Note: Descriptions are shown in the official language in which they were submitted.
=
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DELIVERY DEVICES AND METHODS FOR HEART VALVE REPAIR
This application is a divisional application of Canadian Application No.
2,913,610, filed =
December 1, 2015, which is a divisional application of Canadian Application
No.
2,816,087, filed May 23, 2013, which is a divisional application of Canadian
Application
No. 2,536,412, filed September 1, 2004. =
BACKGROUND OF THE INVENTION
[0001] 1.
Field of the Invention. The present invention relates generally to medical
devices and methods. More particularly, the invention relates to devices,
systems and.
methods for enhancing cardiovascular valve repair, especially the repair of
heart valves such
as the mitral and tricuspid valves. =
[00021 In
recent years, many advances have been made to reduce the invasiveness of
= cardiac stugety. la an attempt to avoid open, stopped-heart procedures,
which may be
= accompanied by high patient morbidity and mortality, many devices and
methods have been
developed for operating on a heart through. smaller incisions, operating on a
beating heart, ,
and even performing cardiac procedures via transvascular access. Different
types of cardiac
procedures, such as cardiac ablation techniques for treating atrial
fibrillation, stenting
procedures for atherosclerosis, and valve repair procedures for :treating
conditions such as
mitral valve regurgitation have experienced significant technological
advances: In
implementing many minimally invasive cardiac surgery techniques, especially
beating-heart
techniques, one of the most significant challenges is positioning a treatment
device (or
multiple devices) in a desired location in or around the heart for performing
the procedure.
Another challenge, once a device is positioned, is to effectively deploy 'a
given treatment into
or on the target cardiac tissue.
[0003] One type of cardiac surgery which may benefit from less
invasive techniques is
heart valve repair. Traditional treatment of heart valve stenosis or
regurgitation, such as. =
mitral or tricuspid regurgitation, typically involves an open-heart surgical
procedure to
replace or repair the valve. Valve repair procedures typically involve
annuloplasty, a set of
techniques designed to restore the valve annulus shape and strengthen the
annulus.
Conventional annuloplasty surgery generally requires a large incision into the
thorax of the
patient (a thoracotomy), and sometimes a median stemotomy (cutting through the
middle, of
the sternum). These open heart, open chest procedures routinely involve
placing the patient
on a cardiopulmonary bypass machine for sustained periods so that the
patient's heart and
lungs can be artificially stopped during the procedure. Finally, valve repair
and. replacement
procedures are typically technically challenging and require a relatively
large incision
through the wall of the heart to access tlie valve.
CA 3059577 2019-10-22
[00041 Due
to the. highly invasive nature of open heart valve repair or replacement, many
patients, such as elderly patients, patients having recently undergone other
surgical
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la
CA 3059577 2019-10-22
procedures, patients with comorbid medical conditions, children, late-stage
heart failure
patients, and the like, are often considered too high-risk to undergo heart
valve surgery and
are relegated to progressive deterioration and cardiac enlargement. Often,
such patients have
no feasible alternative treatments for their heart valve conditions.
(0005] To obviate this situation, a number of devices and methods
for repairing cardiac
valves in a less invasive maruaer have been described. Some devices provide
for heart valve
repair through minimally invasive incisions or intravascularly, while Others
improve upon
open heart surgical procedures on beating hearts, stopped hearts or both. As
mentioned
above, difficulties in performing minimally invasive intracardiac surgery
include positioning
a minimally invasive treatment device in a desired location for performing a
procedure and
effectively deploying a given treatment into or on the target cardiac tissue.
'In heart valve
repair procedures, for example, it is often essential for a physician to
secure one or more
treatment devices to valve annulus tissue. Annular tissue tends to be more
fibrous than
surrounding muscular or valve leaflet tissue, thus providing a more suitable
location for
securing such treatment devices, such as anchors, to treat a heart valve.
Positioning an
anchor deliver device in a desired location adjacent the annular tissue may
often be
challenging, especially in an intravascular procedure when visualization of
the location is
[0006] Devices and methods that address these difficulties are
described in U.S. Patent Publications 2004/243227, 2004/193191, and
2005/55087 and U.S. Patent 6,986,775.
.For.example, these references describe devices and methods for exposing,
stabilizing and/or performing a procedure on a heart valve annulus, such as a
mitral valve
annulus. Many of the devices and methods previously described by the inventors
have been
found to be highly effective, but improvements are still being sought.
[0007] Therefore, it would be beneficial to have improved methods,
devices and systems
for enhancing heart valve annulus treatment procedures. Ideally, such methods,
devices and
systems would facilitate positioning of one or more devices in a left
ventricle or elsewhere
for performing a procedure on a heart valve annulus, visualizing the annulus
and/or the like.
Additionally, such methods, devices and systems would ideally be introduced
intravascularly.
At least some of these objectives will be met by the present invention.
[0008] 2. Description of the Background Art. Published U.S.
Application Nos.
2002/0156526,2003/0220685, 2004/0019378, 2004/0003819, 2004/0030382 and
2
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CA 3059577 2019-10-22
2004/0039442, and U.S. Patent Nos. 6,629,534 and 6,619,291 describe catheter-
based
methods for performing annuloplasty. Published U.S. Application 2002/0042621
describes a
heart valve annuloplasty system with constrictable plication bands which are
optionally
attached to a linkage strip. Published U.S. Application 2002/0087169 describes
a remote
controlled catheter system which can be used to deliver anchors and a tether
for performing
an annuloplasty procedure. Other patent publications of interest include
W001/26586;
US2001/0005787; US2001/0014800; US2002/0013621; US2002/0029-080;
US2002/0035361; U52002/0042621; US2002/0095167; and 1552003/0074012. U.S.
patents
of interest include 4,014,492; 4,042,979; 4,043,504; 4,055,861; 4,700,250;
5,366,479;
5,450,860; 5,571,215; 5,674,279; 5,709,695; 5,752,518; 5,848,969;5,860,992;
5,904,651;
5,961,539; 5,972,004; 6,165,183; 6,197,017; 6,250,308; 6,260,552; 6,283,993;
6,269,819;
6,312,447; 6,332,893; and 6,524,338. Publications of interest include De
Simone et at.
(1993) Am. J. Cardiol. 73:721-722, and Downing et al. (2001) Heart Surgery
Forum,
Abstract 7025.
= BRIEF SUMMARY OF THE INVENTION
[0009] Devices, systems and methods of the present invention are
generally used to
facilitate transvascular, minimally invasive and other "less invasive"
surgical procedures, by
facilitating the delivery of treatment devices at a treatment site. "Less
invasive," for the
purposes of this application, means any procedure that is less invasive than
traditional, large-
incision, open surgical procedures. Thus, a less invasive procedure may be an
open surgical
procedure involving one or more relatively small incisions, a procedure
performed via
transvascular percutaneous access, a transvascular procedure via cut-down, a
laparoscopic or
other endoscopic procedure, or the like. Generally, any procedurein which a
goal is to
minimize or reduce invasiveness to the patient may be considered less
invasive.
Furthermore, although the terms "less invasive" and "minimally invasive" may
sometimes be
used interchangeably in this application, neither these nor terms used to
describe a particular
subset of surgical or other procedures should be interpreted to limit the
scope of the
invention. Generally, devices and methods of the invention may be used in
performing or
enhancing any suitable procedure.
[00101 The present application typically describes devices, systems
and methods for
performing heart valve repair procedures, and more specifically heart valve
annuloplasty
procedures such as mitral valve annuloplasty to treat mitral regurgitation.
Devices and
=
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CA 3059577 2019-10-22
methods of the invention, however, may be used in any suitable procedure, both
cardiac and
non-cardiac. For example, they may be used in procedures to repair any heart
valve, to repair
an atrial-septal defect, to access and possibly perform a valve repair or
other procedure from
(or through) the coronary sinus, to place one or more pacemaker leads, to
perform a cardiac
ablation procedure such as ablating around pulmonary veins to treat atrial
fibrillation, and/or
the like. In other embodiments, the devices and methods may be used to enhance
a
laparoscopic or other endoscopic procedure on any part of the body, suth as
the bladder,
stomach, gastroesophageal junction, vasculature, gall bladder, or the like.
Therefore,
although the following description typically focuses on mitral valve and other
heart valve
repair, such description should not be interpreted to limit the scope of the
invention as
defined by the claims.
[001.11 That being said, the present invention generally provides
devices, systems and
methods for enhanced treatment of a cardiac valve annulus such as a mitral
valve annulus.
Methods generally involve contacting an anchor delivery device with a length
of a valve
annulus, delivering a plurality of coupled anchors from the anchor delivery
device to secure
the anchors to the annulus, and drawing the anchors together to
circumferentially tighten the
annulus. One device generally includes an elongate catheter having a housing
at or near the
distal end for releasably housing a plurality of coupled anchors. The device
may be
positioned such that the housing abuts or is close to valve annular tissue,
such as at an
intersection of the left ventricular wall and one or more _antral valve
leaflets of the heart.
Some embodiments include self-securing anchors, which may changefrom
undeployed to
deployed configurations. Anchors may be drawn together to tighten the annulus
by cinching
a tether slidably coupled with the anchors and/or by a self-deforming member
coupled with
the anchors. Another device includes a steerable guide catheter for helping
position the
anchor delivery device for treating a valve annulus.
[0012] In many cases, methods of the present invention will be
performed on a
beating heart. Access to the beating heart may be accomplished by any
available technique,
including intravascular, transthoracic, and the like. Intravaseular access to
a heart valve may
be achieved Using any suitable route or method. To perform a procedure on a
mitral valve,
for example, in one embodiment a catheter may be advanced through a femoral
artery, to the
aorta, and into the left ventricle of the heart, to contact a length of the
mitral valve.
Alternatively, access may be gained through the venous system, to a central
vein, into the
right atrium of the heart, and across the interatrial septum to the left side
of the heart to
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CA 3059577 2019-10-22
=
contact a length of the mitral valve. In either of these two types of
intravascular access, the
catheter will often easily be advanced, once it enters the left side of the
heart, into a space
defined by the left ventricular wall, one or more mitral valve leaflets, and
chordae tendineae
of the left ventricle. This space provides a convenient conduit for further
advancement of the
catheter to a desired location for performing mitral valve repair. In
alternative embodiments,
a catheter device may access the coronary sinus and a valve procedure may be
performed
directly from the sinus. Furthermore, in addition to beating heart accen",
methods of the
present invention may be Used for intravascular stopped heart access as well
as stopped heart
open chest procedures. Any suitable intravascular or other access method is
contemplated
within the scope of the invention.
[0013] According to one. aspect of the present invention, a device
for applying coupled
anchors to an annulus of a heart valve comprises: an elongate shaft having a
proximal end
and a distal end; a housing adjacent the distal end; a plurality of coupled
anchors disposed
within the housing; at least one anchor contacting member for causing the
anchors to be
delivered from the housing; and at least one actuator at or near the proximal
end of the shaft
for affecting the anchor contacting member to cause delivery of the anchors to
the valve
annulus.
[0014J In some embodiments, the elongate shaft comprises a flexible
catheter which is
advancable intravascularly to the heart. In a preferred embodiment, a flexible
elongate shaft
has a diameter of about 5 French (1.67 mm) or less and deploys anchors having
a radius,
when deployed; of about 3 mm or more. The housing itself may house any
suitable number
of anchors. In one embodiment, for example, the housing holds between 1 anchor
and 20
anchors, and more preferably about 340 anchors, and in one embodiment 10
anchors. Also
in some embodiments, the housing is sufficiently flexible to allow the housing
to conform to
the annulus. For example, the housing may conform to the annulus at an
intersection of a left
ventricular wall and one or more mitral valve leaflets of the heart. The
housing may thus be
positioned or advanced through the subvalvular space as discussed above. In
some
embodiments, the housing is coupled with an actuator for deforming the housing
to conform
it to the annulus. The housing may have any suitable configuration, but in
some
embodiments it has a cross section with a shape that is roughly semi-circular,
circular, oval,
part of an oval, a partial or complete ellipse, or the like. For example, a
housing with an
elliptical shape may sometimes be used to help ensure that an anchor
delivering surface of the
housing conies into contact with the annular tissue. In various embodiments,
the housing .
CA 3059577 2019-10-22
may have one or multiple openings for allowing egress of the anchors. In one
embodiment,
for example, the housing has multiple openings, each opening suitable for
egress of one
anchor.
[0015] In some embodiments, the housing includes a shape-changing
portion, typically a
distal portion. Such embodiments may further include a first tensioning cord
coupled with
the shape-changing portion for applying tension to the shape-changing portion
to cause it to
bend in at least a first direction. Optionally, a second tensioning cord -May
be coupled with
the shape-changing portion for applying tension to the shape-changing portion
to cause it to
bend in at least a second direction. The first direction, for example, may be
approximately a =
C-shape for conforming to the annulus and the second direction comprises an
upward or
proximal direction for applying force to the annulus. In some embodiments, the
shape-
changing portion includes multiple notches along at least one side to control
bending into a
curve which conforms to the shape of the annulus. Alternatively, the shape-
changing portion
may comprise multiple stacked segments coupled with at least the first
tensioning member to
control bending into the shape of the annulus. In other embodiments, the shape-
changing
= portion comprises a shape-memory material configured to conform to the
shape of the
annulus. In some embodiments, the shape-changing portion further comprises at
least one
lumen for introducing a fluid to cause the shape-memory material to conform to
the-shape of
the annulus. The distal portion of the housing may alternatively be coupled
with a shaped
expandable balloon for deforming the distal portion. In some embodiments, the
housing may
be coupled with an expandable member such that when the expandable member
expands, it
helps wedge, drive or press the housing against valve annulus tissue. For
example, such an
expandable member may help to wedge a housing into the corner formed by a
ventricular
wall and a valve leaflet.
