The method
may also include pulling a second suture connected to the
annuloplasty ring through the catheter to deploy 982 a plurality of
tissue anchors from the annuloplasty ring. Deployment 982 of the
anchors may also be completed via manipulation of an anchor
deployment knob, as described in greater detail herein. With the
anchors deployed 982 and the annuloplasty ring fastened to the
tissue of the target valve, the expansion tool may be released 984.
The annuloplasty ring may be contracted 986 to transition the
annuloplasty ring in the operable geometry to a contracted state to
decrease the A-P distance, thereby decreasing the A-P distance of
the target heart valve to improve coaptation and reduce
regurgitation through the target heart valve. In some embodiments,
contraction 986 of the annuloplasty ring may be completed by
biasing elements that have stored potential energy during expansion
of the annuloplasty ring.
[0142] In various embodiments, the annuloplasty ring may be
detached 988 from the catheter and the first and second sutures,
and the catheter may be removed 990 from the heart. In some
embodiments, the ring may be detached 988 via manipulation of a
ring release knob on a deployment handle, as described in greater
detail herein.
[0143] FIG. 9B depicts a flow diagram of a second illustrative
method of placing an annuloplasty ring at a target valve according
to an embodiment. The method may include inserting 1050 a distal
end of a catheter into a target tissue, such as the heart. The
method of insertion 1050 is not limited by this disclosure and may
be any method, particularly methods described herein with respect
to FIGS. 8A-8C. The annuloplasty ring may be inserted 1052 in the
proximal end of the catheter and advanced 1054 through the catheter
and out of the distal end such that it is placed at the location of
the target tissue. In some embodiments, advancing 1054 may include
guiding the annuloplasty via the delivery system described herein.
When the annuloplasty ring is inserted 1052 and advanced 1054, it
may be in an elongate insertion geometry, as described in greater
detail herein. In some embodiments, the annuloplasty ring may be
attached to a catheter. As the ring advances 1054 out of the
catheter, it may be allowed 1056 to transition to an annular
operable geometry, as described in greater detail herein. In some
embodiments, advancing 1054 and/or allowing 1056 the annuloplasty
ring may include manipulating a ring closure knob located on a
deployment handle, as described in greater detail herein.
[0144] The ends of the annuloplasty ring may be drawn 1058
together, such as, for example, by pulling a first suture connected
to the annuloplasty ring through the catheter. In some embodiments,
the ends may be drawn 1058 together via manipulating a ring closure
knob located on a deployment handle, as described in greater detail
herein. In some embodiments, a ring closure lock may lock the two
ends of the ring together once they have been sufficiently drawn
1058 together. In some embodiments, drawing 1058 the ends together
may further include manipulating a ring snap knob on a deployment
handle to cause the ends to snap together, as described in greater
detail herein.
[0145] The annuloplasty ring may be contacted 1060 with a posterior
side of the valve. Such contacting 1060 may generally be completed
via the delivery system, as described in greater detail herein. Use
of the delivery system may include manipulating at the stabilizer,
as described in greater detail herein. A first portion of the
anchors may be deployed 1062, such as, for example, the posterior
zone anchors (as described herein). Thus, in some embodiments,
anchors located in two posterior zones may be deployed
sequentially. Alternatively, anchors located in two posterior zones
may be deployed simultaneously. Deployment 1062 may effect
engagement of the one or more posterior zones of the annuloplasty
ring (or a portion thereof) to the posterior side of the valve. As
previously described herein, deployment 1062 may be completed via
manipulation of an anchor deployment knob.
[0146] The valve tissue may be dragged 1064, via the delivery
system, such that the annuloplasty ring may be contacted 1066 to
the anterior side of the valve. Use of the delivery system may
include manipulating at least the stabilizer, as described in
greater detail herein. A second portion of the anchors may be
deployed 1068, such as, for example, the anterior zone anchors (as
described herein). Thus, in some embodiments, anchors located in
two anterior zones may be deployed sequentially. Alternatively,
anchors located in two anterior zones may be deployed
simultaneously. Deployment 1068 may effect engagement of the
anterior zone of the annuloplasty ring (or a portion thereof) to
the anterior side of the valve.
[0147] With the anchors deployed 1062, 1068 and the annuloplasty
ring fastened to the tissue of the target valve, the stabilizer may
be released 1070. The annuloplasty ring may be contracted 1072 to
transition the annuloplasty ring in the operable geometry to a
contracted state to decrease the A-P distance, thereby decreasing
the A-P distance of the target heart valve to improve coaptation
and reduce regurgitation through the target heart valve. In some
embodiments, contraction 1072 of the annuloplasty ring may be
completed by biasing elements that have stored potential energy
during expansion of the annuloplasty ring.
[0148] In various embodiments, the annuloplasty ring may be
detached 1074 from the catheter and the first and second sutures,
and the catheter may be removed 1076 from the heart. In some
embodiments, the ring may be detached 1074 via manipulation of a
ring release knob on a deployment handle, as described in greater
detail herein.
[0149] FIGS. 9C, 9D, 9E, and 9F depict schematic diagrams
illustrating transcatheter delivery of an annuloplasty ring 902
from a delivery system 900 according to various embodiments. FIG.
9C depicts a perspective view of a distal end 910 of the delivery
system 900. As shown in FIG. 9C, the annuloplasty ring 902 may be
in the elongate insertion geometry and partially deployed from the
distal end 910 of a delivery catheter 914 in a first deployment
stage. In the first stage, the annuloplasty ring 902 may be still
substantially in the elongate insertion geometry. As shown in FIG.
9C, a first suture 919 for snapping together the ends of the
annuloplasty ring 902 may pass through a male snap 912 of a ring
closure lock 950 (shown in FIG. 9E).
[0150] FIG. 9D is a perspective view of the annuloplasty ring 902
in a second stage of partial deployment from the delivery catheter
914. In the second stage, the portion of the annuloplasty ring 902
that has exited the delivery catheter 914 has begun to transition
(due to the shape memory materials used in the annuloplasty ring)
from the elongate insertion geometry to the annular operable
geometry.
[0151] FIG. 9E is a perspective view of the annuloplasty ring 902
in a third stage of deployment in which a ring shuttle 916 of the
delivery system 900 has substantially pushed the annuloplasty ring
out of the delivery catheter 914, but the plane of the annuloplasty
ring is still aligned with (for example, parallel to) the
longitudinal axis of the delivery catheter. In FIG. 9E, the
annuloplasty ring 902 may be in a configuration, for example,
immediately before a ring deployment wire 923 cooperates with the
pivot 108 to rotate the annuloplasty ring 902 (see FIG. 9F). In the
configuration shown in FIG. 9E, the distal end of the ring
deployment wire 923 may include a bend or hook 932 as it passes
through a hole in the pivot 108. The ring deployment wire 923
includes a superelastic shape memory material (such as, for
example, nitinol), and bending the distal end of the ring
deployment wire 923 into the hook 932 shape may spring load the
annuloplasty ring 902 within the outer jacket delivery catheter 914
such that the annuloplasty ring 902 automatically rotates about the
pivot 108 upon exiting the outer jacket delivery catheter 914. At
this third stage of deployment, the hook 932 shape formed in the
superelastic ring deployment wire 923 is ready to unload (return to
a heat-set memorized straight configuration) as soon as the
delivery catheter 914 no longer prevents it from doing so. The
suture 919 may be used to draw together the male components 952 and
female components 954 of a ring closure lock 950.
