U.S. patent application number 15/387415 was filed with the patent office on 2017-04-06 for method and apparatus for reshaping a ventricle.
This patent application is currently assigned to Edwards Lifesciences Corporation. The applicant listed for this patent is Edwards Lifesciences Corporation. Invention is credited to Stanton J. Rowe.
Application Number | 20170095333 15/387415 |
Document ID | / |
Family ID | 39275576 |
Filed Date | 2017-04-06 |
United States Patent
Application |
20170095333 |
Kind Code |
A1 |
Rowe; Stanton J. |
April 6, 2017 |
METHOD AND APPARATUS FOR RESHAPING A VENTRICLE
Abstract
Methods are provided for reshaping the left ventricle to a more
conical shape to counter the effects of dilation, thereby improving
pumping efficiency. In an exemplary embodiment, a reshaping
apparatus comprises an implantable body that can be delivered to a
dilated left ventricle via the patient's vasculature in a
minimally-invasive procedure. When deployed inside the left
ventricle, the implantable body applies a longitudinal (downward)
force against the inner surface of the left ventricle, thereby
causing the left ventricle to distend or elongate downwardly. The
implantable body preferably includes an anchor which is deployed
adjacent the mitral valve for maintaining the longitudinal force
against the inner surface of the left ventricle.
Inventors: |
Rowe; Stanton J.; (Newport
Coast, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Edwards Lifesciences Corporation |
Irvine |
CA |
US |
|
|
Assignee: |
Edwards Lifesciences
Corporation
Irvine
CA
|
Family ID: |
39275576 |
Appl. No.: |
15/387415 |
Filed: |
December 21, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14524950 |
Oct 27, 2014 |
9561105 |
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15387415 |
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13252060 |
Oct 3, 2011 |
8870936 |
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14524950 |
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11695583 |
Apr 2, 2007 |
8029556 |
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13252060 |
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60849242 |
Oct 4, 2006 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/2418 20130101;
A61F 2230/0041 20130101; A61F 2/95 20130101; A61F 2/2466 20130101;
A61F 2/2487 20130101; A61F 2/06 20130101; A61F 2/2445 20130101;
A61F 2/2481 20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. An apparatus for altering a shape of a heart comprising: a
tension member having first and second end portions; a first anchor
member connected to the first end portion of the tension member and
comprising a plurality of radially self-expanding tissue engaging
members that are configured to anchor themselves to tissue of an
inner wall at a first location inside the heart; and a second
anchor member connected to the second end portion of the tension
member and comprising a plurality of radially self-expanding tissue
engaging members that are configured to anchor themselves to tissue
of an inner wall at a second location inside the heart; wherein
when the tension member is placed in tension between the first and
second anchor members, the inner walls are drawn toward each other
to alter a shape of the heart.
2. The apparatus of claim 1, wherein the tension member comprises a
suture line.
3. The apparatus of claim 1, wherein the anchor members are
self-deploying.
4. A method for reshaping a dilated ventricle of a patient
comprising: positioning a tension member having first and second
ends in the ventricle; securing the first end of the tension member
to a first inner wall of the ventricle and securing the second end
of the tension member to a second inner wall of the ventricle; and
tensioning the tension member to draw the inner walls toward each
other.
5. The method of claim 4, wherein the tension member comprises a
suture line.
6. The method of claim 4, wherein the first and second ends of the
tension member are secured to the inner walls with respective
expandable anchor members.
7. The method of claim 6, wherein each anchor member comprises
radially expandable prongs that grab the tissue of the inner walls
to secure the ends of the tension member in place.
8. The method of claim 4, wherein: the tension member comprises a
first tension member; and the method further comprises securing the
first end of a second tension member to the first inner wall,
securing a second end of the second tension member to the second
inner wall, tensioning the second tension member, and connecting
the first and second tension members to each other at a location
between the inner walls.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a divisional of U.S. application
Ser. No. 14/524,950, filed Oct. 27, 2014, which is a continuation
of U.S. application Ser. No. 13/252,060, filed Oct. 3, 2011, now
U.S. Pat. No. 8,870,936, which is a continuation of U.S.
application Ser. No. 11/695,583, filed Apr. 2, 2007, now U.S. Pat.
No. 8,029,556, which claims the benefit of U.S. Provisional
Application No. 60/849,242, filed Oct. 4, 2006.
FIELD
[0002] The present invention relates to medical devices and methods
and, more particularly, to a medical device and method for treating
a dilated ventricle.
BACKGROUND
[0003] A healthy left ventricle of a human heart, which is the
primary pumping chamber, is generally conical or apical in shape in
that it is longer (along a longitudinal axis extending in a
direction from the aortic valve to the apex) than it is wide (along
a transverse axis extending between opposing walls at the widest
point of the left ventricle) and descends from a base with a
decreasing cross-sectional circumference to a point or apex. The
pumping of blood from the left ventricle is accomplished by a
squeezing motion and a twisting or torsional motion.
[0004] The squeezing motion occurs between the lateral wall of the
left ventricle and the septum. The twisting motion is a result of
heart muscle fibers that extend in a circular or spiral direction
around the heart. When these fibers contract, they produce a
gradient of angular displacements of the myocardium from the apex
to the base about the longitudinal axis of heart. The resultant
force vectors extend at angles from about 30 to 60 degrees to the
flow of blood through the aortic valve. The contraction of the
heart is manifested as a counterclockwise rotation of the apex
relative to the base, when viewed from the apex. A healthy heart
can pump blood from the left ventricle in a very efficient manner
due to the spiral contractility of the heart.