[0016] As explained above, anchors of the device may have any suitable
shape, size and
properties and may be made of any suitable materials. Anchors may be self-
deforming in
some embodiments, thus having an undeployed shape when constrained in the
housing of the
delivery device and assuming a deployed shape after release from the housing.
In one
embodiment, each of the plurality of coupled anchors has a generally straight
configuration,
with two sharpened tips and a loop between the two. Upon deployment, such an
anchor may
curve, with each tip curving in an opposite direction to bite into tissue. The
loop, in turn,
may act as an eye for a tether. In another embodiment, each anchor may have a
C-shaped or
semicircular undeployed shape and an overlapping circle or key ring deployed
shape. In such
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CA 3059577 2019-10-22
an embodiment, the open ends of the C are typically sharpened, to enable the
anchor to enter
tissue of a valve annulus. As the C-shaped anchor contacts and enters the
tissue, it also
closes, and the ends overlap to form a circle or key-ring-shaped deployed
anchor. Such an
anchor may be applied such that it rests flush with the surface of the annular
tissue without
protruding sharp ends or other parts. The anchors may be made of Nitinol,
shape-memory
stainless steel, or any other super-elastic or shape-memory material.
Alternatively, the
anchors may be spring loaded or otherwise housed within the housing so as to
change from
an undeployed to a deployed shape upon release from the housing.
[0017J In
some embodiments, the anchors are slidably coupled with a tether. In such
embodiments, each of the plurality of anchors may include at least one eyelet,
with the tether
slidably passing through the eyelet of each anchor. Alternatively, the tether
may extend
, along the anchors to be positioned between the anchors and annular
tissue upon deployment.
In other embodiments, the anchors may be coupled by a self-deforming coupling
member
fixedly coupled with each anchor. For example, the coupling member (or
"backbone") may
comprise a Nitinol member having an undeployed shape approximating a straight
line and a
deployed shape of a line having multiple bends. Upon changing from the
'undeployed shaped
to the deployed shape, the coupling member may cinch the anchors to
circumferentially
tighten the valve annulus. Some embodiments may include both a tether and a
self-
deforming coupling member, with both being available to provide cinching of a
valve
annulus.
[0018I In
some embodiments, the at least one anchor contacting member comprises at
least one retractable force applying device which, when retracted proximally
relative to the
housing, sequentially contacts the anchors to apply force to the anchors such
that they exit the
housing via at least one opening in the housing. Such a force applying device,
for example,
may comprise a ball, plate, anchor, hook, plunger or the like, coupled with a
cord, wire, tether
or the like. When the tether is pulled proximally, the ball contacts the
distal-most anchor in
the delivery device and forces it out an opening in the device. When retracted
further, the
ball then contacts the next anchor, forcing it out, and so on. In alternative
embodiments, the
at least one anchor contacting member comprises at least one movable retaining
member.
For example, such a movable retaining member may comprise one or more anchor
retaining
mandrels, slidably disposed in the housing so that retracting the mandrel(s)
releases one or
more of the anchors. Sometimes, for example, two mandrels are positioned in
the housing to
retain two arms of each anchor, for example when. the undeployed shape of each
anchor is
=
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. -
approximately a C-shape or semicircle. The mandrel (or mandrels) may typically
be retracted
to release anchors one at a time, in groups, or all at once.
[0019] In some embodiments, the at least one actuator includes means
for cinching the
coupled anchors to reduce the circumference of the valve annulus. Such an
actuator may
comprise, for example, a trigger, a handle, a plunger, a squeeze-activated
device, a syringe-
grip device, a foot-operated device, or the like. Some embodiments of the
device also include
at least one expandable member disposed within the housing for pushing the
anchors out of
the housing.
[0020] in yet another aspect of the invention, a device for applying
multiple tethered
anchors to an annulus of a heart valve comprises: a flexible elongate catheter
having a distal
portion for delivering the tethered anchors, the distal portion having a cross-
sectional
diameter of about 1.67 mm or less; a plurality of tethered anchors disposed
within the distal
portion, each anchor having a radius of at least about 3 mm when deployed from
the housing; j
and at least one anehor delivery member coupled with the catheter for causing
the anchors to
be delivered from the catheter.
[00211 In another aspect of the invention, a self-securing anchor for
attaching to annular
tissue of a heart valve comprises .a super-elastic or shape-memory material
having a relatively
elongate undeployed shape allowing the anchor to be disposed within a delivery
catheter
having a cross-sectional diameter of 1.67 nun or less, and assuming a deployed
shape with a
radius of at least 3 nun Upon its release from the delivery device. Generally,
such an anchor
may have two sharpened tips of the anchor curve in opposite directions when
the anchor is
released from the delivery device. Optionally, the anchor may include an
eyelet disposed
between the two sharpened tips.
[0022] In still another aspect of the present invention, a self-
securing anchor for attaching
to annular tissue of a heart valve comprises a shape-metnory material having
an opened
arcuate undeployed shape and assuming a closed shape with overlapping ends
after release
from constraint. The undeployed and deployed shapes may be any suitable
shapes. In one
embodiment, for example, the undeployed shape is approximately a C-shape or
semicircle
having two sharpened ends, and the deployed shape is a closed circle in which
the two ends
overlap. In some embodiments, the anchor is configured to lie flush with the
annular tissue
when secured to the tissue. Any super-elastic or shape-memory material may be
used to form
the anchor, such as Nitinol Or any other suitable material.
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CA 3059577 2019-10-22
[0023] According to a further aspect of the present invention, an
anchor assembly for use
within a patient includes: a catheter-type housing, having an open interior,
constructed to be
passable through a blood vessel and into a heart; a series of tissue-
engageable anchors
removably housed within the housing, the anchors comprising a distal anchor
and a proximal
anchor within the open interior of the housing; and a tether serially coupling
the anchors to
one another. In one embodiment, at least a portion of the housing is flexible.
Such an
= embodiment may optionally further include means for urging the flexible
portion of the
housing from a first configuration to a second, radially outwardly expanded,
curved
configuration. In some embodiments, the housing is steerable.
[0024] In some embodiments, the distal anchor is fixed to the tether
and the proximal
anchor is slidably coupled to the tether. Also in some embodiments, the tether
may be
located substantially external of the catheter-type housing. In one
embodiment, the anchors
are self-forming and self-securing. In one embodiment, at least one of the
anchors comprises
a bioactive agent. Alternatively, at least one of the anchors may comprise an
electrode. For
example, such an electrode may sense at least one of impedance, temperature,
and electrical
signals. In another embodiment, the electrode comprises an energy-application
electrode to
supply energy to tissue at least one of ablation and sub-ablation amounts.
[0025] In another aspect of the present invention, an anchor assembly
for use within a
patient includes: a catheter-type housing, having an open interior,
constructed to be passable
through a blood vessel and into a heart, at least a portion of the housing
being flexible; means
for urging the flexible portion of the housing from a first configuration to a
second, radially
outwardly expanded, curved configuration; a series of tissue-engageable
anchors removably
housed within the open interior of the housing, the anchors comprising a
distal anchor fixed
to the tether and a proximal anchor slidably coupled to the tether; the
anchors being self-
forming and self-securing anchors; and a tether serially coupling the anchors
to one another.
[0026] In another aspect of the invention, an anchor device for use
within a patient
includes: an elongate housing having a longitudinal axis; a self-forming
tissue-engageable
anchor carried by and deployable from of the housing; the anchor having a
first part and a
second part, the seeond part having a tissue-piercing tip; the anchor
placeable in a relatively
straight, undeployed state generally parallel to the longitudinal axis when
carried by the
housing; and the anchor naturally assuming a curved, tissue-engaging deployed
state after
being deployed from the housing. In one embodiment, the elongate housing has
an open
interior; the anchor is carried within and deployable from the open interior;
and the housing
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CA 3059577 2019-10-22
has air opening sized for passage of the anchor therethrough when the anchor
is deployed
from the housing.
[00271 Optionally, at least a portion of the elongate housing may be
flexible. In some
embodiments, the elongate housing is steerable. In one embodiment, the anchor
comprises
the first part and at least two of the second parts extending from the first
part. In one
embodiment, for example, the second parts extend in directions generally
opposite one
another when in the deployed state. In one such embodiment, the second parts
of said anchor
have generally circular or semicircular shapes when in the deployed state.
[0028] In some embodiments, the anchor is oriented generally
perpendicular to the
longitudinal axis when in the deployed state. Also in some embodiments, the
second part of
the anchor may have a generally circular or semicircular shape when in the
deployed state. In
some embodiments, the device may further comprise a series of the anchors, the
anchors
comprising a distal anchor and a proximal anchor, and a tether serially
coupling the anchors
to one another. In some embodiments, the housing has the diametrical dimension
d and the
anchor in the deployed state has a diametrical dimension D, and the ratio of D
to d is at least
about 3.5. In other embodiments, the ratio of D to d is at least about 4.4,
and more preferably
at least about 7, and even. more preferably at least about 8.8. As mentioned
above, in some
embodiments, the anchor may comprise a bioactive agent or electrode.
[0029j In another aspect of the present invention, a tissue anchor
assembly comprises: an
anchor comprising: a basesand a resilient, self-forming, tissue-engaging
portion extending
from the base, the tissue-engaging portion comprising a tissue-piercing tip;
the tissue-
engaging portion movable between a curved, unrestrained state and a restrained
state; a
coupling element coupled to the anchor; a housing; and the anchor releasably
mounted to the
housing with the tissue-engaging portion in the restrained state, the tissue-
engaging portion
transferable from the restrained state to the unrestrained state when the
anchor is released
from the housing so that the tissue-piercing tip passing into tissue secures
the anchor to the
tissue as the tissue-engaging portion moves to the curved, unrestrained state
without any
further force applied to the anchor.
[00301 in some embodiments, the tissue-engaging portion has a
generally circular or
semicircular shape when in the unrestrained state. In some embodiments, the
tissue-engaging
portion is straightened when in the restrained state. Optionally, the anchor
may comprise first
and second of the tissue-engaging portions. For example, in one embodiment,
the first tissue-
engaging portion comprises a hook. In another embodiment, each of the first
and second
CA 3059577 2019-10-22
tissue-engaging portions comprises a hook. In such an embodiment, for example,
the hooks
may extend in directions generally opposite one another when in the
unrestrained state.
Other tissue-engaging portions may also extend in directions generally
opposite one another
when in the unrestrained state.
[0031] In some embodiments, the coupling element comprises a tether
coupled to the
base of the anchor. In one embodiment, the tether is slidably coupled to the
base of the
anchor. In another embodiment, the coupling element comprises a flaible string-
like
element. In such embodiments, the housing may comprise a tubular housing.
Optionally, the
anchor may be releasably mounted within the tubular housing. Optionally, the
device may
further include a plurality of anchors with the coupling element coupled to
each anchor. In
some embodiments, at least one anchor is slidably coupled to the coupling
element and
another of the anchOrs is fastened to the coupling element.
[0032] In another aspect of the present invention, a tissue anchor
assembly comprises: a
plurality of anchors, each anchor comprising a base and first and second self-
forming, tissue-
engaging portions extending from the base, the tissue-engaging portions each
comprising a
tissue-piercing tip; the tissue-engaging portions each movable between a
curved, unrestrained
state and a straightened, restrained state; the tissue-engaging portions each
having a generally
circular or semicircular shape when in the unrestrained state; a tether
coupled to the bases of
the anchors; at least one said anchor being slidably coupled to the tether and
another of said
anchors being fastened to the tether; a housing; and the anchors and tether
being releasably
mounted to the housing with the tissue-engaging portions in the restrained
state, the tissue-
engaging portions transferable from the restrained state to the unrestrained
state when the
anchors and tether are released from the housing so that the tissue-piercing
tips passing into
tissue secures the anchor to the tissue as the tissue-engaging portion moves
to the curved,
unrestrained state without any further force applied to the anchor. µ.
[00331 In another aspect of the invention, a tissue anchor assembly
includes: an anchor
comprising a base and a resilient, self-forming, tissue-engaging portion
extending from the
base, the tissue-engaging portion comprising a tissue-piercing tip; the tissue-
engaging portion
movable between a curved, unreStrained state and a restrained state; a
coupling element
coupled to the anchor; a housing; the anchor releasably mounted to the housing
with the
tissue-engaging portion in the restrained state, the tissue-engaging portion
transformable from
the restrained state to the unrestrained state when the anchor is released
from the housing;
and the tissue-engaging portion comprising means for pulling the anchor into
the tissue as the
11
CA 3059577 2019-10-22
tissue-piercing tip passes into tissue and the tissue-engaging portion moves
to the curved,
unrestrained state. In various embodiments, the assembly may include any of
the features
described above.
[0034] In some embodiments, the assembly may further include a
plurality of anchors
with the coupling element coupled to each anchor. In some embodiments, at
least one anchor
is slidably coupled to the cdupling element and another of said anchors is
fastened to the
coupling element. In some embodiments, the anchor pulling means coMprises
means for
storing potential energy when in the restrained state. Again, in various
embodiments the
anchor(s) may comprise a bioactive agent or an electrode. For example, the
electrode may
sense at least one of impedance, temperature, and electrical signals.
Alternatively, the
electrode may comprise an energy-application electrode to supply energy to
tissue at least
one of ablation and sub-ablation amounts.
[0035] In another aspect of the.present invention, a tissue anchor
assembly includes: a
plurality of anchors, each anchor comprising a base and a first and second
resilient, self-
forming, tissue-engaging portions extending from the base, the tissue-engaging
portions each
comprising a tissue-piercing tip; the tissue-engaging portions each movable
between a
curved, unrestrained state and a restrained state; the tissue-engaging
portions each having a
generally circular or semicircular shape when in the unrestrained state; a
coupling element
coupled to each of the anchors; a tubular housing; the anchors releasably
mounted within the
housing with the tissue-engaging portions in the restrained state, the tissue-
engaging portions
transformable from the restrained state to the unrestrained state when the
anchors are released
from the housing; the tissue-engaging portions comprising means for pulling
the anchors into
the tissue as the tissue-piereing tips pass into tissue and the tissue-
engaging portions move to
the curved, unrestrained states; and the anchor pulling means comprising means
for storing
potential energy when in the restrained state.
