Note: Descriptions are shown in the official language in which they were submitted.
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
METHOD AND APPARATUS FOR
IMPROVING MITRAL VALVE FUNCTION
Reference To Pending Prior Patent Applications
This patent application:
(1) is a continuation-in-part of pending prior
U.S. Patent Application Serial No. 10/068,264, filed
02/05102 by Daniel C. Taylor et al. for METHOD AND
APPARATUS FOR IMPROVING MITRAL VALVE FUNCTION
(Attorney's Docket No. VIA-29);
(2) is a continuation-in-part of pending prior
U.S. Patent Application Serial No. 10/112,354, filed
03/29/02 by John Liddicoat et al. for METHOD AND
APPARATUS FOR IMPROVING MITRAL VALVE FUNCTION
(Attorney's Docket No. VIA-19202122);
(3) is a continuation-in-part of pending prior
U.S. Patent Application Serial No, 10/218,649, filed
08/14/02 by Daniel C. Taylor et al. for METHOD AND
APPARATUS FOR IMPROVING MITRAL VALVE FUNCTION
(Attorney's Docket No. VIA-23);
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
_ 2 _
(4) is a continuation-in-part of pending prior
U.S. Patent Application Serial No. 10/280,401, filed
10/25102 by William E. Cohn et al, for METHOD AND
APPARATUS FOR IMPROVING MITRAL VALVE FUNCTION
(Attorney's Docket No. VIA-30);
(5) is a continuation-in-part of pending prior
U.S. Patent Application Serial No. 10/342,03'4, filed
01/14/03 by Daniel C. Taylor et al. for METHOD AND
APPARATUS FOR REDUCING MITRAL REGURGITATION
(Attorney's Docket No. VIA-31)~ and
(6) claims benefit of pending prior U.S.
Provisional Patent Application Serial No. 60/3,91,790,
filed 06/26/02 by William E. Cohn et al. for METHOD
AND APPARATUS FOR IMPROVING MITRAL VALVE FUNCTION
(Attorney's Docket No. VIA-34 PROV).
The six (6) aforementioned patent applications
are hereby incorporated herein by reference.
Field Of The Invention
This invention relates to surgical methods and
apparatus in general, and more particularly to
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 3 -
surgical methods and apparatus for improving mitral
valve function.
Background Of The Invention
Mitral valve repair is the procedure of choice to
correct mitral regurgitation of all etiologies. With
the use of current surgical techniques, between 700
and 950 of regurgitant mitral valves can be repaired.
The advantages of mitral valve repair over mu ral
valve replacement are well documented. These include
better preservation of cardiac function and reduced
risk of anticoagulant-related hemorrhage,
thromboembolism and endocarditis.
In current practice, mitral valve surgery
requires an extremely invasive approach that includes
a chest wall incision, cardiopulmonary bypass, cardiac
and pulmonary arrest, and an incision on the heart
itself to gain access to the mitral valve. Such a
procedure is associated with high morbidity anal
mortality. Due to the risks associated with this
procedure, many of the sickest patients are denied the
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 4 -
potential benefits of surgical correction of mitral
regurgitation. In addition, patients with moderate,
symptomatic mitral regurgitation are denied early
intervention and undergo surgical correction only
after the development of cardiac dysfunction.
Mitral regurgitation is a common occurrence in
patients with heart failure and a source of important
morbidity and mortality in these patients. Mitral
regurgitation in patients with heart failure is caused
by changes in the geometric configurations of the left
ventricle, papillary muscles and mitral annulus.
These geometric alterations result in incomplete
coaptation of the mitral leaflets at systole. In this
situation, mitral regurgitation is corrected by
placating the mitral valve annulus, either by sutures
alone or by sutures in combination with a support
ring, so as to reduce the circumference of the
distended annulus and restore the original geometry of
the mitral valve annulus.
More particularly, current surgical practice for
mitral valve repair.generally requires that the mitral
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 5 -
valve annulus be reduced in radius by surgically
opening the left atrium and then fixing sutures, or
more commonly sutures in combination with a support
ring, to the internal surface of the annulus; this
structure is used to cinch the annulus, in a
pursestring-like fashion, to a smaller radius, thereby
reducing mitral regurgitation by improving leaflet
coaptation.
This method of mitral valve repair, generally
termed "annuloplasty", effectively reduces mitral
regurgitation in heart failure patients. This, in
turn, reduces symptoms of heart failure, improves
quality of life and increases longetivity.
Unfortunately, however, the invasive nature of mu ral
valve surgery and the attendant risks render most
heart failure patients poor surgical candidates.
Thus, a less invasive means to increase leaflet
coaptation and thereby reduce mitral regurgitation in
heart failure patients would make this therapy
available to a much greater percentage of patients.
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 6 -
Mitral regurgitation also occurs in approximately
200 of patients suffering acute myocardial infarction.
In addition, mitral regurgitation is the primary cause
of cardiogenic shock in approximately 100 of patients
who develop severe hemodynamic instability in the
setting of acute myocardial infarction. Patients with
mural regurgitation and cardiogenic shock have about
a 50o hospital mortality. Elimination of mitral
regurgitation in these patients would be of
significant benefit. Unfortunately, however, patients
with acute mitral regurgitation complicating acute
myocardial infarction are particularly high-risk
surgical candidates, and are therefore not good
candidates for a traditional annuloplasty procedure.
Thus, a minimally~invasive means to effect a temporary
reduction or elimination of mitral regurgitation in
these critically ill patients would afford them the
time to recover from the myocardial infarction or
other acute life-threatening events and make them
better candidates for medical, interventional or
surgical therapy.
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
Summary Of The Invention
As a result, one object of the present invention
is to provide an improved method and apparatus for
reducing mitral regurgitation.
Another object of the present invention is to
provide a method and apparatus for reducing mitral
regurgitation which is minimally invasive.
Another object of the present invention is to
provide a method and apparatus for reducing mitral
regurgitation which can be deployed either permanently
(e.g., for patients suffering from heart failure) or
temporarily (e. g., for patients suffering from mitral
regurgitation with acute myocardial infarction).
These and other objects are addressed by the
present invention, which comprises an improved method
and apparatus for reducing mitral regurgitation.
In one form of the invention, there is provided a
method for reducing mitral regurgitation comprising:
inserting apparatus into the coronary sinus of a
patient in the vicinity of the posterior leaflet of
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
_ g _
the mitral valve, the apparatus being adapted to
straighten the natural curvature of at least a portion
of the coronary sinus in the vicinity of the posterior
leaflet of the mitral valve, whereby to move the
posterior annulus anteriorly and thereby improve
leaflet coaptation.
In another form of the invention, there is
provided a method for reducing mitral regurgitation
comprising:
inserting apparatus into the coronary sinus of a
patient in the vicinity of the posterior leaflet of
the mitral valve, the apparatus being adapted to move
at least a portion of the coronary sinus in the
vicinity of the posterior leaflet of the mitral valve
anteriorly, whereby to move the posterior annulus
anteriorly and thereby improve leaflet coaptation.
In another form of the invention, there is
provided a method for reducing mu ral regurgitation
comprising:
inserting apparatus into the coronary sinus of a
patient in the vicinity of the posterior leaflet of
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 9 -
the mitral valve, the apparatus being adapted to
reduce the degree of natural curvature of at least a
portion of the coronary sinus in the vicinity of the
posterior leaflet of the mitral valve, whereby to move
the posterior annulus anteriorly and thereby improve
leaflet coaptation.
In another form of the invention, there is
provided a method for reducing mitral regurgitation
comprising:
inserting apparatus into the coronary sinus of a
patient in the vicinity of the posterior leaflet of
the mitral valve, the apparatus being adapted to
increase the natural radius of curvature of at least a
portion of the coronary sinus in th.e vicinity of the
posterior leaflet of the mitral valve, whereby to move
the posterior annulus anteriorly and thereby improve
leaflet coaptation.
In another.form of the invention, there is
provided a method for reducing mitral regurgitation
comprising:
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 10 -
inserting apparatus into the coronary sinus of a
patient in the vicinity of the posterior leaflet of
the mitral valve, the apparatus having a distal end, a
proximal end and an intermediate portion, the
apparatus being configured so that when the apparatus
is positioned in the coronary sinus in the vicinity of
the posterior leaflet of the mitral valve, the distal
and proximal ends will apply a posteriorly-directed
force to the walls of the coronary sinus and the
intermediate portion will apply an anteriorly-directed
force to the walls of the coronary sinus, whereby to
move the posterior annulus anteriorly and thereby
improve leaflet coaptation.
In another form of the invention, there is
provided a method for reducing mural regurgitation
comprising:
inserting a substantially straight elongated body
into the coronary sinus of a patient in the vicinity
of the posterior leaflet of the mitral valve, the
length of the substantially straight elongated body
being sized relative to the natural curvature of the
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 11 -
coronary sinus in the vicinity of the posterior
leaflet of the mitral valve so that when the
substantially straight elongated body is positioned in
the coronary sinus, it will cause at least a portion
of the coronary sinus to assume a substantially
straight configuration adjacent to the posterior
leaflet of the mitral valve, whereby to increase the
radius of curvature of the mitral annulus and thereby
improve leaflet coaptation.
In another form of the invention, there is
provided a method for reducing mitral regurgitation
comprising:
inserting a substantially rigid elongated body
into the coronary sinus of a patient in the vicinity
of the posterior leaflet of the mitral valve, the
substantially rigid elongated body being configured
relative to the natural curvature of the coronary
sinus in the vicinity of the posterior leaflet of the
mitral valve so that when the substantially rigid
elongated body is positioned in the coronary sinus, it
will cause at least a portion of the coronary sinus to
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 12 -
assume a different configuration adjacent to the
posterior leaflet of the mitral valve, whereby to move
the posterior annulus anteriorly and thereby improve
leaflet coaptation.
In another form of the invention, there is
provided a method for reducing mitral regurgitation
comprising:
inserting a substantially straight, substantially
rigid,elongated body into the coronary sinus of a
patient in the vicinity of the posterior leaflet of
the mitral valve, the length of the substantially
straight, substantially rigid elongated body being
sized relative to the natural curvature of the
coronary sinus in the vicinity of the posterior
leaflet of the mitral valve so that when the
substantially straight, substantially rigid elongated
body is positioned in the coronary sinus, it will
cause at least a portion of the coronary sinus to
assume a substantially straight configuration adjacent
to the posterior leaflet of the mitral valve, whereby
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 13 -
to increase the radius of curvature of the mitral
annulus and thereby improve leaflet coaptation.