[0005] Chronic congestive heart failure and other disease processes
can cause the heart to enlarge or dilate from a conical shape to a
shorter and wider shape, which in turn causes the muscle fibers to
become reoriented. As a result of the dilation, the orientation of
the muscle fibers produces lines of force directed generally
laterally of the left ventricle at about 90 degrees relative to the
outward flow of the blood. Hence, blood is pushed inwardly (toward
the center of the left ventricle), rather than at an acute angle
relative to the outward blood flow, thereby greatly reducing the
pumping efficiency of the left ventricle. In a similar manner,
dilation of the heart also can adversely affect the function of the
right ventricle.
[0006] A variety of treatment procedures have been proposed over
the years for treating left ventricular dilatation. However, these
procedures typically involve radical open-heart surgeries designed
to surgically reduce the volume of the left ventricle. In recent
years, several new minimally invasive techniques for improving
heart function have been proposed that do not require opening the
chest or cardiopulmonary by-pass. However, none of these procedures
has gained widespread acceptance and most fail to address the
underlying cause of the problem.
[0007] Accordingly, an urgent need exists for a new device and
method for treating left ventricular dilatation.
SUMMARY
[0008] According to one aspect, the present disclosure concerns
embodiments of a reshaping apparatus and methods for restoring the
conical shape of a dilated heart ventricle, or at least reshaping
the ventricle to a more conical shape to counter the effects of
dilation, thereby improving pumping efficiency. In particular
embodiments, the left ventricle is reshaped in a non-surgical or
minimally-invasive procedure without opening the chest or
cardiopulmonary by-pass. The shape of the left ventricle can be
altered by applying a longitudinal force to the apex of the left
ventricle to move the apex downward (relative to the base of the
heart), such as by pushing or pulling the apex downwardly. By
applying such a force (i.e., pushing or pulling) on the apex, the
left ventricle becomes longer and thinner and thereby achieves a
more conical shape. As a result, the muscle fibers are better
oriented to accomplish torsional motion of the heart, thereby
increasing the efficiency and work capability of the left
ventricle. The embodiments disclosed herein can also be used to
reshape a dilated right ventricle of the heart.
[0009] A reshaping device according to one exemplary embodiment
comprises an implantable body that can be delivered to a dilated
left ventricle via the patient's vasculature in a
minimally-invasive procedure. When deployed inside the left
ventricle, the body is adapted to apply a longitudinal (downward)
force against the inner surface of the left ventricle that causes
the ventricle to distend or elongate downwardly relative to the
base of the heart so as to at least partially restore the conical
shape of the heart. The body can include a radially compressible
and expandable anchor member and an elongated pusher that extends
from the anchor member. The anchor member can have a configuration
similar to that of a conventional stent and can be deployed within
the left ventricular outflow tract, for example just below the
aortic valve. Once deployed, the pusher member extends downwardly
from the anchor member and has a distal end portion that engages
and pushes against the inner surface of the left ventricle.
[0010] In one alternative embodiment, the reshaping device may
comprise an elongate pusher member and an anchor member configured
to apply a lateral force against the surrounding tissue, which is
effective to move the anterior leaflet of the mitral valve toward
the posterior leaflet for improving leaflet coaption, thereby
reducing or eliminating mitral valve regurgitation. In another
embodiment, the reshaping device may comprise an elongate pusher
member and an anchor member in the form of a prosthetic valve
assembly configured for deployment within the aortic annulus. In
this embodiment, the reshaping device can be used to replace the
function of the aortic valve as well as to reshape the left
ventricle to counter the effects of dilation.
[0011] In other alternative embodiments, a reshaping apparatus for
reshaping a dilated ventricle can include one or more tension
members, such as suture lines, that are connected to tissue at
opposing locations inside the ventricle. The tension members are
placed in tension to pull the opposing walls of the ventricle into
closer proximity to reshape the dilated ventricle. For example,
each tension member can be a suture loop that extends through
tissue at opposite locations on the inner walls of the ventricle.
Alternatively, the tension members can be secured to the inner
walls of the ventricle using self-deploying anchor members that can
be deployed within the ventricle using a delivery catheter. After
the anchor members are deployed at predetermined locations within
the ventricle, tension members, such as suture lines, can be
connected to the anchor members and placed in tension to draw the
inner walls of the ventricle into closer proximity.
[0012] In one representative embodiment, a device for reshaping a
ventricle of a heart comprises anchor means for anchoring the
device to tissue inside the heart, and pusher means for applying a
pushing force against the inside of the ventricle to cause the apex
of the heart to move away from the anchor means to distend the
heart in a direction extending from the base of the heart to the
apex.
[0013] In another representative embodiment, an apparatus for
altering a shape of a heart comprises a tension member having first
and second end portions. A first anchor member is connected to the
first end portion of the tension member and comprises a plurality
of radially self-expanding tissue engaging members that are
configured to anchor themselves to tissue at a first location
inside the heart. A second anchor member is connected to the second
end portion of the tension member and comprises a plurality of
radially self-expanding tissue engaging members that are configured
to anchor themselves to tissue at a second location inside the
heart. The tension member is placed in tension between the first
and second anchor members such that inner walls of the heart are
drawn toward each other to alter a shape of the heart.
