U.S. patent application number 11/111044 was filed with the patent office on 2005-08-25 for method and apparatus for performing catheter-based annuloplasty using local plications.
This patent application is currently assigned to Mitralign, Inc.. Invention is credited to Hlavka, Edwin J., Spence, Paul A..
Application Number | 20050184122 11/111044 |
Document ID | / |
Family ID | 32176514 |
Filed Date | 2005-08-25 |
United States Patent
Application |
20050184122 |
Kind Code |
A1 |
Hlavka, Edwin J. ; et
al. |
August 25, 2005 |
Method and apparatus for performing catheter-based annuloplasty
using local plications
Abstract
A minimally invasive method of performing annuloplasty.
According to one aspect, a method for performing annuloplasty
includes creating a first plication in the tissue near a mitral
valve of a heart, using at least a first plication element, and
creating a second plication in the tissue near the mitral valve
such that the second plication is substantially coupled to the
first plication.
Inventors: |
Hlavka, Edwin J.; (Palo
Alto, CA) ; Spence, Paul A.; (Louisville,
KY) |
Correspondence
Address: |
WOOD, HERRON & EVANS, LLP
2700 CAREW TOWER
441 VINE STREET
CINCINNATI
OH
45202
US
|
Assignee: |
Mitralign, Inc.
New York
NY
|
Family ID: |
32176514 |
Appl. No.: |
11/111044 |
Filed: |
April 21, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11111044 |
Apr 21, 2005 |
|
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PCT/US03/33382 |
Oct 21, 2003 |
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60420095 |
Oct 21, 2002 |
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Current U.S.
Class: |
227/175.1 ;
128/898 |
Current CPC
Class: |
A61B 17/0643 20130101;
A61B 2017/0472 20130101; A61B 17/0487 20130101; A61B 17/0644
20130101; A61B 2017/0496 20130101; A61B 2017/00243 20130101; A61B
2017/0649 20130101; A61B 2017/0417 20130101; A61B 2017/0462
20130101; A61B 17/00234 20130101; A61B 2017/00349 20130101; A61B
2017/0464 20130101; A61B 17/0469 20130101; A61B 2017/00867
20130101 |
Class at
Publication: |
227/175.1 ;
128/898 |
International
Class: |
A61B 017/068 |
Claims
What is claimed is:
1. A method for performing annuloplasty, the method comprising:
creating a first plication in the tissue near a mitral valve of a
heart, the first plication being created using at least a first
plication element; and creating a second plication in the tissue
near the mitral valve, wherein the second plication is
substantially coupled to the first plication.
2. The method of claim 1 further including: accessing a left
ventricle of the heart to provide the first plication element to
the left ventricle; and engaging the first plication element to the
tissue near the mitral valve, wherein engaging the first plication
element includes causing the first plication element to
substantially pass through a portion of the tissue to substantially
anchor the first plication element to the tissue near the mitral
valve.
3. The method of claim 2 wherein the first plication element is an
anchor arrangement with a tail, and creating the first plication in
the tissue near the mitral valve includes: accessing the left
ventricle of the heart to provide a second plication element to the
left ventricle, the second plication element being an anchor
arrangement with a tail; engaging the second plication element to
the tissue near the mitral valve, the second plication element
being separated from the first plication element by a first
distance, wherein engaging the second plication element includes
causing the second plication element to substantially pass through
the tissue to substantially anchor the second plication element to
the tissue near the mitral valve; and providing a first locker
element over the tail of the first plication element and the tail
of the second plication element.
4. The method of claim 3 wherein creating the second plication in
the tissue near the mitral valve includes: accessing the left
ventricle of the heart to provide a third plication element to the
left ventricle, the third plication element being an anchor
arrangement with a tail; engaging the third plication element to
the tissue near the mitral valve, the third plication element being
separated from the second plication element by a second distance,
wherein engaging the third plication element includes causing the
third plication element to substantially pass through the tissue to
substantially anchor the third plication element to the tissue near
the mitral valve; and providing a second locker element over the
tail of the second plication element and the tail of the third
plication element.
5. The method of claim 4 wherein the first distance and the second
distance are approximately the same.
6. The method of claim 2 wherein the first plication element is
delivered to the left ventricle using a catheter.
7. The method of claim 5 wherein the catheter has a deflectable
tip.
8. The method of claim 2 further including: accessing the left
ventricle using an incrementor catheter, the incrementor catheter
including a first section and a second section, wherein the first
section is arranged to be tracked over a tail of the first
plication element.
9. The method of claim 8 further including: deploying the
incrementor catheter, wherein deploying the incrementor catheter
includes positioning a tip of the second section at the first
distance distance away from a tip of the first section.
10. A method for performing annuloplasty, the method comprising:
accessing a heart to provide a plurality of plication elements to
the heart, the plurality of plication elements being provided to
the heart through a catheter arrangement, the plication elements
including a first anchor arrangement; engaging the first anchor
arrangement to tissue near a mitral valve of the heart using the
catheter arrangement to substantially anchor the first anchor
arrangement to the tissue near the mitral valve; and creating at
least a first plication and a second plication using the first
anchor arrangement.
11. The method of claim 10 wherein engaging the first anchor
arrangement includes causing the first anchor arrangement to
substantially pass through the tissue near the mitral valve.
12. The method of claim 11 wherein the plurality of plication
elements includes a first locking element and a second locking
element, and accessing the heart to provide the plurality of
elements to the heart includes: accessing a left ventricle of the
heart to provide the first locking element to the left ventricle;
substantially deploying the first locking element over the first
anchor arrangement to create the first plication; and substantially
deploying the second locking element over the first anchor
arrangement to create the second plication.
13. The method of claim 12 wherein the first anchor arrangement
includes a tail portion, and substantially deploying the first
locking element over the first anchor arrangement includes
substantially deploying the first locking element over the tail
portion and substantially deploying the second locking element over
the second anchor arrangement includes substantially deploying the
second locking element over the tail portion.
14. The method of claim 13 wherein creating at least the first
plication and the second plication using the first anchor
arrangement includes: applying tension to the tail portion to
create the first plication using the first locking element; and
applying tension to the tail portion to create the second plication
using the second locking element.
15. The method of claim 14 wherein tension is applied to the tail
portion to create the first plication and to create the second
plication substantially simultaneously.
16. The method of claim 10 wherein the catheter arrangement has a
deflectable tip.
17. A method for performing annuloplasty, the method comprising:
accessing an area of a heart using a catheter arrangement, the
catheter arrangement including a first portion; temporarily
anchoring the first portion of the catheter arrangement to the
tissue near the mitral valve of the heart; providing an anchor
element to the area; and engaging the anchor element to the tissue
near the mitral valve, wherein the first portion of the catheter
arrangement is arranged to substantially provide a counter-traction
force associated with engaging the anchor element.
18. The method of claim 17 wherein engaging the anchor element to
the tissue near the mitral valve includes causing the anchor
element to substantially pass through a portion of the tissue near
the mitral valve to substantially anchor the anchor element to the
tissue near the mitral valve.
19. The method of claim 18 wherein the area is a left ventricle of
the heart.
20. The method of claim 19 further including: substantially
detaching the first portion of the catheter arrangement from the
tissue near the mitral valve.
21. The method of claim 19 wherein the first portion of the
catheter arrangement is a tip of the catheter arrangement.
22. The method of claim 19 wherein the first portion of the
catheter arrangement is a coiled wire of the catheter
arrangement.
23. The method of claim 19 wherein providing the anchor element to
the left ventricle includes providing the anchor element using the
catheter arrangement.
24. The method of claim 23 wherein the catheter arrangement has a
deflectable tip and a pull wire arranged to deflect the deflectable
tip to position one of the anchor element and the first
portion.
25. A method for performing annuloplasty, the method comprising:
accessing an area of a heart using a catheter arrangement, the
catheter arrangement including a first portion; temporarily
anchoring the first portion of the catheter arrangement to the
tissue near the mitral valve of the heart; providing an anchor
element to the area; and engaging the anchor element to the tissue
near the mitral valve, wherein the first portion of the catheter
arrangement is arranged to substantially position a tip of the
catheter arrangement at the tissue near the mitral valve.
26. The method of claim 25 wherein engaging the anchor element to
the tissue near the mitral valve includes causing the anchor
element to substantially pass through a portion of the tissue near
the mitral valve to substantially anchor the anchor element to the
tissue near the mitral valve.
27. The method of claim 26 wherein the area is a left ventricle of
the heart.
28. The method of claim 27 further including: substantially
detaching the first portion of the catheter arrangement from the
tissue near the mitral valve.
29. The method of claim 27 wherein the first portion of the
catheter arrangement is the tip of the catheter arrangement.
30. The method of claim 27 wherein the first portion of the
catheter arrangement is a coiled wire of the catheter
arrangement.
31. The method of claim 27 wherein providing the anchor element to
the left ventricle includes providing the anchor element using the
catheter arrangement.
32. The method of claim 31 wherein the catheter arrangement has a
deflectable tip and a pull wire arranged to deflect the deflectable
tip to position one of the anchor element and the first
portion.
33. A method for performing annuloplasty, the method comprising:
accessing an area of a heart to provide a first plication element
to the area using a catheter arrangement, the catheter arrangement
including a first portion and a second portion; substantially
anchoring the first portion of the catheter arrangement to tissue
near a mitral valve of the heart; positioning a tip of the second
portion of the catheter arrangement at a first distance from the
first portion; and substantially engaging the first anchor to the
tissue near the mitral valve of the heart using the second portion
of the catheter arrangement.
34. The method of claim 33 wherein substantially anchoring the
first portion of the catheter arrangement to tissue near the mitral
valve of the heart includes: positioning the first portion of the
catheter arrangement over a guide, the guide being substantially
anchored to the tissue near the mitral valve.
35. The method of claim 33 wherein the first anchor includes a
tail, the method further including: substantially unanchoring the
first portion of the catheter arrangement from tissue near a mitral
valve of the heart; positioning the first portion of the catheter
arrangement over the tail; positioning the tip of the second
portion of the catheter arrangement at a second distance from the
first portion; and substantially engaging a second anchor to the
tissue near the mitral valve of the heart using the second portion
of the catheter arrangement.
36. The method of claim 35 further including: creating a plication
using at least the first anchor and the second anchor.
37. A method for performing annuloplasty, the method comprising:
accessing an area of a heart to provide a first plication element
to the area using a catheter arrangement, the catheter arrangement
including a deflectable tip area and a pull wire arranged to cause
the deflectable tip area to deflect; altering a curvature in the
tip area to reach tissue near a mitral valve of the heart, wherein
altering the curvature includes substantially actively controlling
the pull wire; and engaging the first plication element to the
tissue near the mitral valve.
38. The method of claim 37 wherein engaging the first plication
element includes causing the first plication element to
substantially pass through a portion of the tissue to substantially
anchor the first plication element to the tissue near the mitral
valve.
39. The method of claim 38 wherein the area is a left ventricle of
the heart.
40. The method of claim 38 wherein the catheter arrangement is a
hook catheter arrangement, the tip area being substantially shaped
as a hook.
41. The method of claim 40 wherein the catheter arrangement further
includes a temporary anchor, and the method further includes:
deploying the temporary anchor; and substantially temporarily
anchoring the temporary anchor to the tissue near the mitral
valve.
42. The method of claim 41 wherein the method further includes:
unanchoring the temporary anchor from the tissue near the mitral
valve.
43. The method of claim 40 further including: deploying an anchor
element through the catheter arrangement; and anchoring the anchor
element to the tissue near the mitral valve.
44. A method for performing annuloplasty, the method comprising:
accessing an area of a heart using a catheter arrangement, the
catheter arrangement including a deflectable tip portion and a pull
wire arranged to cause the deflectable tip area to deflect;
altering a curvature in the tip area to reach tissue near a mitral
valve of the heart, wherein altering the curvature includes
substantially actively controlling the pull wire to position the
tip area; and temporarily engaging the tip area to the tissue near
the mitral valve, wherein temporarily engaging the tip area to the
tissue near the mitral valve enables the catheter arrangement to
deliver at least a first plication element to the tissue near the
mitral valve.
45. The method of claim 44 further including engaging the first
plication element to the tissue near the mitral valve, wherein
engaging the first plication element includes causing the first
plication element to substantially pass through a portion of the
tissue to substantially anchor the first plication element to the
tissue near the mitral valve.
46. The method of claim 45 wherein the area is a left ventricle of
the heart.
47. The method of claim 45 wherein the catheter arrangement is a
hook catheter arrangement, the tip area being substantially shaped
as a hook.
48. A method for performing annuloplasty, the method comprising:
accessing a left ventricle of a heart to provide a first plication
element to the left ventricle using a catheter arrangement;
creating a curvature in the catheter arrangement to reach tissue
near a mitral valve of the heart, the curvature being at an
orthogonal orientation with respect to the mitral valve; and
engaging the first plication element to the tissue near the mitral
valve, wherein engaging the first plication element includes
causing the first plication element to substantially pass through a
portion of the tissue to substantially anchor the first plication
element to the tissue near the mitral valve.
49. The method of claim 48 wherein creating the curvature includes
creating approximately a 180 degree curve in the catheter
arrangement.
50. The method of claim 48 further including: accessing the left
ventricle using an incrementor catheter, the incrementor catheter
including a first section and a second section, wherein the first
section is arranged to be tracked over a tail of the first
plication element.
51. The method of claim 50 further including: deploying the
incrementor catheter, wherein deploying the incrementor catheter
includes positioning a tip of the second section at a distance away
from a tip of the first section.
52. The method of claim 51 further including: engaging a second
plication element to the tissue at approximately the distance away
from the first plication element using the second section.
53. The method of claim 52 further including: creating a plication
using the first plication element and the second plication
element.