In another form of the invention, there is
provided an apparatus for reducing mitral
regurgitation comprising:
a body having a distal end, a proximal end and an
intermediate portion, the body being configured so
that when the body is positioned in the coronary sinus
in the vicinity of the posterior leaflet of the mitral .
value, the distal and proximal ends will apply a
posteriorly-directed force to the walls of the
coronary sinus, and the intermediate portion will
apply an anteriorly-directed force to the walls of the
coronary sinus, whereby to move the posterior annulus
of the mitral valve anteriorly and thereby improve
leaflet coaptation.
In another form of the invention, there is
provided an apparatus for reducing mu ral
regurgitation comprising:
a substantially straight elongated body adapted
to be inserted into the coronary sinus of a patient in
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 14 -
the vicinity of the posterior leaflet of the mitral
valve, the length of the substantially straight
elongated body being sized relative to the natural
curvature of the coronary sinus in the vicinity of the
posterior leaflet of the mu ral valve so that when the
substantially straight elongated body is positioned in
the coronary sinus, it will cause at least a portion
of the coronary sinus to assume a substantially
straight configuration adjacent to the posterior
leaflet of the mitral valve, whereby to increase the
radius of curvature of the mitral annulus, moving it
anteriorly, and thereby improve leaflet coaptation.
In another form of the invention, there is
provided an apparatus for reducing mitral
regurgitation comprising:
a substantially rigid elongated body adapted to
be inserted into the coronary sinus of a patient in
the vicinity of the posterior leaflet of the mural
valve, the substantially rigid elongated body being
configured relative to the natural curvature of the
coronary sinus in the vicinity of the posterior
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 15 -
leaflet of the mitral valve so that when the
substantially rigid elongated body is positioned in
the coronary sinus, it will cause at least a portion
of the coronary sinus to assume a different
configuration adjacent to the posterior leaflet of the
mitral valve, whereby to move the posterior annulus
anteriorly and thereby improve leaflet coaptation.
In another form of the invention, there is
provided an apparatus for reducing mu ral
regurgitation comprising:
a substantially straight, substantially rigid
elongated body adapted to be inserted into the
coronary sinus of a patient in the vicinity of the
posterior leaflet of the mitral valve, the length of
the substantially straight, substantially rigid
elongated body being sized relative to the natural
curvature of the coronary sinus in the vicinity of the
posterior leaflet of the mitral valve so that when the
substantially straight, substantially rigid elongated
body is positioned in the coronary sinus, it will
cause at least a portion of the coronary sinus to
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 16 -
assume a substantially straight configuration adjacent
to the posterior leaflet of the mitral valve, whereby
to increase the radius of curvature of the mitral
annulus, moving it anteriorly, and thereby improve
leaflet coaptation.
In another form of the invention, there is
provided a method for reducing mitral regurgitation
comprising:
inserting apparatus into the coronary sinus of a
patient in the vicinity of the posterior leaflet of
the mitral valve, the apparatus being adapted to
straighten the natural curvature of at least a~ portion
of the coronary sinus in the vicinity of the posterior
leaflet of the mitral valve, whereby to move the
posterior annulus anteriorly and thereby improve
leaflet coaptation;
the apparatus comprising an elongated body having
a degree of curvature, in an unstressed state, which
is less than the degree of curvature of the coronary
sinus prior to insertion of the elongated body into
the coronary sinus, and the apparatus being more rigid
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 17 -
than the anatomical tissue disposed between the
apparatus and the mitral valve, whereby disposition of
the apparatus in the coronary sinus will move the
posterior annulus anteriorly and improve leaflet
coaptation.
In another form of the invention, there is
provided a method for reducing mitral regurgitation
comprising:
inserting apparatus into the coronary sinus of a
patient in the vicinity of the posterior leaflet of
the mitral valve, the apparatus being adapted to move
at least a portion of the coronary sinus in the
vicinity of the posterior leaflet of the mitral valve
anteriorly, whereby to move the posterior annulus
anteriorly and thereby improve leaflet coaptation;
the apparatus comprising an elongated body having
a straighter configuration, in an unstressed
condition, than the coronary sinus prior to insertion
of the elongated body into the coronary sinus, and the
apparatus being more rigid than the anatomical tissue
disposed between the apparatus and the mitral valve,
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 18 -
whereby disposition of the apparatus in the coronary
sinus will move the posterior annulus anteriorly and
improve leaflet coaptation.
In another form of the invention, there is
provided a method for reducing mitral regurgitation
comprising:
inserting apparatus into the coronary sinus of a
patient in the vicinity of the posterior leaflet of
the mitral valve, the apparatus being adapted to
reduce the degree of natural curvature of at least a
portion of the coronary sinus in the vicinity.of the
posterior leaflet of the mitral valve, whereby to move
the posterior annulus anteriorly and thereby improve
leaflet coaptation; the apparatus comprising an
elongated body having a relatively straight
configuration in an unstressed condition, and the
apparatus being more rigid than the anatomical tissue
disposed between the apparatus and the mitral valve,
whereby disposition of the apparatus in the coronary
sinus will move the posterior annulus anteriorly and
improve leaflet coaptation.
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 19 -
In another form of the invention, there is
provided a method for reducing mitral regurgitation
comprising:
inserting apparatus into the coronary sinus of a
patient in the vicinity of the posterior leaflet of
the mitral valve, the apparatus being adapted to
increase the natural radius of curvature of at least a
portion of the coronary sinus in the vicinity of the
posterior leaflet of the mitral valve, whereby to move
the posterior annulus anteriorly and thereby improve
leaflet coaptation;
the apparatus comprising an elongated body having
a relatively straight configuration in an unstressed
condition, and the apparatus being more rigid than the
anatomical tissue disposed between the apparatus and
the mitral valve, whereby disposition of the apparatus
in the coronary sinus will move the posterior annulus
anteriorly and improve leaflet coaptation.
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 20 -
In another form of the invention, there is
provided a method for reducing mitral regurgitation
comprising:
inserting apparatus into the coronary sinus of a
patient in the vicinity of the posterior leaflet of
the mitral valve, the apparatus having a distal end, a
proximal end and an intermediate portion, the
apparatus being configured so that when the apparatus
is positioned in the coronary sinus in the vicinity of
the posterior leaflet of the mitral valve, the distal
and proximal ends will apply a posteriorly-directed
force to the walls of the coronary sinus and the
intermediate portion will apply an anteriorly-directed
force to the walls of the coronary sinus, whereby to
move the posterior annulus anteriorly and thereby
improve leaflet coaptation;
the apparatus comprising an elongated body having
a relatively straight configuration in an unstressed
condition, and the apparatus being more rigid than the
anatomical tissue disposed between the apparatus and
the mitral valve, whereby disposition of the apparatus
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 21 -
in the coronary sinus will move the posterior .annulus
anteriorly and improve leaflet coaptation.
In another form of the invention, there is
provided a method for reducing mitral regurgitation
comprising:
inserting a substantially straight elongated body
into the coronary sinus of a patient in the vicinity
of the posterior leaflet of the mitral valve, the
length of the substantially straight elongated body
being sized relative to the natural curvature of the
coronary sinus in the vicinity of the posterior
leaflet of the mitral valve so that when the
substantially straight elongated body is positioned in
the coronary sinus, it will cause at least a portion
of the coronary sinus to assume a substantially
straight configuration adjacent to the posterior
leaflet of the mitral valve, whereby to increase the
radius of curvature of the mitral annulus and thereby
improve leaflet coaptation;
the substantially straight elongated body
comprising a bar having a substantially straight
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 22 -
configuration in an unstressed condition, and the
apparatus being more rigid than the anatomical tissue
disposed between the apparatus and the mitral valve,
whereby disposition of the apparatus in the coronary
sinus will move the posterior annulus anteriorly and
improve leaflet coaptation.
In another form of the invention, there is
provided a method for reducing mitral regurgitation
comprising:
inserting a substantially rigid elongated body
into the coronary sinus of a patient in the vicinity
of the posterior leaflet of the mitral valve, the
substantially rigid elongated body being configured
relative to the natural curvature of the coronary
sinus in the vicinity of the posterior leaflet of the
mitral valve so that when the substantially rigid
elongated body is positioned in the coronary sinus, it
will cause at least a portion of the coronary sinus to
assume a different configuration adjacent to the
posterior leaflet of the mitral valve, whereby to move
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 23 -
the posterior annulus anteriorly and thereby improve
leaflet coaptation;
the substantially rigid elongated body comprising
a bar having a relatively straight configuration in an
unstressed condition, and the apparatus being more
rigid than the anatomical tissue disposed between the
apparatus and the mitral valve, whereby disposition of
the apparatus in the coronary sinus will move the
posterior annulus anteriorly and improve leaflet
coaptation.
In another form of the invention, there is
provided a method for reducing mitral regurgitation
comprising:
inserting a substantially straight, substantially
rigid elongated body into the coronary sinus of a
patient in the vicinity of the posterior leaflet of
the mitral valve, the length of the substantially
straight, substantially rigid elongated body being
sized relative to the natural curvature of the
coronary sinus in the vicinity of the posterior
leaflet of the mitral valve so that when the
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- .24 -
substantially straight, substantially rigid elongated
body is positioned in the coronary sinus, it will
cause at least a portion~of the coronary sinus to
assume a substantially straight configuration adjacent
to the posterior leaflet of the mitral valve, whereby
to increase the radius of curvature of the mitral
annulus and thereby improve leaflet coaptation;
the substantially straight, substantially rigid
elongated body comprising a bar having a substantially
straight confilguration in an unstressed condition, and
the apparatus being more rigid than the anatomical
tissue disposed between the apparatus and the mitral
valve, whereby disposition of the apparatus in the
coronary sinus will move the posterior annulus
anteriorly and improve leaflet coaptation.
In another form of the invention, there is
provided an apparatus for reducing mitral
regurgitation comprising:
a body having a distal end, a proximal end and an
intermediate portion, the body being configured so
that when the body is positioned in the coronary sinus
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 25 -
in the vicinity of the posterior leaflet of the mitral
valve, the distal and proximal ends will apply a
posteriorly-directed force to the walls of the
coronary sinus, and the intermediate portion will
apply an anteriorly-directed force to the walls of the
coronary sinus, whereby to move the posterior annulus
of the mitral valve anteriorly and thereby improve
leaflet coaptation;
the body comprising a bar having a relatively
straight configuration in an unstressed condition, and
the apparatus being more rigid than the anatomical
tissue disposed between the apparatus and the mitral
valve, whereby disposition of the apparatus in the
coronary sinus will move the posterior annulus
anteriorly and improve leaflet coaptation.
