U.S. patent application number 10/784674 was filed with the patent office on 2004-08-26 for mitral and tricuspid valve repair.
This patent application is currently assigned to St. Jude Medical, Inc.. Invention is credited to Bergman, Darrin J., Hinnenkamp, Thomas F., Holmberg, William R., Kuehn, Stephen T., Moore, Scott D., Shepherd, Terry L..
Application Number | 20040167539 10/784674 |
Document ID | / |
Family ID | 22363588 |
Filed Date | 2004-08-26 |
United States Patent
Application |
20040167539 |
Kind Code |
A1 |
Kuehn, Stephen T. ; et
al. |
August 26, 2004 |
Mitral and tricuspid valve repair
Abstract
A novel approach to mitral or tricuspid valve repair involves
the performance of an edge-to-edge fastening/securing of opposing
heart valve leaflets through a catheter entering the heart. Thus, a
device is introduced including a leaflet fastener applicator
through a cardiac catheter or other suitable catheter. The leaflet
fastener applicator and cardiac catheter can be formed into a kit.
A gripper can be used to hold the heart valve leaflets while they
are fastened.
Inventors: |
Kuehn, Stephen T.;
(Woodbury, MN) ; Hinnenkamp, Thomas F.; (White
Bear Lake, MN) ; Holmberg, William R.; (New Richmond,
WI) ; Bergman, Darrin J.; (Shoreview, MN) ;
Moore, Scott D.; (Columbia Heights, MN) ; Shepherd,
Terry L.; (Shoreview, MN) |
Correspondence
Address: |
Hallie A. Finucane
Altera Law Group
Suite 100
6500 City West Parkway
Minneapolis
MN
55344-7704
US
|
Assignee: |
St. Jude Medical, Inc.
|
Family ID: |
22363588 |
Appl. No.: |
10/784674 |
Filed: |
February 23, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10784674 |
Feb 23, 2004 |
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09543076 |
Apr 5, 2000 |
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6695866 |
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09543076 |
Apr 5, 2000 |
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09115820 |
Jul 15, 1998 |
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6165183 |
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Current U.S.
Class: |
606/108 ;
623/2.11 |
Current CPC
Class: |
A61B 2017/306 20130101;
A61B 17/068 20130101; A61B 2017/00783 20130101; A61B 17/0643
20130101; A61B 2017/2926 20130101; A61B 17/064 20130101; A61B
2017/00243 20130101; A61B 17/1227 20130101; A61B 2017/0647
20130101; A61B 2017/00353 20130101 |
Class at
Publication: |
606/108 ;
623/002.11 |
International
Class: |
A61F 011/00; A61F
002/24 |
Claims
What is claimed is:
1. A kit comprising a cardiac catheter and a leaflet fastener
applicator, said cardiac catheter having suitable dimensions for
deployment and insertion into a human heart in the vicinity of the
mitral or tricuspid valve, said leaflet fastener applicator having
a size allowing insertion through said cardiac catheter and being
capable of holding portions of opposing heart valve leaflets.
2. The kit of claim 1 wherein said fastener applicator comprises
opposing jaws, one of said jaws having a site for holding a tack
and the second of said jaws having a site for holding a cap.
3. The kit of claim 1 wherein said fastener applicator comprises a
stapler.
4. The kit of claim 1 wherein said fastener applicator comprises a
needle and suture, which passes through a leaflet.
5. The kit of claim 1 wherein said fastener applicator comprises
sets of opposing arms where each set has suitable dimensions for
holding a heart valve leaflet.
6. The kit of claim 1 wherein said fastener applicator comprises a
ring.
7. The kit of claim 1 wherein said fastener applicator comprises a
clip button including a first element with spikes and a second
element that clips onto said first element.
8. The kit of claim 1 further comprising a gripper, said gripper
including a tube having a proximal end and a distal end, opposing
gripper arms at said distal end of said tube, and an actuator at
said proximal end of said tube such that motion of said actuator
changes the relative position of said gripper arms.
9. The kit of claim 1 further comprising a gripper, said gripper
having a suitable opening for the application of suction to a heart
valve.
10. The kit of claim 1 further comprising instructions describing
use of said cardiac catheter and said leaflet fastener
applicator.
11. A method of repairing a valve of a beating heart, said method
comprising: a) inserting the distal end of a catheter into the
heart to provide access to said valve; and b) fastening together
portions of leaflets of said valve using a leaflet fastener
applicator inserted through said catheter.
12. The method of claim 11 wherein the catheter is inserted through
an opening in the wall of said beating heart.
13. The method of claim 11 wherein the catheter is introduced into
the heart by way of a blood vessel.
14. The method of claim 11 wherein said fastening of said opposing
leaflets comprises placement of a sharp projection through said
leaflets.
15. The method of claim 11 wherein said fastening of said leaflets
comprises suturing together said opposing leaflets.
16. The method of claim 11 further comprising gripping said
leaflets with a gripper prior to fastening said leaflets.
17. The method of claim 16 wherein said gripper comprise a tube
having a proximal end and a distal end, opposing gripper arms at
said distal end of said tube, and an actuator at said proximal end
of said tube such that motion of said actuator change the relative
position of said gripper arms.
18. The method of claim 16 wherein said gripper has a suitable
opening for the application of suction to a heart valve.
19. The method of claim 11 further comprising inserting a wire
through said wall of said heart to initiate an opening through
which said cardiac catheter is inserted.
20. The method of claim 11 further comprising making an incision in
the wall of the heart for said insertion of said catheter.
21. A device comprising a catheter and a leaflet fastener
applicator, said catheter having a proximal end, a distal end and
suitable dimensions for insertion into a heart, said leaflet
fastener applicator passing through said catheter such that an
actuating element projects from said proximal end of said catheter
while a fastening element projects from said distal end of said
catheter.
22. The device of claim 21 wherein said actuating element comprises
a length of suture extending to said distal end of said leaflet
fastener applicator.
23. The device of claim 21 wherein said actuating element comprises
a lever that controls the delivery of a fastener.
24. The device of claim 21 further comprising a gripper inserted
through said cardiac catheter such that gripping appendages project
from said distal end and an actuating element projects from said
proximal end, where said actuating element controls said gripping
appendages.
25. A heart valve leaflet fastener comprising two pairs of arms,
each pair having a suitable size for fastening heart valve leaflets
and said two pairs of arms capable of fastening two adjacent
leaflets.
