Indian Patents
Title of Invention

AN INCREMENTOR CATHETER
Abstract 5 The present invention relates to a minimally invasive method of performing annuloplasty. According to one aspect of the present invention, a method for performing annuloplasty includes creating a first plication in the tissue near a mitra1 valve of a hean, using at least a first plication element, and creating a second plication in the tissue near the mitra1 valve such that the second plication is substantially coupied to the first plication.
Full Text The present invention claims priority of U.S. Provisional Patent Application No,
60/420,095, filed October 21, 2002, which is hereby incorporated by reference in its entirety.
5 CROSS REFERENCE TO RELATED APPLICATIONS
The present invention is related to U.S. Patent No, 6,619,291 entitled "Method and
Apparatus for Catheber-Based Annuloplasty," filed April 24, 2001 and issued Septembcr 16,
2003, and to co-pending U.S. Patent Application No. 09/866,550, entitled 'Method and
Apparatus for Catheter-Based Annuloplasty Using Local Plications which are each
10 incorporated herein by reference in their entireties.
BACKGROUND OF THE INVENTION
1. Field of Invention
The present invention relates generally to techniqves For treating mitra1 valve
insufficiencies such as mitra1 valve leakage, More particularly, the present invention relates to
15 systems and methods for treating a leaking mitra1 valve in a minimally invasive manner,
2 Description of the Related Art
Congestive he an failure (CHF), which is often associated with an enlargement of the
heart, is a leading cause of death. As a result, the market far the treatment of CHF is becoming
increasingly prevalent. For instance. the trestment of CHE is a leading expenditure of Medicare
20 and Medieaid 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.
Referring ini0ially to Fig. I, the anatomy of a heart, specifically the left side of a heart,
will be described. The left side of a heart 104 inoludes 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
25 prevent regurgitation of blood back into left ventricle 112. A mitra1 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
Mitra1 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
30 serve as "tension members" that prevent the leaflets of mitra1 valve 116 from opening
indiscriminately. When left ventricle 12 contracts, cordae tendonae 124 allow the anterior
leaflet to open upwards until limited, in motion by cordse tendonae 124. Normally. the upward
limit of opening corresponds to a meeting of the anterior and posterior leaflets and the
1

prevention of backflow, Cordae tendonae 124 arise from a. columnar carnae 128 or, more
speciftcally, a musculi papillares of colunmae carnal 128.
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
5 inlerventricular septum 136 which separates left ventricle 112 from a right ventricle (not shown)
of heart 104. Trateculae 132 are generally located in left ventricle 112 below columnae camae
128.
Fig, 2a is cut-away top-view representation of mitra1 valve 116 and aortic valve 120.
Aortic valve 120 has a valve wall 204 that is surrounded-by a skeleton 208a of fibrous material
10 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 mitra1 valve 116. Mitra1 valve 116 includes an anteriot leaflet
212 and a posterior leaflet 216, as discussed above Anterior leaflet 212 and posterior leaflet
216 are generally thin, flexible membranes, When mitra1 valve 116 is dosed as shown in Fig.
15 2a), anterior leaflei 212 and posterior leaflet 216 are generally aligned and contact one anothier to-
create a seal. Alternativly, when mitrai valve 116 Js opened, blood may flow through an
opening crested between anterior leaflet 212 and posterior leaflet 216.
Many problems relating to mitra1 valve 116 may occur and these insufficiencies may
cause many types of ailments. Such problems include, but are not limited to, mitra1
20 regurgitation Mitra1 regurgitation, or leakage, is the backflow of blood from left ventricle 112
into the left atrium 106 due to an imperfect closure of mitra1 valve 116. That is, leakage often
occurs when a gap is created between anterior leaflet 212 and posterior leaflet 216.
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. POT example, a gap
25 may exist due to congenitd maiformations, because of ischsmic disease, or because a heart has
been damaged by a previous heart atrack. A gap may also be crested 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
30 generally docs not stretch. As shown in Fig. 2b, a gap 220 between anterior leaflet 212 and
stretched posteriot leaflet 216 is created when wall 134 stretches. Hence, due to the existence
of gup 220, mitra1 valve 116 is unabte to dose properly, and moy begin to leak.
Leakage- through mitra1 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
35 through mitra1 valve 116, or general mitra1 insufficiency, is often considered to be a precursorto
CHE. There are generally different levels of symptoms associated with heart failure. Such
2

levels are classified by the New York Heart Association (NYHA) functional classification
system. The levels range from a Class level which is associated with an asymptomatic patent
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
5 cardiac insufficiency even at rest. In general, correcting for mitra1 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.
Treatments used lu correct for mitra1 valve leakage or, more generally, CHF, are
10 typically highly invasive, open-heart surgical procedures. Ventricular assist devices such as
artificial hearts may be imiplanted in a patient whose own heart is failing. The implantation af 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
15 ventricular assist device. While induncing the risks of blood clots associated with the ventriculer
assist device is desirable, anti-coagulant therapies may increase the risk of uncontrollable
bleeding in a patient, e.g., as a resull of a fall, which is not desirable.
Rather than impianting a ventricular assist device, bi-ventricular pacing devices similar
to pace makers may be implanted in some cases eg., cases in which a heart beats inefficiently in
20 a particular asynchronous manner. While the implantation of a bi-ventricular pacing devica 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.
Open-heart surgical procedures which are intended to correct for mitra1 valve leakage,
specifically. involve the implantation of replacement valves. Valves from animals, e,gr, pigs,
25 may be used to replace a milral valve 116 in a human. While the use of a pig valve may
relatively successfully replace a mitra1 valve, such vaves 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 10 replace a leaking mitra1 valve, However, when a mechanical valve is
implanted, there is an increased risk of thromboembolism. and a patient is gensraily required to
30 undergo extended anti-coagulant therapies.
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.
35 One open-heart surgical procedure that is particularly successful in correcting for mitra1
valve leakage and, in addition, mitra1 regurgitation, is an annutoplasty procedure. During an
3

