U.S. patent application number 14/502000 was filed with the patent office on 2015-04-02 for apparatus and method for treating a regurgitant heart valve.
The applicant listed for this patent is THE CLEVELAND CLINIC FOUNDATION. Invention is credited to Jose L. Navia.
Application Number | 20150094803 14/502000 |
Document ID | / |
Family ID | 51799301 |
Filed Date | 2015-04-02 |
United States Patent
Application |
20150094803 |
Kind Code |
A1 |
Navia; Jose L. |
April 2, 2015 |
APPARATUS AND METHOD FOR TREATING A REGURGITANT HEART VALVE
Abstract
An apparatus is provided for treating regurgitation of blood
flow through a diseased heart valve, which includes an annulus,
anterior and posterior valve leaflets, and a subvalvular apparatus.
The apparatus includes a substantially annular support member, at
least one infra-annular support member securely connected thereto,
and at least one anchoring element associated with the at least one
infra-annular support member. The at least one anchoring element is
configured to securely receive a prosthetic chordae tendineae for
attachment to a papillary muscle. The posterior end portion is
dimensioned for attachment to a posterior portion of the diseased
heart valve annulus. The at least one infra-annular support member
is securely connected to the substantially annular support member.
The at least one infra-annular support member is dimensioned to
extend below at least one of the posterior and anterior valve
leaflets and across or behind at least one subvalvular
structure.
Inventors: |
Navia; Jose L.; (Shaker
Hts., OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
THE CLEVELAND CLINIC FOUNDATION |
Cleveland |
OH |
US |
|
|
Family ID: |
51799301 |
Appl. No.: |
14/502000 |
Filed: |
September 30, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61884406 |
Sep 30, 2013 |
|
|
|
Current U.S.
Class: |
623/2.36 |
Current CPC
Class: |
A61F 2/2457 20130101;
A61F 2230/0095 20130101; A61F 2/2454 20130101; A61F 2230/0013
20130101; A61F 2/2445 20130101 |
Class at
Publication: |
623/2.36 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. An apparatus for treating regurgitation of blood flow through a
diseased heart valve, the diseased heart valve including an
annulus, an anterior valve leaflet, a posterior valve leaflet and a
subvalvular apparatus, said apparatus comprising: a substantially
annular support member having at least a first intermediate
portion, a second intermediate portion, and a posterior end portion
extending between said first and second intermediate portions, said
posterior end portion being dimensioned for attachment to a
posterior portion of the annulus of the diseased heart valve; at
least one infra-annular support member securely connected to said
substantially annular support member at a first location, said at
least one infra-annular support member being dimensioned to extend
below at least one of the posterior and anterior valve leaflets and
across or behind at least one subvalvular structure; and at least
one anchoring element associated with said at least one
infra-annular support member, said at least one anchoring element
being configured to securely receive a prosthetic chordae tendineae
for attachment to a papillary muscle.
2. The apparatus of claim 1, wherein said at least one anchoring
element has a semi-circular shape.
3. The apparatus of claim 1, wherein said at least one anchoring
element is indirectly or directly associated with a surface of said
at least one infra-annular support member so that an aperture is
formed between said surface and a portion of said at least one
anchoring element.
4. The apparatus of claim 1, wherein attachment of the prosthetic
chordae tendineae between the papillary muscle and said at least
one anchor element causes the papillary muscle to move medially and
improve cardiac functioning by creating a reverse remodeling of a
posterior left ventricular wall, improving valve leaflet
coaptation, and reducing tension across the native chordae.
5. The apparatus of claim 1, wherein attachment of the prosthetic
chordae tendineae between the papillary muscle and said at least
one anchor element stabilizes the position of the papillary muscles
and prevents late apical migration of the subvalvular
apparatus.
6. An apparatus for treating regurgitation of blood flow through a
diseased heart valve, the diseased heart valve including an
annulus, an anterior valve leaflet, a posterior valve leaflet and a
subvalvular apparatus, said apparatus comprising: a substantially
annular support member having at least a first intermediate
portion, a second intermediate portion, and a posterior end portion
extending between said first and second intermediate portions, said
posterior end portion being dimensioned for attachment to a
posterior portion of the annulus of the diseased heart valve; a
first infra-annular support member securely connected to said
substantially annular support member at a first location; a second
infra-annular support member securely connected to said
substantially annular support member at a second location; and at
least one anchoring element associated with one or both of said
first and second infra-annular support members, said at least one
anchoring element being configured to securely receive a prosthetic
chordae tendineae for attachment to a papillary muscle; wherein
said first and second infra-annular support members are dimensioned
to extend below at least one of the posterior and anterior valve
leaflets and across or behind at least one subvalvular
structure.
7. The apparatus of claim 6, wherein said at least one anchoring
element has a semi-circular shape.
8. The apparatus of claim 6, wherein at least one of said first and
second anchoring elements is indirectly or directly associated with
a surface of said at least one infra-annular support member so that
an aperture is formed between said surface and a portion of said
first and second anchoring elements.
9. The apparatus of claim 6, wherein attachment of the prosthetic
chordae tendineae between the papillary muscle and said at least
one anchor element causes the papillary muscle to move medially and
improve cardiac functioning by creating a reverse remodeling of a
posterior left ventricular wall, improving valve leaflet
coaptation, and reducing tension across the native chordae.
10. The apparatus of claim 6, wherein attachment of the prosthetic
chordae tendineae between the papillary muscle and said at least
one anchor element stabilizes the position of the papillary muscles
and prevents late apical migration of the subvalvular
apparatus.
11. A method for treating regurgitation of blood flow through a
diseased heart valve, the diseased heart valve including an
annulus, an anterior valve leaflet, a posterior valve leaflet and a
subvalvular apparatus, said method comprising the steps of:
providing an apparatus comprising a substantially annular support
member, at least one infra-annular support member securely
connected thereto, and at least one anchoring element associated
with the at least one infra-annular support member, the
substantially annular support member having at least a first
intermediate portion, a second intermediate portion and a posterior
end portion extending between the first and second intermediate
portions; attaching the substantially annular support member to the
annulus of the diseased heart valve; and attaching proximal and
distal ends of a prosthetic chordae tendineae to the at least one
anchoring element and a papillary muscle, respectively; wherein the
substantially annular support member is attached so that the at
least one infra-annular support member extends below at least one
of the posterior and anterior valve leaflets and across or behind
at least one subvalvular structure to prevent or substantially
reduce regurgitation of blood flow through the diseased heart
valve; wherein the prosthetic chordae tendineae is attached so that
the papillary muscle is caused to move medially and improve cardiac
functioning by creating a reverse remodeling of a posterior left
ventricular wall, improving valve leaflet coaptation, and reducing
tension across the native chordae.
12. The method of claim 11, wherein said providing step further
includes providing at least one anchoring element having a
semi-circular shape.
13. The method of claim 11, wherein said providing step further
comprises providing at least one anchoring element that is
indirectly or directly associated with a surface of the at least
one infra-annular support member so that an aperture is formed
between the surface and a portion of the at least one anchoring
element.
14. The method of claim 11, wherein attachment of the prosthetic
chordae tendineae between the papillary muscle and the at least one
anchor element stabilizes the position of the papillary muscles and
prevents late apical migration of the subvalvular apparatus.
15. The method of claim 11, wherein the subject is suffering from
Carpentier's type I dysfunction.
16. The method of claim 11, wherein the subject is suffering from
Carpentier's type IIIb dysfunction.
Description
RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional
Patent Application Ser. No. 61/884,406, filed Sep. 30, 2013, the
entirety of which is hereby incorporated by reference for all
purposes.
TECHNICAL FIELD
[0002] The present disclosure relates generally to apparatus and
methods for treating dysfunctional heart valves, and more
particularly to apparatus and related methods that provide
sub-valvular leaflet support, as well as sub-valvular apparatus
support to passively assist in preventing or mitigating heart valve
regurgitation.
BACKGROUND
[0003] The opening and closing of heart valves occur primarily as a
result of pressure differences. For example, the opening and
closing of the mitral valve occurs as a result of the pressure
differences between the left atrium and the left ventricle. During
ventricular diastole, the venous return of blood from the pulmonary
veins into the left atrium causes the pressure in the atrium to
exceed that in the left ventricle. As a result, the mitral valve
opens and allows blood to enter the left ventricle. As the left
ventricle contracts during ventricular systole, the
intraventricular pressure rises above the pressure in the atrium
and pushes the mitral valve shut.
[0004] When the high pressure produced by contraction of the left
ventricle pushes the valve leaflets too much, the leaflets become
everted and prolapse results. This is normally prevented by
contraction of the papillary muscles within the left ventricle,
which are connected to the mitral valve leaflets by the chordae
tendineae (chords). Contraction of the papillary muscles is
simultaneous with the contraction of the left ventricle and serves
to keep healthy mitral valve leaflets tightly shut at peak
contraction pressures.
[0005] Mitral valve malfunction can stem from a variety of
etiologies. For example, the causes of mitral regurgitation can
range from intrinsic disease of the leaflets (e.g., mainly due to
degenerative disease in patients with mitral valve prolapse), to
functional mitral regurgitation (FMR), in which the valve is
anatomically normal but stretched due to tethering and annular
dilatation. Although mitral regurgitation in intrinsic disease
occurs initially as leaflet disease, secondary annular dilatation
occurs in the large majority of patients by the time they present
for treatment. The larger proportion of patients with mitral
regurgitation includes those without intrinsic disease of the
leaflets, i.e., FMR.
[0006] Surgical correction of FMR is based upon overcorrection of
concomitant annular dilatation using an undersized, complete, and
rigid annuloplasty ring that is intended to reduce the diameter of
the mitral annulus and allow for leaflet coaptation. Although
complete correction of mitral regurgitation has been surgically
demonstrated, an important recurrence of mitral regurgitation after
annuloplasty valve repair is common (25%) because the left
ventricle continues to dilate or remodel, thereby causing further
tethering of the mitral leaflets.
SUMMARY
[0007] According to one aspect of the present disclosure, an
apparatus is provided for treating regurgitation of blood flow
through a diseased heart valve. The diseased heart valve includes
an annulus, an anterior valve leaflet, and a posterior valve
leaflet. The apparatus includes a substantially annular support
member, at least one infra-annular support member securely
connected thereto, and at least one anchoring element associated
with the at least one infra-annular support member. The at least
one anchoring element is configured to securely receive a
prosthetic chordae tendineae for attachment to a papillary muscle.
The substantially annular support member has at least a first
intermediate portion, a second intermediate portion, and a
posterior end portion extending between the first and second
intermediate portions. The posterior end portion is dimensioned for
attachment to a posterior portion of the annulus of the diseased
heart valve. The at least one infra-annular support member is
securely connected to the substantially annular support member at a
first location. The at least one infra-annular support member is
dimensioned to extend below the posterior and anterior valve
leaflets and across or behind at least one subvalvular
structure.
[0008] According to another aspect of the present disclosure, an
apparatus is provided for treating regurgitation of blood flow
through a diseased heart valve. The diseased heart valve includes
an annulus, an anterior valve leaflet, and a posterior valve
leaflet. The apparatus includes a substantially annular support
member, a first infra-annular support member, a second
infra-annular support member, and at least one anchoring element
associated with at least one of the first and second infra-annular
support members. The at least one anchoring element is configured
to securely receive a prosthetic chordae tendineae for attachment
to a papillary muscle. The substantially annular support member has
at least a first intermediate portion, a second intermediate
portion, and a posterior end portion extending between the first
and second intermediate portions. The posterior end portion is
dimensioned for attachment to a posterior portion of the annulus of
the diseased heart valve. The first infra-annular support member is
securely connected to the substantially annular support member at a
first location. The second infra-annular support member is securely
connected to the substantially annular support member at a second
location. The first and second infra-annular support members are
dimensioned to extend below at least one of the posterior and
anterior valve leaflets and across or behind at least one
subvalvular structure.
[0009] According to another aspect of the present disclosure, a
method is provided for treating regurgitation of blood flow through
a diseased heart valve. The diseased heart valve includes an
annulus, an anterior valve leaflet and a posterior valve leaflet.