26. The heart valve leaflet fastener of claim 26 wherein said arms
flex relative to a central core, and wherein said fastener has a
locked position where each said pair of arms meet under
tension.
27. The heart valve leaflet fastener of claim 26 wherein one of
said arms of each pair includes a projection for piercing a
leaflet.
28. A heart valve gripper/fastener applicator comprising a gripper
and a fastener applicator wherein said gripper and said fastener
applicator extend from a single shaft.
29. The gripper/fastener of claim 28 wherein said gripper comprises
two opposing jaws.
30. The gripper/fastener of claim 28 wherein said fastener
comprises two opposing jaws, one of said jaws having a site for
holding a tack and the second of said jaws having a site for
holding a cap.
31. A heart valve leaflet fastener applicator comprising two
opposing jaws, one of said jaws having a site for holding a tack
and the second of said jaws having a site for holding a cap.
32. The heart valve leaflet fastener applicator of claim 31 wherein
said jaw having a site for holding a tack further comprises a slot
wherein a tack can be shifted to a position opposite said site for
holding a cap.
33. A gripper comprising a plunger that slides over an inner shaft
and arms having suitable dimensions for gripping heart valve
leaflets, said plunger slides such that interaction of heart valve
leaflets with said plunger directs said leaflets toward said
arms.
34. The gripper of claim 33 wherein said plunger is a balloon
plunger that can be inflated and deflated.
35. A fastener applicator comprising a first shaft, a first portion
of a button clip having a sharp projection for piercing a heart
valve leaflet, a second shaft that slides over said first shaft,
and a second portion of said button clip having an opening to
engage the projection of said first portion of said button clip,
said second portion of said button clip sliding over said first
shaft and not over said second shaft such that second shaft can
direct said second portion toward said first portion.
Description
BACKGROUND OF THE INVENTION
[0001] The invention relates to the repair of mitral and tricuspid
valves exhibiting valve regurgitation. More particularly, the
invention relates to apparatus and methods suitable for a less
invasive repair of a mitral or tricuspid heart valve.
[0002] Mitral regurgitation, i.e., backward leakage of blood at the
mitral heart valve, results in reduced pumping efficiency.
Furthermore, compensatory mechanisms such as hypertrophy and
dilation of the ventricle suggest early treatment to prevent
progressive deterioration of ventricular function. Diagnosis of
mitral regurgitation can be performed using visualization with
transesophageal echocardiography or by echocardiodiography. In
particular, defective leaflet coaptation and the site and direction
of the regurgitant flow can be examined to evaluate likely modes of
failure.
[0003] Mitral valve prolapse, i.e., myxomatous degeneration of
mitral valve leaflets, is the most common cause of mitral
regurgitation in North America. Rheumatic heart disease was the
most common cause of mitral regurgitation in the U.S.A. thirty
years ago and is still the most common cause of mitral
regurgitation in developing countries. Chronic rheumatic heart
disease results in retraction, deformity and rigidity of one or
both mitral valve cusps as well as structural abnormalities in the
commissures, chordae tendinae and papillary muscles. Ischemic
mitral regurgitation (IMR), i.e., anemia of the valve tissue due to
reduced arterial blood flow feeding the valve tissue, is the second
most common cause of mitral valve regurgitation. Studies suggest
that annular irregularities and posterior papillary muscle fibrosis
with scarring of the underlying ventricular wall may be associated
with IMR.
[0004] Many cases of mitral regurgitation can be repaired by
modifications of the original valve in a procedure generally
referred to as valvuloplasty. These repair procedures typically
involve a full sternotomy and quadrangular resection of the
anterior leaflet, while on cardiopulmonary bypass. Repairs can also
involve reattachment of chordae tendinae, which tether the valve
leaflets, or removal of leaflet tissue to correct misshapen or
enlarged valve leaflets. In some cases, the base of the valve is
secured using an annuloplasty ring. Valves that are heavily
calcified or significantly compromised by disease may need to be
replaced.
[0005] As an alternative to these repair techniques, an
edge-to-edge suturing of the anterior and posterior mitral valve
leaflets can be performed. Commonly referred to as a "bow-tie"
repair, edge-to-edge suturing ensures leaflet coaptation without
performing a quadrangular resection of the anterior leaflet. The
bow-tie repair generally involves the use of a centrally located
suture, although a suture can be placed close to a commissure, or
multiple sutures can be used to complete the repair. A centrally
placed suture creates a double orifice valve, which resembles a
bow-tie.
[0006] The bow-tie repair procedure has been applied using invasive
procedures by placing the patient on extracorporeal circulation. An
incision is made to provide access into the left atrium of the
heart. Following suturing, the atrium is closed. Such repairs can
result in a significant decrease in mitral regurgitation along with
a corresponding increase in the ejection fraction.
SUMMARY OF THE INVENTION
[0007] In a first aspect, the invention relates to a kit including
a cardiac catheter and a leaflet fastener applicator. The cardiac
catheter generally has suitable dimensions for deployment and
insertion into a human heart in the vicinity of the mitral or
tricuspid valve. The leaflet fastener applicator generally has a
size allowing insertion through the cardiac catheter and is capable
of holding portions of opposing heart valve leaflets.
[0008] In another aspect, the invention relates to a method of
repairing the mitral or tricuspid valve of a beating heart, the
method including:
[0009] a) inserting the distal end of a catheter into the heart to
provide access to the valve; and
[0010] b) fastening together portions of leaflets of the valve
using a leaflet fastener applicator inserted through the
catheter.
[0011] In another aspect, the invention relates to a device
including a catheter and a leaflet fastener applicator. The
catheter has a proximal end, a distal end and suitable dimensions
for insertion into a heart. The leaflet fastener applicator passes
through the catheter such that an actuating element projects from
the proximal end of the catheter while a fastening element projects
from the distal end of the catheter.
[0012] In another aspect, the invention relates to a heart valve
leaflet fastener including two pairs of arms. Each pair of arms is
of a suitable size for fastening heart valve leaflets together. The
two pairs of arms are capable of fastening two adjacent
leaflets.
[0013] In another aspect, the invention relates to a heart valve
gripper/fastener applicator including a gripper and a fastener
applicator wherein the gripper and the fastener applicator extend
from a single shaft.
[0014] In another aspect, the invention relates to a heart valve
leaflet fastener applicator including two opposing jaws. One of the
jaws has a site for holding a tack, and the second jaw has a site
for holding a cap.