In another form of the invention, there is
provided an apparatus for reducing mitral
regurgitation comprising:
a substantially straight elongated body adapted
to be inserted into the coronary sinus of a patient in
the vicinity of the posterior leaflet of the mitral
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 26 -
valve, the length of the substantially straight
elongated body being sized relative to the natural
curvature of the coronary sinus in the vicinity of the
posterior leaflet of the mitral valve so that when the
substantially straight elongated body is positioned in -
the coronary sinus, it will cause at least a portion
of the coronary sinus to assume a substantially
straight configuration adjacent to the posterior
leaflet of the mitral valve, whereby to increase the
radius of curvature of the mitral annulus, moving it
anteriorly, and thereby improve leaflet coaptation;
the body comprising a bar having a substantially
straight configuration in an unstressed condition, and
the apparatus being more rigid than the anatomical
tissue disposed between the apparatus and the mitral
value, whereby disposition of the apparatus in the
coronary sinus will move the posterior annulus
anteriorly and improve leaflet coaptation.
In another form of the invention, there is
provided an apparatus for reducing mitral
regurgitation comprising:
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 27 -
a substantially rigid elongated body adapted to
be inserted into the coronary sinus of a patient in
the vicinity of the posterior leaflet of the mitral
valve, the substantially rigid elongated body being
configured relative to the natural curvature of the
coronary sinus in the vicinity of the posterior
leaflet of the mitral valve so that when the
substantially rigid elongated body is positioned in
the coronary sinus, it will cause at least a portion
of the coronary sinus to assume a different
configuration adjacent to the posterior leaflet of the
mitral valve, whereby to move the posterior annulus
anteriorly and thereby improve leaflet coaptation;
the body comprising a bar having a substantially
straight configuration in an unstressed condition, and
the apparatus being more rigid than the anatomical
tissue disposed between the apparatus and the mitral
valve, whereby disposition of the apparatus in the
coronary sinus will move the posterior annulus
anteriorly and improve leaflet coaptation.
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
_ ~8 _
In another form of the invention, there is
provided an apparatus for reducing mitral
regurgitation comprising:
a substantially straight, substantially rigid
elongated body adapted to be inserted into the'
coronary sinus of a patient in the vicinity of the
posterior leaflet of the mitral valve, the length of
the substantially straight, substantially rigid
elongated body being sized relative to the natural
curvature of the coronary sinus in the vicinity of the
posterior leaflet of the mural valve so that when the
substantially straight, substantially rigid elongated
body is positioned in the coronary sinus, it will
cause at least a portion of the coronary sinus to
assume a substantially straight configuration adjacent
to the posterior leaflet of the mitral valve, whereby
to increase the radius of curvature of the mitral
annulus, moving it anteriorly, and thereby improve
leaflet coaptation;
the body comprising a bar having a substantially
straight configuration in an unstressed condition, and
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 29 -
the apparatus being more rigid than the anatomical
tissue disposed between the apparatus and the mitral
valve, whereby disposition of the apparatus in the
coronary sinus will move the posterior annulus
anteriorly and improve leaflet coaptation.
In another form of the invention, there is
provided a method for reducing mitral regurgitation
comprising:
inserting apparatus into the coronary sinus of a
patient in the vicinity of the posterior leaflet of
the mitral valve, the apparatus being adapted to
invert the natural curvature of at least a portion of
the coronary sinus in the vicinity of the posterior
leaflet of the mural valve, whereby to move the
posterior annulus anteriorly and thereby improve
leaflet coaptation, wherein said apparatus comprises a
bar and a stabilizing scaffold connected to said bar.
In another form of the invention, there is
provided an apparatus for reducing mitral
regurgitation comprising:
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 30 -
an elongated body adapted to be inserted into the
coronary sinus of a patient in the vicinity of the
posterior leaflet of the mitral valve, the apparatus
being adapted to invert the natural curvature of at
least a portion of the coronary sinus in the vicinity
of the posterior leaflet of the mitral valve, whereby
to move the posterior annulus anteriorly and thereby
improve leaflet coaptation, wherein said apparatus
comprises a bar and a stabilizing scaffold connected
to said bar.
Significantly, the present invention may be
practiced in a minimally invasive manner, either
perrrianently or temporarily, so as to reduce mitral
regurgitation.
Brief Description Of The Drawincts
These and other objects and features of the
present invention will be more fully disclosed or
rendered obvious by the following detailed description
of the preferred embodiments of the invention,. which
is to be considered together with the accompanying
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 31 -
drawings wherein like numbers refer to like parts and
further wherein:
Fig. 1 is a schematic view of portions of the
human vascular system;
Fig. 2 is a schematic view of portions of the
human heart;
Fig. 3 is a schematic view of a preferred system
formed in accordance with the present invention;
Figs. 4-7 are a series of views illustrating use
of the system of Fig. 3 to reduce mitral
regurgitation;
Fig. 8 shows an alternative form of delivery
catheter;
Fig. 9 shows an alternative form of flexible push
rod;
Fig. 10 shows another alternative form of the
present invention;
Fig. 11 shows another alternative form of the
present invention;
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 32 -
Figs. 12-14 show alternative constructions for
the elongated body which comprises one form of the
present invention;
Fig. 15 shows an alternative system formed in
accordance with the present invention;
Fig. 16 shows how the system of Fig. 15 is
configured during deployment of the system's elongated
body;
Figs. 17-19 are side elevational views of further
alternative embodiments of the elongated body;
Fig. 20 is a diagrammatic illustration of. forces
engaging upon an operative portion of the inventive
assemblies;
Fig. 21 is a schematic view of another
alternative form of the present invention;
Fig. 22 is a schematic view showing the
construction of Fig. 21 deployed in a coronary sinus;
Fig. 23 is.a schematic view of another
alternative form of the present invention;
Fig. 24 is a schematic view showing the
construction of Fig. 23 deployed in a coronary sinus;
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 33 -
Fig. 25 is a schematic illustration of a normal
mitral valve;
Fig. 26 is a schematic illustration of a
regurgitant mitral valve;
Figs. 27 and 28 are schematic illustrations
showing an elongated body inserted into the coronary
sinus, wherein the elongated body comprises a central
portion which is substantially straight and
substantially rigid;
Figs. 29 and 30 are schematic illustrations
showing another elongated body inserted into the
coronary sinus, wherein the elongated body comprises
elastic central and end portions;
Figs. 31 and 32 are schematic illustrations
showing another elongated body inserted into the
coronary sinus, wherein the elongated body has a
variable elasticity along its length.
Fig. 33 is a schematic illustration showing the
force deformation curve for the two materials Nitinol
and stainless steel;
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 34 -
Figs. 34 and 35 are side elevational views of
further alternative embodiments of the elongated body;
Fig. 36 is a schematic view of a still further
alternative embodiment of the elongated body;
Fig. 37 is a diagrammatic side elevational view
showing the elongated body of Fig. 35 in cooperative
engagement with a stabilizing scaffold;
Fig. 38 is a diagrammatic sectional illustration
of a step in the deployment of the stabilizing
scaffold of Fig. 37;
Fig. 39 is a diagrammatic illustration of the
elongated body and stabilizing scaffold of Fig. 37
shown in place in a coronary sinus;
Fig. 40 is a schematic view of another form of
the present invention;
Fig. 41 is a sectional view taken along line
41-41 of Fig. 40;
Fig. 42 is a schematic view of another form of
the present invention;
Fig. 43 is a sectional view taken along line
43-43 of Fig. 42;
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 35 -
Fig. 44 is a schematic view of another form of
the present invention;
Fig. 45 is a sectional view taken along line
44-44of Fig. 44;
Fig. 46 is a schematic view showing the
construction of Figs. 40-45 being deployed in a
coronary sinus;
Fig. 47 is a schematic view of another form of
the present invention;
Figs. 48-51 show alternative constructions for
combining elongated bodies and stabilizing scaffolds;
Fig. 52 is a diagrammatic perspective view of the
combination of elongated body and stabilizing scaffold
of Fig. 51;
Fig. 53 is a perspective view of an elongated
body having ribs extending therefrom;
Fig. 54 is a top plan view of the elongated body
and rib assembly of Fig. 53;
Fig. 55 is a schematic perspective view of
another combination of elongated body and stabilizing
scaffold;
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 36 -
Fig. 56 is a diagrammatic perspective view of a
combination of elongated body and stabilizing scaffold
in which the structure of the stabilizing scaffold
includes a plurality of elongated body components;
Fig. 57 is a diagrammatic side elevational view
of an elongated body constructed entirely of
stabilizing scaffold members;
Fig. 5S is a schematic side view showing another
combination of elongated body and stabilizing
scaffolds formed in accordance with the present
invention;
Fig. 59 is a schematic side view showing the
stabilizing scaffolds of Figs. 57 deployed in the
coronary sinus of a patient;
Fig. 60 is a schematic side view showing the
combination of elongated body and stabilizing
scaffolds of Figs. 57 deployed in the coronary sinus
of a patient;
Fig. 61 is a schematic side view showing another
combination of elongated body and stabilizing
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 37 -
scaffolds formed in accordance with the present
invention;
Fig. 62 is a schematic side view showing the
stabilizing scaffolds of Figs. 60 deployed in the
coronary sinus of a patient; and
Fig. 63 is a schematic side view showing the
combination of elongated body and stabilizing
scaffolds of Fig. 60 deployed in the coronary sinus of
a patient.
Detailed Description Of The Preferred Embodiments
The coronary sinus is the largest vein in the
human heart. During a large portion of its course in
the atrioventricular groove, the coronary sinus
typically extends adjacent to the left atrium of the
heart for a distance of approximately 5 to 10
centimeters. Significantly, for a portion of its
length, e.g., typically approximately 7-9 cm, the
coronary sinus extends substantially adjacent to the
posterior perimeter of the mitral annulus. The
present invention takes advantage of this fact. More
particularly, by deploying novel apparatus in the
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 38 -
coronary sinus, adjacent to the posterior leaflet of
the mitral valve, the natural curvature of the
coronary sinus may be modified in the vicinity of the
posterior leaflet of the mitral valve, whereby to move
the posterior annulus anteriorly so as to improve
leaflet coaptation and, as a result, reduce mu ral
regurgitation.
In one preferred embodiment of the present
invention, the novel apparatus comprises an elongated
body having a substantially straight configuration,
the length of the elongated body being sized so that
when the elongated body is positioned in the coronary
sinus in the vicinity of the posterior leaflet of the
mitral valve, the elongated body will cause at least a
portion of the coronary sinus to assume a straighter
configuration adjacent to the posterior leaflet of the
mitral valve, whereby to move the posterior annulus
anteriorly and thereby improve leaflet coaptation.
And in one preferred embodiment of the present
invention, access to the coronary sinus is gained
percutaneously, e.g., the elongated body is introduced
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 39 -
into the patient's vascular system via the jugular
vein or via the left subclavian vein, passed down the
superior vena cava, passed through the right atrium
and then passed into the coronary sinus, where it is
deployed., Alternatively, the elongated body may be
introduced into the coronary sinus through a small
incision in the heart, or through some other incision
into the patient's vascular system.
