U.S. patent application number 12/952057 was filed with the patent office on 2011-03-17 for percutaneous mitral valve annuloplasty delivery system.
Invention is credited to Ryan Braxtan, Brian J. Doll, Lucas S. Gordon, Leonard Kowalsky, Mark L. Mathis, Gregory Nieminen.
Application Number | 20110066234 12/952057 |
Document ID | / |
Family ID | 46302862 |
Filed Date | 2011-03-17 |
United States Patent
Application |
20110066234 |
Kind Code |
A1 |
Gordon; Lucas S. ; et
al. |
March 17, 2011 |
Percutaneous Mitral Valve Annuloplasty Delivery System
Abstract
The invention is a tissue shaping system, including a tissue
shaping device with an expandable anchor and a lock; a delivery
catheter; a delivery mechanism adapted to deliver the tissue
shaping device from outside a patient to a target site within a
lumen within the patient via the delivery catheter; and an actuator
adapted to deliver an actuation force to the lock to lock the
anchor in an expanded configuration. The invention is also a system
adapted to percutaneously deliver and deploy a tissue shaping
device at a target site within a lumen of a patient. The system
includes: a handle; a delivery mechanism supported by the handle
and adapted to deliver the tissue shaping device from outside the
patient to the treatment site via a delivery catheter; and an
actuator supported by the handle and adapted to deliver an
actuation force to lock an anchor of the tissue shaping device in
an expanded configuration.
Inventors: |
Gordon; Lucas S.; (Issaquah,
WA) ; Mathis; Mark L.; (Fremont, CA) ;
Nieminen; Gregory; (Bothell, WA) ; Kowalsky;
Leonard; (Bothell, WA) ; Braxtan; Ryan;
(Sammamish, WA) ; Doll; Brian J.; (Sammamish,
WA) |
Family ID: |
46302862 |
Appl. No.: |
12/952057 |
Filed: |
November 22, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10946332 |
Sep 20, 2004 |
7837729 |
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12952057 |
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10313914 |
Dec 5, 2002 |
7316708 |
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10946332 |
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10331143 |
Dec 26, 2002 |
6793673 |
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10313914 |
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Current U.S.
Class: |
623/2.11 |
Current CPC
Class: |
A61F 2/9517 20200501;
A61F 2/95 20130101; A61F 2/2451 20130101; A61F 2002/9511 20130101;
A61B 17/3468 20130101 |
Class at
Publication: |
623/2.11 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. A tissue shaping system comprising: a tissue shaping device
comprising an expandable anchor and a lock; a delivery catheter; a
delivery mechanism adapted to deliver the tissue shaping device
from outside a patient to a target site within a lumen within the
patient via the delivery catheter; and an actuator adapted to
deliver an actuation force to the lock to lock the anchor in an
expanded configuration.
2. The tissue shaping system of claim 1 wherein the delivery
mechanism comprises a pusher.
3. The tissue shaping system of claim 1 tissue shaping system
further comprising a cartridge adapted to contain the tissue
shaping device, the delivery mechanism being further adapted to
deliver the tissue shaping device from the cartridge to the
delivery catheter.
4. The tissue shaping system of claim 1 tissue shaping system
further comprising a dye port adapted to admit an imaging contrast
agent to the lumen.
5. The tissue shaping system of claim 4 wherein the delivery
catheter and delivery mechanism are further adapted to permit
delivery of imaging contrast agent from the dye port to the lumen
during delivery and deployment of the tissue shaping device.
6. The tissue shaping system of claim 4 further comprising a
connector extending from a proximal end of the delivery catheter,
the connector comprising the dye port and a device port, the
delivery mechanism being further adapted to deliver the tissue
shaping device from outside the patient to the delivery catheter
through the device port.
7. The tissue shaping system of claim 6 further comprising a
cartridge adapted to contain the tissue shaping device and adapted
to connect to the device port of the connector.
8. The tissue shaping system of claim 1 further comprising a handle
associated with the delivery mechanism.
9. The tissue shaping system of claim 8 wherein the handle is
adapted to support the actuator.
10. The tissue shaping system of claim 8 further comprising a
cartridge adapted to contain the tissue shaping device.
11. The tissue shaping system of claim 10 wherein the cartridge is
further adapted to engage the handle during delivery and/or
deployment of the tissue shaping device.
12. The tissue shaping system of claim 1 wherein the actuator is
further adapted to operate the delivery mechanism to move the
tissue shaping device with respect to the delivery catheter.
13. The tissue shaping system of claim 12 wherein the actuator is
further adapted to move the tissue shaping device with respect to
the delivery catheter to expose the anchor.
14. The tissue shaping system of claim 12 wherein the actuator is
further adapted to recapture the anchor into the delivery
catheter.
15. The tissue shaping system of claim 12 wherein the actuator
comprises a rotating nut.
16. The tissue shaping system of claim 1 wherein the actuator is
adapted to move the delivery catheter distally to lock the
anchor.
17. The tissue shaping system of claim 1 further comprising a
locking sleeve, the actuator being further adapted to move the
locking sleeve distally to lock the anchor.
18. The tissue shaping system of claim 1 further comprising an
attachment mechanism adapted to attach the tissue shaping device to
the delivery mechanism.
