U.S. patent application number 15/229717 was filed with the patent office on 2016-12-08 for method and apparatus for circulatory valve repair.
The applicant listed for this patent is The Trustees of Columbia University in the City of New York. Invention is credited to William Allen, Gerald M. Lemole, Howard P. Levin, Alan Lotvin, Mehmet C. Oz, Juan P. Umana.
Application Number | 20160354082 15/229717 |
Document ID | / |
Family ID | 21969192 |
Filed Date | 2016-12-08 |
United States Patent
Application |
20160354082 |
Kind Code |
A1 |
Oz; Mehmet C. ; et
al. |
December 8, 2016 |
METHOD AND APPARATUS FOR CIRCULATORY VALVE REPAIR
Abstract
An apparatus for the repair of a cardiovascular valve has
leaflets comprising a grasper capable of grabbing and co-apting the
leaflets of the valve. In a preferred embodiment, the grasper has
jaws that grasp and immobilize the leaflets, and then a fastener is
inserted to co-apt the leaflets. The apparatus is particularly
useful for repairing mitral valves to cure mitral
regurgitation.
Inventors: |
Oz; Mehmet C.; (Cliffside
Park, NJ) ; Lemole; Gerald M.; (Huntingdon Valley,
CT) ; Lotvin; Alan; (Upper Saddle River, NJ) ;
Umana; Juan P.; (New York, NY) ; Allen; William;
(Stratford, CT) ; Levin; Howard P.; (Teaneck,
NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
The Trustees of Columbia University in the City of New
York |
New York |
NY |
US |
|
|
Family ID: |
21969192 |
Appl. No.: |
15/229717 |
Filed: |
August 5, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14225750 |
Mar 26, 2014 |
9427237 |
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15229717 |
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13370690 |
Feb 10, 2012 |
8721665 |
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14225750 |
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12209336 |
Sep 12, 2008 |
8133239 |
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13370690 |
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10883412 |
Jun 30, 2004 |
7509959 |
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12209336 |
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09950163 |
Oct 15, 2002 |
7758596 |
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10883412 |
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09747558 |
Dec 23, 2000 |
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09950163 |
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09254111 |
Feb 25, 1999 |
6269819 |
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PCT/US98/13240 |
Jun 25, 1998 |
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09747558 |
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60051078 |
Jun 27, 1997 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00243
20130101; A61B 17/10 20130101; A61B 17/0644 20130101; A61B 17/0686
20130101; A61B 2017/0649 20130101; A61B 17/08 20130101; A61B 17/064
20130101; A61F 2/2427 20130101; A61B 17/1285 20130101; A61B 17/122
20130101 |
International
Class: |
A61B 17/068 20060101
A61B017/068; A61B 17/064 20060101 A61B017/064 |
Claims
1-12. (canceled)
13. A medical device for fastening cardiac valve leaflets,
comprising a percutaneous catheter having opposing distal and
proximal ends, and a deployable clip having first and second jaw
elements moveable between an open and closed configuration, wherein
the deployable clip is detachably engaged to the distal end of the
percutaneous catheter.
14. The medical device as in claim 13, wherein at least one of the
first and second jaw elements include one or more barbs extending
from a surface.
15. The medical device as in claim 13, wherein the first and second
jaw elements are arranged in a substantially U-shaped configuration
when in an open configuration.
16. The medical device as in claim 13, wherein the movable jaw
elements are capable of fastening together cardiac valve leaflets
when in the closed configuration.
17. The medical device as in claim 13, wherein the cardiac valve
leaflets are part of the aortic or mitral valve of a subject.
18. The medical device as in claim 13, wherein the first jaw
element is pivotably connected to the second jaw element.
19. The medical device as in claim 13, wherein the first and second
jaw elements include suction elements.
20. A medical device for fastening cardiac valve leaflets,
comprising a percutaneous catheter having a distal and proximal
ends, a deployable clip having a stationary first jaw element
pivotably engaged to a moveable second jaw element, wherein the
deployable clip is detachably engaged to the distal end of the
percutaneous catheter.
21. The medical device of claim 20, wherein the moveable second jaw
element pivots toward the stationary jaw element when actuated.
22. The medical device of claim 20, wherein at least one of the jaw
elements include a barb extending from a surface.
23. The medical device of claim 20, wherein each of the first and
second jaw elements have laterally inwardly extending barbs.
24. A method of treating a subject having a cardiac valve
condition, the method of treatment comprising: introducing a
medical device including a deployable clip having movable first and
second jaw elements into a subject; positioning the deployable clip
in proximity to the cardiac valve leaflets, wherein the movable
first and second jaw elements are disposed about the cardiac valve
leaflets in a first open position, actuating the moveable first and
second jaw elements to a closed position to physically fasten
together the cardiac valve leaflets between the first and second
jaw elements, and deploying the clip from the medical device.
25. The method of claim 24, wherein the cardiac valve condition is
mitral valve prolapse.
26. The method of claim 24, wherein the cardiac condition is mitral
regurgitation.
27. The method of claim 24 wherein cardiac valve leaflets are
mitral valve leaflets, and further wherein the mitral valve
leaflets are permanently fastened.
28. The method of claim 24, wherein the cardiac condition is aortic
valve insufficiency.