[0015] In another aspect, the invention relates to a gripper
including a plunger that slides over an inner shaft, and arms
having suitable dimensions for gripping heart valve leaflets. The
plunger slides such that the interaction of heart valve leaflets
with the plunger directs the leaflets toward the arms.
[0016] In another aspect, the invention relates to a fastener
applicator including a first shaft, a first portion of a button
clip having a sharp projection for piercing a heart valve leaflet,
a second shaft that slides over the first shaft, and a second
portion of the button clip having an opening to engage the
projection of the first portion of the button clip. The second
portion of the button clip slides over the first shaft and not over
the second shaft such that the second shaft can direct the second
portion toward the first portion.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 is a side view of one embodiment of a cardiac
catheter.
[0018] FIG. 2 is a perspective view of the proximal end of the
cardiac catheter of FIG. 1.
[0019] FIG. 3 is a side view of a suture knot securing two leaflets
together.
[0020] FIG. 4 is a side view of a knot pusher.
[0021] FIG. 5 is a perspective view of sutured heart valve leaflets
being secured with a suture clip with a portion of a cardiac
catheter cut away to expose structure within the catheter.
[0022] FIG. 6 is a perspective view of endoscopic scissors being
used to cut a suture.
[0023] FIG. 7 is a perspective view of heart valve leaflets secured
with attached wires that have suture attached at one end.
[0024] FIG. 8 is a side view of heart valve leaflets each pierced
by a barbed needle where the barbed needles are attached to each
other with suture.
[0025] FIG. 9 is an enlarged view of a barbed needle of FIG. 8.
[0026] FIG. 10 is a side view of a push rod useful for the
deployment of the barbed needles of FIG. 8.
[0027] FIG. 11 is a side view of barbed needles with flexible wire
attached to the needle.
[0028] FIG. 12 is a side view of heart valve leaflets with the
barbed needles of FIG. 11 piercing the heart valve leaflets and a
push rod gripping the suture connecting the two barbed needles.
[0029] FIG. 13A is a side view of a fastener with a corresponding
applicator inserted between two heart valve leaflets prior to
deployment.
[0030] FIG. 13B is a side view of the fastener and applicator of
FIG. 13A with arms extended on either side of the heart valve
leaflets.
[0031] FIG. 13C is a side view of the fastener and applicator of
FIG. 13 A where the arms are being pushed together to grab the
leaflets.
[0032] FIG. 13D is a side view of the fastener and applicator
reaching a locked position where the leaflets are held firmly in
place.
[0033] FIG. 13E is a side view of the leaflets secured in place by
the fastener of FIG. 13A after the applicator is removed.
[0034] FIG. 13F is a sectional view of the engagement mechanism
used to secure and detach the fastener of FIG. 13A from the
applicator used to deploy the fastener.
[0035] FIG. 14A is a perspective view of a gripper/fastener with
spring loaded arms being deployed from a cardiac catheter with a
portion of the cardiac catheter cut away to expose structure within
the catheter.
[0036] FIG. 14B is a perspective view of the gripper/fastener of
FIG. 14A with two spring loaded arms being free of the cardiac
catheter with a portion of the cardiac catheter cut away to expose
structure within the catheter.
[0037] FIG. 14C is a perspective view of the spring loaded fastener
of FIG. 14A deployed holding heart valve leaflets following release
of the deployment device with a portion of the cardiac catheter cut
away to expose structure within the catheter.
[0038] FIG. 14D is a perspective view of an alternative embodiment
of the arms of the spring loaded fastener where the arms are
curved.
[0039] FIG. 15 is a side view of a needle fastener with a suction
based gripper.
[0040] FIG. 16 is side view of a gripper mounted adjacent a
fastener applicator being directed toward heart valve leaflets.
[0041] FIG. 17 is an enlarged perspective view of the gripper and
fastener applicator of FIG. 16.
[0042] FIG. 18A is a sectional side view of the gripper of FIG.
17.
[0043] FIG. 18B is an exploded side view of an alternative
embodiment of the gripper of FIG. 18A, the alternative embodiment
being based on a cam, where the rod and moveable jaw have been
removed from the remainder of the gripper.
[0044] FIG. 18C is a side view of the embodiment shown in FIG.
18B.
[0045] FIG. 18D is a view down the end of the shaft from the
proximal end toward the jaws, where the ball of the cam is shown in
both an open and closed position.
[0046] Fiqs. 19A-C are sectional views of the fastener applicator
of FIG. 17 where the section in FIG. 19B is taken at a right angle
relative to the sections in FIGS. 19A and 19C. Hidden structures
are shown with phantom lines.
[0047] FIG. 19D is a side view of the tack and cap of FIG. 19A
secured together, shown in phantom.
[0048] FIG. 20 is a side view of a gripper with a plunger used to
direct the leaflets to gripper arms.
[0049] FIG. 21 is a side view of an alternative embodiment of a
gripper with spring loaded arms and a balloon plunger that directs
the leaflets to the spring loaded arms.
[0050] FIG. 22 is a side view of hooks used as gripper
elements.
[0051] FIG. 23 is a side view of a spring fastener with a suction
based gripper.
[0052] FIG. 24 is a side view of heart valve leaflets secured with
a spring fastener of FIG. 23.
[0053] FIG. 25 is a perspective view of a portion of a clip button
held by a deployment device, the clip button being useful for
fastening heart valve leaflets.
[0054] FIG. 25A is a perspective view of the tip of a first
applicator.
[0055] FIG. 26 is a perspective view of the clip button of FIG. 25
and associated deployment devices, with the two portions of the
clip button aligned.
[0056] FIG. 27 is a front view of a first portion of the clip
button of FIG. 26.
[0057] FIG. 28 is a side view of the first portion of the clip
button of FIG. 26.
[0058] FIG. 29 is a side view of the second portion of the clip
button of FIG. 26.
[0059] FIG. 30 is a rear view of the second portion of the clip
button of FIG. 26.
[0060] FIG. 31 is a side view of the second portion of the clip
button of FIG. 26 rotated 90 degrees relative to the view in FIG.
29.
[0061] FIG. 32 is a side view of the two portions of the clip
button of FIG. 26 fastened together.
[0062] FIG. 33 is a sectional side view of a spring loaded ring in
a loaded position.
[0063] FIG. 34 is a sectional side view of the spring loaded ring
of FIG. 33 in an extended position.
[0064] FIG. 35 is a side view of a crimp ring in an uncrimped
position.
[0065] FIG. 36 is a side view of the crimp ring of FIG. 35
following crimping.
