U.S. patent application number 16/576025 was filed with the patent office on 2020-01-09 for tissue shaping device.
The applicant listed for this patent is Cruz BEESON, Leonard KOWALSKY, Mark L. MATHIS, David G. REUTER. Invention is credited to Cruz BEESON, Leonard KOWALSKY, Mark L. MATHIS, David G. REUTER.
Application Number | 20200008943 16/576025 |
Document ID | / |
Family ID | 29399956 |
Filed Date | 2020-01-09 |
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United States Patent
Application |
20200008943 |
Kind Code |
A1 |
MATHIS; Mark L. ; et
al. |
January 9, 2020 |
TISSUE SHAPING DEVICE
Abstract
An anchor anchors a therapeutic device having an elongated body
within a body lumen. The anchor includes a fixation member carried
on the device which is adjustable from a first configuration that
permits placement of the device in the body lumen to a second
configuration that anchors the device within the body lumen. The
anchor further includes a lock that locks the fixation member in
the second configuration. The fixation member may be locked in any
one of a plurality of intermediate points between the first
configuration and a maximum second configuration.
Inventors: |
MATHIS; Mark L.; (Fremont,
CA) ; KOWALSKY; Leonard; (Bothell, WA) ;
REUTER; David G.; (Bothell, WA) ; BEESON; Cruz;
(Chico, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MATHIS; Mark L.
KOWALSKY; Leonard
REUTER; David G.
BEESON; Cruz |
Fremont
Bothell
Bothell
Chico |
CA
WA
WA
CA |
US
US
US
US |
|
|
Family ID: |
29399956 |
Appl. No.: |
16/576025 |
Filed: |
September 19, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15261628 |
Sep 9, 2016 |
10456258 |
|
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16576025 |
|
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|
|
10994153 |
Nov 19, 2004 |
9474608 |
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15261628 |
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10142637 |
May 8, 2002 |
6824562 |
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10994153 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/2466 20130101;
A61F 2250/0004 20130101; A61F 2250/0012 20130101; A61F 2250/0086
20130101; A61F 2230/0023 20130101; A61F 2210/0014 20130101; A61F
2250/0008 20130101; A61F 2002/91591 20130101; A61F 2/2451 20130101;
A61F 2310/00023 20130101; A61F 2310/00017 20130101; A61F 2220/0091
20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. A mitral valve therapy device comprising: a distal expandable
anchor, a proximal expandable anchor, and a connecting member
extending between the distal expandable anchor and the proximal
expandable anchor, the distal expandable anchor having a distal
expanded configuration and the proximal expandable anchor having a
proximal expanded configuration, wherein the distal anchor includes
a distal expandable member and a proximal expandable member, the
distal expandable member coupled to the proximal expandable
member.
2. The device of claim 1, wherein the distal expandable member
extends from a distal anchor distal end to a distal anchor apex,
and wherein the proximal expandable member extends from the distal
anchor apex to a distal anchor proximal end.
3. The device of claim 1, wherein the distal expandable member is
coupled to the proximal expandable member at a distal anchor
apex.
4. The device of claim 1, wherein a distal end of the proximal
expandable member is coupled to proximal end of the distal
expandable member.
5. The device of claim 4, wherein the distal end of the proximal
expandable member is coupled to the proximal end of the distal
expandable member at an apex of the distal anchor.
6. The device of claim 1, wherein the distal expandable member has
a hoop configuration, to which a distal end of the proximal
expandable member is attached.
7. The device of claim 1, wherein the distal expandable member
extends radially inward from a distal anchor apex to a distal
anchor distal end.
8. The device of claim 1, wherein the proximal expandable member
extends radially inward from a distal anchor apex to a distal
anchor proximal end.
9. A mitral valve therapy device comprising: a distal expandable
anchor, a proximal expandable anchor, and a connecting member
extending between the distal expandable anchor and the proximal
expandable anchor, the distal expandable anchor having a distal
expanded configuration and the proximal expandable anchor having a
proximal expanded configuration, the distal anchor including a
first expansion member and a second expansion member, the first
expansion member extending radially outward from a distal anchor
securing member in a first direction, the second expansion member
extending radially outward from the distal anchor securing member
in a second direction, the second direction different than the
first direction.