[0152] FIG. 9F depicts a perspective view of the annuloplasty ring
902 in a fourth stage of deployment in which the plane of the
annuloplasty ring (in its annular operable geometry) has been
changed to be perpendicular to the longitudinal axis of the
delivery catheter 914. As shown in FIG. 9F, the superelastic ring
deployment wire 923 has returned to its heat set (memorized)
straight configuration. At this fourth stage of deployment, the
plane of the annuloplasty ring 902 may be configured to be parallel
to the plane of the heart valve annulus. In situ within the heart,
a longitudinal axis of the delivery catheter 914 may be oriented
parallel to the direction of blood through the valve and
approximately perpendicular to the plane of the heart valve. The
annuloplasty ring 902, when oriented such that the plane of the
annuloplasty ring is transverse to (and perpendicular or
approximately perpendicular to) the longitudinal axis of the
delivery catheter 914, may be oriented such that the plane of the
annuloplasty ring is parallel or approximately parallel to the
plane of the heart valve.
[0153] In further stages of deployment, the annuloplasty ring 902
may be expanded and/or pressed against the heart valve annulus
before deploying the anchors (such as the curved anchors 104 shown
in FIGS. 1A and 1B). As discussed herein, certain anchors may
propel themselves into the tissue of the heart valve annulus upon
being deployed. In other embodiments, the anchors (such as the
linear anchors 710 shown in FIG. 7) may be deployed before pressing
the annuloplasty ring 902 against the annulus. After the
annuloplasty ring 902 is anchored to the heart valve annulus and
transitioned to the contracted state, the ring deployment wire 923
may be pulled from the hole in the pivot 108 to release the
annuloplasty ring 902 from the ring shuttle 916. Any remaining
sutures, such as the first suture 919, may also be cut and/or
pulled from the annuloplasty ring 902 before the delivery catheter
914 is removed from the heart. In some embodiments, removal of the
ring deployment wire 923 and/or any remaining sutures may be
completed via one or more of the knobs, as described in greater
detail herein.
[0154] FIG. 10 depicts a schematic diagram of a perspective,
partial cross-sectional view of a heart 1000 during the expansion
of an adjustable annuloplasty ring 1002 using an expansion tool
1004, preparatory to affixation to the annulus of the mitral valve
1006 according to an embodiment. As shown in FIG. 10, a delivery
catheter 1010 may extend from the left ventricle into the left
atrium through the leaflets of the mitral valve 1006. Thus, this
illustrated embodiment may correspond to, for example, a
trans-apical approach or a retrograde approach, as discussed
herein. Those with ordinary skill in the art will recognize from
the present disclosure that similar principles as those illustrated
may be used for trans-septal approaches.
[0155] In FIG. 10, an expansion tool 1004 may be used to expand the
annuloplasty ring 1002. The annuloplasty ring 1002 may be
positioned on or next to the annulus of the mitral valve 1006. The
expansion tool 1004 may be disposed within the annuloplasty ring
1002 (and within the target valve 1006) to expand the annuloplasty
ring 1002 to transition it from a contracted state to an expanded
state. The expansion tool 1004 of the illustrated embodiment of
FIG. 10 is a balloon expansion tool 1004. The balloon expansion
tool 1004 may be inflated to expand the annuloplasty ring 1002 to
an expanded state. In some embodiments, the balloon expansion tool
1004 may include a plurality of sections and may be considered a
"multi-chamber" balloon with a plurality of chambers. In particular
embodiments, the balloon expansion tool 1004 may have two chambers.
In other embodiments, a balloon expansion tool 1004 may have a
single chamber.
[0156] In the embodiment shown in FIG. 10, the inflated balloon
expansion tool 1004 may reduce or prevent the flow of blood through
the mitral valve during at least part of the implantation
procedure. In such embodiments, inflation of the balloon expansion
tool 1004 may last 20 seconds or less to prevent adverse
consequences of occluding the mitral valve 1006. In other
embodiments, such as the embodiment of an expansion tool shown in
FIGS. 11, 12A-12E, 13A-13D, and 14A-14B, blood may be allowed to
flow through the target valve 1006 during the entire procedure.
[0157] FIG. 11 depicts a schematic diagram of a perspective,
partial cross-sectional view of a heart 1100 during the expansion
of an adjustable annuloplasty ring 1102 using a cage or basket tool
1104 as an expansion tool, preparatory to affixation to the annulus
of the mitral valve 1106 according to another embodiment.
[0158] The basket expansion tool 1104 may include a plurality of
flexible members 1108 that lay flat against a central rod 1114
during insertion of the basket expansion tool through the delivery
catheter (see FIG. 10) and may be forced into an expanded
configuration (shown in FIG. 11) when the central rod is pushed
into an end cap 1112. In another embodiment, each of the plurality
of flexible members 1108 may include a superelastic material so as
to spring from a delivery catheter into the expanded configuration
shown in FIG. 11.
[0159] FIGS. 12A and 12B depict schematic diagrams of perspective
views of an illustrative stabilizer, generally designated 1200,
that may be used in lieu of the expansion tool according to an
embodiment. FIG. 12A depicts a perspective view of the stabilizer
1200 separated from other components of the percutaneous
annuloplasty system. FIG. 12B depicts the stabilizer 1200 disposed
through a delivery catheter 1204 and engaging an annuloplasty ring
1250.
[0160] In order to achieve sufficient intimate contact between an
annuloplasty ring 1250 (shown in FIG. 12B) and the tissue of the
target heart valve (for example, the annulus of the heart valve),
the stabilizer 1200 may be used to position, orient, and otherwise
manipulate the annuloplasty ring 1250 in the annular operable
geometry, prior to affixation to tissue of the valve. The
stabilizer 1200 may have a metallic rib structure having a
plurality of arms 1202a, 1202b, 1202c (collectively 1202) or prongs
configured to extend outward at an angle from a central column
1203. While only three arms 1202 are shown in the present
embodiment, those having ordinary skill in the art will recognize
any number of arms may be suitable without departing from the scope
of the present disclosure. For example, the stabilizer 1200 may
have 2, 3, 4, 5, 6, 7, 8, 9, 10 or more arms 1202. The rib
structure, specifically the arms 1202 and central column 1203, may
be laser cut from a shape memory material, such as nitinol. The
stabilizer 1200 may be cut from a hollow tube such that the central
column 1203 has a hollow cylindrical shape. The arms 1202 may be
heat set to extend at an angle from the central column 1203.
[0161] The illustrated stabilizer 1200 of FIGS. 12A and 12B may
include three arms 1202 arranged, for example, as a tripod. The
plurality of arms 1202 of the stabilizer 1200 may be loaded into a
delivery catheter 1204 together with the annuloplasty ring 1250
(for example, configured in the elongate insertion geometry). As
the arms 1202 emerge from a distal end of the delivery catheter
1204, they may automatically expand outward. The stabilizer 1200,
and specifically the plurality of arms 1202, may be configured to
align with and engage the annuloplasty ring 1250 as shown in FIG.
12B. When aligned and engaged with the annuloplasty ring 1250, the
stabilizer 1200 may be used to push/pull the annuloplasty ring 1250
toward the tissue of an annulus of a heart valve.