[0066] FIG. 37 is a perspective view of a ring fastener being
positioned with an applicator toward heart valve leaflets, where a
portion of the cardiac catheter is cut away to permit the
visibility of structure within the catheter.
[0067] FIG. 38 is a perspective view of the applicator of FIG. 37
following deployment of the ring fastener.
[0068] FIG. 39 is a side view of one embodiment of an automatic
suture device positioned near heart valve leaflets.
[0069] FIG. 40 is a side view of the automatic suture device of
FIG. 39 gripping the heart valve leaflets with needles.
[0070] FIG. 41 is a sectional view of one of the needles of the
automatic suture device of FIG. 39.
[0071] FIG. 42 is sectional view of the automatic suture device of
FIG. 39 with an ultrasonic welder positioned for placement at its
ultimate welding position.
[0072] FIG. 43 is a side view of an alternative embodiment of an
automatic suture device.
[0073] FIG. 44 is a perspective view of the automatic suture device
of FIG. 43.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0074] Methods have been developed for performing less invasive
mitral valve repairs. While the discussion focuses on the repair of
mitral heart valves, the repair approaches can be used for the
repair of tricuspid valves using straightforward modification of
the described procedures and instruments. In particular, the
repairs can be performed on a beating heart such that the patient
does not have to be placed on cardiopulmonary bypass.
[0075] Access into the heart for mitral valve repair is obtained by
securing a passageway from the exterior of the body into the body
and into the heart to provide access into the left atrium or left
ventricle. With suitable instruments inserted through the
passageway, the mitral leaflets are grabbed, and the edges of the
leaflets are secured together. The gripping and securing or
fastening procedures can be performed simultaneously in some
embodiments of the invention, or they can be performed separately.
A suitable method of visualization may be used to guide the
manipulations. Manipulations to the mitral valve can be conducted
under ultrasound or fluoroscopy to show correct placement of the
devices and of the repair and to verify effectiveness of the
repair.
[0076] One approach to introduce the instruments into the heart
involves the direct introduction of a passageway through the wall
of the heart. To introduce the passageway or a cardiac catheter
into the body, a small incision is made in the chest. Instruments
generally used to position catheters can be used to guide the
cardiac catheter to the heart and into the heart wall, as described
further below. Use of properly selected instruments for the
introduction of the cardiac catheter reduces the amount of trauma
to the heart. Upon completion of the mitral valve repair, the
instruments are removed through the cardiac catheter, the cardiac
catheter is removed, and the incision in the heart wall is
repaired, for example, with suture.
[0077] Alternatively, the instruments can be introduced into the
heart by a vascular approach. In these approaches, a catheter is
introduced into an artery or vein and directed into the heart.
These vascular approaches are described further below.
[0078] Suitable gripping and fastening instruments have appropriate
dimensions to fit through the cardiac catheter into the heart. In
general, the instruments have a tubular section or shaft between a
distal end and a proximal end. The tubular section may be flexible.
The distal end of the instrument is inserted through the cardiac
catheter into the heart. The gripping and/or securing/fastening
elements are located at the distal end of the instrument. One or
more actuating elements are located at the proximal end.
[0079] In some embodiments, a single element performs the gripping
and fastening functions. In other words, a fastening element grips
the tissue during the fastening process such that a separately
identifiable gripping element is not present. For example, suture
can be placed through each leaflet such that tightening of the
suture draws the two portions of the leaflets together.
[0080] Alternatively, the gripping and fastening elements can be
distinct, separate instruments. For certain embodiments,
functionally distinct gripping and fastening elements can be
integrated into a single instrument such that a single tubular
section is needed. Alternatively, the distinct gripping and
fastening elements can be located on separate instruments, each
having a separate tubular section. If the gripping and fastening
elements are located on separate instruments, the tubular sections
of the instruments can have suitable dimensions such that the two
tubular sections can be inserted simultaneously through a single
cardiac catheter. Alternatively, one or more additional cardiac
catheters can be introduced into the heart to provide separate
instrument passageways for the gripping and fastening instruments
and any other instruments used to facilitate the procedure. Also,
one or more additional cardiac catheters can be used to provide a
means of direct visualization.
[0081] Instruments
[0082] The mitral valve repair device generally includes a
gripper/fastener applicator instrument, and may include a cardiac
catheter or other suitable catheter. The cardiac catheter generally
has an elongated tubular section and proximal and distal ends each
with an opening. For example, the cardiac catheter can be a
catheter introducer used for standard intravascular placement or a
similar instrument. An embodiment of a cardiac catheter 126 is
displayed in FIG. 1. Proximal end 102 includes opening 104, as
shown in FIG. 2, through which a gripper/fastener applicator
instrument is introduced. Proximal end 102 preferably includes a
hemostasis valve 106 to prevent blood from flowing out of the
cardiac catheter. Standard designs used in the catheter art can be
used for the hemostasis valve.
[0083] Tubular section 108 of cardiac catheter 100 preferably is
flexible so that it can be guided through the body to the desired
location. Generally, tubular section 108 has a length from about 4
cm to about 15 cm and a diameter from about3 mm (9 French (F)) to
about 10 mm (30 F), more preferably from about 3 mm (9 F) to about
8 mm (24 F). However, tubular section 108 can be selected to have a
suitable length appropriate for the specific procedure used.
Tubular section 108 preferably has a tapered end 110 to assist with
introduction of cardiac catheter 100 into the heart.
[0084] The gripper/fastener applicator instrument can have one
functional element that accomplishes both the gripping and
fastening operations simultaneously (e.g., FIG. 19), or two
functional elements with one element performing the gripping and a
second performing the fastening (e.g., FIG. 17). Two functional
elements can be integrated together on a single instrument, or they
can operate together as two separate instruments through the
cardiac catheter(s). One or more cardiac catheters can be used, as
needed or desired. Specific embodiments are described below.
[0085] A first type of gripper/fastener applicator has one
functional device that accomplishes both gripping and fastening
functions. Several embodiments of the first type of
gripper/fastener applicator can be based on attachment of suture
that is tied off to secure. the leaflets together.
[0086] Referring to FIG. 3, sutures 120 placed through the
respective valve leaflets 122, 124 can be tied outside of the body.
Sutures 120 can be positioned using a needle or needles that are
passed through leaflets and withdrawn through cardiac catheter 126.
