U.S. patent application number 10/819499 was filed with the patent office on 2004-09-30 for anchor and pull mitral valve device and method.
Invention is credited to Adams, John M., Alferness, Clifton A., Mathis, Mark L., Reuter, David G..
Application Number | 20040193260 10/819499 |
Document ID | / |
Family ID | 21752298 |
Filed Date | 2004-09-30 |
United States Patent
Application |
20040193260 |
Kind Code |
A1 |
Alferness, Clifton A. ; et
al. |
September 30, 2004 |
Anchor and pull mitral valve device and method
Abstract
A device, system, and method effects mitral valve annulus
geometry of a heart. The device includes a first anchor configured
to be positioned within and fixed to the coronary sinus of the
heart adjacent the mitral valve annulus within the heart. A cable
is fixed to the first anchor and extends proximately therefrom and
slidingly through a second anchor which is positioned and fixed in
the heart proximal to the first anchor. A lock locks the cable to
the second anchor when tension is applied to the cable for
effecting the mitral valve annulus geometry.
Inventors: |
Alferness, Clifton A.;
(Redmond, WA) ; Adams, John M.; (Sammamish,
WA) ; Mathis, Mark L.; (Kirkland, WA) ;
Reuter, David G.; (Bothell, WA) |
Correspondence
Address: |
WILSON SONSINI GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO
CA
943041050
|
Family ID: |
21752298 |
Appl. No.: |
10/819499 |
Filed: |
April 6, 2004 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10819499 |
Apr 6, 2004 |
|
|
|
10011867 |
Dec 5, 2001 |
|
|
|
Current U.S.
Class: |
623/2.11 ;
623/2.36 |
Current CPC
Class: |
A61F 2/2451 20130101;
A61F 2/2466 20130101 |
Class at
Publication: |
623/002.11 ;
623/002.36 |
International
Class: |
A61F 002/24 |
Claims
1.-43. (Canceled)
44. An assembly for effecting the condition of a mitral valve
annulus of a heart comprising: a mitral valve therapy device that
reshapes the mitral valve annulus of the heart when placed within
the coronary sinus of the heart adjacent the mitral valve annulus,
the mitral valve therapy device having a proximal end including a
coupling structure; a catheter having a lumen that directs the
mitral valve therapy device into the coronary sinus of the heart; a
second coupling structure that is lockable on the device coupling
structure; and a locking member that locks the device coupling
structure to the second coupling structure and that releases the
device coupling structure from the second coupling structure.
45. The assembly of claim 44 further including a pusher member that
pushes the device through the catheter lumen, the pusher member
having a distal end that engages the device proximal end.
46. The assembly of claim 45 wherein the pusher member carries the
second coupling structure at the distal end of the pusher
member.
47. The assembly of claim 44 wherein the device coupling structure
and the second coupling structure comprise a pair of interlocking
structures and wherein the locking member comprises a slide-lock
sheath closely fitted to the interlocking structures.
48. The assembly of claim 47 wherein the interlocking structures
are formed from tubing and wherein the slide-lock sheath is
tubular.
49. An assembly for effecting the condition of a mitral valve
annulus of a heart comprising: device means for reshaping the
mitral valve annulus of the heart when placed within the coronary
sinus of the heart adjacent the mitral valve annulus, the device
means having a proximal end including a coupling means for coupling
the device means; catheter means having a lumen that directs the
mitral valve therapy device into the coronary sinus of the heart;
second coupling means for locking with the device coupling means;
and locking means for locking the device coupling means to the
second coupling means and releasing the device coupling means from
the second coupling means.
50. The assembly of claim 49 further comprising a pusher means for
pushing the device means through the catheter means lumen, the
pusher means having a lumen, and wherein the second coupling means
and the locking means extend through the pusher means lumen.
51. The assembly of claim 49 wherein the device coupling means and
the second coupling means comprise interlocking means for
releasably locking the device coupling means and the second
coupling means, and wherein the locking means includes retaining
means for retaining the interlocking means in an interlocked
condition.
52. The assembly of claim 51 wherein the retaining means is
displaceable for releasing the interlocked condition of the
interlocking means.
53. An assembly for effecting the condition of a mitral 30 valve
annulus of a heart comprising: a mitral valve therapy device that
reshapes the mitral valve annulus of the heart when placed within
the coronary sinus of the heart adjacent the mitral valve annulus,
the mitral valve therapy device having a proximal end including a
coupling structure; a guide member that directs the mitral valve
therapy device into the coronary sinus of the heart; a second
coupling structure that is lockable on the device coupling
structure; and a locking member that locks the device coupling
structure to the second coupling structure and that releases the
device coupling structure from the second coupling structure.