[0014] In another representative embodiment, a method for reshaping
a dilated ventricle of a patient comprises applying a longitudinal
force against an apex portion of the ventricle to elongate the
ventricle. The force can be applied by deploying a reshaping device
inside the dilated ventricle. The reshaping device is configured to
apply a pushing force against an inner surface of the ventricle at
the apex to cause the ventricle to elongate. Alternatively, the
longitudinal force can be applied to the apex portion by securing a
first end portion of a tension member to the outer surface of the
apex portion and securing a second end portion of the tension
member to a body part below the apex portion to draw the apex
portion downwardly and toward the body part, thereby elongating the
ventricle.
[0015] In yet another representative embodiment, a method for
reshaping a dilated ventricle of a patient comprises positioning a
tension member having first and second ends in the ventricle,
securing the first end of the tension member to a first inner wall
of the ventricle and securing the second end of the tension member
to a second inner wall of the ventricle, and tensioning the tension
member to draw the inner walls toward each other.
[0016] The foregoing and other features and advantages of the
invention will become more apparent from the following detailed
description, which proceeds with reference to the accompanying
figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 illustrates a cross-sectional view of a heart for
background purposes.
[0018] FIG. 2 illustrates a cross-sectional view of a heart having
a dilated left ventricle.
[0019] FIG. 3 is a side view of an exemplary embodiment of a
reshaping device that is implantable in a dilated left ventricle
for reshaping the ventricle.
[0020] FIG. 4 is a cross-sectional view of a heart showing the
reshaping device shown in FIG. 3 deployed in the left
ventricle.
[0021] FIGS. 5A-5C are schematic side views showing the reshaping
device of FIG. 3 being deployed from a delivery catheter that can
be used to deliver the reshaping device to the implantation site
via the patient's vasculature, according to one embodiment.
[0022] FIGS. 6A-6C are side views of a variation of the embodiment
of FIG. 3 illustrating a technique for adjusting the overall length
of the reshaping device.
[0023] FIG. 7 is a cross-sectional view of a heart showing another
exemplary embodiment of a reshaping device incorporating a
prosthetic aortic valve that is deployed within the native aortic
valve.
[0024] FIG. 8 is a cross-sectional view of a heart showing another
exemplary embodiment of a reshaping device incorporating a
prosthetic aortic valve that is deployed within the native aortic
valve and is adapted to provide a lateral force against the
anterior mitral valve leaflet to improve leaflet coaption.
[0025] FIGS. 9A and 9B are cross-sectional views of a heart
illustrating a technique for securing a suture loop to the inner
walls of the left ventricle for reshaping the ventricle.
[0026] FIG. 10 is a cross-sectional view of a heart showing a
reshaping device comprising plurality of tension members secured to
the inner walls of the left ventricle for reshaping the ventricle,
according to another embodiment.
[0027] FIG. 11 is a partial, cross-sectional view of a left
ventricle showing a catheter being used to secure suture lines to
anchor members secured to the inner walls of the left
ventricle.
[0028] FIG. 12 is a transverse cross-sectional view of a left
ventricle showing a plurality of suture lines placed in tension
across the ventricle for reshaping the ventricle.
[0029] FIG. 13A is a perspective view of an exemplary embodiment of
an anchor member for a suture line shown in an expanded state.
[0030] FIG. 13B is a perspective view of the anchor member of FIG.
13A shown in a compressed state for delivery to the heart.
[0031] FIGS. 14A-14C illustrate an exemplary embodiment of a
delivery catheter being used to deploy the anchor member of FIGS.
13A and 13B.
[0032] FIG. 15 is a cross-sectional view of a heart showing tension
members secured to the outside of the heart at the apex for
reshaping the heart, according to one embodiment.
[0033] FIG. 16 is a cross-sectional view of a heart showing a
tension member secured to the outside of the heart at the apex for
reshaping the heart, according to another embodiment.
DETAILED DESCRIPTION
[0034] As used herein, the singular forms "a," "an," and "the"
refer to one or more than one, unless the context clearly dictates
otherwise.
[0035] As used herein, the term "includes" means "comprises." For
example, a device that includes or comprises A and B contains A and
B but may optionally contain C or other components other than A and
B. A device that includes or comprises A or B may contain A or B or
A and B, and optionally one or more other components such as C.
[0036] With reference to FIGS. 1 and 4, a four-chambered heart 10
is illustrated for background purposes. On the left side of the
heart, the mitral valve 12 is located between the left atrium 14
and left ventricle 16. The mitral valve generally comprises two
leaflets, an anterior leaflet 12a and a posterior leaflet 12b. The
mitral valve leaflets are attached to a mitral valve annulus 18,
which is defined as the portion of tissue surrounding the mitral
valve orifice. The left atrium 14 receives oxygenated blood from
the pulmonary veins 20. The oxygenated blood that is collected in
the left atrium 14 enters the left ventricle 16 through the mitral
valve 12.
[0037] Contraction of the left ventricle 16 forces blood through
the left ventricular outflow tract and into the aorta 40 (FIG. 4).
The aortic valve 28 is located between the left ventricle 16 and
the aorta 40 for ensuring that blood flows in only one direction
(i.e., from the left ventricle to the aorta). As used herein, the
left ventricular outflow tract (LVOT) is intended to generally
include the portion of the heart through which blood is channeled
from the left ventricle to the aorta. The LVOT shall include the
aortic valve annulus and the adjacent region extending directly
below the aortic valve annulus and the portion of the ascending
aorta adjacent the aortic valve.