[0162] The illustrated stabilizer of FIGS. 12A and 12B may be
configured to engage a top surface of the annuloplasty ring 1250,
through the annuloplasty ring, to pull the annuloplasty ring
downward. For example, the plurality of arms 1202 may include a
curved, angled, or hooked portion at a distal end to facilitate
engagement with the annuloplasty ring 1250. The stabilizer 1200 may
be used to pull the annuloplasty ring 1250 toward the heart valve
to facilitate intimate contact of the annuloplasty ring with the
annulus. Intimate contact, or close abutment, of the annuloplasty
ring 1250 with the annulus of the valve may enhance an anchor
deployment process to fasten the annuloplasty ring 1250 to the
annulus.
[0163] In some embodiments, the stabilizer 1200, particularly the
arms 1202, may also be configured to function as an expansion tool
to engage the annuloplasty ring 1250 and effectuate and/or
facilitate transition of the annuloplasty ring from a contracted
state to an expanded state. For example, a superelastic property
and memorized shape of the plurality of arms 1202 may effectuate
expansion of the annuloplasty ring 1250. The superelastic arms 1202
may engage an inner surface of the annuloplasty ring 1250 and exert
outward force to expand the annuloplasty ring. In other
embodiments, a suture or other elongate member may enable
percutaneous manipulation of one or more of the plurality of arms
to effectuate expansion of the annuloplasty ring 1250.
[0164] FIGS. 12C and 12D depict a stabilizer 1200 that includes a
balloon 1280. The balloon 1280 may pass through the central column
1203 of the stabilizer 1200. When the balloon 1280 is inflated, it
may cause the arms 1202 of the stabilizer 1200 to expand. By
expanding the stabilizer 1200, the ring 1250 (FIG. 12E) may be
expanded to its expanded configuration. In some embodiments, the
ring 1250 (FIG. 12E) may also be contracted when the balloon 1280
is deflated and the tool 1200 is retracted.
[0165] FIG. 12E depicts a schematic diagram that demonstrates how
various holes 1270 may be used to guide one or more sutures 1271
that exit the ring 1250, as described in greater detail herein. The
sutures 1271 may be used for deployment or recapturing of the
anchors held within the ring 1250. In some embodiments, the sutures
1271 may extend through the windows in the ring and/or dedicated
holes in the laser cut pattern of the ring, as described herein.
The holes in the tool 1200 may allow the sutures 1271 to be
gathered together and guided through the hollow central column 1203
and the catheter 1204 via the handle at the proximal end of the
catheter, as described in greater detail herein.
[0166] In various embodiments, the expansion tool and/or the
stabilizer may be configured to complete one or more additional
tasks. Illustrative additional tasks are not limited by this
disclosure, and may include, for example, navigating the
annuloplasty ring within a chamber of a heart, creating an intimate
contact between the annuloplasty ring and the target tissue (such
as a valve annulus), expanding the annuloplasty ring, and
stabilizing the annuloplasty ring during various deployment and
anchoring processes, as described in greater detail herein.
[0167] FIGS. 13A and 13B depict schematic diagrams of perspective
views of an illustrative stabilizer 1300 to be used as an expansion
tool of a percutaneous annuloplasty system according to an
embodiment. The illustrated stabilizer 1300 may include one or more
arms or prongs 1302, such as, for example, two arms 1302a, 1302b.
FIG. 13A depicts a perspective view of the stabilizer 1300
separated from other components of the percutaneous annuloplasty
system. FIG. 13B depicts the stabilizer 1300 disposed through a
delivery catheter 1306 and engaging an annuloplasty ring 1350. The
stabilizer 1300 may be used to position, orient, and otherwise
manipulate the annuloplasty ring 1350 to achieve intimate contact
in abutment with tissue of the annulus of a target heart valve.
[0168] Referring generally and collectively to FIGS. 13A-13D, the
arms 1302 of the stabilizer 1300 may be configured to extend
outward at an angle from a central column 1304, thereby forming a
rib structure. The rib structure, particularly the arms 1302 and
central column 1304, may be laser cut from a shape memory material,
such as, for example, nitinol. The stabilizer 1300 may be cut from
a hollow tube such that the central column 1304 has a hollow
cylindrical shape. The arms 1302 may be heat set to extend at an
angle from the central column 1304.
[0169] The illustrated stabilizer 1300 of FIGS. 13A and 13B may
include two arms 1302a, 1302b arranged, for example as a bipod. The
two arms 1302a, 1302b in cooperation with a ring shuttle 1361 of a
delivery system of the percutaneous annuloplasty system form a
tripod structure engaging the annuloplasty ring 1350 at three
points. The plurality of arms 1302 may be loaded into a delivery
catheter 1306 together with the annuloplasty ring 1350 (for
example, configured in the elongate insertion geometry). As the
arms 1302 extend from a distal end of the delivery catheter 1306,
they may automatically expand outward and may be configured to
align with and engage the annuloplasty ring 1350 as shown in FIG.
13B. When aligned and engaged with the annuloplasty ring 1350, the
stabilizer 1300 may be used to push/pull the annuloplasty ring
toward the tissue of the annulus of a valve.
[0170] The illustrated stabilizer of FIGS. 13A and 13B may be
configured to engage a top surface of the annuloplasty ring 1350 to
pull the annuloplasty ring. For example, the plurality of arms 1302
may include a curved, angled, or hooked portion at a distal end to
facilitate engagement with the annuloplasty ring 1350. The
stabilizer 1300 may be used to pull the annuloplasty ring 1350
toward the heart valve to facilitate intimate contact of the
annuloplasty ring with the annulus to enhance an anchor deployment
process to fasten the annuloplasty ring to the annulus.
[0171] The stabilizer 1300, particularly the arms 1302, may also be
configured to function as an expansion tool to engage the
annuloplasty ring 1350 and effectuate and/or facilitate transition
of the annuloplasty ring from a contracted state to an expanded
state. For example, a superelastic property and memorized shape of
the plurality of arms 1302 may enable the arms to engage an inner
surface of the annuloplasty ring 1350 and via its inherent material
properties, exert outward force to expand the annuloplasty ring. In
other embodiments, a suture or other elongate member may enable
percutaneous manipulation of one or more of the plurality of arms
1302 to effectuate expansion of the annuloplasty ring 1350.
[0172] In some embodiments, the arms 1302 of the stabilizer 1300
may also include a feature that locks the stabilizer against the
annuloplasty ring 1350, thereby preventing each arm from moving
relative to another, such as, for example, after the deployment and
during creation of intimate contact between the ring and the
tissue. For example, the arms 1302 of the stabilizer 1300 may each
have at least one strat 1303a, 1303b (collectively 1303). Each
strat 1303 may prevent its respective arm 1302 from sliding on the
annuloplasty ring 1350 and may allow and/or facilitate engagement
on a particular position of the ring. In some embodiments, a
particular position of engagement on the annuloplasty ring 1350 may
ensure a proper ring size, shape, and/or orientation. After
aligning the stabilizer 1300 relative to the annuloplasty ring
1350, the stabilizer may be fixed in relation to the ring by the
strats 1303. By manipulating the tool 1300, the operator may be
able to manipulate the position and orientation of the annuloplasty
ring 1350.
[0173] In various embodiments, as shown in FIGS. 13E-13I, the
annuloplasty ring 1350 may also have at least one strat 1355a,
1355b (collectively 1355). Each strat 1355 may prevent the
annuloplasty ring 1350 from sliding when attached to the arms 1302.