54. An assembly for effecting the condition of a mitral valve
annulus of a heart comprising: device means for reshaping the
mitral valve annulus of the heart when placed within the coronary
sinus of the heart adjacent the mitral valve annulus, the device
means having a proximal end including a coupling means for coupling
the device means; guide means for directing the mitral valve
therapy device into the coronary sinus of the heart; second
coupling means for locking with the device coupling means; and
locking means for locking the device coupling means to the second
coupling means and releasing the device coupling means from the
second coupling means.
Description
FIELD OF THE INVENTION
[0001] The present invention generally relates to a device and
method for treating dilated cardiomyopathy of a heart. The present
invention more particularly relates to a device and method for
reshaping the mitral valve annulus.
BACKGROUND OF THE INVENTION
[0002] The human heart generally includes four valves. Of these
valves, a most critical one is known as the mitral valve. The
mitral valve is located in the left atrial ventricular opening
between the left atrium and left ventricle. The mitral valve is
intended to prevent regurgitation of blood from the left ventricle
into the left atrium when the left ventricle contracts. In
preventing blood regurgitation the mitral valve must be able to
withstand considerable back pressure as the left ventricle
contracts.
[0003] The valve cusps of the mitral valve are anchored to muscular
wall of the heart by delicate but strong fibrous cords in order to
support the cusps during left ventricular contraction. In a healthy
mitral valve, the geometry of the mitral valve ensures that the
cusps overlie each other to preclude regurgitation of the blood
during left ventricular contraction.
[0004] The normal functioning of the mitral valve in preventing
regurgitation can be impaired by dilated cardiomyopathy caused by
disease or certain natural defects. For example, certain diseases
may cause dilation of the mitral valve annulus. This can result in
deformation of the mitral valve geometry to cause ineffective
closure of the mitral valve during left ventricular contraction.
Such ineffective closure results in leakage through the mitral
valve and regurgitation. Diseases such as bacterial inflammations
of the heart or heart failure can cause the aforementioned
distortion or dilation of the mitral valve annulus. Needless to
say, mitral valve regurgitation must not go uncorrected.
[0005] One method of repairing a mitral valve having impaired
function is to completely replace the valve. This method has been
found to be particularly suitable for replacing a mitral valve when
one of the cusps has been severely damaged or deformed. While the
replacement of the entire valve eliminates the immediate problem
associated with a dilated mitral valve annulus, presently available
prosthetic heart valves do not possess the same durability as
natural heart valves.
[0006] Various other surgical procedures have been developed to
correct the deformation of the mitral valve annulus and thus retain
the intact natural heart valve function. These surgical techniques
involve repairing the shape of the dilated or deformed valve
annulus. Such techniques, generally known as annuloplasty, require
surgically restricting the valve annulus to minimize dilation.
Here, a prosthesis is typically sutured about the base of the valve
leaflets to reshape the valve annulus and restrict the movement of
the valve annulus during the opening and closing of the mitral
valve.
[0007] Many different types of prostheses have been developed for
use in such surgery. In general, prostheses are annular or
partially annular shaped members which fit about the base of the
valve annulus. The annular or partially annular shaped members may
be formed from a rigid material, such as a metal, or from a
flexible material.
[0008] While the prior art methods mentioned above have been able
to achieve some success in treating mitral regurgitation, they have
not been without problems and potential adverse consequences. For
example, these procedures require open heart surgery. Such
procedures are expensive, are extremely invasive requiring
considerable recovery time, and pose the concomitant mortality
risks associated with such procedures. Moreover, such open heart
procedures are particularly stressful on patients with a comprised
cardiac condition. Given these factors, such procedures are often
reserved as a last resort and hence are employed late in the mitral
regurgitation progression. Further, the effectiveness of such
procedures is difficult to assess during the procedure and may not
be known until a much later time. Hence, the ability to make
adjustments to or changes in the prostheses to obtain optimum
effectiveness is extremely limited. Later corrections, if made at
all, require still another open heart surgery.
[0009] An improved therapy to treat mitral regurgitation without
resorting to open heart surgery has recently been proposed. This is
rendered possible by the realization that the coronary sinus of a
heart is near to and at least partially encircles the mitral valve
annulus and then extends into a venous system including the great
cardiac vein. As used herein, the term "coronary sinus" is meant to
refer to not only the coronary sinus itself but in addition, the
venous system associated with the coronary sinus including the
great cardiac vein. The therapy contemplates the use of a device
introduced into the coronary sinus to reshape and advantageously
effect the geometry of the mitral valve annulus.