One step of the method includes providing an apparatus comprising a
substantially annular support member, at least one infra-annular
support member that is securely connected thereto, and at least one
anchoring element associated with the at least one infra-annular
support member. The substantially annular support member includes
at least a first intermediate portion, a second intermediate
portion, and a posterior end portion extending between the first
and second intermediate portions. Next, the substantially annular
support member is attached to the annulus of the diseased heart
valve so that the at least one infra-annular support member extends
below at least one of the posterior and anterior valve leaflets and
across or behind at least one subvalvular structure to prevent or
substantially reduce regurgitation of blood flow through the
diseased heart valve. The proximal and distal ends of the
prosthetic chordae tendineae are then attached to the at least one
anchoring element and a papillary muscle, respectively, so that the
papillary muscle is caused to move medially and improve cardiac
functioning by creating a reverse remodeling of a posterior left
ventricular wall, improving valve leaflet coaptation, and reducing
tension across the native chordae.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The foregoing and other features of the present disclosure
will become apparent to those skilled in the art to which the
present disclosure relates upon reading the following description
with reference to the accompanying drawings, in which:
[0011] FIG. 1A is a perspective view of an apparatus for treating
regurgitation of blood flow through a mitral valve constructed in
accordance with one aspect of the present disclosure;
[0012] FIG. 1B is a top view of the apparatus in FIG. 1A implanted
about a diseased mitral valve;
[0013] FIG. 1C is a top view of the apparatus in FIG. 1A showing
markers to facilitate attachment of the apparatus 10 to the mitral
annulus;
[0014] FIG. 1D is a side view of the apparatus in FIG. 1A;
[0015] FIG. 1E is a cross-sectional view taken along Line 1E-1E in
FIG. 1D;
[0016] FIG. 1F is a top view showing an alternative configuration
of the apparatus in FIG. 1B;
[0017] FIG. 1G is a top view showing an alternative configuration
of the apparatus in FIG. 1F;
[0018] FIG. 1H is a perspective view showing an adjustment
mechanism included as part of the apparatus in FIG. 1A;
[0019] FIG. 1I is a side view of the apparatus in FIG. 1H showing
manipulation of the adjustment mechanism in FIG. 1H;
[0020] FIG. 1J is a top view of the apparatus in FIG. 1I showing
manipulation of the adjustment mechanism;
[0021] FIG. 1K is a cross-sectional view of a human heart showing
percutaneous adjustment of the apparatus in FIG. 1J;
[0022] FIG. 2 is a cross-sectional view showing the left side of a
human heart;
[0023] FIG. 3A is a perspective view showing an alternative
configuration of the apparatus in FIG. 1A;
[0024] FIG. 3B is a top view showing the apparatus in FIG. 3A
implanted about a diseased mitral valve;
[0025] FIG. 3C is a perspective view showing an alternative
configuration of the apparatus in FIG. 3A;
[0026] FIG. 3D is a top view showing the apparatus in FIG. 3C
implanted about a diseased mitral valve;
[0027] FIG. 4A is a top view showing an alternative configuration
of the apparatus in FIG. 1A implanted about a diseased mitral
valve;
[0028] FIG. 4B is a perspective view of the apparatus in FIG.
4A;
[0029] FIG. 4C is a cross-sectional view showing the apparatus of
FIGS. 4A-B implanted about a diseased mitral valve;
[0030] FIG. 4D is a perspective view showing the apparatus of FIGS.
4A-B implanted about a diseased mitral valve;
[0031] FIG. 4E is a schematic illustration showing annular and
sub-annular levels of remodeling of the mitral valve in FIGS.
4C-D;
[0032] FIG. 5A is a perspective view showing an alternative
configuration of the apparatus in FIGS. 4A-B;
[0033] FIG. 5B is a perspective view showing another alternative
configuration of the apparatus in FIG. 5A;
[0034] FIG. 6A is a perspective view showing an alternative
configuration of the apparatus in FIG. 1A;
[0035] FIG. 6B is a perspective view showing an alternative
configuration of the apparatus in FIG. 6A;
[0036] FIG. 6C is a perspective view showing another alternative
configuration of the apparatus in FIG. 6A;
[0037] FIG. 7A is a top view showing an alternative configuration
of the apparatus in FIG. 1A;
[0038] FIG. 7B is a perspective view of the apparatus in FIG.
7A;
[0039] FIG. 7C is a side view of the apparatus in FIGS. 7A-B;
[0040] FIG. 8A is a perspective view of a sizing device constructed
in accordance with another aspect of the present disclosure;
[0041] FIG. 8B is a magnified side view showing a distal portion of
the sizing device in FIG. 8A;
[0042] FIG. 8C is a top view of a sizing member comprising the
sizing device in FIG. 8A;
[0043] FIG. 8D is a top view showing the apparatus in FIG. 1A
coupled to a delivery device or holder;
[0044] FIG. 8E is a magnified perspective view showing a portion of
the delivery device or holder (FIG. 8D) being coupled to the
apparatus in FIG. 1A;
[0045] FIG. 9A is a perspective view showing the apparatus in FIG.
7A implanted about a diseased mitral valve;
[0046] FIG. 9B is a cross-sectional view of the apparatus in FIG.
9A;
[0047] FIG. 9C is a cross-sectional showing an infra-annular
posterior support member of the apparatus in FIG. 9B extending
about an inferior free edge of the posterior mitral leaflet;
[0048] FIG. 10A is a perspective view showing an alternative
configuration of the apparatus in FIGS. 7A-B;
[0049] FIG. 10B is a perspective view showing the apparatus in FIG.
10A implanted about a diseased mitral valve;
[0050] FIG. 11A is a perspective view showing an alternative
configuration of the apparatus in FIGS. 7A-B;
[0051] FIG. 11B is a perspective view showing the apparatus in FIG.
11A implanted about a diseased mitral valve;
[0052] FIG. 12A is a perspective view showing an alternative
configuration of the apparatus in FIGS. 7A-B;
[0053] FIG. 12B is a side view of the apparatus in FIG. 12A;
[0054] FIG. 12C is a perspective view showing the apparatus in
FIGS. 12A-B implanted about a diseased mitral valve;
[0055] FIG. 13A is a plan view showing an alternative configuration
of the apparatus in FIGS. 7A-B;
[0056] FIG. 13B is a side view of the apparatus in FIG. 13A;
[0057] FIG. 14A is a top view of an apparatus for treating
regurgitation of blood flow through a tricuspid valve constructed
in accordance with another aspect of the present disclosure;
[0058] FIG. 14B is a perspective view of the apparatus in FIG.
14A;
[0059] FIG. 14C is a side view of the apparatus in FIG. 14A;
[0060] FIG. 14D is a perspective view showing an alternative
configuration of the apparatus in FIG. 14A;
[0061] FIG. 14E is a perspective view showing another alternative
configuration of the apparatus in FIG. 14A;
[0062] FIG. 15 is a cross-sectional view of a human heart;
[0063] FIG. 16A is a perspective view showing the apparatus in FIG.
14A implanted about a diseased tricuspid valve;
[0064] FIG. 16B is a perspective view showing an inferior aspect of
the tricuspid valve in FIG. 16A;
[0065] FIG. 17A is a perspective view showing an alternative
configuration of the apparatus in FIG. 14A;
[0066] FIG. 17B is a perspective view of the apparatus in FIG. 17A
implanted about a diseased tricuspid valve;
[0067] FIG. 17C is a perspective view showing an inferior aspect of
the tricuspid valve in FIG. 17B;
[0068] FIG. 17D is a perspective view showing an alternative
configuration of the apparatus in FIG. 17A;
[0069] FIG. 17E is a perspective view showing another alternative
configuration of the apparatus in FIG. 17A;
[0070] FIG. 18A is a perspective view showing an alternative
configuration of the apparatus in FIG. 14A;
[0071] FIG. 18B is a perspective view showing an alternative
configuration of the apparatus in FIG. 18A;
[0072] FIG. 18C is a perspective view showing another alternative
configuration of the apparatus in FIG. 18B;
[0073] FIGS. 19A-B are a schematic illustration showing an
alternative configuration of the apparatus in FIGS. 1A-18C;
[0074] FIG. 20 is a side view of the apparatus shown in FIG.
19A;
[0075] FIG. 21 is a perspective view of the apparatus shown in FIG.
20;
[0076] FIG. 22 is a another side view of the apparatus in FIG.
20;
[0077] FIG. 23 is a schematic illustration showing an alternative
configuration of the apparatus in FIGS. 19A-B implanted in a heart
ventricle;
[0078] FIG. 24 is a schematic illustration showing another
alternative configuration of the apparatus in FIGS. 19A-B implanted
in a heart ventricle;
[0079] FIG. 25 is a cross-sectional view showing the apparatus in
FIG. 19A implanted in a heart ventricle;
[0080] FIGS. 26A-B shows a regurgitant heart valve (left) being
treated with the apparatus in FIG. 19B; and
[0081] FIG. 27A-B shows a regurgitant heart valve FIG. 27A being
treated with an alternative configuration of the apparatus in FIG.
19B.
DETAILED DESCRIPTION
[0082] The present disclosure relates generally to apparatus and
methods for treating dysfunctional heart valves, and more
particularly to apparatus and related methods that provide
sub-valvular leaflet support, as well as sub-valvular apparatus
support to passively assist in preventing or mitigating heart valve
regurgitation. The present disclosure generally provides an
annuloplasty ring system having an infra-annular, free-edge leaflet
and subvalvular apparatus supporting mechanism that prevents valve
leaflet tethering and regurgitation during systole. Advantageously,
the present disclosure provides simultaneous annular and
sub-annular levels of cardiac remodeling of a cardiac valve (mitral
and tricuspid) to correct and normalize the level and angle of
leaflet coaptation, prevent valve leaflet tethering, and resolve
recurrent valve regurgitation over time. Consequently, the present
disclosure provides treatment for not only regurgitation (e.g.,
functional mitral regurgitation), but also regurgitation caused by
dilated and ischemic cardiomyopathy.
[0083] As representative of one aspect of the present disclosure,
FIGS. 1A-E illustrate an apparatus 10 for treating regurgitation of
blood flow through a diseased heart valve, such as a mitral valve
12 (FIG. 2). As shown in FIG. 2, the mitral valve 12 is located
between the left atrium 14 and the left ventricle 16, and functions
to prevent the backflow of blood from the left ventricle into the
left atrium during contraction. The mitral valve 12 has a D-shaped
annulus 18 that defines the opening between the left atrium 14 and
the left ventricle 16, and includes oppositely disposed anterior
and posterior portions 20 and 22. The mitral valve 12 is formed by
two leaflets; namely, the anterior leaflet 24 and the posterior
leaflet 26, each of which includes oppositely disposed superior and
inferior surfaces 28 and 30. The anterior leaflet 24 extends along
the generally planar base of the D-shaped valve annulus 18 between
two fibrous trigones (not shown). The posterior leaflet 26 extends
arcuately around the curved portion of the D-shaped annulus 18 of
the mitral valve 12. Chordae tendineae 32 and 32' respectively
extend between the inferior free edge 34 of the anterior mitral
leaflet 24 and the inferior free edge 36 of the posterior mitral
leaflet 26 to the papillary muscles 38 and 38' in the left
ventricle 16.
[0084] Referring to FIGS. 1A-E, the apparatus 10 comprises a
substantially annular support member 40 and at least one
infra-annular support member, such as an infra-annular posterior
support member 42 securely connected thereto. The apparatus 10 has
a three-dimensional (3D) shape that corresponds to the saddle-like
shape of the mitral annulus 18. The 3D shape allows the apparatus
10 to complement the 3D shape of the mitral valve 12 during the
complex physiological motion associated with the cardiac cycle.
This removes the need for leaflet resection and/or annulus
plication because the apparatus 10, when implanted about the mitral
valve 12 (e.g., within or on the annulus 18), passively assists in
providing leaflet support without becoming deformed during the
cardiac cycle.
[0085] The substantially annular support member 40 comprises at
least a first intermediate portion 44, a second intermediate
portion 46, and a posterior end portion 48 that extends between the
first and second intermediate portions. As used herein, the term
"substantially annular" can be used to describe an annular support
member 40 having a circular or semi-circular configuration. Thus,
the term "substantially annular" can refer to an annular support
member 40 that is fully annular, fully circular, oval, partially
circular, C-shaped, D-shaped, U-shaped, etc. As used herein, the
term "substantially" can refer to the complete or nearly complete
extent or degree of an action, characteristic, property, state,
structure, item or result. For example, an annular support member
40 that is "substantially" annular would mean that the support
member is either completely annular or nearly completely annular.