annuloplasty procedure, an annuloplasty ring may be implanted on the mitra1 valve to cause the
size of a stretched mitra1 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 mitra1 valve That is annuloplasty ring 304 is
5 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 DACROM mesli covering.
In order for annuloplasty ring 304 to be implanted, a surgeon surgically attaches
annuloplasty ring 304 to the mitra1 valve on the arrial side of the mural valve. Conventional
methods for installing ring 304 require open-heart surgery which involve opening a patient's
10 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 lop portion of mitra1
valve 316. In. sewing annuloplasty ring 304 onto mitra1 valve 316, a surgeon generally
alternately acquires a relatively large amount of tissue ftom mitra1 tissue, e.g., a one-eighth inch
bile of tissue, using a needle and thread, followed by a smaller biti from annuloplasty ring 304,
15 Once a thread has loosely coupled annuloplasty ring 304 to mitra1 valve tissue, annuloplasty ring
304 is slid onto mitra1 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.504 and the
thread which binds annuloplasty ring 304 to the mitra1 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
20 closed off. After the mitra1 valve is shaped by ring 304, the anterior and posterior leaflets 320,
318 will reform lo create a new contact line and will enable mitra1 valve 318 to appear and to
function as a normal mitra1 valve.
Once implanted, tissue generally gnows over annuloplasty ring 304, and a line of contact
between annuloplasty ring 304 and mitra1 valve 316 will essentially enable mitra1 valve 316 to
25 appear and function as a normal mitra1 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.
A second surgical procedure which is generally effective in reducing mitra1 valve leakage
30 involves placing a single edge-to-edge suture in this mitra1 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 anea at approximately the
center of a gap 408 defined between an anterior leaflet 420 and a posterior leaflet 418 of a mitra1
valve 416. Once stitch 404 is in place, stitch 404 is pulled in to form a suture which holds
35 anterior leaflet 420 against posterior leaflet 418, as shown. By reducing the size of gap 408, the
amount of leakage through mitra1 valve 416 may be- subsantially reduced.
4

Although the placement of edge-to-edge stitch 404 is generally successful in teducing the
amount of mitra1 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 biaod pressure causes the heart to dilate
5 outward, and may pul 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 edgt-to-edge stitch 404 may become undone, or tear
mitra1 valve tissue.
Another surgical procedure which reduces mitra1 valve leakage involves placing sutures
10 along a mitra1 vaive annulus around the posterior leaflet. A surgical procedure which places
sutures along a mitra1 valve with be described with respect to Fig. 5b. Sutures 504 are formed
along an annulus 540 of a mitra1 valve 516 around a posterior leaflet 518 of mitra1 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
15 546 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.
The placement of sutures 504 along anuulus 540 in addition to the tightening of sutures
20 504, is generally successful in reducing mitra1 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.
While invasive surgical procedures have proven to be effective in the treatment of mitra1
valve leakage, invasive surgical procedures often have significant drawbacks, Any time a
25 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 l classification, may choosy not to have corrective
30 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 mitra1 valve may not undergo surgery.
Therefore, what is needed is a minimally invasive treatment for mitra1 valve leakage.
Specifically, whnt is desired is a. method for reducing leakage between an anerior leaflet and a
35 posierior leaflet of a mitra1 valve that does not require conventional surgical intervetion.
SUMMARY OF THE INVENTION
5

The present invention relates to a non-invasive method of performing annuloplasty.
Performing an annuloplasty.on a mitra1 valve by accessing the left ventricle of the heart as for
example using a catheter, enables complicated surgical procedures to be avoided when treating
mitra1 valve leakage. Avoiding open-heart surgical procedures generally makes annuloplasty
5 more accessible to patients who may benefit from annuloplasty As mitra1 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 mitra1 valve, may greatly improve the quality of life,of
many patients who might rot be suitable for invasive annuloplasty procedures.
10 According to one aspect of the present invention, a method for performing annuloplasty
includes creating a first plication in the tissue near a mitra1 valve of a heart, using at least a first
plication element, and creating a second plication in the tissue near the mitra1 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
15 left ventricle. and engaging the First plication element to the tissue near the mitra1 valve.
Engaging the first plication element includes causing the first plication element to substantrially
pass through a portion of the tissue to substantially anchor the first plication element to the tissue
near the mitra1 valve.
According to another aspect of the present invention, a method for performing
20 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 mitra1 valve of the hear using the catherer arrangement by causing
the first anchor arrangement to substantially pass through the tissue to substantially anchor the
25 first anchor arrangement to the tissue near the mitra1 valve Finally, the method includes
creating at least a first plication and a second plication using the first anchor arrangement.
In accordance with still another embodiment of the present invention, a method for
performing annuloplasry 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
30 substantially anchoring the first portion of the catheter arrangement to tissue near a mitra1 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 mitra1 valve of the heart using the second portion of the catheter
arrangement, Substantially engaging the first anchor includes causing the first anchor to
35 substantially pass through n portion of the tissue to substantially anchor the first anchor to the
tissue near the mitra1 valve using the second portion of the catheter arrangement. In one
6

embodiment. substantially anchoring the first portion of the catheter arrangement to tissue near
the mitra1 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 mitra1 valve.
These and other advantages of the present invention will become apparent upon reading
5 the following detailed descriptions and studying the various figures of the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention may best be understood by reference to the fallowing description taken in
conjunction with the accompanying drawings in which:
Fig. 1 is a cross-sectional front-view representation of the left side of a human heart.
10 Fig. 2a is a cut-away top-view representation of the mitra1 valve and the aortic valve of
Fig, 1
Fig, 2b is a cut-away representation of a stretched mitra1 valve and an aortic valve.
Fig. 3 is a representation of an annular ring that is suitable for use in performing a
conventional annulop1asty procedure.
15 Fig. 4 is a representation of a mitra1 valve and an aortic- valve after the annular ring of
Fig. 3 has been implanted.
Fig. 5a is a representation of a mitra1 valve and an aortic valve after a- single edge-to-edge
suture has been applied to reduce mitra1 regurgitation.
Fig. 5b is a representation of a mitra1 valve and an aortic valve after sutures along a
20 mitra1 valve annulus have been applied to reduce mitra1 regurgitation.
Fig. 6a is a representation of a delivery tube and a J-catheter in accordance with an
embodiment of the present invention.
Fig. 6b is a cut-away front view of the left side of a heart in which the delivery tube and
the J-catherer of fig, 6a have been inserted in accordance with an embodiment of the present
25 invention.
Fig. 7a is a representation of a catheter assembly in accordance with an embodiment of
the present invention.
Fig 7b is a cross-sectional representation of the catheter assembly of Fig, 7a in
accordance with an embodiment of the present invention.
30 Fig. 7c is a cut-a way top-view representation of a left ventricle in which the gutter
catheter of Figs. 7a and 7b has been positioned in accordance with in embodiment of the present
invention.
Fig. 8 is a cu1-away top-view representation of a left ventricle in which a guide wire-has
been positioned in accordance with art embodiment of the present invention.
7