54. An incrementor catheter comprising: a first lumen, the first
lumen being arranged to track over a wire, the wire being
substantially anchored within a left ventricle of a heart; and a
second lumen, the second lumen having a second tip that is arranged
to be moved at a distance away from a first tip of the first lumen,
wherein the second lumen is arranged to carry and to deploy a
plication element.
55. A method for performing annuloplasty comprising: temporarily
fixing a helical coil of a first element in tissue near a mitral
valve of the heart, the first element including a tail; and
tracking a catheter arrangement over the tail, wherein the catheter
arrangement is arranged to substantially permanently fix a second
element to the tissue.
56. The method of claim 55 wherein the catheter arrangement is an
incrementor catheter.
57. The method of claim 55 wherein temporarily fixing the helical
coil of the first element includes using one of an L-shaped
catheter and a hook catheter to temporarily fix the helical
coil.
58. An incrementor catheter comprising: a main catheter, and first
and second distal catheter portions coupled with the main catheter,
the first and second distal catheter portions having respective
first and second lumens, the second distal catheter portion
arranged to be moved laterally a first distance away from the first
distal catheter portion, an elongate guide member receivable in the
first lumen, and a first plication element receivable in and
deployable from the second lumen.
59. The incrementor catheter of claim 58, wherein the elongate
guide member further comprises a guide wire.
60. The incrementor catheter of claim 58, wherein the elongate
guide member further comprises a tether coupled with a tissue
anchor.
61. The incrementor catheter of claim 60, wherein the tissue anchor
further comprises a temporary anchor.
62. The incrementor catheter of claim 60, wherein the tissue anchor
further comprises a second plication element.
63. The incrementor catheter of claim 62, wherein the first and
second plication elements are T-bars.
64. The incrementor catheter of claim 62 further comprising a
locker configured to couple the first and second plication elements
together.
Description
[0001] This application is a continuation of PCT/US03/33382 filed
on Oct. 21, 2003 which claims priority of U.S. Provisional Patent
Application No. 60/420,095, filed Oct. 21, 2002. The disclosure of
each priority application is hereby incorporated by reference
herein in its entirety.
CROSS REFERENCE TO RELATED APPLICATIONS
[0002] The present invention is related to U.S. Pat. No. 6,619,291
entitled "Method and Apparatus for Catheter-Based Annuloplasty,"
filed Apr. 24, 2001 and issued Sep. 16, 2003, and to co-pending
U.S. patent application Ser. No. 09/866,550, entitled "Method and
Apparatus for Catheter-Based Annuloplasty Using Local Plications,
which are each incorporated herein by reference in their
entireties.
BACKGROUND OF THE INVENTION
[0003] 1. Field of Invention
[0004] The present invention relates generally to techniques for
treating mitral valve insufficiencies such as mitral valve leakage.
More particularly, the present invention relates to systems and
methods for treating a leaking mitral valve in a minimally invasive
manner.
[0005] 2. Description of the Related Art
[0006] Congestive heart failure (CHF), which is often associated
with an enlargement of the heart, is a leading cause of death. As a
result, the market for the treatment of CHF is becoming
increasingly prevalent. For instance, the treatment of CHF is a
leading expenditure of Medicare and Medicaid dollars in the United
States of America. Typically, the treatment of CHF enables many who
suffer from CHF to enjoy an improved quality of life.
[0007] Referring initially to FIG. 1, the anatomy of a heart,
specifically the left side of a heart, will be described. The left
side of a heart 104 includes a left atrium 108 and a left ventricle
112. An aorta 114 receives blood from left ventricle 112 through an
aortic valve 120, which serves to prevent regurgitation of blood
back into left ventricle 112. A mitral valve 116 is disposed
between left atrium 108 and left ventricle 112, and effectively
controls the flow of blood between left atrium 108 and left
ventricle 112.
[0008] Mitral valve 116, which will be described below in more
detail with respect to FIG. 2a, includes an anterior leaflet and a
posterior leaflet that are coupled to cordae tendonae 124 which
serve as "tension members" that prevent the leaflets of mitral
valve 116 from opening indiscriminately. When left ventricle 112
contracts, cordae tendonae 124 allow the anterior leaflet to open
upwards until limited in motion by cordae tendonae 124. Normally,
the upward limit of opening corresponds to a meeting of the
anterior and posterior leaflets and the prevention of backflow.
Cordae tendonae 124 arise from a columnae carnae 128 or, more
specifically, a musculi papillares of columnae carnae 128.
[0009] Left ventricle 112 includes trabeculae 132 which are fibrous
cords of connective tissue that are attached to wall 134 of left
ventricle 112. Trabeculae 132 are also attached to an
interventricular septum 136 which separates left ventricle 112 from
a right ventricle (not shown) of heart 104. Trabeculae 132 are
generally located in left ventricle 112 below columnae carnae
128.
[0010] FIG. 2a is a cut-away top-view representation of mitral
valve 116 and aortic valve 120. Aortic valve 120 has a valve wall
204 that is surrounded by a skeleton 208a of fibrous material.
Skeleton 208a may generally be considered to be a fibrous structure
that effectively forms a ring around aortic valve 120. A fibrous
ring 208b, which is substantially the same type of structure as
skeleton 208a, extends around mitral valve 116. Mitral valve 116
includes an anterior leaflet 212 and a posterior leaflet 216, as
discussed above. Anterior leaflet 212 and posterior leaflet 216 are
generally thin, flexible membranes. When mitral valve 116 is closed
(as shown in FIG. 2a), anterior leaflet 212 and posterior leaflet
216 are generally aligned and contact one another to create a seal.
Alternatively, when mitral valve 116 is opened, blood may flow
through an opening created between anterior leaflet 212 and
posterior leaflet 216.
[0011] Many problems relating to mitral valve 116 may occur and
these insufficiencies may cause many types of ailments. Such
problems include, but are not limited to, mitral regurgitation.
Mitral regurgitation, or leakage, is the backflow of blood from
left ventricle 112 into the left atrium 108 due to an imperfect
closure of mitral valve 116. That is, leakage often occurs when a
gap is created between anterior leaflet 212 and posterior leaflet
216.
[0012] In general, a relatively significant gap may exist between
anterior leaflet 212 and posterior leaflet 216 (as shown in FIG.
2b) for a variety of different reasons. For example, a gap may
exist due to congenital malformations, because of ischemic disease,
or because a heart has been damaged by a previous heart attack. A
gap may also be created when congestive heart failure, e.g.,
cardiomyopathy, or some other type of distress causes a heart to be
enlarged. When a heart is enlarged, the walls of the heart, e.g.,
wall 134 of a left ventricle, may stretch or dilate, causing
posterior leaflet 216 to stretch. It should be appreciated that
anterior leaflet 212 generally does not stretch. As shown in FIG.
2b, a gap 220 between anterior leaflet 212 and stretched posterior
leaflet 216' is created when wall 134' stretches. Hence, due to the
existence of gap 220, mitral valve 116 is unable to close properly,
and may begin to leak.
[0013] Leakage through mitral valve 116 generally causes a heart to
operate less efficiently, as the heart must work harder to maintain
a proper amount of blood flow therethrough. Leakage through mitral
valve 116, or general mitral insufficiency, is often considered to
be a precursor to CHF. There are generally different levels of
symptoms associated with heart failure. Such levels are classified
by the New York Heart Association (NYHA) functional classification
system. The levels range from a Class 1 level which is associated
with an asymptomatic patient who has substantially no physical
limitations to a Class 4 level which is associated with a patient
who is unable to carry out any physical activity without
discomfort, and has symptoms of cardiac insufficiency even at rest.
In general, correcting for mitral valve leakage may be successful
in allowing the NYHA classification grade of a patient to be
reduced. For instance, a patient with a Class 4 classification may
have his classification reduced to Class 3 and, hence, be
relatively comfortable at rest.
[0014] Treatments used to correct for mitral valve leakage or, more
generally, CHF, are typically highly invasive, open-heart surgical
procedures. Ventricular assist devices such as artificial hearts
may be implanted in a patient whose own heart is failing. The
implantation of a ventricular assist device is often expensive, and
a patient with a ventricular assist device must be placed on
extended anti-coagulant therapy. As will be appreciated by those
skilled in the art, anti-coagulant therapy reduces the risk of
blood clots being formed, as for example, within the ventricular
assist device. While reducing the risks of blood clots associated
with the ventricular assist device is desirable, anti-coagulant
therapies may increase the risk of uncontrollable bleeding in a
patient, e.g., as a result of a fall, which is not desirable.
[0015] Rather than implanting a ventricular assist device,
bi-ventricular pacing devices similar to pace makers may be
implanted in some cases, e.g., cases in which a heart beats
inefficiently in a particular asynchronous manner. While the
implantation of a bi-ventricular pacing device may be effective,
not all heart patients are suitable for receiving a bi-ventricular
pacing device. Further, the implantation of a bi-ventricular pacing
device is expensive.
[0016] Open-heart surgical procedures which are intended to correct
for mitral valve leakage, specifically, involve the implantation of
replacement valves. Valves from animals, e.g., pigs, may be used to
replace a mitral valve 116 in a human. While the use of a pig valve
may relatively successfully replace a mitral valve, such valves
generally wear out, thereby requiring additional open surgery at a
later date. Mechanical valves, which are less likely to wear out,
may also be used to replace a leaking mitral valve. However, when a
mechanical valve is implanted, there is an increased risk of
thromboembolism, and a patient is generally required to undergo
extended anti-coagulant therapies.
[0017] A less invasive surgical procedure involves heart bypass
surgery associated with a port access procedure. For a port access
procedure, the heart may be accessed by cutting a few ribs, as
opposed to opening the entire chest of a patient. In other words, a
few ribs may be cut in a port access procedure, rather than opening
a patient's sternum.
[0018] One open-heart surgical procedure that is particularly
successful in correcting for mitral valve leakage and, in addition,
mitral regurgitation, is an annuloplasty procedure. During an
annuloplasty procedure, an annuloplasty ring may be implanted on
the mitral valve to cause the size of a stretched mitral valve 116
to be reduced to a relatively normal size. FIG. 3 is a schematic
representation of an annuloplasty ring. An annuloplasty ring 304 is
shaped approximately like the contour of a normal mitral valve.
That is, annuloplasty ring 304 is shaped substantially like the
letter "D." Typically, annuloplasty ring 304 may be formed from a
rod or tube of biocompatible material, e.g., plastic, that has a
DACRON mesh covering.
[0019] In order for annuloplasty ring 304 to be implanted, a
surgeon surgically attaches annuloplasty ring 304 to the mitral
valve on the atrial side of the mitral valve. Conventional methods
for installing ring 304 require open-heart surgery which involve
opening a patient's sternum and placing the patient on a heart
bypass machine. As shown in FIG. 4, annuloplasty ring 304 is sewn
to a posterior leaflet 318 and an anterior leaflet 320 of a top
portion of mitral valve 316. In sewing annuloplasty ring 304 onto
mitral valve 316, a surgeon generally alternately acquires a
relatively large amount of tissue from mitral tissue, e.g., a
one-eighth inch bite of tissue, using a needle and thread, followed
by a smaller bite from annuloplasty ring 304. Once a thread has
loosely coupled annuloplasty ring 304 to mitral valve tissue,
annuloplasty ring 304 is slid onto mitral valve 316 such that
tissue that was previously stretched out, e.g., due to an enlarged
heart, is effectively pulled in using tension applied by
annuloplasty ring 304 and the thread which binds annuloplasty ring
304 to the mitral valve tissue. As a result, a gap, such as gap 220
of FIG. 2b, between anterior leaflet 320 and posterior leaflet 318
may be substantially closed off. After the mitral valve is shaped
by ring 304, the anterior and posterior leaflets 320, 318 will
reform to create a new contact line and will enable mitral valve
318 to appear and to function as a normal mitral valve.
[0020] Once implanted, tissue generally grows over annuloplasty
ring 304, and a line of contact between annuloplasty ring 304 and
mitral valve 316 will essentially enable mitral valve 316 to appear
and function as a normal mitral valve. Although a patient who
receives annuloplasty ring 304 may be subjected to anti-coagulant
therapies, the therapies are not extensive, as a patient is only
subjected to the therapies for a matter of weeks, e.g., until
tissue grows over annuloplasty ring 304.
[0021] A second surgical procedure which is generally effective in
reducing mitral valve leakage involves placing a single
edge-to-edge suture in the mitral valve. With reference to FIG. 5a,
such a surgical procedure, e.g., an Alfieri stitch procedure or a
bow-tie repair procedure, will be described. An edge-to-edge stitch
404 is used to stitch together an area at approximately the center
of a gap 408 defined between an anterior leaflet 420 and a
posterior leaflet 418 of a mitral valve 416. Once stitch 404 is in
place, stitch 404 is pulled in to form a suture which holds
anterior leaflet 420 against posterior leaflet 418, as shown. By
reducing the size of gap 408, the amount of leakage through mitral
valve 416 may be substantially reduced.
[0022] Although the placement of edge-to-edge stitch 404 is
generally successful in reducing the amount of mitral valve leakage
through gap 408, edge-to-edge stitch 404 is conventionally made
through open-heart surgery. In addition, the use of edge-to-edge
stitch 404 is generally not suitable for a patient with an
enlarged, dilated heart, as blood pressure causes the heart to
dilate outward, and may put a relatively large amount of stress on
edge-to-edge stitch 404. For instance, blood pressure of
approximately 120/80 or higher is typically sufficient to cause the
heart to dilate outward to the extent that edge-to-edge stitch 404
may become undone, or tear mitral valve tissue.
[0023] Another surgical procedure which reduces mitral valve
leakage involves placing sutures along a mitral valve annulus
around the posterior leaflet. A surgical procedure which places
sutures along a mitral valve with be described with respect to FIG.