[0010] The device includes a resilient member having a cross
sectional dimension for being received within the coronary sinus of
the heart and a longitudinal dimension having an unstressed arched
configuration when placed in the coronary sinus. The device
partially encircles and exerts an inward pressure on the mitral
valve. The inward pressure constricts the mitral valve annulus, or
at least a portion of it, to essentially restore the mitral valve
geometry. This promotes effective valve sealing action and
eliminates mitral regurgitation.
[0011] The device may be implanted in the coronary sinus using only
percutaneous techniques similar to the techniques used to implant
cardiac leads such as pacemaker leads. One proposed system for
implanting the device includes an elongated introducer configured
for being releasably coupled to the device. The introducer is
preferably flexible to permit it to advance the device into the
heart and into the coronary sinus through the coronary sinus
ostium. To promote guidance, an elongated sheath is first advanced
into the coronary sinus. Then, the device and introducer are moved
through a lumen of the sheath until the device is in position
within the coronary sinus. Because the device is formed of
resilient material, it conforms to the curvatures of the lumen as
it is advanced through the sheath. The sheath is then partially
retracted to permit the device to assume its unstressed arched
configuration. Once the device is properly positioned, the
introducer is then decoupled from the device and retracted through
the sheath. The procedure is then completed by the retraction of
the sheath. As a result, the device is left within the coronary
sinus to exert the inward pressure on the mitral valve to restore
mitral valve geometry.
[0012] The foregoing therapy has many advantages over the
traditional open heart surgery approach. Since the device, system
and method may be employed in a comparatively noninvasive
procedure, mitral valve regurgitation may be treated at an early
stage in the mitral regurgitation progression. Further, the device
may be placed with relative ease by any minimally invasive
cardiologist. Still further, since the heart remains completely
intact throughout the procedure, the effectiveness of the procedure
may be readily determined. Moreover, should adjustments be deemed
desirable, such adjustments may be made during the procedure and
before the patient is sent to recovery.
[0013] Another approach to treat mitral regurgitation with a device
in the coronary sinus is based upon the observation that the
application of a localized force against a discrete portion of the
mitral valve annulus can terminate mitral regurgitation. This
suggests that mitral valve dilation may be localized and
nonuniform. Hence, the device applies a force to one or more
discrete portions of the atrial wall of the coronary sinus to
provide localized mitral valve annulus reshaping instead of
generalized reshaping of the mitral valve annulus. Such localized
therapy would have all the benefits of the generalized therapy. In
addition, a localized therapy device may be easier to implant and
adjust. The present invention provides a still further alternative
for treating mitral regurgitation with a device placed in the
coronary sinus adjacent to the mitral valve annulus.
SUMMARY OF THE INVENTION
[0014] The present invention provides a device for effecting mitral
valve annulus geometry of a heart. The device includes a first
anchor configured to be positioned within and fixed to the coronary
sinus of the heart adjacent the mitral valve annulus within the
heart, a cable fixed to the first anchor and extending proximally
from the first anchor within the heart, a second anchor configured
to be positioned in and fixed in the heart proximal to the first
anchor and arranged to slidingly receive the cable, and a lock that
locks the cable on the second anchor. As a result, when the first
and second anchors are fixed within the heart, the cable is drawn
proximally, and the cable is locked on the second anchor, the
geometry of the mitral valve is effected.
[0015] The second anchor may be configured to be positioned and
fixed in the coronary sinus. Alternatively, the second anchor may
be configured to be positioned and fixed in the right atrium.
[0016] The first anchor may be self-expanding to fix the first
anchor in the coronary sinus. Similarly, the second anchor may be
self-expanding to fix the second anchor in the heart.
[0017] The second anchor may include the lock. The lock may include
a ratchet. Further, the cable may include a coupling configured for
releasable connection to a cable tension assembly.
[0018] The present invention further provides a device for
effecting mitral valve annulus geometry in a heart including first
anchor means for anchoring within the coronary sinus of the heart
adjacent to the mitral valve annulus and second anchor means for
anchoring within the heart proximal to the first anchor means. The
device further includes cable means fixed to the first anchor means
and extending proximally from the first anchor means, the cable
means being slidably received by the second anchor means for
spanning between the first and second anchor means, and lock means
for locking the second anchor means to the cable means.
[0019] The present invention still further provides a method of
effecting mitral valve annulus geometry in a heart. The method
includes the steps of fixing a first anchor within the coronary
sinus of the heart adjacent to the mitral valve annulus, anchoring
a second anchor within the heart proximal to the first anchor,
fixing a cable to the first anchor, the cable extending proximally
from the first anchor and slidably through the second anchor,
displacing the cable proximally relative to the second anchor to
create tension in the cable, and locking the second anchor to the
cable.