A knot pusher 130 (FIG. 4) can be used to push a knot tied outside
of the body to the leaflets such that the knot pulls the leaflets
together. Variations on the design of the needle and the knot
pusher can be used to accomplish the same purposes. Alternatively,
rather than tying a knot, a suture clip 132 can be used to fasten
sutures 120, as shown in FIG. 5. Suture clip 132 is pushed into
place up to leaflets 122, 124 with a clip pusher 134. Suture clip
132 is shaped such that suture can be fed through clip 132 only in
one direction. Once sutures 120 are tied or clipped, suture 120 can
be cut with endoscopic scissors 136, as shown in FIG. 6, or other
similar device.
[0087] Another suture based gripper/fastener embodiment is depicted
in FIG. 7. Instead of passing suture through each leaflet, the
suture 150 can be secured to the edge of leaflets 122, 124 with a
piece of wire 152 at one end of suture 150. Wire 152 can be
sharpened spiral or coiled wire, such as a pacemaker lead. Wire 152
can be crimped on the edge of a particular leaflet 122, 124. As
described above, the suture can be tied outside the heart, the knot
can be pushed to the leaflets, and the suture 150 can be cut.
[0088] Another embodiment of a single element gripper/fastener
applicator involves the use of barbed needles. Referring to FIG. 8,
a barbed needle 200 penetrates each leaflet 122, 124. If the repair
requires further securing of the leaflets, additional needles may
be deployed. Barbed needles 200 are connected to each other by
suture 206. Each needle 200 can include a plurality of barbs 208
(FIG. 9). Barbed needles 200 can be deployed individually with a
push rod 210 (FIG. 10). Push rod 210 generally has releasable jaws
212 for holding barbed needles 200 during deployment. Jaws 212 are
activated by lever 214 at the handle end 216 of push rod 210.
Alternatively, suitable push rods or other mechanical trigger
actuators, such as spring activated mechanisms, can be used to
deploy barbed needles 200.
[0089] In order to use a short enough piece of suture 206 to hold
the leaflets closed while having enough flexibility to deploy
barbed needles 200, the embodiment in FIG. 8 can be modified as
shown in FIG. 11. Each barbed needle 222 has a wire 224 extending
from needle 222. Suture 226 connects the two wires 224. Barbed
needles 222 can be deployed in the same way as depicted in FIG. 8.
Referring to FIG. 12, push rod 210 with jaws 212 or a similar
device can be passed into the heart through cardiac catheter 126 to
grab suture 226. Push rod 210 is rotated to wind suture 226 and
ultimately to wind wires 224. The winding of wires 224 draws barbed
needles 222 closer together, resulting in leaflets 122, 124 being
drawn closer together. Wires 224 preferably are made of material,
such as stainless steel, which is malleable enough that they can be
wound together with forces transmitted through the suture yet
resilient enough that the wires do not unwind from the load
transmitted by leaflets 122, 124.
[0090] Alternatively, suture can be connected directly to each
barbed needle and looped around the other needle. Pulling each
suture then draws each barb to the other. Additional knots can be
pushed down from outside the body through cardiac catheter 126 to
secure the two sutures together.
[0091] In other embodiments of a single element gripper/fastener
applicator, a gripping/fastener applicator device is deployed and
later released using an applicator. For example, referring to FIG.
13A, a deploying wand 250 is inserted through cardiac catheter 126.
Outer sleeve 254 holds gripper arms 256, 258, 260, 262 in place
against inner core 264. Deploying wand 250 is inserted between
leaflets 122, 124. Referring to FIG. 13B, outer sleeve 254 is
pulled away from gripper arms 256, 258, 260, 262 to permit gripper
arms to extend once the outer sleeve 254 no longer holds them in
place.
[0092] With gripper arms 256, 258, 260, 262 extending on both side
of leaflets 122, 124, inner core 264 is pulled inward and outer
sleeve 254 is pushed outward in the direction of arrow 266 (FIG.
13C), such that arms are being pushed together to grab the
leaflets. Referring to FIG. 13D, gripper arms 256, 258, 260, 262
hold leaflets 122, 124 in place. The position of gripper arms 256,
258, 260, 262 along inner core 264 is locked in place by stops 270.
Gripper arms 256, 258, 260, 262 are extended beyond an equilibrium
position such that restorative forces tend to pull gripper arms
toward inner core 264. Referring to FIG. 13E, end 272 of inner core
264, while gripping and fastening leaflets 122, 124, is released
from the remaining portions of inner core 264 by disengaging a
locking mechanism thereby securing the leaflets with the fastening
device. Inner core 264 is removed through cardiac catheter 126. The
locking mechanism can have any of a variety of conventional
structures, so as to grip and fasten leaflets 122, 124. One
embodiment of a suitable locking mechanism is depicted in FIG. 13F.
Pivoting latches 280 lock into flanges 282. Wires 284 can be used
to release latches 280 from flanges 282. Gripper arms 256, 258,
260, 262 generally have a length from about 2 mm to about 10 mm.
Inner core 264 generally has a diameter from about 1 mm to about 8
mm.
[0093] A similar embodiment of the invention is depicted in FIG.
14. In single element gripper/fastener applicator 300, arms 302,
304, 306, 308 are spring loaded. As arms 302, 304, 306, 308 are
pushed free of the end 310 of cardiac catheter 126., they extend
due to the spring loading feature. In FIG. 14B, gripper/fastener
applicator 300 is depicted with arms 302, 306 extended. Arms 302,
306 have pointed tips 314, 316 that can pierce leaflets 122, 124.
As depicted in FIG. 14C, once arms 304, 308 are free of the cardiac
catheter 126, arms 304, 308 extend on one side of the leaflets to
grasp leaflets 122, 124 along with arms 302, 306, which extend on
the other side of leaflets 122, 124. Arms 304, 308 have clasps 322,
324 that engage pointed tips 314, 316 such that arms 302, 304, 306,
308 firmly grasp leaflets 122, 124 therebetween. Grasper/fastener
applicator 300 is released from applicator 326 by rotating knob 328
such that knob 328 passes through passageway 330 within base 332.
In an alternative embodiment, arms 302, 304, 306, 308 are curved as
depicted in FIG. 14D.
[0094] The second type of gripper/fastener applicator has two
distinct elements, a gripper element and a fastener applicator
element. The gripper element and the fastener applicator element
can be located at the respective distal ends of two distinct
shafts. For certain embodiments the gripper element and the
fastener applicator elements can be integrated on a single shaft
and may be adapted to move relative to one another as appropriate
for the procedure that is being performed, i.e., gripping or
fastening. In this way, a single shaft can be guided through the
cardiac catheter.