In some embodiments, each strat 1355 may allow and/or facilitate
engagement of a particular portion of the annuloplasty ring 1350
with a particular arm 1302. In some embodiments, a particular
position of engagement of the strats 1355 on the annuloplasty ring
1350 may ensure a proper ring size, shape, and orientation. After
aligning the stabilizer 1300 (FIG. 13C) relative to the
annuloplasty ring 1350, the stabilizer may be fixed in relation to
the ring by the strats 1355. In some embodiments, the strats 1355
on the annuloplasty ring 1350 may be used in conjunction with the
strats 1303 on the arms 1392 of the stabilizer. In other
embodiments, the strats 1355 on the annuloplasty ring 1350 may be
used in lieu of the strats 1303 on the arms 1392 of the
stabilizer.
[0174] FIGS. 14A and 14B depict diagrams illustrating perspective
views of a stabilizer 1400 of a percutaneous annuloplasty system
according to an embodiment. The stabilizer 1400 may be configured
to push and/or press an annuloplasty ring 1450 (from above) into
intimate contact with, or abutment against, an annulus of a target
heart valve. The illustrated stabilizer 1400 may include a
plurality of arms or prongs 1402, such as, for example two arms
1402a, 1402b. FIG. 14A depicts a perspective view of the stabilizer
1400 separated from other components of the percutaneous
annuloplasty system. FIG. 14B depicts the stabilizer 1400 disposed
through a delivery catheter 1406 and engaging an annuloplasty ring
1450 from above. The stabilizer 1400 may be used to position,
orient, and/or otherwise manipulate the annuloplasty ring 1450 to
achieve intimate contact with or abutment against tissue of the
annulus of a target heart valve.
[0175] The arms 1402 of the stabilizer 1400 may be configured to
extend outward at an angle from a central column 1404, thereby
forming a rib structure. The rib structure, particularly the arms
1402 and central column 1404, may be laser cut from a shape memory
material, such as nitinol. The stabilizer 1400 may be cut from a
hollow tube such that the central column 1404 has a hollow
cylindrical shape. The arms 1402 may be heat set to extend at an
angle from the central column 1404.
[0176] The illustrated stabilizer 1400 of FIGS. 14A and 14B may
include two arms 1402a, 1402b arranged, for example, in the shape
of a bipod. The two arms 1402a, 1402b, in cooperation with a ring
shuttle 1451 of the percutaneous annuloplasty system, may form a
tripod structure engaging the annuloplasty ring 1450 at three
points. The plurality of arms 1402 may be loaded into a delivery
catheter 1406 together with the annuloplasty ring 1450 (for
example, configured in the elongate insertion geometry). As the
arms 1402 emerge from a distal end of the delivery catheter 1406,
they may automatically expand outward and may be configured to
align with and engage the annuloplasty ring 1450, as shown in FIG.
14B. When aligned and engaged with the annuloplasty ring 1450, the
stabilizer 1400 may be used to push/pull the annuloplasty ring
toward the tissue of an annulus of a heart valve.
[0177] The illustrated stabilizer of FIGS. 14A and 14B may be
configured to engage a top surface of the annuloplasty ring 1450
from above to push the annuloplasty ring. For example, the
plurality of arms 1402 may include a curved, angled, and/or hooked
portion at a distal end to facilitate engagement with the
annuloplasty ring 1450. The stabilizer 1400 may be used to push the
annuloplasty ring 1450 from above in a downward direction toward
the heart valve to facilitate intimate contact of the annuloplasty
ring with the annulus to enhance an anchor deployment process
and/or to aid in the fastening of the annuloplasty ring to the
annulus.
[0178] The stabilizer 1400, particularly the arms 1402, may also be
configured to function as an expansion tool to engage the
annuloplasty ring 1450, effectuate, and/or facilitate transition of
the annuloplasty ring from a contracted state to an expanded state.
For example, a superelastic property and shape memory property of
the plurality of arms 1402 may enable the arms to engage an inner
surface of the annuloplasty ring 1450 and exert an outward force to
expand the annuloplasty ring. The stabilizer 1400 may be
manipulated to expand the annuloplasty ring 1450 within the annulus
of the target valve, or otherwise press the annuloplasty ring
against the valve and thereby effectuating expansion of the
annuloplasty ring to the expanded state. In other embodiments, a
suture or other elongated member may enable percutaneous
manipulation of one or more of the plurality of arms 1402 to
effectuate expansion of the annuloplasty ring 1450.
[0179] FIG. 15A depicts a diagram of a perspective view of an
illustrative proximal end handle, generally designated 1500, of a
percutaneous annuloplasty system according to an embodiment. FIG.
15B depicts a diagram of a perspective cross-sectional view of the
proximal end handle 1500 of FIG. 15A. In various embodiments, the
proximal end handle 1500 may enable percutaneous transcatheter
deployment of an annuloplasty ring. More particularly, the proximal
end handle 1500 may enable percutaneous manipulation of an
annuloplasty system configured to deliver, configure, and/or orient
an annuloplasty ring and to fasten the annuloplasty ring to the
annulus of a target valve.
[0180] In various embodiments, the proximal end handle 1500 may
include one or more rotating knobs that are configured to perform
or enable one or more functions. In some embodiments, one rotatable
knob may be used for each function to be performed. In other
embodiments, one rotatable knob may be used for a plurality of
functions. A ring closure knob 1502 may enable closure of the
annuloplasty ring to transition from an elongated insertion
geometry to an annular operable geometry, as described in greater
detail herein. A ring snap knob 1504 may enable snapping together
of first and second ends (for example, distal and proximal ends) of
the annuloplasty ring or other manipulation of a ring closure lock,
as described herein. An anchor deployment knob 1506 may enable
deployment of anchors of an annuloplasty ring to fasten the
annuloplasty ring to the annulus of the target heart valve, as
described herein. An A-P adjustment knob 1508 may enable
contraction of the annuloplasty ring from an expanded state to a
contracted state, as described herein. In other embodiments, the
A-P adjustment knob 1508 may also enable manipulation of a
stabilizer to facilitate expansion of the annuloplasty ring to an
expanded state (for example, prior to deployment of the anchors). A
ring release knob 1510 may enable release of the annuloplasty ring
from a delivery system and/or delivery shuttle of a percutaneous
annuloplasty system. Additional or fewer knobs may be possible,
depending on the functions to be performed. Furthermore, the
positioning of each knob relative to other knobs as shown in FIG.
15A is merely illustrative. Accordingly, those having ordinary
skill in the art will recognize other positions of each knob
relative to other knobs as being included within the scope of this
disclosure.
[0181] In various embodiments, each of the knobs 1502, 1504, 1506,
1508, 1510 may be coupled to an independent system of cables and/or
sutures. Manipulation of a respective cable and/or suture may be
achieved by rotating the respective knob 1502, 1504, 1506, 1508,
1510. As shown in FIG. 15B, each of the knobs 1502, 1504, 1506,
1508, 1510 may be mechanically coupled to a respective translation
gear mechanism. The gear mechanism may be connected to a respective
cable or suture that is configured to perform a given function.
[0182] FIGS. 16A and 16B depict diagrams of perspective views of an
illustrative delivery system, generally designated 1600, of a
percutaneous annuloplasty system, according to an embodiment. In
some embodiments, the delivery system 1600 may include a plurality
of sections, such as, for example, a distal end section 1700, a
catheter section 1800, and/or a proximal handle section 1900. The
delivery system 1600 may be configured to enable percutaneous
transcatheter deployment of an annuloplasty ring, as described
herein. More particularly, the delivery system 1600 may enable
percutaneous manipulation of an annuloplasty system configured to
deliver, configure, and/or orient an annuloplasty ring. Further,
the delivery system 1600 may be configured to fasten the
annuloplasty ring to the annulus of a target heart valve, as
described in greater detail herein.