And in one preferred embodiment of the present
invention, the elongated body is guided into position
in the coronary sinus by (i) passing it through a
pre-positioned catheter, and/or (ii) passing it over a
pre-positioned guidewire, and/or (iii) passing it
guide-free (e. g., on the end of a steerable delivery
tool) to the surgical site.
Once deployed, the novel apparatus may be left in
position permanently (e. g., in the case of patients
suffering from mitral regurgitation associated with
heart failure) or the novel apparatus may be left in
position only temporarily (e.g., in the case of
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 40 -
patients suffering from mitral regurgitation
associated with acute myocardial infarction).
Visualization of the procedure may be obtained by
fluoroscopy, echocardiography, intravascular
ultrasound, angioscopy, real-time magnetic resonance
imaging, etc. The efficacy of the procedure may be
determined through echocardiography, although other
imaging modalities may also be suitable.
Looking now at Fig, 1, there are shown aspects of
the cardiovascular system 3 of a patient. More
particularly, cardiovascular system 3. generally
comprises the heart 6, the superior vena cava 9, the
right subclavian vein 12, the left subclavian vein 15,
the jugular vein 18, and the inferior vena cava 21.
Superior versa cava 9 and inferior versa cava 21
communicate with the heart's right atrium 24. The
coronary ostium 27 leads to coronary sinus 30. At the
far end 31 (Fig. 2) of coronary sinus 30, the vascular
structure leads to the vertically-descending anterior
interventricular vein ("AIV") 32 (see Figs. 1 and 2).
For the purposes of the present invention, it can
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 41 -
generally be convenient to consider the term "coronary
sinus" to mean the vascular structure extending
between coronary ostium 27 and AIV 32.
As seen in Fig. 2, between coronary ostium 27 and
AIV 32, coronary sinus 30 generally extends
substantially adjacent to the posterior perimeter of
the annulus 33 of the mitral valve 36. Mitral valve
36 comprises a posterior leaflet 39 and an anterior
leaflet 42. In the case of a regurgitant mitral
valve, posterior leaflet 39 and anterior leaflet 42
will generally fail to properly coapt at systole,
thereby leaving an intervening gap 45 which can permit
the undesired regurgitation to occur.
Looking next at Fig. 3, there is shown a system
100 which comprises one preferred embodiment of the
present invention. More particularly, system 100
generally comprises a guidewire 103, a delivery
catheter 106 and a push rod 109.
Guidewire 103 comprises a flexible body 112
having a distal end 115 and a proximal end 118. The
distal end 115 of guidewire 103 preferably includes a
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 42 -
spring tip 121 for allowing the distal end of
guidewire 103 to atraumatically traverse vascular
structures, i.e., while the guidewire 103 is being
passed through the vascular system of a patient.
Delivery catheter 106 comprises a flexible body
124 having a distal end 127 and a proximal end 130,
preferably with an adjustable valve 133 attached. A
central lumen 136 extends from distal end 127 to
proximal end 130. In some circumstances it may be
desirable to provide a securing mechanism for securing
the distal end 127 of the delivery catheter 106 within
a vascular structure. By way of example but not
limitation, an inflatable balloon 139 may be
positioned about the exterior of flexible body 124,
just proximal to distal end 127, with an inflation
lumen 142 extending between balloon 139 and an
inflation fitting 145.
Push rod 109 comprises a flexible body 148 having
a distal end 151 and a proximal end 154. A
substantially, straight, substantially rigid elongated
body 157, which may have a variety of different
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 43 -
lengths, is formed on flexible body 148, proximal to
distal end 151. A removable proximal stiffener (or
handle) 160 may be placed between elongated body 157
and proximal end 154 so as to facilitate the manual
gripping of flexible body 148, e.g., for advancement
or retraction purposes.
System 100 may be used as follows to reduce
mitral regurgitation.
First, distal end 115 of guidewire 103 is passed
down the jugular vein 18 (or the left subclavian vein
15) of a patient, down superior vena cava 9, through
right atrium 24 of the heart, and then along coronary
sinus 30. See Fig. 4. It will be appreciated that as
flexible guidewire 103 is passed down coronary sinus
30, the guidewire will tend to assume the natural
curved shape of the coronary sinus, due to the
flexible nature of the guidewire. The guidewire's
atraumatic spring tip 121 will help ensure minimal
damage to vascular structures as guidewire 103 is
maneuvered into position.
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 44 -
Next, distal end 127 of delivery catheter 106 is
placed over proximal end 118 of guidewire 103 and
passed down the guidewire until the distal end 127 of
the delivery catheter 106 is positioned in coronary
sinus 30. See Fig. 5. Again, it will be appreciated
that as the flexible delivery catheter 106 passes down
the coronary sinus, the delivery catheter will tend to
assume the natural curved shape of the coronary sinus,
due to the flexible nature of the delivery catheter.
Once delivery catheter 106 has been positioned
within the coronary sinus, guidewire 103 is removed.
See Fig. 6. Either before or after guidewire 103 is
removed, balloon 139 may be inflated so as to secure
the distal end 127 of delivery catheter 106 in
position within coronary sinus 30.
Next, push rod 109 is passed down the central
lumen 136 of delivery catheter 106. As the push rod's
substantially straight, substantially rigid elongated
body 157 is passed down central lumen 136 of delivery
catheter 106, the substantially straight,
substantially rigid elongated body 157 will force the
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 45 -
delivery catheter 106 to assume a substantially
straight configuration at the point where the
substantially straight, substantially rigid elongated
body 157 currently resides (Fig. 7). As push rod 109
is pushed down delivery catheter 106, balloon 139 will
act to hold the distal end 1~7 of the delivery
catheter 106 in position within coronary sinus 30.
Push rod 109 is pushed down delivery catheter
106, utilizing proximal handle 160 (Fig. 3) as needed,
until the substantially straight, substantially rigid
elongated body 157 is located adjacent to the
posterior annulus 33 of mitral valve 36. See Fig. 7.
As this occurs, the presence of the substantially
straight, substantially rigid elongated body 157
within delivery catheter 106 will cause at least a
portion of coronary sinus 30 to assume a substantially
straight configuration at this point, so that the
posterior annulus 33 of mitral valve 36 is forced
anteriorly. This will cause the mitral valve's
posterior leaflet 39 to also move anteriorly so as to
improve mitral valve leaflet coaptation and thereby
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 46 -
reduce (or completely eliminate) mitral valve
regurgitation. In this respect it should be
appreciated that the posterior annulus may be 'shifted
anteriorly so as to achieve, or to attempt to achieve
to the extent anatomically possible,
leaflet-to-leaflet engagement or leaflet-to-annulus
engagement (e.g., where a leaflet may be tethered due
to left ventricular distortion). Both of these types
of engagement, or targeted engagement, are intended to
be encompassed by the terms "improved leaflet
coaptation" and/or "increased leaflet coaptation" and
the like. Using standard visualization means (e. g.
echocardiography and/or fluoroscopy), the exact
position of the substantially straight, substantially
rigid elongated body 157 is adjusted so as to reduce
(or completely eliminate) regurgitation in mitral
valve 36.
In this respect it should be appreciated that the
substantially straight, substantially rigid elongated
body 157 is preferably sized so as to be somewhat less
than the length of the coronary sinus between coronary
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 47 -
ostium 27 and AIV 32. However, in some circumstances
it may be desirable to size the substantially
straight, substantially rigid elongated body 157 so
that it will extend out of the coronary sinus 30 and
into the right atrium 24.
Furthermore, it should also be appreciated that
the system provides a degree of tactile feedback to
the user during deployment. More particularly,
substantial resistance will typically be encountered
as the substantially straight, substantially rigid
elongated body 157 is pushed out of right atrium 24
and into coronary sinus 30: then resistance will
typically drop as body 157 is moved through the
coronary sinus; and then resistance will typically
increase significantly again as the distal end 151
(Fig. 3) of push rod 109, and/or the leading distal
tip of body 157, comes to the far end 31 of the
coronary sinus. Thus, there is something of a tactile
"sweet spot" when the substantially straight,
substantially rigid elongated body 157 is located in
the coronary sinus between coronary ostium 27 and AIV
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 48 -
32, and this tactile "sweet spot" can be helpful to
the user in properly positioning the substantially
straight, substantially rigid elongated body 157 in
coronary sinus 30.
At this point in the procedure, the substantially
straight, substantially rigid elongated body 157 is
locked in position, e.g., by closing the delivery
catheter's adjustable valve 133 (Fig. 3), and balloon
139 may be deflated.
System 100 (less guidewire 103, which was
previously removed) is left in this position until it
is no longer needed. In some cases (e. g., in the case
of patient suffering from mitral regurgitation
associated with acute myocardial infarction), this may
mean that system 100 is left in position for a period
of hours, days or weeks. In other cases (e.g., in the
case of patient suffering from mitral regurgitation
associated with.heart failure), system 100 may be
substantially permanent. If and when system 100 is to
be removed, push rod 109 is removed from delivery
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 49 -
catheter 106, and then delivery catheter 106 is
removed from the patient.
Thus it will be seen that with the present
invention, the substantially straight, substantially
rigid elongated body 157 is essentially force-fit into
the normally curved portion of the coronary sinus
adjacent to the mitral valve's posterior leaflet. By
properly sizing the length of the substantially
straight, substantially rigid elongated body 157
relative to the natural curvature of the patient's
anatomy, and by properly positioning the substantially
straight, substantially rigid elongated body 157 in
the patient's coronary sinus, the substantially
straight, substantially rigid elongated body will
cause at least a portion of the coronary sinus to
assume a substantially straight configuration adjacent
to the posterior leaflet 39 of the mural valve 36.
This action will in turn drive the posterior annulus
of the mu ral valve anteriorly, so as to improve
leaflet coaptation and thereby reduce mitral
regurgitation. Thus, by inserting the substantially
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 50 -
straight, substantially rigid elongated body 1.57 into
the coronary sinus 30 adjacent to the posterior
leaflet 39 of the mitral valve 36, the annulus 33 of
the mitral valve is effectively manipulated so that it
will assume an increased radius of curvature.
As noted above, by properly sizing the length of
the substantially straight, substantially rigid
elongated body 157 relative to the natural curvature
of the patient's anatomy, and by properly positioning
the substantially straight, substantially rigid
elongated body 157 in the patient's coronary sinus,
the substantially straight, substantially rigid
elongated body 157 will cause at least a portion of
the coronary sinus to assume a substantially straight
configuration adjacent to the posterior leaflet 39 of
the mitral valve 36, whereby to drive the posterior
annulus of the mitral valve anteriorly, so as ~to
improve leaflet coaptation and thereby reduce mitral
regurgitation. To this end, push rod 109 is
preferably provided as part of a kit having a
plurality of different push rods 109, each with a
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 51 -
differently-sized elongated body 157, whereby a
physician may select and deploy the
appropriately-sized elongated body 257 for a specific
patient's anatomy. Furthermore, if upon deployment it
should be discovered (e. g., under echocardiography
and/or fluoroscopy) that a different size of elongated
body 157 is needed, the first push rod 109 may be
replaced by a second push rod 109 having the desired
size of elongated body 157.