[0038] As best shown in FIG. 1, on the right side of the heart, the
tricuspid valve 22 is located between the right atrium 24 and the
right ventricle 26. The right atrium 24 receives blood from the
superior vena cava 30 and the inferior vena cava 32. The superior
vena cava 30 returns de-oxygenated blood from the upper part of the
body and the inferior vena cava 32 returns de-oxygenated blood from
the lower part of the body. The right atrium 24 also receives blood
from the heart muscle itself via the coronary sinus. The blood in
the right atrium 24 enters into the right ventricle 26 through the
tricuspid valve 22. Contraction of the right ventricle forces blood
through the right ventricular outflow tract and into the pulmonary
arteries. The pulmonic valve 44 (FIG. 4) is located between the
right ventricle 26 and the pulmonary trunk 42 for ensuring that
blood flows in only one direction from the right ventricle to the
pulmonary trunk. The blood enters the lungs for oxygenation and is
returned to the left atrium 16 via the pulmonary veins 20.
[0039] The left and right sides of the heart are separated by a
wall generally referred to as the septum 34. The portion of the
septum that separates the two upper chambers (the right and left
atria) of the heart is termed the artial (or interatrial) septum 36
while the portion of the septum that lies between the two lower
chambers (the right and left ventricles) of the heart is called the
ventricular (or interventricular) septum 38. As shown in FIGS. 1
and 4, a healthy heart has a generally conical shape that tapers
from a base 46 to an apex 48.
[0040] As discussed above, heart disease can cause dilation of the
heart, resulting in greatly reduced pumping efficiency of the left
ventricle. As depicted in FIG. 2, dilatation causes the posterior
wall of the left ventricle to distend outward and the apex to move
upward, as generally shown by arrows A. The dilatation results in a
left ventricle having an undesirable round shape, as generally
shown in FIG. 2. Heart disease can also cause dilation of the other
chambers of the heart.
[0041] According to one aspect, the present disclosure concerns
embodiments of a reshaping apparatus and methods for restoring the
conical shape of a dilated left ventricle, or at least reshaping
the left ventricle to a more conical shape to improve pumping
efficiency. In particular embodiments, the left ventricle is
reshaped in a non-surgical or minimally-invasive procedure without
opening the chest or cardiopulmonary by-pass. The shape of the left
ventricle can be altered by applying a longitudinal force to the
apex of the left ventricle to move the apex downward (relative to
the base of the heart), such as by pushing or pulling the apex
downwardly. By applying such a force (i.e., pushing or pulling) on
the apex, the left ventricle becomes longer and thinner and thereby
achieves a more conical shape. As a result, the muscle fibers are
better oriented to accomplish torsional motion of the heart,
thereby increasing the efficiency and work capability of the left
ventricle. The embodiments disclosed herein can also be used to
reshape the right ventricle of the heart.
[0042] With reference to FIG. 3, an exemplary embodiment of a
reshaping device 50 for reshaping a left ventricle is now shown for
purposes of illustration. The device 50 is configured for
deployment within a left ventricle and generally comprises a body
having an anchor member 52 and an elongate pusher member, or arm,
54 mounted to the anchor member 52. The pusher member 54 in the
illustrated embodiment is a substantially J-shaped member having a
proximal end connected to the anchor member and an arcuate,
atraumatic flexible tip portion 56 shaped for engagement with the
inner surface of the left ventricle. The pusher member 54 is
configured for pushing against the inner surface of the left
ventricle after the device 50 is deployed in the left ventricle, as
further described below.
[0043] The pusher member 52 is preferably formed from a round wire
or a generally flat, ribbon-like piece of material. Alternatively,
the pusher member 52 can comprise an elongated tubular body that
can be formed from a mesh material, such as used to form stents, or
a solid (non-perforated) material. The pusher member 50 can be made
of any suitable biocompatible material, such as, for example,
stainless steel or a polymer.
[0044] In the illustrated embodiment, the anchor member 52 takes
the form of a radially compressible and expandable stent that is
adapted to expand to a size sufficient to engage adjacent tissue in
the heart and anchor the device firmly in place. The anchor member
52 can include various attachment elements (not shown), such as
barbs, staples, flanges, and the like for enhancing the ability of
the anchor member to anchor to the surrounding tissue. In one
specific implementation, for example, the anchor member 52 can be
sized for deployment within the left ventricular outflow tract,
such as at a location just beneath the aortic valve. In another
implementation, the anchor member 52 can be configured for
deployment within the mitral valve annulus, within the aortic valve
annulus, or within the left atrium.
[0045] The anchor member 52 can be a self-expanding or
balloon-expandable stent. When a self-expanding stent is used, the
stent can be formed from a shape memory material, such as, for
example, Nitinol, and can be delivered using a sheath. After
reaching the treatment site, the device 50 is advanced out of the
distal end of the sheath and the stent 52 expands into contact with
the surrounding tissue. When in the form of a balloon-expandable
stent, the stent can be formed from stainless steel or any of
various other suitable materials. The balloon-expandable stent 52
can be configured to be crimped to a reduced diameter and placed
over a deflated balloon on the distal end portion of an elongate
balloon catheter.