5b. Sutures 504 are formed along an annulus 540 of a mitral valve
516 around a posterior leaflet 518 of mitral valve 516, and may be
formed as a double track, e.g., in two "rows," from a single strand
of suture material. Sutures 504 are tied off at approximately a
central point 506 of posterior leaflet 518. Pledgets 546 are often
positioned under selected sutures 504, e.g., at central point 506,
to prevent sutures 504 from tearing through annulus 540. When
sutures 504 are tied off, annulus 540 may effectively be tightened
to a desired size such that the size of a gap 508 between posterior
leaflet 518 and an anterior leaflet 520 may be reduced.
[0024] The placement of sutures 504 along annulus 540, in addition
to the tightening of sutures 504, is generally successful in
reducing mitral valve leakage. However, the placement of sutures
504 is conventionally accomplished through open-heart surgical
procedures. That is, like other conventional procedures, a
suture-based annuloplasty procedure is invasive.
[0025] While invasive surgical procedures have proven to be
effective in the treatment of mitral valve leakage, invasive
surgical procedures often have significant drawbacks. Any time a
patient undergoes open-heart surgery, there is a risk of infection.
Opening the sternum and using a cardiopulmonary bypass machine has
also been shown to result in a significant incidence of both short
and long term neurological deficits. Further, given the complexity
of open-heart surgery, and the significant associated recovery
time, people who are not greatly inconvenienced by CHF symptoms,
e.g., people at a Class 1 classification, may choose not to have
corrective surgery. In addition, people who most need open heart
surgery, e.g., people at a Class 4 classification, may either be
too frail or too weak to undergo the surgery. Hence, many people
who may benefit from a surgically repaired mitral valve may not
undergo surgery.
[0026] Therefore, what is needed is a minimally invasive treatment
for mitral valve leakage. Specifically, what is desired is a method
for reducing leakage between an anterior leaflet and a posterior
leaflet of a mitral valve that does not require conventional
surgical intervention.
SUMMARY OF THE INVENTION
[0027] The present invention relates to a non-invasive method of
performing annuloplasty. Performing an annuloplasty on a mitral
valve by accessing the left ventricle of the heart, as for example
using a catheter, enables complicated surgical procedures to be
avoided when treating mitral valve leakage. Avoiding open-heart
surgical procedures generally makes annuloplasty more accessible to
patients who may benefit from annuloplasty. As mitral valve leakage
is often considered to be an early indicator of congestive heart
failure, a minimally invasive annuloplasty procedure that corrects
for leakage problems, such as one which involves positioning
discrete plications in fibrous tissue around the mitral valve, may
greatly improve the quality of life of many patients who might not
be suitable for invasive annuloplasty procedures.
[0028] According to one aspect of the present invention, a method
for performing annuloplasty includes creating a first plication in
the tissue near a mitral valve of a heart, using at least a first
plication element, and creating a second plication in the tissue
near the mitral valve such that the second plication is
substantially coupled to the first plication. In one embodiment,
the method also includes accessing a left ventricle of the heart to
provide the first plication element to the left ventricle, and
engaging the first plication element to the tissue near the mitral
valve. Engaging the first plication element includes causing the
first plication element to substantially pass through a portion of
the tissue to substantially anchor the first plication element to
the tissue near the mitral valve.
[0029] According to another aspect of the present invention, a
method for performing annuloplasty includes accessing a heart to
provide a plurality of plication elements to the heart. The
plurality of plication elements are provided to the heart through a
catheter arrangement, and include a first anchor arrangement. The
method also includes engaging the first anchor arrangement to
tissue near a mitral valve of the heart using the catheter
arrangement by causing the first anchor arrangement to
substantially pass through the tissue to substantially anchor the
first anchor arrangement to the tissue near the mitral valve.
Finally, the method includes creating at least a first plication
and a second plication using the first anchor arrangement.
[0030] In accordance with still another embodiment of the present
invention, a method for performing annuloplasty includes accessing
an area of a heart to provide a first plication element to the area
using a catheter arrangement which has a first portion and a second
portion, and substantially anchoring the first portion of the
catheter arrangement to tissue near a mitral valve of the heart.
The method further includes positioning a tip of the second portion
of the catheter arrangement at a first distance from the first
portion, and substantially engaging the first anchor to the tissue
near the mitral valve of the heart using the second portion of the
catheter arrangement. Substantially engaging the first anchor
includes causing the first anchor to substantially pass through a
portion of the tissue to substantially anchor the first anchor to
the tissue near the mitral valve using the second portion of the
catheter arrangement. In one embodiment, substantially anchoring
the first portion of the catheter arrangement to tissue near the
mitral valve of the heart includes positioning the first portion of
the catheter arrangement over a guide that is at least temporarily
anchored to the tissue near the mitral valve.
[0031] These and other advantages of the present invention will
become apparent upon reading the following detailed descriptions
and studying the various figures of the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0032] The invention may best be understood by reference to the
following description taken in conjunction with the accompanying
drawings in which:
[0033] FIG. 1 is a cross-sectional front-view representation of the
left side of a human heart.
[0034] FIG. 2a is a cut-away top-view representation of the mitral
valve and the aortic valve of FIG. 1.
[0035] FIG. 2b is a cut-away representation of a stretched mitral
valve and an aortic valve.
[0036] FIG. 3 is a representation of an annular ring that is
suitable for use in performing a conventional annuloplasty
procedure.
[0037] FIG. 4 is a representation of a mitral valve and an aortic
valve after the annular ring of FIG. 3 has been implanted.
[0038] FIG. 5a is a representation of a mitral valve and an aortic
valve after a single edge-to-edge suture has been applied to reduce
mitral regurgitation.
[0039] FIG. 5b is a representation of a mitral valve and an aortic
valve after sutures along a mitral valve annulus have been applied
to reduce mitral regurgitation.
[0040] FIG. 6a is a representation of a delivery tube and a
J-catheter in accordance with an embodiment of the present
invention.
[0041] FIG. 6b is a cut-away front view of the left side of a heart
in which the delivery tube and the J-catheter of FIG. 6a have been
inserted in accordance with an embodiment of the present
invention.
[0042] FIG. 7a is a representation of a catheter assembly in
accordance with an embodiment of the present invention.
[0043] FIG. 7b is a cross-sectional representation of the catheter
assembly of FIG. 7a in accordance with an embodiment of the present
invention.
[0044] FIG. 7c is a cut-away top-view representation of a left
ventricle in which the gutter catheter of FIGS. 7a and 7b has been
positioned in accordance with an embodiment of the present
invention.
[0045] FIG. 8 is a cut-away top-view representation of a left
ventricle in which a guide wire has been positioned in accordance
with an embodiment of the present invention.
[0046] FIG. 9a is a cut-away top-view representation of a left
ventricle of the heart in which local plication suture structures
have been implanted in accordance with an embodiment of the present
invention.
[0047] FIG. 9b is a cut-away top-view representation of a left
ventricle of the heart in which local plication suture structures
which are coupled have been implanted in accordance with an
embodiment of the present invention.
[0048] FIG. 10a is a representation of a suture structure after
T-bars have been introduced to an atrial side of a mitral valve
through fibrous tissue near the mitral valve in accordance with an
embodiment of the present invention.
[0049] FIG. 10b is a representation of the suture structure of FIG.
10a after the T-bars have been engaged to the fibrous tissue in
accordance with an embodiment of the present invention.
[0050] FIG. 11 is a representation of a suture structure which
includes a locking element with a spring in accordance with an
embodiment of the present invention.
[0051] FIG. 12a is a representation of a suture structure which
includes a locking element with a resorbable component in
accordance with an embodiment of the present invention.
[0052] FIG. 12b is a representation of the suture structure of FIG.
12a after the resorbable component has degraded in accordance with
an embodiment of the present invention.
[0053] FIG. 12c is a representation of the suture structure of FIG.
12b after a plication has been created in accordance with an
embodiment of the present invention.
[0054] FIG. 13a is a representation of a first catheter which is
suitable for use in delivering and implementing a suture structure
in accordance with an embodiment of the present invention.
[0055] FIG. 13b is a representation of a second catheter which is
suitable for use in delivering and implementing a suture structure
in accordance with an embodiment of the present invention.
[0056] FIG. 13c is a representation of a third catheter assembly
which is suitable for use in delivering and implementing a suture
structure in accordance with an embodiment of the present
invention.
[0057] FIGS. 14a and 14b are a process flow diagram which
illustrates the steps associated with one method of performing
annuloplasty using a suture structure and a catheter in accordance
with an embodiment of the present invention.
[0058] FIG. 15 is a cut-away top-view representation of a left
ventricle of the heart in which local plication elements have been
implanted in accordance with an embodiment of the present
invention.
[0059] FIG. 16a is a representation of a local plication element
which has spring-like characteristics in accordance with an
embodiment of the present invention.
[0060] FIG. 16b is a representation of the local plication element
of FIG. 16a after forces have been applied to open the local
plication element in accordance with an embodiment of the present
invention.
[0061] FIG. 16c is a representation of the local plication element
of FIG. 16b after tips of the local plication element pierce
through tissue in accordance with an embodiment of the present
invention.
[0062] FIG. 16d is a representation of the local plication element
of FIG. 16c after the tips of the local plication element engage
the tissue to form a local plication in accordance with an
embodiment of the present invention.
[0063] FIG. 17a is a representation of a local plication element,
which is formed from a shape memory material, in an open state in
accordance with an embodiment of the present invention.
[0064] FIG. 17b is a representation of the local plication element
of FIG. 17a in a closed state in accordance with an embodiment of
the present invention.
[0065] FIG. 18a is a representation of a first self-locking clip
which is suitable for use in forming a local plication in
accordance with an embodiment of the present invention.
[0066] FIG. 18b is a representation of a second self-locking clip
which is suitable for use in forming a local plication in
accordance with an embodiment of the present invention.
[0067] FIG. 19 is a representation of a plication-creating locking
mechanism in accordance with an embodiment of the present
invention.
[0068] FIG. 20a is a representation of the plication-creating
locking mechanism of FIG. 19 as provided within the left ventricle
of a heart in accordance with an embodiment of the present
invention.
[0069] FIG. 20b is a representation of the plication-creating
locking mechanism of FIG. 20a after forces have been applied to
cause tines of the mechanism to contact tissue in accordance with
an embodiment of the present invention.
[0070] FIG. 20c is a representation of the plication-creating
locking mechanism of FIG. 20b after tissue has been gathered
between the tines of the mechanism in accordance with an embodiment
of the present invention.
[0071] FIG. 20d is a representation of the plication-creating
locking mechanism of FIG. 20c after a local plication has been
formed in accordance with an embodiment of the present
invention.
[0072] FIGS. 21a and 21b are a process flow diagram which
illustrates the steps associated with one method of performing
annuloplasty using a local plication element and a catheter in
accordance with an embodiment of the present invention.
[0073] FIG. 22a is a cut-away front view of the left side of a
heart in which an L-shaped catheter has been inserted in accordance
with an embodiment of the present invention.
[0074] FIG. 22b is a cut-away front view of the left side of a
heart in which an L-shaped catheter has been inserted and extended
in accordance with an embodiment of the present invention.
[0075] FIG. 22c is a cut-away front view of the left side of a
heart in which an L-shaped catheter has been inserted, extended,
and curved in accordance with an embodiment of the present
invention.
[0076] FIG. 23a is representation of a portion of a first catheter
which may use suction to engage against tissue in accordance with
an embodiment of the present invention.
[0077] FIG. 23b is representation of a portion of a first catheter
which may use suction to engage against tissue in accordance with
an embodiment of the present invention.
[0078] FIG. 24a is representation of a portion of a wire with a
helical coil which may be used as a temporary anchor in accordance
with an embodiment of the present invention.
[0079] FIG. 24b is representation of a portion of a catheter with a
helical coil which may be used as a temporary anchor in accordance
with an embodiment of the present invention.
[0080] FIG. 25 is a representation of an anchor which is deployed
and anchored into tissue in accordance with an embodiment of the
present invention.
[0081] FIG. 26a is a representation of a portion of an incrementor
catheter in a closed configuration which is positioned over a tail
of an anchor in accordance with an embodiment of the present
invention.
[0082] FIG. 26b is a representation of a portion of an incrementor
catheter in an open configuration which is positioned over a tail
and is extended such that a first section and a second section of
the incrementor have tips that are separated by a distance in
accordance with an embodiment of the present invention.
[0083] FIG. 27 is a representation of two anchors which may be used
to create a plication in accordance with an embodiment of the
present invention.
[0084] FIGS. 28a-f are representations of anchors and lockers which
are used in a process of creating a daisy chain of plications in
accordance with an embodiment of the present invention.
[0085] FIG. 29a is a cut-away front view of the left side of a
heart in which a hook catheter has been inserted in accordance with
an embodiment of the present invention.
[0086] FIG. 29b is a cut-away front view of the left side of a
heart in which a hook catheter is positioned beneath a mitral valve
in accordance with an embodiment of the present invention.
[0087] FIG. 29c is a cut-away front view of the left side of a
heart in which a temporary anchor has been inserted in accordance
with an embodiment of the present invention.
[0088] FIG. 29d is a cut-away front view of the left side of a
heart in which a hook catheter which carries a permanent anchor is
inserted in accordance with an embodiment of the present
invention.
[0089] FIG. 29e is a cut-away front view of the left side of a
heart in which a permanent anchor has been inserted in accordance
with an embodiment of the present invention.
[0090] FIG. 29f is a cut-away front view of the left side of a
heart in which an incrementor catheter has been inserted in
accordance with an embodiment of the present invention.
[0091] FIG. 29g is a cut-away front view of the left side of a
heart in which two permanent anchors have been inserted in
accordance with an embodiment of the present invention.
[0092] FIG. 29h is a cut-away front view of the left side of a
heart in which two permanent anchors and a locking device or locker
have been inserted in accordance with an embodiment of the present
invention.