The exact allowable degree of deviation from absolute annularity
may in some cases depend on the specific context. Generally
speaking, however, the nearness of annularity will be so as to have
the same overall result as if absolute and total annularity were
obtained.
[0086] As shown in FIGS. 1A-C, the substantially annular support
member 40 can be entirely annular and comprise a first intermediate
portion 44, a second intermediate portion 46, a posterior end
portion 48 extending between the first and second intermediate
portions, and an anterior end portion 50 that extends between the
first and second intermediate portions and is oppositely disposed
from the posterior end portion. Alternatively, as shown in FIGS.
1F-G, the substantially annular support member 40 can be partly
annular and comprise a first intermediate portion 44, a second
intermediate portion 46, and a posterior end portion 48 extending
between the first and second intermediate portions.
[0087] The anterior end portion 50 and the posterior end portion 48
are dimensioned for attachment to the anterior and posterior
portions 20 and 22 of the mitral annulus 18, respectively. For
example, the posterior end portion 48, the first intermediate
portion 44, and the second intermediate portion 46 form a
continuous arc so that the posterior end portion has a concave
shape relative to the anterior end portion 50. Similarly, the
anterior end portion 50, the first intermediate portion 44, and the
second intermediate portion 46 form a continuous arc so that the
anterior end portion has a convex shape relative to the posterior
end portion 48. As shown in FIG. 1D, the substantially annular
support member 40 also includes a longitudinal axis LA. The
substantially annular support member 40 can have a rigid or
semi-rigid configuration.
[0088] The apparatus 10 also includes at least one infra-annular
posterior support member 42 that is securely and directly connected
to the substantially annular support member at a first location 52.
As shown in FIGS. 1A-3B, for example, the apparatus 10 includes
only one infra-annular posterior support member 42. The
infra-annular posterior support member 42 is dimensioned, shaped,
and configured to extend below the posterior mitral leaflet 26 and
across or behind at least one subvalvular structure when the
apparatus 10 is implanted on or about the mitral annulus 18. A
subvalvular structure associated with the mitral valve 12 can
include, but is not limited to: an inferior aspect of the posterior
leaflet 26, such as an inferior free edge 36 of the posterior
leaflet; an inferior aspect of the anterior leaflet 24, such as an
inferior free edge 34 of the anterior leaflet; chordae tendineae 32
associated with the posterior leaflet; chordae tendineae 32'
associated with the anterior leaflet; one or more papillary muscles
38 associated with the tendineae chordae of the posterior leaflet;
one or more papillary muscles 38' associated with the chordae
tendineae of the anterior leaflet; and combinations thereof.
[0089] The infra-annular posterior support member 42 can be shaped,
configured, and dimensioned to extend across or behind an entire
single subvalvular structure, the entirety of two or more
subvalvular structures, a portion of a single subvalvular
structure, or a portion of two or more subvalvular structures. For
example, the infra-annular posterior support member 42 can be
configured to extend below the posterior mitral leaflet 26 and
across or behind a portion of the inferior free edge 36 of the
posterior mitral leaflet or, alternatively, across or behind a
portion of only the inferior free edge of the posterior mitral
leaflet. Additionally, the infra-annular posterior support member
42 can be configured to extend below the posterior mitral leaflet
26 and across or behind the entire chordae tendineae 32 and/or
papillary muscle(s) 38 associated with the posterior mitral leaflet
or, alternatively, a portion of the chordae tendineae of the
posterior mitral leaflet. In either or both of these cases, the
shape of the infra-annular posterior support member 42 mirrors the
3D shape of the posterior mitral leaflet 26, and in particular the
inferior free edge 26 thereof, to prevent or mitigate the
restricted motion of the posterior mitral leaflet and, in turn,
prevent or mitigate regurgitation of blood flow through the mitral
valve 12.
[0090] As shown in FIG. 1D, infra-annular posterior support member
42 extends at an angle A and at a distance D below the longitudinal
axis LA of the substantially annular support member 40. The angle A
of the infra-annular posterior support member 42 is such that the
infra-annular posterior support member facilitates optimal leaflet
coaptation. In one example of the present disclosure, the angle A
can be between about 10.degree. and about 60.degree. (e.g., about
30.degree.). Similarly, the distance D is such that the
infra-annular posterior support member 42 extends below the
posterior mitral leaflet 26 to enable the infra-annular posterior
support member to facilitate optimal leaflet coaptation.
[0091] The infra-annular posterior support member 42 can have a
rigid or semi-rigid configuration. Where the infra-annular
posterior support member 42 has a semi-rigid configuration, for
example, the infra-annular posterior support member can be bendable
or adjustable to various positions. The infra-annular posterior
support member 42 can additionally or optionally include an
adjustment mechanism 54 (FIGS. 1H-K) for selectively adjusting the
position thereof relative to the longitudinal axis LA. As shown in
FIG. 1I, the adjustment mechanism 54 permits the angle A and/or
distance D and/or lateral position LP of the infra-annular
posterior support member 42 to be selectively adjusted prior to,
during, and/or following implantation of the apparatus 10.
[0092] To optimize leaflet coaptation, the angle A and/or distance
D and/or lateral position LP of the infra-annular posterior support
member 42 can be selectively adjusted depending upon the anatomic
leaflet configuration, the subvalvular apparatus configuration
(e.g., the chordae tendineae 32 and 32' and the papillary muscles
38 and 38'), and/or the free-edge leaflet coaptation angle. The
lateral position LP refers to the position of the infra-annular
posterior support member 42 relative to the posterior end portion
48 of substantially annular support member 40 and along an axis
that is parallel (or substantially parallel) to the longitudinal
axis LA. As shown in FIG. 1J, the adjustment mechanism 54 can be
operated to adjust the lateral position LP of the infra-annular
posterior support member 42 into a pre-set position (indicated by
arrow and dashed lines). For example, the apparatus 10 can include
three pre-set positions (indicated by "1", "2" and "3"). It will be
appreciated that the adjustment mechanism 54 can also be operated
to adjust the angle A and/or distance D of the infra-annular
posterior support member 42 into a pre-set position.
[0093] In one example of the present disclosure, the adjustment
mechanism 54 can include an actuation member 56 (FIGS. 1H and 1J),
such as a screw (e.g., a ratchet-like mechanism) that is at least
partially disposed within the substantially annular support member
40 and operably connected to the infra-annular posterior support
member 42. The actuation member 56 can be selectively manipulated
(e.g., turned, pushed, pulled, etc.) to adjust (e.g., increase or
decrease) the angle A and/or the distance D and/or the lateral
position LP of the infra-annular posterior support member 42.
[0094] The actuation member 56 can be selectively manipulated via
an adjustment tool 58 (FIGS. 1I-K). The configuration of the
adjustment tool 58 will depend upon the time at which the position
of the infra-annular posterior support member 42 is in need of
adjustment. Where adjustment is needed during an open-heart
procedure, for example, the adjustment tool 58 can be configured
like a screw driver or other similar device that can be easily
hand-held and manipulated by a surgeon (FIG. 1J). Alternatively,
where adjustment is needed at a time following implantation of the
apparatus 10, the adjustment tool 58 can be configured as a
catheter to allow percutaneous adjustment of the infra-annular
posterior support member 42 (FIGS. 1I and 1K).
[0095] Generally speaking, the actuation member 56 can be
selectively manipulated under direct vision during open-heart
surgery, using a percutaneous transeptal approach (FIG. 1K), using
electromagnetic force (discussed below), and/or by
echocardiographic guidance. For example, the adjustment tool 58 can
be left attached to the actuation member 56 by magnetic force and
externalized through the left atrial wall so that after coming off
cardiopulmonary bypass, the infra-annular posterior support member
42 can be adjusted (e.g., under echocardiographic guidance) by
manipulating the actuation member to achieve the optimal angle of
leaflet coaptation and thereby eliminate mitral and/or tricuspid
valve regurgitation. Thereafter, the magnetic force can be
discontinued and the adjustment tool 58 withdrawn.
[0096] It will be appreciated that the adjustment mechanism 54 can
have other configurations that enable selective adjustment of the
infra-annular posterior support member 42. For example, all or only
a portion of the infra-annular posterior support member 42 can be
made of a shape memory material whose shape (and orientation) can
be adjusted by selective application of energy thereto. If
recurrent mitral and/or tricuspid regurgitation occurs over time,
the adjustment mechanism 54 advantageously permits the position of
the infra-annular posterior support member 42 to be adjusted
without the need for additional open-heart surgeries.
[0097] The infra-annular posterior support member 42 (FIG. 1C)
comprises an engaging portion 60 and an integral neck portion 62
that extends from the engaging portion to the first location 52.
The engaging portion 60 is configured to contact at least one
subvalvular structure, and generally has an elongated S-shaped
configuration. The engaging portion 60 can have a circular
cross-sectional profile, a V-shaped cross-sectional profile, and
elliptical cross-sectional profile, a square-shaped cross-sectional
profile, or any other geometric cross-sectional profile. The
engaging portion 60 can have an arcuate configuration. As shown in
FIG. 1C, for example, the engaging portion 60 can have a convex
shape relative to the posterior end portion 48 of the substantially
annular support member 40.
[0098] The neck portion 62 is integrally formed with the engaging
portion 60. The neck portion 62 is dimensioned to extend between,
or nearly between, a respective one of the commissures of the
mitral valve leaflets 24 and 26. As such, the first location 52 is
typically, but not necessarily, adjacent one of the commissures. As
shown in FIGS. 1B-C, the neck portion 62 includes oppositely
disposed first and second ends 64 and 66 that are integrally formed
with the substantially annular support member 40 (i.e., at the
first location 52) and the engaging portion 60, respectively. For
example, the first end 64 of the neck portion 62 is integrally
formed with the second intermediate portion 46 of the substantially
annular support member 40.
[0099] All or only a portion of the apparatus 10 can be made of a
rigid or semi-rigid material that allows manual deformation, and
yet is rigid enough to withstand further deformation once implanted
(i.e., when subject to normal physiological stresses). Non-limiting
examples of materials for constructing the apparatus 10 can include
biocompatible, medical-grade metals, such as metal alloys,
plastics, Nitinol, stainless steel, titanium, pyrrolitic carbon,
cobalt chromium, and the like.
[0100] All or only a portion of the apparatus 10 can be covered
with a layer 68 of biocompatible material (FIG. 1E). The layer 68
of biocompatible material can comprise a synthetic material, such
as DACRON, woven velour, polyurethane, PTFE, ePTFE, or
heparin-coated fabric. Alternatively, the layer 68 can comprise a
biological material, such as bovine or equine pericardium, a
homograft, patient graft, or a cell-seeded tissue. The layer 68 can
cover the inside surface of the substantially annular support
member 40 and/or the infra-annular posterior support member 42, the
outside surface of the substantially annular support member and/or
the infra-annular posterior support member, or can be wrapped
around both the inside and outside surfaces. As shown in FIG. 1E,
for example, the layer 68 may be attached around the entire
circumference of the substantially annular support member 40. It
should be appreciated that the layer 68 can cover any portion of
the apparatus 10.
[0101] As also shown FIG. 1C, the layer 68 can include at least one
marker 70 to facilitate attachment of the apparatus 10 to the
mitral annulus 18. The marker 70 can comprise a pre-formed hole to
facilitate suture placement and/or a color indicator to indicate
where sutures should be placed to stabilize of the apparatus 10 in
vivo. It should be appreciated that a portion of the apparatus 10
can be enlarged or reinforced at the level of the trigones (not
shown) to facilitate implantation and leaflet coaptation by
including additional biocompatible layers about the desired
portion(s).