[0046] FIG. 4 shows the device 50 deployed in the left ventricle
16. As shown, the anchor member 52 is deployed in the left
ventricular outflow tract just below the aortic valve 28 and the
tip portion 56 of the pusher member 54 engages an inferior inner
surface portion 80 of the left ventricle. The overall length L
(FIG. 3) of the device 50 when deployed is selected such that the
tip portion 56 pushes downwardly against the inner surface 80 while
the anchor member 52 is secured firmly in place below the aortic
valve 28. The force applied by the pusher member 54 causes the left
ventricle 16 to distend or elongate longitudinally in a direction
extending from the base 46 to the apex 48. When compared with FIG.
2, it can be seen that the device 50 has reshaped the left
ventricle to provide it with a more conical shape. As described
above, the resulting conical shape improves the pumping efficiency
of the heart. The device also can be configured to be deployed in a
dilated right ventricle 26 for reshaping the right ventricle in an
analogous procedure.
[0047] The overall length L of the device 50 can be selected to
achieve a desired reshaping of the left ventricle. Increasing the
length L of the device 50 will increase the change in length of the
left ventricle between the aortic valve and the apex while
decreasing the length L of the device 50 will decrease the change
in length of the left ventricle.
[0048] The anchor member 52 can also be used to help treat mitral
valve regurgitation. Regurgitation through the mitral valve 12
occurs when the mitral valve fails to close properly, allowing
blood from the left ventricle 16 to leak into the left atrium 14.
Regurgitation typically is caused by changes in the geometric
configurations of the left ventricle, papillary muscles, and the
mitral valve annulus. As shown in FIG. 4, the anchor member 52 can
be sized to engage tissue 82 extending from the aortic valve
adjacent the anterior portion of the mitral valve 12. When the
anchor member 52 is deployed, it applies a lateral force against
the tissue 82. This force urges the anterior leaflet 12a toward the
posterior leaflet 12b for improving leaflet coaption, thereby
reducing or eliminating mitral valve regurgitation.
[0049] FIGS. 5A-5C schematically illustrate an exemplary embodiment
of a delivery catheter 100 for delivering and deploying the device
50 in the left ventricle. The catheter 100 in the illustrated
embodiment is adapted to be used with a device 50 that has a
radially self-expandable anchor member 52. The apparatus 100
includes an elongated delivery sheath 102 (the distal end portion
of which is shown in FIGS. 5A-5C) and a pusher member, or advancing
member, 104 slidably received in the lumen of the deliver sheath
102.
[0050] The catheter 100 can be introduced percutaneously into the
patient's vasculature (e.g., into a peripheral artery such as the
femoral artery) and advanced to the implantation site. In certain
embodiments, for example, the catheter is sized for insertion
through a small incision in the groin and has a length of at least
about 80 cm, preferably about 90 to 100 cm, to allow transluminal
positioning of the shaft from the femoral and iliac arteries to the
ascending aorta in a retrograde approach. Alternatively, the
catheter may have a shorter length, e.g. about 20 to 60 cm, for
introduction through the iliac artery, through the brachial artery,
through the carotid or subclavian arteries, or through a
penetration in the aorta itself. In the femoral approach, the
catheter desirably is long enough and flexible enough to traverse
the path through the femoral artery, iliac artery, descending aorta
and aortic arch. At the same time, the catheter desirably has
sufficient pushability to be advanced to the ascending aorta by
pushing on the proximal end, and has sufficient axial, bending, and
torsional stiffness to allow the physician to control the position
of the distal end, even when the catheter is in a tortuous vascular
structure. Alternatively, the catheter may be passed through a port
between ribs in the patient's thorax above the heart and through an
incision in the aortic arch, in a so-called minimally-invasive
procedure.
[0051] As shown in FIG. 5A, during advancement to the left
ventricle, the device 50 is initially contained within the delivery
sheath 102 with the anchor member 52 retained in a radially
compressed state. In the retrograde approach, the distal portion of
the delivery sheath 102 is advanced through the aorta 40 (FIG. 4),
across the aortic valve 28 and into the left ventricle 16 to
position the sheath distal end adjacent the inner surface 80 of the
left ventricle. Once properly positioned, the sheath 102 is
retracted relative to the pusher member 104 and the device 50 to
expose the curved tip portion 56, as shown in FIG. 5B. The operator
pushes the tip portion 56 firmly against the surface 80 to distend
the left ventricle and to position the anchor member 52 in a
deployment position below the aortic valve 28. As depicted in FIG.
5C, the sheath 102 can then be withdrawn further to advance the
anchor member 52 through the distal end of the sheath, thereby
allowing the anchor member 52 to expand into contact with the
surrounding tissue to retain the device firmly in place with the
tip portion 56 bearing against the inner surface 80.
[0052] The pusher member 54 of the reshaping device 50 can be
configured to have a variable or adjustable length to achieve a
desired reshaping of the left ventricle. For example, as
illustrated in FIGS. 6A-6B, the pusher member 54 can have an inner
lumen that receives a dowel or stylet 60 that is slidable within
lumen. The stylet 60 is preferably a substantially rigid member
that can resist bending or flexing when the device is deployed in
the heart. The stylet 60 can be inserted into and withdrawn from
the tip portion 56 to adjust the overall length of the device 50.
In FIG. 6A, for example, the device has an overall length L.sub.1.
As the stylet 60 is inserted into the tip portion 56, as shown in
FIG. 6B, the stylet 60 straightens a segment of the tip portion 56
to increase the overall length of the device to a length L.sub.2.