29. The method of claim 24 wherein cardiac valve leaflets are
aortic valve leaflets, and further wherein the cardiac valve
leaflets are permanently fastened.
30. The method of claim 24 wherein the medical device is introduced
into the subject transvenously and the deployable clip enter the
left atrium through the interatrial septum.
31. The method of claim 24, wherein the medical device is
introduced into the subject through a femoral artery and is
advanced percutaneously to the heart.
32. The method of claim 24, wherein the deployable clip includes
first and second jaw elements in a U-shaped configuration when in
open.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of co-pending, commonly
assigned U.S. patent application Ser. No. 13/370,690, filed Feb.
10, 2012, which is in turn a continuation of commonly assigned U.S.
patent application Ser. No. 12/209,336, filed Sep. 12, 2008, now
U.S. Pat. No. 8,133,239, which in turn is a divisional of commonly
assigned U.S. patent application Ser. No. 10/883,412, filed Jun.
30, 2004, now U.S. Pat. No. 7,509,959, which in turn is a
continuation of commonly assigned U.S. patent application Ser. No.
09/950,163, filed Oct. 15, 2002, now U.S. Pat. No. 7,758,596, which
in turn is a continuation of commonly assigned U.S. patent
application Ser. No. 09/747,558, filed Dec. 23, 2000, now
abandoned, which in turn is a continuation of commonly assigned
U.S. patent application Ser. No. 09/254,111, filed Feb. 25, 1999,
now U.S. Pat. No. 6,269,819, which in turn is a National Phase of
commonly assigned PCT Patent Application No. PCT/US98/13240, filed
Jun. 25, 1998, which is based upon and claims the benefit of the
priority of U.S. Provisional Patent Application No. 60/051,078,
filed Jun. 27, 1997, each of which is incorporated herein by
reference in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to the field of
circulatory valve repair. More particularly, the present invention
relates to the field of the repair of heart valves and specifically
for the repair of mitral heart valves, for patients suffering from
mitral regurgitation.
BACKGROUND OF THE INVENTION
[0003] There are four valves in the heart that serve to direct the
flow of blood through the two sides of the heart in a forward
direction. On the left side, the mitral and aortic valves direct
oxygenated blood coming from the lungs, through the left side of
the heart, into the aorta for distribution to the body. On the
right side, the tricuspid valve, located between the right atrium
and the right ventricle, and the pulmonary valve, located between
the right ventricle and the pulmonary artery, direct de-oxygenated
blood coming from the body, through the right side of the heart,
into the pulmonary artery for distribution to the lungs. The
anatomy of the heart and the structure and terminology of heart
valves are described and illustrated in detail in numerous
reference works on anatomy and cardiac surgery, including standard
texts such as Surgery of the Chest (Sabiston and Spencer, eds.,
Saunders Publ., Philadelphia) and Cardiac Surgery by Kirklin and
Barrett-Boyes, Pathology and Abnormalities of Heart Valves,
incorporated herein by reference.
[0004] All four heart valves are passive structures in that they do
not themselves expend any energy and do not perform any active
contractile function. They consist of moveable "leaflets" that are
designed simply to open and close in response to differential
pressures on either side of the valve. The mitral valve has two
leaflets, and the tricuspid valve has three. The aortic and
pulmonary valves are referred to as "semilunar valves" because of
the unique appearance of their leaflets, which are most aptly
termed "cusps" and are shaped somewhat like a half-moon. The
components of the mitral valve assembly include the mitral valve
annulus; the anterior leaflet; the posterior leaflet; two papillary
muscles which are attached at their bases to the interior surface
of the left ventricular wall; and multiple chordae tendineae, which
couple the mitral valve leaflets to the papillary muscles.
[0005] The problems that can develop with valves can be classified
into two categories: (1) stenosis, in which a valve does not open
properly, or (2) insufficiency, or regurgitation, in which a valve
does not close properly.
[0006] Mitral regurgitation ("MR") is caused by dysfunction of the
mitral subvalvular apparatus or direct injury to the valve
leaflets. Multiple etiologies can lead to mitral regurgitation,
with myxomatous degeneration of the valve and ischemic heart
disease accounting for close to 60% of cases. Repair of the
diseased valve requires major surgery on cardiopulmonary bypass to
allow access to the valve. Consequently, some patients in the early
or late stages of the disease are not considered appropriate
candidates due to the high risk associated with the operation.
Multiple studies have demonstrated that prosthetic replacement of
the mitral valve can lead to significant postoperative left
ventricular dysfunction and often requires lifelong treatment with
anticoagulants. Mitral valve repair, using a posterior annuloplasty
ring, has demonstrated improved results with better ventricular
recovery. Nevertheless, recent studies performed by the inventors
(Umana et al., Surg Forum 1997) have revealed that posterior ring
annuloplasty causes changes in ventricular geometry that lead to
paradoxical movement of the normal papillary muscles, further
deteriorating ventricular performance. In contrast, the "bow-tie"
repair in which the anterior and posterior leaflets of the mitral
valve are fixed in opposition appears to enhance annular
contractility while preserving ventricular architecture. This has
resulted in improved postoperative ventricular function almost
uniformly.