[0183] FIGS. 17A and 17B depict illustrative examples of a full
assembly of a ring 1710, a stabilizer 1730, and a distal end of the
catheter 1740 as configured in a target site after deployment of
the ring from the catheter. FIGS. 17A and 17B further depict an
illustrative example of an attachment mechanism between the ring
1710 and the stabilizer 1730. As described in greater detail
herein, the connection may be accomplished between a pivot point
1712 on the ring 1710 and the ring shuttle 1722 on the stabilizer
1730 via a wire 1723 that may be configured to pass through the
catheter 1740 to the proximal end of the delivery system.
[0184] Also shown in FIGS. 17A and 17B is an illustrative example
of a delivery system 1700 showing, at the distal end, a solid piece
1721. The solid piece 1721 may be manufactured from any material,
such as, for example, stainless steel. The solid piece 1721 may be
configured for one or more functions. Illustrative functions may
include, but are not limited to, holding the ring shuttle 1722 in a
particular position, locating the stabilizer 1730 in relation to
the ring shuttle and/or the ring 1710 at the target site, and
guiding the sutures from the ring through the holes 1724 towards
the proximal end of the delivery system 1740.
[0185] FIGS. 18A and 18B depict a longitudinal cross-sectional view
of an illustrative catheter, generally designated 1800, connecting
the distal end of the delivery system 1700 (FIGS. 17A and 17B) to
the proximal end of the delivery system 1900 (FIGS. 19A and 19B).
The catheter 1800 may include one or more lumens 1810 containing,
but not limited to, a hollow outer sleeve 1811 that is attached to
the proximal end of the delivery system 1910.
[0186] In various embodiments, an inner hollow shaft 1812 may be
located within the hollow outer sleeve 1811. Referring also to FIG.
19A, the inner hollow shaft 1812 may be connected to a moving
member 1931 that is configured to transfer movement of a rotating
knob 1932 to the inner hollow shaft 1812 and to the solid piece
1721 (FIGS. 17A and 17B) at the distal end of the delivery system
1700 (FIGS. 17A and 17B).
[0187] In some embodiments, a stabilizer shaft 1813 may be located
within the inner hollow shaft 1812. The stabilizer shaft 1813 may
connect the stabilizer 1730 to the proximal end of the delivery
system 1700 (FIGS. 16A and 16B). In some embodiments, the
stabilizer shaft 1813 may be configured to allow distal control of
the stabilizer 1730 from the proximal end 1950 (FIG. 19A). In some
embodiments, a guidewire or pig-tail catheter 1814 may be passed
through the center of the stabilizer shaft 1813. The guidewire or
pig-tail catheter 1814 may generally be one of a commonly used tool
in the cardiovascular field to function as a guide in the heart
chambers and/or to function as a conduit for injection of contrast
media for fluoroscopy.
[0188] FIGS. 19A, 19B, and 19C depict an illustrative embodiment
for the proximal side of the delivery system 1900, which may
function as a handle. The system 1900 may include one or more
functional mechanisms. Illustrative functional mechanisms may
include, but are not limited to, a ring deployment mechanism 1930,
a ring closure or snapping mechanism 1940, a barb or anchor
deployment mechanism 1920, and control channel mechanism for the
ring release wire 1723 (FIGS. 17A and 17B). The ring deployment
mechanism 1930 may include a rotating knob 1932 and/or a moving
member 1931 that may be attached to the inner hollow shaft 1812. In
some embodiments, the knob 1932 may be configured to be rotated
such that the ring 1710 (FIGS. 17A and 17B) is pushed distally and
away through the outer sleeve 1811, thereby deploying from the
catheter. The end of the suture 1960 from the ring 1710 (FIGS. 17A
and 17B) may be fixed at the proximal end 1950 such that when the
ring deploys, the suture may be placed under a constant
tension.
[0189] FIG. 19B depicts an illustrative suture 1960 attached to the
ring 1710 at the distal end 1951. The suture may pass through the
proximal end of the ring 1715, the ring shuttle 1722, the solid
piece 1721 and the outer sleeve 1811 to the proximal end of the
delivery system 1950 (FIG. 19A). The total length of the suture
1960 may be the length of a first portion a plus the length of a
second portion b (a+b).
[0190] FIG. 19C depicts an illustrative ring 1710 after deployment
from the outer sleeve 1811. As shown in FIG. 19C, the suture 1960
may remain the same length as it is attached at the same points of
the ring 1710 relative to the delivery system. Accordingly, the
suture 1960 may be placed under tension.
[0191] Referring again to FIG. 19A, a channel 1920 may be provided
for one or more barb deployment elongated members (such as, for
example, sutures) to be held and pulled once barbs and/or anchors
are deployed, as described in greater detail herein. Any number of
barb deployment members may be placed via the channel 1920. In some
embodiments, the number of barb deployment members may correspond
to a number of windows, as described herein. For example, 1 barb
deployment member, 2 barb deployment members, 3 barb deployment
members, 4 barb deployment members, 5 barb deployment members, 6
barb deployment members, 7 barb deployment members, 8 barb
deployment members, 9 barb deployment members, 10 barb deployment
members or more may be placed via the channel 1920.
[0192] An annuloplasty ring, as disclosed above, may be used to
adjust the shape of an annulus of a cardiovascular valve, thereby
bringing its leaflets into a functional geometry. Additionally,
such a device may be used to provide a stabilizing platform for a
replacement cardiovascular valve if the natural cardiovascular
valve is defective, degraded, or diseased. Such a use may be
indicated if the natural valve structure and its environment are
too deformable to permit long-term placement of the replacement
valve. Natural cardiovascular valves that may be treated in this
manner may include cardiac valves or venous valves. Cardiac valves
may include the mitral valve, the aortic valve, the tricuspid
valve, and the pulmonary valve. In the disclosure below, reference
is made to an adjustable stabilizing ring that may be used in
conjunction with a replacement valve. It may be understood that
embodiments of such an adjustable stabilizing ring, along with the
variety of systems, implements, and catheters that may be used for
its deployment in the cardiovascular system, may include the
embodiments of annuloplasty rings and the systems, implements, and
catheters that have been disclosed hereinabove.
[0193] One embodiment of such an adjustable stabilizing ring is
depicted in FIGS. 20A-C. The adjustable stabilizing ring may
include a body member capable of assuming one or more different
geometrical shapes. In some non-limiting embodiments the body
member may be composed of a memory metal, a nickel titanium alloy,
a stainless steel alloy, or a cobalt-chrome alloy, alone or in
combination. Such materials may have physical and/or mechanical
properties that may permit the body member to assume the one or
more geometrical shapes. In some embodiments, the adjustable
stabilizing ring may initially be present in an elongate geometry
2010a as depicted in FIG. 20A. Such a geometry may allow the body
member of the stabilizing ring to be inserted into the heart or
vasculature by means of a narrow catheter.
[0194] In another embodiment, the body member of the adjustable
stabilizing ring may transition from the elongate geometry 2010a to
an annular operable geometry 2010b, as depicted in FIG. 20B. The
annular operable geometry 2010b may take on any closed geometric
shape including, without limitation, a circular shape, an oval
shape, a D-shape, or any other continuously enclosed smooth shape.