The stylet 60 can be further advanced into the tip portion 56 to
increase the overall length of the device to a greater length
L.sub.3. Conversely, withdrawing the stylet 60 from the tip portion
60 allows the segment of the tip portion that does not contain the
stylet to assume a curved shape, thereby shortening the overall
length of the device. A detachable, elongated control member 62,
such as a wire, can be attached to the proximal end of the stylet
60 for moving the stylet relative the pusher member 54. The control
member 62 can have a proximal end located outside the patient to
allow the surgeon to adjust the length of the reshaping device
after the device is deployed in the heart.
[0053] FIG. 7 shows another embodiment of an implantable reshaping
device, indicated at 150. The reshaping device 150 includes a
pusher member 152 and an anchor member 154 that comprises a
prosthetic valve assembly. The valve assembly 154 comprises a
radially compressible and expandable stent, or frame, 156 that
mounts a flexible valve member 158. The stent 156 and valve member
158 can be deployed within the aortic annulus to replace the
function of the native valve. Thus, in this embodiment, the stent
156 serves the dual functions of anchoring the reshaping device 150
in place for reshaping the left ventricle and supporting the valve
member 158. Once deployed, the pusher member 152 applies a
longitudinally directed force against the inner surface 80 of the
left ventricle, forcing the apex 48 to move downwardly relative to
the base 48 to counter the effects of dilation.
[0054] The stent 156 in the illustrated embodiment comprises a
plurality of angularly-spaced axial struts, or support members,
that extend axially (longitudinally) of the stent. The stent 156
can also include a plurality of axially-spaced, circumferential
bands, or struts, attached to the axial struts. The circumferential
struts are formed with multiple bends that allow the stent to be
compressed to a smaller diameter for delivery to an implantation
site and expanded to its functional size for anchoring the valve
assembly to the native valve tissue. For example, each of the
circumferential struts in the illustrated configuration includes a
plurality of linear strut members arranged in a zig-zag or
saw-tooth configuration defining bends between adjacent strut
members.
[0055] In alternative embodiments, the stent can have other
configurations. For example, one or more of the circumferential
bands can have a curved or serpentine shape rather than a zig-zag
shape. Further, the stent can include various attachment elements
(not shown), such as barbs, staples, flanges, and the like for
enhancing the ability of the stent to anchor to the surrounding
tissue.
[0056] The valve member 158 can have a leafed-valve configuration,
such as a tricuspid valve configuration. The valve member 158 can
be formed from three pieces of pliant material connected to each
other at seams aligned with axial struts of the frame 156 to form
collapsible leaflets. The valve member 158 can be made from
biological matter, such as natural tissue, pericardial tissue (such
as bovine, porcine or equine pericardium), a harvested natural
valve or other biological tissue. Alternatively, the valve member
158 can be made from biocompatible polymers or similar
materials.
[0057] Various other self-expanding and balloon expandable
prosthetic valve configurations also can be used. Additional
details regarding other valves that can be utilized are disclosed
in U.S. Pat. No. 5,411,552; U.S. Pat. No. 6,730,118 and U.S.
Publication No. 2004/0186563, which are incorporated herein by
reference.
[0058] In yet another embodiment, as shown in FIG. 8, a reshaping
device 200 comprises a pusher member 202 connected to a prosthetic
valve assembly 204. The valve assembly 204 includes an outer frame
or stent 206 that mounts a flexible valve member (not shown). In
this embodiment, the stent 206 has a generally tubular upper
portion 208 that is deployed in the aortic annulus and a flared or
enlarged lower portion 210 that extends below the aortic annulus
and has a larger diameter. The lower portion may be sized for
engaging and applying a lateral force to the tissue 82 below the
aortic annulus, thereby urging the anterior mitral valve leaflet
12a toward the posterior leaflet 12b to improve leaflet coaption.
In this embodiment, the flexible valve member may be mounted to the
stent 206 within the tubular upper portion 208, preferably adjacent
to the native aortic valve. Alternatively, the flexible valve
member may be mounted to the stent within the enlarged lower
portion, wherein the valve assembly may have a larger diameter and
greater flow area. Although the prosthetic valve assembly in FIG. 8
is described as comprising a portion of a reshaping device for
treating the left ventricle, alternative embodiments of the
prosthetic valve assembly may also be configured for use in
alternative applications. For example, the flared stent may be used
solely as a replacement valve (i.e., without a pusher member)
configured to support a valve member in the enlarged lower portion
210. As described above, such a configuration provides a prosthetic
valve having a valve member with a larger flow area for improving
blood flow through the heart. Additional details regarding a
prosthetic valve assembly having a flared stent suitable for use
with the above embodiments can be found in Applicant's co-pending
U.S. Publication No. 2007/0061010.
[0059] In alternative embodiments, a reshaping device can include a
prosthetic mitral valve connected to an elongated pusher member.
The prosthetic mitral valve is deployed within the mitral valve
annulus of a dilated heart and the pusher member extends downwardly
therefrom and applies a force against the inner surface 80 to
distend the left ventricle. The prosthetic valve therefore replaces
the function of the native valve and serves as an anchor member for
securing the reshaping device in place.
[0060] In other embodiments, other types of prostheses that are
deployable in the mitral valve or in the left atrium for treating
mitral valve regurgitation can be mounted to a reshaping device.
Such prostheses can serve the additional function of anchoring the
reshaping device in place. Details regarding the structure and use
of various embodiments of prosthesis for treating a mitral valve
can be found in Applicant's co-pending U.S. Publication No.
2006/0058871 and U.S. Publication No. 2006/0241745, the contents of
which are hereby incorporated by reference.