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.
Fig. 9b is a cut-away top-view representation of a left ventricle of the heart in which
5 local plication suture structures which are coupled have been implanted in accordance with an
embodiment of the present invention.
Fig. 10a is a representation of a suture structure after T-bars have been introduced to an
atrial side of a mitra1 valve through fibrous tissue near the mitra1 valve in accordance with an
embodiment of the present invention.
10 Fig. 10b is a representation of the suture structure of Fig, 10a after the T-bats have been
engaged to the fibrous tissue in accordance with an Embodiment: of the present invention.
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.
Fig. 12a is a representation of a suture structure which includes a locking element with a
15 resorbable component in accordance with an embodiment of the present invention.
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.
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.
20 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.
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.-.
Fig. 13c is a representation of a third catheter assembly which is suitable for use in
25 delivering and implementing a suture structure tn accordance with an embodiment of the present
invention.
Figs. 14a and 14b are a process flow diagram which illustrates the steps associated with
ont method of per forming annuloplasly using a suture structure and a catheter in accordance
with an embodiment of the present invention-
30 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.
Fig 16a is a representation of a local plication element which has spring-like
characteristies in accordance with an embodiment of the present invention.
8

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.
Fig, 16c is a representation of the local plication element of Fig. 16b after tips of the
5 local plication element pierce through tissue in accordance with an embodiment of the present
invention.
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.
10 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.
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.
Fig- 18a is a representation of a first self-locking clip which is suitable for use in forming
15 a local plication in accordance with an embodiment of the present invention.
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.
Fig. 19 is a representation of a plication-creating locking mechanism in accordance with
aa embodiment of the present invention.
20 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.
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
25 embodiment of the present invention.
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
Fig. 20d is a representation of the plication-creating locking mechanism of Fig. 20c after
30 a local plicaiion has been formed in accordance with an embodimeni of the present invention.
Figs. 21a und 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.
Fig. 22a is a cut-away front view of the left side of a heart in which an L-shaped catheter
35 has been inserted in accordance with an embodiment of the present invention.
9

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
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
5 invention.
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.
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.
10 Fig, 24 a is representation of a portion of a wire with a helical coil which may be used us
a temporary anchor in accordance with an embodiment of the present invention.
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.
Fig. 25 is a representation of an anchor which is deployed and anchored into tissue in
15 accordance with an embodiment of the present invention.
Fig, 26a is. a representation of a portion of an increment catheter in a closed
configuration which is positioned overs tail of an anchor in accordance with an embodiment of
The present invention.
Fig- 26b is a representation of a portion of an incrementor catheter in an open
20 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 embodoment of the present invention.
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.
25 Figs. 28a-t 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.
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.
Fig. 29b is a cut-away front view of the left. side of a heart in which a hook catheter is
30 positioned beneath a mitra1 valve in accordance with an embodiment of the present invention.
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.
Fig, 29d is a cut-away front view of the left side of a heart in which a book catheter
which carries a permanent anchor is inserted in accordance with an embodiment of the present
35 invention.
10

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
Fig. 29f is a cut-away front view of the left side of a heart in which an incrermentor
catheter has been inserted in accordance with an embodiment of the present invention,
5 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.
Fig. 29h is a cut-away front view of the left side of a heart in which two pemanent
anchors and a locking device or locker have been inserted in accordance with an embodiment of
the present invention.
10 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
Invasive, open-heart surgical procedures are generally effective in the treatment of mitra1
15 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. Ay such, open-heart surgical procedures to correrct mitra1 valve leakage or, more
generally, mitra1 valve insufficiency, are not suitable for many patients who would likely benefit
20 from reducing or eliminating the mitra1 valve leakage.
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 mitra1 valve.
25 i.e., under a mitra1 valve. Catheters may also be used to couple the plication implants to fibrous
tissue associated with the skeleton of the heart around the mitra1 valve.
The use of catheters to perform an annuloplasty procedure by delivering and engaging
plication implants or structures enabled the annuloplasty procedure to be performed without
open-heart surgery, and without a bypass procedure. Recovery time associated with the
30 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 mighl previously not have received treatment for mitra1
valve leakage, e.g.. frail patients and asymptomatic patients, may choose to undergo catheter-
based annuloplasty.
35 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 Horta. Inserting the delivery tube and the
11

J-catheter through the aorta ensiles the left ventricle of the heart to be reached substantially
without conning into contact with trabeculae or the eordae tendgnae in the left ventricle, fig- 6a
is a diagrammatic representation of a. delivery tube and a J-calheter m accordance with an
embodiment of the present invention. Delivery tube 604 has a substantially circular cross
5 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.
In general, delivery tube 604 is an elongated body which may be formed from- a flexible,
durable, biocompatable material such as nylon, urethane, or a blend of nylon and urelhare, e.g.,
PEBAX®. Likewise, J-catheter 608 which is also an elongated body, may also be formed from
10 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 facilituce the positioning of a gutter catheter, as will be described below
with respect to Figs. 7a-c.
15 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 presem invention. As shown, after
delivery tube 604 and J-catheter 608 are effectively "snaked" or inserted through a femoral
artery, portions of delivery mbe 604 and of J-catheter 608 are positioned within an aorta 620 of a
heart 616. A tip 62G of J-catheter 608 which is substantially oriented at a right angle from the
20 body of J-catheter 6O8 and an end of delivery tube 604 are oriented such that they pass through
an aortic vafve 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 lip of the catheter along wall 632. In one
25 embodiment, tip 626 is oriented such that it is positioned approximately just below a mitra1
valve 628 on the ventricular side of mitra1 valve 628.
Once, positioned wilhin left venricle 624, J-catherer 608 may be roated 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
30 that is effectively defined between a plane associated with papillary muscles 640, a plane
associated with the posterior leaflet of mitra1 valve 628. cordae tendonae 642, and wall 632. A
"gutter" is located in such an area brregion and more specifically, is positioned subsiantially
right under mitra1 valve 628 where there is a relatively infiignificani amount of trabeculae.
With reference to Figs. 7a-7c. 2 gutter catheter will be described in accordance with an
35 embodiment of the present invention. A gutter catheter 704, wnich is part of a catheter assembly
702 as shown in Fig. 7a, is arranged to be extended through J-catheter 626 such that gutter
12