An adjustable stabilizing ring having a D-shaped annular operable
geometry 2010b may have dimensions appropriate to the size of the
natural valve annulus for which it may be used. The dimensions may
include an anterior-posterior diameter of about 17 mm to about 23
mm, and a commissure-commissure diameter of about 28 mm to about 36
mm. Non-limiting examples of an anterior-posterior diameter may
include a diameter of about 17 mm, about 18 mm, about 19 mm, about
20 mm, about 21 mm, about 22 mm, about 23 mm, or ranges between any
two of these values (including endpoints). Non-limiting examples of
a commissure-commissure diameter may include a diameter of about 28
mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33
mm, about 34 mm, about 35 mm, about 36 mm, or ranges between any
two of these values (including endpoints). In the annular operable
geometry 2010b, the adjustable stabilizing ring may be rigid or
semi-rigid.
[0195] The stabilizing ring in its annular operable geometry 2010b
may also include one or more anchors 2020 as depicted in FIG. 20C.
Such anchors 2020 may be deployed to engage the tissue of a
cardiovascular valve, such as the annular region. Over time, the
engaged tissue may grow around the individual anchors 2020 thereby
forming a mechanical bond that can stabilize the ring in place near
the natural cardiovascular valve.
[0196] Because the stabilizing ring may be emplaced in the heart or
vasculature through the use of a catheter, it may not be possible
for the physician or other health care professional to visualize
the placement directly. Imaging technology may be required to
determine the proper placement of the stabilizing ring. In some
embodiments, the stabilizing ring may be radiopaque or include
radiopaque material to permit its visualization during
emplacement.
[0197] Because the stabilizing ring may be stabilized near the
natural cardiovascular valve by the anchors 2020, a replacement
valve that is placed in mechanical contact with the ring may be
similarly stabilized. Such a replacement valve may be composed of
an implantable valve frame to which one or more valve leaflets are
attached. The implantable valve frame may be composed of any
material that is biocompatible and resistant to thrombus formation.
Non-limiting examples of such valve frame material may include
memory metal, a nickel titanium alloy, a stainless steel alloy, and
a cobalt-chrome alloy. Such a replacement valve may include the
same number of valve leaflets as the natural valve that it may
replace. Thus, the replacement valve may include an implantable
valve frame having one, two, or three valve leaflets in contact
therewith.
[0198] Implantable valve frames may include a variety of shapes and
sizes, some non-limiting examples of which are depicted in FIGS.
21A-H. As depicted in FIG. 21A, one embodiment of an implantable
valve frame may include a frame having a D-shaped cross-section
2110a and a constricted profile 2120a (depicted in FIG. 21C). As
depicted in FIG. 21B, another embodiment of an implantable valve
frame may include a frame having a circular cross-section 2110b and
a constricted profile 2120a (also depicted in FIG. 21C). As
depicted in FIG. 21D, another embodiment of an implantable valve
frame may include a frame having a D-shaped cross-section 2110a and
a straight profile 2120b (also depicted in FIG. 21E) In still
another embodiment, an implantable valve frame may include a frame
having a circular cross section (2110b as illustrated in FIG. 21B)
and a straight profile (2120b as illustrated in FIG. 21D).
[0199] In some embodiments, as depicted in FIGS. 21F and 21G, an
implantable valve frame may be formed from a first support element
2130a, a second support element 2130b, and at least one bridging
element 2120c extending from the first support element to the
second support element. The one, two, or three replacement valve
leaflets, associated with the implantable valve frame may be at
least partially secured to the first support element 2130a, the
second support element 2130b, the at least one bridging element
2120c, or any combination thereof. In some embodiments, the at
least one bridging element 2120c may be composed of a single
continuous surface having a first end in physical contact with the
entire first support element 2130a and a second end in physical
contact with the entire second support element 2130b. In some
embodiments, the implantable valve frame may be composed of a first
support element 2130a, a second support element 2130b, and at least
one bridging element 2120c, any one or more of which may be
composed of a collapsible material. In some embodiments, the
implantable valve frame may be composed of a first support element
2130a, a second support element 2130b, and at least one bridging
element 2120c in which the at least one bridging element extends
radially inwards toward a central axis of the valve frame. It may
be recognized that such a radially inward extent, for a valve frame
having a single bridging element, may result in a valve frame
having a constricted profile as depicted in FIGS. 21A-C. In some
embodiments, the implantable valve frame may be composed of a first
support element 2130a, a second support element 2130b, and at least
one bridging element 2120c, any one or more of which may be
composed of a woven material.
[0200] In another embodiment, depicted in FIG. 21G, the at least
one bridging element may be composed of a plurality of independent
or mutually linked bridging elements 2120d. Some embodiments may
include a plurality of bridging elements arranged in a criss-cross
manner, such as may be found in an expandable gate. In alternative
embodiments, the at least one bridging element may be constructed
in the manner of a vascular stent. A valve frame having bridging
elements arranged as associated linked components may be used in
conjunction with a stabilizing ring having anchors. The linked
components in the system may be rigid or semi-rigid depending on
the nature of the linkage among the linked components. It may be
recognized that implantable valve frames in general may be at least
partially collapsible, collapsible, rigid, or semi-rigid according
to their individual designs.
[0201] FIG. 21H further depicts a pliable coating material 2170
that may be applied to the stabilizing ring 2150. It may be
appreciated that the stabilizing ring 2150, the valve frame, or
both may be coated with such a pliable coating material 2170. In
some embodiments, the pliable coating material 2170 may be composed
of a polymer. In one non-limiting example, the pliable material may
be a polyester.
[0202] FIGS. 22A-C depict several non-limiting examples of
implantable valve frames including replacement valves that may be
incorporated therein. Thus, FIG. 22A depicts a frame having a
D-shaped cross-section with a constricted profile 2220a
incorporating a bi-leaflet valve 2230a. FIG. 22B depicts a frame
having a circular cross-section with a constricted profile 2220b
incorporating a tri-leaflet valve 2230b. FIG. 22C depicts a frame
having a D-shaped cross-section with a cylindrical profile 2220c
incorporating a bi-leaflet valve 2230a.
[0203] It may be appreciated that alternative frames and leaflet
systems may be contemplated in addition to the examples depicted
herein. Thus, a frame may include a cylindrical profile, a
constricted profile, a bulging profile, or any other profile
appropriate for stabilizing one or more valve leaflets as required
for the function of the replacement valve. A frame may also have a
D-shaped cross section, a circular cross section, an oval cross
section, or a cross section having any closed geometrical shape
appropriate for stabilizing one or more valve leaflets as required
for the function of the replacement valve. The valve frames may
also secure one, two, three, or other number of valve leaflets as
required for the function of the replacement valve.