[0093] FIG. 30 is a process flow diagram which illustrates the
steps associated with one method of creating a plication using an
incrementor catheter in accordance with an embodiment of the
present invention.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0094] Invasive, open-heart surgical procedures are generally
effective in the treatment of mitral valve leakage. However,
open-heart surgical procedures may be particularly hazardous to
some patients, e.g., frail patients or patients who are considered
as being very ill, and undesirable to other patients, e.g.,
patients who are asymptomatic and do not wish to undergo a surgical
procedure. As such, open-heart surgical procedures to correct
mitral valve leakage or, more generally, mitral valve
insufficiency, are not suitable for many patients who would likely
benefit from reducing or eliminating the mitral valve leakage.
[0095] A catheter-based annuloplasty procedure enables annuloplasty
to be performed on a patient without requiring that the patient
undergo open-heart surgery, or be placed on cardiopulmonary bypass.
Catheters may be introduced into the left ventricle of a heart
through the aorta to position a guide wire and plication implants
on the ventricular side of a mitral valve, i.e., under a mitral
valve. Catheters may also be used to couple the plication implants
to fibrous tissue associated with the skeleton of the heart around
the mitral valve.
[0096] The use of catheters to perform an annuloplasty procedure by
delivering and engaging plication implants or structures enables
the annuloplasty procedure to be performed without open-heart
surgery, and without a bypass procedure. Recovery time associated
with the annuloplasty, as well as the risks associated with
annuloplasty, may be substantially minimized when the annuloplasty
is catheter-based. As a result, annuloplasty becomes a more
accessible procedure, since many patients who might previously not
have received treatment for mitral valve leakage, e.g., frail
patients and asymptomatic patients, may choose to undergo
catheter-based annuloplasty.
[0097] To begin a catheter-based annuloplasty procedure, a delivery
tube and a J-catheter may be inserted into a left ventricle of the
heart through the aorta. Inserting the delivery tube and the
J-catheter through the aorta enables the left ventricle of the
heart to be reached substantially without coming into contact with
trabeculae or the cordae tendonae in the left ventricle. FIG. 6a is
a diagrammatic representation of a delivery tube and a J-catheter
in accordance with an embodiment of the present invention. Delivery
tube 604 has a substantially circular cross section, and is
configured to receive a J-catheter 608. J-catheter 608 is arranged
to move longitudinally through and opening in delivery tube 604 as
needed.
[0098] In general, delivery tube 604 is an elongated body which may
be formed from a flexible, durable, biocompatible material such as
nylon, urethane, or a blend of nylon and urethane, e.g.,
PEBAX.RTM.. Likewise, J-catheter 608, which is also an elongated
body, may also be formed from a biocompatible material. A material
used to form J-catheter 608 is typically also relatively flexible.
In the described embodiment, a tip of J-catheter 608 is rigid
enough to allow the tip of J-catheter 608 to maintain a relatively
curved shape, e.g., a "J" shape. The curve in J-catheter 608 is
configured to facilitate the positioning of a gutter catheter, as
will be described below with respect to FIGS. 7a-c.
[0099] FIG. 6b is a schematic representation of delivery tube 604
and J-catheter 608 positioned within a heart in accordance with an
embodiment of the present invention. As shown, after delivery tube
604 and J-catheter 608 are effectively "snaked" or inserted through
a femoral artery, portions of delivery tube 604 and of J-catheter
608 are positioned within an aorta 620 of a heart 616. A tip 626 of
J-catheter 608, which is substantially oriented at a right angle
from the body of J-catheter 608, and an end of delivery tube 604
are oriented such that they pass through an aortic valve 630.
Hence, an end of delivery tube 604 and tip 626 are positioned at a
top portion of left ventricle 624, where wall 632 of left ventricle
624 is relatively smooth. The relative smoothness of the top
portion of left ventricle 624 enables a catheter to be properly
positioned within left ventricle 624 by guiding the tip of the
catheter along wall 632. In one embodiment, tip 626 is oriented
such that it is positioned approximately just below a mitral valve
628 on the ventricular side of mitral valve 628.
[0100] Once positioned within left ventricle 624, J-catheter 608
may be rotated within delivery tube 604 such that tip 626 is may
enable a gutter catheter fed therethrough to run along the contour
of wall 632. Typically, the gutter catheter runs along the contour
of wall 632 in an area that is effectively defined between a plane
associated with papillary muscles 640, a plane associated with the
posterior leaflet of mitral valve 628, cordae tendonae 642, and
wall 632. A "gutter" is located in such an area or region and, more
specifically, is positioned substantially right under mitral valve
628 where there is a relatively insignificant amount of
trabeculae.
[0101] With reference to FIGS. 7a-7c, a gutter catheter will be
described in accordance with an embodiment of the present
invention. A gutter catheter 704, which is part of a catheter
assembly 702 as shown in FIG. 7a, is arranged to be extended
through J-catheter 626 such that gutter catheter 704 may be steered
within a left ventricle just beneath a mitral valve. Gutter
catheter 704, which may include a balloon tip (not shown), is
typically formed from a flexible material such as nylon, urethane,
or PEBAX.RTM.. In one embodiment, gutter catheter 704, which is
steerable, may be formed using a shape memory material.
[0102] As shown in FIG. 7a and FIG. 7b, which represents a cross
section of catheter assembly 702 taken at a location 710, gutter
catheter 704 is at least partially positioned within J-catheter 608
which, in turn, is at least partially positioned within delivery
tube 604. Gutter catheter 704 may be free to rotate within and
extend through J-catheter 608, while J-catheter 608 may be free to
rotate within and extend through delivery tube 604.
[0103] Referring next to FIG. 7c, the positioning of gutter
catheter 704 within a left ventricle of the heart will be described
in accordance with an embodiment of the present invention. It
should be appreciated that the representation of gutter catheter
704 within a left ventricle 720 has not been drawn to scale, for
ease of illustration and ease of discussion. For instance, the
distance between a wall 724 of left ventricle 720 and a mitral
valve 728 has been exaggerated. In addition, it should also be
appreciated that the positioning of delivery tube 604 and, hence,
J-catheter 608 and gutter catheter 704 within aortic valve 732 may
vary.
[0104] Gutter catheter 704 protrudes through tip 626 of J-catheter
608, and, through steering, essentially forms an arc shape similar
to that of mitral valve 728 along the contour of a wall 724 of left
ventricle 720 just beneath mitral valve 728, i.e., along the gutter
of left ventricle 720. Wall 724 of left ventricle 720 is relatively
smooth just beneath mitral valve 728, i.e., generally does not
include trabeculae. Hence, inserting catheter assembly 702 through
an aortic valve 732 into an upper portion left ventricle 720 allows
gutter catheter 704 to be navigated within left ventricle 720 along
wall 724 substantially without being obstructed by trabeculae or
cordae tendonae.
[0105] Gutter catheter 704 generally includes an opening or lumen
(not shown) that is sized to accommodate a guide wire through which
a guide wire may be inserted. The opening may be located along the
central axis of gutter catheter 704, i.e., central axis 730 as
shown in FIG. 7a. Delivering a guide wire through gutter catheter
704 enables the guide wire to effectively follow the contour of
wall 724. In general, the guide wire may include an anchoring tip
which enables the guide wire to be substantially anchored against
wall 724. FIG. 8 is a diagrammatic top-view cut-away representation
of a left side of a heart in which a guide wire has been positioned
in accordance with an embodiment of the present invention. It
should be appreciated that the representation of the left side of a
heart in FIG. 8 has not been drawn to scale, and that various
features have been exaggerated for ease of discussion. A guide wire
802 is positioned along wall 724 of left ventricle 720. Once guide
wire 802 is inserted through gutter catheter 704 of FIGS. 7a-7c,
and anchored against wall 724 using an anchoring tip 806, gutter
catheter 704, along with J-catheter 708, are withdrawn from the
body of the patient. It should be appreciated that delivery tube
604 typically remains positioned within the aorta after guide wire
802 is anchored to wall 724.
[0106] Guide wire 802, which may be formed from a material such as
stainless steel or a shape memory material, is generally anchored
such that guide wire 802 effectively passes along a large portion
of wall 724. Typically, guide wire 802 serves as a track over which
a catheter that carries plication structures may be positioned,
i.e., a lumen of a catheter that delivers a plication element may
pass over guide wire 802. Such a catheter may include a balloon
structure (not shown), or an expandable structure, that may
facilitate the positioning of local plication structures by pushing
the local plication structures substantially against the fibrous
tissue around the mitral valve.
[0107] Forming local plications causes bunches of the fibrous
tissue around the mitral valve to be captured or gathered, thereby
causing dilation of the mitral valve to be reduced. In general, the
local plications are discrete plications formed in the fibrous
tissue around the mitral valve using suture structures or discrete
mechanical elements. FIG. 9a is a representation of a top-down
cut-away view of a left ventricle of the heart in which local
plication suture structures have been implanted in accordance with
an embodiment of the present invention. Suture structures, which
include T-bars 904 and threads 907, are implanted in tissue near a
mitral valve 916, e.g., an annulus of mitral valve 916. Typically,
the tissue in which suture structures are implanted is fibrous
tissue 940 which is located substantially around mitral valve 916.
Suitable suture structures include, but are not limited to,
structures which include T-bars 904 and threads 907, as will be
described below with reference to FIGS. 10a, 10b, 11, and
12a-c.
[0108] Since T-bars 904 or similar structures, when implanted, may
cut through tissue 940, pledgets 905 may against a ventricular side
tissue 940 to effectively "cushion" T-bars 904. Hence, portions of
T-bars 904 are positioned above mitral valve 916, i.e., on an
atrial side of mitral valve 916, while pledgets 905 are positioned
on the ventricular side of mitral valve 916. It should be
appreciated that additional or alternative pledgets may be
positioned on the atrial side of mitral valve 916, substantially
between tissue 940 and T-bars 904. Catheters which deliver suture
structures 904 to an atrial side of mitral valve 916 from a
ventricular side of mitral valve 916 will be discussed below with
respect to FIGS. 13a-c.
[0109] In the described embodiment, T-bars 904 are coupled such
that every two T-bars, e.g., T-bars 904a, is coupled by a thread,
e.g., thread 907a. Thread 907a is configured to enable T-bars 904a
to be tensioned together and locked against tissue 940. Locking
T-bars 904a enables tissue 940 to be bunched or slightly gathered,
thereby effectively constraining the size, e.g., arc length, of
mitral valve 916 by reducing the an arc length associated with
tissue 940. In other words, the presence of T-bars 904 which
cooperate with thread 907 to function substantially as sutures,
allows the size of a gap 908 between an anterior leaflet 920 and a
posterior leaflet 918 to be reduced and, further, to be
substantially prevented from increasing. As will be appreciated by
those skilled in the art, over time, scar tissue (not shown) may
form over pledgets 905 and T-bars 904.
[0110] Generally, the number of T-bars 904 used to locally bunch or
gather tissue 940 may be widely varied. For instance, when
substantially only a small, localized regurgitant jet occurs in
mitral valve 916, only a small number of T-bars 904 may be
implemented in proximity to the regurgitant jet. Alternatively,
when the size of gap 908 is significant, and there is a relatively
large amount of mitral valve leakage, then a relatively large
number of T-bars 904 and, hence, pledgets 905 may be used to reduce
the size of gap 908 by reducing the arc length of mitral valve 916.
Some pledgets 905 may be arranged to at least partially overlap. To
correct for a regurgitant jet that is centralized to only one
section of mitral valve 916, T-bars 904 may be implemented as
plicating elements near the regurgitant jet, and as reinforcing
elements away from the regurgitant jet, e.g., to prevent
progression of mitral valve disease from causing a substantial gap
to eventually form.
[0111] While the coupling of two T-bars 904a with thread 907a has
been described, it should be understood that the number of T-bars
904 coupled by a thread or threads 907 may vary. For example, if
multiple T-bars 904 are coupled by multiple threads 907, then it
may be possible to gather more fibrous tissue using fewer total
T-bars 904. With reference to FIG. 9b, the use of multiple T-bars
904 which are coupled by multiple threads 907 will be described.
T-bars 904c are coupled by a thread 907c, while T-bars 904d are
coupled by a thread 907c. Similarly, T-bars 904e are coupled by a
thread 907e. T-bar 904d' is further coupled by a thread 907f to
T-bar 904c", and T-bars 904d" is also coupled by a thread 907g to
T-bar 904e'. As will be discussed below, threads 907 enable T-bars
904 to be pulled against pledgets 905 and, hence, tissue 940. Such
coupling of T-bars 904 enables plications in tissue 940 to be made
between T-bars 904c, between T-bars 904d, and between T-bars 904e,
while allowing tissue to be at least somewhat gathered between
T-bar 904c" and T-bar 904d', and between T-bar 904d" and T-bar
904e'.
[0112] In general, the configurations of suture structures which
include T-bars 904 and threads 907 may vary. One embodiment of a
suitable suture structure is shown in FIGS. 10a and 10b. FIGS. 10a
and 10b are representations of a suture structure after T-bars have
been introduced to an atrial side of fibrous tissue near a mitral
valve in accordance with an embodiment of the present invention.
For purposes of illustration, it should be understood that the
elements and structures represented in FIGS. 10a and 10b, as well
as substantially all other figures, have not been drawn to scale. A
suture structure 1000 includes T-bars 904, or reinforcing elements,
that are coupled to thread 907 such that when thread 907 is pulled,
T-bars 904 effectively push against tissue 940. As shown in FIG.
10b, pulling on thread 907 and pushing on a locking element 1002
causes locking element 1002 to contact a ventricular side of tissue
940 and to effectively hold T-bars 904 against tissue 940.
Specifically, pulling on a loop 1004 of thread 907 while pushing on
locking element 1002 tightens T-bars 904 against tissue 940 such
that a plication 1006 may be formed in tissue 940 when locking
element 1002 locks into position to lock T-bars 904 into place.