[0036] According to another aspect of the present invention, an anchor
device for use
within a patient includes: an elongate carrier constructed to be passable
through a blood
vessel and into a heart; a series of tissue-engageable anchors releasably
carried by the
elongate carrier, the anchors comprising a distal anchor, a first intermediate
anchor and a
proximal anchor; a tether serially coupling the anchors to one another, the
tether having a
distal end secured to the distal anchor or engageable with the distal anchor
when the tether is
pulled in a proximal direction; at least the proximal anchor being slidably
coupled to the
tether; and a separator positioned along the tether between adjacent ones of
the anchors to
=
12
CA 3059577 2019-10-22
restrict how close the adjacent ones of the anchors can come to one another
when the tether is
placed in tension.
[0037] In some embodiments, the elongate carrier comprises
a catheter-type housing
having an open interior. For example, the anchors may in some embodiments be
releasably
housed within the open interior of the housing. In some embodiments, the
adjacent anchors
are the distal and first intermediate anchors. In some embodiments, the
anchors are self-
forming and self-securing. Also in some embodiments, the separatorComprises a
generally
tubular member. In such embodiments, the tether may optionally pass through
the generally
tubular member.
[0038] In some embodiments, the separator has a textured
outer surface. Also in serne
embodiments, the separator is nonporous. Alternatively, the separator may be
porous. In one
embodiment, the porous separator comprises pores, and the pores are provided
by cutouts
formed in the separator. In an alternative embodiment, the separator may be
woven or
braided. Such a separator may be rigid in one embodiment. In some embodiments,
the
separator is effectively axially incompressible. In alternative embodiments,
the separator is
axially compressible from a first length to a second, compressed length. In
some
embodiments, the axially compressible separators are joined to one another. In
other
embodiments, the separator comprises first and second portions engaging the
tether and a
third portion connecting the first and second portions. For example, the third
portion may
extend to one side of and generally parallel to the tether.
[0039] In one embodiment, the elongate carrier has a
longitudinal axis; the anchors are
self-forming tissue-engageable anchors; the anchors each have a first part and
a second part,
the second part having a tissue-piercing tip; the elongate carrier having
openings sized for
passage of the anchors therethrough; the anchors placeable in a relatively
straight,
undeployed state generally parallel to the longitudinal axis within the
elongate carrier; and
the anchors naturally assuming a curved, tissue-engaging deployed state after
passing through
the opening in the elongate carrier. In some of such embodiments, at least a
portion of the
= elongate carrier is flexible. Also in some embodiments, the elongate
carrier is steerable. In
some embodiments, at least one of the anchors comprises the first part, and at
least two of the
second parts extend from the first part. In such embodiments, the second parts
may extend in
= directions generally opposite one another when in the deployed state. The
second parts, in
turn, may have generally circular or semicircular shapes when in the deployed
state.
13
CA 3059577 2019-10-22
[00401 In some embodiments, the anchors are oriented generally
perpendicular to the
longitudinal axis when in the deployed state. In some embodiments, each anchor
has a
generally circular or semicircular shape when in the deployed state. In one
embodiment, the
elongate carrier has a diametrical dimension d and the anchors in the deployed
state have a
diametrical dimension D, arid the ratio of D to d is at least about 3.5. In
other embodiments,
the ratio of D to d is at least about 4.4, and more preferably at least about
7, and even more
preferably at least about 8.8. In some embodiments, the elongate carrier
comprises proximal
and distal portions, the anchors being carried by the distal portion, the
distal portion being
releasable from the proximal portions, the distal portion being pierceable by
the anchors.
[00411 In another aspect of the present invention, an anchor device
for use within a
patient comprises: an elongate carrier, having a longitudinal axis,
constructed to be passable
through a blood vessel and into a heart, at least a portion of the elongate
carrier being
flexible; a series of self-forming, tissue-engageable anchors releasably
carried by the elongate
carrier, the anchors comprising a distal anchor, a first intermediate anchor
and a proximal
anchor; the anchors each having a first part and at least two second parts
extending from the
first part, each second part having a tissue-piercing tip; the elongate
carrier having openings
sized for passage of the anchors therethrough; the anchors placeable in a
relatively straight,
undeployed state generally parallel to the longitudinal axis within the
elongate carrier; the
anchors naturally assuming a curved, tissue-engaging deployed state after
passing through the
opening in the elongate carrier; the second parts having generally circular or
semicircular
shapes when in the deployed state; the anchors being oriented generally
perpendicular to the
longitudinal axis when in the deployed state; the elongate carrier having a
diametrical
dimension d and the anchors in the deployed state having a diametrical
dimension D, the ratio
of D to d being at least 3.5; a tether serially coupling the anchors to one
another, the tether
having a distal end secured to the distal anchor or engageable with the distal
anchor when the
tether is pulled in a proximal direction; at least the proximal anchor being
slidably coupled to
the tether; and a separator poSitioned along the tether between adjacent ones
of the anchors to
restrict how close the adjacent ones of the anchors can come to one another
when the tether is
placed in tension.
[0042] According to another aspect of the present invention, a device
for facilitating
placethent of one or more devices in contact with a heart valve annulus
comprises: an
elongate catheter body having a proximal portion and a distal portion; at
least one tensioning
member coupled with the proximal portion of the catheter body and extending to
the distal
14
CA 3059577 2019-10-22
portion; and at least one tensioning actuator coupled with the proximal
portion and the
tensioning member for applying tension to the tensioning member to deform the
distal
portion to allow it to conform generally to a shape of the valve annulus.
Typically, the
catheter body may be advanced intravascularly to the heart to contact the
annulus. In some
embodiments, for example, the catheter body maybe advanced through an aorta
and into a
left ventricle of the heart to contact the valve annulus.
[0043] In some embodiments, the proximal portion of the catheter-
body is relatively stiff
compared to the distal portion. Also in some embodiments, the catheter body
further
comprises a rounded, atraumatic distal tip. The catheter body may optionally
further include
at least one radiopaque portion at or near the distal tip for enhancing
visualization. The
catheter body may also .include at least one lumen extending through the
proximal and distal
portions for passing one or more fluids.
, [0044] In some embodiments, the at least one tensioning member
comprises two
tensioning members, allowing the distal portion to be deformed in at least two
different
directions. The at least one tensioning member may be made of an suitable
material, such as
but not limited to Nitinol, polyester, nylon, polypropylene and/or other
polymers. The at
least one tensioning actuator, in some embodiments, comprises a knob coupled
with the
tensioning member, wherein turning the knob in one direction applies tension
to the
tensioning member to deform the distal portion, and wherein turning the knob
in an opposite
direction releases tension from the tensioning member to return to the distal
portion to a less
deformed configuration.
[0045] Some embodiments of the device further include at least one
urging member
coupled with the distal portion of the catheter body for urging the distal
portion into contact
with the valve annulus. For example, the at least one urging member may
comprise an
expandable member for expanding within a space in a left ventricle formed by a
left
ventricular wall, at least one mitral valve leaflet and chordae tendiniae of
the heart. In an
alternative embodiment, the at least one urging member comprises at least one
magnet
coupled with the distal portion for applying attractive magnetic force between
itself and an
oppositely charged magnet disposed in a coronary sinus adjacent the valve
annulus.
[0046] Some embodiments further include a housing coupled with the
proximal end of
the catheter body, wherein the tensioning actuator is coupled with the
housing. Optionally,
the housing may further comprise at least one fluid inlet port in fluid
conununication with at
least one lumen in the elongate shaft for introducing one or more fluids into
the lumen(s).
CA 3059577 2019-10-22
[0047] In another aspect of the present invention, a system for
facilitating placement of
one or more devices in contact with a heart valve annulus includes: a shaped
guide catheter
having at least one curve toward a distal end for positioning the distal end
in a position below
the mitral valve; a steerable guide catheter passable through the shaped guide
catheter and
having a steerable distal end for advancing around a length of the valve
annulus below the
mitral valve; and a guide sheath passable over the steerable guide catheter
through the shaped
guide catheter, wherein the one or more devices are passable through the guide
sheath to
contact the mitral valve annulus. Generally, the shaped guide catheter,
steerable guide
catheter and guide sheath may have any of the various functions and features
described
above, in various embodiments.
[0048] In one embodiment, for example, the shaped guide catheter
includes a proximal
curve approximately perpendicular to a central axis of the shaped guide
catheter for bringing
the distal end of the catheter into a plane approximately parallel with a
plane of the mitral
valve and a distal curve having a radius of curvature approximately the same
as a radius of
curvature of the mitral valve annulus. In one embodiment, the steerable guide
catheter
comprises: an elongate catheter body having a proximal portion and a distal
portion; at least
one tensioning member coupled with the proximal portion of the catheter body
and extending'
to the distal portion; and at least one tensioning actuator coupled with the
proximal portion.
and the tensioning member for applying tension to the tensioning member to
deform the
distal portion to allow it to conform generally to a shape of the valve
annulus. In various
embodiment, this steerable guide catheter may have any of the features of the
catheter device
described above.
[0049] In some embodiments of the system, a distal portion of the
guide sheath is
detachable from a proximal portion of the guide sheath to remain in attached
to the valve
annulus after an annulus treatment procedure. For example, the detachable
distal portion may
comprise a tubular member comprising Dacron or the like. In some embodiments,
the
detachable distal portion is cinchable to tighten the mitral valve annulus.
[0050] In some embodiments, the system may further include at least
one urging member
coupled with at least one of the shaped guide catheter, the steerable guide
catheter and the
=
guide sheath. For example, the urging member may comprise an expandable member
for
expanding within a space in a left ventricle formed by a left ventricular
wall, at least one
mitral valve leaflet and chordae tendiniae of the heart. Alternatively, the
urging member may
comprise at least one magnet coupled with at least one of the shaped guide
catheter, the
16
CA 3059577 2019-10-22
= steerable,guide catheter and the guide sheath for applying attractive
magnetic force between
itself and an oppositely charged magnet disposed in a coronary sinus adjacent
the valve
annulus.
[0051] Any suitable device or combination of devices may be
advanced into contact with
. the mitral valve annulus in various embodiments. In some embodiments, for
example, the
system includes an anchor delivery device passable through the guide sheath to
contact and
apply coupled anchors to the mitral valve annulus. The system may additionally
or
alternatively include a visualization device passable through the guide sheath
to facilitate
visualization of the mitral valve annulus. For example, the visualization
device may
comprise, but is not limited to, an ultrasound device, a camera, an endoscope
or a fiber optic
device.
[0052] According to a farther aspect of the present invention, a
device for performing a
procedure on heart valve annulus includes: a flexible, elongate catheter
having a proximal
portion and a shaped distal portion, the distal portion having at least one
aperture for allowing
passage of tissue anchors; multiple tissue anchors releasably housed in the
shaped distal
portion; at least one cinchable tether slidably coupled with the tissue
anchors; and at least one
anchor delivery member housed in the distal portion for delivering the anchors
out of the at
least, one aperture to engage tissue of the valve annulus.
[00531 In some embodiments, the shaped distal portion comprises at
least a first curve.
The first curve may have any suitable shape, radius of curvature or the like,
such as in one
embodiment where the first curve has a radius of curvature between 1.27 cm and
3.81 cm. In
some embodiments, the shaped distal portion further comprises a second curve.
The first and
second curves may be adapted to orient a distal-most portion of the catheter
at an angle of
between 45 and 90 , relative to the proximal portion of the catheter
immediately adjacent the
distal portion. In sorne embodiments, the second curve has a radius of
curvature
approximating a radius of curvature of the heart valve. In an alternative
embodiment, the
second, curve has a radius of curvature greater than a radius of curvature of
the heart valve,
wherein the greater radius of curvature causes the distal portion to press
outward against the
valve annulus. Optionally, at least one of the first and second curves may
have the same
shape as a corresponding curve in a guide catheter used tbr delivering the
elongate catheter
into contact with the valve annulus. For example, first and second curves in
the elongate
catheter may correspond to first and second corresponding curves in the guide
catheter. ln
= 17 =
CA 3059577 2019-10-22
such embodiments, the elongate catheter, when advanced through the guide
catheter, is
oriented such that the at least one aperture contacts the valve annulus
tissue.
[0054] Some embodiments of the device further include at least one
stabilizing member
coupled with the elongate catheter for maintaining the distal portion in
contact with valve
annulus tissue. In some embodiments, for example, the stabilizing member
comprises a
spiral-shaped member extending from the distal portion to press against heart
wall tissue, thus
.urging the distal portion against the annulus tissue. Optionally, a distal
end of the spiral-
shaped member may be adapted to engage and press against a junction of one or
more
papillary muscles and heart wall tissue. In other embodiments, the stabilizing
member
comprises an arch-shaped shape-memory or spring-loaded member extending from
the distal
portion to press against heart wall tissue, thus urging the distal portion
against the annulus
tissue. In one embodiment, a portion of the arch-shaped member is adapted to
engage and
press against a junction of one or more papillary muscles and heart wall
tissue. The device
may optionally further include an expandable member coupled with the arch-
shaped member
for inflating to further press against the heart wall tissue. In other
embodiment, the
stabilizing member comprises multiple springs extending from the distal
portion to press
against heart wall tissue, thus urging the distal portion against the annulus
tissue.
Alternatively, the stabilizing member may include a curved balloon coupled
with the distal
portion of the catheter, the curved balloon having a greater radius of
curvature than a radius
of curvature of the valve annulus. Inflating the balloon thus urges the distal
portion against
the annulus tissue.