catheter 704 may be steeted within a left ventricle just beneath a mitra1 valve. Gutter catheter
704, which may include a balloon tip (not shown), is typically formed from a flexible material
such as nylon, arethane, of PEBAX®. In one embodiment, gutter catheter 704, which is
stcerable, may he formed using a shape memory material.
5 As shown in Figs 7a and Fig. 7b, which represents a crass section of catheter assembly
702 token at a location 710, gutter catheter 704 h 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.
10 Referring next to Fig. 7c. the positioning of gutter catheter 704 within a left Ventricle, of
the heart will be discribed 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 case of illustration and case of discussion. For instance, the distance
between a wall 724 of left ventricle 720 and a mitra1 valve 728 has been exaggerated. In
15 addition, it should also be appreciated that the positioning of delivery tube 604 and, hence, J-
catheier 608 and guner catheter 704 within aortic valve 732 may vary.
Gutter catheter 704 protrudes through tip 626 of J-catheier 608. and through stcering,
essentially forms an arc shape similar to that of mitra1 valve. 728 along the contour of a wall 724
of left ventricle 720 just beneath mitra1 valve 728, i.e.. along the gutter of left ventricle 720.
20 Wall 724 of left ventricle 720 is relatively smooth just beneath mitra1 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 he navigated within left
ventricle 720 along wall 724 substantially wrthorn being obstructed by trabeculae or ordae
tendemae.
25 Gutter catheter 704 generally includes an opening or lumen (not shown) that is sized to
accommodate a guide wire through which a guide wife 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
30 the guide wire to be substantially anchored against wall 724. Fig. 8 is a diagrammatic top-view
but-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 thai various
features have been exaggerated for ease of discussion. A guide wire 802 is positioned along
35 wall 724 of left venrride 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
13

with J-catheter 708, are withdrawn from the body of the patient It should he appreciated that
delivery tube 604 typically remains positioned within the aorta after guide wire 802 is anchored
to wall 724.
Guide wire 802 which may be formed from a material such as stainless steel or a shape
5 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
10 structures by pushing the local plication structures substantially against the fibrous tissue around
the mitra1 valve.
Forming local plications causes bunches of the fibrous tissue around the mitra1 valve to
be captured or gathered. Thereby causing dilation of the mitra1 valve to be reduced. In general,
the local plications are discrete plications formed in the fibrous tissue around the mitra1 valve
15 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-
liave 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 mitra1 valve
916. e.g, an annulus of rnrtral vatve 916. Typically, the tissue in which sufure structures are
20 implanted is fibrous tissue 940 which is located substantially around mitra1 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.
Since T-bars 904 or similar structure8 when implanted, may cut through tissue 940,
pledgets 905 may against a veatricular side tissue 940 to effectively cushion" T-bars 904.
25 Hence, portions of T-bars 904 are positioned above mitra1 valve 916, i,e., on an atrial side of
mitra1 valve 916, whits pledgets 905 arc- positioned on the ventricular side of mitra1 valve 916.
It should be appreciated that additional or alternative pledgets may be positioned on the atrial
side of mitra1 valve 916, substantially between tissue 940 and T-bars 904. Catheters which
deliver suturs.structures 904 to an atrial side of mitra1 valve 916 fram a ventricular side of mitra1
30 valve 916 will be discussed below with respect to Figs. 13a-c.
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 rensioned together and locked against tissue 940. Locking T-bars 904a enables tissue
940 to he bunched or slightly gathered, thereby effectively constraining the size, e.g. are length,
35 of mitra1 valve 916 by reducing the an are length associated with tissue 940. In other words the
presence of T-bars 904 which cooperate with thread 907 to function substantially as sutures,
14

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 lime, scar tissue (not shown) may form over pledgets 905 and T-
bars 904.
5 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
mitra1 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 mitra1 valve leakage, then a relatively large number of T-bars 904 and, hence,
10 pledgets 905 may be used to reduce the size of gap 908 by reducing the are length of mitra1
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 mitra1 valve 916, T-bars 904 may be
implemented as plicating elements near the regurgitant jet, and as reinforcing elements away
from the negurgitant jet, e.g., to prevent progression of mitral valve disease from causing a
15 substantial gap to eventually form.
While the coupling of two T-bara 904a with thread 907a has been described, it should be
understood that the -number of T-bars 904 coatipled by a thread or threads 907 may vary. For
example, if multiple T-bjtrs 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
20 multiple T-bars 904 which are coupled by multiple threads 907 will be described. T-bars 904c
are coupled by a thread 90 7c, while T-bars 9O4d are coupled by a thread 907c. Similarly, T-bars
904e are coupled by a thread 307e. T-bar 904d' is further coupled by a thread 907f to T-bar
904c”, and T-bars 904d”" to 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.
25 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'.
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.
30 Fig. 10s and 10b are representtions of a suture structure after T- bars have been introducred to an
atria side of fibrous tissue near a mitra1 valve in accordance with an embodiment of the present
invention. For purposed 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
35 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
15

locking eletnenl 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 lightens 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
5 place.
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 ptedgets 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 fonn, and may be
10 formed from a material such as surgical, e.g., Bacron, mean. However, it should be appreciated
that pledgets 905 in 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.
Locking element 1002 may be a one-way locking element, e.g,, an element which may
15 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, II 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
20 T-bars 904 and may also be used to engage locking element 1002 will be discussed below with
reference to Figs. 13a-c.
Like locking element 1002, T-bars 904 may also he formed from a biocomparible
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 substanially any material
25 which is typically used to form sutures. Suitable materials include, but arc not limited to, silk,
prolene braided Dscron, and polytetraflouroethylene (PTFE, or GoreTex).
As mentioned above, the configuration of locking element 1002 may vary. For example,
a locking element may induces 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
30 elements of suture structurs 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.
Locking element 1102 includes solid elements 1102a and a spring element 1102b.
35 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
16