[0113] Pledgets 905, as will be appreciated by those skilled in the
art, may serve as plication anchors for T-bars 904 which
essentially function as sutures. That is, pledgets 905 may prevent
T-bars 904 from cutting through tissue 940. In general, the
configuration of pledgets 905 may vary widely. For example,
pledgets 905 may have a substantially tubular form, and may be
formed from a material such as surgical, e.g., Dacron, mesh.
However, it should be appreciated that pledgets 905 may be formed
in substantially any shape and from substantially any material
which promotes or supports the growth of scar tissue therethrough.
Suitable materials include, but are not limited to silk and
substantially any biocompatible porous or fibrous material.
[0114] Locking element 1002 may be a one-way locking element, e.g.,
an element which may not be easily unlocked once it is locked, that
is formed from a biocompatible polymer. The configuration of a
locking element 1002 may be widely varied. Alternative
configurations of locking element 1002 will be described below with
respect to FIG. 11 and FIGS. 12a-c. In order to engage locking
element 1002 against pledgets 905, a catheter which is used to
deliver T-bars 904 may be used to push locking element 1002 into a
locked position. A catheter which delivers T-bars 904 and may also
be used to engage locking element 1002 will be discussed below with
reference to FIGS. 13a-c.
[0115] Like locking element 1002, T-bars 904 may also be formed
from a biocompatible polymer. Thread 907, which may be coupled to
T-bars 904 through tying T-bars 904 to thread 907 or molding T-bars
904 over thread 907, may be formed from substantially any material
which is typically used to form sutures. Suitable materials
include, but are not limited to, silk, prolene, braided Dacron, and
polytetrafluoroethylene (PTFE, or GoreTex).
[0116] As mentioned above, the configuration of locking element
1002 may vary. For example, a locking element may include a spring
element as shown in FIG. 11. A suture structure 1100 include T-bars
1104, a thread 1107, and a locking element 1102. For ease of
illustration, the elements of suture structure 1100 have not been
drawn to scale. Although suture structure 1100 is not illustrated
as including a pledget, it should be appreciated that suture
structure 1100 may include a pledget or pledgets which serve as
reinforcing elements which generally support the growth of scar
tissue.
[0117] Locking element 1102 includes solid elements 1102a and a
spring element 1102b. Although solid elements 1102a may be formed
from a biocompatible polymer, solid elements 1102a may also be
formed from material which is typically used to form pledgets.
Spring element 1102b is arranged to be held in an extended
position, as shown, while a loop 1114 in thread 1107 is pulled on.
Once T-bars 1104 are in contact with tissue 1140, solid elements
1102a may come into contact with tissue 1140, and spring element
1102b may contract to create a spring force that pulls solid
elements 1102a toward each other. In other words, once T-bars 1104
are properly positioned against tissue 1140, locking element 1102
may be locked to form a plication or local bunching of tissue
1140.
[0118] In one embodiment, the formation of scar tissue on the
fibrous tissue which is in proximity to a mitral valve may be
promoted before a plication is formed, or before the fibrous tissue
is gathered to compensate for mitral valve insufficiency. With
reference to FIGS. 12a-c, a locking element which promotes the
growth of scar tissue before a plication is formed will be
described in accordance with an embodiment of the present
invention. As shown in FIG. 12a, a suture structure 1200, which is
not drawn to scale, includes a locking element 1204, a thread 1207,
and T-bars 1204. Locking element 1204, which includes solid
elements 1202a, a spring element 1202b, and a resorbable polymer
overmold 1202c formed over spring element 1202b is coupled to
thread 1207 on a ventricular side of tissue 1240.
[0119] Overmold 1202c, which may be formed from a resorbable
lactide polymer such as PURASORB, which is available from PURAC
America of Lincolnshire, Ill., is formed over spring element 1202b
while spring element 1202b is in an extended position. Overmold
1202c is arranged to remain intact while scar tissue 1250 forms
over solid elements 1202a. In one embodiment, in order to
facilitate the formation of scar tissue, solid elements 1202a may
be formed from material that is porous or fibrous, e.g., "pledget
material."
[0120] Once scar tissue is formed over solid elements 1202a,
overmold 1202c breaks down, e.g., degrades, to expose spring
element 1202b, as shown in FIG. 12b. As will be understood by one
of skill in the art, the chemical composition of overmold 1202c may
be tuned such that the amount of time that elapses before overmold
1202c breaks down may be controlled, e.g., controlled to break down
after a desired amount of scar tissue is expected to be formed.
Hence, once overmold 1202c breaks down, and spring element 1202b is
allowed to contract, as shown in FIG. 12c, enough scar tissue 1250
will generally have formed over solid elements 1202a to effectively
bond solid elements 1202a against tissue 1240 to allow for the
formation of a relatively strong plication or gathering of tissue
1240.
[0121] While a loop 1214 of thread 1207 may be allowed to remain
extended into a left ventricle of a heart, thread 1207 may be cut,
i.e., loop 1214 may be effectively removed, to reduce the amount of
loose thread 1207 in the heart. Alternatively, loose thread 1207
may effectively be eliminated by gathering thread 1207 around a
cylindrical arrangement (not shown) positioned over locking element
1202. That is, a spool or similar element may be included as a part
of suture structure 1200 to enable loose thread 1207 to either be
gathered within the spool or gathered around the exterior of the
spool.
[0122] The use of overmold 1202c enables anchoring forces which
hold T-bars 1204 and locking element 1202 in position to be
relatively low, as substantially no significant forces act on
tissue 1240 until after scar tissue or tissue ingrowth is created.
Once scar tissue is created, and overmold 1202c has degraded, then
spring 1202b compresses. The anchoring forces generated at this
time may be relatively high. However, as scar tissue has been
created, the likelihood that T-bars 1204 cut into tissue 1240 at
this time is generally relatively low.
[0123] As mentioned above, catheters may be used to deliver suture
structures into a heart, and to engage the suture structures to
tissue around the mitral valve of the heart. One embodiment of a
suture structure delivery catheter which is suitable for use in a
catheter-based annuloplasty that uses local plications will be
described with respect to FIG. 13a. A delivery catheter 1300 may be
positioned over a guide wire, e.g., guide wire 802 as shown in FIG.
8, which serves as a track to enable delivery catheter 1300 to be
delivered in the gutter of a heart. It should be appreciated that
the elements of delivery catheter 1302 have not been drawn to
scale. Within delivery catheter 1300 is a wire 1308 which carries
T-bars 1304 of a suture structure. In one embodiment, T-bars 1300
are coupled to a thread 1307 and a locking element 1300 to form the
suture structure. Typically, a pointed or sharpened end 1311 of
wire 1308 is configured to penetrate tissue (not shown), e.g.,
fibrous tissue of the heart near a mitral valve. Once end 1311 and
T-bar 1304 are located above fibrous tissue, e.g., on an atrial
side of a mitral valve, wire 1308 may be retracted a repositioned.
After wire 1308 is repositioned, end 1311 may once again penetrate
tissue to effectively deposit T-bar 1304 over tissue on the atrial
side of the mitral valve.
[0124] Wire 1308 or, more specifically, end 1311 may be used to
pull thread 1307 and to push locking element 1302 into position
against tissue near the mitral valve. By way of example, end 1311
may pull on thread 1307 until T-bars 1304 contact the tissue. Then,
end 1311 may be used to lock locking element 1302 against the
tissue and, as a result, create a plication in the tissue to
effectively shrink the annulus of the mitral valve.
[0125] In order to create additional plications, wire 1308 and, in
one embodiment, delivery catheter 1300, may be retracted entirely
out of a patient to enable additional T-bars to be loaded onto wire
1308. Once additional T-bars are positioned on wire 1308, wire 1308
may be reinserted into delivery catheter 1300, and delivery
catheter 1300 may be used to enable another plication to be created
in the tissue which is located near the mitral valve.
[0126] FIG. 13b is a representation of a second catheter which is
suitable for delivering a suture structure in accordance with an
embodiment of the present invention. A catheter 1340, which is not
drawn to scale and which may include a lumen (not shown) that is
arranged to be inserted over a guide wire, includes two wires 1348
which are arranged to cooperate to carry a suture structure. As
shown, wire 1348a carries a T-bar 1344a while wire 1348b carries a
T-bar 1344b which are coupled by a thread 1347 and, together with a
locking element 1342, form a suture structure. Tips 1351 of wires
1348 pass through tissue near a mitral valve to deposit T-bars 1344
above the mitral valve. Once T-bars 1344 are deposited, tips 1351
may be used to pull T-bars 1344 against the tissue, as well as to
lock locking element 1342 against an opposite side of the tissue.
By way of example, tip 1351b may be configured to pull on thread
1347 while tip 1351a pushes against locking element 1342.
[0127] With reference to FIG. 13c, a catheter arrangement which may
deploy T-bars from its tip will be described in accordance with an
embodiment of the present invention. A catheter arrangement 1360
includes two catheters which each carry a T-bar 1364. It should be
appreciated that the elements of FIG. 13c have not been drawn to
scale for ease of illustration. Specifically, catheter 1360a
carries T-bar 1364a at its tip, while catheter 1360b carries T-bar
1364b at its tip. A thread 1367 couples T-bars 1364 together such
that a locking element 1362 through which thread 1367 passes may
lock T-bars 1364 substantially against tissue of a heart.
[0128] In one embodiment, catheter arrangement 1360 may require the
use of two guide wires to guide each of catheter 1360a and catheter
1360b into the gutter of the heart. Alternatively, catheter 1360a
and catheter 1360b may be arranged such that both catheter 1360a
and catheter 1360b may be guided through the gutter of the heart
through the use of a single guide wire.
[0129] Catheter 1360a is configured to push T-bar 1364a through
tissue near the mitral valve of the heart, and to release T-bar
1364a once T-bar 1364a is located on an atrial side of the mitral
valve. Similarly, catheter 1360b is configured to push T-bar 1364b
through the tissue, and to release T-bar 1364b. T-bars 1364 may be
released, for example, when heat is applied to a dielectric
associated with catheters 1360 that causes T-bars 1364 to be
effectively snapped off. Alternatively, a mechanical mechanism (not
shown) that engages T-bars 1364 to catheters 1360 may be disengaged
to release T-bars 1354. Once T-bars 1364 are positioned on the
atrial side of the mitral valve, catheter 1360 may be used to pull
on thread 1367 and to push on locking element 1362.
[0130] With reference to FIGS. 14a and 14b, the performance of an
annuloplasty procedure using a catheter-based system which implants
suture structures in tissue near a mitral valve will be described
in accordance with an embodiment of the present invention. Once a
patient is prepared, e.g., sedated, an annuloplasty procedure 1400
may begin with the insertion of a delivery tube and a J-catheter
into the left ventricle of the heart of the patient. The delivery
tube and the J-catheter may be inserted into the body of the
patient through the femoral artery, and threaded through the
femoral artery and the aorta into the left ventricle of the heart.
Generally, the J-catheter is positioned within the delivery tube.
One embodiment of the delivery tube and a J-catheter were described
above with respect to FIGS. 6a and 6b. As will be appreciated by
those skilled in the art, the delivery tube and the J-catheter are
typically each threaded through the aortic valve to reach the left
ventricle.
[0131] Once the delivery tube and the J-catheter are positioned
within the left ventricle, a gutter catheter may be extended
through the J-catheter in step 1408. As was discussed above with
reference to FIGS. 7a-c, the gutter catheter is arranged to
effectively run against a gutter of the wall of the left ventricle
substantially immediately under the mitral valve. Specifically, the
gutter catheter may be positioned in the space in the left
ventricle between the mitral valve and the musculi papillares, or
papillary muscles. The gutter catheter often has a tip that is
steerable and flexible. In one embodiment, the tip of the gutter
catheter may be coupled to an inflatable balloon. The J-catheter
serves, among other purposes, the purpose of allowing the gutter
catheter to be initially oriented in a proper direction such that
the gutter catheter may be positioned along the wall of the left
ventricle.
[0132] In step 1412, a guide wire with an anchoring feature may be
delivered through the gutter catheter, e.g., through a lumen or
opening in the gutter catheter. The guide wire is delivered through
the gutter catheter such that it follows the contour of the gutter
catheter against the wall of the left ventricle. After the guide
wire is delivered, the anchoring feature of the guide wire is
anchored on the wall of the left ventricle in step 1416. Anchoring
the guide wire, or otherwise implanting the guide wire, on the wall
of the left ventricle enables the guide wire to maintain its
position within the left ventricle.
[0133] The J-catheter and the gutter catheter are pulled out of the
left ventricle through the femoral artery in step 1420, leaving the
guide wire anchored within the left ventricle, as was discussed
above with respect to FIG. 8. A T-bar assembly delivery catheter
which carries a T-bar assembly is then inserted through the femoral
artery into the left ventricle over the guide wire in step 1436. In
one embodiment, the T-bar assembly delivery catheter carries an
uninflated balloon.
[0134] After the T-bar assembly delivery catheter is inserted into
the left ventricle, the balloon is inflated in step 1428. Inflating
the balloon, e.g., an elastomeric balloon, at a relatively modest
pressure using, for example, an air supply coupled to the balloon
through the T-bar assembly delivery catheter, serves to enable
substantially any catheter which uses the guide wire as a track to
be pressed up against the fibrous tissue around the mitral valve.
Generally, the inflated balloon substantially occupies the space
between the mitral valve and the papillary muscles. In one
embodiment, more than one balloon may be inflated in the left
ventricle.
[0135] Once the balloon is inflated in step 1428. The T-bar
assembly delivery catheter effectively delivers T-bars, or similar
mechanisms, pledgets, and thread which are arranged to attach or
otherwise couple with an annulus of the mitral valve, e.g., the
fibrous tissue of the skeleton around the mitral valve, to create
plications. Suitable catheters were described above with respect to
FIGS. 13a-c. In step 1440, a plication is created using the T-bar
assembly in substantially any suitable tissue near the mitral
valve. For example, a plication may be created by essentially
forcing T-bars through the tissue, then locking the T-bars against
the tissue using a locking mechanism of the T-bar assembly.