[0055] In some embodiments, the device further includes at least one
termination member
for enhancing attachment of a terminal tissue anchor to the heart valve
annulus. In some
embodiment, the termination member is slidably couplable with the tether. In
some
embodiments, the termination member is coupled with the tether via a
termination catheter
device. The termination member may include, for example, at least one
deployable tissue
attachment member deployable from a retracted configuration for delivery to an
expanded
configuration for attachment to the valve annulus tissue. The tissue
attachment members may
include a plurality of members, such as but not limited to barbs, points,
needles, hooks, tines,
rakes, wires, teeth and/or the like. In some embodiments, the tissue
attachment members
comprise a shape-memory or super-elastic material. The tissue attachment
members may, for
example, be disposed circumferentially about a cylindrical member adapted to
slide over the
18 .
CA 3059577 2019-10-22
tether. Alternatively, the tissue attachment members may be disposed along a
portion of a
cylindrical member adapted to slide over the tether.
[0056] In some embodiments, the tissue attachment members further
include a pusher for
pushing the tissue attachment member out of the elongate catheter and into the
valve annulus
tissue. In some embodiments, the tissue attachment members are adapted to
engage the
terminal tissue anchor. In one embodiment, the tissue attachment members are
adapted to
enter into the valve annulus tissue in a direction from the terminal tissue
anchor toward the
other tissue anchors. Optionally, the tissue attachment members may further
include a fiber,
matrix, textile or mesh disposed on at least a portion of the tissue
attachment member for
enhancing tissue in-growth over the tissue attachment member.
[0057] In some embodiments, 'each of the tissue anchors comprises at
least one tissue
engagement feature for preventing the anchors from being pulled out of the
valve annulus
tissue when the tether is cinched. For example, the tissue engagement
feature(s) may include
a barb on each end of each tissue anchor. Such a barb may face inward toward a
center of the
anchor or outward away from the center. In another embodiment, the tissue
engagement
features comprise a plurality of bends in each anchor. Optionally, each of the
tissue anchors
may include at least one support member for preventing the anchors from being
pulled out of
the valve annulus tissue when the tether is cinched. For example, the support
member may
comprise an attachment point of one arm of each anchor to another arm of each
anchor, the
attachment point positioned adjacent an eyelet of the anchor. Optionally, a
constraining
member may be disposed over the attachment point to provide further support.
The
constraining member may include, for example, a band, tie, sleeve, belt or the
like. In some
embodiments of the device, each of the tissue anchors comprises at least one
tissue adhesion
feature adapted to enhance attachment of the tissue anchors to the valve
annulus tissue. For
example, the tissue adhesion feature may comprise one or more materials
disposed over at
least part of each anchor, the material(s) selected to promote encapsulation
of the anchors
within the valve annulus tissue. In onc embodiment, the anchor delivery member
comprises
an anchor contacting member for contacting and urging the anchors out of the
at least one
aperture and a pull cord coupled with the anchor contacting member for
applying force to the
anchor contacting member to contact and urge the anchors.
[0058] In another aspect of the invention, a device for constricting a
valve annulus in a
heart includes a plurality of slidably coupled tissue anchors, each anchor
including at least
one tissue attachment feature for enhancing attachment of the anchor to valve
annulus tissue,
19
CA 3059577 2019-10-22
= and at least one cinchable tether slidably coupled with at least some of
the tissue anchors and
fixedly attached to at least a first of the anchors. The tissue attachment
features may
comprise any of a number of suitable features. In one embodiment, for example,
a surface
feature is included along at least a portion of each anchor, such. as a
porous, textured or
coated surface. In other embodiments, the attachment feature comprises at
least one circular
or hooked portion of each anchor having a small radius of curvature.
Alternatively or
additionally, the attachment feature may comprise a barb at each end of-each
anchor.
[0059] According
to another aspect of the present invention, a catheter assembly
=
includes: a guide sheath having a guide sheath axis; an elongate device
slidably extendable
within the guide sheath, the elongate device having an elongate device axis;
the guide sheath
comprising a sheath orientation portion placeable in a chosen shape; and the
elongate device
comprising a device orientation portion placeable in said chosen shape. In
this aspect of the =
invention, the chosen shape of the sheath and device orientation portions tend
to cause the
= sheath and device orientation portions to assume complementary rotary
orientations when the
sheath and device orientation portions are axially aligned.
10060-1`' -. In some embodiments, at least a chosen one of the guide sheath
and elongate
device are steerable. In some embodiments, the sheath orientation portion is
located at a =
distal end of the guide sheath. Also in some embodiments, the device
orientation portion is
located at a position spaced apart from a distal end of the elongate device.
In some
embodiments, the chosenshape comprises a first curved portion and a second
curved portion.
In some embodiments, the chosen shape comprises a first curved portion in a
first plane and. a
second curved portion in a second plane. Alternatively, said chosen shape may
comprise a
first curved portion in a first plane and a second curved portion in a second
plane, said first
and second planes being different planes. In some embodiments, the sheath
orientation
portion assumes the chosen shape when in a relaxed state. In some embodiments,
the sheath
and device orientation portions each assume the chosen shape when in a relaxed
state.
[0061] In another
aspect of the present invention, a method for creating a catheter
assembly having orientation-seeking inner and outer members comprises:
selecting a first
chosen location for a sheath orientation portion of a sheath; selecting a
second chosen
location for an elongate device orientation portion of an elongate device, the
elongate device
slidably extendable within the guide sheath; creating the sheath orientation
portion at the first
chosen location of the sheath, the sheath orientation portion placeable in a
chosen shape; and
creating the elongate device orientation portion at the second chosen loCation
of the sheath,
CA 3059577 2019-10-22
the device orientation portion placeahle in said chosen shape, whereby the
chosen shape of
the sheath and device orientation portions tend to cause the sheath and device
orientation
poqiOns to assume complementary rotary orientations when the sheath and device
orientation
portions are axially aliped.
[0062) In some embodiments, the first chosen location selecting step
comprises selecting
the distal end of the guide sheath as the first chosen location. Also in some
embodiments, the
second chosen location selecting step comprises selecting a position speed
apart from a
distal end of the elongate device as the second chosen location. In other
embodiments, the
sheath orientation portion creating step comprises forming a first curved
portion and a second
curved portion. Optionally, the sheath orientation portion creating step niay
involve forming
a first curved portion in a first plane and a second curved portion in a
second plane. In some
embodiments, the forming step is carried out with said first and second planes
being different
planes. In some embodiments, the sheath orientation portion creating step is
carried out with
the sheath orientation portion naturally assuming the chosen shape when in a
relaxed state.
[0063) In another aspect of the present invention, a method for
orienting the inner and
outer members of a catheter assembly involves: selecting a catheter assembly
comprising: a
guide sheath having a guide sheath axis and a distal end; an elongate device
slidably
extendable within the guide sheath, the elongate device having an elongate
device axis; the
guide sheath comprising a sheath orientation portion, the sheath orientation
portion placeable
in a chosen shape; and the elongate device comprising a device orientation
portion, the device
orientation portion plaeeable in said chosen shape; placing the distal end of
the guide sheath
at a chosen location; axially aligning the sheath and device orientation
portions so that the
guide sheath and elongate device are at a chosen axial orientation; and
axially repositioning,
as necessary, the guide sheath and elongate device away from and back into the
chosen axial
orientation until the sheath and device orientation portions to .assume
complementary rotary
orientations. In some embodiments, the catheter assembly selecting step is
carried out with
the first chosen location at the distal end of the guide sheath. In some
embodiments, the
axially aligning step is carried out with the distal end of the elongate
device at a position
distal of the distal end of the guide sheath.
[0064) In another aspect of the present invention, a method for
creating a catheter
assembly having orientation-seeking inner and outer members comprises:
selecting a first
chosen location for a sheath orientation portion of a sheath; selecting a
second chosen
location for an elongate device orientation portion of an elongate device, the
elongate device
21
CA 3059577 2019-10-22
slidably extendable within the guide sheath; creating the sheath orientation
portion at the first
chosen location of the sheath, the sheath orientation portion placeable in a
chosen shape; and
creating the elongate device orientation portion at the second chosen location
of the sheath,
the device orientation portion placeable in said chosen shape, whereby the
chosen shape of
the sheath and device orientation portions tend to cause the sheath and device
orientation
portions to assume complementary rotary orientations when the sheath and
device orientation
portions are axially aligned. _
[00651 In some embodiments, the first chosen location selecting step
comprises selecting
the distal end of the guide sheath as the first chosen location. Also in some
embodiments, the
second chosen location selecting step comprises selecting a position spaced
apart from a
distal end of the elongate device as the second chosen location. In other
embodiments, the
sheath orientation portion creating step comprises forming a first curved
portion and a second
curved portion. Optionally, the sheath orientation portion creating step may
involve forming
a first curved portion in a first plane and a second curved portion in a
second plane. In some
embodiments, the forming step is carried out with said first and second planes
being different
planes. In some embodiments, the sheath orientation portion creating step is
carried out with
the sheath orientation portion naturally assuming the chosen shape when in a
relaxed state.
[00661 In another aspect of the present invention, a method for
orienting the inner and
outer members of a catheter assembly involves: selecting a catheter assembly
comprising: a
guide sheath having a guide sheath axis and a distal end; an elongate device
slidably
extendable within the guide sheath, the elongate device having an elongate
device axis; the
guide sheath comprising a sheath orientation portion, the sheath orientation
portion placeable
in a chosen shape; and the elongate device comprising a device orientation
portion, the device
orientation portion placeable in said chosen shape; placing the distal end of
the guide sheath
at a chosen location; axially aligning the sheath and device orientation
portions so that the
guide sheath and elongate device are at a chosen axial orientation; and
axially repositioning,
as necessary, the guide sheath and elongate device away from and back into the
chosen axial
orientation until the sheath and device orientation portions to assume
complementary rotary
orientations. In some embodiments, the catheter assembly selecting step is
carried out with
the first chosen location at the distal end of the guide sheath. In some
embodiments, the
axially aligning step is carried out with the distal end of the elongate
device at a position
distal of the distal end of the guide sheath.
=
?2
=
CA 3059577 2019-10-22
[0067] These and other aspects and embodiments are described more
fully below with
reference to the drawing figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0068] Fig. 1 is a cross-sectional view of a heart with a flexible
anchor delivery device
being positioned for treatment of a mitral valve annulus, according to one
embodiment of the
present invention;
[0069] Figs. 2A and 2B are cross-sectional views of a portion of a
heart, schematically
showing positioning of a flexible device for treatment of a mitral valve
annulus, according to
. one embodiment of the present invention;
[0070] Figs. 2C and 2D are cross-sectional views of a portion of a
heart, showing
positioning of a flexible anchor delivery device for treatment of a mitral
valve annulus,
according to one embodiment of the present invention;
[0071] Fig. 3 is a perspective view of a distal portion of an anchor
delivery device,
=
according to one embodiment of the invention;
[00721 Fig. 4 is a perspective view of a segment of a distal portion
of an anchor delivery
device, with anchors in an undeployed shape and position;
[0073] Fig. 5 is a different perspective view of the segment of the device
shown in Fig. 4;
[0074] Fig. 6 is a perspective view of a segment of a distal portion of an
anchor delivery
device, with anchors in a deployed shape and position;
[0075] Figs. 7A-7E are cross-sectional views of an anchor delivery device,
illustrating a
method for delivering anchors to valve annulus tissue, according to one
embodiment of the
invention;
[00761 Figs. 8A and 8B are top-views of a plurality of anchors coupled to a
self-
deforming coupling member or "backbone," with the backbone shown in an
undeployed
shape and a deployed shape;
[0077] Figs. 9A-9C are various perspective views of a distal portion of a
flexible anchor
delivery device according to one embodiment of the present invention;
[0078] Figs. 10A-10F demonstrate a method for applying anchors to a valve
annulus and
cinching the anchors to tighten the annulus, using an anchor delivery device
according to an
embodiment of the invention;
[0079] Fig. 11 shows a heart in cross-section with a guide catheter device
advanced
through the aorta into the left ventricle according to an embodiment of the
invention;
23
CA 3059577 2019-10-22
[0080] Fig. 11A shows a distal end of an anchor delivery device passing
through a guide
catheter according to an embodiment of the invention;
[0081) Fig. 11B shows middle portions of an anchor delivery device and a
guide catheter
having corresponding orientation portions according to an embodiment of the
invention;
[0082] Figs. 12A-12D show various embodiments of support members for
supporting an
anchor delivery device against a valve annulus;
[0083] Figs. 13A-13C show a device and method for facilitating teimination
and load
distribution of a series of anchors according to one embodiment of the
invention;
[0084] Figs. 14A-14F demonstrate a method for advancing an anchor delivery
device to a
position for treating a heart valve according to an embodiment of the
invention;
[0085] Figs. 15A and 15B are side cross-sectional views of a guide catheter
device for
facilitating positioning of an anchor delivery device according to an
embodiment of the
invention;
[0086] Figs. 16A-16E show improved tissue anchors according to various
embodiments
of the present invention;
[0087] Figs. 17A-17C show a self-forming anchor attaching to tissue of a
valve annulus
according to one embodiment of the present invention;
[0088J Figs. 18 shows a self-forming anchor attaching to tissue of a valve
annulus
according to another embodiment of the present invention;
[0089] Fig. 19A shows an anchor device having a sleeve between two adjacent
anchors
according to one embodiment of the invention; and
[0090] Fig. 19B shows an anchor device having a sleeve between three
anchors according
to one embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0091] Devices, systems and methods of the present invention are
generally used to
facilitate transvascular, minimally invasive and other "less invasive"
surgical procedures, by
facilitating the delivery of treatment devices at a treatment site. Although
the following
description focuses on use of devices and methods of the invention for mitral
valve repair, the
devices and methods may be used in any suitable procedure, both cardiac and
noricardiac.