[0204] Regardless of the shape of the implantable valve frame, the
valve frame may be configured to be delivered by means of a
catheter. Catheters disclosed above with respect to the implanting
of an annuloplasty ring (or adjustable stabilizing ring) may also
be used to deliver the implantable valve frames. In some examples,
a catheter may be used to deploy a stabilizing ring and a valve
frame. Alternative examples may include a catheter for deploying a
valve frame that is different from the catheter used to deploy a
stabilizing ring. It may be understood that the deployed
implantable valve frame may be physically larger than a lumen of a
catheter used for its deployment. Thus, the implantable valve frame
may be delivered by the catheter at the locus of the natural valve
in an at least partially collapsed state. Upon deployment, the
implantable valve frame may be expanded to a functional (expanded)
state. In some embodiments, the implantable valve may expand from
its at least partially collapsed state to its expanded state under
the actions of an expansion device. In one example, the expansion
device may be a balloon placed adjacent to the at least partially
collapsed valve frame. Such an expansion device may expand the
valve frame as the balloon is inflated. In other embodiments, the
implantable valve frame may be self-expanding. Such self-expanding
implantable valve frames may be composed of a memory metal, such as
a nickel titanium alloy.
[0205] FIGS. 23A-D depict non-limiting examples of a combination
system including an implantable valve frame and an adjustable
stabilizer ring. In each of FIGS. 23A-D, an adjustable stabilizing
ring 2320 having extended anchors 2330 is depicted inclosing at
least some portion of a valve frame (2310a,b). In some embodiments,
the stabilizing ring 2320 may be in physical contact with at least
a portion of an exterior surface of the valve frame (2310a,b).
[0206] As depicted in FIGS. 23A and 23B, the implantable valve
frame 2310a may be a D-shaped frame having a constriction with
which the stabilizing ring 2320 is in contact. As depicted in FIG.
23B, such a combination system of valve frame 2310a and adjustable
stabilizing ring 2320 may house a two-leaflet valve 2340. It may be
noted in FIGS. 23A and 23B that the valve frame 2310a may have a
geometry permitting continuous physical contact between the portion
of the valve frame exterior surface and the stabilizing ring
2320.
[0207] As depicted in FIGS. 23C and 23D, the implantable valve
frame 2310b may be a cylindrical frame having a constriction with
which the stabilizing ring 2320 is in contact. As depicted in FIG.
23D, such a combination system of valve frame 2310b and adjustable
stabilizing ring 2320 may house a three-leaflet valve 2350. It may
be noted in FIGS. 23C and 23D that the valve frame 2310b may have a
geometry in which only partial physical contact is made between the
portion of the valve frame exterior surface and the stabilizing
ring 2320.
[0208] In addition to the configurations depicted in FIGS. 23A-D, a
stabilizing ring 2320 may form a continuous physical contact with a
portion of a valve frame having a D-shape cross-section, a circular
cross-section, an oval cross-section, or any other continuous
geometrical cross-section. Alternatively, a stabilizing ring 2320
may form only a partial physical contact with a portion of a valve
frame having a D-shape cross-section, a circular cross-section, an
oval cross-section, or any other continuous geometrical
cross-section. Further, a stabilizing ring 2320 may form a
continuous physical contact or a partial physical contact with an
exterior surface of a valve frame having a constricted profile, a
straight profile, or a bulging profile. It may further be
understood that a stabilizing ring 2320 may form a continuous
physical contact or a partial physical contact with any portion of
an exterior surface of a valve frame regardless of the valve frame
profile.
[0209] It may be understood that other combination systems of valve
frames and stabilizing rings may be contemplated. Thus, an
implantable valve frame may be composed of a plurality of
individual segments affixed to each other to form a criss-cross
geometry or more complex geometry made from straight or curved
links. Alternative implantable valve frames may include interlaced
segments In alternative non-limiting embodiments, a combination
system may include multiple stabilizing rings. In one non-limiting
example, a first stabilizing ring may be in mechanical
communication with a proximal end of an implantable valve frame,
and a second stabilizing ring may be in mechanical communication
with a distal end of an implantable valve frame.
[0210] In other examples, the implantable valve frame may
incorporate features to assist in stabilizing its physical contact
with the adjustable stabilizing ring. Such a valve frame is
depicted in FIGS. 24A and 24B. As depicted in FIG. 24A, the
implantable valve frame 2410 may include at least one frame anchor
2420 in mechanical communication with an exterior side or bridging
element of the valve frame. As depicted in FIG. 24B, the adjustable
stabilizing ring 2430 may be disposed in such a manner as to
contact the one or more frame anchors 2420. It should be understood
that the frame anchors 2420 may be distinguished from the anchors
2440 incorporated into the stabilizing ring that may be used to
anchor the stabilizing ring in the annular tissue around the
natural valve.
[0211] Although FIGS. 24A and 24B depict a valve frame having a
D-shaped cross-section and a constricted profile, it may be
understood that any suitable valve frame may incorporate frame
anchors 2420 to assist in the mechanical communication of an
exterior surface of the valve frame and the adjustable stabilizing
ring. Non-limiting examples of such valve frames may be
characterized by a straight profile, a constricted profile, a
bulging profile, a circular cross-section, a D-shaped
cross-section, an oval cross-section, any continuous geometrical
cross-section, one or more interleaved bridging segments, a
continuous bridging segment, a plurality of bridging segments, and
other shapes, sizes, constructions, and geometries as known in the
art.
[0212] FIG. 25 is a flow chart of an exemplary method of
stabilizing a replacement of a cardiovascular valve. The distal end
of a catheter containing at least the stabilizing ring in an
elongate geometry and a delivery system thereof may be inserted
2510 into a damaged or otherwise non-functioning natural valve. The
delivery system may be used to guide 2520 the ring in the elongate
geometry from a proximal end of the catheter to the distal end of
the catheter. The adjustable stabilizing ring may transition 2540
to an annular operable geometry upon exiting the distal end of the
catheter proximate to the valve annulus. Once the stabilizing ring
is in its operable geometry, the anchors of the ring may be
deployed 2550.
[0213] It may be understood that the deployment of the stabilizing
ring, including the anchors, may be sufficient to treat a malformed
cardiovascular valve in the manner of an annuloplasty as disclosed
above. Over time, a health care professional may determine that
replacement of the natural valve may be required. Subsequent
procedures may then be used to provide a replacement valve at the
site of the previous annuloplasty. A catheter may be used to guide
2560 the implantable valve frame through the natural cardiovascular
valve and through the center of the pre-implanted adjustable
stabilizing ring. The valve frame may be engaged 2570 with the
stabilizing ring, thereby stabilizing the position of the
implantable valve frame with respect to the natural cardiovascular
valve. In some embodiments of the method shown in FIG. 25, the
stabilizing ring and the valve frame may be introduced into the
cardiovascular system during the same surgical procedure. In
alternative embodiments, some period of time may lapse between the
placement of the stabilizing ring and the placement of the valve
frame. For example, the stabilizing ring may be implanted initially
to stabilize a natural cardiovascular valve, but a replacement
valve may be introduced if the patient shows signs that the
stabilizing ring alone is insufficient to treat the valve
pathology. Alternatively, the stabilizing ring may be introduced
initially and the patient's vascular system may be permitted a
period of time to incorporate the stabilizing ring into the tissue
before the replacement valve is introduced. In this manner, the
patient's vascular tissue may grow into or around the stabilizing
ring to anchor or form a seal around the ring before the
replacement valve is implanted.
[0214] In some embodiments, the implantable valve frame may be
engaged with the stabilizing ring by allowing or causing the
implantable valve frame to expand to a functional size, thereby
forming a mechanical contact between the implantable valve frame
and the adjustable stabilizing ring. In some non-limiting examples,
the valve frame may be allowed to self-expand. Such self-expanding
valve frames may be composed of a memory material that may expand
to a pre-set shape. In some alternative non-limiting examples, the
valve frame may expand under the influence of an expansion device.
