U.S. patent application number 11/003696 was filed with the patent office on 2005-08-11 for system and method for delivering a left atrial appendage containment device.
Invention is credited to Kume, Stewart M., van der Burg, Erik J..
Application Number | 20050177182 11/003696 |
Document ID | / |
Family ID | 37452480 |
Filed Date | 2005-08-11 |
United States Patent
Application |
20050177182 |
Kind Code |
A1 |
van der Burg, Erik J. ; et
al. |
August 11, 2005 |
System and method for delivering a left atrial appendage
containment device
Abstract
A method of delivering and deploying the device for containing
the emboli during a surgical procedure proximate to the heart.
Access is gained to the heart and the left atrium such that a
distal end of the delivery sheath can be located near the left
atrial appendage. A distal end of a delivery catheter can be loaded
with the device in a collapsed position and passed through the
delivery sheath thereby delivering the device within the left
atrial appendage. The device is expanded to contain emboli in the
left atrium appendage.
Inventors: |
van der Burg, Erik J.; (Los
Gatos, CA) ; Kume, Stewart M.; (Belmont, CA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Family ID: |
37452480 |
Appl. No.: |
11/003696 |
Filed: |
December 3, 2004 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
60526960 |
Dec 4, 2003 |
|
|
|
Current U.S.
Class: |
606/157 |
Current CPC
Class: |
A61B 2017/00615
20130101; A61F 2/243 20130101; A61B 2017/00632 20130101; A61B
17/12172 20130101; A61F 2002/018 20130101; A61F 2230/008 20130101;
A61B 2017/00575 20130101; A61B 2017/00592 20130101; A61F 2002/9665
20130101; A61B 17/12122 20130101; A61F 2230/0071 20130101; A61F
2/2439 20130101; A61B 2017/003 20130101; A61F 2230/0006 20130101;
A61B 2017/00579 20130101; A61B 2017/12095 20130101; A61B 2017/00623
20130101; A61B 17/0057 20130101; A61B 2017/12054 20130101; A61F
2002/9505 20130101; A61F 2002/9511 20130101; A61B 2017/00597
20130101; A61B 17/12022 20130101 |
Class at
Publication: |
606/157 |
International
Class: |
A61B 017/08 |
Claims
What is claimed is:
1. A method of delivering a device to a left atrial appendage
comprising: forming an opening in a chest of a patient suitable for
surgical heart procedures; advancing an implantable device through
the opening and into a left atrium; and passing the implantable
device through the left atrium and positioning the implantable
device at the left atrial appendage.
2. The method of claim 1, wherein the opening in the chest is
formed by a sternotomy incision.
3. The method of claim 1, wherein the implantable device is
positioned at the left atrial appendage as an adjunct to a surgical
heart procedure.
4. The method of claim 3, wherein the surgical heart procedure
comprises treatment of a valve of the heart.
5. The method of claim 4, wherein the treatment comprises one of
repairing or replacing the valve of the heart.
6. The method of claim 1, wherein the implantable device is
manually implanted by holding the device in a person's hand,
passing the device and a portion of the hand into the left atrium,
and manually pushing the device into the left atrial appendage.
7. The method of claim 1, wherein the advancing of the device
comprises: passing a delivery sheath through the opening in the
chest of a patient; positioning a distal end of the delivery sheath
proximate to the left atrial appendage; advancing distally the
device through the delivery sheath; and delivering the device out
of the distal end and into the left atrial appendage.
8. The method of claim 7, wherein the device is delivered out of
the distal end of the delivery sheath when the distal end extends
into the left atrial appendage.
9. The method of claim 7, further comprising distally advancing a
push rod through the delivery sheath such that a distal end of the
push rod pushes the device through the delivery sheath and out of
the distal end of the delivery sheath.
10. A method of delivering a device to a left atrial appendage
comprising: forming an aperture in the outer wall of a left atrium
of a heart; advancing a delivery sheath through the aperture and
into the left atrium; positioning a distal end of the delivery
sheath proximate to an orifice of the left atrial appendage while
the delivery sheath extends through the left atrium and the
aperture; advancing a device through the delivery sheath and out of
the distal end; and implanting the device at the left atrial
appendage.
11. The method of claim 10, wherein the device is delivered out of
the distal end when the delivery sheath passes through the orifice
and the distal end is positioned within the left atrial
appendage.
12. The method of claim 10, further comprising: positioning a
transition catheter within the delivery sheath, the transition
catheter extends distally from the distal end of the delivery
sheath and forms a blunt tip; advancing the delivery sheath and
transition catheter and into the left atrium until the distal end
of the delivery sheath is proximate to an orifice of a left atrial
appendage; and removing the transition catheter from the delivery
sheath and then distally advancing the device through the delivery
sheath.
13. The method of claim 10, wherein the delivery sheath has a
curved distal portion shaped to direct the distal end of the
delivery sheath towards the left atrial appendage.