[0007] The present invention addresses the needs of all patients
with mitral regurgitation without mitral stenosis, including those
who heretofore may have been excluded due to having only moderate
MR or being too sick to be candidates for major surgery.
[0008] The present invention finds utility not only for the repair
of mitral valves but for all valves of the circulatory system,
including aortic valves, tricuspid valves, and venous valves.
[0009] Techniques for improving the efficacy of corporeal valves
are known. For example, Laufer et al., U.S. Pat. No. 5,609,598
describes a valving system for treatment of chronic venous
insufficiency. The system has inherent limitations in terms of its
effectiveness for the procedure described and its applicability, if
any, to other valves, especially cardiac valves.
SUMMARY OF THE INVENTION
[0010] The present invention is directed to a method and apparatus
for use in heart valve repair involving the use of an inserted
device or grasper for grabbing and clasping together the anterior
and posterior leaflets of the valve, by insertion into the left
ventricle through the right chest via a thoracoscope, through the
jugular vein, or through the femoral artery. The grasper will grab
both leaflets, preferably after the heart has been stopped or
slowed pharmacologically. The correctness of the initial grasp is
assessed by, for example, intraoperative echocardiography, to
ensure, for example, in the case of the mitral valve, that the
mitral regurgitation is resolved. If not, the grasper will be able
to "adjust" the leaflets to allow better coaptation or, if needed,
re-grab the leaflets in a different location.
[0011] Either inherent to the grasper, as an integrally attached
component, or as a separate device, a fastening device is
introduced and a fastener is deployed to securely hold the leaflets
in place after the grasper has been released. The remaining portion
of the device, or optionally any separate device, is then
removed.
[0012] Accessory devices needed for the procedure include
instruments for thoracoscopic or percutaneous approaches. While the
preferred method and apparatus described herein below is discussed
with reference to its use in connection with mitral valve repair,
it is contemplated that the same or substantially similar apparatus
and methodology would also be useful in repairing other valves
found in the human circulatory systems, particularly other heart
valves, such as, for example, venous valves, aortic valves and
tricuspid valves, amongst others.
OBJECTS OF THE INVENTION
[0013] It is an object of the invention to provide a method for the
repair of heart valves to increase their efficiency.
[0014] It is a further object of the invention to provide for a
method for the repair of mitral valves to reduce mitral
regurgitation.
[0015] It is also an object of the invention to provide for a
method for the repair of the mitral valves which eliminates the
need for cardiopulmonary bypass surgery.
[0016] It is a further object of the invention to provide for an
apparatus for percutaneous insertion into the heart to effect the
repair of a heart valve.
[0017] It is a yet further object of the invention to provide for
the repair of a mitral valve by percutaneous insertion of a
grasping and fastening device into the heart to repair a mitral
valve and reduce or eliminate mitral regurgitation.
[0018] These and other objects of the invention will become
apparent to one skilled in the art from the more detailed
description given below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIGS. 1 to 4 are each a schematic representation of a
portion of the human heart showing the mitral valve, the left
ventricle, and an apparatus of the invention in operation;
[0020] FIG. 5 is a schematic representation of an embodiment of the
distal portion of an apparatus of the invention useful for grasping
a mitral valve;
[0021] FIG. 6 is a schematic representation of an embodiment of a
distal portion of an apparatus of the invention showing a
configuration of a fastener holder and a fastener clip in the open
position;
[0022] FIG. 7 is a schematic representation of an embodiment of
FIG. 6 showing the release and closure of the fastener clip;
[0023] FIG. 8 is a detailed, partly cross-sectional schematic
representation of the distal end of a preferred embodiment of a
grasper device according to the invention in the open position;
[0024] FIG. 9 is a detailed, partly cross-sectional schematic
representation of the preferred embodiment of a grasper device
according to the invention shown in FIG. 8 in a closed position
depicting the translocated adjustable grasper and fastener anvil
within the jaws;
[0025] FIG. 10 is a cross-sectional representation across line
10-10 of the adjustable grasper shown in FIG. 9;
[0026] FIG. 11 is a detailed schematic representation of a
preferred embodiment of the grasper device of the apparatus of the
invention in the closed position with the integral closure means
shown;
[0027] FIG. 12 is a detailed schematic representation of the
preferred embodiment depicted in FIG. 9 showing the closure means
piercing the leaflets of the valve;
[0028] FIG. 13 is a detailed, partly cross-sectional schematic
representation of yet another preferred embodiment of the distal
end of a grasper device according to the invention showing the use
of a coil closure means;
[0029] FIGS. 14, 15, and 16 are partly cross-sectional schematic
representations of another embodiment of the invention, wherein a
self-closing closure is used;
[0030] FIG. 17 is a schematic representation of the self-sealing
closure;
[0031] FIGS. 18 and 19 are schematic representations of an
embodiment of the invention with a three-piece closure;
[0032] FIG. 20 is a schematic representation of an embodiment of
the invention with a three-piece closure;
[0033] FIGS. 21 and 22 are oblique, schematic representations of a
valve leaflet closure useful according to the invention;
[0034] FIG. 23 is a partial cross-sectional view of the closure
shown in FIGS. 21 and 22;
[0035] FIG. 24 is an oblique, schematic representation of another
valve leaflet closure useful according to the invention;
[0036] FIG. 25 is a partial cross-sectional view of the closure in
FIG. 24 in position;
[0037] FIGS. 26 to 28 are each an oblique, schematic representation
of a spiral coil valve leaflet closure useful according to the
invention;
[0038] FIG. 29 is an oblique schematic representation of a U-shaped
valve leaflet closure useful according to the invention; and
[0039] FIG. 30 is a partly cross-sectional view of the closure
shown in FIG. 29.