[0102] At least a portion of the apparatus 10 can be treated with
one or a combination of therapeutic agents capable of eluting into
a cardiac chamber and/or a cardiac tissue. The therapeutic agent
can be capable of preventing a variety of pathological conditions
including, but not limited to, arrhythmias, thrombosis, stenosis,
apoptosis, and inflammation. Accordingly, the therapeutic agent may
include at least one of an anti-arrhythmic agent, anticoagulant, an
antioxidant, a fibrinolytic, a steroid, an anti-apoptotic agent, an
anti-overgrowth agent (i.e., capable of preventing epithelial cell
overgrowth), and/or an anti-inflammatory agent. Optionally or
additionally, the therapeutic agent may be capable of treating or
preventing other disease or disease processes, such as microbial
infections and heart failure. In these instances, the therapeutic
agent may include an anti-microbial agent (e.g., an antibiotic), an
inotropic agent, a chronotropic agent, and/or a biological agent,
such as a cell or protein.
[0103] Another aspect of the present disclosure is illustrated in
FIGS. 3A-D. The apparatus 10, shown in FIGS. 3A-D is identically
constructed as the apparatus 10 shown in FIGS. 1A-I, except as
described below. In FIGS. 3A-D, structures that are identical as
structures in FIGS. 1A-I use the same reference numbers, whereas
structures that are similar but not identical carry the suffix "a".
It should be appreciated that the apparatus 10, can be constructed
from any of the materials described above, and that the apparatus
can include a layer 68 of biocompatible material and/or a
therapeutic agent(s), as also described above.
[0104] As shown in FIGS. 3A-B, the infra-annular posterior support
member 42.sub.a can have a bifurcated configuration comprising
spaced apart first and second engaging portions 72 and 74. The
first and second engaging portions 72 and 74 can be spaced apart,
and axially offset from one another (relative to a central axis
CA), by a distance D1 (FIG. 3A). Generally, the distance D1 can be
varied depending upon mitral valve anatomy, the particular valvular
insufficiency from which a subject is suffering, as well as other
factors. In particular, the distance D1 can be varied to facilitate
contact between the first and second engaging portions 72 and 74
and one or more subvalvular structures. For example, the distance
D1 can be varied so that the first engaging portion 72 contacts a
portion of the inferior free edge 36 of the posterior mitral
leaflet 26, and the second engaging portion 74 contacts a portion
of the chordae tendineae 32 and/or papillary muscle(s) 38
associated with the posterior mitral leaflet.
[0105] As shown in FIGS. 3C-D, the infra-annular posterior support
member 42 can alternatively have an arcuate, loop-shaped
configuration that includes an aperture 134 extending therethrough.
The engaging portion 60 of the infra-annular posterior support
member 42 can have a concave shape relative to the anterior end
portion 50 of the substantially annular support member 40.
Additionally, the engaging portion 60 of the infra-annular
posterior support member 42 can extend across or behind all or only
a portion of at least one subvalvular structure.
[0106] Another aspect of the present disclosure is illustrated in
FIGS. 4A-E. The apparatus 10.sub.b shown in FIGS. 4A-E is
identically constructed as the apparatus 10 shown in FIGS. 1A-I,
except as described below. In FIGS. 4A-E, structures that are
identical as structures in FIGS. 1A-I use the same reference
numbers, whereas structures that are similar but not identical
carry the suffix "b". It should be appreciated that the apparatus
10.sub.b can be constructed from any of the materials described
above, and that the apparatus can include a layer 68 of
biocompatible material and/or a therapeutic agent(s), as also
described above
[0107] As shown in FIGS. 4A-B, the infra-annular posterior support
member 42.sub.b can have a bifurcated configuration comprising
spaced apart first and second engaging portions 72 and 74. The
first and second engaging portions 72 and 74 can be spaced apart,
and radially offset from one another (relative to a central axis
CA), by a distance D2. Generally, the distance D2 can be varied
depending upon mitral valve anatomy, the particular valvular
insufficiency from which a subject is suffering, as well as other
factors. In particular, the distance D2 can be varied to facilitate
contact between the first and second engaging portions 72 and 74
and one or more subvalvular structures. For example, the distance
D2 can be varied so that the first engaging portion 72 contacts a
portion of the inferior free edge 34 of the anterior mitral leaflet
24 and/or the chordae tendineae 32' (and/or papillary muscle(s)
38') associated with the anterior mitral leaflet, and the second
engaging portion 74 contacts a portion of the inferior free edge 36
of the posterior mitral leaflet 26 and/or chordae tendineae 32
(and/or papillary muscle(s) 38') associated with the posterior
mitral leaflet. As shown in FIGS. 4C-E and described in more detail
below, two levels of cardiac remodeling can occur when the
apparatus 10.sub.b is securely implanted.
[0108] Another aspect of the present disclosure is illustrated in
FIGS. 5A-B. The apparatus 10.sub.c shown in FIGS. 5A-B is
identically constructed as the apparatus 10 shown in FIGS. 1A-B,
except as described below. In FIGS. 5A-B, structures that are
identical as structures in FIGS. 1A-B use the same reference
numbers, whereas structures that are similar but not identical
carry the suffix "c". It should be appreciated that the apparatus
10.sub.c can be constructed from any of the materials described
above, and that the apparatus can include a layer 68 of
biocompatible material and/or a therapeutic agent(s), as also
described above.
[0109] The apparatus includes a Y-shaped or fork-shaped
infra-annular support member 76 comprising an infra-annular
anterior support portion 78 that is oppositely disposed from an
infra-annular posterior support portion 80. The infra-annular
anterior support portion 78 and the infra-annular posterior support
portion 80 are integrally connected at a first location 52 of the
substantially annular support 40 member via a common neck portion
82. The first location 52 can be on either the first or second
intermediate portions 44 and 46 and located adjacent a mitral
commissure.
[0110] As shown in FIG. 5A, each of the infra-annular anterior
support portion 78 and the infra-annular posterior support portion
80 comprises spaced apart first and second engaging portions 72 and
74. The first and second engaging portions 72 and 74 can be spaced
apart, and axially offset from one another (relative to a central
axis CA), by a distance D1. Alternatively, each of the
infra-annular anterior support portion 78 and the infra-annular
posterior support portion 80 can have an elongated, loop-shaped
configuration (FIG. 5B). The infra-annular anterior support portion
78 is radially spaced apart from the infra-annular posterior
support portion 80 by a distance D2. It will be appreciated that
the distance D1 and/or distance D2 can be varied to optimize
leaflet coaptation.
[0111] Another aspect of the present disclosure is illustrated in
FIGS. 6A-C. The apparatus 10.sub.d shown in FIGS. 6A-C is
identically constructed as the apparatus 10 shown in FIGS. 1A-I,
except as described below. In FIGS. 6A-C, structures that are
identical as structures in FIGS. 1A-I use the same reference
numbers, whereas structures that are similar but not identical
carry the suffix "d". It should be appreciated that the apparatus
10.sub.d can be constructed from any of the materials described
above, and that the apparatus can include a layer 68 of
biocompatible material and/or a therapeutic agent(s), as also
described above.
[0112] As shown in FIGS. 6A-C, the apparatus 10.sub.d comprises a
substantially annular support member 40 and an infra-annular
posterior and anterior support member 180 that is securely
connected thereto. The substantially annular support member 40 can
be entirely annular and comprise a first intermediate portion 44, a
second intermediate portion 46, a posterior end portion 48
extending between the first and second intermediate portions, and
an anterior end portion 50 extending between the first and second
intermediate portions opposite the posterior end portion.
Alternatively, the substantially annular support member 40 can be
partly annular and comprise a first intermediate portion 44, a
second intermediate portion 46, and a posterior end portion 48
extending between the first and second intermediate portions.
[0113] The anterior end portion 50 and the posterior end portion 48
are dimensioned for attachment to the anterior and posterior
portions 20 and 22 of the mitral annulus 18, respectively. For
example, the posterior end portion 48, the first intermediate
portion 44, and the second intermediate portion 46 form a
continuous arc so that the posterior end portion has a concave
shape relative to the anterior end portion 50. Similarly, the
anterior end portion 50, the first intermediate portion 44, and the
second intermediate portion 46 form a continuous arc so that the
anterior end portion has a convex shape relative to the posterior
end portion 48. Like the apparatus 10 shown in FIG. 1D, the
substantially annular support member 40 of the apparatus 10.sub.d
also includes a longitudinal axis LA. The substantially annular
support member 40 can have a rigid or semi-rigid configuration.
[0114] The infra-annular posterior and anterior support member 180
is dimensioned, shaped, and configured to extend below the
posterior and anterior mitral leaflets 26 and 24 and across or
behind at least one subvalvular structure when the apparatus
10.sub.d is implanted on or about the mitral annulus 18. The
infra-annular posterior and anterior support member 180 is securely
and directly connected to the substantially annular support member
40 at a first location 52. As shown in FIG. 6A, for example, the
infra-annular posterior and anterior support member 180 is securely
and directly connected to the second intermediate portion 46.
Although not shown, it will be appreciated that the infra-annular
posterior and anterior support member 180 can alternatively be
securely and directly connected to the first intermediate portion
44.
[0115] The infra-annular posterior and anterior support member 180
comprises a hook-shaped engaging portion 182 that is integrally and
directly connected to the substantially annular support member 40
via a neck portion 62. The engaging portion 182 further comprises a
first engaging portion 184, a second engaging portion 186, and a
bend portion 188 extending between the first and second engaging
portions. Each of the first and second engaging portions 184 and
186 has a continuous, arc-shaped (or arcuate) configuration
configured to extend across or behind at least one subvalvular
structure. The first and second engaging portions 184 and 186 can
have concave and convex shapes (respectively) relative to the
anterior end portion 50 of the substantially annular support member
40.
[0116] The first engaging portion 184 is configured to extend
across or behind at least one subvalvular structure, such as: an
inferior aspect of the posterior leaflet 26, such as an inferior
free edge 36 of the posterior leaflet; chordae tendineae 32
associated with the posterior leaflet; one or more papillary
muscles 38 associated with the tendineae chordae of the posterior
leaflet; and combinations thereof. Additionally, the second
engaging portion 186 is configured to extend across or behind at
least one subvalvular structure, such as: an inferior aspect of the
anterior leaflet 24, such as an inferior free edge 34 of the
anterior leaflet; chordae tendineae 32' associated with the
anterior leaflet; one or more papillary muscles 38' associated with
the chordae tendineae of the anterior leaflet; and combinations
thereof.
[0117] The first and second engaging portions 184 and 186 can be
located in the same lateral plane (i.e., a plane that extends below
and parallel or substantially parallel to the longitudinal axis LA)
or, alternatively, offset from one another relative to a central
axis CA. In this manner, the first and second engaging portions 184
and 186 can be positioned to contact the same or different
corresponding subvalvular structures. Where the first and second
engaging portions 184 and 186 are offset from one another, for
example, the first engaging portion can be configured to extend
across or behind an inferior aspect of the posterior leaflet 26
(e.g., an inferior free edge 36 of the posterior leaflet), and the
second engaging portion can be configured to extend across or
behind chordae tendineae 32' associated with the anterior leaflet
24.
[0118] Alternative configurations of the infra-annular posterior
and inferior support member 180 are illustrated in FIGS. 6B-C. As
shown in FIG. 6B, the engaging portion 182 of the infra-annular
posterior and anterior support member 180 can have a bifurcated
configuration comprising spaced apart first and second engaging
members 190 and 192. The first and second engaging members 190 and
192 can be spaced apart, and axially offset from one another
(relative to a central axis CA), by a distance D1. Generally, the
distance D1 can be varied depending upon mitral valve anatomy, the
particular valvular insufficiency from which a subject is
suffering, as well as other factors. In particular, the distance D1
can be varied to facilitate contact between the first and second
engaging members 190 and 192 and one or more subvalvular
structures. Each of the first and second engaging members 190 and
192 includes first and second engaging portions 184 and 186, as
described above.
[0119] As shown in FIG. 6C, the engaging portion 182 of the
infra-annular posterior and anterior support member 180 can
alternatively have an arcuate, loop-shaped configuration that
includes an aperture 134 extending therethrough. The loop-shaped
engaging portion 182 can comprise first and second engaging members
190 and 192 that join at a common arcuate bend 194. The first and
second engaging members 190 and 192 can be spaced apart, and
axially offset from one another (relative to a central axis CA), by
a distance D1. Generally, the distance D1 can be varied depending
upon mitral valve anatomy, the particular valvular insufficiency
from which a subject is suffering, as well as other factors.