19. The tissue shaping system of claim 18 wherein the attachment
mechanism comprises a tether attached to the tissue shaping
device.
20. The tissue shaping system of claim 18 wherein the attachment
mechanism is further adapted to release the tissue shaping device
from the delivery mechanism.
Description
CROSS-REFERENCE
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/946,332, filed Sep. 20, 2004, now U.S. Pat.
No. 7,837,729, which is a continuation-in-part of U.S. patent
application Ser. No. 10/313,914, filed Dec. 5, 2002, now U.S. Pat.
No. 7,316,708, and of U.S. patent application Ser. No. 10/331,143,
filed Dec. 26, 2002, now U.S. Pat. No. 6,793,673; which
applications are incorporated herein by reference in their entirety
and to which applications we claim priority under 35 USC
.sctn.120.
BACKGROUND OF THE INVENTION
[0002] The invention relates generally to percutaneous delivery
systems for tissue shaping devices intended to be delivered through
a lumen to a site within a vessel of the patient to modify target
tissue adjacent to the vessel. In particular, the invention relates
to delivery systems for percutaneous mitral valve annuloplasty
devices and methods for using the same.
[0003] Tissue shaping devices for treating mitral valve
regurgitation have been described. See, e.g., U.S. patent
application Ser. No. 10/142,637 (now U.S. Pat. No. 6,824,562),
"Body Lumen Device Anchor, Device and Assembly;" U.S. patent
application Ser. No. 10/331,143 (now U.S. Pat. No. 6,793,673),
"System and Method to Effect the Mitral Valve Annulus of a Heart;"
U.S. patent application Ser. No. 10/429,172, "Device and Method for
Modifying the Shape of a Body Organ;" and U.S. patent application
Ser. No. 10/742,516, "Tissue Shaping Device With Conformable
Anchors." These devices are intended to be delivered percutaneously
to a site within a patient's coronary sinus and deployed to reshape
the mitral valve annulus adjacent to the coronary sinus.
[0004] During deployment of such tissue shaping devices one or more
anchors may need to be expanded and locked using actuation forces
delivered from outside the patient. Thus, the percutaneous delivery
and deployment of tissue shaping devices may require the physician
to perform remote operations on the device and on the patient
through the device. What is needed, therefore, is a delivery system
that permits the physician to perform these tasks.
SUMMARY OF THE INVENTION
[0005] The present invention provides a tissue shaping delivery
system and method. One aspect of the invention is a tissue shaping
system including a tissue shaping device with an expandable anchor
and a lock; a delivery catheter; a delivery mechanism (including,
e.g., a pusher) adapted to deliver the tissue shaping device from
outside a patient to a target site within a lumen within the
patient via the delivery catheter; and an actuator adapted to
deliver an actuation force to the lock to lock the anchor in an
expanded configuration. In some embodiments, the invention includes
a cartridge adapted to contain the tissue shaping device, the
delivery mechanism being further adapted to deliver the tissue
shaping device from the cartridge to the delivery catheter. The
tissue shaping system may also include a dye port adapted to admit
an imaging contrast agent to the lumen, such as during delivery and
deployment of the tissue shaping device. The dye port may be part
of a connector extending from a proximal end of the delivery
catheter, with the connector also, including a device port, the
delivery mechanism being further adapted to delivery the tissue
shaping device from outside the patient to the delivery catheter
through the device port.
[0006] In some embodiments the tissue shaping system includes a
handle associated with the delivery mechanism. The handle may be
adapted to support the actuator. In embodiments in which the system
includes a cartridge adapted to contain the tissue shaping device,
the cartridge may be further adapted to engage the handle during
delivery and/or deployment of the tissue shaping device.
[0007] In some embodiments of the tissue shaping system, the
actuator is further adapted to operate the delivery mechanism to
move the tissue shaping device with respect to the delivery
catheter to, e.g., expose or recapture the anchor. In some
embodiments, the actuator is a rotating nut.
[0008] In some embodiments of this aspect of the invention the
actuator is adapted to move the delivery catheter distally to lock
the anchor. In other embodiments the tissue shaping system may also
include a locking sleeve, the actuator being further adapted to
move the locking sleeve distally to lock the anchor.
[0009] In some embodiments the tissue shaping system includes an
attachment mechanism adapted to attach the tissue shaping device to
the delivery mechanism, such as a tether attached to the tissue
shaping device. The attachment mechanism may be further adapted to
release the tissue shaping device from the delivery mechanism, such
as through the use of a hitch wire and a tether attached to the
tissue shaping device. The attachment mechanism may also include a
hitch wire actuator adapted to move the hitch wire to release the
tether from the device and/or a device release interlock adapted to
prevent release of the device prior to actuating the anchor lock
actuator.
[0010] In some embodiments of the tissue shaping system, the tissue
shaping device further includes a second anchor, the actuator being
further adapted to deliver an actuation force to a second anchor
lock to lock the second anchor in an expanded configuration. The
system may alternatively have a second actuator, the second
actuator being further adapted to deliver an actuation force to the
second anchor lock to lock the second anchor in an expanded
configuration. A handle may support the first and second
actuators.