In one preferred form of the invention, a
diagnostic push rod 109 may first be inserted into the
coronary sinus of the patient for the purpose of
initially determining the appropriate length of
elongated body 157 for that particular patient's
anatomy; again, a series of differently-sized
diagnostic push rids 109 may be sequentially inserted
into the patient's coronary sinus so as to determine
the preferred size for the elongated body 157.
Thereafter, an appropriately-sized therapeutic push
rod 109 may be inserted into the coronary sinus so as
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 52 -
to improve leaflet coaptation and thereby reduce
mitral regurgitation.
Furthermore, prior to inserting a diagnostic push
rod 109 into the coronary sinus of the patient, the
doctor may make a preliminary assessment of the size
of the coronary sinus for the purpose of determining
an initial estimated length for the elongated body 157
of diagnostic push rod 109. This may be done under
fluoroscopy using a guidewire 103 having radioopaque
markers thereon, or by using a delivery catheter 106
having radioopaque markers thereon, or by inserting
another device (e.g., a flexible element) into the
coronary sinus, where that device has radioopaque
markers thereon, or in other ways which will be
apparent to those skilled in the art. Using the
radioopaque markers, the doctor makes a preliminary
assessment of the size of the coronary sinus, whereby
to determine an initial estimated length for the
elongated body 157 of diagnostic push rod 109; the
diagnostic push rod 109 is then switched out as needed
until the proper length of elongated body 157 is
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 53 -
determined, whereupon the appropriately-sized
diagnostic push rod is replaced by the therapeutic
push rod 109.
It has also been found that by inserting the
substantially straight, substantially rigid elongated
body 157 into the coronary sinus adjacent to the
posterior leaflet of the mitral value, the patient's
left ventricle may also be remodeled so as to help
alleviate congestive heart failure.
It is significant to note that with the present
invention, the distal and proximal ends of the
substantially straight, substantially rigid elongated
body 157 apply a posteriorly-directed force on the
walls of coronary sinus 30 (e. g., as shown with arrows
P in Fig. 7), while the intermediate portion o~f the
substantially straight, substantially rigid elongated
body 157 applies an anteriorly-directed force on the
walls of coronary sinus 30 (e. g., as shown with arrows
A in Fig. 7).
In some cases the proximal end 130 (Fig. 3) of
delivery catheter 106 may be fixed to the patient's
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 54 -
outer skin using standard patient care methods such as
adhesive tape, pursestring sutures, skin staples, etc.
In other cases proximal end 130 of delivery catheter
106 may include a sewing cuff whereby the delivery
catheter may be secured to the patient's tissue by
suturing. See, for example, Fig. 8, where a sewing
cuff 166 is shown attached to the proximal end 130 of
delivery catheter 106. If desired, an element 169 may
be provided proximal to adjustable valve 133, whereby
flexible push rod 109 may be made fast to delivery
catheter 106 without using adjustable valve 133 (Fig.
3). By way of example, element 169 may comprise a
crimpable element to secure flexible push rod 109 to
delivery catheter 106, which is in turn secured to the
patient, e.g., with sewing cuff 166. If desired, the
proximal end of the assembly may be embedded under the
skin of the patient, e.g., in the case of a permanent
implant.
As noted above, it can be helpful to anchor the
distal end of delivery catheter 106 in position within
the coronary sinus prior to pushing push rod 109 into
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 55 -
the delivery catheter. Such an arrangement will keep
the delivery catheter in place as the substantially
straight, substantially rigid elongated body 157 makes
the turn within the right atrium and enters the
coronary sinus. In the absence of such anchoring, the
push rod may drive the delivery catheter down the
inferior vena cava 21. More particularly, by securing
the distal end of delivery catheter 106 to the walls
of coronary sinus 30, the delivery catheter can be
stabilized against diversion down the inferior vena
cava 21 when the substantially straight, substantially
rigid elongated body 157 encounters initial resistance
to making the turn into the coronary sinus. The
balloon 139 is one way of accomplishing such
anchoring. However, it is also possible to utilize
other types of securing mechanisms to anchor the
distal end 127 of delivery catheter 106 in position
within coronary sinus 30, e.g., spring clips, ribs,
etc.
If desired, the distal end 151 of push rod 109
may itself be provided with a distal anchor, e.g.,
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 56 -
such as the distal anchor 172 shown in Fig. 9. Such a
distal anchor on push rod 109 can help hold the
substantially straight, substantially rigid elongated
body 157 in proper position within coronary sinus 30.
It is also possible to prevent diversion of
delivery catheter 106 down inferior vena cava 21
without anchoring the distal end of delivery catheter
106 to the walls of the coronary sinus. More
particularly, and looking now at Fig. 10, there is
shown a support catheter 173 which is formed out of a
more rigid material than the flexible body 124 of
delivery catheter 106. Support catheter 173 is
constructed so that its distal end 174 can be
positioned in coronary ostium 27 and then its sidewall
174A can support delivery catheter 106 adjacent to
inferior vena cava 21 when push rod 109 is passed down
delivery catheter 106, whereby to prevent delivery
catheter 106 from diverting down inferior vena cava
106. Fig. 10 also shows an introducer catheter 174B
at the entrance to jugular vein 18.
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 57 -
In the preceding discussion of system 100, push
rod 109 is described as being advanced to the surgical
site through the delivery catheter 106 and remaining
within delivery catheter 106 while at the surgical
site and, when push rod 109 is to be removed, removing
push rod 109 and then delivery catheter 106. However,
if. desired, once push rod 109 has been deployed at the
surgical site, delivery catheter 106 may then be
removed, leaving just push rod 109 at the surgical
site. See, for example, Fig. 11.
It is also possible to advance push rod 109
directly to the surgical site without passing it
through a delivery catheter; in this case, push rod
109 would be advanced on its own through the
intervening vascular structure until it is deployed in
coronary sinus 30.
As noted above, as push rod 109 is advanced to
the region adjacent to the posterior annulus of the
mitral valve, the substantially straight,
substantially rigid elongated body 157 will distort
the natural configuration of the coronary sinus so
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 58 -
that it will assume a substantially straight
configuration. While this action induces the desired
valve remodeling, it can also induce a significant
stress on the walls of the coronary sinus,
particularly at the distal and proximal ends of the
substantially straight, substantially rigid elongated
body 157, where stress will be concentrated (see the
arrows P in Fig. 7). To this end, the construction of
the substantially straight, substantially rigid
elongated body 157 may be modified somewhat so as to
better distribute this stress.
More particularly, and looking next at Fig. 12,
the distal and proximal ends of substantially
straight, substantially rigid elongated body 157 may
include relatively flexible portions 175 to help
better distribute the stress exerted on the walls of
the coronary sinus. Additionally, and/or
alternatively, any taper applied to the distal and
proximal ends of substantially straight, substantially
rigid elongated body 157 may be elongated, e.g., such
as shown at 178 in Fig. 13, so as to better distribute
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 59 -
the stress imposed on the walls of the coronary sinus.
In one preferred form of the invention, and looking
now at Fig. 14, the substantially straight,
substantially rigid elongated body 157 may have
relatively long relatively flexible portions 175 with
relatively elongated tapers 178. If desired, each of
the relatively long, relatively flexible portions 175
with relatively elongated tapers 178 may be as long
as, or longer than, the substantially straight,
substantially rigid intermediate portion of elongated
body 157.
Looking next at Fig. 15, there is shown a system
181 which comprises another preferred embodiment of
the present invention. More particularly, system 181
generally comprises the guidewire 103, a substantially
straight, substantially rigid elongated body 184 and a
push cannula 187.
Guidewire 103 is as previously described.
Substantially straight, substantially rigid
elongated body 184, which is provided in a variety of
different lengths, comprises a distal end 188 and a
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 60 -
proximal end 190. A central lumen 193 extends between
distal end 188 and proximal end 190. Central lumen
193 accommodates guidewire 103.
Push cannula 187 comprises a distal end 194 and a
proximal end 196. A central lumen 199 extends between
distal end 194 and proximal end 196. Central lumen
199 accommodates guidewire 103.
System 181 may be used as follows to reduce
mitral regurgitation.
First, distal end 115 of guidewire 103 is passed
down jugular vein 18 (or the left subclavian vein 15)
of a patient, down superior vena cava 9, through right
atrium 24 of the heart, and along coronary sinus 30.
It will be appreciated that as flexible guidewire 103
is passed down coronary sinus 30, the guidewire will
tend to assume the natural curved shape of the
coronary sinus, due to the flexible nature of the
guidewire. The guidewire's atraumatic spring tip 121
will help minimize damage to vascular structures as
the guidewire is advanced into position.
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 61 -
Next, distal end 188 of substantially straight,
substantially rigid elongated body 184 is placed over
proximal end 118 of guidewire 103 and passed a short
distance down the guidewire. Then the distal end 194
of push cannula 187 is placed over proximal end 118 of
guidewire 103, and then push cannula 187 is advanced
down the guidewire. As push cannula 187 is advanced
down the guidewire, its distal end 194 pushes the
substantially straight, substantially rigid elongated
body 184 ahead of it. See Fig. 16.
As the substantially straight, substantially
rigid elongated body 184 is passed down the coronary
sinus, it will force the coronary sinus to assume a
substantially straight configuration at the point
where the substantially straight, substantially rigid
elongated body 184 currently resides. Push. cannula
187 is pushed down guidewire as needed, until the
substantially straight, substantially rigid elongated
body 184 is located adjacent to the posterior annulus
of the mitral valve. As this occurs, the presence of
the substantially straight, substantially rigid
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 62 -
elongated body 184 in the coronary sinus will cause
the coronary sinus to assume a substantially straight
configuration at this point, so that the posterior
annulus of the mitral valve is forced anteriorly.
This will cause the posterior mitral valve leaflet to
also move anteriorly so as to improve leaflet
coaptation and thereby reduce (or completely
eliminate) mitral valve regurgitation. Using standard
visualization means (e. g. echocardiography and/or
fluoroscopy), the exact position of the substantially
straight, substantially rigid elongated body may be
adjusted so as to reduce (or completely eliminate)
regurgitation in the mitral valve.
If desired, the push cannula 187 may be provided
with a releasably attachable interface (e.g., a
grasper) so that it may releasably secure the proximal
end 190 of the substantially straight, substantially
rigid elongated body 184. Such a feature will permit
the substantially straight, substantially rigid
elongated body to be pulled backward within the
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 63 -
coronary sinus, either for positioning or removal
purposes.