[0020] The present invention still further provides a system for
effecting mitral valve annulus geometry. The system includes a
mitral valve annulus device comprising a first anchor configured to
be positioned within and fixed to the coronary sinus of the heart
adjacent to mitral valve annulus within the heart, a cable fixed to
the first anchor and extending proximally from the first anchor
within the heart, a second anchor configured to be positioned and
fixed in the heart proximal to the first anchor and arranged to
slidingly receive the cable, and a lock that locks the cable on the
second anchor. The system further includes a delivery assembly that
deploys the mitral valve annulus device, the delivery assembly
including a first push tool that engages the first anchor to
position the first anchor within the coronary sinus, a second push
tool that engages the second anchor to position the second anchor
in the heart, and a tensioning member connectable to the cable that
provides tension to the cable between the first and second
anchors.
[0021] The present invention still further provides a method of
effecting mitral valve geometry of a heart including the steps of
advancing a guide catheter into the coronary sinus of the heart
adjacent to the mitral valve annulus, pushing a self-deploying
first anchor down and out of the guide catheter to deploy the first
anchor in the coronary sinus adjacent to the mitral valve annulus,
providing the first anchor with a cable extending proximally from
the first anchor and through a second self-deploying anchor, and
displacing the second self-deploying anchor down the guide catheter
to a position proximal to the first anchor. The method further
includes the steps of withdrawing the guide catheter while holding
the second anchor to deploy the second anchor, pulling on the cable
to create tension in the cable, and locking the cable to the second
anchor.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] The features of the present invention which are believed to
be novel are set forth with particularity in the appended claims.
The invention, together with further aspects and advantages
thereof, may best be understood by making reference to the
following description taken in conjunction with the accompanying
drawings, and the several figures of which like reference numerals
identify identical elements, and wherein:
[0023] FIG. 1 is a superior view of a human heart with the atria
removed;
[0024] FIG. 2 is a superior view of a human heart similar to FIG. 1
illustrating a deployed mitral valve device embodying the present
invention;
[0025] FIG. 3 is a superior view of a human heart similar to FIG. 2
illustrating an intermediate step in the deployment of the mitral
valve device of FIG. 2 embodying the present invention;
[0026] FIG. 4 is a perspective view with portions cut away of the
device of FIG. 2 and a delivery assembly for deploying the device
in accordance with an embodiment of the present invention;
[0027] FIG. 5 is a perspective view illustrating details of the
coupling and locking mechanisms employed in the device and assembly
of FIGS. 3 and 4; and
[0028] FIG. 6 is a further superior view of a human heart similar
to that of FIG. 1 illustrating a further mitral valve device
embodying the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0029] Referring now to FIG. 1, it is a superior view of a human
heart 10 with the atria removed to expose the mitral valve 12, the
coronary sinus 14, the coronary artery 15, and the circumflex
artery 17 of the heart 10 to lend a better understanding of the
present invention. Also generally shown in FIG. 1 are the pulmonary
valve 22, the aortic valve 24, and the tricuspid valve 26 of the
heart 10.
[0030] The mitral valve 12 includes an anterior cusp 16, a
posterior cusp 18 and an annulus 20. The annulus encircles the
cusps 16 and 18 and maintains their spacing to provide a complete
closure during a left ventricular contraction. As is well known,
the coronary sinus 14 partially encircles the mitral valve 12
adjacent to the mitral valve annulus 20. As is also known, the
coronary sinus is part of the venus system of the heart and extends
along the AV groove between the left atrium and the left ventricle.
This places the coronary sinus essentially within the same plane as
the mitral valve annulus making the coronary sinus available for
placement of the mitral valve therapy device of the present
invention therein.
[0031] FIG. 2 shows a mitral valve therapy device 30 embodying the
present invention. As may be noted in FIG. 2, the device 30
includes a first anchor 32, a cable 34, and a second anchor 36.
[0032] The first anchor 32 is located at the distal end of the
device 30. The anchor 32 is self-expanding so as to be
self-deployable when released in the coronary sinus 14. More
specifically, the anchor 32 may be formed of a material such as
Nitinol, a nickel/titanium alloy of the type well known in the art
having shape memory. The anchor 32 has a toggle bolt-like
configuration which expands when released to engage the inner wall
of the coronary sinus 14 for anchoring or fixing the anchor 32
therein. Preferably, the anchor 32 is positioned just proximally to
the crossover point 19 of the coronary sinus 14 and a circumflex
artery 17.