[0011] Another aspect of the invention provides a system adapted to
percutaneously deliver and deploy a tissue shaping device at a
target site within a lumen of a patient, including: a handle; a
delivery mechanism (possibly including a pusher) supported by the
handle and adapted to deliver the tissue shaping device from
outside the patient to the treatment site via a delivery catheter;
and an actuator supported by the handle and adapted to deliver an
actuation force to lock an anchor of the tissue shaping device in
an expanded configuration. In some embodiments the handle has a
cartridge interface adapted to mate with a cartridge containing a
tissue shaping device, and the delivery system may be further
adapted to deliver the tissue shaping device from a delivery
catheter to the target site when a tissue shaping device cartridge
engages the cartridge interface. In some embodiments, the actuator
may include the cartridge interface. In some embodiments the
actuator may include a rotating member with threads adapted to mate
with threads on a cartridge.
[0012] In some embodiments the system includes a locking sleeve,
the actuator being further adapted to move the locking sleeve
distally to lock the anchor. The handle may include a channel, with
the actuator being disposed in the channel, and the actuator may
include an actuator lock adapted to prevent movement of the
actuator within the channel.
[0013] In some embodiments the system includes a device attachment
mechanism supported by the handle and adapted to attach the tissue
shaping device to the handle. The attachment mechanism may include
a tether attached to the handle and/or a hitch wire attached to the
handle. In embodiments with a hitch wire the attachment mechanism
further may a hitch wire actuator adapted to move the hitch wire to
release the device and possibly a device release interlock adapted
to prevent operation of the hitch wire actuator prior to actuating
the anchor lock actuator.
INCORPORATION BY REFERENCE
[0014] All publications and patent applications mentioned in this
specification are herein incorporated by reference to the same
extent as if each individual publication or patent application was
specifically and individually indicated to be incorporated by
reference.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The novel features of the invention are set forth with
particularity in the appended claims. A better understanding of the
features and advantages of the present invention will be obtained
by reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention
are utilized, and the accompanying drawings of which:
[0016] FIG. 1 is a cross-sectional view of a human heart showing a
tissue shaping device in the lumen of the coronary sinus.
[0017] FIG. 2 is a schematic view of a tissue shaping device
delivery system according to this invention.
[0018] FIG. 3 is a cross-sectional view showing a step in the
delivery and deployment of a tissue shaping device according to
this invention.
[0019] FIG. 4 is a cross-sectional view showing another step in the
delivery and deployment of a tissue shaping device according to
this invention.
[0020] FIG. 5 is a cross-sectional view showing another step in the
delivery and deployment of a tissue shaping device according to
this invention.
[0021] FIG. 6 is a cross-sectional view showing another step in the
delivery and deployment of a tissue shaping device according to
this invention.
[0022] FIG. 7 is a cross-sectional view showing a step in the
recapture of a tissue shaping device according to this
invention.
[0023] FIG. 8 is a cross-sectional view showing a step in the
recapture of a tissue shaping device according to this
invention.
[0024] FIG. 9 shows an attachment mechanism for a tissue shaping
device delivery system.
[0025] FIG. 10 shows another attachment mechanism for a tissue
shaping device delivery system.
[0026] FIG. 11 shows yet another attachment mechanism for a tissue
shaping device delivery system.
[0027] FIG. 12 shows still another attachment mechanism for a
tissue shaping device delivery system.
[0028] FIG. 13 is a detail of the attachment mechanism of FIG. 12
in a disengaged configuration.
[0029] FIG. 14 is a perspective view of a tissue shaping device
delivery system according to this invention.
[0030] FIG. 15 is another perspective view of the tissue shaping
device delivery system of FIG. 14 showing a tissue shaping device
without a cartridge.
[0031] FIG. 16 is an exploded view of the tissue shaping device and
delivery system of FIG. 15.
[0032] FIG. 17 is a partial cross-sectional view of certain
portions of the tissue shaping device delivery system of FIG.
15.
[0033] FIG. 18 is a detailed cross-sectional view of a portion of
the tissue shaping device shown in FIG. 17.
[0034] FIG. 19 is a perspective view of a cartridge for the tissue
shaping device delivery system of FIG. 14.
[0035] FIG. 20 is a cross-sectional view of the cartridge of FIG.
19.
[0036] FIG. 21 is a cross-sectional view of a delivery catheter and
connector for use with the tissue shaping device delivery system of
FIGS. 14-20.
DETAILED DESCRIPTION OF THE INVENTION
[0037] While the invention relates to methods and devices for
delivering tissue shaping devices generally, the invention will be
described with respect to tissue shaping devices delivered to the
coronary sinus of the heart to reshape the mitral valve annulus to
treat mitral valve regurgitation. As used herein, "coronary sinus"
includes the great cardiac vein as well as the coronary sinus of
the heart.
[0038] FIG. 1 shows a cross-section of a human heart 10 with the
atria removed to show the mitral valve 12, the mitral valve annulus
14 and the coronary sinus 16. A tissue shaping device 20 in the
form of a percutaneous mitral valve annuloplasty device is disposed
within the coronary sinus to reshape the mitral valve annulus 14 to
provide for improved coaptation of the mitral valve leaflets. As
shown, tissue shaping device 20 has an expandable distal anchor 22,
a distal anchor lock 24, an expandable proximal anchor 26, a
proximal anchor lock 28, and a connector 30 extending between the
distal and proximal anchors. Proximal anchor lock 28 has serves as
a delivery system attachment mechanism, as explained below.