10. A tissue reshaping device, comprising: a distal expandable
anchor, a proximal expandable anchor, and a connecting member
having a fixed length between the distal expandable anchor and the
proximal expandable anchor, the distal expandable anchor having a
fully expanded configuration and the proximal expandable anchor
having a fully expanded configuration, the distal expandable anchor
comprising a body, the body having, in a side view, a proximal
region that extends radially outward from the connecting member to
an apex of the distal expandable anchor, and a distal region that
is distal to the apex, the distal region extending radially inwards
from the apex towards a distal end of the distal expandable
anchor.
11. The device of claim 10, wherein the proximal region extends
radially outward and distally from the connecting member to the
apex.
12. The device of claim 11, wherein the proximal region includes a
proximal end of the body that extends from the connecting member.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/261,628, filed Sep. 9, 2016, which is a
continuation of U.S. patent application Ser. No. 10/994,153, filed
Nov. 19, 2004, now U.S. Pat. No. 9,474,608 (issued Oct. 25, 2016)
which is a divisional of U.S. application Ser. No. 10/142,637,
filed May 8, 2002, now U.S. Pat. No. 6,824,562 (issued Nov. 30,
2004), each of which are incorporated herein by reference in its
entirety.
INCORPORATION BY REFERENCE
[0002] All publications and patent applications mentioned in this
specification are incorporated herein by reference in their
entirety to the same extent as if each individual publication or
patent application was specifically and individually indicated to
be incorporated by reference.
FIELD
[0003] The present invention generally relates to an anchor for use
with a device which requires anchoring in a body lumen. The present
invention more particularly relates to a mitral valve annulus
device and assembly wherein the device is deployed and anchored in
the coronary sinus of a heart adjacent the mitral valve annulus to
reshape the mitral valve annulus.
BACKGROUND
[0004] The human heart generally includes four valves. Of these
valves, a most critical one is known as the mitral valve. The
mitral valve is located in the left atrial ventricular opening
between the left atrium and left ventricle. The mitral valve is
intended to prevent regurgitation of blood from the left ventricle
into the left atrium when the left ventricle contracts. In
preventing blood regurgitation the mitral valve must be able to
withstand considerable back pressure as the left ventricle
contracts.
[0005] The valve cusps of the mitral valve are anchored to muscular
wall of the heart by delicate but strong fibrous cords in order to
support the cusps during left ventricular contraction. In a healthy
mitral valve, the geometry of the mitral valve ensures that the
cusps overlie each other to preclude regurgitation of the blood
during left ventricular contraction.
[0006] The normal functioning of the mitral valve in preventing
regurgitation can be impaired by dilated cardiomyopathy caused by
disease or certain natural defects. For example, certain diseases
may cause dilation of the mitral valve annulus. This can result in
deformation of the mitral valve geometry to cause ineffective
closure of the mitral valve during left ventricular contraction.
Such ineffective closure results in leakage through the mitral
valve and regurgitation. Diseases such as bacterial inflammations
of the heart or heart failure can cause the aforementioned
distortion or dilation of the mitral valve annulus. Needless to
say, mitral valve regurgitation must not go uncorrected.
[0007] One method of repairing a mitral valve having impaired
function is to completely replace the valve. This method has been
found to be particularly suitable for replacing a mitral valve when
one of the cusps has been severely damaged or deformed. While the
replacement of the entire valve eliminates the immediate problem
associated with a dilated mitral valve annulus, presently available
prosthetic heart valves do not possess the same durability as
natural heart valves.
[0008] Various other surgical procedures have been developed to
correct the deformation of the mitral valve annulus and thus retain
the intact natural heart valve function. These surgical techniques
involve repairing the shape of the dilated or deformed valve
annulus. Such techniques, generally known as annuloplasty, require
surgically restricting the valve annulus to minimize dilation.
Here, a prosthesis is typically sutured about the base of the valve
leaflets to reshape the valve annulus and restrict the movement of
the valve annulus during the opening and closing of the mitral
valve.
[0009] Many different types of prostheses have been developed for
use in such surgery. In general, prostheses are annular or
partially annular shaped members which fit about the base of the
valve annulus. The annular or partially annular shaped members may
be formed from a rigid material, such as a metal, or from a
flexible material.