Thus it will be seen that with the present
invention, the substantially straight, substantially
rigid elongated body 184 is essentially force-fit into
the normally curved portion of the coronary sinus
adjacent to the mu ral valve's posterior leaflet. By
properly sizing the length of the substantially
straight, substantially rigid elongated body 184
relative to the natural curvature of the patient's
anatomy, and by properly positioning the substantially
straight, substantially rigid elongated body 184 in
the patient's coronary sinus, the substantially
straight, substantially rigid elongated body 184 will
cause at least a portion of the coronary sinus to
assume a substantially straight configuration adjacent
to the posterior leaflet 39 of the mitral valve 36.
This action will in turn drive the posterior annulus
of the mitral valve anteriorly, so as to improve
leaflet coaptation and thereby reduce mitral
regurgitation. Thus, by inserting the substantially.
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 64 -
straight, substantially rigid elongated body 184 into
the coronary sinus 30 adjacent to the posterior
leaflet 39 of the mitral valve 36, the annulus 33 of
the mitral valve is effectively manipulated so that it
will assume an increased radius of curvature.
As noted above, by properly sizing the length of
the substantially straight, substantially rigid
elongated body 184 relative to the natural curvature
of the patient's anatomy, and by properly positioning
the substantially straight, substantially rigid
elongated body 184 in the patient's coronary sinus,
the substantially straight, substantially rigid
elongated body 184 will cause at least a portion of
the coronary sinus to assume a substantially straight
configuration adjacent to the posterior leaflet 39 of
the mitral valve 36, whereby to drive the posterior
annulus of the mitral valve anteriorly, so as to
improve leaflet coaptation and thereby reduce mitral
regurgitation. To this end, the substantially
straight, substantially rigid elongated body 184 is
preferably provided as part of a kit having a
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 65 -
plurality of different substantially straight,
substantially rigid elongated bodies 184, each with a
differently-sized elongated body 184, whereby a
physician may select and deploy the
appropriately-sized elongated body 184 for a specific
patient's anatomy. Furthermore, if upon deployment it
should be discovered (e. g., under echocardiography
and/or fluoroscopy) that a different size of elongated
body 184 is needed, the first elongated body 184 may
be replaced by a second elongated body 184 having the
size needed to achieve the desired therapeutic result.
In one preferred form of the invention, a
diagnostic elongated body 184 may first be inserted
into the coronary sinus of the patient for the purpose
of initially determining the appropriate length of
elongated body 184 for that particular patient's
anatomy; again, a series of differently-sized
diagnostic elongated bodies may be sequentially
inserted into the patient's coronary sinus so as to
determine the preferred size of the therapeutic
elongated body 184. Thereafter, an
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 66 -
appropriately-sized therapeutic elongated body 184 may
be inserted into the coronary sinus so as to improve
leaflet coaptation and thereby reduce mitral
regurgitation.
Furthermore, prior to inserting a diagnostic
elongated body 184 into the coronary sinus of the
patient, the doctor may make a preliminary assessment
of the size of the coronary sinus for the purpose of
determining an initial estimated length for the
diagnostic elongated body 184. This may be done under
fluoroscopy using a guidewire 103 having radioopaque
markers thereon, or by inserting another device (e. g.,
a flexible element) into the coronary sinus, where
that device has radioopaque markers thereon, or in
other ways which will be apparent to those skilled in
the art. Using the radioopaque markers, the doctor
makes a preliminary assessment of the size of the
coronary sinus, whereby to determine an initial
estimated length for the diagnostic elongated body
184; the diagnostic elongated body 184 is then
switched out as needed until the proper length of
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 67 -
diagnostic elongated body 184 is determined, whereupon
the appropriately-sized diagnostic elongated body 184
is replaced by the therapeutic elongated body 184.
As also noted above, as the substantially
straight, substantially rigid elongated body 184 is
advanced to the region adjacent to the posterior
annulus of the mitral valve, the substantially
straight, substantially rigid elongated body 184 will
distort the natural configuration of the coronary
sinus so that it will assume a substantially straight
configuration. While this action induces the desired
valve remodeling, it can also induce a significant
stress on the walls of the coronary sinus,
particularly at the distal and proximal ends of the
substantially straight, substantially rigid elongated
body 184, where stress will be concentrated (see, for
example, the arrows P in Fig. 7). To this end, the
construction of the substantially straight,
substantially rigid elongated body 184 may be modified
somewhat so as to better distribute this stress.
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 68 -
More particularly, and looking next at Fig. 17,
the distal and proximal ends of substantially
straight, substantially rigid elongated body 184 may
include relatively flexible portions 188A, 190A to
help better distribute the stress exerted on the walls
of the coronary sinus. Additionally, and/or
alternatively, any taper applied to the distal and
proximal ends of substantially straight, substantially
rigid elongated body 184 may be elongated, e.g., such
as shown at 188B, 1908 in Fig. 18, so as to better
distribute the stress imposed on the walls of the
coronary sinus. In one preferred form of the
invention, and looking now at Fig. 19, the
substantially straight, substantially rigid elongated
body 184 may have relatively long relatively flexible
portions 188A, 190A with relatively elongated tapers
188B, 190B. If desired, each of the relatively long,
relatively flexible portions 188A, 190A with
relatively elongated tapers 188B, 190B may be as long
as, or longer than, the substantially straight,
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 69 -
substantially rigid intermediate portion of elongated
body 184.
In the preceding discussion, elongated body 157
(or 184) is generally described as being substantially
straight and substantially rigid, with or without
relatively flexible portions 175 (Fig. 12) (or 188A,
190A, Fig. 17) and/or tapers 178 (Fig. 13) (or 188B,
190B, Fig. 18) and/or elongated relatively flexible
tapered portions 175, 178 (Fig. 14) (188A, 188B, 190A,
190B, Fig. 19). However, it should be appreciated
that the terms "substantially straight",
"substantially rigid", "relatively flexible" and the
like are meant to be interpreted in the context of the
anatomical tissue involved and should not be
interpreted in an absolute sense.
Fundamentally, elongated body 157 (or 184) is
constructed so that (1) its intermediate portion
imparts an anteriorly-directed force on the walls of
the coronary sinus (e.g., as shown by the arrows A in
Fig. 7), and (2) its distal and proximal ends impart a
posteriorly-directed force on the walls of the.
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 70 -
coronary sinus (e. g., as shown by the arrows P in Fig.
7). Conversely, a high center load Z1 (Fig. 20) is
imparted to the intermediate portion of elongated body
157 (or 184) by the mitral annulus, and smaller end
loads L2 (Fig. 20) are directed to the distal and
proximal ends of elongated body 157 (or 184) by the
posterior portions of the coronary sinus.
Among other things, such an effect can be created
by using an elongated body 157 (or 184) which is (1)
straighter (but not necessarily perfectly straight)
than the natural curvature of the portion of the
coronary sinus adjacent to the posterior leaflet of
the mitral annulus, and (2) more rigid (but not
necessarily perfectly rigid) than the anatomical
tissue which is to be displaced by the deployed
elongated body 157 (or 184).
As noted above, in order to better distribute the
loads on the proximal portions of the coronary sinus,
the distal and proximal ends of elongated body 157 (or
184) may have relatively flexible portions 175 (Fig.
12) (or 188A, 190A, Fig. 17) and/or tapers 178 (Fig.
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 71 -
13) (or 188B, 190B, Fig. 18) and/or elongated
relatively flexible tapered portions 175, 178 (Fig.
14) (188A, 188B, 190A, 190B, Fig. 19). Furthermore,
the flexibility of these portions 175 (188A, 190A),
178 (188B, 190B) and/or 175, 178 (188A, 188B, 190A,
190B) can vary along their length; thus, the elongated
relatively flexible tapered portions 175, 178 (Fig.
14) (188A, 188B, 190A, 190B, Fig. 19) can become more
flexible as they extend toward their outer ends.
Indeed, there is nothing in the present invention
which requires that the intermediate portion of
elongated body 157 (or 184) be absolutely rigid; in
fact, it will function satisfactorily so long as it is
substantially resistive to the high center load h1
(Fig. 20) imposed by the mitral annulus. The design
is further enhanced by having the distal and proximal
ends of elongated body 157 (or 184) be somewhat less
resistive to the smaller end loads L2 (Fig. 20)
directed by the posterior walls of the coronary sinus.
Thus, a satisfactory design may be implemented with a
device which has a rigidity gradient along its length,
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
with a highest rigidity at or near the center and
lower rigidity at or near its two ends (or,
conversely, a flexibility gradient along its length,
with a lowest flexibility at or near the center and a
higher flexibility at or near its two ends). This may
be accomplished by tapering the elongated body; and/or
by varying its composition and/or material properties;
and/or by other techniques which will be apparent to a
person skilled in the art in view of the present
disclosure. Or a satisfactory design may be
implemented with a device which has some degree of
flexibility along its entire length; and this
flexibility may vary with length or it may be
substantially constant along the entire length of the
elongated body 157 (or 184).
Thus, as noted above, a satisfactory design may
be implemented with an elongated body 157 (or 184)
which is straighter (but not necessarily perfectly
straight) than the natural curvature of the portion of
the coronary sinus adjacent to the posterior leaflet
of the mitral annulus, and (2) more rigid (but not
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 73 -
necessarily perfectly rigid) than the anatomical
tissue which is to be displaced by the deployed
elongated body 157 (or 184).
In other alternative embodiments, the elongated
body 157, 184 may be formed by two or more
substantially straight, substantially rigid segments R
connected together by one or more flexible segments F.
See, for example, Figs. 21 and 22, which shows such a
construction. By varying the relative lengths of
segments R and F, and by varying the relative rigidity
of substantially rigid segments R and by varying the
relative flexibility of flexible segments F, superior
annulus displacement may be effected, whereby to
better reduce mitral regurgitation.
Figs. 23 and 24 show another preferred
construction, where substantially straight,
substantially rigid elongated body 157, 184 comprises
a plurality of segments S1, S3 and S3; where segment S1
is configured to have a selected degree of
flexibility, segments S2 are configured to have a lower
degree of flexibility than segment, and segments S3 are
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 74 -
configured to have a higher degree of flexibility than
segment S1. Segments S1, S~ and S3 may be formed
integral with one another or they may be connected
together by joints. As a result of this construction,
segment S1 will carry the load of reconfiguring the
mu ral annulus, segments S2 will transfer that load far
outboard to segments S3, and segments S3 will dissipate
that load outboard to the side walls of the coronary
sinus. In one preferred form of the invention,
segment S1 is constructed so as to have a degree of
flexibility which will support the remodeling ~of the
mitral annulus yet permit the segment S1 to roughly
conform to the arc of curvature of the mu ral annulus
at the point of engagement; the segment S2 is
constructed so as to have a degree of flexibility
sufficiently low so that substantially all of the load
generated by the remodeling of the mitral annulus will
be transferred to the segments S3; and the segments S2
have a length sufficiently long that
posteriorly-directed forces on the walls of the
coronary sinus (e. g., as shown by the arrows P in Fig.
