U.S. patent application number 11/245535 was filed with the patent office on 2006-02-09 for transvenous staples, assembly and method for mitral valve repair.
Invention is credited to John M. Adams, Scott J. Wolf.
Application Number | 20060030882 11/245535 |
Document ID | / |
Family ID | 27804207 |
Filed Date | 2006-02-09 |
United States Patent
Application |
20060030882 |
Kind Code |
A1 |
Adams; John M. ; et
al. |
February 9, 2006 |
Transvenous staples, assembly and method for mitral valve
repair
Abstract
A mitral valve staple device treats mitral regurgitation of a
heart. The device includes first and second leg portions, each leg
portion terminating in a tissue piercing end, and a connection
portion extending between the first and second leg portions. The
connection portion has an initial stressed and distorted
configuration to separate the first and second leg portion by a
first distance when the tissue piercing ends pierce the mitral
valve annulus and a final unstressed and undistorted configuration
after the tissue piercing ends pierce the mitral valve annulus to
separate the first and second leg portions by a second distance
which is shorter than the first distance. The device is deployed
within the heart transvenously through a catheter positioned in the
coronary sinus adjacent the mitral valve annulus. A tool forces the
mitral valve staple device through the wall of the catheter for
deployment in the heart.
Inventors: |
Adams; John M.; (Sammamish,
WA) ; Wolf; Scott J.; (Bellevue, WA) |
Correspondence
Address: |
WILSON SONSINI GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO
CA
94304-1050
US
|
Family ID: |
27804207 |
Appl. No.: |
11/245535 |
Filed: |
October 7, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10093323 |
Mar 6, 2002 |
|
|
|
11245535 |
Oct 7, 2005 |
|
|
|
Current U.S.
Class: |
606/219 |
Current CPC
Class: |
A61B 17/0684 20130101;
A61B 2017/00783 20130101; A61B 2017/00867 20130101; A61F 2/2451
20130101; A61B 17/00234 20130101; A61B 2017/22052 20130101 |
Class at
Publication: |
606/219 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
Claims
1. A device for effecting mitral valve annulus geometry of a heart,
the device comprising: first and second leg portions, each leg
portion terminating in a tissue piercing end; and a connection
portion extending between the first and second leg portions, the
connection portion having an initial stressed and distorted
configuration to separate the first and second leg portions by a
first distance when the tissue piercing ends pierce the mitral
valve annulus and a final unstressed and undistorted configuration
after the tissue piercing ends pierce the mitral valve annulus to
separate the first and second leg portions by a second distance,
the second distance being shorter than the first distance.
2. The device of claim 1 wherein the leg portions and connection
portion are formed of the same material stock.
3. The device of claim 2 wherein the leg portions and the
connection portion are formed from Nitinol.
4. A device for effecting mitral valve annulus geometry of a heart,
the device comprising: first and second tissue piercing portions,
each tissue piercing portion terminating in a tissue piercing end;
and a connection portion extending between the first and second
tissue piercing portions, the connection portion having an initial
stressed and distorted configuration to separate the first and
second tissue piercing portions by a first distance when the tissue
piercing ends pierce the mitral valve annulus and a final
unstressed and undistorted configuration after the tissue piercing
ends pierce the mitral valve annulus to separate the first and
second tissue piercing portions by a second distance, the second
distance being shorter than the first distance.
5. A device for effecting tissue geometry of an organ, the device
comprising: first and second leg portions, each leg portion
terminating in a tissue piercing end; and a connection portion
extending between the first and second leg portions, the connection
portion having an initial stressed and distorted configuration to
separate the first and second leg portions by a first distance when
the tissue piercing ends pierce the tissue and a final unstressed
and undistorted configuration after the tissue piercing ends pierce
the tissue to separate the first and second leg portions by a
second distance, the second distance being shorter than the first
distance.
Description
CROSS-REFERENCE
[0001] This application is a continuation application of Ser. No.
10/093,323, filed Mar. 6, 2002, which is incorporated herein by
reference in its entirety and to which application we claim
priority under 35 USC .sctn. 120.
FIELD OF THE INVENTION
[0002] The present invention generally relates to a device,
assembly and method for treating dilated cardiomyopathy of a heart.
The present invention more particularly relates to mitral valve
annulus staple devices and an assembly and method for deploying
such staple device to reshape the mitral valve annulus.
BACKGROUND OF THE INVENTION
[0003] 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.
[0004] 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.
[0005] 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.
[0006] One method of repairing a mitral valve heaving 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.
[0007] 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.
[0008] 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.
[0009] 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.
[0010] 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.
[0011] 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.
[0012] 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.
[0013] 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.
[0014] 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 regurgitation 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.