[0010] While the prior art methods mentioned above have been able
to achieve some success in treating mitral regurgitation, they have
not been without problems and potential adverse consequences. For
example, these procedures require open heart surgery. Such
procedures are expensive, are extremely invasive requiring
considerable recovery time, and pose the concomitant mortality
risks associated with such procedures. Moreover, such open heart
procedures are particularly stressful on patients with a
compromised cardiac condition. Given these factors, such procedures
are often reserved as a last resort and hence are employed late in
the mitral regurgitation progression. Further, the effectiveness of
such procedures is difficult to assess during the procedure and may
not be known until a much later time. Hence, the ability to make
adjustments to or changes in the prostheses to obtain
optimum-effectiveness is extremely limited. Later corrections, if
made at all, require still another open heart surgery.
[0011] An improved therapy to treat mitral regurgitation without
resorting to open heart surgery has recently been proposed. This is
rendered possible by the realization that the coronary sinus of a
heart is near to and at least partially encircles the mitral valve
annulus and then extends into a venous system including the great
cardiac vein. As used herein, the term "coronary sinus" is meant to
refer to not only the coronary sinus itself but in addition, the
venous system associated with the coronary sinus including the
great cardiac vein. The therapy contemplates the use of a device
introduced into the coronary sinus to reshape and advantageously
effect the geometry of the mitral valve annulus.
[0012] The device includes a resilient member having a cross
sectional dimension for being received within the coronary sinus of
the heart and a longitudinal dimension having an unstressed arched
configuration when placed in the coronary sinus. The device
partially encircles and exerts an inward pressure on the mitral
valve. The inward pressure constricts the mitral valve annulus, or
at least a portion of it, to essentially restore the mitral valve
geometry. This promotes effective valve sealing action and
eliminates mitral regurgitation.
[0013] The device may be implanted in the coronary sinus using only
percutaneous techniques similar to the techniques used to implant
cardiac leads such as pacemaker leads. One proposed system for
implanting the device includes an elongated introducer configured
for being releasably coupled to the device. The introducer is
preferably flexible to permit it to advance the device into the
heart and into the coronary sinus through the coronary sinus
ostium. To promote guidance, an elongated sheath is first advanced
into the coronary sinus. Then, the device and introducer are moved
through a lumen of the sheath until the device is in position
within the coronary sinus. Because the device is formed of
resilient material, it conforms to the curvatures of the lumen as
it is advanced through the sheath. The sheath is then partially
retracted to permit the device to assume its unstressed arched
configuration. Once the device is properly positioned, the
introducer is then decoupled from the device and retracted through
the sheath. The procedure is then completed by the retraction of
the sheath. As a result, the device is left within the coronary
sinus to exert the inward pressure on the mitral valve to restore
mitral valve geometry.
[0014] The foregoing therapy has many advantages over the
traditional open heart surgery approach. Since the device, system
and method may be employed in a comparatively noninvasive
procedure, mitral valve regurgitation may be treated at an early
stage in the mitral regurgitation progression. Further, the device
may be placed with relative ease by any minimally invasive
cardiologist. Still further, since the heart remains completely
intact throughout the procedure, the effectiveness of the procedure
may be readily determined. Moreover, should adjustments be deemed
desirable, such adjustments may be made during the procedure and
before the patient is sent to recovery.
[0015] Another approach to treat mitral regurgitation with a device
in the coronary sinus is based upon the observation that the
application of a localized force against a discrete portion of the
mitral valve annulus can terminate mitral regurgitation. This
suggests that mitral regurgitation may be localized and nonuniform.
Hence, the device applies a force to one or more discrete portions
of the atrial wall of the coronary sinus to provide localized
mitral valve annulus reshaping instead of generalized reshaping of
the mitral valve annulus. Such localized therapy would have all the
benefits of the generalized therapy. In addition, a localized
therapy device may be easier to implant and adjust.