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 75 -
7) will be applied substantially proximal and distal
of the valve commissures. In this fashion a purely
straightening effect applies outward pressure that
tensions the fibrous continuity of the base of the
heart rather than between the commissures where such
forces might tend to induce regurgitation. Among
other things, such a construction has been formed to
center itself naturally in the region around the
posterior leaflet and conforms naturally to the
curvature of the posterior leaflet. If desired, such
a "5-zone" elongated body can be formed out of a
single material, with different diameters being used
to create the different body zones.
Thus it will be seen that in various alternative
embodiments, the elongated body 157 and/or 184 may be
flexible along at least a portion of its length.
Regional flexibility and regional stiffness may allow
for straightening of select locations of the coronary
sinus and corresponding locations of the posterior
mitral annulus. This can cause regions of the mitral
annulus to move anteriorly, thus causing regional
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 76 -
improvements in leaflet coaptation. In addition, the
elongated body may be formed by two end segments
connected together by a filament: by anchoring the two
end segments relative to the anatomy and pulling the
filament taught, the naturally curved wall of the
coronary sinus can be straightened, whereby to move
the posterior mitral annulus anteriorly and thereby
reduce mitral regurgitation.
By varying the rigidity of elongated body 157,
184, it is possible to effect a range of anatomical
changes to the mitral valve. More particularly, Fig.
25 shows a normal mitral valve 36 where the leaflets
39, 42 adequately coapt, and Fig. 26 shows a
regurgitant mitral valve 36 where the leaflet 39, 42
do not adequately,coapt.
Where the central portion of elongated body 157,
184 is large and substantially absolutely rigid
relative to the anatomy, and the two ends of elongated
body 157, 184 terminate in relatively flexible
sections (e.g., a construction such as is shown in
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
_ 77 _
Figs. 14 and 19), anatomical displacement can be
substantially as that shown in Figs. 27 and 28.
Where elongated body 157, 184 has a bar with some
flexibility at both its center S1 and its two ends S3,
and relative inflexibility in the connecting portions
SZ (e.g., a construction such as is shown in Figs. 23
and 24) it can be made to provide a flexible sling for
supporting the annulus and making a gentle engagement
with the walls of the coronary sinus, such as that
shown in Figs. 29 and 30. In one preferred form of
the invention, elongated body 157, 184 has its
flexibility tailored along its length so that it
closely conforms to the geometry of the natural
annulus, whereby to move the posterior annulus (and
hence the posterior leaflet) towards the anterior
leaflet while supporting the posterior annulus in its
natural curvature, such as that shown in Figs. 31 and
32.
In one preferred construction, the elongated body
157, 184 has its geometry and flexibility tailored'so
that the posteriorly directed forces on the walls of
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
_ 78 _
the coronary sinus (e.g., as shown by the arrows P in
Fig. 7) will be applied in locations primarily
proximal and distal of the anterior and posterior
commissures respectively. See, for example, Figs. 30
and 32, which show how the illustrated constructions
impart their forces on the patient's anatomy, i.e.,
the intermediate portions imparting the
anteriorly-directed force on the walls of the coronary
sinus (as shown by the arrows A) and the distal and
proximal ends imparting the posteriorly-directed force
on the walls of the coronary sinus (as shown by the
arrows P). By applying the posteriorly-directed
forces P in the area of the valve commissures,
side-jetting in the region of the commissures is
minimized and superior leaflet coaptation attained.
In addition to the foregoing, it will be
appreciated that the amount of force applied t.o the
mitral annulus will be a function of the size and
geometry of elongated body 157, 184 and its
flexibility. In one preferred form of the invention,
it is preferred that the size, geometry and resiliency
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 79 -
of the elongated body 157, 184 be such that a
relatively high force (e. g., approximately 2-5 pounds
of force) will be applied to the central section of
the mitral annulus, whereby substantially complete
remodeling will typically be achieved immediately upon
insertion of the elongated body 157, 184 into the
coronary sinus. In another preferred form of the
invention, it is preferred that the size, geometry and
resiliency of the elongated body 157, 184 be such that
a significantly lesser force (e.g., apprdximately 1-3
pounds of pressure) will be applied to the mitral
annulus, whereby only partial remodeling will
typically be achieved immediately upon insertion of
the elongated body 157, 184 into the coronary sinus;
however, by forming elongated body 157, 184 out of a
sufficiently resilient or preferably superelastic
material such as Nitinol, the elongated body will
thereafter continue to apply a remodeling force to the
mitral annulus, even in the case where the anatomy
begins to move in response to the applied load, thus
gradually effecting the complete remodeling desired.
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 80 -
In this latter situation, were elongated body
157, 184 is formed out of a resilient material and the
desired valve remodeling is to be gradually effected
over time, it is frequently desirable that the force
applied by elongated body 157, 184 remain relatively
constant over time. To this end, certain materials
may be more desirable than other materials. More
particularly, and looking next at Fig. 33, there is
shown a schematic illustration showing the force
deformation curve for two material, Nitinol and
stainless steel. As seen in Fig. 33, as Nitinol is
deformed during initial implantation and then relaxed.
during subsequent tissue remodeling, it applies a
relatively constant force to the tissue; however, as
stainless steel is deformed and then relaxed, it
applies a widely changing force to the tissue. Thus,
it is generally desired that elongated body 157, 184
be formed at least in part out of Nitinol or other
superelastic material.
In addition to the foregoing, elongated body 157
and/or 184 may have any of a variety of non-straight
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 81 -
shapes along its length. For example, the elongated
body maybe wavy, spiraled, or curved along all or a
portion of its length. By way of example, elongated
body 157 and/or 184 may have a curved configuration so
as to invert the natural curvature of the coronary
sinus, i.e., so that it is bowed towards the anterior
annulus. Or the elongated body may have a compound
shape along its length, e.g., it may have a sort of
"w" shape, with the center of the "w" being directed
towards the anterior annulus. Any of these or other
alternate shapes may effect the anterior displacement
of the posterior annulus that results in reduction of
the mitral valve regurgitation.
Referring next to Figs. 34-36, it will be seen
that the elongated body 157 and/or 184 may be provided
with annular ribs 200 extending radially outwardly
(Figs. 34 and 35) from the body 157, 184. The ribs
200 engage the walls of delivery catheter 106 or,
where delivery catheter 106 is not used or where
delivery catheter 106 has been previously removed, the
walls of the coronary sinus 30, so as to mitigate
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 82 -
against migration of the body 157, 184 over time. The
ribs 200 may also be defined by annular grooves 202
(Fig. 36) in the body 157, 184, in which case
circumferential surfaces 204 of the ribs 200 are
coincident with the body circumferential surface 205.
The ribs 200 may be provided with substantially flat
circumferential edges 206 (Figs. 34 and 36) or with
circumferential edges 207 of a generally
frusto-conical configuration (Fig. 35). In the latter
case, it is preferred that the slopese208 of the edges
207 of some of the ribs 200 be facing a proximal
direction, while the slopes 208 of the remaining ribs
face a distal direction (Fig. 35). In the case where
elongated body 157, 184 includes flexible portions 175
(Fig. 12) (or 188A, 190A, Fig. 17) and/or tapers 178
(Fig. 13) or (188B, 1908, Fig. 18), and or elongated
relatively flexible tapered portions 175, 178 (Fig.
14) (or 188A, 188B, 190A, 190B, Fig. 19), ribs 200 may
be formed on these structures as well.
In Fig. 37, there is shown an alternative
embodiment in which a stabilizing scaffold 210 is used
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 83 -
in combination with the elongated body 157, 184 shown
in Fig. 34. In this embodiment, the stabilizing
scaffold 210 comprises a generally cylindrical spar
frame which is placed in the coronary sinus where it
engages, and is securely anchored to, the walls of the
coronary sinus, and thereafter, the elongated body
157, 184 (with the ribs 200 thereon) is placed in the
stabilizing scaffold 210. The ribs 200 of,the
elongated body 157, 184 engage portions of the
stabilizing scaffold 210 such that the elongated body
is securely anchored in place in the coronary sinus
30. For example, where stabilizing scaffold 210
comprises openings between the spars of its frame,
ribs 200 can interact with the spars and openings to
help lock the elongated body 157, 184 to stabilizing
scaffold 210.
Mare particularly, with this form of the
invention, stabilizing scaffold 210 is securely
anchored to the walls of the coronary sinus (e.g., by
outward expansion, and/or by tissue penetration into
scaffold openings, and/or by barbs carried by the
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 84 -
scaffold, etc.), and the elongated body 157, 184 (with
the ribs 200 thereon) is securely anchored to
stabilizing scaffold 210 (e. g., by rib-to-scaffold
engagement), whereby to (1) help secure the elongated
body 157, 184 against longitudinal migration, whereby
to provide maintainable reductions in mu ral
regurgitation, and/or (2) help support the coronary
sinus 30 at the point where the greatest load L1 (Fig.
20) is imposed on the coronary sinus, and/or (3) help
distribute the concentrated end loads L2 (Fig. 20) of
the elongated body 157, 184 to a larger region of the
coronary sinus, whereby to minimize trauma to the host
blood vessel, and/or (4) help limit conformational
changes to the cross-section of the blood vessel in
response to the loads applied to the inside of the
blood vessel, whereby to ensure reliable blood flow
and minimize vascular trauma. In this respect it
should be appreciated that the coronary sinus
generally has differing characteristics (e. g.,
diameter, wall firmness, etc.) along its length, and
the stabilizing scaffold 210 can be correspondingly
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 85 -
engineered to exhibit differing characteristics along
its own length. By way of example but not limitation,
stabilizing scaffold 210 can have a smaller diameter
at its distal end and a larger diameter at its
proximal end, in order to correspond to the typical
geometry of the coronary sinus. By way of further
example but not limitation, stabilizing scaffold 210
might be engineered to provide greater support at the
proximal end of the coronary sinus (where the vein is
frequently relatively soft) and lesser support at the
distal end of the coronary sinus (where the vein is
frequently relatively firm).
In one form of the invention, where elongated
body 157 is to be placed inside the stabilizing
scaffold 210 in the coronary sinus 30, the guidewire
103 in first advanced into the coronary sinus, as
described hereinabove. A scaffold-deploying catheter
212 having the stabilizing scaffold 210 therein (Fig.