[0015] A still further approach to treat mitral regurgitation from
the coronary sinus of the heart contemplates a device having 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. When the first and
second anchors are fixed within the heart, the cable may be drawn
proximally and locked on the second anchor. The geometry of the
mitral valve is thereby effected. This approach provides
flexibility in that the second anchor may be positioned and fixed
in the coronary sinus or alternatively, the second anchor may be
positioned and fixed in the right atrium. This approach further
allows adjustments in the cable tension after implant.
[0016] A still further alternative for treating mitral
regurgitation contemplates a device having a first anchor
configured to be positioned within and anchored to the coronary
sinus of the heart adjacent the mitral valve annulus within the
heart. A second anchor is configured to be positioned within the
heart proximal to the first anchor and adjacent the mitral valve
annulus within the heart. A connecting member, having a fixed
length, is permanently attached to the first and second anchors. As
a result, when the first and second anchors are within the heart
with the first anchor anchored in the coronary sinus, the second
anchor may be displaced proximally to effect the geometry of the
mitral valve annulus and released to maintain the effect on the
mitral valve geometry. The second anchor may be configured, when
deployed, to anchor against distal movement but be moveable
proximally within the coronary sinus. The present invention
provides a still further approach for treating mitral
regurgitation.
SUMMARY OF THE INVENTION
[0017] The invention provides a device for effecting tissue
geometry of an organ. The device includes first and second leg
portions, each leg portion terminating in a tissue piercing end,
and a connection portion extending between the first and second leg
portions, the connection portion having an initial stressed and
distorted configuration to separate the first and second leg
portions by a first distance when the tissue piercing ends pierce
the tissue and a final unstressed and undistorted configuration
after the tissue piercing ends pierce the tissue to separate the
first and second leg portions by a second distance, the second
distance being shorter than the first distance.
[0018] The present invention further provides a device for
effecting mitral valve annulus geometry of a heart. The device
includes first and second leg portions, each leg portion
terminating in a tissue piercing end, and a connection portion
extending between the first and second leg portions. The connection
portion has an initial stressed and distorted configuration to
separate the first and second leg portions by a first distance when
the tissue piercing ends pierce the mitral valve annulus and a
final unstressed and undistorted configuration after the tissue
piercing ends pierce the mitral valve annulus to separate the first
and second leg portions by a second distance, the second distance
being shorter than the first distance.
[0019] The initial configuration of the connection portion may be a
first arched configuration and the final configuration of the
connection portion may be a second arched configuration, wherein
the second arched configuration is arched in a direction opposite
the first arched configuration. The device may be configured such
that when the connection portion is in the second arched
configuration, the tissue piercing ends of the leg portions point
toward each other. The leg portions and connection portion are
preferably formed of the same material stock, as from Nitinol, for
example.
[0020] The invention further provides a device for effecting mitral
valve annulus geometry of a heart. The device includes first and
second tissue piercing portions, each tissue piercing portion
terminating in a tissue piercing end, and a connection portion
extending between the first and second tissue piercing portions,
the connection portion having an initial stressed and distorted
configuration to separate the first and second tissue piercing
portions by a first distance when the tissue piercing ends pierce
the mitral valve annulus and a final unstressed and undistorted
configuration after the tissue piercing ends pierce the mitral
valve annulus to separate the first and second tissue piercing
portions by a second distance, the second distance being shorter
than the first distance.
[0021] The invention further provides an assembly for effecting
mitral valve annulus geometry of a heart. The assembly includes an
elongated catheter being placeable in the coronary sinus of the
heart adjacent the mitral valve annulus. The assembly further
includes at least one staple carried within the catheter, the at
least one staple including first and second leg portions, each leg
portion terminating in a tissue piercing end, and a connection
portion extending between the first and second leg portions, the
connection portion having an initial stressed and distorted
configuration to separate the first and second leg portions by a
first distance when the tissue piercing ends pierce the mitral
valve annulus and a final unstressed and undistorted configuration
after the tissue piercing ends pierce the mitral valve annulus to
separate the first and second leg portions by a second distance,
the second distance being shorter than the first distance. The
assembly further includes a tool that forces the at least one
staple from the catheter to cause the tissue piercing ends of the
first and second leg portions of the at least one staple to pierce
the mitral valve annulus with the connection portion of the at
least one staple in the initial configuration.
[0022] The at least one staple is preferably configured so that the
tissue piercing ends of the first and second leg portions point
away from each other when the connection portion is in the initial
configuration and the tissue piercing ends of the first and second
leg portions point toward each other when the connection portion is
in the final configuration.
[0023] The catheter preferably includes a tubular wall wherein the
tool forces the at least one staple through the tubular wall of the
catheter. To that end, the tubular wall may include a break-away
slot adjacent the at least one staple that permits the at least one
staple to be forced therethrough.