[0016] A still further approach to treat mitral regurgitation from
the coronary sinus of the heart contemplates a device having a
first anchor configured to be positioned within and fixed to the
coronary sinus of the heart adjacent the mitral valve annulus
within the heart, a cable fixed to the first anchor and extending
proximally from the first anchor within the heart, a second anchor
configured to be positioned in and fixed in the heart proximal to
the first anchor and arranged to slidingly receive the cable, and a
lock that locks the cable on the second anchor. When the first and
second anchors are fixed within the heart, the cable may be drawn
proximally and locked on the second anchor. The geometry of the
mitral valve is thereby effected. This approach provides
flexibility in that the second anchor may be positioned and fixed
in the coronary sinus or alternatively, the second anchor may be
positioned and fixed in the right atrium. This approach further
allows adjustments in the cable tension after implant.
[0017] A still further alternative for treating mitral
regurgitation contemplates a device having a first anchor
configured to be positioned within and anchored to the coronary
sinus of the heart adjacent the mitral valve annulus within the
heart. A second anchor is configured to be positioned within the
heart proximal to the first anchor and adjacent the mitral valve
annulus within the heart. A connecting member, having a fixed
length, is permanently attached to the first and second anchors. As
a result, when the first and second anchors are within the heart
with the first anchor anchored in the coronary sinus, the second
anchor may be displaced proximally to effect the geometry of the
mitral valve annulus and released to maintain the effect on the
mitral valve geometry. The second anchor may be configured, when
deployed, to anchor against distal movement but be movable
proximally to permit the second anchor to be displaced proximally
within the coronary sinus.
[0018] A further device that effects the condition of a mitral
valve annulus of a heart also includes an elongated member
dimensioned to be placed in the coronary sinus of the heart
adjacent the mitral valve annulus. Here, the elongated member is
flexible when placed in the heart in a first orientation to
position the device in the coronary sinus adjacent the mitral valve
annulus and relatively inflexible when rotated into a second
orientation after the device is positioned in the coronary sinus
adjacent to the mitral valve annulus.
[0019] The device thus has a first radius of curvature when in the
first orientation and a second and greater radius of curvature when
in the second orientation to effect the mitral valve geometry. Once
positioned and in the second orientation, the device is anchored
against both longitudinal and rotational movement.
[0020] Devices, other than those described above may be placed in
body lumens other than the coronary sinus for therapeutic effect.
All such devices must be anchored against movement when deployed at
least for an acute phase until the natural body mechanisms produce
sufficient fibrotic tissue about the devices for permanent
fixation. While the device anchors must protect against device
movement, they must also allow ready deployment to facilitate
device implant. However, it is desirable that the anchors also be
readily releasable, at least during the acute phase to permit
device position adjustment or even device removal if required. All
of these factors are especially important for devices implanted in
the heart because of the potential need for precise device
positioning during implant and the extreme movement of the heart
during heartbeats.
SUMMARY OF THE DISCLOSURE
[0021] The invention provides an anchor that anchors a device
having an elongated body in a body lumen. The anchor includes a
fixation member carried on the device, the fixation member being
adjustable from a first configuration that permits placement of the
device in the body lumen to a second configuration that anchors the
device within the body lumen, and a lock that locks the fixation
member in the second configuration.
[0022] The lock is releasable to release the fixation member from
the second configuration to permit the device to be removed from
the body lumen. The fixation member may also be deformable to
permit the device to be moved within the body lumen.
[0023] The fixation member is adjustable from the first
configuration to a maximum second configuration. The lock may be
configured to lock the fixation member at any one of a plurality of
intermediate points between the first configuration and the maximum
second configuration.
[0024] The fixation member may be elongated and have a first end
hingedly coupled to the device body. The fixation member may thus
extend along the device body closely spaced to the device body when
in the first configuration and be pivoted from the device body to
the second configuration to engage and anchor the device in the
body lumen.
[0025] The anchor may further include a support that renders the
fixation member substantially rigid when in the second
configuration. The support may be an extension of the fixation
member, wherein the fixation member includes a second end opposite
the first end and wherein the lock locks the fixation member second
end on the device body.
[0026] The fixation member may include a second end opposite the
first end. The support may include a support member having a first
end hingedly coupled to the fixation member second end and a second
end opposite the support member first end. The lock may lock the
support member second end on the device body. The support member
second end may be slidable along the device body. The anchor may
include a plurality of the fixation members and/or a plurality of
support members.