When used for treatment of a cardiac valve annulus, the inventive methods
generally involve
contacting an anchor delivery device with a length of the valve annulus,
delivering a plurality
of coupled anchors from the anchor delivery device, and drawing the anchors
together to
= 24
CA 3059577 2019-10-22
=
tighten the annulus. Devices include an elongate catheter having a housing at
or near the
distal end for releasably housing a plurality of coupled anchors, as well as
delivery devices
for facilitating advancement and/or positioning of an anchor delivery device.
Devices may be
positioned such that the housing abuts or is close to valve annular tissue,
such as in a location
within the left ventricle defined by the left ventricular wall, a mitral valve
leaflet and chordae
tendineae. Self-securing anchors having any of a number of different
configurations may be
used in some embodiments. Additional devices include delivery devices for
facilitating
delivery and/or placement of an anchor delivery device at a treatment site.
[0092] In
many cases, methods of the present invention will be performed on a beating
heart. Access to the beating heart may be accomplished by any available
technique,
including intravaseular, transtlioracic, and the like. In addition to beating
heart access, the
methods of the present invention may be used for intravascular stopped heart
access as well
as stopped heart open chest procedures.
[0093]
Referring now to Figure 1, a heart H is shown in cross section, with an
elongate
anchor delivery device 100 introduced within the heart H. Generally, delivery
device 100
comprises an elongate body with a distal portion 102 configured to deliver
anchors to a heart
valve annulus. (In Figs. 1, 2A and. 2B, distal portion 102 is shown
diagrammatically without
anchors or anchor-delivery mechanism to enhance clarity of the figures.) In
some
embodiments, the elongate body comprises a rigid shaft, while in other
embodiments it
comprises a flexible catheter, so that distal portion 102 may be positioned in
the heart H and
under one or more valve leaflets to engage a valve annulus via a transvaseular
approach.
Transvascular access may be gained, for example, through the internal jugular
vein (not
shown) to the superior vena cava SVC to the right atrium RA, across the
interatrial septum to
the left atrium LA, and then under one or more mitral valve leaflets MVL to a
position within
the left ventricle (LV) under the valve annulus (not shown). Alternatively,
access to the heart
may be achieved via the femoral vein and the inferior vena cava. In other
embodiments,
access may be gained via the coronary sinus (not shown) and through the atrial
wall into the
left atrium.. In still other embodiments, access may be aehieved via a femoral
artery and the
aorta, into the left ventricle, and under the mitral valve. This access route
will be described in
further detail below. Any other suitable access route is also contemplated
within the scope of
the present invention.
[0094] In
other embodiments, access to the heart H may be transthoracic, :with delivery
device 100 being introduced into the heart via an incision or port on the
heart wall Even
=
CA 3059577 2019-10-22
open heart surgical procedures may benefit from methods and devices of the
invention.
Furthermore, some embodiments may be used to enhance procedures on the
tricuspid valve
annulus, adjacent the tricuspid valve leaflets TVL, or any other cardiac or
vascular valve.
Therefore, although the following description typically focuses on minimally
invasive or less
invasive antral valve repair for treating mitral regurgitation, the invention
is in no way
limited to that use.
[0095) With reference now to Figures 2A and 2B, a method for po-
sitioning delivery
device 100 for treating a mitral valve annulus VA is depicted diagrammatically
in a cross-
sectional view. First, as in Figure 2A, distal portion 102 is positioned in a
desired location
under a mitral valve leaflet L and adjacent a ventricular wall VW. (Again,
distal portion 102
is shown without anchors or anchor-delivery mechanism for demonstrative
purposes.) The
valve annulus VA generally comprises an area of heart wall tissue at the
junction of the
ventricular wall VW and the atrial wall AW that is relatively fibrous and,
thus, significantly
stronger that leaflet tissue and other heart wall tissue.
[0096] Distal portion 102 may be advanced into position under the
valve annulus by any
suitable technique, some of which are described below in further detail.
Generally, distal
portion 102 may be used to deliver anchors to the valve annulus, to stabilize
and/or expose
the annulus, or both. In one embodiment, using a delivery device having a
flexible elongate
body as shown in Figure 1, a flexible distal portion 102 may be passed from
the right atrium
RA through the interatrial septum in the area of the foramen ovale (not
shown¨behind the
aorta A), into the left atrium LA and thus the left ventricle LV.
Alternatively, flexible distal
portion 102 may be advanced through the aorta A and into the left ventricle
LV, for example
using access through a femoral artery. Oftentimes, distal portion 102 will
then naturally
travel, upon further advancement, under the posterior valve leaflet L into a
space defined
above a subvalvular space 104 roughly defined for the purposes of this
application as a space
bordered by the inner surface of the left ventricular wall VW, the inferior
surface of antral
valve leaflets L, and cordae tendineae CT connected to the ventricular wall VW
and the
leaflet L. It has been found that a flexible anchor delivery catheter, such as
the delivery
devices of the present invention, when passed under the mitral valve via an
intravascular
approach, often enters subvalvular space 104 relatively easily and may be
advanced along
space 104 either partially or completely around the circumference of the
valve. Once in
space 104, distal portion 102 may be conveniently positioned at the
intersection of the valve
leaflet(s) and the ventricular wall VW, which intersection is immediately
adjacent or very
26
CA 3059577 2019-10-22
near to the valve annulus VA, as shown in Figure 2A. These are but examples of
possible =
access routes of au .anchor delivery device to a valve annulus, and any other
access routes
may be used.
[0097] hi some embodiments, distal portion 102 includes a shape-
changing portion Which.
= enables distal portion 102 to conform to the shape of the valve annulus
VA. The catheter
may be introduced through the vasculature with the shape-changing distal
portion in a
generally straight, flexible configuration. Once it is in place beneath tile
leaflet at the
intersection between the leaflet and the interior ventricular wall, the shape
of dist:al portion
102 is changed to conform to the annulus and usually the shape is "locked" to
provide
sufficient stiffness or rigidity to permit the application of force from
distal portion 102 to the
=
annulus. Shaping and optionally locking distal portion 102 may be accomplished
in any of a
number of ways. For example, in sonic embodiments, a shape-changing portioc
may be
sectioned, notched, slotted or segmented and one of more tensioning members
such as
tensioning cords, wires or other tensioning devices coupled with the shape-
changing portion = =
may be used to shape and rigidify dit.al portion 102. A segmented distal
portion, for
example, may include multiple segments coupled with two tensioning members,
each
providing a different direction of articulation to the distal portion. A first
bend may be
created by tensioning a first member to give the distal portion a C-shape or
similar shape to
conform to the valve annulus, while a second bend may be created by tensioning
a second
member to articulate the C-shaped member upwards against the annulus. In
another
=
embodiment, a shaped expandable member, such as a balloon, may be coupled with
distal
portion 102 to provide for shape changing/deforming. In. various embodiments,
any
configurations and combinations may be used to give distal portion 102 a
desired shape.
=
[0098] In transthora.cic and other embodiments, distal portion 102
may be shaped, and the
method may simply involve introducing distal portion 102 under the valve
leaflets. The
shaped distal portion 102 may be rigid or formed from any suitable super-
elastic or shape
memory material, such as nitinol, spring stainless steel, or the like.
[0099) In addition to delivering anchors to the valve annulus VA,
delivery device 100
(and specifically distal portion 102) may be used to stabilize and/or expose
the valve annulus
VA. Such stabilization and exposure are described fully in 'U.S. Patent
Application Serial
No. 10/656797. For example, once distal portion 102 is positioned under the
annulus, force may
he applied to distal portion 102 to stabilize the valve annulus VA., as shown
in Figure 2B. Such
force may be directed in any
27
=
CA 3059577 2019-10-22
suitable direction to expose, position and/or stabilize the annulus. For
example, upward and
lateral force is shown in Figure 28 by the solid-headed arrow drawn from the
center of distal
portion 102. In other cases, only upward, only lateral, or any other suitable
force(s) may be
applied. With application of force to distal portion 102, the valve annulus VA
is caused to
rise or project outwardly, thus exposing the annulus for easier viewing and
access. The
applied force may also stabilize the valve annulus VA, also facilitating
surgical procedures
and visualization.
[01001 Some embodiments may include a stabilization component as well
as an anchor
delivery component. For example, some embodiments may include two flexible
members,
one for contacting the atrial side of a valve annulus and the other for
contacting the
ventrioular side. hi some embodiments, such flexible members may be used to
"clamp" the
annulus between them. One of such members may be an anchor delivery member and
the
other may be a stabilization member, for example. Any combination and
configuration of
stabilization and/or anchor delivery members is contemplated.
[01011 Referring now to Figures 2C and 2D, an anchor delivery device
108 is shown
delivering an anchor 110 to a valve annulus VA. Of course, these are again
representational
figures and are not drawn to scale. Anchor 110 is shown first housed within
delivery device
108 (Fig. 2C) and then delivered to the annulus VA (Fig. 2D). As is shown, in
one
embodiment anchors 110 may have a relatively straight configuration when
housed in
delivery device 108, perhaps with, two sharpened tips and a loop in between
the tips. Upon
deployment from delivery device 108, the tips of anchor 110 may curve in
opposite directions
to form two semi-circles, circles, ovals, overlapping helices or the like.
This is but one
example of a type of self-securing anchor which may be delivered to a valve
annulus.
Typically, multiple coupled anchors 110 are delivered, and the anchors 110 are
drawn
together to tighten the valve annulus. Methods for anchor delivery and for
drawing anchors
together are described further below.
[0102] Although delivery device 108 is shown having a circular cross-
sectional shape in
Figs. 2C and 2D, it may alternatively have any other suitable shape. In. one
embodiment, for
example, it may be advantageous to provide a delivery device having an ovoid
or elliptical
cross-sectional shape. Such a shape may help ensure that the device is
aligned, when
positioned between in a comer formed by a ventricular wall and a valve
leaflet, such that one
or more openings in the delivery device is oriented to deliver the anchors
into valve annulus
tissue. To further enhance contacting of the valve annulus and/or orientation
of the delivery
28
CA 3059577 2019-10-22
=
device, some embodiments may further include an expandable Member, coupled
with the
delivery device, which expands to urge or press or wedge the delivery device
into the comer
formed by the ventricle wall and the leaflet to contact the valve annulus.
Such enhancements
are described further below.
[0103] With reference now to Figure 3, one embodiment of a portion of
an anchor
delivery device 200 suitably includes an elongate shaft 204 having a distal
portion 202
configured to deliver a plurality of anchors 210, coupled with a tether -212,
to tissue of a valve
annulus. Tethered anchors 210 are housed within a housing 206 of distal
portion 202, along
with one or more anchor retaining mandrels 214 and an expandable member 208.
Many
variations may be made to one or more of these features, and various parts may
be added or
eliminated, without departing from the scope.of the invention. Some of these
variations are
described further below, but no specific embodiment(s) should be construed to
limit the scope
of the invention as defined by the appended claims:
[01041 Housing 206 may be flexible or rigid in various embodiments.
In some
embodiments, for example, flexible housing 206 may be comprised of multiple
segments
configured such that housing 206 is deformable by tensioning a tensioning
member coupled
to the segments. In some embodiments, housing 206 is formed from an elastic
material
having a geometry selected to engage and optionally shape or constrict the
valve annulus.
For example, the rings may be formed from super-elastic material, shape memory
alloy such
as Nitinol, spring stainless steel, or the like. In other instances, housing
206 could be formed
from an inflatable or other structure can be selectively rigidified in situ,
such as a gooseneck
or lockable element shaft, any of the rigidifying structures described above,
or any other
rigidifying structure.
[0105] "Anchors," for the purposes of this application, is defined to
mean any fasteners.
Thus, anchors 210 may comprise C-shaped or semicircular hooks, curved hooks of
other
shapes, straight hooks, barbed hooks, clips of any kind, T-tags, or any other
suitable
fastener(s). In one embodiment, as described above, anchors may comprise two
tips that
curve in opposite directions upon deployment, forming two intersecting semi-
circles, circles,
ovals, helices or the like. In some embodiments; anchors 210 are self-
deforming. By "self-
deforming" it is meant that anchors 210 change from a first undeployed shape
to a second
deployed shape upon release of anchors 210 from restraint in housing 206. Such
self-
deforming anchors 210 may change shape as they are released from housing 206
and enter
- valve annulus tissue, to secure themselves to the tissue. Thus, a crimping
device or other
29
CA 3059577 2019-10-22
similar mechanism is not required on distal end 202 to apply force to anchors
210 to attach
them to annular tissue.
[0106] Self-deforming anchors 210 may be made of any suitable
material, such as a
super-elastic or shape-memory material like Nitinol or spring stainless steel.
In other
embodiments, anchors 210 may be made of a non-shape-memory material and made
be
loaded into housing 206 in such a way that they change shape upon release.
Alternatively,
anchors 210 that are not self-deforming may be used, and such anchors may be
secured to
tissue via crimping, firing or the like: Even self-securing anchors may be
crimped in some
embodiments, to provide enhanced attachment to tissue. In some embodiments,
anchors 210
may comprise one or more bioactive agent. In another embodiment, anchors 210
may
comprise electrodes. Such electrodes, for example, may sense various
parameters, such as but
not limited to impedance, temperature and electrical signals. In other
embodiments, such
electrodes may be used to supply energy to tissue at ablation or sub-ablation
amounts.
Delivery of anchors may be accomplished by any suitable device and technique,
such as by
simply releasing the anchors by hydraulic balloon delivery as discussed
further below. Any
number, size and shape of anchors 210 may be included in housing 206.
[0107] In one embodiment, anchors 210 are generally C-shaped or
semicircular in their
undeployed form, with the ends of the C being sharpened to penetrate tissue.