[0039] FIG. 2 is a schematic drawing showing the general elements
of a delivery system 40 adapted to delivering and deploying a
tissue shaping device to a target site within the lumen of a vessel
in or around a patient's heart 42. A delivery catheter 44 has been
inserted through an opening 46 formed in the patient's jugular vein
or other blood vessel and advanced into the heart. Delivery system
40 interacts with delivery catheter 44 to deliver and deploy the
tissue shaping device at the target site within the patient.
[0040] FIGS. 3-6 show steps from the delivery and deployment of a
tissue shaping device having at least one anchor similar to the
anchors of device 20 of FIG. 1. In FIG. 3, a tissue shaping device
50 has been delivered to a target site within the lumen of a vessel
54 via a delivery catheter 56. FIG. 3 shows an expandable anchor 52
of tissue shaping device 50 beginning to emerge from catheter 56.
In this embodiment, this action is due to proximal movement of
catheter 56 while device 50 is held stationary. In alternative
embodiments, the device could be delivered from the distal end of
the catheter by pushing the device distally while holding the
catheter stationary or a combination of distal movement of the
device and proximal movement of the catheter. Anchor 52 is shown in
a collapsed, unexpanded configuration.
[0041] A delivery system 70 provides the mechanisms to deliver and
deploy device 50 from outside the patient. Actuator 72 and delivery
mechanism 74 associated with catheter 56 and device 50,
respectively, provide for the relative movement between device 50
and catheter 56. For example, delivery mechanism 74 may be a pusher
used to advance device 50 down catheter 56 to the target site shown
in FIG. 3, and actuator 72 can be used to pull catheter 56
proximally while delivery mechanism 74 holds device 50 stationary
within vessel 54. Actuator 72 and delivery mechanism 74 may be
supported by a handle or other housing 76.
[0042] In FIG. 4, catheter 56 has been pulled further proximally by
actuator 72 so that anchor 52 is completely outside of catheter 56
and has started to self-expand. In this embodiment, anchor 52 is
formed from a shape memory material (such as Nitinol) and has been
treated so as to expand upon emergence from the catheter.
[0043] FIGS. 5 and 6 show how the delivery system may be used to
further expand and lock anchor 52. Formed in the proximal side 58
of anchor 52 is a loop 60 encircling a proximally extending
connector 62. Connector 62 may connect with other elements at the
proximal side of device 50, such as a second anchor, depending on
device design. As shown in FIG. 5, while delivery mechanism 74
holds device 50 stationary, actuator 72 has moved delivery catheter
56 distally to engage the proximal side 58 of anchor 52 and to move
it distally to further expand anchor 52.
[0044] As shown in FIG. 6, further distal movement of delivery
catheter 56 with respect to device 50 has pushed loop 60 distally
over a lock bump 64. Lock bump 64 cams inward in response to the
distal force of loop 60, then returns to its prior shape to hold
loop 60 distal to lock bump 64. Delivery catheter may then be moved
proximally to perform other functions or to be removed from the
patient.
[0045] After deployment of a tissue shaping device, it may become
necessary to reposition the device or to remove the device from the
patient. FIGS. 7 and 8 demonstrate the recapture of tissue shaping
device 50 back into delivery catheter 56 after delivery and
deployment.
[0046] In FIG. 7, delivery mechanism 74 holds device 50 stationary
while delivery catheter 56 is advanced distally against anchor 52
by actuator 72. The actuation force against anchor 52 collapses the
anchor, allowing delivery catheter to recapture the device as shown
in FIG. 8. The catheter and device can then be removed from the
patient or moved to another target site.
[0047] FIG. 9 shows an attachment mechanism between a tissue
shaping device 80 and a delivery mechanism, such as pusher 82,
within a delivery catheter 84. Pusher extends outside of the
patient and is attached to a handle or other housing 86, such as
through an actuator. Pusher 82 may be operated by an actuator or by
the handle itself to advance device 80 distally through catheter 84
or to hold device 80 stationary against a proximal force exerted on
device 80, such as when delivery catheter 84 is withdrawn
proximally by an actuator 88.
[0048] Device 80 has an attachment eyelet 90. A tether 92 extending
down pusher 82 has a loop 94 formed at its distal end. The proximal
ends of tether 92 are preferably attached to handle 86. Loop 94
extends through eyelet 90, and a hitch wire 96 passes through loop
94 and into the proximal end of device 80 as shown, thereby
preventing loop 94 from being withdrawn from eyelet 90. Tether 92
can be used to pull device 80 proximally or to hold device 80
stationary against a distal force exerted on device 80, such as
during recapture. Tether 92 may also be used to hold device 80
tightly against pusher 82 during delivery and deployment of the
device.
[0049] To release device 80 from the delivery mechanism, hitch wire
96 may be disengaged from device 80. In this embodiment, hitch wire
96 is disengaged by moving the hitch wire proximally through the
action of a hitch wire actuator 98 while holding device 80
stationary with pusher 92. When hitch wire 96 is disengaged from
device 80 and moved proximal to the loop of tether 92, proximal
movement of tether 92 will pull the tether's loop out of eyelet
90.