[0027] The invention further provides a device that effects the
condition of a mitral valve annulus of a heart. The device includes
an elongated body dimensioned to be placed in the coronary sinus of
the heart adjacent the mitral valve annulus. The device further
includes a fixation member carried by the device, the fixation
member being adjustable from a first configuration that permits
placement of the device in the coronary sinus to a second
configuration that anchors the device within the coronary sinus,
and a lock that locks the fixation member in the second
configuration.
[0028] The lock is releasable to release the fixation member from
the second configuration to permit the device to be moved within
the coronary sinus. The fixation member may be deformable to permit
the device to be moved within the coronary sinus.
[0029] The fixation member may be adjustable from the first
configuration to a maximum second configuration and the lock may
lock the fixation member at any one of a plurality of intermediate
points between the first configuration and the maximum second
configuration.
[0030] The fixation member is elongated and has a first end
hingedly coupled to the device body. The fixation member may extend
along the device body closely spaced to the device body when in the
first configuration and may be pivoted from the device body when in
the second configuration to engage the coronary sinus and anchor
the device in the coronary sinus. The device may further include a
support that renders the fixation member substantially rigid when
in the second configuration. The support may be an extension of the
fixation member, wherein the fixation member includes a second end
opposite the first end and wherein the lock locks the fixation
member second end on the device body. The fixation member second
end may be slidable along the device body and the device may
include a plurality of the fixation members.
[0031] The fixation member may include a second end opposite the
first end. The support may be a separate support member having a
first end hingedly coupled to the fixation member second end and
second end opposite the support member first end. The lock may then
lock the support member second end on the device body. The support
member second end may be slidable along the device body. The device
may include a plurality of the fixation members and support
members.
[0032] The invention further provides an assembly that effects the
condition of a mitral valve annulus of a heart. The assembly
includes a mitral valve therapy device dimensioned to be placed in
the coronary sinus adjacent the mitral valve annulus. The device
includes an elongated body, a fixation member carried by the
device, the fixation member being adjustable from a first
configuration that permits placement of the device in the coronary
sinus to a second configuration that anchors the device within the
coronary sinus, and a lock that locks the fixation member in the
second configuration. The assembly further includes a flexible
catheter having a lumen that receives the device and being
dimensioned to be advanced into the coronary sinus to place the
device adjacent the coronary sinus.
[0033] The assembly may further include an elongated pusher that is
received by the lumen of the catheter proximal to the device and
that permits the device and the catheter to be moved opposite each
other. The assembly may further include a tether receivable by the
catheter lumen and engageable with the device to pull the device
distally with respect to the catheter. The catheter may be used to
transition the fixation member from the first configuration to the
second configuration. For example, the fixation member may be
elongated and have a first end hingedly coupled to the device body.
The fixation member may then extend along the device body when in
the first configuration and the fixation member may be pivoted from
the device body into the second configuration by distal movement of
the catheter with respect to the device to cause the fixation
member to engage the coronary sinus and anchor the device in the
coronary sinus.
BRIEF DESCRIPTION OF THE DRAWINGS
[0034] The features of the present invention which are believed to
be novel are set forth with particularity in the appended claims.
The invention, together with further aspects and advantages
thereof, may best be understood by making reference to the
following description taken in conjunction with the accompanying
drawings, in the several figures of which like reference numerals
identify identical elements, and wherein:
[0035] FIG. 1 is a superior view of a human heart with the atria
removed;
[0036] FIG. 2 is a superior view of a human heart similar to FIG. 1
illustrating a mitral valve therapy device including an anchor
embodying the present invention deployed therein along with an
assembly embodying the present invention for deploying the
device;
[0037] FIG. 3 is a side view with portions cut away illustrating a
first step in deploying the device anchor of the device of FIG.