Midway along
the C-shaped anchor 210, an eyelet may be formed for allowing slidable passage
of tether
212. To maintain anchors 210 in their C-shaped, undeployed state, anchors 210
may be
retained within housing 206 by two mandrels 214, one mandrel 214 retaining
each of the two
arms of the C-shape of each anchor 210. Mandrels 214 may be retractable within
elongate
catheter body 204 to release anchors 210 and allow them to change from their
undeployed C-
shape to a deployed shape. The deployed shape, for example, may approximate a
complete
circle or a circle with overlapping ends, the latter appearing similar to a
key ring. Such
anchors are described further below, but generally may be advantageous in
their ability to
secure themselves to annular tissue by changing from their undeployed to their
deployed
shape. In some embodiments, anchors 210 are also configured to lie flush with
a tissue
surface after being deployed. By "flush" it is meant that no significant
amount of an anchor
protrudes from the surface, although some small portion may protrude.
[0108] Tether 212 may be one long piece of material or two or more
pieces and may
comprise any suitable material, such as suture, suture-like material, a Dacron
strip or the like.
Retaining mandrels 214 may also have any suitable configuration and be made of
any
CA 3059577 2019-10-22
suitable material, such as stainless steel, titanium, Nitinol, or the like.
Various embodiments
may have one mandrel, two mandrels, or more than two mandrels.
[0109] In some embodiments, anchors 210 may be released from mandrels
214 to contact
and secure themselves to annular tissue without any further force applied by
delivery device
200. Some embodiments, however, may also include one or more expandable
members 208,
which may be expanded to help drive anchors 210 into tissue. Expandable
member(s) 208
may have any suitable size and configuration and may be made of any suitable
material(s).
Hydraulic systems such as expandable members are-known in the art, and any
known or as
yet undiscovered expandable member may be included in housing 206 as part of
the present
invention.
[0110] Referring now to Figures 4 and 5, a segment of a distal
portion 302 of an anchor
delivery device suitably includes a housing 306; multiple tensioning members
320 for
applying tension to housing 306 to change its shape, two anchor retaining
mandrels 314
slidably disposed in housing 306, multiple anchors 310 slidably coupled with a
tether 312,
and an expandable member 308 disposed between anchors 310 and housing 306. As
can be
seen in Figs. 4 and 5, housing 306 may include multiple segments to allow the
overall shape
of housing 306 to be changed by applying tension to tensioning members 320. As
also is
evident from the drawings, "C-shaped" anchors 310 may actually have an almost
straight
Configuration when retained by mandrels 314 in housing 306. Thus, for the
purposes of this
application, "C-shaped" or "semicircular" refers to a very broad range of
shapes including a
portion of a circle, a slightly curved line, a slightly curved line with art
eyelet at one point
along the line, and the like.
[0111] With reference now to Figure 6, the same segment of distal
portion 302 is shown,
but mandrels 314 have been withdrawn from two mandrel apertures 322, to
release anchors
310 from housing 306. Additionally, expandable member 308 has been expanded to
drive
anchors out of housing 306. Anchors 310, having been released from mandrels
314, have
begun to change from their undeployed, retained shape to their deployed,
released shape.
[0112] Referring now to Figures 7A-7E, a cross-section of a distal
portion 402 of an
anchor delivery device is shown in various stages of delivering an anchor to
tissue of a valve
annulus VA. In Fig. 7A, distal portion 402 is positioned against the valve
annulus, an anchor
410 is retained by two mandrels 414, a tether 412 is slidably disposed through
an eyelet on
anchor 410, and an expandable member 408 is coupled with housing 406 in a
position to
drive anchor 410 out of housing 406. When retained by mandrels 414, anchor 410
is in its
31
CA 3059577 2019-10-22
undeployed shape. As discussed above, mandrels 414 may be slidably retracted,
as
designated by the solid-tipped arrows in Fig. 7A, to release anchor 410. In
various
embodiments, anchors 410 may be released one at a time, such as by retracting
mandrels 414
slowly, may be released in groups, or may all be released simultaneously, such
as by rapid
retraction of mandrels 414.
[0113] In Fig. 7B, anchor 410 has begun to change from its undeployed
shape to its
deployed shape (as demonstrated by the hollow-tipped arrows) and has also
begun to
penetrate the annular tissue VA. Empty mandrel apertures 422 demonstrate that
mandrels
414 have been retracted at least far enough to release anchor 410. In Fig. 7B,
expandable
member 408 has been expanded to drive anchor 410 partially out of housing 406
and further
into the valve annulus VA. Anchor 410 also continues to move from its
undeployed towards
its deployed shape, as shown by the hollow-tipped arrows. In Fig. 7D, anchor
410 has
reached its deployed shape, which is roughly a completed circle with
overlapping ends or a
"key ring" shape. In Fig. 7E, delivery device 402 has been removed, leaving a
tethered
anchor in place in the valve annulus. Of course, there will typically be a
plurality of tethered
anchors secured to the annular tissue. Tether 412 may then be cinched to apply
force to
anchors 410 and cinch and tighten the valve annulus.
[0114] With reference now to Figures 8A and 8B, a diagrammatic
representation of
another embodiment of coupled anchors is shown. Here, anchors 510 are coupled
to a self-
deforming or deformable coupling member or backbone 505. Backbone 505 may be
fabricated, for example, from Nitinol, spring stainless steel, or the like,
and may have any
suitable size or configuration. In one embodiment, as in Fig. 8A, backbone 505
is shaped as
a generally straight line when held in an undeployed state, such as when
restrained within a
housing of an anchor deliver device. When released from the delivery device,
backbone 505
may change to a deployed shape having multiple bends, as shown in Fig. 8B. By
bending,
backbone 505 shortens the longitudinal distance between anchors, as
demonstrated by the
solid-tipped arrows in Fig. 8B. This shortening process may act to cinch a
valve annulus into
which anchors 510 have be secured. Thus, anchors 510 coupled to backbone 505
may be
used to cinch a valve annulus without using a tether or applying tethering
force.
Alternatively, a tether may also be coupled with anchors 510 to further cinch
the annulus. In
such an embodiment, backbone 505 will be at least partially conformable or
cinchable, such
that when force is applied to anchors 510 and backbone 505 via a tether,
backbone 505 bends
further to allow further cinching of the annulus.
32
CA 3059577 2019-10-22
[0115] Referring now to Figures 9A-9C, in one embodiment a flexible
distal portion of an
anchor delivery device 520 suitably includes a housing 522 coupled with an
expandable
member 524. Housing 522 may be configured to house multiple coupled anchors
526 and an
' anchor contacting member 530 coupled with a pull cord 532. Housing 522
may also include
multiple apertures 528 for allowing egress of anchors 526. For clarity,
delivery device 520 is
shown without a tether in Figures 9A and 9C, but Figure 98 shows that a tether
534 may
extend through an eyelet, loop or other portion of each anchor 526, and may
exit each
=
aperture 528 to allow for release of the plurality of anchors 526. The various
features of this
embodiment arc described further below.
[01161 In the embodiment shown in Figures 9A-9C, anchors 526 are
relatively straight
and lie relatively in parallel with the long axis of delivery device 522.
Anchor contacting
member 530, which may comprise any suitable device, such as a ball, plate,
hook, knot,
= plunger, piston, or the like, generally has an outer diameter that is
nearly equal to or slightly
less than the inner diameter of housing 522. Contacting member 530 is disposed
within the
housing, distal to a distal-most anchor 526, and is retracted relative to
housing 522 by pulling
pull cord 532. When retracted, anchor contacting member 530 contacts and
applies force to a
distal-most anchor 526 to release cause that anchor 526 to exit housing 522
via one of the
apertures 528. Contacting member 530 is then pulled farther proximally to
contact and apply
force to the next anchor 526 to deploy that anchor 526, and so on.
[0117] Retracting contacting member 530 to push anchors 526 out of
apertures 528 may
help cause anchors 526 to avidly secure themselves to adjacent tissue. Using
anchors 526
that are relatively straight/flat when undeployed allows anchors 526 with
relatively large
deployed sizes to be disposed in (and delivered from) a relatively small
housing 522. In one
embodiment, for example, anchors 526 that deploy into a shape approximating
two
intersecting semi-circles, circles, ovals, helices, or the like, and that have
a radius of one of
the semi-circles of about 3 ram may be disposed within a housing 522 having a
diameter of
about 5 French (1.67 mm) and more preferably 4 French (1.35 mm) or even
smaller. Such
anchors 526 may measure about 6 mm or more in their widest dimension. In some
embodiments, housing 522 may have a diametrical dimension ("d") and anchor 526
may have
= a diametrical dimension ("D") in the deployed state, and the ratio of D
to d may be at least
about 3.5. In other embodiments, the ratio of D to d may be at least about
4.4, and more
preferably at least about 7, and even more preferably at least about 8.8.
These are only
examples, however, and other larger or smaller anchors 526 may be disposed
within a larger
33
CA 3059577 2019-10-22
or smaller housing 522. Furthermore, any convenient number of anchors 526 may
be
disposed within housing 522. In one embodiment, for example, housing 522 may
hold about
1-20 anchors 526, and more preferably about 3-10 anchors 526. Other
embodiments may
hold more anchors 526.
[0118] Anchor contacting member 530 and pull cord 532 may have any
suitable
configuration and may be manufactured from any material or combination of
materials. In
alternative embodiments, contacting member 530 may be pushed by a-pusher
member to =
contact and deploy anchors 526. Alternatively, any of the anchor deployment
devices and
methods previously described may be used.
[01191 Tether 534, as shown in Figure 913, may comprise any of the
tethers 534 or tether-
like devices already described above, or any other suitable device. Tether 534
is generally
attached to a distal-most anchor 526 at an attachment point 536. The
attachment itself may
be achieved via a knot, weld, adhesive, or by any other suitable attachment
means. Tether
234 then extends through an eyelet, loop or other similar configuration on
each on each of the
anchors 526 so as to be slidably coupled with the anchors 526. In the
embodiment shown,
tether 534 exits each aperture 528, then enters the next-most-proximal
aperture, passes
slidably through a loop on an anchor 526, and exits the same aperture 528. By
entering and
exiting each aperture 528, tether 534 allows the plurality of anchors 526 to
be deployed into
tissue and cinched. Other configurations of housing 522, anchors 526 and
tether 534 may
alternatively be used. For example, housing 522 may include a longitudinal
slit through
which tether 534 may pass, thus allowing tether 534 to reside wholly within
housing before
deployment.
[0120] Expandable member 524 is an optional feature of anchor delivery
device 520, and
thus may be included in some embodiments and not in others. In other words, a
distal portion
of anchor delivery device 520 may include housing, contents of housing, and
other features
either with or without an attached expandable member. Expandable member 524
may
comprise any suitable expandable member currently known or discovered in the
future, and
any method and substance(s) may be used to expand expandable member 524.
Typically,
expandable member 524 will be coupled with a surface of housing 522, will have
a larger
radius than housing 522, and will be configured such that when it is expanded
as housing 522
nears or contacts the valve annulus, expandable member 524 will push or press
housing 522
into enhanced contact with the annulus. For example, expandable member 524 may
be
34
CA 3059577 2019-10-22
configured to expand within a space near the comer formed by a left
ventricular wall and a
mitral valve leaflet.
[0121] With reference now to Figures 10A-10F, a method is shown for
applying a
plurality of tethered anchors 526 to a valve annulus VA in a heart. As shown
in Figure 10A,
an anchor delivery device 520 is first contacted with the valve annulus VA
such that openings
528 are oriented to deploy anchors 526 into the annulus. Such orientation may
be achieved
by any suitable technique. In one embodiment, for example, a housing- 522
having an
elliptical cross-sectional shape may be used to orient openings 528. As just
described,
contact between housing 522 and the valve annulus VA may be enhanced by
expanding
expandable member 524 to wedge housing within a comer adjacent the annulus.
[0122] Generally, delivery device 520 may be advanced into any
suitable location for
treating any valve by any suitable advancing or device placement method. Many
catheter-
based, minimally invasive devices and methods for performing intravascular
procedures, for
example, are well known, and any such devices and methods, as well as any
other devices or
method later developed, may be used to advance or position delivery device 520
in a desired
location. For example, in one embodiment a steerable guide catheter is first
advanced in
retrograde fashion through an aorta, typically via access from a femoral
artery. The steerable
catheter is passed into the left ventricle of the heart and thus into the
space formed by the
mitral valve leaflets, the left ventricular wall and cordae tendineae of the
left ventricle. Once
in this space, the steerable catheter is easily advanced along a portion (or
all) of the
circumference of the mitral valve. A sheath is advanced over the steerable
catheter within the
space below the valve leaflets, and the steerable catheter is removed through
the sheath.
Anchor delivery device 520 may then be advanced through the sheath to a
desired position
within the space, and the sheath may be removed. In some cases, an expandable
member
coupled to delivery device 520 may be expanded to wedge or otherwise move
delivery device
'520 into the comer formed by the left ventricular wall and the valve leaflets
to enhance its
contact with the valve annulus. Of course, this is but one exemplary method
for advancing
delivery device 520 to a position for treating a valve, and any other suitable
method,
combination of devices, etc. may be used.
[01231 As shown in Figure 10B, when delivery device 520 is positioned
in a desired
location for deploying anchors 526, anchor contacting member 530 is retracted
to contaa and
apply force to a most-distal anchor 526 to begin deploying anchor 526 through
aperture 528
and into tissue of the valve annulus VA. Figure .10C show anchor 526 further
deployed out
CA 3059577 2019-10-22
of aperture 528 and into valve annulus VA. Figure 10D shows the valve annulus
VA
transparently so that further deployment of anchors 526 can be seen. As shown,
in one
embodiment of the invention, anchors 526 include two sharpened tips that move
in opposite
directions upon release from housing 522 and upon contacting the valve annulus
VA.