DETAILED DESCRIPTION OF THE INVENTION
[0040] The invention can perhaps be better appreciated by making
reference to the drawings. In FIG. 1 a portion of the human heart
is depicted showing a mitral valve 10, a left ventricle 12 and the
distal end 14 of a grasper apparatus of the invention 16, which has
been inserted through an incision 18 in left ventricle 12. Incision
18 is loosely sutured with sutures 20 to loosely hold distal end 18
and to prevent bleeding.
[0041] Mitral valve 10 comprises anterior leaflet or cusp 22 and
posterior leaflet or cusp 24, as well as two commissural cusps (pot
shown). The primary intent of the invention herein is to secure the
distal sections 26 and 28 of cusps 22 and 24, respectively,
together or substantially adjacent.
[0042] As can be seen in FIG. 2, the jaws 30 of distal end 14 are
separated and positioned exterior to cusps 22 and 24. Then, as
shown in FIG. 3, jaws 30 are clamped together to cause cusp distal
sections 26 and 28 to come together. Once a closure is embedded,
such as the loop closure 32 in FIG. 4, jaws 30 are opened slightly
so that distal section 14 can be withdrawn.
[0043] The distal ends of the grasper means can vary greatly. It is
contemplated that a variety of grasper means may be employed having
differing grasper configurations and elements. For example, it is
contemplated that the grasper means could be of the type wherein
one side of the grasper is stationary and the other side movable.
Alternatively, the grasper means might be of the type wherein both
sides are movable in concert. Another alternative arrangement
comprises a grasper means having multiple grasper elements to
enable one to grasp and hold the leaflets of the valve in multiple
locations. It is also contemplated that the grasper elements
themselves might comprise one or more suction elements to secure
and hold the valve leaflets in place. Preferably the grasper will
have the capacity to adjust the leaflets of, for example, a mitral
valve to obtain optimal coaptation.
[0044] In addition, it is contemplated that the grasper may
comprise additional technology to facilitate the operation of the
grasper. For example, the grasper may have echo doppler probe or a
similar visualization technology that would allow even better
localization of the leaflets and confirmation of ideal
coaptation.
[0045] FIG. 5 depicts the grasper end 36 of a percutaneous
apparatus 38 with jaws 40 in the open position. Jaws 40 of grasper
end 36 are movably engaged about joint 42 such that the jaws may be
easily and freely opened or closed by the operator of the
percutaneous apparatus.
[0046] Depicted in FIG. 6 is an embodiment of the invention showing
one possible configuration of a fastener holder 44 with a fastener
clip 46 in place held in the open position for placement over the
grasped leaflets of a mitral valve, The fastener holder 44 and
fastener clip 46 may be integral with a grasper end as shown in
FIG. 5 or separate from it, in which case it will be necessary to
also provide a secondary percutaneous means for use in delivering
and manipulating the fastener holder 44 and releasing and fixing
the fastener clip 46 in the proper position about the leaves of a
mitral valve, once they have been properly grasped by jaws 40 of
grasper end 36.
[0047] FIG. 7 is a more detailed schematic representation of the
fastener holder 44 with its jaws 48 in their open position and
fastener clip 46 in place in the open position (dotted line), Also
shown is fastener clip 46 in its released, closed position.
Fastener clip 46, which may have a closed diameter of from about 3
to 7 mm, preferably about 5 ram, will be comprised of a suitable
material such as stainless steel, nitinol, or titanium.
[0048] FIG. 8 depicts a detailed, partly cross-sectional schematic
representation of a preferred embodiment of the grasper device of
the present invention, comprising grasper end 50, movable jaws 52
which are movably engaged about joint 54, in the open position, in
proximity to valve leaflets 56. Each jaw 52 has a protruding
grasping surface 58. However, the grasping surface 58 of one jaw 52
is operatively and slidably connected to a control member 60 to
enable one to properly align valve leaflets 56, prior to
fastening.
[0049] In FIG. 9 the grasper device of the apparatus of the
invention shown in FIG. 8 is in a closed position. Moveable jaws 52
have protruding grasper surfaces 58, which engage valve leaflets
56. Leaflets 56 are translocated to a more optimum position for
fastening by the action of control member 60 on one of protruding
grasping surfaces 58, as shown in FIG. 11. Also, stapler action rod
68 is now operatively connected to stapler control member 70.
[0050] FIG. 10 is a schematic representation of a cross-section of
the adjustable grasper depicted in FIG. 9. The jaws comprise
grasper surfaces 58, an upper anvil 62 with recess 71, and a lower
anvil 64 within which is located a staple type fastener 66 to
effect the fastening of valve leaflets.