[0050] FIG. 10 shows another attachment mechanism for a tissue
shaping device and its delivery mechanism. As in the embodiment of
FIG. 9, an eyelet 102 extends proximally from tissue shaping device
100 within delivery catheter 104. The distal end of pusher 106 has
an eyelet 108 at its distal end that overlaps with device eyelet
102 to form an overlap opening 110. A hitch wire 112 extends
through pusher 106 and overlap opening 110 into the proximal end of
tissue shaping device 100.
[0051] As in the previous embodiment, catheter 104, pusher 106 and
hitch wire 112 extend out of the patient to a handle or other
housing 114. Pusher 106 may be operated by an actuator or by handle
114 to advance device 100 distally through catheter 104 or to hold
device 100 stationary against a proximal force exerted on device
100, such as when delivery catheter 104 is withdrawn proximally by
an actuator 116 supported by handle 114. Also, because the
attachment mechanism of this embodiment holds pusher 106 against
device 100, pusher 106 can be used to pull device 100 proximally or
to hold device 100 stationary against a distal force exerted on
device 100, such as during recapture.
[0052] To release device 100 from the delivery mechanism, hitch
wire 112 may be disengaged from device 100. As in the embodiment of
FIG. 9, hitch wire 112 is disengaged by moving the hitch wire
proximally through the action of a hitch wire actuator 118 while
holding device 100 stationary with pusher 106. When hitch wire 112
is disengaged from device 100 and moved proximal to the overlap
opening 110, device 100 is disengaged from the delivery
mechanism.
[0053] FIG. 11 shows an attachment mechanism that can be used to
engage a tissue shaping device after initial deployment for
possible recapture of the device. As in other embodiments, device
120 has a proximal eyelet 122. Retractor 124 has a cable 126
extending through it. Cable 126 has a loop 128 at its distal end
and free ends 130 extending out of the patient, possibly to a
handle or housing (not shown). To engage device 120, retractor 124
and looped cable 126 are advanced to device 120 with loop 128
arranged to be large enough to surround eyelet 122. When loop 128
passes over and around eyelet 122, one or both of the free ends of
cable 126 are pulled proximally to pull loop 128 tightly about
eyelet 122, as shown. Retractor 124 may then be used to pull device
120 proximally, such as for recapture into a catheter.
Alternatively, retractor may be used as a pusher to apply a
distally directed force on device 120, if needed.
[0054] FIGS. 12 and 13 show yet another attachment mechanism
between a tissue shaping device and a delivery mechanism. Tissue
shaping device 140 has a locking structure 142 at its proximal end
designed to mate with a corresponding locking structure 144 at the
distal end of a pusher 146 within catheter 148. A cover 150 is
disposed over the interlocked locking structures to maintain the
connection between device 140 and pusher 146. A tether 152 is
connected to cover 150.
[0055] Catheter 148, pusher 146 and tether 152 extend out of the
patient to a handle or other housing 154. Pusher 146 may be
operated by an actuator or by handle 154 to advance device 140
distally through catheter 148 or to hold device 140 stationary
against a proximal force exerted on device 140, such as when
delivery catheter 148 is withdrawn proximally by an actuator 156
supported by handle 154. Also, because the attachment mechanism of
this embodiment holds pusher 146 against device 140, pusher 146 can
be used to pull device 140 proximally or to hold device 140
stationary against a distal force exerted on device 140, such as
during recapture.
[0056] To release device 140 from the delivery mechanism, tether
152 may be pulled proximally to pull cover 150 off of the locking
structures 142 and 144, such as by use of an actuator 158, while
holding device 100 stationary with pusher 146. Locking structures
142 and 144 are preferably formed from a shape memory material.
When cover 150 is removed from the locking structures, the locking
structures assume an unstressed configuration such as that shown in
FIG. 13, thereby disengaging device 140 from pusher 146.
[0057] FIGS. 14-21 show a tissue shaping device delivery and
deployment system according to one embodiment of this invention.
The system includes a handle 200 supporting delivery, deployment
and attachment mechanisms for a tissue shaping device 202 having
distal and proximal expandable anchors 204 and 206, respectively.
In FIG. 14, the device is disposed in a compressed configuration
within a cartridge 208. In this embodiment, the device will go
directly from cartridge 208 into a delivery catheter for delivery
and deployment in a patient.
[0058] As shown in FIG. 15, a pusher 210 abuts the proximal end of
tissue shaping device 202. Pusher 210 should be flexible and
incompressible, and its properties may vary from section to section
along its length. In one embodiment, pusher 210 is formed at its
distal end from a coiled spring 212 (e.g., to facilitate bending)
and thereafter from a stainless steel hypotube 214. Device 202 is
attached to pusher 210 via a tether 216 and hitch wire 218 in an
arrangement such as that described above with respect to FIG. 9.
The tether has to be strong enough to apply an appropriate
proximally directed force during delivery, deployment and
recapture; the hitch wire has to be stiff enough not to kink or
pull through the eyelet when the tether is pulled proximally. For
example, for use in a tissue shaping system intended to treat
mitral valve regurgitation via the coronary sinus, the tether
preferably can pull up to 18 pounds. In one embodiment, tether 216
is formed from 0.007 inch stainless steel with a full hard temper,
and hitch wire is formed from 0.011 inch 304 stainless steel.