[0095] An embodiment of a distinct gripper and a fastener
applicator integrated onto a single shaft is depicted in FIG. 15.
Gripper/fastener applicator 340 has a spiral needle 342, which
spirals around inner catheter 344. The first step involves applying
suction through an internal lumen of inner catheter 344 by way of
openings 346 to grasp and position a leaflet against inner catheter
344. Once the leaflets are grasped by suction, spiral needle 342 is
advanced and rotated. Rotation of outer sleeve 343 results in the
passage of spiral needle 342 through leaflets 122, 124. Spiral
needle 342 is mounted on outer sleeve 343 that rotates around inner
catheter 344. The outer sleeve can be threaded to provide
appropriate pitch and number of rotations. To hold the leaflets in
place, spiral needle 342 is disengaged from outer sleeve 343 by
disengaging a clamp or the like at the end 345 of outer sleeve 343.
If desired, the needle can be crimped to ensure permanent
attachment. The suction based gripper of FIG. 15 can be used also
with other types of fasteners.
[0096] Referring to FIGS. 16-17, device 400 includes a gripper 402
and a fastener applicator 404 that extend from a shaft 406. Gripper
402 and fastener applicator 404 can be adjacent each other, as
shown in FIG. 17. Alternatively, gripper 402 and fastener
applicator 404 may move relative to each other by sliding in a
tube, track, or similar mechanisms. The relative position of
gripper 402 and fastener applicator 404 can be reversed. In FIG.
17, with fastener applicator 404 in a distal withdrawn position,
gripper 402 can grab leaflets 122, 124. Then, fastener applicator
404 can be opened in the withdrawn position and slid forward to
apply a tack on captured leaflet edges. Therefore, gripper 402
preferably is oriented relative to leaflets 122, 124 as shown in
FIG. 16.
[0097] One embodiment of gripper 402 is depicted in FIG. 18A. In
this embodiment, claw gripper 412 has opposing jaws 414, 416, which
meet at serrated edges 418, 420 in a closed orientation. Serrated
edges 418, 420 assist with the gripping of the leaflets 122, 124.
The extension of rod 422 alters the relative position of jaws 414,
416 by moving a lever 424. Rod 422 extends through shaft 406 to the
distal end of shaft 406 such that a physician can manipulate rod
422 outside of the patient. The length of jaws 414, 416 should be
appropriate for the jaws to reach leaflets 122, 124 at the maximum
anticipated spacing between leaflets 122, 124. If desired, grippers
412 can be used with a shaft separate from a shaft holding a
fastener applicator element. Grippers 412 are designed to grip
leaflets 122, 124 as depicted in FIGS. 16, 17 and 18.
[0098] As an alternative to the lever mechanism shown in FIG. 18A,
a cam can be used to rotate the jaw, as depicted in FIGS. 18B-D. In
particular, jaw 411 rotates around pivot 413. Rotation of rod 415
causes ball 417 to change position relative to the position of rod
415. Ball 417 fits into track 419 in the end of jaw 411. Also, ball
417 fits into a notch in an off center position in the end of rod
415 such that rotation of rod 415 moves ball 417 up or down.
Lowering of the ball results in the opening of jaw 411 relative to
jaw 421. Rod 415 is rotated using lever 423, as shown in FIG. 18D.
Generally a half rotation of rod 415 results in motion of jaw 411
from a closed position to its open. position.
[0099] As depicted in FIG. 17, fastener applicator 404 applies a
fastener, such as a tack. Further details about fastener applicator
404 can be seen in FIG. 19. Fastener applicator 404 holds tack 424
and cap 426 in separate housings for deployment. When jaws 428, 430
are opened by the movement of lever 432 in the direction shown by
the arrow 431 in FIG. 19A, rod 434 slides tack 424 within track 436
to a position aligning cap 426 with tack 424, as shown in FIGS. 19B
and 19C. Jaws 428, 430 rotate relative to each other by way of
lever arm 438 or other mechanical link, such as a cam. When jaws
428, 430 subsequently are closed, tack 424 engages cap 426, as
shown in FIG. 19D, thereby fastening leaflets 122, 124. Jaws 428,
430 can be opened to release tack 424 and fastened leaflets 122,
124.
[0100] While the above grippers and fastener applicators can be
used for an atrial or ventricular approach, other designs for the
gripper are particularly adapted for gripping leaflets from an
atrial approach. Referring to FIG. 20, gripper 438 includes
graspers 440 used to grasp each leaflet 122, 124. To push the
leaflets toward graspers 440, plunger 446 includes two or more arms
450, 452. In an alternative embodiment depicted in FIG. 21, a
balloon plunger 454 is used. Balloon plunger 454 is deflated for
delivery and removal of the instrument through cardiac catheter 126
and inflated within the heart for use to guide the leaflets to the
graspers 440.
[0101] With either embodiment of the plunger, shaft 456 can be
pulled to draw spring loaded graspers 440 toward plunger 446 or 454
to grip leaflets 122, 124 within grasper 440. Alternatively,
plunger 446 or 454 can push leaflets 122, 124 toward graspers 440.
In any case, as plunger 446 or 454 reaches a certain position
relative to graspers 440 so that graspers 440 are within reach of
leaflets 122, 124, shaft 456 is pulled back to retract graspers
440, which clasp leaflets 122, 124 between graspers 440 and grasper
tube 441. Once leaflets 122, 124 are clasped, plunger 446, 454 can
be removed. After leaflets 122, 124 are fastened, graspers 440 can
be released by extending shaft 456 such that gripper 438 can be
withdrawn. Graspers 440 should be less than about 10 mm in length.
Graspers 440 can be curved.
[0102] Another approach to grasping the leaflets from the atrial
side is depicted in FIG. 22. Hooks 470, 472 are deployed through
cardiac catheter 126 to grab leaflets 122, 124. Hooks 470, 472
preferably have sharp tips 480, 482 without barbs. With leaflets
122, 124 held in place, a variety of fasteners, as described
throughout, can be used to fasten leaflets 122, 124. Once leaflets
122, 124 are fastened securely, hooks 470, 472 can be released and
removed by pushing hooks 470, 472 to release the respective
leaflets 122, 124 and rotating hooks 470, 472 such that they do not
grab leaflets 122, 124 when withdrawn.