[0051] As shown in FIGS. 9, 11, and 12, lower anvil 64 has at least
one slanted surface member 72. When stapler action rod 68 is forced
distally against slanted surface member 72, stapler fastener 66 is
forced through leaflets 56 into upper anvil 62 to close stapler
fastener 66.
[0052] In another embodiment of the invention shown in FIG. 13, a
grasper 80 comprises jaws 82, 84. Jaw 82 is movably connected to
rod 86 at pivot point 87, and jaw 84 is movably connected at pivot
point 88 to rod 90. Rod 92 is movably connected to jaw 84 at pivot
94. Operation of rods 90 and 92 causes jaws 82 and 84 to open and
close on valve leaflets 96. Axial to grasper 80 is a sheath 98
containing a drive mechanism 100 for rotating coil fastener 102.
Coil fastener 102 advances in a spiral mode piercing leaflets 96 in
multiple locations as coil 102 is advanced into its final
position.
[0053] Rods 86, 90, and 92 are each operatively connected to one or
more control mechanisms (not shown). Also, distal section jaws 82,
84 may be slidable within grasper sheath 81.
[0054] Another device 110 of the invention is shown in FIGS. 14 to
16, where jaws 112 are operatively connected to a handle mechanism
(not shown). Device 110 comprises a movable sheath 114 that
contains a straightened closure fastener 116 that is capable of
resuming or forming a circular shape to coapt valve leaflets (not
shown). Device 110 has a slidably extruding grasping surface 118
that is operatively connected to the handle mechanism.
[0055] Once jaws 112 are closed, the distal tip of sheath 114 is
advanced distally to be adjacent grasping surface 118 and its
cooperating grasping surface 122. A pusher 124 coerces fastener 116
to advance out of the distal end 126 of sheath 114 to form a
circular shape. Fastener 116 in this shape will coapt valve
leaflets 120, as can be seen in FIG. 17.
[0056] The device 130 of the invention shown in FIGS. 18 and 19 is
intended to form a three-piece closure device. Jaws 132 each
removably hold a closure member 134 having a grasping surface 136.
Located axially with device 130 is a closure crimper 138 that is
removably fastened at the distal end 140 of a device rod 142. When
jaws 132 grasp valve leaflets 144, closure crimper 138 is advanced
distally by device rod 142 to fit over the proximal ends of closure
members 134. The closure formed is shown in FIG. 20.
[0057] While a typical grasper means configuration would normally
require the use of at least one control wire to actuate the grasper
element(s), it is contemplated that multiple separate control wires
could also be effectively employed and manipulated from the
proximal end of the system to allow for the precise control of the
individual grasper elements.
[0058] With regard to the fastening means employed, as noted above
it is contemplated that the fastening means may be constituted as a
single apparatus operating in concert with the grasper means.
Alternatively, the fastening means may be constituted as an
entirely separate device which is totally independent of the
grasper means. More preferably the fastening means will be a
separate device which will function using a monorail type system,
wherein the fastening means will operate independently of the
grasper means, but will ride via a loop over the same
guidewire/catheter which houses and guides the grasper means.
[0059] While the preferred fastener depicted is in the form of a
clip or staple, it is also contemplated that the fasteners employed
to secure the leaflets of the valve may be of a variety of
different configurations, each of which would function with greater
or lesser effectiveness depending upon the operative conditions
which prevail. In addition to clips or staples it is also
contemplated that the following types of fasteners may also be
effectively employed: coils, sutures, dual button fasteners,
cufflink-like fasteners, and the like.
[0060] Suitable suture fasteners would include those which might
require an appropriate mechanism to automatically suture tissue.
Coil fasteners would generally be provided with sharpened ends to
allow one to screw these fasteners into place by threading the
sharpened end through the tissue of the valve leaflet.
[0061] With reference to FIGS. 21 to 23 which depict a sequential
representation of the closure of valve leaflets using one preferred
closure means, shown in FIG. 22 is a clip type closure 150 being
inserted through valve leaflets 152. FIG. 22 shows the clip type
closure 150 in the fastened position. FIG. 23 is a cross-sectional
view of the clip type closure 150 depicted in FIG. 23. Each closure
150 as shown in FIG. 21 would have a thickness of from about 0.5 to
1.8 mm, preferably about 1 mm, a width of from about 0.3 to 0.7 cm,
preferably about 0.5 cm, and a length of from about 0.6 to 1.4 cm,
preferably about 1 cm.
[0062] FIGS. 24 and 25 are each a schematic representation of the
insertion of another preferred closure means of the invention. A
staple-type closure 156 is inserted through valve leaflets 158, and
then closed, as shown in FIG. 26. Closure 156 would preferably have
an overall length (including sides) of from about 1 to 4 cm,
preferably about 3 cm, an effective diameter of from about 0.1 to
0.5 mm, preferably about 0.3 mm, and an opening of from about 0.5
to 1.3 cm, preferably about 1 cm.
[0063] FIGS. 26 to 28 are each a schematic representation of the
insertion of yet another preferred closure. A spiral coil closure
160 can be inserted across valve leaflets 162 in longitudinal,
latitudinal, or transverse fashion, by use of, for example, the
device shown in FIG. 13. Coils 160 will preferably have pointed
ends and will have external dimensions comprising a length of from
about 3 to 7 cm, preferably about 5 cm, and a diameter of from
about 1 to 3 mm, preferably about 2 mm.