Between the two sharpened tips, an anchor 526 may be looped or have any other
suitable
eyelet or other device for allowing slidable coupling with a tether 534.
[0124] Referring now to Figure 10E, anchors 526 are seen in their-
fully deployed or
nearly fully deployed shape, with each pointed tip (or "arm") of each anchor
526 having
curved to form a circle or semi-circle. Of course, in various embodiments
anchors 526 may
have any other suitable deployed and undeployed shapes, as described more
fully above.
Figure 1OF shows anchors 526 deployed into the valve annulus VA and coupled
with tether
534, with the distal-most anchor 526 coupled attached Fixedly to tether 524 at
attachment
point 536. At this stage, tether 534 may be cinched to tighten the annulus,
thus reducing
valve regurgitation. In some embodiments, valve function may be monitored by
means such
as echocardiogram and/or fluoroscopy, and tether 534 may be cinched, loosened,
and
adjusted to achieve a desired amount of tightening as evident via the employed
visualization
technique(s). When a desired amount of tightening is achieved, tether 534 is
then attached to
a most-proximal anchor 526 (or two or more most-proximal anchors 526), using
any suitable
technique, and tether 534 is then cut proximal to the most-proximal anchor
526, thus leaving
the cinched, tethered anchors 526 in place along the valve annulus VA.
Attachment of tether
534 to the most-proximal anchor(s) 526 may be achieved via adhesive, knotting,
crimping,
tying or any other technique, and cutting tether 534 may also be performed via
any technique,
such as with a cutting member coupled with housing 522.
101251 In one embodiment, cinching tether 534, attaching tether 534 to
most-proximal
anchor 526, and cutting tether 534 are achieved using a termination device
(not shown). The
termination device may comprise, for example, a catheter advancable over
tether 534 that
includes a cutting member and a nitinol knot or other attachment member for
attaching tether
534 to most-proximal anchor. The termination catheter may be advanced over
tether 534 to a
location at or near the proximal end of the tethered anchors 526. It may then
be used to apply
opposing force to the most-proximal anchor 526 while tether 534 is cinched.
Attachment and
cutting members may then be used to attach tether 534 to most-proximal anchor
526 and cut
tether 534 just proximal to most-proximal anchor 526. Such a termination
device is only one
=
36
CA 3059577 2019-10-22
possible way of accomplishing the cinching, attachment and cutting steps, and
any other
suitable device(s) or technique(s) may be used.
[0126] In some embodiments, it may be advantageous to deploy a first
number of anchors
526 along a first portion of a valve annulus VA, cinch the first anchors to
tighten that portion
of the annulus, move the delivery device 520 to another portion of the
annulus, and deploy
and cinch a second number of anchors 526 along a second portion of the
annulus. Such a
method may be more convenient, in some cases, than extending delivery device
520 around
all or most of the circumference of the annulus, and may allow a shorter, more
maneuverable
housing 522 to be used.
[0127] In an embodiment similar to that shown in Figs. 10A-10F, an
analogous method
may be used but anchors 526 may be driven out of delivery device 520 through a
biocompatible material attached to delivery device 520, thereby attaching the
biocompatible
material to the valve annulus VA. For example, in one embodiment a Dacron
strip may be
attached to delivery device 520, extending along device 520 and covering
apertures 528.
- Anchors 526 are then driven out of delivery device 520, through the
Dacron strip, into the
valve annulus VA, thus detaching the Dacron strip from device 520 and
attaching it to the
valve annulus VA. Such a biocompatible material may facilitate tissue ingrowth
of anchors
526 and may enhance attachment generally to the valve annulus VA. In an
alternative
embodiment, multiple pieces of biocompatible material, such as separate pieces
of material
disposed over each of apertures 528, may be used. For example, in one
embodiment multiple
discs of Dacron material are disposed over multiple apertures 528.
[0128] In another embodiment, a distal portion of delivery device 520
may be detachable
from a proximal portion of delivery device 520. Such an embodiment may be
configured
such that when anchors 526 are deployed from device 520, the distal portion of
device 520
detaches from the proximal portion and is attached, via anchors 526, to the
valve annulus VA.
In one embodiment, for example, anchors 526 may pierce through the distal
portion of device
520, rather than exiting device 520 through apertures 528. The distal portion
may be
' detachable via any suitable means, such as perforations or the like.
[0129] Referring now to Fig. 11, a cross-sectional depiction ofaheartH
is shown with an
anchor delivery device guide catheter 550 advanced through the aorta A and
into the left
ventricle LV. In a preferred embodiment, this access route to the subannular
space and the
valve annulus may used. Guide catheter 550 is generally a flexible elongate
catheter which
may have one or more curves or bends toward its distal end to facilitate
placement of the
37
CA 3059577 2019-10-22
distal end of catheter 550 in a subannular space 552. Subannular space 552,
which has been
described above in detail, is generally defined by the left ventricular wall,
the mitral valve
leaflets MVL, and cordae tendiniae, and travels along most or ail of the
circumference of the
valve annulus. The distal end of guide catheter 550 may be configured to be
positioned at an
opening into space 552 or within space 552, such that subsequent catheter
devices may be
passed through guide catheter 550 into space 552. In some embodiments, it may
be
advantageous to provide guide catheter 550 with a curvable portion with a
radius in an
expanded/curved state that is greater than a radius of the valve annulus. For
example, in one
embodiment guide catheter 550 in the expanded state has a radius about 25%-50%
larger that
the valve annulus.
[0130] With reference now to Fig. 11A, a distal portion of guide
catheter 550 is shown,
with an anchor delivery device 558 extending through it and out of its distal
end. As shown,
in one embodiment guide catheter 550 includes at least one bend 551 or
curvature, and
anchor delivery device 558 is pre-shaped to include at least one corresponding
bend 553, that
has approximately the same radius of curvature as the bend 551 in guide
catheter 550. In
some embodiments (not shown), guide catheter 550 may have multiple bends 551,
and
anchor delivery device 558 may have multiple corresponding bends 553. In the
embodiment
shown, anchor delivery device 558 includes a proximal bend 553, which
corresponds to the
bend 551 in guide catheter 550, and a distal bend 555. By matching the radii
of curvature of
the proximal bend 553 and the guide catheter bend 551, the distal portion of
anchor delivery
device 558 becomes automatically oriented (when advanced through guide
catheter 550) such
that one or more anchor delivery apertures 557 are in contact with the valve
annulus (not
shown). Moreover, distal bend 555 may have a radius ofcurvature that matches
approximately a radius of curvature of a valve annulus. Alternatively, distal
bend 555 may
have a radius of curvature greater than a valve annulus radius of curvature,
such that the
distal portion of anchor delivery device 558 tends to push radially outward,
enhancing contact
of the device 558 with valve annulus tissue. Such greater radii of curvature
are described in
greater detail below. Proximal bend 553 and distal bend 555 may therefore have
any suitable
angles relative to one another and relative to the more proximal portion of
anchor delivery
device 558. In some embodiments, anchor delivery device 558 is also stcerablc.
[01311 With reference now to Fig. 11B, in the embodiment described
immediately above
and/or in alternative embodiments, an anchor delivery device 588 and a guide
catheter 590
may include one or more corresponding (or "registering") bends or orientation
portions 592a,
38
CA 3059577 2019-10-22
592b at other locations along their lengths. In other words, although bends
551, 553, 555 are
shown in Fig. I lA at or near the distal ends of guide catheter 550 and anchor
delivery device
558, similar bends could be formed at more proximal locations. For example,
Fig. I 1B
shows guide catheter 590 with orientation portion 592a having a chosen shape
when relaxed.
The chosen shape may lie along a two-dimensional or three-dimensional path.
Anchor
delivery device 588 has a corresponding orientation portion 592b along its
length which is
complementary to the shape of orientation portion 592a. The chosen shape may
also be
created by the application of energy, mechanical manipulation or the like.
Such orientation
portions 592a, 592b could be used for further registering or orienting
delivery device 588 to a
desired orientation. Typically, when orientation portions 592a, 592b are
axially aligned,
which can be indicated by orientation markers at the proximal ends of guide
catheter 590 and
anchor delivery device 588 external of the patient, proper rotary orientation
can be sensed
tactically by the physician to help insure the distal end of anchor delivery
device 588 is
properly oriented. Delivery device 588 may be rotated, advanced or. moved in
any suitable
fashion within guide catheter 590 to achieve a desired orientation. The use of
one or more
complementary orientation portions 592a,.592b may be used with any of a number
of various
embodiments of guide catheters and anchor delivery devices.
[0132] In a number-of cases, and with reference now to Figs. 12A-
12D, it may be
advantageous to provide further support to an anchor delivery device 658, to
support the
device 658 against valve annulus tissue and/or to push the device 658 against
valve annulus
tissue to enhance contact with, and anchor delivery into, the tissue. In one
embodiment, as
shown in Fig. 12A, a helical support member 652 may be coupled with a distal
end of anchor
delivery device 658 and may be extended into the left ventricle of a heart (or
other heart
chamber in other embodiments) to contact the heart wall 651 and thus support
anchor
delivery device 658 against the valve annulus tissue. In alternative
embodiments, helical
support member 651 may extend out of a guide catheter 650 to contact the heart
wall 651 and
support anchor delivery device 658. Any suitable means may be used for
extending helical
member 652 into the left ventricle or other chamber. For example, helical
member 652 is
pushed out of guide catheter 650 in one embodiment, but may alternatively be
extended out
of anchor delivery device 658. Helical member 652 may be made of any suitable
material,
such as but not limited to Nitinol, stainless steel or the like.
[01331 In an alternative embodiment, pictured in Fig. 12B, a
deployable U-shaped
support member 662 may be movably coupled with a distal portion of an anchor
delivery
39
=
CA 3059577 2019-10-22
device 668, both of which are advanceable through a guide catheter 660. Upon
being
advanced out of the distal end of guide catheter 660, U-shaped member 662 may
automatically spring out, or alternatively may be manually manipulated to
extend outward, to
contact the inner surface of the heart wall and/or to contact a papillary
muscle 663. As shown
in Fig. 12B, in one embodiment U-shaped member 663 contacts an intersection of
a papillary
muscle 663 with the heart wall, and thus provides upward support (solid-tipped
arrows) to
anchor delivery device 668. Again, such a U-shaped member 662 may
automatically deform
from a straight configuration for delivery through guide catheter 660 into a U-
shaped
configuration, such as if member 662 is made of Nitinol, spring stainless
steel, or other shape
memory or super-elastic material. Alternatively, U-shaped member 662 may be
connected to
anchor delivery device 668 at or near the distal end of the device 668 and may
be pushed
distally to force the U-shaped member 662 to expand into its U-shape. In an
alternative
embodiment, U-shaped member 662 may be attached proximally and may be pulled
into its
expanded configuration. Any suitable method for changing the shape of U-shaped
member
662 from straight to U-shaped may be used in various embodiments. =
[01341 As shown in Fig. 12C, U-shaped member 662 may optionally
include an
expandable member 667, such as an inflatable balloon. Expandable member 667
may be
expanded to provide further force against and support of anchor delivery
device 668, to
enhance its contact with valve annulus tissue. In another embodiment, as shown
in=Fig. 12D,
multiple spring members.672 may be coupled with a distal end of an anchor
delivery device
= 678 to provide force against an inner surface of a heart wall (solid
tipped arrows) to thus
support anchor delivery device 678 against annulus tissue (hollow tipped
arrows). Thus,
various embodiments of the invention may include any of a number of suitable
support
devices for enhancing support of an anchor delivery device against valve
annulus tissue, thus
enhancing the ability of the delivery device to delivery tissue anchors into
the annulus. .
[0135) Referring now to Figs. 13A-13C, in some embodiments it may be
advantageous to
provide one or more devices to enhance the attachment of a terminal tissue
anchor 710 to
valve annulus tissue VA. Typically, in attaching tissue anchors to valve
annulus tissue VA, a
first tethered anchor (not shown) is attached, ad subsequent anchors are then
attached,
ending in a final or terminal anchor 710. A tether 718 is then cinched, to
apply force between
the attached anchors (hollow arrow), thus cinching the valve annulus VA.
Tether 718 is then
typically attached by any suitable means to terminal anchor 710 and then cut
or otherwise
detached proximal to the terminal anchor 710, leaving the cinched, tethered
anchors in place,
CA 3059577 2019-10-22
attached to the valve annulus VA. To relieve some of the tension placed on
terminal anchor
. 710 and/or to provide additional attachment/anchoring strength to the
terminal end of the
tethered anchors, one or more locking members 714 may be deployed at or near
the terminal
end. For example, in one embodiment. locking member 714 comprises a cylinder
slidably
disposed over tether 718, with prongs 712 extending from one end of the
cylinder. Locking
member 714 is deployed out of the distal end of a termination catheter, guide
catheter or the
like (not shown) and is then slid along tether 718, such that prongs 712
contact and enter into
valve annulus tissue VA. In one embodiment, a pusher member 716, such as a
ball slidably
disposed over tether 718, may be used to push locking member 714 forward and
into
engagement with tissue, as shown in Fig. 13B and as designated by solid tipped
arrows. In
some embodiments, locking member 714 engages with terminal anchor 710, as
shown in
Figs. 13B and 130, though such engagement is not required. Once locking member
714 is
fully engaged with valve tissue VA, tether 718 is cut proximal to locking
member 714. In
some embodiments, pusher member 716 remains in place, while in others it may
be removed
before cutting tether 718.
[0136] A number of different variations of locking members are
contemplated in various
embodiments. For example, a two-pronged member may be used, with the prongs
deployable
from a delivery position to and expanded configuration, and with the prongs
optionally
engaging with the terminal anchor 710. In another embodiment, multiple prongs
may be
aligned in a linear fashion along a locking member, such as in a rake-like
configuration. Yet
another embodiment include two prongs for engaging with the terminal anchor
710 and
another prong for engaging with valve annulus tissue VA. Thus, any of a number
of different
embodiments may be employed as part of the present invention. Such locking
members may
be constructed from any suitable material or combination of materials, such as
Nitinol, spring
stainless steel and/or other shape memory or super-elastic materials.