[0033] The cable 34, which may be a single wire, a multi-stranded
wire, a polymer cable or a Nitinol cable, is fixed to the first
anchor 32 and extends proximally therefrom. The cable extends
through the second anchor 36 which is positioned proximally from
the first anchor 32. Here it will be noted that the second anchor
is positioned within the coronary sinus just distal to the ostium
21 of the coronary sinus 14. The second anchor 36 may have a
similar toggle bolt-like configuration and is also preferably
self-expanding to be self-deployable.
[0034] The cable 34 terminates in a coupling 38. As may best be
seen in FIG. 5, the coupling 38 is configured to releasably
interlock with a corresponding coupling 40 carried by a tension
cable 42.
[0035] As may further be noted in FIG. 5, the second or proximal
anchor 36 also includes a locking mechanism 44. Here, the locking
mechanism 44 takes the form of a ratchet or ratchet-like mechanism
46 for locking the second anchor 36 to the cable 32.
[0036] When the device 30 is deployed as shown in FIG. 2, the first
anchor 32 is fixed within the coronary sinus 14. The cable 34
extends proximally from the anchor 32 and slidably through the
second anchor 36. The second anchor 36 is then positioned in its
desired location within the heart proximal to the first anchor 32
and permitted to self-expand for being anchored within the heart.
Then, the tension cable is used to pull proximally on the cable
while the second anchor 36 is preferably held in its fixed
position. Once a desired amount of tension is applied to the cable,
the ratchet positively and permanently locks the cable 34 to the
second anchor 36. With the cable 34 now under tension, the geometry
of the mitral valve annulus 20 is now advantageously effected. The
tension in the cable may be further adjusted while monitoring a
parameter indicative of mitral regurgitation such as Doppler echo
while adjusting the tension. The tension may be further adjusted by
pushing the deployed proximal anchor 36 further down the cable 34
thereby shortening the distance between the proximal and the distal
anchors. Once the proximal anchor position and proper cable tension
is achieved, the tension cable assembly may be removed in a manner
as more fully described hereinafter.
[0037] As will further be noted in FIG. 2, the cable 34 is provided
with a covering 33. The covering 33 is preferably formed of a
compressible material and serves to distribute forces of the cable
applied against the inner wall of the coronary sinus 14. This force
distribution precludes damage to the coronary sinus by the cable
34.
[0038] FIGS. 3 and 4 show further details of the device 30 and its
deployment assembly 50. As will be noted in FIG. 4, the deployment
assembly 50 includes a catheter 52. The catheter 52 has a lumen 54
dimensioned for slidably receiving the device 30 in its predeployed
state. The catheter 52 is advanced into the coronary sinus until
its distal end 56 is at a desired position within the coronary
sinus.
[0039] The assembly 50 further includes a first push tube 58 which
engages a collar 33 of the first anchor 32. The push tube 58 may
then be used to push the first anchor 32 to its desired position
and out of the catheter 52 whereupon, the first anchor 32
self-expands for deployment. Once the first anchor 32 is fixed
within the coronary sinus, the push tube 58 may then be
removed.
[0040] The assembly 50 further includes a second push tube 60
coaxially arranged with the catheter 52 and first push tube 58
which may be fed down the catheter to engage the second anchor 36.
The second push tube 60 is then used to push the second anchor 36
along the cable 34 to its desired position. Then, the catheter 52
is retracted to release the second anchor 36 to permit it to
self-expand and be deployed.
[0041] The tension cable 42 is then coupled to the coupling 38 of
the cable 34 and covered with a sheath 62 to maintain the coupling
of the couplings 38 and 40. Tension is then applied to the cable 34
by proximally pulling on the tension cable 42 while the second push
tube 60 holds the second anchor 36 stationary. When the desired
tension is placed on the cable 34, further adjustment may be made
as previously described. When this is completed, the first anchor
32 and the second anchor 36 are fixed in position with a tension in
the cable 34. The catheter 52, the sheath 62, the second push tube
60, and the tension cable 42 may be removed to complete the
deployment process.
[0042] FIG. 6 shows another mitral valve device 70 embodying the
present invention. The device 70 is similar to the device 30
previously described except that its second or proximal anchor 76
is located and fixed within the right atrium 23 of the heart 10. To
this end, the device 70 includes a first anchor 32, a cable 34, and
a force distributor 33 as previously described. The second anchor
76 is configured so that when it self-expands, it engages the inner
wall 25 of the right atrium 23 to hold it in place. In all other
respects, the device 70 may be identical to the device 30.
[0043] While particular embodiments of the present invention have
been shown and described, modifications may be made, and it is
therefore intended in the appended claims to cover all such changes
and modifications which fall within the true spirit and scope of
the invention as defined by the appended claims.
* * * * *