Specifically, the plication or bunching of tissue may be created by
extending sharpened wires which carry elements such as T-bars
through the tissue, then retracting the sharpened wires, and
pulling the T-bars into place. Positioning the T-bars, and locking
the locking mechanism causes the tissue between the T-bars and the
locking mechanism may bunch together.
[0136] Once the plication is created in step 1440, the balloon is
generally deflated in step 1442. The T-bar assembly delivery
catheter may then be removed through the femoral artery in step
1444. A determination is made in step 1448 after the T-bar assembly
delivery catheter is removed as to whether additional plications
are to be created. If it is determined that additional plications
are to be created, then process flow returns to step 1436 in which
the T-bar assembly delivery catheter, which carries a T-bar
assembly or suture structure, is reinserted into the femoral
artery.
[0137] Alternatively, if it is determined in step 1448 that there
are no more plications to be created, then process flow proceeds to
step 1456 in which the guide wire may be removed. After the guide
wire is removed, the delivery tube may be removed in step 1460.
Once the delivery tube is removed, the annuloplasty procedure is
completed.
[0138] In lieu of using suture structures such as T-bar assemblies
to create local plications, other elements may also be used to
create local plications in fibrous tissue near the mitral valve
during an annuloplasty procedure. FIG. 15 is a cut-away top view
representation of a left side of a heart in which local plications
have been created using individual, discrete elements in accordance
with an embodiment of the present invention. Local plication
elements 1522 are effectively implanted in fibrous tissue 1540
around portions of a mitral valve 1516 in order to reduce the size
of a gap 1508 between an anterior leaflet 1520 and a posterior
leaflet 1518, e.g., to reduce the arc length associated with
posterior leaflet 1518. Local plication elements 1522 are arranged
to gather sections of tissue 1540 to create local plications. The
local plications created by local plication elements 1522, which
are generally mechanical elements, reduce the size of the mitral
valve annulus and, hence, reduce the size of gap 1508. As will be
understood by those skilled in the art, over time, scar tissue may
grow around or over local plication elements 1522.
[0139] The configuration of local plication elements 1522 may be
widely varied. For example, local plication elements 1522 may be
metallic elements which have spring-like characteristics, or
deformable metallic elements which have shape memory
characteristics. Alternatively, each local plication element 1522
may be formed from separate pieces which may be physically locked
together to form a plication. With reference to FIGS. 16a-d, one
embodiment of a local plication element which has spring-like
characteristics will be described in accordance with an embodiment
of the present invention. A local plication element 1622 may be
delivered to a ventricular side, or bottom side, of tissue 1640
which is located near a mitral valve. When delivered, as for
example through a catheter, element 1622 is in a substantially
folded, closed orientation, as shown in FIG. 16a. In other words,
element 1622 is in a closed configuration that facilitates the
delivery of element 1622 through a catheter. After an initial
compressive force is applied at corners 1607 of element 1622, sides
or tines 1609 of element 1622 may unfold or open. As tines 1609
open, tips 1606 of tines 1609 may be pressed against tissue 1640,
as shown in FIG. 16b. The application of compressive force to tines
1609, as well as a pushing force to a bottom 1611 of element 1622,
allows tips 1606 and, hence, tines 1609 to grab tissue 1640 as tips
1606 push through tissue 1640, as shown in FIG. 16c. The closing of
tines 1609, due to compressive forces applied to tines 1609, causes
tissue 1640 to be gathered between tines 1609 and, as a result,
causes a plication 1630 to be formed, as shown in FIG. 16d. In one
embodiment, the catheter (not shown) that delivers element 1622 may
be used to apply forces to element 1622.
[0140] As mentioned above, elements used to create local plications
may be created from shape memory materials. The use of a shape
memory material to create a plication element allows the plication
element to be self-locking. FIG. 17a is a representation of one
plication element which is formed from a shape memory material in
accordance with an embodiment of the present invention. A clip
1704, which may be formed from a shape memory material, i.e., an
alloy of nickel and titanium, is arranged to be in an expanded
state or open state when it is introduced, e.g., by a catheter,
into the gutter of the left ventricle. Typically, holding clip 1704
in an expanded state involves applying force to clip 1704. In one
embodiment, a catheter may hold sides 1708 of clip 1704 to maintain
clip 1704 in an expanded state.
[0141] Once tips 1706 of clip 1704 are pushed through the fibrous
tissue near the mitral valve of the heart such that tips 1706 are
positioned on an atrial side of the mitral valve, force may be
removed from clip 1704. Since clip 1704 is formed from a shape
memory material, once force is removed, clip 1704 forms itself into
its "rest" state of shape, as shown in FIG. 17b. In its rest state
or preferred state, clip 1704 is arranged to gather tissue in an
opening 1712 defined by clip 1704. That is, the default state of
clip 1704 is a closed configuration which is effective to bunch
tissue to create a local plication.
[0142] Another discrete self-locking plication element which is
suitable for creating a local plication is a clip which may twist
from an open position to a closed, or engaged position, once force
applied to hold the clip in an open position is removed. FIG. 18a
is a representation of another self-locking plication element shown
in a closed position in accordance with an embodiment of the
present invention. A clip element 1800, which may be formed from a
material such as stainless steel or a shape memory material, is
preloaded such that once tissue 1830 is positioned in a gap 1810
between a tine 1806 and a time 1808, clip element 1800 may return
to a state which causes tissue 1830 to be pinched within a gap or
space 1810.
[0143] Tine 1806 and tine 1808 first pierce tissue 1830, e.g., the
tissue of an annulus of a mitral valve. As tine 1806 and tine 1808
are drawn together to create a plication, thereby reducing the size
of gap 1810 by reducing a distance 1820, a bottom portion 1812 of
clip element 1800 twists, as for example in a quarter turn,
effectively by virtue of shape memory characteristics of clip
element 1800. Thus, an effective lock that holds tine 1806 and tine
1808 in a closed position such that tissue 1830 is gathered to form
a local plication results.
[0144] In lieu of a preloaded clip element, a clip element may
include a lock mechanism which engages when force is applied. FIG.
18a is a representation of a self-locking plication element which
includes a sliding lock in accordance with an embodiment of the
present invention. A clip element 1850 includes a body 1852 and a
slider 1862 which is arranged to slide over at least a portion of
body 1852. Clip element 1850, which may be formed from a material
such as stainless steel or a shape memory alloy, includes a tip
1856 and a tip 1858 which are substantially separated by a gap 1856
when slider 1862 is in an unlocked position. As shown, slider 1862
is in an unlocked or open position when slider 1862 is positioned
about a tapered neck 1854 of body 1852.
[0145] When clip element 1850 is delivered into a left ventricle,
e.g., using a catheter, clip element 1850 is positioned within the
left ventricle such that tip 1856 and tip 1858 are effectively
pierced through fibrous tissue 1880 near the mitral valve. After
tip 1856 and tip 1858 are positioned substantially on an atrial
side of tissue 1880, force may be applied to slider 1862 to move
slider 1862 in a y-direction 1870b over body 1852. As slider moves
in y-direction 1870b away from tapered neck 1854, slider 1862
forces tip 1856 and tip 1858 together close gap 1860, i.e., tip
1856 and tip 1858 move towards each other in an x-direction 1870a.
When tip 1856 and tip 1858 cooperate to close gap 1860, tissue 1880
is gathered within clip element 1850, thereby creating a local
plication.
[0146] In one embodiment, when slider 1862 is in a closed position
such that tip 1856 and tip 1858 cooperate to close gap 1856, slider
1862 may contact tissue 1880. Hence, in order to promote the growth
of scar tissue over parts of clip element 1850 or, more
specifically, slider 1862, at least a top surface of slider 1862
may be covered with a pledget material, e.g., a mesh which supports
the growth of scar tissue therethrough.
[0147] Locking elements which create local plications may include
elements which have two or more substantially separate pieces which
lock together around tissue. An example of a locking element which
includes two separate pieces is shown in FIG. 19. As shown in FIG.
19, a locking element 2000 may include a receiver piece 2002 and a
locker piece 2004, which may generally be formed from substantially
any suitable material, as for example a biocompatible plastic
material. Receiver piece 2002 and locker piece 2004 each include a
tine 2006. Tines 2006 are arranged to pierce and to engage tissue
to create a local plication.
[0148] A cable tie portion 2010 of locker piece 2004 is configured
to be drawn through an opening 2008 which engages cable tie portion
2010. Opening 2008 includes features (not shown) which allow cable
tie portion 2010 to be pulled through opening 2008 and locked into
position, and which prevent cable tie portion 2010 substantially
from being pushed out of opening 2008. Cable tie portion 2010 is
locked in opening 2008 when bevels 2012 come into contact and
effectively force tines 2006 to clamp down. Once tines 2006 clamp
down, and locker piece 2004 is locked against receiver piece 2002,
a local plication is formed.
[0149] The operation of locking element 2000 will be described with
respect to FIGS. 20a-d in accordance with an embodiment of the
present invention. As shown in FIG. 20a, receiver piece 2002 and
locker piece 2004 may be delivered substantially beneath fibrous
tissue 2050 near a mitral valve (not shown). Receiver piece 2002
and locker piece 2004 may be delivered using a catheter which
includes a top surface 2054. Top surface 2054 of the catheter is
arranged to apply force to tines 2006 such that tines 2006 remain
in an effectively undeployed, e.g., partially bent or folded,
position while being delivered by the catheter.
[0150] Once receiver piece 2002 and locker piece 2004 are
positioned under tissue 2050 near a location where a plication is
to be formed, forces are applied to receiver piece 2002 and locker
piece 2004 to push receiver piece 2002 and locker piece 2004
together and effectively through an opening 2058 in top surface
2054 of the catheter, as shown in FIG. 20b. The forces are
typically applied by mechanisms (not shown) associated with the
catheter. As tines 2006 pass through opening 2058, tines 2006
"open," or deploy in order to pierce tissue 2050.
[0151] After piercing tissue 2050, tines 2006 continue to penetrate
and to gather tissue 2050 while receiver piece 2002 and locker
piece 2004 are pushed together. As receiver piece 2002 and locker
piece 2004 are pushed together, cable tie portion 2010 is inserted
into opening 2008 (shown in FIG. 19) of receiver portion 2002, as
shown in FIG. 20c. Cable tie portion 2010 eventually locks with
respect to opening 2008 when bevels 2012 come into contact. When
bevels 2012 come into contact, tines 2006 close inwards, causing
tissue 2050 to be captured, i.e., causing a local plication 2060 to
be formed. Once a local plication is formed, and force is no longer
required to push receiver piece 2002 and locker piece 2004
together, the catheter which delivered receiver piece 2002 and
locker piece 2004 may be removed from the left ventricle. Referring
next to FIGS. 21a and 21b, an annuloplasty procedure which uses a
catheter-based system to create local plications in tissue near a
mitral valve using discrete elements will be described in
accordance with an embodiment of the present invention. After a
patient is prepared, an annuloplasty procedure 2100 may begin with
the insertion of a delivery tube and a J-catheter into the left
ventricle of the heart of the patient in step 2104. Once the
delivery tube and the J-catheter are positioned within the left
ventricle, a gutter catheter may be extended through the J-catheter
in step 2108. The gutter catheter, as described above, is arranged
to effectively run against a gutter of the wall of the left
ventricle, e.g., between the mitral valve and the papillary
muscles. The gutter catheter often has a tip that is steerable and
flexible.
[0152] In step 2112, a guide wire with an anchoring feature may be
delivered through the gutter catheter, e.g., through a lumen or
opening in the gutter catheter. The guide wire is delivered through
the gutter catheter such that it follows the contour of the gutter
catheter against the wall of the left ventricle. After the guide
wire is delivered, the anchoring feature of the guide wire is
anchored on the wall of the left ventricle in step 2116.
[0153] The J-catheter and the gutter catheter are pulled out of the
left ventricle through the femoral artery in step 2120, leaving the
guide wire anchored within the left ventricle, as was discussed
above with respect to FIG. 8. A plication element delivery catheter
which carries a plication element and, in one embodiment, is
arranged to engage the plication element to the fibrous tissue
around the mitral valve is inserted through the femoral artery into
the left ventricle over the guide wire in step 2132. The plication
element delivery catheter, in the described embodiment, is coupled
to an uninflated balloon which is inflated in step 2134 to
effectively allow the plication element delivery catheter to be
positioned substantially directly under the fibrous tissue. Once
the plication element delivery catheter is positioned in the left
ventricle, e.g., over the guide wire in the gutter of the left
ventricle, and the balloon is inflated, the plication element
delivered by the delivery catheter is engaged to the fibrous tissue
in step 2136. That is, the plication element is coupled to the
fibrous tissue such that a local plication is formed in the fibrous
tissue.
[0154] After the local plication is created in step 2136 by
engaging tissue using the plication element, the balloon is
deflated in step 2138. Upon deflating the balloon, the plication
element delivery catheter may be removed through the femoral artery
in step 2140. A determination is then made in step 2142 as to
whether additional local plications are to be created. That is, it
is determined if other plication elements are to be introduced into
the left ventricle. If it is determined that additional local
plications are to be created, process flow returns to step 2132 in
which the plication element delivery catheter, which carries
another plication element, is reinserted into the femoral
artery.
[0155] Alternatively, if it is determined in step 2142 that there
are no more local plications to be created, then the indication is
that a sufficient number of local plications have already been
created. Accordingly, the guide wire may be removed in step 2148,
and the delivery tube may be removed in step 2152. After the
delivery tube is removed, the annuloplasty procedure is
completed.