[0137] Figs. 14A-14F demonstrate a method for advancing an anchor
delivery device to a
position for treating a mitral valve MV. The mitral valve MV, including mitral
valve leaflets
MVL are represented diagrammatically from an inferior perspective looking up,
to depict a
method for deliveringe device into subannular space 552. In Fig. 14A, first
guide catheter
550 is show extending up to or into subannular space 552, as in Fig. 11. As
shown in Fig.
14B, in one method a second guide catheter 554 may be advanced through first
guide catheter
550 to pass through/along subannular space 554. This second guide catheter 554
is steerable
=
41
CA 3059577 2019-10-22
in one embodiment, as will be described further below, to help conform second
guide catheter
554 to subannular space 552.
[0138] Next, as in Fig. 14C, a guide sheath 556 may be passed over
second guide catheter
554 to extend along subannular space. Sheath 556 is generally a flexible,
tubular member
that can be passed over second guide catheter 554 and within first guide
catheter 550. To
enhance passage and exchange, any of these and other described catheter
members, sheath
members, or the like may be manufactured from and/or coated with one or more
friction
resistant materials. Once sheath 556 is in place, second guide catheter 554
may be
withdrawn, as shown in Fig. 14D. As shown in Fig. 14E, an anchor delivery
device 558 may
then be advanced through sheath 556 to a position for treating the mitral
valve MV. Sheath
556 may then be withdrawn, as in Fig. 14F, leaving anchor delivery device 558
in place for
performing a treatment. A valve annulus treatment may be performed, as
described
extensively above, and anchor delivery device 558 may be withdrawn.. In some
embodiments, anchor delivery device 558 is used to treat one portion of the
valve annulus
and is then moved to another portion, typically the opposite side, to treat
the other portion of
the annulus. In such embodiments, any one or more of the steps just described
may be
repeated. In some embodiments, anchor delivery device 558 is withdrawn through
first guide
catheter 550, and first guide catheter 550 is then withdrawn. In alternative
embodiments, first
guide catheter 550 may be withdrawn before anchor delivery device 558.
[0139) In various embodiments, alternative means may be used to urge
anchor delivery
device 558 into contact with the valve annulus. For example, in one embodiment
an
expandable member is coupled with anchor delivery device 558 and expanded
within the
subannular space 552. In an alternative embodiment, a magnet may be coupled
with anchor
delivery device 558, and another anchor may be disposed within the coronary
sinus, in
proximity to the first magnet. The two magnets may attract one another, thus
pulling the
anchor delivery device 558 into greater contact with the annulus. In another
embodiment,
anchor delivery device 558 in an expanded (or deployed) state may have a
radius of curvature
that is larger than the radius of curvature of the mitral valve annulus, thus
causing device 558
to be urged against the annulus. In one embodiment, for example, the radius of
curvature of
device 558 in the expandecUdeployed state is about 25%-50% larger than the
radius of
curvature of the antral valve annulus.
[0140] Various embodiments may also include visualizing the annulus
using a
visualization member coupled with the anchor delivery device 558 or separate
from the
42
CA 3059577 2019-10-22
device 558. In some embodiments, anchors may be driven through a strip of
detachable,
biocompatible material, such as Dacron, that is coupled with anchor delivery
device 558 but
that detaches to affix to the valve annulus via the anchors. In some
embodiments, the 'strip
may then be cinched to tighten the annulus. In other embodiments, the anchors
may be
driven through a detachable, biocornpatible, distal portion of the guide
sheath 556, and guide
sheath 556 may then remain attached to the annulus via the anchors. Again, in
some
embodiments, the detached sheath may be cinched to tighten the annulus.
[01411 Of course, the method just described is but one
embodiment of a method for
delivering an anchor delivery device to a location for treating a valve
annulus. In various
= alternative embodiments, one or more steps may be added, deleted or
modified while
achieving a similar result. In some embodiments, a similar method may be used
to treat the
mitral valve from a superior/right atrial position or to treat another heart
valve. Additionally,
other devices or modifications of the system just described may be used in
other
embodiments.
[0142] With reference now to Figs. 15A and 15B, one
embodiment of a steerable catheter
device 560 is shown. Steerable catheter device 560 may be used in a method
such as that just
described in reference to Figs. 14A-14F, for example in performing a function
similar to that
performed by second guide catheter 554. In other embodiments, catheter device
560 may
perform any other suitable function. As shown, catheter device 560 suitably
includes an
elongate catheter body having a proximal portion 562 and a distal portion 564.
At least one
= tensioning member 568, such as but not limited to a tensioning cord,
extends from proximal
.portion 562 to distal portion 564 and is coupled with the distal portion 564
and at least one
= tensioning actuator 570/572 on the proximal portion. Tensioning actuator
570/572 may
include, for example, a knob 570 and a barrel 572 for wrapping and unwrapping
tensioning
member 568 to apply and remove tension. Tensioning member 568 is coupled with
distal
= portion 564 at one or more connection points 580. In some embodiments,
catheter device
560 includes a proximal housing 571, handle or the like, coupled to the
proximal end of
proximal portion 562 via a hub 576 or other means. Housing 571 may be coupled
with
tensioning actuator 570/572 and may include one or more arms 574 for infusing
fluid or for .
other functions. In the embodiment shown, arm 574 and housing 571 include a
lumen 567
that is in fluid communication with a fluid lumen 566 of the catheter body.
Fluid may be
introduced through arm 574 to pass through fluid lumen 566 to provide, for
example, for
= contrast material at the distal tip of catheter device 560 to enhance
visualization of device 560
43
=
CA 3059577 2019-10-22
during a procedure. Any other suitable fluid(s) may be passed through lumens
567/566 for
any other purpose. Another lumen 578 may be included in distal portion 564,
through which
tensioning member 568 passes before attaching at a distal location along
distal portion 564.
[0143] Fig. 15B shows catheter device 560 in a deformed/bent
configuration, after
tension has been applied to distal portion 564 by applying tension to
tensioning member 568,
via knob 570 and barrel 572. The bend in distal portion 564 will allow it to
conform more
readily to a valve annulus, while catheter device 560 in its straight
configuration will be more
amenable to passage through vaseulature of the patient. Tensioning member 568
may be
manufactured from any suitable material or combination of materials, such as
but not limited
to Nitinol, polyester, nylon, polypropylene and/or other polymers. Some
embodiments may
include two or more tensioning members 568 and/or two or more tensioning
actuators
570/572 to provide for changes in shape of distal portion 564 in multiple
directions. In
alternative embodiments, knob 570 and barrel 572 may be substituted with any
suitable
devices, such as a pull cord, button, lever or other actuator. Various
alternatives may also be
substituted for tensioning member 568 in various embodiments. For example,
shaped
expandable members, shape memory members and/or the like may be used to change
the
shape of distal portion 564.
[0144] Generally, proximal portion 562 of the catheter body is less
flexible than distal
portion 564. Proximal portion 562 may be made of any suitable material, such
as PEBAX,
PEP, nylon, polyethylene and/or the like, and may include a braided material,
such as
stainless steel, to provide stiffness and strength. Distal portion 564 may be
made of similar or
other materials, but the braided material is typically not included, to
provide for greater
flexibility. Both proximal and distal portions 562/564 may have any suitable
lengths,
diameters, overall configurations and the like. In one embodiment the catheter
body is
approximately 140 cm in length and 6 French in diameter, but any other
suitable sizes may be
used in other embodiments. Either proximal portion 562, distal portion 564 or
preferably
both, may be made from or coated with one or more friction resistant or
lubricating material
to enhance passage of device 560 through an introducer catheter and/or to
enhance passage of
a sheath or other device over catheter device 560.
[0145] With reference now to Figs. 16A-16E, another aspect of the
present invention
includes improved tissue anchors for enhancing anchor attachment to valve
annulus tissue.
Such improved anchors typically include one or more features to help prevent
the anchors
from pulling out of tissue, when the anchors are placed under tension from a
cinched tether,
44
CA 3059577 2019-10-22
and/or to help promote tissue ingrowth of the anchors to further enhance
attachment. In one
embodiment, as shown in Fig. 16A, a tissue anchor 810 includes outwardly
facing hooks 812
or bends at the ends of the two arms of anchor 810. In another embodiment, as
in Fig. 16B, a
tissue anchor 820 includes inwardly facing hooks 822. In a related embodiment,
shown in
Fig. 16D, a tissue anchor 840 includes multiple bends 842. In any of these
embodiments,
hooks 812, 822 or bends 842 have been found to enhance attachment of anchors
810, 820,
840 to tissue and thus prevent anchor pullout. In another embodiment", shown
in Fig. 16C,
two arms of a tissue anchor 830 are attached at an attachment point 832. The
attachment
point 832 may be formed by any suitable technique, such as soldering or the
like. In another
embodiment, as in Fig. 16E, a belt 852 may be disposed over a tissue anchor
850 to hold the
two arms of the anchor together. In either of the embodiments shown in Figs.
16C and 16E,
holding the two arms of the anchor together has be found to reduce pullout of
the anchors
830, 850 from tissue.
[0146] In the embodiments just described or in alternative
embodiments, tissue anchors
may also have one or more features designed to enhance ingrowth and/or
encapsulation of the
anchors into annular tissue. Such features, for example, may include a
coating, a porous
and/or rough surface, an attachment such as a polyester band or belt, or any
other suitable
surface feature or added feature. By promoting encapsulation of tissue
anchors, attachment
strength of the anchors to tissue is enhanced.
[01471 Referring now to Figs. 17A-17C, in many embodiments, self-
forming anchors 900
are stored in the delivery device in a straightened configuration, coupled
with a tether 902, as
shown in Fig. 17A. Basically, anchors 900 are held or restrained in that
straightened state,
while their natural configuration is curved. Thus, when the straightened
anchor 900 is
released from the delivery device into tissue T, the anchor 900 actually pulls
itself into the
tissue T, as shown in Fig. 17B, due to the storage of potential energy in the
straightened state
and the tendency of each of the arms 901 of anchors 900 to drive the tip of
the arm into the
tissue as illustrated. Arms 901 are joined together at a junction 903. Each
arm 901 is braced
against the other arm so that forces exerted by tissue T on each arm 901 are
opposed by the
other arm 901 wherein the arms are joined to one another. This eliminates the
need for an
anchor driving device, such as required with staples, thus substantially
simplifying the
assembly and method. In addition, bracing arms 901 against one another also
helps to reduce
or eliminate problems associated with tissue deflection. As shown by the
hollow-tipped
arrows in Fig. 17B, the anchor 900 pulls itself into tissue T as it assumes
its natural, curved
CA 3059577 2019-10-22
shape, and exerts forces in vertical, horizontal and curved directions.
Finally, after pulling
itself into tissue and assuming its natural shape, as in Fig. 17C, anchor 900
is fully embedded
in the tissue T.
[0148] In an alternative embodiment, as shown in Fig. 18, anchors 910
may have one
curved arm and one straight arm. Such an anchor 910 will still pull itself
into tissue T, thus
embedding itself and positioning the tether 912 flush with the tissue T.
[0149] Referring now to Fig. 19A, some embodiments of a valve ann-
uIus anchor device
may include anchors 922, a tether 924, a distal force applying member 927
coupled with the
tether 924, a termination member 926 and one or more force distributing
sleeves 920
disposed over the tether 924 and between adjacent anchors 922. In one
embodiment, as
shown, a separate sleeve 920 may be disposed between two adjacent anchors
922a, 922b.
Additional sleeves 920 may optionally be disposed between other sets of two
anchors, such
as anchors 922b and 922c. in Fig. 19A, only three anchors 922 are shown for
simplicity, but
= any number of anchors 922 and sleeves 920 between anchors may be used in
various
embodiments. Sleeve 920 acts to distribute force applied between two adjacent
anchors 922,
to help prevent such anchors 922 from pulling out of tissue when force is
applied to tether
924. Sleeve 922 may be made of any suitable material, such as but not limited
to metals,
such as Nitinol, polymers, fabrics and the like. Sleeve 922 may be a solid
cylindrical
member, or alternatively may have patterned cut-outs, like a stent, or be made
of ribbed,
woven, braided, porous, nonporous or any other suitable material, pattern,
configuration or
the like. Sleeve 920 may be essentially rigid and axially incompressible,
while in other
embodiments it may be axially compressible. In one embodiment, sleeve 920 may
be
configured as two rings, disposed adjacent two anchors 922, with the rings
being connected
by a rod or shaft, so that tether 924 is not encircled by the sleeve 922.
[0150] With reference now to Fig. 19B, in an alternative embodiment,
a sleeve 930 may
be disposed over a tether 934 so as to extend between more than two anchors
932. Such a
sleeve 930 may thus distribute force applied between a termination member 936
and a force
applying member 937 so as to help prevent anchor pull-out from tissue. Such a
sleeve 930
may include one or more openings through which one or more middle anchors may
extend.
Again, sleeve 930 may have any suitable configuration, size, shape or the like
and be made of
any suitable material or combination of materials. Sleeve 930 may extend
between three,
four, five or any suitable number of anchors 932 in various embodiments. In an
alternative
46
CA 3059577 2019-10-22
embodiment, sleeve 930 may be pierced by one or more of the anchors 932 and
thus attached
to valve annulus tissue.
[0151] Although the foregoing is a complete and accurate description
of the present
invention, the description provided above is for exemplary purposes only, and
variations may
be made to the embodiments described without departing from the scope of the
invention.
Thus, the above description should not be construed to limit the scope of the
invention as
described in the appended claims.
47
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