element 1102b is arranged to be held in an extended position, as shown, while a loop 1114 in
thread 1107 is puffed 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
5 1104 are properly positioned against tissue 1140, locking element 1102 may be locked to form a
plication or local bunching of tissue 1140.
In one embodiment, the formation of scar tissue on the fibrous tissue which is in
proximity to a mitra1 valve may be promoted before a plication is formed, or before the fibrous.
tissue is gathered to compensate for mitra1 valve insufficiency. With reference to Figs. 12a-c, a
10 locking element which promotes the. growth of scar tissue before a plication is fanned 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 ovennold 1202c formed over spring element 1202b is
15 coupled to thread 1207 on a ventricular side of tissue 1240.
Overmold 1202c, which may bo formed from a resorbable lactide polymer such as
PURASORB. which is available from PURAC America of Lincolnshire, illinois is formed over
spring elemcnt 1202b -while spring element 1202b is in an extended position. Overmold 1202c
is arranged to remain intact white scar tissue 1250 forms over solid elements 1202a. In one
20 embodiment, in order to facilitate the formation of star tissue, solid elements 1202a may be
formed from material that is porous or fibrous e.g., "pledget material."
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 oveimold 1202c may be tuned such that the
25 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 sear 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
30 relatively strong plication or gathering of tissue 1240.
While a loop 1314 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
35 over locking element 1202. That is a spool or similar element may be included as a part of
17

suture strucrure 1200 to enable loose thread 1207 to either be gathered within the spool or
gathered around the exterior of the spool.
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
5 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
As mentioned above, catheters may be used to deliver suture structures into a heart, and
10 to engage the suture structures to tissue around the mitra1 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
15 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 mitra1 valve. Once end 1311
20 and T-bar 1304 are located above fibrous tissue, e.g., on an atrial side, of a mitra1 valve, wire
1308 may be retracted a repositioned. After wire 1308 is repositioned, end 1311 may once agein
penetrate tissue to effectively deposit T-bar 1304 over tissue on the atrial side of the mitra1
valve.
Wire 1308 or, more specifically, end 1311 may be used to pull thread 1307 and to push
25 locking element 1302 into position against tissue near the mitra1 valve. By way of example, end
1311 may pull an 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 mitra1 valve.
In order to create additional plications wire 1308 and in one embodiment, delivery
30 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 mitra1 valve.
Fig. 13b is a representation of a second catheter which is suitable for delivering a suture
35 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
18

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 af wires 1348 pass through tissue near a mitra1 valve to deposit T-bars
5 1344 above the mitra1 valve. Once T-bars 1344 are deposited, tips 1351 may be used to pull T-.
bars 1344 against the tissue, as well as lo lock looking element 1342 against an opposite side of
the tissue. By way of example, lip 1351b may be configured to pull on thread 1347 while tip
1351a pushes against locking element 1342,
With reference to Fig. 13c,a catheter arrangement which may deploy T-bais from its tip
10 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 fer ease of illustration
Specifically, catheter 1360a carries T-bar 1364a at its tip, while catheter 1360b carries T-bar
1364b at its tip. A Lhrcad 1367 couples T-bars 1364 together such that locking element 1362
15 through which thread 1367 passes may lock T-bars 1364 substantially against tissue of a heart.
In one embodiment, catheter arrangement 1360 may require the use of two guide wires lo
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 I 360a and catheter
1360b may be guided through the gutter of the heart through the use of a single guide wire.
20 Catheter 1360a is configured to push T-bar 1364a through tissue near the mitra1 valve of
lite heart. and to release T-bar 1364a once T-bar 1364a is located on an atrial side of the mitra1
valve. Similarly, catheter 1360b is configured to push T-bar 1364b through the tissue, and to
release T-bar 1164b. 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.
25 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 arts positioned on the atrial side of
the mitra1 valve, catheter 1360 may be used to pull on thread 1367 and to push on locking
element 1362.
With reference to Figs. 14a and 14b, the performance of an anouloplasty procedure using
30 a catheter-baaed system which implants suture structures in tissue near a mitra1 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 cube and a,1-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
35 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 tibe and a
19

J-oathetcr were described above with respect to Figs 6a and 6b. As will bs 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 1eft ventricle.
Once the delivery tube and the J-catheter are positioned within the left ventricle, a gutter
5 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 mitra1 valve. Specifically, the
gutter catheter may be positioned in the space in the left ventricle between the mitra1 vajve and
the musculi papillares or papillary muscles The gutter catheter often has a tip that is steerable
10 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.
In step 1412, a guide wire with an anchoring feature may be delivered through the gutter
15 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
20 position within the left ventricle.
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
25 step 1436. In one embodiment the T-bar assembly delivery catheter carries an uninflated
balloon.
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
30 delivery catheter, serves to enable substantially any catheter which uses ihe guide wire as a track
to be pressed up against the fibrous tissue around the mitra1 valve Generally the inflated
balloon substantially occupies the space between the mitra1 valve and the papillary muscles. In
one embodiment, more than one balloon may be inflated in the left ventricle.
Once the balloon is inflated in step 1428. The T-bar assembly delivery catheter
35 effectively delivers T-bars or similar mechanisms pledgets and thread which are arranged to
attach or otherwise couple with an annulus of the mitra1 valve. e.g., the fibrous tissue of the
20

skeleton around the mitra1 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 mitra1 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
5 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.
10 Once the plication is created in step 1440, the balloon is generally deflated in step 1442.
The T-bar assembly delivery cathetere 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
15 deliver caether. which carries a T-bar assembly or suture, structure, is reinserted rate the
femoral artery.
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
20 tube is removed, the annuloplasty procedure is completed.
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 mitra1 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
25 with an embodiment of the present invention Local plication elements 1522 are effectively
implanted in fibrous tissue 1540 around portions of a mitra1 valve 15116 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
30 plication elements 1522, which are generally mechanical elements reduce ihe size of the mitra1
valve annul us 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,
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
35 or deformable metallic elements which have shape memory characteristics. Alternatively, each
local plication element 1522 may be formed from sepaiate pieces which may be physically
21