[0103] Once one embodiment of grasper is holding the leaflets,
another type of grasper generally can be substituted for that
grasper to hold the leaflets. A wider variety of graspers are
suitable for grasping already held leaflets. In this way, a
fastener applicator can be used with a more appropriate grasper, if
desired. Furthermore, multiple grippers can be used to grasp the
leaflets to be fastened. For instance, a hook as shown in FIG. 22
can be used to grab one leaflet while jaws such as shown in FIGS.
18A-D can be used to grab the other leaflet. As another example,
two sets of jaws can be used, each grabbing one leaflet.
[0104] With respect to fastener applicators, a spring fastener
embodiment is depicted in FIGS. 23-24. Leaflets 122, 124 are drawn
into cavities 500, 502 with suction similar to that applied by the
device in FIG. 15. Vacuum is applied by way of lumen 504. Spring
506 is pushed and rotated using rotating shaft 508. End 510 of
spring 506 catches a leaflet such that rotating the spring 506
causes spring 506 to spiral through leaflets 122, 124 as shown in
FIG. 24, fastening leaflets 122, 124 together. After spring 506 is
placed through the leaflets, vacuum is released and lumen 504 is
withdrawn.
[0105] Referring to FIGS. 25-32, another embodiment of a fastener
applicator uses a fastener clip button 540 which includes a first
portion 542 and a second portion 544. Referring to FIGS. 27 and 28,
first portion 542 includes spikes 546 extending from a first
surface 548 of base 550. Base 550 has notches 552 at the edge of
second surface 554 at a position rotated 90 degrees relative to
spikes 546. The center of base 550 has an opening 556 with wings
558 oriented toward notches 552. Second surface 554 includes
indentations 560 adjacent opening 556 oriented toward spikes
546.
[0106] Referring to FIGS. 29-31, second portion 544 includes
perforations 566 which have a diameter equal to or slightly smaller
than spikes 546. Tabs 568 extend from first surface 570 of base
572. Tabs 568 include lips 574 that can engage notches 552. Base
572 includes an opening 578 with wings 580. Base 572 is slightly
noncircular to allow for tabs 568.
[0107] FIG. 32 displays first portion 542 engaged with second
portion 544. When portions 542, 544 are engaged, spikes 546 engage
perforations 566 and tabs 568 engage notches 552. The leaflets are
positioned in the separation between base 550 and base 572.
[0108] Referring to FIG. 25, to deploy clip button 540, first
portion 542 is positioned with first applicator 580. First
applicator 580 includes a central core 582 with a knob 584 at the
end of the central core 582, as shown in FIG. 25A. Knob 584 engages
indentations 560 when first portion is positioned on first
applicator 580, and can pass through wings 558 when oriented
accordingly for removal of first applicator 580. First applicator
580 also includes tubular portion 588, which slides over central
core 582. When knob 584 engages indentations 560 and tubular
portion 588 engages first surface 548, first portion 542 is held
firmly by first applicator 580. Preferably, first portion 542 is
placed in position near the leaflets prior to grasping of the
leaflets by a gripper. Once grasped, the leaflets can be pierced
with spikes 546 of first portion 542.
[0109] After spikes 546 are inserted through the leaflets, tubular
portion 588 can be removed through cardiac catheter 126. Then,
second applicator 590 can be slid over central core 582, as shown
in FIG. 26. Second applicator 590 is used to engage second portion
544 with first portion 542. Second applicator 590 can push second
portion 544 into place, or, alternatively, second applicator 590
can hold second portion 544 using a fastener such as threads or a
clamp, as first portion 542 is pulled against it. After second
portion 544 engages first portion 542, second applicator 590 is
removed through cardiac catheter 126. Central core 582 is removed
by first rotating knob 584 such that knob 584 passes through wings
558 and 580. Clip button 540 remains fastened to the mitral valves
leaflets.
[0110] Another embodiment of a fastener uses a deformable ring.
Different variations of the ring are available. A first embodiment
of a spring loaded ring is depicted in FIGS. 33 and 34. Spring
loaded ring 600 has a first spike 632 at the end of crescent
portion 604. Second spike 606 is initially located in cavity 608
within crescent portion 604. Spring 610 is located between second
spike 606 and surface 612. A button lock 614 holds second spike 606
within crescent portion 604 until deployment of spring loaded ring
600. When the lock 614 is released, first spike 602 and second
spike 606 pierce the leaflets and secure them together. Alternative
embodiments of the spring loaded ring can employ dual springs with
a spike being propelled by each spring. If desired, the spikes can
be retractable such that the ring is used to hold the leaflets
while another fastening approach is used to secure the
leaflets.
[0111] Referring to FIGS. 35 and 36, crimp ring 630 includes points
632, 634 and handles 636, 638. Between handles 636, 638 is a notch
641. Notch 640 provides a weak location for bending points 632, 634
toward each other, as shown in FIG. 36. Crimp ring 630 is placed
near the grasped leaflet. Then, handles 636, 638 are rotated away
from each other to place the crimp ring 630 in the closed crimped
position shown in FIG. 36 with points 632, 634 piercing respective
leaflets.
[0112] Rings such as spring loaded ring 600 and crimp ring 630 can
be applied with an applicator 640, as depicted in FIGS. 37 and 38.
Ring 642 is brought up to leaflets 122, 124 and deformed to pierce
leaflets 122, 124. Applicator 641 can include lever arms 650 and/or
other implements to assist with deployment of rings 600 or 630. For
example, for spring loaded ring 600, either lever arms 650 or
another implement releases lock 614. For crimp ring 630, lever arms
650 hold handles 636, 638 and rotate handles to crimp the ring to
bring points 632, 634 toward each other.
[0113] An automatic suture device can be used as a fastener. One
embodiment of an automatic suture device is described in U.S. Pat.
No. 5,417,700, to Egan, incorporated herein by reference. Referring
to FIGS. 39-42, suture device 658 includes hollow needles 660, 662,
which can rotate to pierce leaflets 122, 124. Suture 664 (FIG. 42)
is threaded through channel 666 (FIG. 41) within hollow needles
660, 662. Suture 664 can be secured with an ultrasonic weld formed
between weld anvil 668 and welding horn 670. Suture 664 can be
pulled tight prior to welding.
[0114] An alternative embodiment of an automatic suture device is
shown in FIGS. 43 and 44. The suture device 700 includes a curved
needle 702. Needle 702 has a point 704 and a blunt end 706. Needle
702 lies within slot 708. Suture 710 is threaded through channel
712. Suture 710 exits channel 712, crosses to the opposite opening
into slot 708, circumscribes slot 708 and attaches to needle 702 at
blunt end 706.