[0120] It will be appreciated that the apparatus 10.sub.d can
additionally or optionally include other features as the apparatus
10 shown in FIGS. 1A-B and described above. For example, the
apparatus 10.sub.d can include: an adjustable mechanism 54; a layer
68 of biocompatible material; at least one marker 70 to facilitate
attachment of the apparatus to the mitral annulus 18; and/or one or
a combination of therapeutic agents.
[0121] Another aspect of the present disclosure is illustrated in
FIGS. 7A-C. The apparatus 10.sub.e shown in FIGS. 7A-C is
identically constructed as the apparatus 10 shown in FIGS. 1A-I,
except as described below. In FIGS. 7A-C, structures that are
identical as structures in FIGS. 1A-I use the same reference
numbers, whereas structures that are similar but not identical
carry the suffix "e". It should be appreciated that the apparatus
10.sub.e can be constructed from any of the materials described
above, and that the apparatus can include a layer 68 of
biocompatible material and/or a therapeutic agent(s), as also
described above.
[0122] As shown in FIGS. 7A-C, the apparatus 10.sub.e comprises a
substantially annular support member 40, a first infra-annular
posterior support member 42', and a second infra-annular posterior
support member 42''. The substantially annular support member 40
can be entirely annular and comprise a first intermediate portion
44, a second intermediate portion 46, a posterior end portion 48
extending between the first and second intermediate portions, and
an anterior end portion 50 extending between the first and second
intermediate portions opposite the posterior end portion.
Alternatively, the substantially annular support member 40 can be
partly annular and comprise a first intermediate portion 44, a
second intermediate portion 46, and a posterior end portion 48
extending between the first and second intermediate portions.
[0123] The anterior end portion 50 and the posterior end portion 48
are dimensioned for attachment to the anterior and posterior
portions 20 and 22 of the mitral annulus 18, respectively. For
example, the posterior end portion 48, the first intermediate
portion 44, and the second intermediate portion 46 form a
continuous arc so that the posterior end portion has a concave
shape relative to the anterior end portion 50. Similarly, the
anterior end portion 50, the first intermediate portion 44, and the
second intermediate portion 46 form a continuous arc so that the
anterior end portion has a convex shape relative to the posterior
end portion 48. As shown in FIG. 7C, the substantially annular
support member 40 also includes a longitudinal axis LA. The
substantially annular support member 40 can have a rigid or
semi-rigid configuration.
[0124] The first and second infra-annular posterior support members
42' and 42'' are dimensioned, shaped, and configured to extend
below the posterior mitral leaflet 26 and across or behind at least
one subvalvular structure when the apparatus 10.sub.e is implanted
on or about the mitral annulus 18. The first infra-annular
posterior support member 42' is securely and directly connected to
the substantially annular support member 40 at a first location 52,
and the second infra-annular posterior support member 42'' is
securely and directly connected to the substantially annular
support member at a second location 84 that is different than the
first location. As shown in FIG. 7A, for example, the first
infra-annular posterior support member 42' is securely and directly
connected to the first intermediate portion 44, and the second
infra-annular posterior support member 42'' is securely and
directly connected to the second intermediate portion 46.
[0125] Each of the first and second infra-annular posterior support
members 42' and 42'' extends at an angle A1 and A2 (FIG. 7C),
respectively, and at a distance D3 and D4 below the longitudinal
axis LA of the substantially annular support member 40. The angle
A1 and A2 of each of the first and second infra-annular posterior
support members 42' and 42'', respectively, is such that the first
and second infra-annular posterior support members facilitate
optimal leaflet coaptation. In one example of the present
disclosure, the angle A1 and A2 of one or both of the first and
second infra-annular posterior support members 42' and 42'' can be
about 10.degree. to about 60.degree. (e.g., about 30.degree.). It
will be appreciated that the angle A1 and A2 can be the same or
different. Similarly, the distance D3 and D4 is such that a portion
of each of the first and second infra-annular posterior support
members 42' and 42'', respectively, extends below the posterior
mitral leaflet 26 to enable the first and second infra-annular
first and second posterior support members to facilitate optimal
leaflet coaptation. It will also be appreciated that the distance
D3 and D4 can be the same or different.
[0126] Each of the first and second infra-annular posterior support
members 42' and 42'' is configured similarly or identically as the
infra-annular posterior support member 42 shown in FIGS. 1A-B and
described above. For example, each of the first and second
infra-annular posterior support members 42' and 42'' comprises an
engaging portion 60 (FIG. 7A) and an integral neck portion 62 that
extends from the engaging portion to the first location 52. The
engaging portion 60 of each of the first and second infra-annular
posterior support members 42' and 42'' can have an arcuate shape
such that each of the engaging portions has a concave shape
relative to the anterior end portion 50 of the substantially
annular support member 40.
[0127] It will be appreciated that the apparatus 10.sub.e can
additionally or optionally include other features as the apparatus
10 shown in FIGS. 1A-B and described above. For example, the
apparatus 10.sub.e can include: an adjustable mechanism 54; a layer
68 of biocompatible material; at least one marker 70 to facilitate
attachment of the apparatus to the mitral annulus 18; and/or one or
a combination of therapeutic agents.
[0128] Another aspect of the present disclosure is illustrated in
FIGS. 8A-9C and includes a method for treating regurgitation of
blood flow through a regurgitant mitral valve 12. Although the
method of the present disclosure will be described below using the
apparatus 10.sub.e illustrated in FIGS. 7A-B, it should be
appreciated that any of the apparatus described herein may also be
used to treat regurgitation of blood flow through a diseased mitral
valve. For example, the apparatus 10.sub.f shown in FIGS. 13A-B may
be used to treat a dysfunctional (e.g., restricted motion) anterior
mitral valve leaflet 24.
[0129] As described above, the apparatus 10.sub.e (FIGS. 7A-B)
comprises a D-shaped annular support member 40 having a
saddle-shaped, 3D configuration dimensioned for attachment to the
mitral annulus 18. The apparatus 10.sub.e additionally includes
oppositely disposed first and second infra-annular posterior
support members 42' and 42'' that are integrally formed with the
first and second intermediate portions 44 and 46 of the
substantially annular support member 40, respectively. Although not
shown in FIGS. 7A-B, it will be appreciated that all or only a
portion of the apparatus 10.sub.e (e.g., the substantially annular
support member 40) can be covered with a layer 68 of biocompatible
material, such as a sewing ring.
[0130] To treat the regurgitant mitral valve 12, the dimensions of
the mitral valve are first obtained to determine optimal dimensions
for the apparatus 10.sub.e. Sizing of the mitral valve 12 can be
performed using a valve sizing device. Examples of valve sizing
devices are known in the art and can include commercially-available
sizers, such as those from the ATS OPEN PIVOT STANDARD SIZER series
(ATS Medical, Inc. Minneapolis, Minn.). In one example of the
present disclosure, the dimensions of the mitral valve 12 can be
determined using the valve sizing device 86 disclosed in U.S.
Patent Publication No. 2009/0132036 A1 to Navia (hereinafter, "the
'036 application"), which is hereby incorporated by reference in
its entirety.
[0131] As shown in FIGS. 8A-C, the sizing device 86 comprises a
handle member 88 securely attached to a sizing member 90. The
handle member 88 includes a handle 92 fluidly connected to a distal
attachment portion 94. The handle 92 is for guiding the sizing
device 86, and the distal attachment portion 94 is for connecting
the handle to the sizing member 90. Referring to FIGS. 8B-C, the
sizing member 90 includes an annular support member 96 having an
anterior end portion 98, a posterior end portion 100, and first and
second oppositely disposed intermediate portions 102 and 104
extending between the anterior and posterior end portions. The
annular support member 96 has a planar configuration (FIG. 8B) can
have a 3D or saddle-shaped configuration.
[0132] The sizing member 90 defines a longitudinal axis 106 (FIG.
8B) and includes a bracing portion 108 having an attachment
mechanism 110, such as an aperture for mating to the distal
attachment portion 94 of the handle member 88. As shown in FIG. 8B,
the bracing portion 108 extends above the longitudinal axis 106 of
the annular support member 96. The sizing member 90 further
includes an infra-annular support member 112 for supporting a heart
valve leaflet (e.g., an inferior aspect of a posterior leaflet 26,
such as an inferior free edge 36) and subvalvular apparatus (e.g.,
chordae tendineae 32 and 32' and/or papillary muscle(s) 38 and
38'). As shown in FIG. 8B, the infra-annular support member 112
extends below the longitudinal axis 106 of the annular support
member 96. In one example of the present disclosure, the
infra-annular support member 112 can be dimensioned to extend below
the posterior mitral leaflet 26 and engage at least one subvalvular
structure.
[0133] To determine the dimensions of the mitral valve 12 using the
sizing device 86, access to the mitral valve is gained via an
open-chest surgical procedure. During the procedure, the mitral
valve 12 is visualized so that the sizing device 86, and in
particular the sizing member 90, can be positioned about a superior
aspect of the mitral valve 12. Using the handle 92 to guide the
sizing member 90 into the left atrium 14, the sizing device 86 is
positioned about the mitral valve 12 so that the annular support
member 96 contacts the mitral valve annulus 18 and the
infra-annular support member 112 contacts or engages at least one
subvalvular structure from behind.
[0134] Next, blood flow through the mitral valve 12 is monitored to
assess coaptation between the anterior and posterior mitral
leaflets 24 and 26. Differently dimensioned sizing members 90 can
be placed over the mitral valve 12 until substantially normal
coaptation of the mitral valve is observed. "Normal blood flow" can
refer to the movement of blood through a mammalian valve or
vasculature that is unimpeded and progresses under
physiologically-normal pressures and at a physiologically-normal
rate. When substantially normal blood flow is observed through the
mitral valve 12, the dimensions of the sizing member 90 are noted
and an apparatus 10, having dimensions that correspond to the
dimensions of the sizing member is selected for implantation. It
should be appreciated that a saline solution test may additionally
or alternatively be used to assess proper leaflet coaptation and
blood flow through the mitral valve 12.
[0135] After selecting an appropriately-dimensioned apparatus
10.sub.e, the apparatus is attached to a delivery device 114 or
holder (FIGS. 8D-E), such as the one disclosed in the '036
application. As shown in FIGS. 8D-E, the delivery device 114 or
holder comprises a ring-shaped support member 116 having an
anterior end portion 118, a posterior end portion 120, and
oppositely disposed first and second intermediate portions 122 and
124 extending between the anterior and posterior end portions. The
delivery device 114 or holder includes an attachment mechanism 126,
such as an aperture for connecting to the distal attachment portion
94 of the sizing device 86 (or similar to that). The ring-shaped
support member 116 has a C-shaped cross-section that defines a
channel 128 (FIG. 8E). The channel 128 extends around the periphery
of the ring-shaped support member 116 and includes a plurality of
extensions 130 to facilitate attachment of the apparatus 10.sub.e
to the delivery device 114 or holder. The delivery device 114 or
holder also includes a plurality of suture attachment points 132
through which sutures can be threaded to attach the apparatus
10.sub.e to the delivery device or holder. The apparatus 10, can be
released by cutting sutures over different points 132.
[0136] To begin the implant procedure of the apparatus 10.sub.e, a
silicone tube (not shown) is passed through at least one commissure
of the mitral valve 12 and placed behind at least one subvalvular
structure, such as the chordae tendineae 32 and 32' and/or
papillary muscle(s) 38 and 38' associated with the posterior mitral
leaflet 26. Once the apparatus 10.sub.e is securely attached to the
delivery device 114, sutures (not shown) are placed in the mitral
annulus 18. The delivery device 114 is then positioned about the
superior aspect of the mitral valve 12. Next, the sutures are
passed through the marker(s) 70 (e.g., holes), while the delivery
device engages the mitral valve 12 and the substantially annular
support member 40 of the apparatus 10.sub.e is advanced toward the
mitral annulus 18. Next, the silicone tube is manipulated so that
an open end of the tube engages a distal end of at least one of the
first and second infra-annular posterior support members 42' and
42''. The tube is then gently pulled from its non-engaged end,
which causes the first and second infra-annular posterior support
members 42' and 42'' to move through the commissures and engage at
least one subvalvular structure from behind. The tube is then
disengaged, followed by removal of the handle portion 88 and
tightening of the sutures so that the apparatus 10.sub.e is
securely positioned about the mitral valve 12. After tightening of
the sutures is complete, the sutures are cut so that the delivery
device 114 or holder is detached from the apparatus 10.sub.e and
removed from the left atrium 14.