Tether 216 and hitch wire 218 extend through the pusher's lumen.
Pusher 210, tether 216 and hitch wire 218 are attached to and
supported by handle 200, as discussed below with respect to FIGS.
17 and 18.
[0059] Surrounding pusher 210 is a locking sleeve 220 whose inner
diameter is close to the outer diameter of pusher 210 in order to
minimize backflow of blood or other fluids. The proximal end of
locking sleeve 220 is supported by a slider (not shown) resting in
a circular track formed by the handle housing. Actuator knobs 222
are threaded into holes formed in the sides of the slider, and the
slider and actuator knobs are attached to the locking sleeve 220 by
adhesive. One of the actuator knobs may be provided with an
actuation interlock, such as a screw down portion 223 that screws
against the handle housing to prevent movement of the actuator
knobs and locking sleeve. As shown in FIG. 16, actuator knobs 222
fit in tracks 224 formed in handle 200.
[0060] When assembling the delivery system, pusher 210 is placed
within locking sleeve 220. Handle housing 226 has two parts, 228
and 230, which are placed and screwed together around the locking
sleeve and pusher. As shown in FIG. 18, assembly of the two halves
of handle housing 226 attaches the proximal end of pusher 210 to
handle 200 with a press fit connection (which may be supplemented
with adhesive) in a pusher connection area 232 of handle housing
226. Locking sleeve actuator knobs 222 are in the tracks 224, as
discussed above.
[0061] Hitch wire 218 and tether 216 are then threaded into the
central lumen of pusher 210, and device 202 is attached by placing
the looped end of tether 216 through an eyelet (not shown) on the
proximal end of device 202. Hitch wire 218 passes through the
looped end of tether 216 into the device's proximal anchor crimp
tube 207. (Placement of the distal end of the hitch wire inside the
crimp tube helps prevent injury to the patient's heart or blood
vessels by the hitch wire.)
[0062] Tether 216 and hitch wire 218 extend proximally from the
proximal end of pusher 210 through the proximal end of pusher
connection area 232 and through holes formed in a disc 236 disposed
proximal to pusher connection area 232 and jack nut 234. A crimp
tube 238 or other connector attaches to the proximal end of tether
216 to prevent it from passing distally through disc 236; excess
portions of tether 216 may be cut off. A jack nut 234 threaded
around the outside of pusher connection area 232 may then be
rotated about pusher connection area 232 to move jack nut 234, disc
236 and crimp tube 238 proximally with respect to the handle
housing, thereby tightening tether 216 and pulling device 202 tight
against pusher 210.
[0063] A release knob 240 is threaded onto handle housing 226
around pusher connection area 232 with track portions 242 lining up
with handle tracks 224, as shown. Hitch wire 218 extends proximally
through release knob 240 and a second disc 244, and the proximal
end of hitch wire 218 is crimped with one or more crimp tubes 246
to prevent distal movement of hitch wire 218 with respect to the
handle. A cap 248 covers the distal end of hitch wire 218 to
prevent injury to the user from the sharp wire end.
[0064] Prior to delivery and deployment, the eyelet of the proximal
anchor 206 is pulled proximally over the pusher coil 212, and the
eyelet of the distal anchor is pulled proximally over the connector
between the two anchors. Device 202 is then compressed and loaded
into cartridge 208 with the distal anchor 204 at the distal end of
the cartridge and with the pusher, tether and hitch wire extending
from the proximal end of cartridge 208 into handle 200. A loading
tool, such as a two-piece funnel, may be used to assist in the
compression and loading of the device into the cartridge. In a
preferred embodiment, a control nut 250 is threaded onto the
threaded exterior of cartridge 208, as shown in FIG. 14.
[0065] Cartridge 208 is shown in more detail in FIGS. 19 and 20.
Cartridge 208 has a central lumen 252 with a lubricious polymeric
liner. The diameter of central lumen 252 may be substantially the
same as the diameter of a delivery catheter to be used to deliver
device 202. Alternatively, the diameter of central lumen 252 may be
larger than the intended delivery catheter diameter to minimize
stress on the tissue shaping device during sterilization,
temperature changes during shipping, etc. Cartridge 208 has a male
luer connector 254 at its distal end for mating with a
corresponding female luer connector on the delivery catheter, as
described below. The outside of the cartridge preferably has at
least one flat side in order to prevent rotation of the cartridge
with respect to the handle during deployment, as described below.
In the embodiment shown in FIGS. 19 and 20, cartridge 208 has a
hexagonal cross-section presenting six possible orientations for
mating with a flat side formed on the inside of the handle during
delivery and deployment of the tissue shaping device. An O-ring
seal 255 at the proximal end of cartridge 208 seals around locking
sleeve 220 to prevent backflow of blood or other fluids while still
permitting relative movement between locking sleeve 220 and
cartridge 208.
[0066] FIG. 21 shows a delivery catheter 260 and connector 262 for
use with the cartridge and handle of this invention. The length and
diameter of catheter 260 depends on the application. For example,
to deliver a tissue shaping device to the coronary sinus through
the jugular vein to treat mitral valve regurgitation, catheter 260
may be a nine french diameter catheter at least 65 cm. long.