Such an expansion device may be incorporated in the same catheter
as that which delivers and emplaces the implantable valve frame. In
other examples, the expansion device may be deployed from a
catheter that differs from the one used to emplace the valve frame.
In one non-limiting example, the expansion device may be a
balloon-type device or a balloon.
[0215] FIG. 26 is a flow chart of an exemplary method of replacing
a cardiovascular valve. The distal end of a catheter containing at
least an implantable valve frame having the replacement of the
cardiovascular valve and a delivery system thereof may be inserted
2610 into a damaged or otherwise non-functioning natural
cardiovascular valve. The delivery system may be used to guide 2620
the valve frame through the catheter and through the cardiovascular
valve. The valve frame may be expanded 2630, thereby deploying the
replacement cardiovascular valve.
[0216] A delivery system may be used to guide 2640 a stabilizing
ring in an elongate geometry through a catheter. It may be
understood that the same catheter may be used to deploy and guide
the stabilizing ring and the implantable valve frame.
Alternatively, separate catheters may be used to deliver the
implantable valve frame and the stabilizing ring. The distal end of
the catheter may be positioned through the implantable valve frame
and the replacement of the cardiovascular valve. In this manner,
the stabilizing ring, in the elongate geometry may be advanced 2650
out of the catheter at a position distal to the replacement of the
cardiovascular valve. The adjustable stabilizing ring may be
allowed 2660 to transition to an annular operable geometry around
an exterior surface of the implantable valve frame upon exiting the
distal end of the catheter proximate to the valve annulus. The
stabilizing ring in the annular operable geometry may be engaged
2670 to the valve frame. Once the stabilizing ring is in its
operable geometry, the anchors of the ring may be deployed
2680.
[0217] In the above detailed description, reference is made to the
accompanying drawings, which form a part hereof. In the drawings,
similar symbols typically identify similar components, unless
context dictates otherwise. The illustrative embodiments described
in the detailed description, drawings, and claims are not meant to
be limiting. Other embodiments may be used, and other changes may
be made, without departing from the spirit or scope of the subject
matter presented herein. It will be readily understood that the
aspects of the present disclosure, as generally described herein,
and illustrated in the Figures, can be arranged, substituted,
combined, separated, and designed in a wide variety of different
configurations, all of which are explicitly contemplated
herein.
[0218] The present disclosure is not to be limited in terms of the
particular embodiments described in this application, which are
intended as illustrations of various aspects. Many modifications
and variations can be made without departing from its spirit and
scope, as will be apparent to those skilled in the art.
Functionally equivalent methods and apparatuses within the scope of
the disclosure, in addition to those enumerated herein, will be
apparent to those skilled in the art from the foregoing
descriptions. Such modifications and variations are intended to
fall within the scope of the appended claims. The present
disclosure is to be limited only by the terms of the appended
claims, along with the full scope of equivalents to which such
claims are entitled. It is to be understood that this disclosure is
not limited to particular methods, reagents, compounds,
compositions or biological systems, which can, of course, vary. It
is also to be understood that the terminology used herein is for
the purpose of describing particular embodiments only, and is not
intended to be limiting.
[0219] With respect to the use of substantially any plural and/or
singular terms herein, those having skill in the art can translate
from the plural to the singular and/or from the singular to the
plural as is appropriate to the context and/or application. The
various singular/plural permutations may be expressly set forth
herein for sake of clarity.
[0220] It will be understood by those within the art that, in
general, terms used herein, and especially in the appended claims
(for example, bodies of the appended claims) are generally intended
as "open" terms (for example, the term "including" should be
interpreted as "including but not limited to," the term "having"
should be interpreted as "having at least," the term "includes"
should be interpreted as "includes but is not limited to," et
cetera). While various compositions, methods, and devices are
described in terms of "comprising" various components or steps
(interpreted as meaning "including, but not limited to"), the
compositions, methods, and devices can also "consist essentially
of" or "consist of" the various components and steps, and such
terminology should be interpreted as defining essentially
closed-member groups. It will be further understood by those within
the art that if a specific number of an introduced claim recitation
is intended, such an intent will be explicitly recited in the
claim, and in the absence of such recitation no such intent is
present. For example, as an aid to understanding, the following
appended claims may contain usage of the introductory phrases "at
least one" and "one or more" to introduce claim recitations.
However, the use of such phrases should not be construed to imply
that the introduction of a claim recitation by the indefinite
articles "a" or "an" limits any particular claim containing such
introduced claim recitation to embodiments containing only one such
recitation, even when the same claim includes the introductory
phrases "one or more" or "at least one" and indefinite articles
such as "a" or "an" (for example, "a" and/or "an" should be
interpreted to mean "at least one" or "one or more"); the same
holds true for the use of definite articles used to introduce claim
recitations. In addition, even if a specific number of an
introduced claim recitation is explicitly recited, those skilled in
the art will recognize that such recitation should be interpreted
to mean at least the recited number (for example, the bare
recitation of "two recitations," without other modifiers, means at
least two recitations, or two or more recitations). Furthermore, in
those instances where a convention analogous to "at least one of A,
B, and C, et cetera" is used, in general such a construction is
intended in the sense one having skill in the art would understand
the convention (for example, "a system having at least one of A, B,
and C" would include but not be limited to systems that have A
alone, B alone, C alone, A and B together, A and C together, B and
C together, and/or A, B, and C together, et cetera). In those
instances where a convention analogous to "at least one of A, B, or
C, et cetera" is used, in general such a construction is intended
in the sense one having skill in the art would understand the
convention (for example, "a system having at least one of A, B, or
C" would include but not be limited to systems that have A alone, B
alone, C alone, A and B together, A and C together, B and C
together, and/or A, B, and C together, et cetera). It will be
further understood by those within the art that virtually any
disjunctive word and/or phrase presenting two or more alternative
terms, whether in the description, claims, or drawings, should be
understood to contemplate the possibilities of including one of the
terms, either of the terms, or both terms. For example, the phrase
"A or B" will be understood to include the possibilities of "A" or
"B" or "A and B."
[0221] In addition, where features or aspects of the disclosure are
described in terms of Markush groups, those skilled in the art will
recognize that the disclosure is also thereby described in terms of
any individual member or subgroup of members of the Markush
group.
[0222] As will be understood by one skilled in the art, for any and
all purposes, such as in terms of providing a written description,
all ranges disclosed herein also encompass any and all possible
subranges and combinations of subranges thereof. Any listed range
can be easily recognized as sufficiently describing and enabling
the same range being broken down into at least equal halves,
thirds, quarters, fifths, tenths, et cetera As a non-limiting
example, each range discussed herein can be readily broken down
into a lower third, middle third and upper third, et cetera As will
also be understood by one skilled in the art all language such as
"up to," "at least," and the like include the number recited and
refer to ranges which can be subsequently broken down into
subranges as discussed above. Finally, as will be understood by one
skilled in the art, a range includes each individual member. Thus,
for example, a group having 1-3 cells refers to groups having 1, 2,
or 3 cells. Similarly, a group having 1-5 cells refers to groups
having 1, 2, 3, 4, or 5 cells, and so forth.
[0223] Various of the above-disclosed and other features and
functions, or alternatives thereof, may be combined into many other
different systems or applications. Various presently unforeseen or
unanticipated alternatives, modifications, variations or
improvements therein may be subsequently made by those skilled in
the art, each of which is also intended to be encompassed by the
disclosed embodiments.
* * * * *