[0137] With the apparatus 10.sub.e securely in place (FIGS. 9A-C),
two levels of cardiac remodeling can simultaneously occur. At the
sub-annular level, the first and second infra-annular posterior
support members 42' and 42'' support at least one subvalvular
structure (e.g., the inferior free edge 36 of the posterior mitral
leaflet 26, the chordae tendineae 32 and 32' associated with the
posterior leaflet, and/or papillary muscle(s) 38 and 38' associated
with posterior leaflet) during systole by moving forward the
subvalvular structure(s), which reduces the restrictive motion of
the posterior mitral leaflet and prevents or mitigates
regurgitation of blood through the mitral valve 12. Furthermore,
left ventricle remodeling caused by ischemic and dilated
cardiomyopathy is prevented or mitigated by pushing (or moving)
forward (or medially) the posterior left ventricular wall (i.e., a
reverse remodeling mechanism). Simultaneously, at the annular
level, a portion of the posterior left ventricular wall is pushed
forward to prevent or mitigate not only ventricular remodeling
caused by dilated and ischemic cardiomyopathy, but also the
incidence of recurrent mitral regurgitation over time. Also at the
annular level, the 3D saddle-shaped geometry of the apparatus
10.sub.e remodels the mitral annulus 18 and reduces the annular
diameter to improve leaflet coaptation. Upon proper implantation of
the apparatus 10.sub.e, the procedure can be completed so that
normal blood flow can resume through the mitral valve 12.
[0138] FIGS. 10A-12C illustrate other geometric variations of the
apparatus 10 shown in FIGS. 1A-D. As shown in FIG. 10A, for
example, the engaging portion 60 of each of the first and second
infra-annular posterior support members 42' and 42'' can
alternatively have a fork-like configuration. In particular, each
of the engaging portions 60 can include oppositely disposed first
and second engaging portions 72 and 74 that are spaced apart, and
axially offset from each other (relative to a central axis CA), by
a distance D1. The distance D1 can be the same or different between
the first and second infra-annular posterior support members 42'
and 42'', depending upon the anatomy of the subject's mitral valve
12, the particular valvular insufficiency from which the subject is
suffering, as well as other factors. Each of the first and second
engaging portions 72 and 74 can have a concave shape relative to
the anterior end portion 50 of the substantially annular support
member 40. Additionally, each of the first and second engaging
portions 72 and 74 can extend across or behind all or only a
portion of at least one subvalvular structure (FIG. 10B).
[0139] As shown in FIGS. 11A-B, each of the first and second
infra-annular posterior support members 42' and 42'' can
alternatively have an arcuate, loop-shaped configuration that
includes an aperture 134 extending therethrough. The engaging
portion 60 of each of the first and second infra-annular posterior
support members 42' and 42'' can have a concave shape relative to
the anterior end portion 50 of the substantially annular support
member 40. Additionally, the engaging portion 60 of each of the
first and second infra-annular posterior support members 42' and
42'' can extend across or behind all or only a portion of at least
one subvalvular structure (FIG. 11B).
[0140] As shown in FIGS. 12A-C, each of the first and second
infra-annular posterior support members 42' and 42'' can be
configured in a similar fashion as the first and second
infra-annular posterior support members illustrated in FIGS. 7A-B.
As shown in FIG. 12B, however, the first infra-annular posterior
support member 42' is dimensioned to extend a first distance D',
which is less than a second distance D'' that corresponds to the
second infra-annular posterior support member 42''. In other words,
the first distance D' is less than the second distance D'' so that
the first and second infra-annular posterior support members 42'
and 42'' are axially offset from one other relative to a central
axis CA (FIG. 12A).
[0141] As can additionally be seen in FIG. 12A, a length L1 of the
first infra-annular posterior support member 42' is dimensioned to
overlap with a corresponding length L2 of the second infra-annular
posterior support member 42''. The engaging portion 60 of each of
the first and second infra-annular posterior support members 42'
and 42'' can have a concave shape relative to the anterior end
portion 50 of the substantially annular support member 40.
Additionally, the engaging portion 60 of each of the first and
second infra-annular posterior support members 42' and 42'' can
extend across or behind all or only a portion of at least one
subvalvular structure (FIG. 12C).
[0142] Another aspect of the present disclosure is illustrated in
FIGS. 13A-B. The apparatus 10.sub.f shown in FIGS. 13A-B is
identically constructed as the apparatus 10.sub.e shown in FIGS.
7A-B, except as described below. In FIGS. 13A-B, structures that
are identical as structures in FIGS. 7A-B use the same reference
numbers, whereas structures that are similar but not identical
carry the suffix "f". It should be appreciated that the apparatus
10.sub.f can be constructed from any of the materials described
above, and that the apparatus can include a layer 68 of
biocompatible material and/or a therapeutic agent(s), as also
described above.
[0143] As shown in FIGS. 13A-B, the apparatus 10.sub.f comprises a
substantially annular support member 40, a first infra-annular
anterior support member 136, and a second infra-annular anterior
support member 138. The substantially annular support member 40 can
be entirely annular and comprise a first intermediate portion 44, a
second intermediate portion 46, a posterior end portion 48
extending between the first and second intermediate portions, and
an anterior end portion 50 extending between the first and second
intermediate portions and oppositely disposed from the posterior
end portion. Alternatively, the substantially annular support
member 40 can be partly annular and comprise a first intermediate
portion 44, a second intermediate portion 46, and a posterior end
portion 48 extending between the first and second intermediate
portions.
[0144] The anterior end portion 50 (FIGS. 13A-B) and the posterior
end portion 48 are dimensioned for attachment to the anterior and
posterior portions 20 and 22 of the mitral annulus 18,
respectively. For example, the posterior end portion 48, the first
intermediate portion 44, and the second intermediate portion 46
form a continuous arc so that the posterior end portion has a
concave shape relative to the anterior end portion 50. Similarly,
the anterior end portion 50, the first intermediate portion 44, and
the second intermediate portion 46 form a continuous arc so that
the anterior end portion has a convex shape relative to the
posterior end portion 48. As shown in FIG. 13B, the substantially
annular support member 40 also includes a longitudinal axis LA. The
substantially annular support member 40 can have a rigid or
semi-rigid configuration.
[0145] The first and second infra-annular anterior support members
136 and 138 are dimensioned, shaped, and configured to extend below
the anterior mitral leaflet 24 and across or behind at least one
subvalvular structure when the apparatus 10.sub.f is implanted on
or about the mitral annulus 18. The first infra-annular anterior
support member 136 is securely and directly connected to the
substantially annular support member 40 at a first location 52, and
the second infra-annular anterior support member 138 is securely
and directly connected to the substantially annular support member
at a second location 84 that is different than the first location.
As shown in FIG. 13A, for example, the first infra-annular anterior
support member 136 is securely and directly connected to the first
intermediate portion 44, and the second infra-annular anterior
support member 138 is securely and directly connected to the second
intermediate portion 46.
[0146] As shown in FIG. 13B, each of the first and second
infra-annular anterior support members 136 and 138 extends at an
angle A1 and A2 and at a distance D3 and D4, respectively, below
the longitudinal axis LA of the substantially annular support
member 40. The angle A1 and A2 of each of the first and second
infra-annular anterior support members 136 and 138, respectively,
is such that the first and second infra-annular anterior support
members facilitate optimal leaflet coaptation. In one example of
the present disclosure, the angle A1 and A2 of one or both of the
first and second infra-annular anterior support members 136 and
138, respectively, can be about 20.degree. to about 40.degree.
(e.g., about 30.degree.). It will be appreciated that the angle A1
and A2 can be the same or different. Similarly, the distance D3 and
D4 is such that a portion of each of the first and second
infra-annular anterior support members 136 and 138, respectively,
extends below the anterior mitral leaflet 24 to enable the first
and second infra-annular first and second anterior support members
to facilitate optimal leaflet coaptation. It will also be
appreciated that the distance D3 and D4 can be the same or
different.
[0147] Each of the first and second infra-annular anterior support
members 136 and 138 is configured similarly as the infra-annular
posterior support member 42 shown in FIGS. 1A-B and described
above. For example, each of the first and second infra-annular
anterior support members 136 and 138 (FIG. 13A) comprises an
engaging portion 140 and an integral neck portion 142 that extends
from the engaging portion to the first location 52. The engaging
portion 140 of each of the first and second infra-annular anterior
support members 136 and 138 can have an arcuate shape (e.g.,
convex) relative to the anterior end portion 50 of the
substantially annular support member 40.
[0148] It will be appreciated that the apparatus 10.sub.f can
additionally or optionally include other features as the apparatus
10.sub.e shown in FIGS. 7A-B and described above. For example, the
apparatus 10.sub.f can include: an adjustable mechanism 54; a layer
68 of biocompatible material; at least one marker 70 to facilitate
attachment of the apparatus to the mitral annulus 18; and/or one or
a combination of therapeutic agents.
[0149] Another aspect of the present disclosure is illustrated in
FIGS. 14A-C. The apparatus 10.sub.g shown in FIGS. 14A-C is
identically constructed as the apparatus 10 and 10.sub.f shown in
FIGS. 1A-E and FIGS. 13A-B, respectively, except as described
below. In FIGS. 14A-C, structures that are identical as structures
in FIGS. 1A-E and FIGS. 13A-B use the same reference numbers,
whereas structures that are similar but not identical carry the
suffix "g". It should be appreciated that the apparatus 10.sub.g
can be constructed from any of the materials described above, and
that the apparatus can include a layer 68 of biocompatible material
and/or a therapeutic agent(s), as also described above.
[0150] As shown in FIG. 15, the tricuspid valve 144 is located
between the right atrium 146 and the right ventricle 148. The
tricuspid valve 144 is made up of the three valve leaflets
(discussed below), the annulus 150, the supporting chordae
tendineae (generally indicated at 152), and the papillary muscles
(generally indicated at 154). The tricuspid valve 144 itself is
slightly inclined to the vertical so that the margins of the valve
are anterosuperior, inferior, and septal, and the leaflets take
their name from these attachment sites. The anterosuperior leaflet
156 is the largest leaflet and is interposed between the
atrioventricular orifice (not shown) and the conus arteriosus (not
shown). The posterior leaflet 158 is the next largest leaflet and
is named for its relative posterior position and relationship to
the margin of the right ventricle 148. The third and smallest
leaflet, the septal leaflet 160, is attached to the right and left
fibrous trigones (not shown) and the atrial and ventricular septa.
The tricuspid subvalvular apparatus consists of anterior,
posterior, and septal papillary muscles 154 and their true chordae
tendineae 152. False chordae (not shown) can connect two papillary
muscles 154, connect a papillary muscle to the ventricular wall, or
connect points on the ventricular walls. The true chordae 152
typically originate from the apical third of the papillary muscle
154 but can originate from the ventricular walls, as is the case
for the septal leaflet 160.
[0151] Referring again to FIGS. 14A-C, the apparatus 10.sub.g can
comprise a substantially annular support member 40.sub.g and at
least one infra-annular anterior support member 162 securely
connected thereto. The substantially annular support member
40.sub.g can have a 3D shape that corresponds to the 3D shape of
the tricuspid annulus 150 (FIG. 15). The substantially annular
support member 40.sub.g can define a longitudinal axis LA (FIG.
14C) and include an anterior end portion 50.sub.g, a posterior end
portion 48.sub.g, and oppositely disposed first and second
intermediate portions 44.sub.g and 46.sub.g extending between the
anterior and posterior end portions. The anterior end portion
50.sub.g and the posterior end portion 48.sub.g are dimensioned for
attachment to anterior and posterior portions of the tricuspid
annulus 150 (FIG. 15), respectively. Although the substantially
annular support member 40.sub.g (FIGS. 14A-C) is shown as having a
C-shaped or partial ring configuration, it will be appreciated that
the substantially annular support member can have other
configurations, such a completely annular ring configuration.