14. A method of delivering a device to a left atrial appendage
comprising: providing a delivery sheath having a lumen and a distal
end; providing a transition catheter having a tip configured to
reduce injury to a patient; advancing the delivery sheath and
transition catheter along the right atrium and through a
transseptal hole and into the left atrium until a distal end of the
delivery sheath is proximate to an orifice of a left atrial
appendage; removing the transition catheter from the delivery
sheath; distally advancing a device through the delivery sheath;
and implanting the device at the left atrial appendage while the
distal end of the delivery sheath is disposed within the left
atrial appendage.
15. The method of claim 14, wherein the device is distally advanced
through the delivery sheath by distally moving a delivery catheter
through the delivery sheath after the transition catheter has been
removed from the delivery sheath.
16. The method of claim 15, wherein the device is implanted by
operating the delivery catheter and expanding the device.
17. A method of delivering a device to a left atrial appendage
comprising: providing a left atrium access path through a pulmonary
vein to a left atrial appendage; advancing a delivery sheath along
the left atrium access path until the delivery sheath is located
proximate to the left atrial appendage; advancing an implant
through the delivery sheath until the implant passes out of a
distal end of the delivery sheath; and implanting the device at the
left atrial appendage.
18. The method of claim 17, wherein the device is an expandable
implant configured to prevent passage of embolic material from the
left atrial appendage.
19. The method of claim 17, wherein the delivery sheath has a
curved distal portion shaped to direct the distal end of the
delivery sheath towards the left atrial appendage.
20. A system for delivering a device to the left atrial appendage,
the system comprising: an implant sized and configured to prevent
passage of embolic material from a left atrial appendage; a
delivery sheath defining a lumen and a distal end; a transition
catheter having an atraumatic tip and configured to slide through
the lumen of the delivery sheath, the transition catheter being
adapted to extend from the distal end of the delivery sheath when
the distal end is proximate to the left atrial appendage; and a
delivery catheter removably coupled to the implant, the delivery
catheter and implant being configured to pass through the lumen of
the delivery sheath to the left atrial appendage.
21. The system of claim 20, wherein the atraumatic tip is a soft
blunt tip.
22. The system of claim 20, wherein the delivery sheath has a
curved distal portion shaped to direct the distal end of the
delivery sheath towards the left atrial appendage.
23. A system for delivering a device to the left atrial appendage,
the system comprising: an implant sized and configured to prevent
passage of embolic material from a left atrial appendage; and a
delivery device configured to carry the implant to the left atrial
appendage, the delivery device having a length configured to access
the left atrial appendage through an opening in a chest of a
patient, the delivery device having a length of about 80 cm or
less.
24. The system of claim 23, wherein the delivery device is a
delivery sheath having a lumen configured to receive the implant
therein.
25. The system of claim 24, further comprising a delivery catheter
configured to releasably engage the implant.
26. The system of claim 23, wherein the delivery sheath has a
length that is greater than about 10 cm.
27. The system of claim 23, wherein the delivery device comprises a
delivery catheter configured to releasably engage the implant.
28. The system of claim 27, wherein the delivery device further
comprises a delivery sheath, the delivery catheter has length that
is about 10 cm to about 30 cm greater than the length of the
delivery sheath.
29. The system of claim 23, wherein the delivery device has a
length of about 30 cm or less.
30. The system of claim 23, wherein the implant is configured to be
positioned within the left atrial appendage.
31. The system of claim 23, wherein the implant is configured to be
expanded within the left atrial appendage.
32. A system for delivering a device into the left atrial
appendage, the system comprising: an implant sized and configured
to prevent passage of embolic material from a left atrial
appendage; a delivery device configured to carry the implant to the
left atrial appendage, the delivery device having a length
configured to access the left atrial appendage through an opening
in a chest of a patient; and means for providing surgical access to
the left atrial appendage through the chest of the patient.
33. The system of claim 32, wherein the means for providing
surgical access comprises at least one selected from the group
consisting of a retractor, rib spreader, clamp, a trocar and a
laparoscopic instrument.
34. The system of claim 32, wherein the means for providing
surgical access to the left atrial appendage comprises surgical
retractors.
35. The system of claim 32, wherein the means for providing
surgical access to the left atrial appendage comprises a
trocar.
36. The system of claim 32, wherein the means for providing
surgical access to the left atrial appendage comprises means for
providing access through the left atrium wall.
37. A system for delivering a device into the left atrial appendage
of a patient, the system comprising: an implant sized and
configured to prevent passage of embolic material from a left
atrial appendage; a delivery device configured to carry the implant
to the left atrial appendage, the delivery device having a length
configured to access the left atrial appendage through an opening
in a chest of a patient; and means for performing a surgical heart
procedure in the heart of the patient.
38. The system of claim 37, wherein the means for performing a
surgical heart procedure comprises at least one selected from the
group consisting of a retractor, rib spreader, forceps, and
clamp.