Catheter 260 may also have a radiopaque market on its distal end
for visualization via fluoroscopy. When it needs to negotiate bends
and turns to reach the target treatment site, catheter 260 may be
more flexible at its distal tip than along its proximal end.
Catheter 260 may also be braided to increase its compression
strength, which aids in locking anchors, recapturing devices, etc.,
as described below.
[0067] Y-shaped connector 262 is attached to the proximal end of
catheter 260 by adhesive and a shrink tube 264. Connector 262 has a
main channel 266 with a female luer connection 268 adapted to mate
with the luer connection of cartridge 208. A second channel 270
meets the main channel 266 proximal to the proximal end of delivery
catheter 260. Second channel 270 also has a luer connection to
permit it to be connected to a source of imaging contrast agent,
such as dye. Second channel 270 enables a dye source to be
connected and for dye to be injected even during use of the main
channel to deliver and deploy the tissue shaping device. (The space
between the inner diameter of the delivery catheter and the outer
diameter of the locking sleeve permits contrast dye to flow
distally to the target treatment site.) A cap 272 may be used to
close off second channel 270 when not in use. The diameters of both
channels transition down from the standard luer fitting size to the
diameter of the delivery catheter.
[0068] A first step for using the tissue shaping system of this
invention to treat mitral valve regurgitation is to access the
coronary sinus of the patient's heart. One way of reaching the
coronary sinus is to insert a sheath into the patient's jugular
vein. A guide catheter with a precurved tip may then be inserted
into the sheath and advanced to coronary sinus ostium within the
right atrium of the heart. A guidewire may then be advanced through
the guide catheter and into the coronary sinus, and the guide
catheter may be removed from the patient, leaving the guidewire
behind. The delivery catheter 260 may then be advanced along the
guidewire, and the guidewire may be removed.
[0069] The anatomy of the heart varies from patient to patient. For
example, the diameter and length of the coronary sinus are
patient-dependent as well as the location of coronaries arteries
that may pass between the coronary sinus and the heart. One
optional method step, therefore, is to introduce dye or another
imaging contrast agent into the coronary sinus through the delivery
catheter (such as through the Y-shaped connector 262) to perform a
venogram while performing an angiogram on the coronary arteries in
a known manner. These images will identify the relative positions
of the coronary sinus and coronary arteries and will give a
relative indication of the length and diameter of the coronary
sinus at the target treatment site.
[0070] In addition, in order to calibrate the venogram with the
actual size of the imaged vessels, a marker catheter may be
inserted into the coronary sinus through the delivery catheter
during the venogram. The marker catheter has radiopaque markings a
fixed distance apart. By measuring on the venogram the distance
between markings on the marker catheter, a correction factor may be
devised to correct the measured diameter and length of the coronary
sinus. Alternatively, radiopaque markings may be added to the
delivery catheter itself, thereby eliminating the need to insert a
marker catheter to obtain the correction factor measurements. Dye
may also be injected during delivery and deployment of the tissue
shaping device for imaging purposes.
[0071] After removal of the marker catheter, the delivery system
may be attached to the delivery catheter. Prior to the start of the
procedure, locking sleeve 220 is in its proximal-most position so
that locking sleeve actuator knobs 222 are in slots 242 of release
knob 240, and screw down portion 223 is screwed against housing 226
to hold locking sleeve 220 in place. Pusher 210 and locking sleeve
220 extend from the distal end of handle 200 to the device 202
within cartridge 208. The lengths of pusher 210 and locking sleeve
220 correspond to the length of delivery catheter 260, as discussed
below. Lengths of pusher 210 and locking sleeve 220 may be exposed
between handle 200 and cartridge 208.
[0072] To begin delivering tissue shaping device 202 to the
patient's coronary sinus, cartridge 208 (containing tissue shaping
device 202) and delivery catheter 260 are then connected at luer
connection 268 of the main channel of Y-connector 262. The distal
tip of the delivery catheter is in place in the coronary sinus at
the distal end of the target treatment site. To begin delivery of
the device from cartridge 208 into delivery catheter 260, handle
200 is advanced distally toward cartridge 208 and delivery catheter
260. As the handle advances toward the cartridge and toward the
patient, pusher 210 moves device 202 distally out of cartridge 208
into Y-connector 262 and then into delivery catheter 260. The
structure of the point where the Y-connector's second channel 270
meets the main channel 266--specifically, reduced diameter portion
274 and tab 276--helps prevent the tissue shaping device from
expanding and getting caught at the junction of the two
channels.
[0073] In certain embodiments of the invention, the advancing
handle 200 reaches cartridge 208 when or before device 202 reaches
the distal end of delivery catheter 260. For example, in the
embodiment shown in FIGS. 14-21, the relative lengths of device
202, pusher 210, handle 200 and delivery catheter 260 are such that
the distal end of handle 200 reaches the proximal end of cartridge
208 before device 202 reaches the distal end of delivery catheter
260. After this point, further advancement of handle 200 places
handle housing 226 around cartridge 208 so that cartridge 208 moves
inside the handle. A flat interior surface (not shown) formed in
handle 200 mates with one of the flat sides of cartridge 208 to
prevent relative rotation between the cartridge and the handle as
control nut 250 rotates.