[0152] As shown in FIGS. 14A-C, the apparatus 10.sub.g includes an
infra-annular anterior support member 162. It will be appreciated,
however, that the apparatus 10.sub.g can include more than one
infra-annular anterior support member 162 (FIGS. 14D-E) and/or one
or more infra-annular support members for supporting the septal
leaflet 160 (FIGS. 17A-E) and/or posterior tricuspid leaflet 158.
The infra-annular anterior support member 162 is dimensioned to
extend below the anterosuperior leaflet 156 and across or behind
all or only a portion of at least one subvalvular structure. The
infra-annular anterior support member 162 illustrated in FIGS.
14A-C can be dimensioned to extend across or behind the entire
inferior free edge (not shown) of the anterosuperior tricuspid
leaflet 156, only a portion of the inferior free edge of the
anterosuperior tricuspid leaflet, all or only a portion of the
chordae tendineae 152 associated with the anterosuperior tricuspid
leaflet, and/or all or only a portion of a papillary muscle 154
associated with the anterosuperior tricuspid leaflet.
[0153] It will be appreciated that the infra-annular anterior
support member 162 can be shaped, configured, and dimensioned to
extend across or behind other subvalvular structures, such as: the
entire inferior free edge (not shown) of the septal tricuspid
leaflet 160; only a portion of the inferior free edge of the septal
tricuspid leaflet; all or only a portion of the chordae tendineae
152 associated with the septal tricuspid leaflet; all or only a
portion of a papillary muscle 154 associated with the septal
tricuspid leaflet; the entire inferior free edge (not shown) of the
posterior tricuspid leaflet 158; only a portion of the inferior
free edge of the posterior tricuspid leaflet; all or only a portion
of the chordae tendineae associated with the posterior tricuspid
leaflet; and/or all or only a portion of a papillary muscle
associated with the posterior tricuspid leaflet.
[0154] The infra-annular anterior support member 162 can have a
rigid or semi-rigid configuration. Where the infra-annular anterior
support member 162 has a semi-rigid configuration, for example, the
first infra-annular anterior support member can be bendable or
adjustable to various positions. The infra-annular anterior support
member 162 can additionally or optionally include an adjustment
mechanism 54 (as described above) for selectively adjusting the
position thereof relative to the longitudinal axis LA of the
substantially annular support member 40.sub.g.
[0155] As shown in FIG. 14C, the infra-annular anterior support
member 162 extends at an angle A3 and at a distance D5 below the
longitudinal axis LA of the substantially annular support member
40.sub.f. The angle A3 of the infra-annular anterior support member
162 is such that the first infra-annular anterior support member
facilitates optimal leaflet coaptation. In one example of the
present disclosure, the angle A3 of the infra-annular anterior
support member 162 can be about 20.degree. to about 40.degree.
(e.g., about 30.degree.). Similarly, the distance D5 is such that a
portion of the infra-annular anterior support member 162 extends
below the anterosuperior tricuspid leaflet 156 to facilitate
optimal leaflet coaptation.
[0156] The infra-annular anterior support member 162 has an
elongated, substantially U-shaped configuration and includes a neck
portion 164 (FIG. 14A) that is integrally formed with an engaging
portion 166. The neck portion 164 is dimensioned to extend between,
or nearly between, a respective one of the commissures of the
tricuspid valve leaflets 156, 158 and 160. As shown in FIGS. 14A-B,
the neck portion 164 includes oppositely disposed first and second
ends 168 and 170 that are integrally formed with the substantially
annular support member 40.sub.g and the engaging portion 166,
respectively. For example, the first end 168 of the neck portion
164 can be integrally formed with the first intermediate portion
44.sub.g of the substantially annular support member 40.sub.f.
[0157] The engaging portion 166 of the infra-annular anterior
support member 162 has a concave shape relative to the posterior
end portion 48.sub.g of the substantially annular support member
40.sub.g. All or only a portion of the engaging portion 166 is
dimensioned to contact all or only a portion of a subvalvular
structure upon implantation. It will be appreciated that the
infra-annular anterior support member 162 can have any one or
combination of the configurations shown in FIGS. 4A-B, 5-6, 14D-E
and 17D-E; provided, of course, that the engaging portion 166 has a
concave shape relative to either the anterior end portion 50.sub.g
or the posterior end portion 48.sub.g of the substantially annular
support member 40.sub.g.
[0158] Another aspect of the present disclosure is illustrated in
FIGS. 16A-B and includes a method for treating regurgitation of
blood flow through a regurgitant tricuspid valve 144. Although the
method will be described below using the apparatus 10.sub.g
illustrated in FIGS. 14A-C, it should be appreciated that an
apparatus comprising any one or combination of the geometric
variations discussed herein may also be used to treat regurgitation
of blood flow through a diseased tricuspid valve 144.
[0159] As described above, the apparatus 10.sub.g (FIGS. 14A-C)
comprises a partial ring-shaped annular support member 40.sub.g
having a 3D configuration dimensioned for attachment to the
tricuspid annulus 150. The apparatus 10.sub.g additionally includes
an infra-annular anterior support member 162 that is integrally
formed with the first intermediate portion 44.sub.f of the
substantially annular support member 40.sub.g. Although not shown
in FIGS. 14A-C, it will be appreciated that all or only a portion
of the apparatus 10.sub.f (e.g., the annular support member
40.sub.f) can be covered with a layer 68 of biocompatible material,
such as a sewing ring, at least one marker 70, and/or one or a
combination of therapeutic agents.
[0160] The method can be performed in a substantially identical
manner as the method for treating a regurgitant mitral valve 12
described above. For example, the dimensions of the tricuspid valve
144 can first be obtained to determine optimal dimensions for the
apparatus 10.sub.g. Sizing of the tricuspid valve 144 can be
performed using a valve sizing device, such as the sizing device 86
described above. After determining the dimensions of the tricuspid
valve 144, blood flow through the tricuspid valve can be monitored
to assess coaptation between the anterosuperior, posterior, and
septal leaflets 156, 158 and 160 (as described above). Differently
dimensioned sizing members 90 can be placed over the tricuspid
valve 144 until substantially normal fluid flow (e.g., blood or
saline) through the tricuspid valve is observed. When substantially
normal blood flow is observed through the tricuspid valve 144, the
dimensions of the sizing member 90 are noted and an apparatus
10.sub.g having dimensions that correspond to the dimensions of the
sizing member is selected for implantation. It should be
appreciated that a saline solution test may additionally or
alternatively be used to assess fluid flow and proper leaflet
coaptation through the tricuspid valve 144.
[0161] After selecting an appropriately-dimensioned apparatus
10.sub.g, the apparatus is attached to a delivery device 114 or
holder as described above. To begin the implant procedure, a
silicone tube (not shown) is passed through at least one commissure
of the tricuspid valve 144 and placed behind at least one
subvalvular structure, such as the chordae tendineae 152 and/or
papillary muscle(s) 154 associated with the anterosuperior
tricuspid leaflet 156. Once the apparatus 10.sub.g is securely
attached to the delivery device 114, sutures (not shown) are placed
in the tricuspid annulus 150. The delivery device 114 is then
positioned about the superior aspect of the tricuspid valve 144.
Next, the sutures are passed through the marker(s) 70 (e.g.,
holes), while the delivery device 114 engages the tricuspid valve
144 and the substantially annular support member 40.sub.g of the
apparatus 10.sub.g is advanced toward the tricuspid annulus
150.
[0162] After doing so, the silicone tube is manipulated so that an
open end of the tube engages a distal end of the infra-annular
anterior support member 162. The tube is then gently pulled from
its non-engaged end, which causes the infra-annular anterior
support member 162 to move through the commissure and engage at
least one subvalvular structure. The tube is then disengaged,
followed by removal of the handle member 88 and tightening of the
sutures so that the apparatus 10.sub.g is securely positioned about
the tricuspid valve 144. After tightening of the sutures is
complete, the sutures are cut so that the delivery device 114 or
holder is detached from the apparatus 10.sub.g and removed from the
right atrium 146.
[0163] With the apparatus 10.sub.g securely in place (FIGS. 16A-B),
two levels of cardiac remodeling can simultaneously occur. At the
sub-annular level, the infra-annular anterior support member 162
supports at least one subvalvular structure (e.g., the inferior
free edge of the anterosuperior tricuspid leaflet 156, the chordae
tendineae 152 associated with the anterior leaflet, and/or
papillary muscle(s) 154 associated with anterior leaflet) during
systole by moving forward the subvalvular structure(s), which
reduces the restrictive motion of the anterior leaflet 24 and
prevents or mitigates regurgitation of blood through the tricuspid
valve 144. Furthermore, ventricular remodeling caused by ischemic
and dilated cardiomyopathy is prevented or mitigated by pushing (or
moving) forward the anterior and inferior wall of the right
ventricle 148. Also at the annular level, the 3D saddle-shaped
geometry of the apparatus 10.sub.g remodels the tricuspid annulus
150 and reduces the annular diameter to improve leaflet coaptation.
Upon proper implantation of the apparatus 10.sub.g, the procedure
can be completed so that normal blood flow can resume through the
tricuspid valve 144.
[0164] Another aspect of the present disclosure is illustrated in
FIGS. 18A-C. The apparatus 10.sub.h shown in FIGS. 18A-C is
identically constructed as the apparatus 10.sub.g shown in FIGS.
14A-C, except as described below. In FIGS. 18A-C, structures that
are identical as structures in FIGS. 14A-C use the same reference
numbers, whereas structures that are similar but not identical
carry the suffix "h". It should be appreciated that the apparatus
10.sub.h can be constructed from any of the materials described
above, and that the apparatus can include a layer 68 of
biocompatible material and/or a therapeutic agent(s), as also
described above.
[0165] The apparatus 10.sub.h can comprise a substantially annular
support member 40.sub.g and at least one infra-annular
tri-structure support member 200 securely connected thereto. The
substantially annular support member 40.sub.g can have a 3D shape
that corresponds to the 3D shape of the tricuspid annulus 150 (FIG.
15). The substantially annular support member 40.sub.g can define a
longitudinal axis LA (as shown in FIG. 14C) and include an anterior
end portion 50.sub.g, a posterior end portion 48.sub.g, and
oppositely disposed first and second intermediate portions
44.sub.gand 46.sub.g extending between the anterior and posterior
end portions. The anterior end portion 50.sub.g and the posterior
end portion 48.sub.g are dimensioned for attachment to anterior and
posterior portions of the tricuspid annulus 150 (FIG. 15),
respectively. Although the substantially annular support member
40.sub.g is shown as having a C-shaped or partial ring
configuration, it will be appreciated that the substantially
annular support member can have other configurations, such a
completely annular ring configuration.
[0166] The infra-annular tri-structure support member 200 is
dimensioned, shaped, and configured to extend below the
anterosuperior, posterior, and septal leaflets 156, 158, and 160
and across or behind at least one subvalvular structure when the
apparatus 10.sub.h is implanted on or about the tricuspid annulus
150. The infra-annular tri-structure leaflet support member 200 is
securely and directly connected to the substantially annular
support member 40.sub.g at a first location 202. As shown in FIG.
6A, for example, the infra-annular tri-structure leaflet support
member 200 is securely and directly connected to the first
intermediate portion 44.sub.g. Although not shown, it will be
appreciated that the infra-annular tri-structure support member 200
can alternatively be securely and directly connected to the second
intermediate portion 46.sub.g.
[0167] The infra-annular tri-structure support member 200 comprises
a hook-shaped engaging portion 182.sub.h that is integrally and
directly connected to the substantially annular support member
40.sub.g via a neck portion 164. The engaging portion 182.sub.h
further comprises a first engaging portion 184.sub.h, a second
engaging portion 186.sub.h, and a bend portion 188.sub.h extending
between the first and second engaging portions. Each of the first
and second engaging portions 184.sub.h and 186.sub.h has a
continuous, arc-shaped (or arcuate) configuration configured to
extend across or behind at least one subvalvular structure. The
first and second engaging portions 184.sub.h and 186.sub.h can have
concave and convex shapes (respectively) relative to the anterior
end portion 50.sub.g of the substantially annular support member
40.sub.g.