[0024] The at least one staple may comprise a plurality of staples.
The catheter tubular wall may in turn include a plurality of
break-away slots, each slot being adjacent to a respective given
one of the staples, the slots permitting the staples to be forced
through the tubular wall of the catheter and into the mitral valve
annulus. The tool is preferably configured to force the plurality
of staples from the catheter substantially simultaneously.
[0025] The assembly may further include an urging member that urges
the catheter along and against a wall of the coronary sinus
adjacent to the mitral valve annulus. The urging member may be an
elongated balloon carried by the catheter.
[0026] The invention still further provides a method of effecting
mitral valve annulus geometry of a heart. The method includes the
steps of providing at least one staple including first and second
leg portions, each leg portion terminating in a tissue piercing
end, and a connection portion extending between the first and
second leg portions, the connection portion having an initial
stressed and distorted configuration to separate the first and
second leg portions by a first distance when the tissue piercing
ends pierce the mitral valve annulus and a final unstressed and
undistorted configuration after the tissue piercing ends pierce the
mitral valve annulus to separate the first and second leg portions
by a second distance, the second distance being shorter than the
first distance, placing the at least one staple into a catheter,
and locating the catheter in the coronary sinus of the heart so
that the at least one staple is adjacent the mitral valve annulus.
The method includes the further step of releasing the at least one
staple from the catheter to cause the tissue piercing ends of the
first and second leg portions of the at least one staple to pierce
the mitral valve annulus with the connection portion of the at
least one staple in the initial configuration and causing the
connection portion to assume the final configuration.
[0027] The invention still further provides an assembly for
effecting mitral valve annulus geometry of a heart. The assembly
includes
INCORPORATION BY REFERENCE
[0028] All publications and patent applications mentioned in this
specification are herein incorporated by reference to the same
extent as if each individual publication or patent application was
specifically and individually indicated to be incorporated by
reference.
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] The novel features of the invention are set forth with
particularity in the appended claims. A better understanding of the
features and advantages of the present invention will be obtained
by reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention
are utilized, and the accompanying drawings of which:
[0030] 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, in the several figures of which like reference numerals
identify identical elements, and wherein:
[0031] FIG. 1 is a superior view of a human heart with the atria
removed;
[0032] FIG. 2 is a side plan view of a staple device embodying the
present invention shown in an initial stressed and distorted
configuration within a deployment catheter;
[0033] FIG. 3 is a side plan view of the staple device of FIG. 2
shown in a final unstressed and undistorted configuration;
[0034] FIG. 4 is a side view of the deployment catheter
illustrating a slot portion through which the staple device may be
forced for deployment;
[0035] FIG. 5 is a side view illustrating the staple after being
forced through the slot portion of the catheter;
[0036] FIG. 6 is a side view of an assembly embodying the present
invention shown within a coronary sinus and ready for deployment of
a plurality of staple devices in accordance with the present
invention;
[0037] FIG. 7 is a superior view of a human heart similar to FIG. 1
illustrating a first step in the deployment of mitral valve staple
devices embodying the present invention;
[0038] FIG. 8 is a view similar to FIG. 7 illustrating a further
step in the deployment of the staple devices; and
[0039] FIG. 9 is a superior view of a human heart similar to FIG. 7
illustrating the mitral valve staple devices deployed in the
heart.
DETAILED DESCRIPTION OF THE INVENTION
[0040] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that methods and structures
within the scope of these claims and their equivalents be covered
thereby.
[0041] 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.
[0042] 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 staple devices of the present
invention therein.
[0043] FIG. 2 shows a mitral valve therapy staple device 30
embodying the present invention. The device 30 is shown confined
within a deployment catheter 40 which will be described
subsequently. The device 30 includes first and second tissue
piercing leg portions 32 and 34 and a connection portion 36 between
the leg portions 32 and 34. The leg portions 32 and 34 terminate in
tissue piercing ends 33 and 35, respectively.
[0044] The device 30 is confined within the catheter 40 in a first
or initial configuration. The initial configuration is exhibited by
the connecting member 36 having a first arcuate or arched
configuration, as illustrated, with the tissue piercing ends 33 and
35 pointing away from each other.
[0045] The device 30 is formed of a material having shape memory so
that once deployed, the connection portion 36 assumes a second or
final configuration to be described with respect to FIG. 3 wherein
the connection portion assumes a second arched configuration which
is arched in a direction opposite than the first arched
configuration illustrated in FIG. 2. To that end, the device 30 may
be formed of, for example, Nitinol, a material well known for shape
memory characteristics. Other suitable materials may include
stainless steel or biocompatible plastic materials. Preferably, the
connection portion 36 and leg portions 32 and 34 are formed of the
same material stock as, for example, from a strip of Nitinol.