[0064] The overall diameter and/or the differential turns of coil
160 may be uniform or they may vary. For example, the diameter at
each end of coil 160 could be the same as, greater than, or less
than the diameter of the middle portion of the coil. Similarly, the
ratio of the turns of the coil to the length, i.e., the pitch,
could be consistent, or the pitch could be greater or less at each
end of the coil. The diameter of the coil wire will preferably be
consistent.
[0065] Each coil 160 would have a length of from about 3 to 7 cm,
preferably about 5 cm, with a diameter of from about 1 to 3 mm,
preferably about 2 mm, and a coil wire diameter of from about 0.2
to 0.4 mm. The winding of coil 160 should be from about 5 to 10
turns/cm in an unstressed condition.
[0066] In FIGS. 29 and 30 a U-shaped barbed clip-type closure 164
is applied to leaflet 166.
[0067] The device and fasteners used according to the invention
must be comprised of biocompatible, non-immunogenic materials. The
grasper is preferably comprised of rigid materials such as
titanium, nitinol, stainless steel, or rigid polymeric material
such as polyethylene or polyurethane. The clips, staples, coils,
etc., are preferably comprised of titanium, nitinol, or stainless
steel. In some instances fasteners comprised of molded polymeric
material may also be useful.
[0068] There are four different approaches which one might take to
affect a repair of the mitral heart valve according to the
invention:
[0069] Such a procedure might be undertaken while the patient is on
by-pass with an open-chest, either transapical or transatrial. A
median sternotomy is performed, and the patient is placed on
cardiopulmonary bypass by cannulating the ascending aorta and the
right atrium. A purse-string suture is then placed on the apex of
the left ventricle, and a stab incision is performed to insert the
instrument which will grasp and attach the mitral valve leaflets.
Once adequate repair of the valve is attained, the instrument is
removed and the air evacuated from the left ventricle through the
apical incision. The ventricle is then repaired using conventional
wound closure techniques.
[0070] Alternatively, the grasper can be introduced through a
similar stab incision performed over the roof of the left atrium.
The grasper will cross the valve and then be manipulated to revert
to grasp the leaflets from the atrial side and place the suturing
device, just as postulated from the transventricular approach, Once
adequacy of repair is confirmed, the device is extracted and the
atriotomy closed using conventional wound closure techniques.
[0071] This procedure can alternatively be performed with the
patient off bypass, through either a left or right thoracotomy or a
sternotomy incision. The technique would be similar to that
outlined for repair of mitral regurgitation on cardiopulmonary
bypass. After opening the chest, the patient is placed on
medication (beta-blocker) to slow the heart rate to approximately
40 beats per minute, This allows adequate echocardiographic
visualization of the leaflets in order to grasp and attach
them.
[0072] Third, such a procedure can be undertaken thoracoscopically.
The patient is intubated selectively in order to collapse the left
lung, and percutaneous ports are inserted into the left chest,
allowing visualization of the apex of the heart or left atrium.
Through a separate port, the device is introduced into the thoracic
cavity and subsequently into the left ventricle through the apex.
Previously, a purse-string or triangular suture had been placed
around the tip of the ventricle to control bleeding around the
ventricular entry site. Subsequent steps of the repair are
identical to those described for patients with an open chest, off
bypass.
[0073] Should the operation require the patient to be placed on
bypass, this can be attained percutaneously from the groin by
cannulating the femoral artery and vein. This technique could prove
particularly useful in the early stages of development of the
technique, since the surgeon would be able to operate on a
decompressed heart and slow or cease the heart rate as needed,
without hemodynamic compromise.
[0074] Lastly, a percutaneous approach to repair of the mitral
valve would be possible with this invention by inserting the device
either through the femoral artery or jugular vein. When the former
is used, the left ventricle is reached by placing the device across
the aortic valve. The leaflets will be grasped by turning the tip
of the instrument approximately 160.degree. from the entry angle.
As previously stated, the grasper's tips are adjusted to obtain
optimal apposition and the suturing device delivered. If a
transvenous approach is employed, the left atrium is entered
through the interatrial septum and the leaflets are handled as
described for the transatrial technique.
[0075] To determine the relative efficacy of the method of the
invention in effecting the repair of heart valves such as mitral
valves a number of procedures were performed on both animal and
human test subjects as follows:
[0076] Animal Testing
[0077] Six adult sheep underwent ligation of 0M2 and 0M3 through a
left thoracotomy to induce chronic ischemic MR. After 8 weeks,
animals were placed on cardiopulmonary bypass. Using a posterior
approach to the left atrium, a bow-tie repair was performed. A
posterior suture annuloplasty (DeVega) served as control. Snares
were placed on both repairs to allow alternate tightening during
measurements. Ten 2-mm piezo-electric crystals were sutured around
the MV annulus and at the bases and tips of the papillary muscles.
Six crystals were secured to the apex (1), septum (1), and
epicardial short axis of the left ventricle (4) for 3-dimensional
sonomicrometry array localization (3D-SAL) imaging. 3D-SAL
measurements were performed after weaning from cardiopulmonary
bypass at baseline and with each type of repair. Echocardiography
was used to measure MR, MV area, and fractional shortening.