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 mitra1 valve. When
5 delivered, as for example- through a catheter, dement 1622 is in a substantially folded, closed
orientation, as shown in Fig. 16a. In other words dement 1622 is in a closed configuration that
facilitates the delivery of element 1622 through a catheter. After an initial compressive force is
applied at comers 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
10 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 1040 to he gathered between lines 1609
and, as a result causes a plication 1630 to be formed, as shown in Fig. 16d, In one embodiment,
15 the catheter (not shown) that delivers element 1622 may be used to apply forces to element
1622.
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
20 is formed from a shape memory material in accordance with an embodiment of the present
invention. A clip 1704 which may be fanned 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
25 sides 1708 of clip 1704 to maintain clip 1704 in an expanded state.
Once tips 1706 of clip 1704 are pushed through the fibrous lissue near the mitra1 valve of
the heart such that tips 1706 are positioned on an a trial side of the mitra1 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 shovvn in Fig. I7b, In its rest
30 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
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
35 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
22

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.
5 Tine 1806 and tine 1808 first pierce tissue 1830, e.g., the tissue of in annulus of a mitra1
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 0806 and tine 1808 in a closed position
10 such that tissue 1830 is gathered to form a local plication results.
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 Jock 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
15 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.
20 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 thai tip 1856 and tip 1858 are
effectively pierced through fibrous tissue 1880 near the mitra1 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
25 1870b away from tapered neck 1854, slider 1862 forces dp 1856 and lip 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 dip element 1850,
thereby creating a local plication.
In ono embodiment, when slider 1862 is in a closed position such that tip 1856 and tip
30 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, inoie specifically, slider
1862, at leasts top surface of slider 1862 tnay be covered with a pledget material, e.g..a mesh
which supports the growth of scar tissue therethrough.
Locking elements which create local plications may include elements which have two or
35 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
23

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.
5 A cable tie portion 2010 of looker 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 lo 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
10 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
The operation of locking element 2000 will be descrived with respect to Figs. 20a-d in
accordance with an embodiment of the present invenrton. As shown in Fig. 20a, receiver piece
2002 and locker piece 2004 may be delivered substantially beneath fibrous tissue 2050 near a
15 mitra1 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 lines 2006 such that tines 2006 remain in an effectively undeployed, e.g., partially
bent or folded, position while being delivered by ths Catheter.
Once receiver piece 2002 and lacker piece 2004 are positioned under tissue 2050 near a
20 location where a plication is to be formed, forces are applied to receiver piece 2002 and locker
piece 2004 lo 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 ope 2058. tinss 2006 "open," or deploy in order to pierce tissue 2050.
25 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 2003 when bevel a 2012 come into contact. When
30 bevels 2012 come into contact, lines, 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 recei ver piece 2002 and locker piece 2004 together, the catheier which
delivered receiver piece 2002 and locker piece 2004 may he removed from the left ventricle.
Referring next to Figs. 2la and 21h, an annuloplasty procedure which uses a catheter
35 based system to create local plications in tissue near a mitra1 valve using discrete elements will
be described in accordance, witt an. embodiment of the. present invention. After a patient is
24

prepared, an annulaplasty procedure 2100 may begin with the insertign 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-catheeer 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
5 effectively run against a gutter of the wall of the left ventricle, e.g., between the mitra1 valve and
the papillary muscles. The gutter catheter often has it tip that is steerable and flexible.
In step 2112, a guide wine 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
10 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.
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
15 plication element and. in one embodiment, is arranged to engage the plication element to the
fibrous tissue arpund the mitra1 valve is inserted through the femoral artery into the left ventricle
over the guide wire in step 2132. The piication 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
20 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.
25 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 styp 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
30 determined that additional local plications are to be created, process flow returns to step 2132 in
which the plication element delivery catheter, which earnest another plication element, is
reinserted into the femoral artery.
Alternatively, if it is determined in step 2142 that there are no more local plication to be
created, then the indication is that a sufficient number of local plications have already been
35 created. Accordingly, the guide wire may be removed in step 2148. and the delivery tube may
25

be removed in step 2152, After the delivery tube is removed, the annuloplasty procedure is
completed.
A catheter which may enable an orthogonal access to a mitra1 valve may enable the
catheter to be more accurately positioned underneath the mitra1 valve. As discussed above, a
5 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 mitra1 valve. One catheter which may be less likely to
become at least partially tangled in trabeculae, while also enabling an orthogonal access to a
10 mitra1 valve, is an L-shaped catheter, which is shown in Fig. 22a. An L-shaped catheter
arrangement 2200, which includes a deliver 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-eatheter 2202 to maintain an "I." shape when passed through an
aortic valve 2205 into a left ventricle 2204, After delivery tube 2201 and L-shaped catheter
15 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.
Tip 2208 of L-shaped catheter 2202 may be extended in a straight orientation sueh that
lip 2208 effectively forms an "L" with respect to delivery tube 2201 and the remainder of L-
20 shaped catheter 2202. in one embodiment, as tip 2208 is extended under a mitra1 valve 2212 a
siring 2210 or another part, e.g., a wire, that may he 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 mitra1
valve 2212, as shown in Fig. 22c.
25 The use of string 2210 to pull on lip 2208 allows in cooperation with extending L-
shaped catheter 2202, tip 2208 to be moved beneath mitra1 valve 2212 into desired positions.
Hence, desired locations beneath mitra1 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
30 approximately ninety degree curve.
L-shaped catheter 2202 may be used to create plications in mitra1 valve 2212 using a
variety of different methods. Specifically, tip 2208 of L-shaped catheter 2202 may be
temporarily fixed in a poftilion beneath mitra1 valve 2212, e.g., tn a gutter of the heart, during a
process of creating a plication in mitra1 valve 2212. In. one embodiment, suction may be used to
35 gather a portion of tissue near mitra1 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
26