2;
[0038] FIG. 4 is a side view similar to FIG. 3 illustrating a
further step in the deployment of the anchor embodying the present
invention;
[0039] FIG. 5 is a side view similar to FIG. 3 illustrating a
further step in the deployment of the device anchor;
[0040] FIG. 6 is a side view similar to FIG. 3 illustrating the
deployed device anchor;
[0041] FIG. 7 is a side view similar to FIG. 3 illustrating a first
step in the removal of the device anchor;
[0042] FIG. 8 is a side view similar to FIG. 3 illustrating a final
step in the removal of the device anchor;
[0043] FIG. 9 is a side view similar to FIG. 3 illustrating an
alternate embodiment of a deployed device anchor embodying the
present invention;
[0044] FIG. 10 is a side view similar to FIG. 3 illustrating a
further embodiment of a deployed device anchor embodying the
present invention;
[0045] FIG. 11 is a side view similar to FIG. 3 illustrating a
still further embodiment of a deployed device anchor embodying the
present invention; and
[0046] FIG. 12 is an end view of FIG. 11.
DETAILED DESCRIPTION
[0047] Referring now to FIG. 1, it is a superior view of a human
heart 10 with the atria removed to expose the mitral valve 12, the
coronary sinus 14, the coronary artery 15, and the circumflex
artery 17 of the heart 10 to lend a better understanding of the
present invention. Also generally shown in FIG. 1 are the pulmonary
valve 22, the aortic valve 24, and the tricuspid valve 26 of the
heart 10.
[0048] The mitral valve 12 includes an anterior cusp 16, a
posterior cusp 18 and an annulus 20. The annulus encircles the
cusps 16 and 18 and maintains their spacing to provide a complete
closure during a left ventricular contraction. As is well known,
the coronary sinus 14 partially encircles the mitral valve 12
adjacent to the mitral valve annulus 20. As is also known, the
coronary sinus is part of the venous system of the heart and
extends along the AV groove between the left atrium and the left
ventricle. This places the coronary sinus essentially within the
same plane as the mitral valve annulus making the coronary sinus
available for placement of the mitral valve therapy device of the
present invention therein.
[0049] FIG. 2 shows a mitral valve therapy device 30 embodying the
present invention shown deployed in the coronary sinus 14 of the
heart 10 adjacent the mitral valve annulus 20 for effecting the
geometry of the mitral valve annulus. Also shown in FIG. 2 is a
deployment system 50 that deploys the device 30 in the coronary
sinus 14. The device 30 takes the form of an elongated body 32
which includes a distal anchor 34 embodying the present invention
and a proximal anchor 36.
[0050] The anchors 34 and 36 are shown in FIG. 2 in their deployed
configuration. As will be seen hereinafter, upon deployment of the
device 30 in the coronary sinus, the distal anchor 34 is
transitioned from a first configuration to a locked second
configuration. In the process, it is expanded outwardly to anchor
the device in the coronary sinus against both bi-directional
longitudinal and rotational movement. The proximal anchor however,
when deployed, is configured to permit proximal movement. This
allows the device 30 to be tightened within the coronary sinus by
proximal pulling of the anchor 36 after the distal anchor 34 is
deployed. The device 30 may be formed from Nitinol or stainless
steel, for example.
[0051] The deployment system 52 illustrated in FIG. 2 includes an
elongated catheter 50, an elongated pusher 54, and a tether 56. In
deploying the device 30, the tether 56 is first looped about the
proximal anchor 36 of the device 30 as illustrated and the device
is then loaded into the catheter 50. The tether 56 is then threaded
through an internal lumen 58 of the pusher 54 and looped around the
proximal anchor 36 of the device 30 as illustrated. The pusher 54
is then advanced along the tether 56 for engaging the device 30 and
pushing the device distally down the catheter to a predetermined
position at the distal end of the catheter 50. The catheter with
the device 30 loaded therein is then fed into the heart and through
the coronary sinus ostium 31 into the coronary sinus to place the
catheter in a position such that the device 30 is adjacent the
mitral valve annulus 20. Thereafter, the device is maintained in a
stationary position by the pusher 54 as the catheter 50 is
partially withdrawn to expose the distal anchor 34. Once the distal
anchor is exposed, it is deployed by the catheter in a manner to be
described more particularly with respect to FIGS. 3-6. Once the
distal anchor 34 is deployed, the catheter 50 is then retracted
proximally of the proximal anchor 36. This exposes the proximal
anchor 36 and permits the proximal anchor to self deploy. Once the
proximal anchor is deployed, the tether 56 is pulled proximally to
move the proximal anchor 36 in a proximal direction for tightening
the device within the coronary sinus and to an extent which results
in the desired effect on the geometry of the mitral valve annulus
20. During this adjustment process, mitral regurgitation may be
monitored and the device adjusted for optimal results. When the
device 30 is in its final position within the coronary sinus 14,
the pusher 54 and catheter 50 may be removed from the heart. The
tether 56 may be permitted to remain in the heart during an acute
phase to ascertain the effectiveness of the device 30. Should
further adjustment of the device be necessary, the tether 56 may
then be used as a guide for guiding the introduction of the
catheter 50 back into the heart.