TABLE-US-00001 TABLE 1 MR, mitral valve area, and fractional
shortening MVA MR FS (cm.sup.2) Baseline 3.3 0.46 5.4 DeVega 1.4
0.53 3.9 Bow-tie 1.2 0.57 3.3 FS = fractional shortening; MVA =
mitral valve area (planimetry). P = 0.0159 vs. baseline **P =
0.0079 vs. baseline
[0078] As shown from the results presented in Table 1, MR decreased
significantly with both repairs compared with baseline.
Post-operative improvements in fractional shortening was greater in
the bow-tie group but did not reach statistical significance. MVA,
measured by planimetry, decreased more with the bow-tie repair;
nevertheless, the resultant areas were still substantial without
evidence of a transvalvular gradient. Mitral valve annular
contractility (% area change=(maximum area-minimum area)/maximum
area) by 3D-SAL increased from 19.7%.+-.4.0% at baseline to
21.5%.+-.3.2% after bow-tie repair (P=0.026). Suture annuloplasty
decreased annular contractility to 15.7%.+-.3.6% (P=0.0011 vs.
baseline, and P=0.0001 vs. bow-tie).
[0079] The results obtained suggest that current techniques of
mitral valve repair in ischemic MR may further impair left
ventricular performance by limiting systolic function of the
annulus and base of the heart. The bow-tie repair technique which
is the subject of the present invention controls MR and directly
addresses subvalvular dysfunction resulting in improved annular and
left ventricular function.
[0080] Human Testing
[0081] The charts of eleven patients (five males and six females)
undergoing mitral valve repair in conjunction with a central
leaflet suture ("bow-tie" repair) reviewed. Patients were operated
on between August 1996 and April 1997. Mean age was 68 years
(range, 44 to 78). Etiology of mitral regurgitation (MR) was
ischemic in nine patients and degenerative in two, Mitral
regurgitation was attributed to ischemia if any of the following
criteria proposed by Radford et al. was met: (1) rupture of a
papillary muscle chord or head (n=3); (2) infarction of the
papillary muscle in the absence of leaflet pathology (n=3); (3)
clear history of new onset or worsening of mitral regurgitation
after documented myocardial infarction (n=3).
[0082] The diagnosis of MR was established by echocardiography in
10/10 patients, and semi-quantitatively graded as severe (4+),
moderate/severe (3+), mild/moderate (2+), mild (1+), and trace.
Left-sided cardiac catheterization confirmed the presence of MR in
nine patients and the presence of critical coronary artery disease
(CAD) invariably involving the circumflex and posterior descending
artery territories in all patients with ischemic MR. Preoperative
diagnoses and hemodynamics obtained during catheterization are
shown in Table 2. All patients were in NYHA class III or IV at the
time of surgery.
TABLE-US-00002 TABLE 2 Preoperative diagnosis and hemodynamics.
Patient Diagnosis Age CO PCWP v-wave 1 Unstable angina 59 4.2 30 80
2 CAD/torn post. chord 78 2.4 6 10 3 CAD 74 n/a 14 15 4 CAD/MIx3 64
n/a n/a n/a 5 Unstable angina/MIx2 44 4.0 26 41 6 Ischemic VSD 77
4.0 28 21 7 AI/MR 77 4.5 29 39 8 CAD/APM rupture 67 4.3 27 65 9
CAD/V-tach arrest 71 4.1 20 28 10 Degenerative MR 70 3.5 20 21 11
AMI/PPM rupture 67 4.1 33 60 AI--aortic insufficiency; AMI--acute
myocardial infarction; APM--anterior papillary muscle;
CAD--coronary artery disease; post--posterior; PPM--posterior
papillary muscle; VSD--ventricular septal defect;
v-tach--ventricular tachycardia
[0083] With the patient under anesthesia, the valve is visualized
on transesophageal echocardiogram (TEE) and the likely mode of
failure determined, with special emphasis on the presence of
leaflet prolapse and site and direction of the regurgitant jet.
After the heart was stopped, a bulb syringe with cold saline is
used to distend the left ventricle and confirm the mode of valve
failure. A conventional repair using an annuloplasty right is
generally performed and the valve is re-inspected with saline
injection.
[0084] If the leaflet edges do not oppose each other in a
concentric circle parallel to the annuloplasty ring, and continued
regurgitation is observed, then a "bow-tie" repair is initiated. If
the repair is performed from the transventricular or transaortic
exposure, a single figure of eight 4-0 prolene suture is placed
without screening leaflet eight 4-0 prolene suture is placed
without screening leaflet-coaptation. Using a 4-0 prolene suture,
the anterior leaflet is attached to the corresponding posterior
leaflet at the site of malapposition. The FIG. 8 suture is placed
through each leaflet just as the edge turns down to attach to the
primary chordae. This is usually the most cephalad site where the
two leaflets would touch during systole and creates the largest
area of coaptation possible.