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, swction may be used to secure
or firmly anchor tip 2208 against mitra1 valve 2212 such that an anchor for a plication may be
deployed with improved accuracy. When tip 2208 is anchored into tissue near mitra1 valve
5 2212, an anchor for a plication or a temporary anchor may be more precisely placed, as the
position of tip 2208 is effectively fixed.
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 mitra1 valve in
accordance with an embodiment of the present invetior. As shown in Fig. 23a, a tip 23O8 of a
10 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 he 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
15 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 mitra1 valve
generally allows plication elements to be more accurateiy deployed using the catheter.
In lieu of using suction to anchor the tip area of a catheter to tissue near a mitra1 valve, a
wire with a toil which may be extended through a catheter such that the wire may be temporarily
20 anchored into tissue near the mitra1 valve such that other catheters may irack 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
25 temporary anchor that is anchored into tissue near a mitra1 valve in accordance with an
embodiment of the present invention. A wire 2430 with a coiled tip 2432. as shown in Pig. 24a,
may be cxtended through a catheter (not shown) white a tip of the catheter may, in one
embodiment, effectively be anchored against tissue near a mitra1 valve. Wire 2430 may be
inserted in a catheter (not shown) such that a longitudinal axis of wire 2430 is parallel to a
30 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 human that is coaxial with the center of the helical tip to enable a T-bars
35 that is pushed down the lumen to pass through the center of the helix as the T-bar is effectively
27

forced Foiled 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. g., the catheter may include a coiled tip
A wire 2430 with a coiled tip 2432 may generally be used as a temporary anchor which
may remain coupled to tissue sven after a catheter through which wire 2430 was deployed is
5 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.
In general, temporary fixation is a relatively reversible process. By effectively
lemporarily fixing or anchoring a catheter or a coiled tip of a wire against mitra1 valve tissue or
10 tissue near a mitra1 valve, it is relatively easy to position, release, and re-position the wire and,
hence, a catheter that traces 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.
15 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.
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
20 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 toupled to a tethra or a tail 2500, is deplyed
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
25 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
30 previously anchored into position by guiding a catheter over a temporary anchor (not shown).
An incrementor catheter may use tail 2500 as a guide over which the incrementor
catheter may be positioned. Art incrementor catheter, as shown in Fig. 26a, may generally
include two sections. A first section 2602 of art incrementor catheter 2600, may be inserted over
tail 2500. In one- embodimenl, first section 2602 may be used to insert anchor 2504, e.g.._ when
35 incrementor catheter 2600 is configured as an L-shaped catheter.
28

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. 26 b The
positioning of first section 2602 over tail 2500 enables first section 2602 to be temporarily fixed.
5 With first section 2602 being temporarily fixed, second section 2604 may be controlled such that
a lip 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.
Additionally, when first section 2602 is temporarily fixed, the position, of first section
2602 may be maintained for enough time to pet form substantially all desired tests and to
10 withstand forces associated with the desired test. Further, substantially all forces associated with
the manipulation of incrementor catheter 2602.
Distance 'd' may be substantially any distanct. 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
15 used to deploy either a temporary or permanent anphor (not shown), second section 2604 is
effectively a working lumen of incrementor catheter 2600.
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.t contrast agents for
20 fluoroscopy or thicrospheres for ultrasound, may increase contrast and promote visibility.
Typically, Such injections may be into a ventricular space, within mitra1 valve tissue, or in
through the mitra1 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,
25 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 2004 of incrementor catheter 2600 of
Fig. 26b, are separated by distance 'd.' Each anchor 2504, 2704 has a tail section, i.g.. tail 2500
and a tail 2700, respectively. which, after incrementor catheter 1600 of Fig. 26b is withdrawn
30 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.
In general, a daisy chain of plications maybe created using an incrementor catheter
That is the incrementor catheter may be used to anchor a series of anchors which are each
35 substantially separated by a distance 'd. Once a daisy chain of anchors is in place in mitra1
valve tissue, pairs of the anchors may effectively be tied off to create a series or a daisy chain of
29

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 mitraJ valve annulua or tissue near a mitra1
5 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 28O2a 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 intrementor
cathstsr.
10 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 plicalion 2820 to be effectively created. Tail 2806b remains
untritnmed, us second anchor 2802b is arranged to be included in a second plication of a daisy
15 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.
A locker 2810b may be delivered over tail 2806b and tail 2806c, and tail 2806b may be
20 tensioned. lockedr and trimmed as shown in Fig. 28e. When lail 2806c is tensioned, a second
plication 2830 is created, as shown in Fig, 28f. it should be appreciated that if tait 2806 is also
locked and trimmed, then a daisy chain of two plications2820. 2830 is completed.
Alternatively, if imore 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
25 plications.
Instead of using an L-shaped catheter to create anchor points substantially any other
suitable catheter may be used to access tissise near a mitra1 valve or a mitra1 valve annulus e.g.,,
to achieve a substantially orthogonal access to mitra1 valve tissue. In one embodiment, a
suitable catheter may be a hook catheter which effectively includes an approximately 180 degree
30 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 tenninus of a curved portion
2903 of hook catheter 2900. is inserted through an aortic valve 2904 into a left ventricle 2906.
Once, hook catheter 2900 is positioned or, more sptcifically, once tip 2902 Is positioned
35 near mitra1 valve tissue 2908, a string 2910 which may be coupled 10 tip 2902 as shown in Fig.
29b may be pulled on or tensionsd and slackened, as appropriate, to enable tip 2902 to be
30

positioned in a desired location with respect to mitra1 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 axilly translatable. By allowing string 2910 to enable tip 902 to be positioned in a desired
location, look catheter 2900 may effectively be considered to be a deflectable or steerable lip
5 catheter. A temporary anchor, e.g., a helical coil such as helical coil 2432 of Fig. 24a, may be
anchored to mitra1 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 mitra1 valve tissue 2908 such that wire
10 2922 may serve as a guide over which a catheter, as for example either a catheter such as a book
catheter which delivers a permanent anchor Gran tncrementor catheter, which may also deliver a
permanent anchor, may be positioned.
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-
15 bar 2940 may be pushed through mitra1 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 mitra1 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.
After T-bar 2940 or, more generally, an anchor is in position, then an incremental
20 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 increnientor catheter 2930 is positioned such that a
first section 2952 of incrernentor 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
25 incremenlor 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, incremenlot
catheter 2950 may be removed from left ventricle 2906
The use of an incrementor catheter 2950 allows two T-bare, e.g., T-bar 2940 and T-har
30 2980 of Fig. 29g, to be anchored to mitra1 valve tissue 2908 such thai 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.
In order to create a plication using T-bars 2940, 2980, a locking bar 2990, as shown in
35 Fig, 29h, may be provided over tails 2942,2982 such that mitra1 valve tissue 2908 may
31