[0115] Suture 710 is pulled, which rotates needle 702, impaling
leaflets 122, 124 with point 704. Needle 702 is rotated about 360
degrees such that needle 702 has passed through leaflets 122, 124.
Following complete rotation of needle 702, suture 710 is threaded
through leaflets 122, 124. Withdrawal of suture device 700 through
the catheter introducer pulls suture 710 through leaflets 122, 124.
Suture 710 can be tied, as described above with respect to FIG. 3,
to secure leaflets 122, 124. Alternatively, a suture clip 132 can
be used to secure suture 710, as shown in FIG. 5.
[0116] All of the devices described above can be constructed from
standard biocompatible materials including a variety of metals,
such as stainless steel and titanium, and polymers, such as
polysulfone. The materials can be selected as appropriate for a
particular application. Furthermore, the fasteners can be coated
with a surface modifier such as polytetrafluoroethylene (PTFE),
i.e., Teflon.RTM., or an antimicrobial coating, such as silver
metal or a silver compound. Antimicrobial metal coatings are
further described in copending and commonly assigned U.S. patent
application Ser. No. 08/974,992 to Ogle et al., entitled "Medical
Article with Adhered Antimicrobial Metal," incorporated herein by
reference.
[0117] Surgical Procedure
[0118] In preferred embodiments of the procedure, the repairs are
performed on a beating heart. Alternatively, the heart can be
stopped during the procedure. Cardioplegia, i.e., stopped cardiac
contraction, can be induced by certain chemicals such as cold
potassium-containing solutions that are introduced into the
myocardium. The chemical induction of cardioplegia requires the
isolation of the heart and ascending aorta from the rest of the
patient's vascular system. Procedures using cardioplegia are less
desirable since they require cardiopulmonary bypass, which
increases patient risk factors.
[0119] For cardiac catheter based embodiments, one or more access
points are used along the patient's chest, generally positioned
between adjacent ribs. The access points provide access to the
heart. Incisions are made to initiate the access points. Trocar
sheaths, such as those used for the performance of laparoscopic
procedures, can facilitate use of the access points as described in
published PCT application WO 94/18881 to Stanford Surgical
Technologies, Inc., incorporated herein by reference.
Alternatively, soft tissue retractors, such as those used in
pediatric open chest procedures can be utilized to facilitate use
of the access points. Suitable location of the access point(s) can
be determined based on the approach appropriate for the
gripper/fastener applicator to be used.
[0120] Once the heart is accessed, a guide wire can be inserted
through the wall of the heart either near the apex of the heart
into the left ventricle or near the top of the heart into the left
atrium. A dilator can be slid over the guide wire to expand the
opening into the heart. Suitable guidewires and dilators are
available from Daig Corp., Minnetonka, Minn. A cardiac catheter
with a hemostasis valve, described above, is deployed over the
dilator. The cardiac catheter provides access. into the heart to
deliver the repair device or devices.
[0121] Alternatively, a cardiac catheter can be inserted through an
incision in the wall of the heart at the desired location. As
during normal cannulation, a purse string suture can be applied at
the point where the cardiac catheter enters the heart to reduce any
bleeding. The suture can be applied, for example, using a piece of
suture with a needle on both ends. The needles can be manipulated
using forceps or the like. After the desired stitching is
performed, the needles can be cut off using endoscopic scissors.
Additional cardiac catheters can be placed near or into the heart,
as desired.
[0122] Once the cardiac catheter is in place, the gripper/fastener
instruments can be directed at the mitral or tricuspid valve to
perform the repair. All of the instruments are designed such that
the appropriate manipulations by the appropriate health care
professional are performed at the proximal end of the cardiac
catheter.
[0123] Following completion of the bow-tie repair, the cardiac
catheter is removed. The procedures used to deploy the cardiac
catheter preferably minimize the damage to the heart muscle by
separating the tissue without significantly tearing the tissue.
Nevertheless, stitches or staples can be used to close the incision
at the point where the cardiac catheter was inserted. Once access
to the heart has been closed, the incision providing access into
the chest cavity is closed.
[0124] Alternatively, a less invasive, percutaneous vascular
approach can be used. There are two, alternative, percutaneous
vascular approaches to positioning the catheter for the medical
procedure. One is to introduce the catheter into the femoral artery
by a standard introducer sheath and advance it up the aorta, across
the aortic valve into the left ventricle and then position its tip
under the mitral annulus. This is commonly referred to as the
"retrograde" approach.
[0125] The other approach, commonly referred to as the transseptal
approach, is to introduce a transseptal sheath apparatus, a long
single plane curve introducer, into the right femoral vein and
advance it through the inferior vena cava into the right atrium. A
puncture is then made through the fossa ovalis in the intraatrial
septum, and the apparatus is advanced into the left atrium where
the trocar and dilator of the apparatus is removed, leaving the
sheath in position in the left atrium. Once the valve is accessed,
the repair can be completed as described above.
[0126] Edge-to-edge mitral valve repair provides a simple and
effective repair technique relative to complex and surgically
demanding approaches of chordal shortening, resectioning, chordal
transposition or artificial chordae replacement. The edge-to-edge
repair is particularly effective with severe isolated mitral
regurgitation or in association with coronary artery bypass
surgery. The present approach provides the benefits of the
edge-to-edge repair without the trauma of open heart surgery and
cardiopulmonary bypass. Thus, the procedure can be accomplished
concomitant with coronary artery bypass graft (CABG) or as a stand
alone outpatient procedure in a cardiac catheterization laboratory.
The advantages include reduced cost, hospitalization and patient
recovery times. With minimal trauma to the patient, it may be
desirable to perform the repair earlier before the disease has
progressed to a serious level. Thus, more repair procedures may be
performed, preventing further progression of the disease, obviating
the need for more serious invasive procedures.
[0127] The instruments described above may be distributed in the
form of a kit. Generally, the kit includes a fastener applicator
and a suitable cardiac catheter or other catheter for a vascular
approach. The kit may also include a suitable gripper for use with
the fastener applicator. Alternatively, the kit may include only a
fastener (fastener applicator) and/or a gripper. The kit preferably
includes instructions for the performance of mitral and/or
tricuspid valve repair. In particular, the instructions can
describe the particular use of the fastener applicator and/or the
grippers.
[0128] Although the present invention has been described with
reference to preferred embodiments, workers skilled in the art will
recognize that changes may be made in form and detail without
departing from the spirit and scope of the invention.
* * * * *