[0085] At times the suture is very close to a commissure, and the
result is a narrowing of single valve orifice. More commonly, the
suture is closer to the center of the valve and a double orifice
valve is created which resembles a "bow-tie". After visual
confirmation that the repair is satisfactory with cold saline
injection, the atrium is closed, the patient weaned from CPB, and
an intraoperative TEE used to confirm the adequacy of the repair.
Standard as well as exercise transthoracic echocardiograms were
performed prior to discharge to establish the competency of the
"bow-tie" repair as well as the absence of a significant gradient
across the valve.
[0086] Six patients were operated on electively for worsening MR
leading to intractable congestive heart failure or unstable angina.
Four patients underwent emergent operation due to acute worsening
of MR secondary to ischemic anterior papillary muscle rupture
(n=2), acute MI with cardiogenic shock requiring intra-aortic
counterpulsation balloon, severe MR and malignant arrhythmias
(N=1), and acute worsening of chronic degenerative MR (n=1). One
patient had moderate (3+0) MR in association with critical aortic
insufficiency. Mean degree of preoperative MR by echo was
3.5.+-.0.7, with mean ejection fraction (SF) of 42%.+-.17%. Nine
patients underwent preoperative cardiac catheterization. Mean
pulmonary capillary wedge pressure was 23 mm Hg.+-.8 mm Hg, with
mean atrial v-wave of 39 mm Hg.+-.25 mm Hg; mean CO as measured by
thermodilution technique was 3.9 l/min (range 2.4 to 4.5 l/min)
(Table 2). Concomitant procedures performed at the time of MR
included coronary artery bypass grafting (CABG) in eight patients.
Of the two patients with a degenerative etiology of valvular
disease, one required aortic valve replacement, whereas the second
underwent posterior leaflet quadrangular resection and
annuloplasty. Two patients, not included in this series, with
end-stage congestive heart failure (CHF) secondary to ventricular
dilation had "bow-tie" repairs during partial left ventriculectomy.
Nine patients had a posterior ring annuloplasty as primary
procedure for treatment of MR (Table 3). One patient required
repair of ischemic ventricular septal defect (VSD) through a
ventriculotomy, which made insertion of an annuloplasty ring
impractical. This patient's mitral valve was successfully repaired
with a "bow-tie" alone. A second patient presented with acute MR
secondary to rupture of the anterior head of the ppm. Repair of the
papillary muscle was performed using pericardial pledgets. Due to
the lack of annular dilatation and persistence of MR a "bow-tie"
suture was placed without an annuloplasty ring. Control of MR
assessed intraoperatively by direct cold saline injection and TEE
was satisfactory in all patients.
TABLE-US-00003 TABLE 3 Operative indications and concomitant
procedures Patient Operative indication Other procedures 1 MR,
unstable angina CABG, C-E#28 2 Torn post chord, MR Post quad
resection, C-E#32 3 CAD, MR CABG, C-E#32 4 CAD, MR CABG, C-E#30 5
Unstable angina, MR CABG, C-E#28 6 Ischemic VSD, MR CABG 7 Critical
AI, MR AVR, C-E#30 8 CAD, ALM rupture, MR CABG, C-E#26 9 CAD, MR
CABG, C-E#28 10 MR, CHF C-E#30 11 PPM rupture, MR CABG, primary PPM
repair AVR--aortic valve replacement; C-E Cosgrove ring; CHF
congestive heart failure; PPM posterior papillary muscle
[0087] It will thus be seen that the objects set forth above, among
those made apparent from the preceding description, are efficiently
attained and, since certain changes may be made in the
constructions set forth without departing from the spirit and scope
of the invention, it is intended that all matter contained in the
above description and shown in the accompanying drawings shall be
interpreted as illustrative and not in a limiting sense.
[0088] It is also to be understood that the following claims are
intended to cover all of the generic and specific features of the
invention herein described and all statements of the scope of the
invention which, as a matter of language, might be said to fall
there between.
TABLE-US-00004 DRAWING COMPONENTS No. Component 10 mitral valve 12
left ventricle 14 distal end of grasper 16 grasper 18 incision 20
suture 22 anterior leaflet or cusp 24 posterior leaflet or cusp 26
anterior cusp distal section 28 posterior cusp distal section 30
jaw 32 closure loop 36 grasper end 38 percutaneous apparatus 40 jaw
42 joint 44 fastener holder 46 fastener clip 48 jaw 50 grasper end
52 jaw 54 joint 56 valve leaflet 58 protruding grasping surface 60
control number 62 upper anvil 64 lower anvil 66 staple type
fastener 68 staple action rod 71 recess 72 anvil slanted surface 80
grasper 81 grasper sheath 82 jaw 84 jaw 86 rod 87 pivot point 88
pivot point 90 rod 92 rod 94 pivot 96 valve leaflet 98 sheath 100
drive mechanism 102 coil fastener 110 grasper device 112 jaw 114
sheath 116 fastener 118 grasping surface 120 leaflet 122
cooperating grasping surface 124 pusher 130 grasper device 132 jaw
134 closure member 136 grasping surface 138 closure crimper 140 rod
distal end 142 device rod 144 valve leaflet 150 clip-type closure
152 valve leaflet 156 staple-type closure 158 valve leaflet 160
spiral closure 162 valve leaflet 164 barbed-clip closure 166 valve
leaflet
* * * * *