[0052] FIGS. 3-6 illustrate the manner in which the distal anchor
34 may be deployed in the coronary sinus 14 for anchoring the
device 30. It will be appreciated by those skilled in the art, of
course, that the anchor 34 may be utilized in body lumens other
than the coronary sinus and with therapeutic devices other than the
mitral valve annulus therapy device illustrated in FIG. 2.
[0053] In each of FIGS. 3-6 a portion of the coronary sinus has
been removed and the pusher has not been illustrated so as to not
unduly complicate the figures. FIG. 3 shows the catheter 50
disposed within the coronary sinus 14 with the device 30 and distal
anchor within the catheter 50. To that end, the catheter includes a
lumen 60 which is dimensioned to receive the device 30 and the
distal anchor 34 when the distal anchor 34 is in a first
configuration. The distal anchor 34 includes an elongated fixation
member 38 which is hingedly coupled to the distal end of the device
30 at a hinge 40. The elongated fixation member thus extends along
the body of the device 30. The fixation member includes a support
42 which is an extension of the fixation member 38 and which is
hingedly connected to the fixation member 38 at a hinge point 44.
The proximal end of the fixation member 38 includes a loop 46 which
is looped about the device 30 to permit the loop 46 to slide along
the device 30. As will be seen subsequently, the loop 46 forms part
of a lock for locking the anchor 34 in a second configuration for
anchoring in the coronary sinus.
[0054] To complete the anchor, the device 30 includes a resilient
enlarged portion 48 over which the loop 46 may slide. Once the loop
46 is located distally of the enlarged portion 48, it will be held
by the enlarged portion 48 for locking the device in the second
configuration.
[0055] FIG. 4 illustrates the anchor 34 after the catheter 50 has
been moved proximal to the anchor 34. More specifically, it will be
noted that the distal end of the catheter 50 is now proximal to the
loop 46 or proximal end of the anchor 34. The shape memory of the
anchor has caused the anchor to expand and is now partially
transitioned from the first configuration of FIG. 3 to the second
and final configuration to be described with reference to FIG. 6
subsequently.
[0056] FIG. 5 illustrates the anchor 34 being transitioned from the
first configuration to the second configuration. This transition is
implemented by the distal end of the catheter 50 pushing the
proximal end of the anchor 34 in the distal direction. To maintain
the position of the anchor 34 during the transition, the tether 56
is used to hold the device 30 against distal movement.
[0057] The particular configuration of the distal anchor 34 in
accordance with this embodiment may be more particularly seen in
FIG. 5. Here it may be seen that the distal anchor is formed of a
wire having a first end secured to the distal end of the device 30,
folded back and looped around the device and then back to the
distal end of the device. Both ends of the anchor are then crimped
by a crimp 70. This configuration results in a pair of fixation
members 38 each having a support extension 42. In addition, the
fixation members 38 may be formed so as to have a loop
configuration to maximize surface contact with the inner wall of
the coronary sinus 14. As shown, one of the fixation members 38
crosses the other fixation member 38 at a location between a distal
end and a proximal end of the distal anchor 34.
[0058] As the catheter 50 is moved distally, it forces the loop 46
of the anchor 34 over the enlarged portion 48 of the device 30 to a
point distal to the enlarged portion 48. This locks the loop 46
distally of the enlarged portion 48 for locking the anchor 34 in an
enlarged second configuration as illustrated in FIG. 6 to anchor
the device 30 within the coronary sinus 14. More specifically, it
may be seen that the supports 42 have been pivoted at the hinge 44
relative to the fixation member 38. This allows the fixation
members 38 to be supported by the supports 42 and securely locked
by the lock of the loop 46 and enlarged portion 48 of the device
30. The fixation members 38 provide broad surface contact with the
inner wall of the coronary sinus 14. This provides for anchoring
within the coronary sinus of the device 30 against both
bi-directional longitudinal and rotational movement. Once the
anchor 34 is deployed as illustrated in FIG. 6, the catheter 50 may
then be removed as indicated by the arrow 72.