38) is advanced along the guidewire 103 into the
coronary sinus. When the stabilizing scaffold 210 is
in the desired location in the coronary sinus, a
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 86 -
bumper 214, riding-on the guidewire 103, is engaged
with the stabilizing scaffold, and the
scaffold-deploying catheter 212 is pulled back
sufficiently to deploy the stabilizing scaffold 210,
and then is withdrawn, along with the bumper 214,
leaving the stabilizing scaffold 210 and the guidewire
103 in place within coronary sinus 30. The delivery
catheter 106 is then passed along the guidewire 103
until the distal end of the delivery catheter is
positioned in the coronary sinus and within the
stabilizing scaffold. Once the delivery catheter 106
has been positioned within the coronary sinus and
within the stabilizing scaffold, the guidewire 103 is
removed. The push rod 109 is then passed through the
central lumen 136 of the delivery catheter 106 until
the elongated body 157 is located adjacent to the
posterior annulus of the mitral valve 36 and within
stabilizing scaffold 210. The delivery catheter 106
is then withdrawn, whereupon the body ribs 200 engage
the stabilizing scaffold, as described above, leaving
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
_ 87 _
the push rod 109 in place, with the elongated body 157
locked in the stabilizing scaffold 210.
In another form of the present invention, where
elongated body 184 is to be placed inside the
stabilizing scaffold 210 in the coronary sinus, the
guidewire 103 is advanced into the coronary sinus, as
described hereinabove. The scaffold-deploying
catheter 212, with the stabilizing scaffold 210
therein, is mounted on the guidewire 103 and is
advanced into the coronary sinus 30. Then, with the
bumper 214 holding the stabilizing scaffold 210 in
place, the scaffold-deploying catheter 212 is pulled
back sufficiently to deploy the stabilizing scaffold
210, and then is withdrawn, along with the bumper 214,
leaving the guidewire 103 and the stabilizing scaffold
210 in place. The body 184 and the push cannula 187
are then advanced over the guidewire 103 until the
elongated body 184 is disposed in the stabilizing
scaffold 210. The push cannula 187 and guidewire 103
are then withdrawn, leaving the elongated body 184 and
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
_ 88 _
stabilizing scaffold 210 in place, with the elongated
body 184 locked in the stabilizing scaffold.
Referring to Fig. 39, it will be seen that the
greatest load (L1) on the elongated body 157, 184 and
the stabilizing scaffold 210 is at the mid-portion
thereof, mitigating against migration of the
stabilizing scaffold, and therefore the body 157, 184,
either distally or proximally.
Looking next at Figs. 40 and 41, it will also be
seen that the elongated body 157, 184 can have a
diameter substantially less than the diameter of
stabilizing scaffold 210. In this case, stabilizing
scaffold 210 can be provided with a guide 211 for
receiving the elongated body 157, 184. By way of
example, guide 211 may comprise a hollow tube formed
on the inside wall of stabilizing scaffold 210, with
guide 211 being sized to receive the elongated body
157, 184 and secure it relative to stabilizing
scaffold 210. If desired, stabilizing scaffold 210
may terminate short of the ends of elongated body 157,
184, e.g., such as is shown in Figs. 40, 41.
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 89 -
Alternatively, stabilizing scaffold 210 may
co-terminate with the ends of elongated body 157, 184,
e.g., in the manner shown in Figs. 42 and 43, or
stabilizing scaffold 210 may extend beyond the. ends of
elongated body 157, 184, e.g., in the manner shown in
Figs. 44 and 45.
In one preferred method for using the stabilizing
scaffold 210 and the elongated body 157, 184 of Figs.
40, 41, or Figs. 42, 43, or Figs. 44, 45, the
stabilizing scaffold 210 may first be deployed using a
scaffold-deploying catheter 212 and bumper 214 similar
to that shown in Fig. 38, except modified so that
guidewire 103 is off-center so as to extend through
the stabilizing scaffold's guide 211, e.g., in the
manner shown in Fig. 46. The stabilizing scaffold 210
is first deployed in the manner described above, and
the guidewire 103 is used to load elongated body 157,
184 into position within the coronary sinus, including
through the stabilizing scaffold's guide 211.
In another construction, and looking now ~at Fig.
47, elongated body 157, 184 may be pre-loaded into the
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 90 -
stabilizing scaffold's guide 211 when the stabilizing
scaffold is loaded into scaffold-deploying catheter
212; with this construction, the stabilizing scaffold
210 and the elongated body 157, 184 are simultaneously
deployed in the coronary sinus.
As shown in Fig. 48, the body 157, 184 may be
formed as a portion of the stabilizing scaffold 210,
with the stabilizing scaffold portion of the
combination being located at the mid-portion of the
body 157, 184, where the coronary sinus imposes the
greatest load L1, which is the load of the
therapeutically-displaced coronary sinus. Again,
stabilizing scaffold 210 may terminate short of the
ends of elongated body 157, 184 (Fig. 48), or
stabilizing scaffold 210 may co-terminate with the
ends of elongated body 157, 184 (Fig. 49), or
stabilizing scaffold 210 may extend beyond the ends of
elongated body 157, 184 (Fig. 50).
In another embodiment shown in Figs. 51 and 52,
the combination of elongated body 157, 184 and
stabilizing scaffold 210 includes two or more
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 91 -
scaffold portions, such as portions 210A and 210B,
portion 210A disposed in a mid-portion of the
combination, and portion 210B extending through the
portion 210A and extending end-wise therefrom,
defining end portions having greater resiliency. The
body 157, 184 is fixed to the generally
cylindrically-shaped scaffold portion 210A located in
the mid-portion of the body 157, 184, and to the
half-cylindrical scaffold end portions 210B. The
mid-portion 210A, which is the strongest portion of
the combination of elongated body and stabilizing
scaffold, is the portion resisting the greatest load
Z1.
In Figs. 53 and 54, there is shown an alternative
embodiment in which an elongated body 157, 184 has
fixed thereto a series of ribs 215 in two lines of
ribs. As may be seen in Fig. 54, the lines of ribs
215 are preferably offset from each other, such that a
rib on one side of the elongated body 157, 184 is not
opposite a rib on the other side of the elongated
body. This permits the ribs 215 to be flexed toward
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 92 -
the opposite side without engaging a rib of the
opposite side. The flexing of the ribs permits the
ribs to be compressed for disposition in a catheter.
In Fig. 55 there is shown an alternative
construction similar to that of Fig. 54, but showing
the ribs 215 connected to a spine 216, and with the
spine 216 being cannulated so as to receive elongated
body 157, 184 therein.
In Fig. 56 there is shown an alternative
combination elongated body and scaffold assembly in
which the stabilizing scaffold 210 includes elongated
body portions 157, 184 in the form of rods integral
with the scaffold. In the embodiment shown in Fig.
56, at least one body portion 157, 184 extends from
end to end of the assembly, while other body portions
157, 184 extend only through a mid-portion of the
assembly. Thus, the end portions of the assembly are
less rigid than the mid-portion thereof.
Referring to Fig. 57, it will be seen that the
body 157, 184 may comprise only stabilizing scaffolds,
for example stabilizing scaffolds 210', 210" , and
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 93 -
210" ' arranged telescopically, such that the
mid-portion includes all three stabilizing scaffolds
210', 210" , and 210" ', portions immediately outboard
of the mid-portion include the stabilizing scaffolds
210" and 210 " ', while end portions comprise only
stabilizing scaffolds 210"'. Thus, the mid-portion
of the body 157, 184 is the most resistant to
movement, while the end portions are the least
resistant, with zones at stabilizing scaffolds 210"
exercising less resistance than the.mid-portion but
greater than the end portions.
Looking next at Figs. 58-60, there is shown an
alternative combination of elongated body and scaffold
assembly, wherein the elongated body comprises a
5-zone elongated body 157, 184 of the sort shown in
Figs. 23 and 24, and the scaffold comprises three
supporting scaffolds, each of the sort shown in Figs.
40-47, i.e., having a guide 211 for receiving the
elongated body 157, 184. More particularly, the
5-zone elongated body 157, 184 comprises a plurality
of segments S1, S2 and S3, where segment S1 is
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 94 -
configured to have a selected degree of flexibility,
segments Sa are configured to have a lower degree of
flexibility than segment S1, and segments S3 are
configured to have a higher degree of flexibility than
segment S1. As a result of this construction, segment
S1 will carry the load of reconfiguring the mitral
annulus, segments S2 will transfer that load far
outboard to segments S3, and segments S3 will dissipate
that load outboard to the side walls of the coronary
sinus. In a preferred form of the invention, segment
S1 is constructed so as to have a degree of flexibility
which will support the remodeling of the mitral
annulus yet permit the segment S1 to roughly conform to
the arc of curvature of the mitral annulus at the
point of engagement; the segment S~ is constructed so
as to have a degree of flexibility sufficiently low so
that substantially all of the load generated by the
remodeling of the mitral annulus will be transferred
to the segments S3; and the segments S2 have a length
sufficiently long that posteriorly-directed forces on
the walls of the coronary sinus (e.g., as shown by the
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 95 -
arrows P in Fig. 7) will be applied in the area of the
valve commissures. Supporting scaffolds 210 are
positioned in coronary sinus 30 so that one scaffold
210 receives segment S1, one scaffold 210 receives one
segment S~, and the one scaffold 210 receives the other
segment S3. Elongated body 157, 184 may be deployed at
the same time as supporting scaffolds 210 or after
supporting scaffolds 210 have been deployed.
Preferably segments S3 are able to slide in scaffold
guides 211, particularly where elongated body 157, 184
is designed to effect tissue remodeling gradually,
over a prolonged period of time. Among other things,
such a construction has been formed t~ center itself
naturally in the region around the posterior leaflet
and conforms nicely to the curvature of the posterior
leaflet. If desired, such a "5-zone" elongated body
can be formed out of a single material, with different
diameters being used to create the different body
zones.
CA 02526110 2005-11-16
WO 2004/105584 PCT/US2004/016472
- 96 -
It should also be appreciated that scaffold 210
may have a stmt-like configuration or may have
rib-like configuration as shown in Figs. 53 and 54.
Looking next at Figs. 61-63, there is shown a
combination elongated body and scaffold assembly
similar to -that shown in Figs. 58-60, except that the
guide 211 extends between each of the scaffold zones
so as to form a singular scaffold structure which has
three zones engaging the walls of the coronary sinus.
There are thus provided varied stabilizing
scaffold configurations for preventing migration of
the substantially straight, substantially rigid
elongated bodies, and combinations of bodies and
stabilizing scaffolds for similarly preventing, or
mitigating against, such migration.
It is to be understood that the present invention
is by no means limited to the particular constructions
herein disclosed andJor shown in the drawings, but
also comprises any modifications or equivalents within
the scope of the claims.