[0156] A catheter which may enable an orthogonal access to a mitral
valve may enable the catheter to be more accurately positioned
underneath the mitral valve. As discussed above, a catheter may
become at least partially tangled in trabeculae which are located
in the left ventricle of a heart. As such, inserting a catheter
which does not extend too deeply into the left ventricle may
prevent significant tangling. Any tangling may impede the
efficiency with which the catheter may be positioned beneath a
mitral valve. One catheter which may be less likely to become at
least partially tangled in trabeculae, while also enabling an
orthogonal access to a mitral valve, is an L-shaped catheter, which
is shown in FIG. 22a. An L-shaped catheter arrangement 2200, which
includes a delivery tube 2201 and an L-shaped catheter 2202 which
may be formed from a biocompatible material that is typically also
relatively flexible, is arranged to allow the tip of L-catheter
2202 to maintain an "L" shape when passed through an aortic valve
2206 into a left ventricle 2204. After delivery tube 2201 and
L-shaped catheter 2202 are effectively "snaked" or inserted through
a femoral artery, a tip 2208 of L-shaped catheter may be positioned
at a top portion of left ventricle 2204, where there is typically a
minimal amount of trabeculae.
[0157] Tip 2208 of L-shaped catheter 2202 may be extended in a
straight orientation such that tip 2208 effectively forms an "L"
with respect to delivery tube 2201 and the remainder of L-shaped
catheter 2202. In one embodiment, as tip 2208 is extended under a
mitral valve 2212, a string 2210 or another part, e.g., a wire,
that may be coupled to tip 2208 may extend through an opening in
delivery tube 2201 as shown in FIG. 22b. String 2210 may
effectively allow tip 2208 to be bent or otherwise moved around
underneath to position tip 2208 into contact with mitral valve
2212, as shown in FIG. 22c.
[0158] The use of string 2210 to pull on tip 2208 allows, in
cooperation with extending L-shaped catheter 2202, tip 2208 to be
moved beneath mitral valve 2212 into desired positions. Hence,
desired locations beneath mitral valve 2212 may relatively easily
be reached to enable plications (not shown) to be created in the
desired locations. In the described embodiment, string 2210 may
enable a curve to be created in L-shaped catheter 2202 that is
substantially an approximately ninety degree curve.
[0159] L-shaped catheter 2202 may be used to create plications in
mitral valve 2212 using a variety of different methods.
Specifically, tip 2208 of L-shaped catheter 2202 may be temporarily
fixed in a position beneath mitral valve 2212, e.g., in a gutter of
the heart, during a process of creating a plication in mitral valve
2212. In one embodiment, suction may be used to gather a portion of
tissue near mitral valve 2212 either such that a plication may be
made in the portion, or such that a temporary anchor point may be
created. Suction generally enables tissue to be substantially
gathered such that an apparatus, as for example a clip or a similar
apparatus, may be put into place to hold the gathered tissue.
Alternatively, suction may be used to secure or firmly anchor tip
2208 against mitral valve 2212 such that an anchor for a plication
may be deployed with improved accuracy. When tip 2208 is anchored
into tissue near mitral valve 2212, an anchor for a plication or a
temporary anchor may be more precisely placed, as the position of
tip 2208 is effectively fixed.
[0160] FIGS. 23a and 23b are diagrammatic representations of
orientations of a tip area of an L-shaped catheter which may be
used with suction to anchor the tip area to a mitral valve in
accordance with an embodiment of the present invention. As shown in
FIG. 23a, a tip 2308 of a catheter such as an L-shaped catheter,
e.g., L-shaped catheter 2202 of FIG. 22c, may include an opening
2314 on a side of tip 2308. Opening 2314 may be positioned under
tissue 2312 such that when suction is applied through opening 2314,
tip 2308 is effectively temporarily fixed against tissue 2312.
Alternatively, as shown in FIG. 23b, a tip 2318 of an L-shaped
catheter may include an end opening 2324, i.e., an opening at an
endpoint of tip 2318, that allows opening 2324 to contact tissue
2322 such that when suction is applied through opening 2324, tip
2312 is held relatively firmly against tissue 2322. Temporarily
anchoring a catheter near a mitral valve generally allows plication
elements to be more accurately deployed using the catheter.
[0161] In lieu of using suction to anchor the tip area of a
catheter to tissue near a mitral valve, a wire with a coil which
may be extended through a catheter such that the wire may be
temporarily anchored into tissue near the mitral valve such that
other catheters may track over the wire. For example, a wire with a
helical coil or a spiral at the tip may be engaged against tissue
by applying force to the tip of the wire, turning the wire such
that the helical coil portion of the wire turns through the tissue,
the pushing the coil through the tissue. FIGS. 24a and 24b are
diagrammatic representations of a wire with a helical coil which
may be suitable for use in as a temporary anchor that is anchored
into tissue near a mitral valve in accordance with an embodiment of
the present invention. A wire 2430 with a coiled tip 2432, as shown
in FIG. 24a, may be extended through a catheter (not shown) while a
tip of the catheter may, in one embodiment, effectively be anchored
against tissue near a mitral valve. Wire 2430 may be inserted in a
catheter (not shown) such that a longitudinal axis of wire 2430 is
parallel to a longitudinal axis of a tip (not shown) of the
catheter. As shown in FIG. 24b, coiled tip 2432 may extend through
a lumen of a tip 2440 of an L-shaped catheter to enable tip 2440 to
be substantially anchored when coiled tip 2432 is anchored against
tissue. Coiled tip 2432 is incorporated in the tip of the catheter,
and would be engaged by rotating the entire catheter. This design
features a working lumen that is coaxial with the center of the
helical tip to enable a T-bar that is pushed down the lumen to pass
through the center of the helix as the T-bar is effectively forced
through tissue. It should be appreciated that, in one embodiment, a
coiled tip may be included as a part of an L-shaped catheter, i.e.,
the catheter may include a coiled tip.
[0162] A wire 2430 with a coiled tip 2432 may generally be used as
a temporary anchor which may remain coupled to tissue even after a
catheter through which wire 2430 was deployed is retracted. That
is, wire 2430 may serve as a track over which other catheters may
be "run" to enable a particular position, i.e., a position
identified by the location of coiled tip 2432 with respect to the
tissue, to be repeatedly accessed or located by catheters.
[0163] In general, temporary fixation is a relatively reversible
process. By effectively temporarily fixing or anchoring a catheter
or a coiled tip of a wire against mitral valve tissue or tissue
near a mitral valve, it is relatively easy to position, release,
and re-position the wire and, hence, a catheter that tracks over
the wire substantially without trauma, and substantially without
causing an irreversible action to occur. A temporary anchor may
provide a tension or counter-traction force for the application of
a permanent anchor. That is, counter-traction on the temporary
anchor may be used to provide a tissue penetration force for the
permanent anchor. Possible permanent anchors generally include both
single anchor points, e.g., applying one T-bar with a second T-bar
being needed to for a plications, and dual anchor points, e.g.,
applying a clip or a staple which creates a plication between its
points.
[0164] Once a catheter is effectively anchored into position, as
for example over a wire such as wire 2430, then anchors which are
used to create plications may be deployed. Typically, two anchor
points are used to form a single plication. FIG. 25 is a
diagrammatic representation of an anchor which is deployed and
anchored into tissue in accordance with an embodiment of the
present invention. An anchor 2504, which is coupled to a tether or
a tail 2500, is deployed through tissue 2508 such that anchor 2504
is pushed through tissue 2508 while tail 2500 is allowed to extend,
e.g., to an exterior of the body of a patient. In one embodiment,
anchor 2504 may be a temporary anchor which is not actually used in
the creation of a plication but is, instead, used to allow anchors
used for plications to be positioned. In such an embodiment, anchor
2504 may be used to enable a first permanent anchor to be anchored.
Alternatively, anchor 2504 may be an anchor, e.g., a T-bar, which
is intended to be used to create a plication. For ease of
discussion, anchor 2504 is described as being a first permanent
anchor that was previously anchored into position by guiding a
catheter over a temporary anchor (not shown).
[0165] An incrementor catheter may use tail 2500 as a guide over
which the incrementor catheter may be positioned. An incrementor
catheter, as shown in FIG. 26a, may generally include two sections.
A first section 2602 of an incrementor catheter 2600, may be
inserted over tail 2500. In one embodiment, first section 2602 may
be used to insert anchor 2504, e.g., when incrementor catheter 2600
is configured as an L-shaped catheter.
[0166] Once first section 2602 is positioned over tail 2500 such
that first section 2602 is in relatively close proximity to tissue
2508, a second section 2604 may be extended away from first section
2602, as for example by a nominal separation or distance `d,` as
shown in FIG. 26b. The positioning of first section 2602 over tail
2500 enables first section 2602 to be temporarily fixed. With first
section 2602 being temporarily fixed, second section 2604 may be
controlled such that a tip of second section 2604 may be rotated,
extended, or retraced to control the penetration angle of an anchor
(not shown) that is to be deployed.
[0167] Additionally, when first section 2602 is temporarily fixed,
the position of first section 2602 may be maintained for enough
time to perform substantially all desired tests and to withstand
forces associated with the desired test. Further, substantially all
forces associated with the manipulation of incrementor catheter
2602.
[0168] Distance `d` may be substantially any distance, and is
typically selected to be a distance which allows a plication
created using anchor 2504 and an anchor (not shown) that is to be
deployed through second section 2604 to be effectively created.
When second section 2604 is used to deploy either a temporary or
permanent anchor (not shown), second section 2604 is effectively a
working lumen of incrementor catheter 2600.
[0169] The location of anchors may generally be verified using a
number of technologies which include, but are not limited to,
ultrasound techniques, fluoroscopy techniques, and electrical
signals. With some of the technologies, the injection of marking
agents, e.g., contrast agents for fluoroscopy or microspheres for
ultrasound, may increase contrast and promote visibility.
Typically, such injections may be into a ventricular space, within
mitral valve tissue, or in through the mitral valve tissue into
atrial space. It should be appreciated that the verification of
locations may further enable a distance `d` between consecutive
anchors to be more accurately maintained.
[0170] FIG. 27 is a diagrammatic representation of two anchors
which may be used to create a plication in accordance with an
embodiment of the present invention. Anchor 2504 and an anchor
2704, which may be deployed using second section 2604 of
incrementor catheter 2600 of FIG. 26b, are separated by distance
`d.` Each anchor 2504, 2704 has a tail section, i.e., tail 2500 and
a tail 2700, respectively, which, after incrementor catheter 2600
of FIG. 26b is withdrawn from underneath tissue 2508, may be pulled
on or tensioned such that a plication is effectively created
between anchor 2504 and anchor 2704. Once a plication is created,
tails 2500, 2700 may be trimmed.
[0171] In general, a daisy chain of plications may be created using
an incrementor catheter. That is, the incrementor catheter may be
used to anchor a series of anchors which are each substantially
separated by a distance `d.` Once a daisy chain of anchors is in
place in mitral valve tissue, pairs of the anchors may effectively
be tied off to create a series or a daisy chain of plications. With
reference to FIG. 28a-f, a process of creating a daisy chain of
plications will be described in accordance with an embodiment of
the present invention. As shown in FIG. 28a, a first anchor 2802a,
which may be a T-bar, has a tail 2806a such as a suture and is
anchored to tissue 2804. Typically, tissue 2804 is tissue of a
mitral valve annulus, or tissue near a mitral valve. A second
anchor 2802b, which has a tail 2806b is also anchored into tissue
2804. Typically, the distance between second anchor 2802b and first
anchor 2802a is a measured distance, i.e., the distance between
second anchor 2802b and first anchor 2802a is predetermined. In one
embodiment, the distance is substantially controlled using an
incrementor catheter.
[0172] Once first anchor 2802a and second anchor 2802b are in
place, a locker 2810a is delivered over tails 2806a, 2806b, as
shown in FIG. 28b. Once locker 2810a is delivered, tail 2806a may
be tensioned, substantially locked, and trimmed. Tensioning of tail
2806b, as shown in FIG. 28c, allows a first plication 2820 to be
effectively created. Tail 2806b remains untrimmed, as second anchor
2802b is arranged to be included in a second plication of a daisy
chain of plications. That is, second anchor 2802b may effectively
be shared by more than one plication. A third anchor 2802c which
has a tail 2806c, as shown in FIG. 28d, is anchored into tissue
2804 at a specified distance from second anchor 2802b, e.g.,
through the use of an incrementor catheter.
[0173] A locker 2810b may be delivered over tail 2806b and tail
2806c, and tail 2806b may be tensioned, locked, and trimmed as
shown in FIG. 28e. When tail 2806c is tensioned, a second plication
2830 is created, as shown in FIG. 28f. It should be appreciated
that if tail 2806 is also locked and trimmed, then a daisy chain of
two plications 2820, 2830 is completed. Alternatively, if more
plications are to be added, then additional anchors and lockers may
be positioned as appropriate such that tail 2806c serves as a
"starting point" for the additional plications.
[0174] Instead of using an L-shaped catheter to create anchor
points, substantially any other suitable catheter may be used to
access tissue near a mitral valve or a mitral valve annulus, e.g.,
to achieve a substantially orthogonal access to mitral valve
tissue. In one embodiment, a suitable catheter may be a hook
catheter which effectively includes an approximately 180 degree
curve may be used to create anchor points and plications. FIG. 29a
is a diagrammatic representation of a hook catheter in accordance
with an embodiment of the present invention. A hook catheter 2900,
which includes a tip 2902 that is effectively a terminus of a
curved portion 2903 of hook catheter 2900, is inserted through an
aortic valve 2904 into a left ventricle 2906.