[0059] One of the many features of the anchor of the instant
invention is that it may be moved within or removed from the body
lumen in which it is deployed. More specifically, and making
reference to FIG. 6, the anchor 34 may be removed by grabbing the
support members 42 and pulling the loop 46 over the resilient
enlarged portion 48 of the device 30. When the loop 46 is on the
proximal side of the enlarged portion 48, further proximal movement
of the loop 46 will fully transition the anchor 34 from the second
configuration back to the first configuration for removal within
the catheter 50.
[0060] Alternatively, by virtue of the support members, the anchor
34 may be formed of deformable material such as stainless steel.
Using this to advantage, the anchor 34 may be partially collapsed
by the catheter 50 to permit the anchor 34 and hence the device 30
to be moved and repositioned in the coronary sinus after which the
resilience of the anchor material returns the anchor to its locked
and deployed configuration. The anchor may be collapsed by the
catheter 50 as illustrated in FIGS. 7 and 8.
[0061] In FIG. 7, it will be noted that the catheter 50, while the
device is held stationary by the tether, is moved distally over the
enlarged portion 48 and the loop 46. The anchor 34 is now partially
collapsed for movement and repositioning. Once repositioned, the
catheter may be withdrawn to redeploy the anchor 34 which returns
to its second configuration by virtue of its resiliency and shape
memory.
[0062] As seen in FIG. 8, continued distal movement of the catheter
50 causes the anchor 34 to fully collapse. This allows the anchor
34 to be totally drawn into the catheter 50. Once the anchor 34 is
collapsed and within the catheter 50, the device 30 may be removed
by removing the catheter with the device therein or by pulling the
device proximally through the catheter.
[0063] FIGS. 9-12 illustrate alternative embodiments of the anchor
of the present invention. These embodiments are once again
illustrated in connection with the anchoring of a mitral valve
annulus therapy device within the coronary sinus of a heart.
[0064] In FIG. 9, the device 30 is shown having a plurality of
enlarged portions 46. As a result, a plurality of locks are
provided on the device 30 to enable the fixation members to be
locked at any one of a plurality of intermediate points between the
first configuration and a maximum second configuration illustrated
in FIG. 9. This enables the anchor 34 to be sized to a given body
lumen.
[0065] FIG. 10 shows another anchor 84 embodying the present
invention which has a separate fixation member 88 and support
member 92. The second or distal end of the fixation member 88 is
hingedly coupled to a first or distal end of the support member 92
by a hinged connection 94. The fixation member 88 may have a hoop
configuration as the fixation members 38 previously described.
[0066] FIGS. 11 and 12 illustrated a still further anchor 104
having a pair of fixation members 108 and corresponding separate
support members 112. Here, the fixation members 108 are formed by
immediately adjacent anchor wires which, as best seen in FIG. 12,
are disposed at an angle to permit a cardiac lead, indicated by the
dashed circle 120, to pass through the anchor and thus be within
the coronary sinus. Hence, a device having an anchor such as anchor
104 is compatible with the provision of a cardiac lead
therewith.
[0067] As can thus been seen, the present invention provides a new
and improved anchor for anchoring a therapeutic device within a
body lumen. The anchor of the present invention, by virtue of the
lockable support member, creates mechanical advantage to assist
deployment of the anchor. This also increases anchor strength.
Because the support members may be of hooped or looped
configuration, increased contact area between the anchor and the
body lumen can be achieved. In addition, the anchor of the present
invention allows deactivation and repositioning of the anchor or
therapeutic device incorporating the anchor. Still further, because
of the locked support structure, the anchor may be formed of
smaller diameter wire, tube wall, or other materials which without
the locked support provided by the anchor of the present invention
would be unsuitable for this application.
[0068] While particular embodiments of the present invention have
been shown and described, modifications may be made. It is
therefore intended in the appended claims to cover all such changes
and modifications which fall within the true spirit and scope of
the invention.
* * * * *