effectivefy be pinched between T-bars 2940, 2980 and Jacking bar 2990. Once a plication is
created, tails 2942. 2982 may be trimmed or otherwise cut.
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,
5 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 patienl. Ones 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
10 portion and the main portion of the catheter may be reduced to a dimension that is small enough
to prevent langing of the tip in chords or leaflets of the heart. Prolapsing of the tip may
generally occur within tht 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 defleclable, the
tip of the catheter mav he deflected or substantially actively changed into a hook shape within
15 the aorta of the heart, or within the left ventricle of the heart.
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
mitra1 valve annulus and the catheter stgment that includes the hook shape may be rotated such
that it lies against either the antetior or-posterior aspect of the aortic outflow tract, depending
20 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 far example a
medial pl location. a mid P2 location, or lareral P3 location,
25 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 lip 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 ventriple before rehooking the Jip.
30 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 slep 3120. The temporary anchor may be a
35 helical coil, eg, helical coil 2432 of Fig. 24a that is attached by applying a. longitudinal
32

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.
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
5 temporaiy anchor may be the same as methods used to confirm the location of a catheter tip, and
may also include injecting contrast or rnicrospheres into tissue or through tissue to the atrial
space above a mitra1 valve.
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
10 provide a counter-traction force for tissue engagement. Like the temporary anchor, the
permanent anchor generally includes a tail.
Once a permnent anchor is in place an incremental catheter is delivered into thu heart
in step 3180. In- general, the incrernentor 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
15 section of the incrementor catheter over the tail of the first anchor. Aftet the incrementor
catheter is delivered, the incrernentor 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 incrementod 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
20 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 it desired location.
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
25 the locker or locking devicr 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.
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,
30 steps 3180 to 3260 may generally be repealed to create a daisy chain of interlocking plications.
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
35 for mitra1 valve leakage, or mitra1 valve insufficiency, may be applied to introducing plication
elements or suture structures which correct for leakage in other valves. For instance, the above-
33

described procedure may be adapted for use in repair a leaking valve associated with a right
ventricle-
While creating local plications in fibrous tissue associated with the mitra1 valve of the
heart has generally been described, the plications may also be created in other types of tissue
5 which are near, around, in proximity to, or include the mitra1 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 mitra1 valve include tissues associated with the coronary sinus
tissues associated with the myocardium, or tissues associated with the wall of the left ventricle,
fn one embodiment, a plication may be substantially directly formed in the leaflets of the mitra1
10 valve.
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 authoring feature which is located away from the tip of
15 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.
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
20 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 mitra1 valve
through a ventricular wall which is accessed during an open chest surgical procedure.
25 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 annuloplaty procedure. it
should be appreciated, howevar, 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
30 elements. By way of example, a clip element which includes tines may be configured such that
the Lines pierce through pledgets before engaging tissue without departing from the spirit or the
scope of the present invention.
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
35 pledget he 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
34

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.
5 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
10 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 defonnel througt the
application of heat, may pierce tissue. When more heat is applied, the clip may bend more such
15 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 apptied through a catheter.
Suture structures and plication elements have been described as being used to correct for
mitra1 valve insufficiency. In general, suture structures and plication dements may also be used
20 to essentially prevent the onset of mitra1 valve insufficiency. That is. local plications may be
created to effectively stem the progression of mitra1 valve insuffiency be reinforcing the
perimeter of the annulus around the mitra1 valve.
While suture structures that include T-bans thread, and locking dements and are
delivered to a left ventricle using a catheter, maybe used to form discrete plications in fibrous
25 tissue around the mitra1 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 are along the perimeter of the posterior leaflet of the mitra1 valve.
30 Suture struchires 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
there between, as shown, tor 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
35 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.
35

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
5 procedure. Alternatively, different types of clip elements or different types of suture elements
may be usad during a particular anrtuloplasty procedure.
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.
10 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.
36

NEW CLAIMS
1. 58. An incrementor catheter comprising:
a mam catheter, and first and second distal catheter portions coupled with the
man caineter,the first and second distaj 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.
2. 59 The incrementor catheter of claim 58. wherein the elongate guide member further
comprises a guide wire.
3. 60 The incrementor catheter of claim 58, wherein the elongate guide member further
comprises a tether coupled with a tissue anchor.
4. 61 The incrementor catheter of claim 60 wherein the tissue anchor further
comprises a temporary anchor.
5. 62 The incrementor catheter of claim 60, wherein the tissue anchor further
comprises a second plication element.
37

6. 63 The incremenior catheter of claim 62, wherein the first and second plication
elements are T-bars.
7. 64 The incrementor catheter of claim 62 further comprising a locker configured to
couple the first and second plication elements together.

38

5 The present invention relates to a minimally invasive method of performing
annuloplasty. According to one aspect of the present invention, a method for performing
annuloplasty includes creating a first plication in the tissue near a mitra1 valve of a hean, using
at least a first plication element, and creating a second plication in the tissue near the mitra1
valve such that the second plication is substantially coupied to the first plication.

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Patent Number 216305
Indian Patent Application Number 00944/KOLNP/2005
PG Journal Number 11/2008
Publication Date 14-Mar-2008
Grant Date 12-Mar-2008
Date of Filing 20-May-2005
Name of Patentee MITRALIGN INCORORATED
Applicant Address 950 THIRD AVENUE, THIRD FLOOR, NEW YORK, NY 10021, U.S.A.
Inventors:
# Inventor's Name Inventor's Address
1 PAUL A. SPENCE 5818 ORION ROAD LOUISVILLE, KY 40222, U.S.A.
2 EDWIN J. HLAVKA 40 KENT PLACE PALO ALTO, CA 94301, U.S.A.
PCT International Classification Number A61M
PCT International Application Number PCT/US2003/033382
PCT International Filing date 2003-10-21
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 60/420,095 2002-10-21 U.S.A.