[0061] In certain embodiments, apparatuses for reshaping a
ventricle can comprise suture lines or other tension members that
pull the walls of the left ventricle into closer proximity, thereby
countering the effects of heart dilation. In one implementation,
for example, a suture loop extends transversely across the left
ventricle and through tissue at opposing locations in the ventricle
for pulling the ventricle walls closer together.
[0062] FIG. 9A shows an exemplary embodiment of a catheter 300 that
can be used to apply a suture loop 310 to tissue inside the left
ventricle in a minimally invasive procedure. Details regarding the
structure and use of the catheter 300 are disclosed in Applicant's
co-pending U.S. Publication No. 2004/0181238, which is incorporated
herein by reference. The catheter 300 can be advanced through the
patient's vasculature until its distal end portion is positioned in
the left ventricle. The distal end portion of the catheter is
placed against a wall of the left ventricle, such as at a location
on the septum 34, and a needle is advanced from the catheter and
through the tissue for advancing a length of suture through the
tissue. The distal end portion of the catheter is then placed
against an opposing wall of the left ventricle, and another needle
is advanced from the catheter and through the tissue for advancing
another length of suture through the tissue, and thus forming the
suture loop 310 extending through tissue of opposing walls of the
left ventricle. The end portions 312a, 312b of the suture loop
still connected to the catheter 300 are pulled taught to pull the
opposing walls of the left ventricle toward each other to reshape
the left ventricle from a generally round, dilated shape to a more
conical shape. A fastener or connector 314 (FIG. 9B) can be
advanced from the catheter 300 and over the end portions 312a, 312b
to secure the end portions together. The remaining suture leads
extending from the connector 314 can then be cut using a cutting
member in the catheter 300, thus forming the loop 310 shown in FIG.
9B. Additional suture loops can be applied at other locations in
the left ventricle to assist reshaping the left ventricle. For
example, one or more suture loops can be formed above or below the
suture loop 310 or at the same position as the suture loop 310.
[0063] In another embodiment, apparatus for reshaping a ventricle
comprises one or more tension members, such as one or more suture
lines, that are connected to tissue at opposing locations inside
the ventricle using anchor members that engage the myocardium of
the ventricle. For example, with reference to FIG. 10, a reshaping
apparatus comprises tension members 400a, 400b, 400c secured to the
ventricle walls using anchor members 402. A fastener or clip 404
can be provided for attaching the tension members together at a
location within the left ventricle. The tension members are placed
in tension between the respective anchor members and the fastener
to draw the walls of the left ventricle inward to reshape the left
ventricle.
[0064] The tension members can be made of any suitable
biocompatible material, such as traditional suture material. The
tension members in some embodiments can be made of an elastomeric
material, such as polyurethane.
[0065] In one method of delivering the tension members 400 and the
anchor members 402, a catheter is advanced through the patient's
vasculature to position the distal end portion of the catheter
inside the left ventricle. A deployment mechanism of the catheter
is used to deploy the anchor members 402 at selected locations on
the inner walls of the left ventricle. When advanced from the
catheter, engaging elements of the anchor members 402 deploy and
embed themselves in the myocardium, thereby securing the anchor
members in place. The catheter can then be used to attach tension
members 400 to the anchor members 402 and place the tension members
in tension so as to draw the opposing walls of the left ventricle
toward each other.
[0066] FIG. 11 schematically illustrates a method of using a
catheter 420 for securing suture lines to anchor members 402. As
shown, a respective suture line 422a, 422b, 422c, 422d, 422e can be
secured to each anchor member 402. The suture lines can extend
through the catheter to a location outside the body or to a
tension-control mechanism of the catheter. The tension in the
suture lines can be adjusted as desired for reshaping the left
ventricle, such as by manually pulling on the suture lines or by
operating the tension-control mechanism. When sufficiently
reshaped, a clip 424 can be advanced out of the distal end of the
catheter 420 and over the suture lines to secure the suture lines
together. The remaining portions of the suture lines are cut and
removed and the catheter is then removed from the body.
[0067] FIG. 12 illustrates another method of placing anchor members
402 in the left ventricle. A transverse cross-section of a left
ventricle 16 is shown in FIG. 12. In this embodiment, anchor
members 402 are deployed at angularly spaced locations around the
inner circumference of the left ventricle. A respective suture line
450a, 450b, 450c, 450d, 450e, 450f is secured to each anchor member
402 and to a fastener 424 at the center of the left ventricle. The
suture lines are placed in tension between the anchor members 402
and the fastener 424 to draw the walls of the left ventricle
inwardly toward each other. The anchor members 402 can be equally
spaced around the inner surface as shown to equally disperse the
pulling forces on the inner walls of the left ventricle.
[0068] With reference to FIGS. 13A and 13B, an exemplary embodiment
of an anchor member 500 is described in detail. The anchor member
500 in the illustrated embodiment comprises a tubular body 502
having a plurality of elongated prongs, or tissue-engaging members,
504 located at a first end thereof and a coupling member 506
located at a second end thereof. In the illustrated embodiment, the
coupling member 506 takes the form of a loop.
[0069] The elongated prongs 504 are desirably configured to
self-expand from the compressed configuration of FIG. 13B to a
"flowered" or expanded configuration of FIG. 13A. This flowering is
desirably achieved with a self curving area 504a that deflects the
prongs 504 radially outward from the center of the body 502 and
rearward toward the second end of the body. The prongs 504 are
desirably pointed or barbed to facilitate penetration and
engagement with the muscular wall of the heart.