[0168] The first engaging portion 184.sub.h is configured to extend
across or behind at least one subvalvular structure, such as: an
inferior aspect of the posterior leaflet 158, such as an inferior
free edge (not shown) of the posterior leaflet; chordae tendineae
152 associated with the posterior leaflet; one or more papillary
muscles 154 associated with the tendineae chordae of the posterior
leaflet; and combinations thereof. Additionally, the second
engaging portion 186.sub.h is configured to extend across or behind
at least one subvalvular structure, such as: an inferior aspect of
the anterosuperior leaflet 156, such as an inferior free edge (not
shown) of the anterosuperior leaflet; chordae tendineae 152
associated with the anterosuperior leaflet; one or more papillary
muscles 154 associated with the chordae tendineae of the
anterosuperior leaflet; an inferior aspect of the septal leaflet
160, such as an inferior free edge (not shown) of the septal
leaflet; chordae tendineae associated with the septal leaflet; one
or more papillary muscles associated with the chordae tendineae of
the septal leaflet; and combinations thereof. In one example of the
present disclosure, the second engaging portion 186.sub.h is
configured to extend across or behind a subvalvular structure
associated with (or comprising) the anterosuperior and septal
leaflets 156 and 160.
[0169] The first and second engaging portions 184.sub.h and
186.sub.h can be located in the same lateral plane (i.e., a plane
that extends below and parallel or substantially parallel to the
longitudinal axis LA) or, alternatively, offset from one another
relative to a central axis CA (not shown in FIGS. 18A-C). In this
manner, the first and second engaging portions 184.sub.h and
186.sub.h can be positioned to contact the same or different
corresponding subvalvular structures. Where the first and second
engaging portions 184.sub.h and 186.sub.h are offset from one
another, for example, the first engaging portion can be configured
to extend across or behind an inferior aspect of the posterior
leaflet 158 (e.g., an inferior free edge of the posterior leaflet),
and the second engaging portion can be configured to extend across
or behind chordae tendineae 152 associated with the anterosuperior
and septal leaflets 156 and 160.
[0170] Alternative configurations of the infra-annular posterior
and inferior support member 180 are illustrated in FIGS. 6B-C. As
shown in FIG. 6B, the engaging portion 182 of the infra-annular
posterior and anterior support member 180 can have a bifurcated
configuration comprising spaced apart first and second engaging
members 190 and 192. The first and second engaging members 190 and
192 can be spaced apart, and axially offset from one another
(relative to a central axis CA), by a distance D1. Generally, the
distance D1 can be varied depending upon mitral valve anatomy, the
particular valvular insufficiency from which a subject is
suffering, as well as other factors. In particular, the distance D1
can be varied to facilitate contact between the first and second
engaging members 190 and 192 and one or more subvalvular
structures. Each of the first and second engaging members 190 and
192 includes first and second engaging portions 184 and 186, as
described above.
[0171] As shown in FIG. 6C, the engaging portion 182 of the
infra-annular posterior and anterior support member 180 can
alternatively have an arcuate, loop-shaped configuration that
includes an aperture 134 extending therethrough. The loop-shaped
engaging portion 182 can comprise first and second engaging members
190 and 192 that join at a common arcuate bend 194. The first and
second engaging members 190 and 192 can be spaced apart, and
axially offset from one another (relative to a central axis CA), by
a distance D1. Generally, the distance D1 can be varied depending
upon mitral valve anatomy, the particular valvular insufficiency
from which a subject is suffering, as well as other factors.
[0172] It will be appreciated that the apparatus 10.sub.d can
additionally or optionally include other features as the apparatus
10 shown in FIGS. 1A-B and described above. For example, the
apparatus 10.sub.d can include: an adjustable mechanism 54; a layer
68 of biocompatible material; at least one marker 70 to facilitate
attachment of the apparatus to the mitral annulus 18; and/or one or
a combination of therapeutic agents.
[0173] Another aspect of the present disclosure is illustrated in
FIGS. 19A-27. The apparatus 200 shown in FIGS. 19A-27 can be
identically or similarly constructed as the apparatus 10, 10.sub.a,
10.sub.b, 10.sub.c, 10.sub.d, and 10.sub.h shown in FIGS. 1A-18C,
except where described below. It should be appreciated that the
apparatus 200 shown in FIGS. 19A-27 can be constructed from any of
the materials described above, and that the apparatus can include a
layer 68 of biocompatible material and/or a therapeutic agent(s)
(also described above).
[0174] Despite advances in understanding the pathophysiology of
ischemic mitral regurgitation as well as advances in surgical
technique and perioperative care, surgical treatment of ischemic
mitral regurgitation is associated with mortality rates as high as
20% in some series. Observational studies in both experimental
animals and clinical patients reveal that the mechanisms of
ischemic mitral regurgitation are varied. Carpentier's
classification of leaflet motion reveals two plausible mechanisms.
In patients with Carpentier's type I dysfunction, leaflet motion is
unrestricted and ischemic mitral regurgitation occurs on the basis
of annular dilation, with resultant failure of leaflet coaptation.
This is ordinarily treated adequately by ring annuloplasty. In the
case of Carpentier's type IIIb dysfunction, there is tethering of
A3 and P3 segments to the anterior and posterior leaflets,
respectively. This results from posterior displacement of the
posterior papillary muscle and subjacent left ventricle as a
product of myocardial infarction.
[0175] This mechanism is poorly treated by simple mitral
annuloplasty as abundant clinical experience has shown. Ring
annuloplasty fails to restore adequate leaflet coaptation as the
leaflet edges remain tethered below the annular level. Adequate
treatment will only result if the leaflet edges can be allowed to
return to the annular level. In addition, the combination of
annular dilation as well as leaflet tethering may be at play with
individual patients. These patients are also inadequately treated
by ring annuloplasty alone. These latter two mechanisms are likely
the mechanisms responsible for reports of up to 20% residual and/or
progressive mitral regurgitation after annuloplasty alone.
[0176] To address these and other shortcomings, another aspect of
the present disclosure can include the apparatus 200 shown in FIGS.
19A-22 and described below. In some instances, the apparatus 200
can include a substantially annular support member 202, at least
one infra-annular support member 204 securely connected to the
substantially annular support member at a first location 206, and
at least one anchoring element 208 associated with the at least one
infra-annular support member. The substantially annular support
member 202 can have at least a first intermediate portion 210, a
second intermediate portion 212, and a posterior end portion 214
extending between the first and second intermediate portions. The
posterior end portion 214 can be dimensioned for attachment to a
posterior portion of the annulus of a diseased heart valve. The at
least one infra-annular support member 204 can be dimensioned to
extend below at least one of the posterior and anterior valve
leaflets and across or behind at least one subvalvular
structure.
[0177] In other instances, the apparatus 200 can include a
substantially annular support member 202, a first infra-annular
support member 204' securely connected to the substantially annular
support member at a first location 206, a second infra-annular
support member 204'' securely connected to the substantially
annular support member at a second location 216, and at least one
anchoring element 208 associated with one or both of the first and
second infra-annular support members. The substantially annular
support member 202 can have at least a first intermediate portion
210, a second intermediate portion 212, and a posterior end portion
214 extending between the first and second intermediate portions.
The posterior end portion 214 is dimensioned for attachment to a
posterior portion of the annulus of a diseased heart valve. The
first and second infra-annular support members 204' and 204'' are
dimensioned to extend below at least one of the posterior and
anterior valve leaflets and across or behind at least one
subvalvular structure. An apparatus 200 having first and second
infra-annular support members 204' and 204'' is shown in FIG.
19B.
[0178] The at least one anchoring element 208 can be configured to
securely receive a prosthetic chordae tendineae 218 (FIG. 23) for
attachment to a papillary muscle 220. Examples of prosthetic
chordae tendineae 218 that can be securely received by an anchoring
element 208 are disclosed in U.S. Patent Publication No.
2011/0288635 A1 to Miller et al., U.S. Patent Publication No.
2003/0105519 A1 to Fasol et al., and U.S. Patent Publication No.
2006/0259135 A1 to Navia et al. The anchoring element 208 can be
directly or indirectly associated with an infra-annular support
member 204. By "directly associated", it is meant that the
anchoring element 208 is physically attached to at least a surface
222 (FIG. 20) that forms the infra-annular support member 204
without any intervening elements or structures between the surface
and the anchoring element. By "indirectly associated", it is meant
that the anchoring element 208 is physically attached to the
infra-annular support member 204, albeit with one or more
intervening elements or structures extending between the surface
222 and the anchoring element. It will be appreciated that the
infra-annular support member 204 can include only one or two,
three, or more anchoring elements 208.
[0179] The anchoring element 208 can comprise any structure,
component, member, or combination thereof that is configured to
securely receive a prosthetic chordae tendineae 218 for attachment
to a papillary muscle 220 (FIGS. 23-25). As shown in FIGS. 19A-B,
for example, the anchoring element 208 can have a U-shaped or
semi-circular shape that forms an aperture 224 when connected to or
associated with the infra-annular support member 204. In this
instance, the aperture 224 can be configured to receive a portion
of a prosthetic chordae tendineae 218 therethrough. It will be
appreciated that the anchoring element 208 can have a variety of
other shapes and configurations, so long as the anchoring element
is configured to securely receive a prosthetic chordae tendineae
218 for attachment to a papillary muscle 220. For example, the
anchoring element 208 can be V-shaped. Alternatively, the anchoring
element 208 can include a snap, clip, or magnetic member capable of
securely receiving the prosthetic chordae tendineae 218. Where
multiple anchoring elements 208 are present (e.g., on a single
infra-annular support member 204), each of the anchoring elements
can be physically spaced apart from one another (e.g., radially or
axially spaced apart in a parallel or in-series configuration,
respectively). The anchoring element 208 can be integrally formed
with the infra-annular support member 204 (e.g., formed from the
same material) or separately attached thereto (e.g., using an
adhesive). The material used to form the anchoring element 208 can
be the same as, or different from, the material used to form the
infra-annular support member 204.
[0180] Advantageously, the anchoring elements 208 provide a
mechanism for stabilizing the papillary muscles 220 upon
implantation of the apparatus 200, which prevents late apical
migration of the subvalvular apparatus. This mechanism is not
present with existing annuloplasty rings, which only remodel the
valve annulus and do not exert a therapeutic effect on the
papillary muscles and migration of the subvalvular apparatus.
Additionally, this mechanism is not present with conventional
artificial chordae, which fail to provide valve annulus
remodeling.
[0181] Implantation of the apparatus 200 is illustrated in FIGS.
26A-27B. Proximal and distal ends 226 and 228 of the prosthetic
chordae tendineae 218 can be attached to the anchoring element 208
and the head of the papillary muscle 220, respectively. The distal
end 228 of the prosthetic chordae tendineae 218 can be attached to
the head of the papillary muscle 220 using a standard technique.
All or only a portion of the native chordae can be removed from the
patient. Alternatively, the native chordae may remain in the
patient along with the implanted prosthetic chordae tendineae 218.
Advantageously, attachment of the prosthetic chordae tendineae 218
pulls or moves the papillary muscles 220 in a medial direction.
Medial movement of the papillary muscles 220 can improve cardiac
function by creating a reverse remodeling of a posterior left
ventricular wall, improving valve leaflet coaptation, and reducing
tension across the native chordae. When implanted, the apparatus
200 can also stabilize the position of the papillary muscles 220
and prevent late apical migration of the subvavular apparatus,
which is of benefit in these generally unhealthy patients. Thus, in
some instances, the apparatus 200 can be employed to treat a
subject suffering from Carpentier's type I dysfunction or
Carpentier's type IIIb dysfunction. In a patient suffering from
Carpentier's type IIIb dysfunction, for example, implantation of
the apparatus 200 may be especially therapeutic since such patients
suffer from tethering of A3 and P3 segments to the anterior and
posterior leaflets, respectively, and the apparatus advantageously
eliminates the possibility of leaflet tethering below the annular
level while also remodeling the dysfunctional valve at the annular
level.
[0182] From the above description of the disclosure, those skilled
in the art will perceive improvements, changes and modifications.
Such improvements, changes, and modifications are within the skill
of one having ordinary skill the art. All patents, patent
applications, and publication cited herein are incorporated by
reference in their entirety.
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