[0074] In one embodiment, rotating control nut 250 is threaded onto
cartridge 208 prior to use of the system to treat a patient, as
shown in FIG. 14. The location of control nut 250 on cartridge 208
depends on the length of the device 202 within cartridge 208 as
well as the relative lengths of the pusher and delivery catheter.
In this embodiment, these elements are sized and configured so that
control nut 250 engages with, and snaps to, the distal end of
handle 200 at the point during device delivery when device 202 has
reached the distal end of delivery catheter 260. This action
engages cartridge 208 with handle 200 for controlled delivery and
deployment of tissue shaping device 202. Alternatively, control nut
250 can be disposed on the distal end of handle 200 from the start.
In this case, cartridge 208 engages handle 200 through control nut
250 as soon the proximal end of cartridge 208 reaches handle 200,
which may be before device 202 has reached the distal end of
delivery catheter 260.
[0075] After cartridge 208 engages handle 200 through control nut
250, all further relative movement between cartridge 208 and handle
200 is controlled by rotating control nut 208. When tissue shaping
device 202 is at the distal end of catheter 260 at the distal end
of the target treatment site (as determined fluoroscopically, e.g.)
the physician ceases moving handle 200 toward the patient. Instead,
handle 200 (and therefore device 202) is held stationary while
cartridge 208 and delivery catheter 260 are pulled proximally by
rotating control nut 250. This action exposes the device's distal
anchor 204, which begins to self-expand. Control nut 250 is then
rotated the other direction to advance delivery catheter 260
distally to apply a force to the proximal side of anchor 204 to
further expand and lock the anchor, i.e., by advancing the anchor's
lock loop over its lock bump, as described above. Thus, control nut
250 acts as an actuator for expanding and locking the device's
distal anchor.
[0076] After locking the distal anchor, a proximal cinching force
is applied to the device through tether 216 to reshape the mitral
valve annulus by moving handle 200 proximally away from the
patient, preferably while observing the status of the patient's
mitral valve regurgitation and vital signs, such as described in
U.S. patent application Ser. No. 10/366,585, "Method of Implanting
a Mitral Valve Therapy Device." Contrast dye may be injected via
connector 262 to visualize the anchor while cinching. When an
appropriate amount of mitral valve regurgitation has been achieved,
control nut 250 is rotated while holding handle 200 in place to
pull delivery catheter 260 proximally with respect to tissue
shaping device 202, thereby exposing proximal anchor 206, which
begins to self-expand.
[0077] In one embodiment of the invention, locking sleeve 220 is
used in place of the larger diameter delivery catheter to further
expand and lock proximal anchor 206 in order to avoid inadvertent
recapture of the proximal anchor by the delivery catheter. Screw
down portion 223 of knobs 222 is loosened to permit knobs 222 to
slide forward in tracks 224, thereby advancing locking sleeve 220
distally toward anchor 206. Locking sleeve 220 applies a distally
directed force on the proximal side of anchor 206 to further expand
and lock the anchor, i.e., by advancing the anchor's lock loop over
its lock bump, as described above. Thus, knobs 222 act as an
actuator for expanding and locking the device's proximal anchor.
Expansion and locking of the proximal anchor maintains the cinching
action and, therefore, the reduction in mitral valve regurgitation
caused by the device's reshaping of the mitral valve annulus.
[0078] Alternatively, the delivery catheter can be used to expand
and lock the proximal anchor in the same manner as the distal
anchor.
[0079] The delivery system of this embodiment enables the tissue
shaping device to be fully deployed before it is detached from the
delivery system. If the tissue shaping device's placement is
satisfactory, the device is unhitched from the delivery system. To
unhitch, release knob 240 is rotated to move release knob and the
attached hitch wire 218 proximally with respect to device 202. This
action pulls the distal end of hitch wire 218 out of the device's
proximal anchor crimp 207 and releases the looped end of tether
216, thereby disengaging device 202 from the delivery system. The
delivery catheter, tether and hitch wire may then be removed from
the patient.
[0080] The slots 242 in release knob 240 prevent rotation of
release knob 240 when locking sleeve 220 is in its proximal-most
position. This device release interlock feature helps ensure that
the locking sleeve has been used to lock the proximal anchor before
the tissue shaping device is disengaged from the delivery
system.
[0081] In certain instances, after initial deployment but before
disengaging the hitch wire and tether the tissue shaping device may
need to be recaptured and either removed from the patient or
deployed at a different site. In that case, locking sleeve 220 is
advanced distally to the proximal side of proximal anchor 206 by
moving knobs 222 forward in tracks 224. While holding handle 200
stationary to hold device 202 against distal movement through the
action of tether 216, control nut 250 is rotated to advance
delivery catheter 260 distally over locking sleeve 220 to and over
proximal anchor 206, deforming anchor 206 so that it fits back
inside catheter 260. In this manner, control nut 250 is used as a
recapture actuator; use of the control nut to apply the recapture
force helps prevent a sudden inadvertent distal advancement of the
catheter when the anchor collapses and enters the catheter. Once
the proximal anchor has been recaptured into the delivery catheter,
the catheter is then advanced further distally to recapture distal
anchor 204 in the same way. Device 202 can then be moved or removed
from the patient.
[0082] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that methods and structures
within the scope of these claims and their equivalents be covered
thereby.
* * * * *