[0175] Once hook catheter 2900 is positioned or, more specifically,
once tip 2902 is positioned near mitral valve tissue 2908, a string
2910 which may be coupled to tip 2902 as shown in FIG. 29b, may be
pulled on or tensioned and slackened, as appropriate, to enable tip
2902 to be positioned in a desired location with respect to mitral
valve tissue 2908. As will be appreciated by those skilled in the
art, string 2910 is often a wire such as a pull wire or a
deflection wire that is axially translatable. By allowing string
2910 to enable tip 902 to be positioned in a desired location, hook
catheter 2900 may effectively be considered to be a deflectable or
steerable tip catheter. A temporary anchor, e.g., a helical coil
such as helical coil 2432 of FIG. 24a, may be anchored to mitral
valve tissue 2908 by deploying the temporary anchor through hook
catheter 2900. FIG. 29c is a diagrammatic representation of a
temporary anchor that is positioned within a heart in accordance
with an embodiment of the present invention. An anchoring coil
2920, which is coupled to a wire 2922, may be anchored to mitral
valve tissue 2908 such that wire 2922 may serve as a guide over
which a catheter, as for example either a catheter such as a hook
catheter which delivers a permanent anchor or an incrementor
catheter, which may also deliver a permanent anchor, may be
positioned.
[0176] In lieu of using hook catheter 2900 to deploy a temporary
anchor, catheter 2900 may instead be used to deploy a more
permanent anchor such as a T-bar. As shown in FIG. 29d, a T-bar
2940 may be pushed through mitral valve tissue 2908 using tip 2902
of hook catheter 2900. When hook catheter 2900 is withdrawn from
left ventricle 2906, T-bar 2940 effectively remains anchored in
mitral valve tissue 2908, while a tail 2942 of T-bar 2940 may
extend to an exterior of the body of a patient, as shown in FIG.
29e.
[0177] After T-bar 2940 or, more generally, an anchor is in
position, then an incrementor catheter may be snaked or otherwise
passed over tail 2942. FIG. 29f is a diagrammatic representation of
an incrementor catheter that is positioned over tail 2942 in
accordance with an embodiment of the present invention. An
incrementor catheter 2950 is positioned such that a first section
2952 of incrementor catheter 2950 may be guided by tail 2942 until
a tip of first section 2952 is substantially directly under T-bar
2940. Then, a second section 2954 of incrementor catheter 2950 may
be extended until a tip of second section 2954 is positioned
approximately a distance `d` away from T-bar 2940. A second T-bar
(not shown) or anchor may then be deployed using second section
2954. Once a second T-bar is deployed, incrementor catheter 2950
may be removed from left ventricle 2906.
[0178] The use of an incrementor catheter 2950 allows two T-bars,
e.g., T-bar 2940 and T-bar 2980 of FIG. 29g, to be anchored to
mitral valve tissue 2908 such that T-bars 2940, 2980 may be spaced
apart at approximately a distance `d,` while tails 2942, 2982,
respectively, may extend outside of a body of a patient. In other
words, incrementor catheter 2950 generally enables the distance
between adjacent T-bars to be more carefully controlled.
[0179] In order to create a plication using T-bars 2940, 2980, a
locking bar 2990, as shown in FIG. 29h, may be provided over tails
2942, 2982 such that mitral valve tissue 2908 may effectively be
pinched between T-bars 2940, 2980 and locking bar 2990. Once a
plication is created, tails 2942, 2982 may be trimmed or otherwise
cut.
[0180] With reference to FIG. 30, the steps associated with one
method of creating a plication using an access catheter which has a
180 degree retrograde active-curve tip, e.g., a hook catheter, an
incrementor catheter, and a helical coil for creating a temporary
anchor will be described in accordance with an embodiment of the
present invention. A process 3000 begins at step 3020 in which a
catheter, e.g., a hook catheter, is inserted in a substantially
straight configuration through an introducer into a femoral artery
of a patient. Once the catheter is inserted, the tip of the
catheter is prolapsed into a hook shape in step 3040. A gap between
an end of the hook portion and the main portion of the catheter may
be reduced to a dimension that is small enough to prevent tangling
of the tip in chords or leaflets of the heart. Prolapsing of the
tip may generally occur within the aorta of a heart, at a femoral
artery bifurcation, or within the left ventricle of the heart. It
should be appreciated that when the tip of the catheter is
deflectable, the tip of the catheter may be deflected or
substantially actively changed into a hook shape within the aorta
of the heart, or within the left ventricle of the heart.
[0181] In step 3060, the tip of the catheter may be positioned
within the left ventricle. By way of example, the catheter tip may
be positioned at a level that is just inferior to the level of the
mitral valve annulus, and the catheter segment that includes the
hook shape may be rotated such that it lies against either the
anterior or posterior aspect of the aortic outflow tract, depending
upon which aspect is to be treated. In one embodiment, the distal
catheter segment is aligned such that when extended, the tip of the
catheter may point towards one of the entrances to the gutter of
the heart. The entrances to the gutter of the heart may include
substantially any relatively clear entrance to the gutter with
respect to the leaflets of the heart, as for example a medial P1
location, a mid P2 location, or a lateral P3 location.
[0182] After the tip of the catheter is positioned, the tip of the
catheter may be hooked into the gutter in step 3080. Hooking the
catheter tip into the gutter may include repeatedly extending the
retrograde tip to increase the gap between the tip and the proximal
segment of the catheter, retracting the entire catheter and sensing
engagement of the tip with the gutter, and, if necessary, one again
positioning the tip of the catheter in the left ventricle before
rehooking the tip.
[0183] Once the catheter tip is hooked into the gutter, the
location of the tip is confirmed in step 3100. Confirming the
location of the tip may include, but is not limited to, as
previously mentioned, sensing electrical signals of the heart,
fluoroscopy with or without the injection of contrast, and
ultrasound with or without the injection of microspheres. When the
tip location is confirmed, a temporary anchor may be attached in
step 3120. The temporary anchor may be a helical coil, e.g.,
helical coil 2432 of FIG. 24a, that is attached by applying a
longitudinal pressure and torque. Typically, when the helical coil
is attached, a lumen or a tail of the helical coil remains
connected to the helical coil.
[0184] In the described embodiment, after the temporary anchor is
attached, the location of the temporary anchor is confirmed in step
3140. Methods used to confirm the location of the temporary anchor
may be the same as methods used to confirm the location of a
catheter tip, and may also include injecting contrast or
microspheres into tissue or through tissue to the atrial space
above a mitral valve.
[0185] A permanent anchor is attached in step 3160 using the
connection to the temporary anchor as a guide. The permanent anchor
may be attached to the same location, and may provide a
counter-traction force for tissue engagement. Like the temporary
anchor, the permanent anchor generally includes a tail.
[0186] Once a permanent anchor is in place, an incrementor catheter
is delivered into the heart in step 3180. In general, the
incrementor catheter is delivered in a closed configuration to the
location of the first anchor, e.g., the permanent anchor attached
in step 3160, by tracking a first section of the incrementor
catheter over the tail of the first anchor. After the incrementor
catheter is delivered, the incrementor catheter may be deployed in
step 3200 to create a nominal distance or gap between the first
anchor location and the working lumen, e.g., a second section, of
the incrementor catheter. Then, in step 3220, a second permanent
anchor may be applied at the nominal distance from the first
permanent anchor. It should be appreciated that temporary anchors
may be used to facilitate the positioning of the second permanent
anchor. Applying the second permanent anchor typically includes
retracting the incrementor catheter once the second permanent
anchor is anchored into a desired location.
[0187] After both the first permanent anchor and the second
permanent anchor are applied, a locker is delivered into the heart
in step 3240. Delivering the locker generally includes tracking the
locker or locking device over the two tails of the first and the
second permanent anchors. The locker may be fixed into position by
applying tension to the locker to create a plication substantially
between the two permanent anchors.
[0188] Once the locker has been tensioned, the tails of the anchors
may be severed, and the process of creating a plication is
completed. It should be appreciated that, in one embodiment, steps
3180 to 3260 may generally be repeated to create a daisy chain of
interlocking plications.
[0189] Although only a few embodiments of the present invention
have been described, it should be understood that the present
invention may be embodied in many other specific forms without
departing from the spirit or the scope of the present invention. By
way of example, methods of introducing plication elements or suture
structures into the left ventricle to correct for mitral valve
leakage, or mitral valve insufficiency, may be applied to
introducing plication elements or suture structures which correct
for leakage in other valves. For instance, the above-described
procedure may be adapted for use in repair a leaking valve
associated with a right ventricle.
[0190] While creating local plications in fibrous tissue associated
with the mitral valve of the heart has generally been described,
the plications may also be created in other types of tissue which
are near, around, in proximity to, or include the mitral valve. As
will be appreciated by those skilled in the art, other tissues to
which plications may be formed that are near, around, in proximity
to, or include the mitral valve include tissues associated with the
coronary sinus, tissues associated with the myocardium, or tissues
associated with the wall of the left ventricle. In one embodiment,
a plication may be substantially directly formed in the leaflets of
the mitral valve.
[0191] It should be understood that although a guide wire has been
described as including an anchoring tip to anchor the guide wire to
a wall of the left ventricle, a guide wire may be anchored with
respect to the left ventricle in substantially any suitable manner.
By way of example, a guide wire may include an anchoring feature
which is located away from the tip of the guide wire. In addition,
a guide wire may more generally be any suitable guiding element
which is configured to facilitate the positioning of an
implant.
[0192] While access to the gutter of the left ventricle has been
described as being associated with a minimally invasive catheter
annuloplasty procedure in which local plications are formed, it
should be understood that the gutter of the left ventricle may also
be accessed, e.g., for an annuloplasty procedure, as a part of a
surgical procedure in which local plications are formed. For
instance, the aorta of a heart may be accessed through an open
chest surgical procedure before a catheter is inserted into the
aorta to reach the left ventricle. Alternatively, suture structures
or plications elements may be introduced on a ventricular side of a
mitral valve through a ventricular wall which is accessed during an
open chest surgical procedure.
[0193] Pledgets have been described as being used in conjunction
with, or as a part of, suture structures to facilitate the growth
of scar tissue as a result of an annuloplasty procedure. It should
be appreciated, however, that the use of pledgets is optional. In
addition, although pledgets have generally not been described as
being used with clip elements which create local plications, it
should be understood that pledgets may also be implemented with
respect to clip elements. By way of example, a clip element which
includes tines may be configured such that the tines pierce through
pledgets before engaging tissue without departing from the spirit
or the scope of the present invention.
[0194] When a clip element has tines that are arranged to pierce
through a pledget before engaging tissue, the pledget may be of a
hollow, substantially cylindrical shape that enables the pledget be
delivered to a left ventricle over a guide wire positioned in the
gutter of the left ventricle. The clip element may then be
delivered by a catheter through the pledget. A substantially
cylindrically shaped, hollow pledget which is to be used with a
suture structure may also be delivered over a guide wire, and the
suture structure may then be delivered through the pledget.
Delivering the suture structure through the pledget may enable a
loop of thread that remains after the suture structure is locked
into place to remain substantially within the pledget.
[0195] The configuration of clip elements may generally vary
widely. Specifically, the shape of clip elements, the size of clip
elements, and the materials from which the clip elements are formed
may be widely varied. For instance, in addition to clip elements
that are formed from shape memory material, preloaded, or
self-locking using mechanical structures, clip elements may also be
formed from thermally expandable materials. That is, a clip may be
formed such that it is in an open or flat position when delivered
into a left ventricle. Such a clip may have an outer or "bottom"
element that has a relatively high coefficient of thermal
expansion, and an inner or "top" element that deforms under the
load generated by the outer element when heat is applied to cause
the outer element to bend. Such a clip, once bent or deformed
through the application of heat, may pierce tissue. When more heat
is applied, the clip may bend more such that tissue is engaged
between ends or sides of the clip to create a local plication. In
such a system, the inner material may be arranged to maintain its
deformed shape once heat is no longer applied, and the heat may be
applied through a catheter.
[0196] Suture structures and plication elements have been described
as being used to correct for mitral valve insufficiency. In
general, suture structures and plication elements may also be used
to essentially prevent the onset of mitral valve insufficiency.
That is, local plications may be created to effectively stem the
progression of mitral valve insuffiency be reinforcing the
perimeter of the annulus around the mitral valve.
[0197] While suture structures that include T-bars, thread, and
locking elements, and are delivered to a left ventricle using a
catheter, may be used to form discrete plications in fibrous tissue
around the mitral valve, it should be appreciated that sutures may
also be sewn into the fibrous tissue. For example, a catheter which
is inserted into the left ventricle through the aorta may be
configured to sew sutures into the fibrous tissue using mechanisms
carried by the catheter. Such sutures that are sewn into the
fibrous tissue may be sewn in any conventional orientation, e.g.,
in an arc along the perimeter of the posterior leaflet of the
mitral valve.
[0198] Suture structures that include T-bars have generally been
described as including two T-bars which are located at ends of a
thread, with a locking element and pledgets located therebetween,
as shown, for example, in FIG. 10a. The configuration of suture
structures, however, may vary widely. By way of example, a suture
structure with two T-bars may include one T-bar at one end of the
thread and a second T-bar which is located along the length of the
thread such that pulling on a loose end of the thread pulls the two
T-bars together. Alternatively, a suture structure may include more
than two T-bars.
[0199] In general, the use of a single element type to create local
plications during an annuloplasty procedure has been described. It
should be understood that in one embodiment, different element
types may be used in a single annuloplasty procedure. For instance,
both clip elements and suture elements may be used to create
plications during a single annuloplasty procedure. Alternatively,
different types of clip elements or different types of suture
elements may be used during a particular annuloplasty
procedure.
[0200] The steps associated with performing a catheter-based
annuloplasty may be widely varied. Steps may generally be added,
removed, reordered, and altered without departing from the spirit
or the scope of the present invention. Therefore, the present
examples are to be considered as illustrative and not restrictive,
and the invention is not to be limited to the details given herein,
but may be modified within the scope of the appended claims.
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