[0070] The anchor member 500 can be formed from a single tube of
shape memory material, such as, for example, Nitinol. During
manufacture, the shape memory material may be cut using a
mechanical or laser cutting tool. After cutting the tube, the
expanded or flowered shape can be imparted to the memory of the
shape memory material with techniques known in the art (e.g. heat
setting the shape). Methods for manufacturing the anchor member are
described in detail in Applicant's co-pending U.S. Provisional
Application No. 60/801,446 [Attorney Docket: PVI-5897PRO], which is
incorporated herein by reference. In one preferred construction,
the anchor member can be formed to have an expanded configuration
that conforms to the contours of the particular surface area of the
heart where the anchor member is to be deployed.
[0071] The surface of the anchor member 500, including the prongs
504, is desirably configured to promote tissue growth onto and even
into its surface. In one example this growth is achieved by
providing the anchor member with a relatively rough and/or porous
surface. Additionally, biological coatings of the types known in
the art can be included on the surface of the anchor member 500 to
promote healing and tissue growth.
[0072] FIGS. 14A-14C illustrate an exemplary method of deploying
the anchor member 500 using a delivery catheter 510. As shown in
FIG. 14A, the anchor member 500 is disposed in the distal end
portion of an outer sheath 512 of the delivery catheter 510. A
pusher member, or shaft, 514 extends coaxially through the deliver
sheath 512 and has a distal end in contact with the anchor member
500. The anchor member and pusher member are slidably received
within the outer sheath 512. The outer sheath maintains the anchor
member in a compressed configuration during delivery to the
implantation site.
[0073] The anchor member 500 can be delivered to the heart
percutaneously in a retrograde or antegrade approach, or
alternatively, it can be inserted through an incision in the chest,
through the cardiac tissue and into the left ventricle. When the
anchor member is properly positioned at a desired target location
within the left ventricle, the outer sheath 512 is retracted
relative to the pusher member 514 and the anchor member 500, as
illustrated in FIGS. 14B and 14C. As the anchor member 500 advances
from the open end of the sheath, the prongs 504 expand outwardly.
In certain embodiments, the expansion of the prongs advantageously
pulls the anchor member 500 out of the sheath 512.
[0074] As the prongs 504 exit the outer sheath 512, the prongs 204
expand, bending back towards the body 202 while grabbing nearby
heart tissue. The action of the prongs engaging and embedding
themselves in the tissue maintains the anchor member 500 in a
stable position within the heart and resists against movement from
heart beats, blood flow, and similar actions. In this respect, the
anchor member 500 "self-deploys" within the heart, requiring little
or no extra pressure from the delivery device 510 to anchor within
the muscular wall of the heart.
[0075] After implantation in the heart, tissue grows over the
anchor member 500, preferably leaving only the coupling member 506
exposed within the left ventricle. It has been found that adequate
tissue growth over the anchor member 500 can occur in two or three
weeks. However, the amount of time required may depend on various
factors such as the particular deployment location of the anchor
member 500, the surface features or coatings of the anchor member
500, and/or the condition of the patient.
[0076] The coupling member 506 provides a point of attachment for
connecting a tension member. A tension member can be connected to
an anchor member immediately following deployment of the anchor
member in the heart. Alternatively, in some cases, it may be
desirable to allow for a suitable time period for tissue to grow
over the anchor member before a tension member is connected to the
coupling member 506 of the anchor member.
[0077] With reference now to FIG. 15, another exemplary reshaping
apparatus 600 configured to reshape the geometry of the heart is
illustrated. In this embodiment, one or more tension members, or
tethers, 602 (e.g., suture lines) are provided for pulling downward
on the apex of the heart. In the illustrated embodiment, the upper
ends of the tension members 602 are attached along the apex 48 of
the heart (e.g., to the outside of the heart muscle) using a single
anchor member 604 as shown or using a respective anchor member 604
for each tension member 602. The anchor member 604 can have a
construction similar to the anchor member 500 described above. The
lower ends 606 of the tension members can be fixed or tied off to a
rigid structure within the body, such as a rib. Sufficient tension
is applied to the tension members 602 to apply a longitudinal force
to the apex that pulls the apex downwardly relative to the base of
the heart. As can be appreciated, applying a pulling force to the
outside of the heart is effective to reshape the geometry of the
left and right ventricles.
[0078] FIG. 16 shows a reshaping apparatus 700, according to
another embodiment, that applies a force to the outside of the
heart for reshaping the geometry of the heart. The apparatus 700 in
the illustrated embodiment comprises a patch 702 that can be
secured to the outer surface of the heart muscle along the apex 48.
In one exemplary embodiment, a bioglue may be used to secure the
patch 702 to the heart. A tension member 704 (e.g., a suture line)
has an upper end 706 secured to the patch 702 and a lower end 708
that can be fixed or tied off to a rigid structure within the body,
such as a rib. When securing the ends of the tension member,
sufficient tension is applied to the tension member to pull the
apex downwardly relative to the base of the heart to reshape both
the left and right ventricles.
[0079] In view of the many possible embodiments to which the
principles of the disclosed invention may be applied, it should be
recognized that the illustrated embodiments are only preferred
examples of the invention and should not be taken as limiting the
scope of the invention. Rather, the scope of the invention is
defined by the following claims. I therefore claim as my invention
all that comes within the scope and spirit of these claims.
* * * * *