[0046] When the staple device 30 is deployed in the heart, the
device 30 assumes its final configuration illustrated in FIG. 3.
Here it may be seen that the connection member 36 has assumed an
arched configuration opposite than that shown in FIG. 2. The final
configuration of the connection member 36 causes the leg portions
32 and 34 to be more closely spaced together. In addition, in
accordance with this preferred embodiment, when the device 30 is in
its final configuration, the tissue piercing ends 33 and 35 point
towards each other.
[0047] Referring now to FIGS. 4 and 5, they illustrate the
deployment catheter 40 in greater detail. Here it may be seen that
the deployment catheter 40 includes a tubular wall 42 in which a
slot 44 is formed. The staple device 30 is positioned adjacent the
slot 44 to permit the staple device 30 to be forced through the
tubular sidewall 42 and more particularly through the slot 44 for
deployment in the heart. The slot 44 preferably comprises a reduced
thickness of the tubular wall 42 to provide an effective seal prior
to deployment but permitting a relatively modest force to urge the
device 30 through the slot 44 and into the mitral valve annulus as
will be described hereinafter. Hence, the slot 44 is a break-away
slot providing seal integrity prior to deployment but permitting
the staple 30 to be forced through the tubular wall 42 of the
catheter 40 into the heart.
[0048] FIG. 6 is a side view showing the catheter 40 within the
coronary sinus 14. Also illustrated in FIG. 6 is a tool 50 which
may be utilized for forcing the staples 30 through the tubular wall
42 of the catheter 40. Also shown in FIG. 6 is an urging member 60
which urges the catheter 40 against the wall of the coronary sinus
adjacent the mitral valve annulus.
[0049] More specifically, the tool 50 includes a surface contour 52
which corresponds to the contour of the staple devices 30 when in
the initial configuration. Displacement of the tool 50 in a
proximal direction as indicated by the arrow 54 causes the tool 50
to urge or force the staple devices 30 through the tubular wall 42
of the catheter 40. As noted in FIG. 6, the plurality of staple
devices 30 are urged or forced through the tubular wall 42 for
deployment substantially simultaneously.
[0050] The urging member 60 preferably takes the form of an
inflatable balloon 62. Preferably, the inflatable balloon 62 is
inflatable by a conduit 64 and is carried by the catheter 40. Prior
to deployment of the staple devices 30, the catheter 40 is placed
in the coronary sinus adjacent the mitral valve annulus with the
balloon 62 deflated. Thereafter, the balloon 62 is inflated so as
to urge the catheter 40 against the wall of the coronary sinus
adjacent the mitral valve annulus as illustrated. Thereafter, the
tool 50 may be displaced proximally to urge or force the staple
devices 30 through the tubular wall 42 of the catheter 40 for
deployment.
[0051] The deployment of the staple devices 30 is shown more
particularly in FIGS. 7 and 8. In FIG. 7, it can be seen that the
catheter 40 is positioned within the coronary sinus 14 adjacent to
the mitral valve annulus 20. The balloon 62 has been inflated so as
to urge the catheter 40 against the wall of the coronary sinus 14
which is adjacent the mitral valve annulus 20. The assembly is now
ready to deploy the mitral valve staple devices 30.
[0052] Referring now to FIG. 8, it will be noted that the tool 50
is being displaced proximally and is forcing the staple devices 30
through the tubular wall 42 of the catheter 40. The leg portions
are extending through the wall of the coronary sinus into the
mitral valve annulus 20 or at least near to the annulus. Once the
mitral valve staple devices 30 have been forced through the
catheter sidewall with the leg portions piercing the mitral valve
annulus, the staple devices will assume their final configuration.
This is shown more particularly in FIG. 9.
[0053] In FIG. 9, it can be seen that the connection portions 36 of
the mitral valve staple devices 30 have assumed their final
configuration. During the process of transitioning from the initial
configuration to the final configuration, the tissue piercing leg
portions have gathered-up mitral valve annulus tissue to tighten
the mitral valve annulus. More specifically, as will be noted in
FIG. 9, the radius of curvature of the mitral valve annulus 20 in a
portion designated 70 has been dramatically increased. This
tightening up of the mitral valve annulus will promote more
efficient mitral valve action and advantageously terminate mitral
regurgitation. While the tissue piercing leg portions are
illustrated as piercing entirely through the mitral valve annulus,
it will be appreciated by those skilled in the art that the mitral
valve annulus wall need not necessarily be pierced entirely through
and that the tissue piercing leg portions need only pierce into the
mitral valve annulus.
[0054] 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 claims.
* * * * *