39. The system of claim 37, wherein means for performing a surgical
heart procedure comprises at least one selected from the group
consisting of cauterizing instruments or substances,
electrosurgical pen, suction apparatus, approximators, rongeur,
clip applier, stapler, suture, needle holder, and bulldogs.
40. The system of claim 37, wherein the means for performing a
surgical heart procedure comprises at least one selected from the
group consisting of a sizing ring, balloon, caliper, and gage.
41. A system for delivering a device to the left atrial appendage
of a patient, the system comprising: an implant sized and
configured to prevent passage of embolic material from a left
atrial appendage; and a delivery device configured to carry the
implant to the left atrial appendage, the delivery device sized and
configured to access the left atrial appendage through a pulmonary
vein, the delivery device having a length of about 50 cm or
less.
42. The system of claim 41, wherein the delivery sheath has a
length in the range of about 15 cm to about 50 cm.
43. The system of claim 41, further comprising a delivery catheter,
wherein the delivery catheter has length that is about 10 cm to
about 30 cm greater than the length of the delivery device.
44. The system of claim 41, further comprising means for accessing
the pulmonary vein through the chest of the patient.
Description
RELATED APPLICATIONS
[0001] This application claims the priority benefit under 35 U.S.C.
.sctn. 119(e) of the provisional application 60/526,960, filed Dec.
4, 2003, which is hereby incorporated by reference in its
entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] Embodiments of this invention relate in general to a system
and method for delivering a left atrial appendage containment
device.
[0004] 2. Description of the Related Art
[0005] Embolic stroke is the nation's third leading killer for
adults, and is a major cause of disability. There are over 700,000
strokes per year in the United States alone. Of these, roughly
100,000 are hemorrhagic, and 600,000 are ischemic (either due to
vessel narrowing or to embolism). The most common cause of embolic
stroke emanating from the heart is thrombus formation due to atrial
fibrillation. Approximately 80,000 strokes per year are
attributable to atrial fibrillation. Atrial fibrillation is an
arrhythmia of the heart that results in a rapid and chaotic
heartbeat that produces lower cardiac output and irregular and
turbulent blood flow in the vascular system. There are over five
million people worldwide with atrial fibrillation, with about four
hundred thousand new cases reported each year. Atrial fibrillation
is associated with a 500 percent greater risk of stroke due to the
condition. A patient with atrial fibrillation typically has a
significantly decreased quality of life due, in part, to the fear
of a stroke, and the pharmaceutical regimen necessary to reduce
that risk.
[0006] For patients who develop atrial thrombus from atrial
fibrillation, the clot normally occurs in the left atrial appendage
(LAA) of the heart. The LAA is a cavity which looks like a small
finger or windsock and which is connected to the lateral wall of
the left atrium between the mitral valve and the root of the left
pulmonary vein. The LAA normally contracts with the rest of the
left atrium during a normal heart cycle, thus keeping blood from
becoming stagnant therein, but often fails to contract with any
vigor in patients experiencing atrial fibrillation due to the
discoordinate electrical signals associated with AF. As a result,
thrombus formation is predisposed to form in the stagnant blood
within the LAA.
[0007] Blackshear and Odell have reported that of the 1288 patients
with non-rheumatic atrial fibrillation involved in their study, 221
(17%) had thrombus detected in the left atrium of the heart.
Blackshear J L, Odell J A., Appendage Obliteration to Reduce Stroke
in Cardiac Surgical Patients With Atrial Fibrillation. Ann Thorac.
Surg., 1996.61(2):755-9. Of the patients with atrial thrombus, 201
(91%) had the atrial thrombus located within the left atrial
appendage. The foregoing suggests that the elimination or
containment of thrombus formed within the LAA of patients with
atrial fibrillation would significantly reduce the incidence of
stroke in those patients.
[0008] Pharmacological therapies for stroke prevention such as oral
or systemic administration of warfarin or the like have been
inadequate due to serious side effects of the medications and lack
of patient compliance in taking the medication. Invasive surgical
or thorascopic techniques have been used to obliterate the LAA,
however, many patients are not suitable candidates for such
surgical procedures due to a compromised condition or having
previously undergone cardiac surgery. In addition, the perceived
risks of even a thorascopic surgical procedure often outweigh the
potential benefits. See Blackshear and Odell, above. See also
Lindsay B D., Obliteration of the Left Atrial Appendage: A Concept
Worth Testing, Ann Thorac. Surg., 1996.61(2):515.
[0009] During surgical procedures, such as mitral valve repair,
thrombus in the left atrial appendage may leave the LAA and enter
the blood stream of a patient. The thrombus in the blood stream of
the patient can cause embolic stroke. There are known techniques
for closing off the LAA so that thrombus cannot enter the patient's
blood stream. For example, surgeons have used staples or sutures to
close the orifice of the LAA, such that the closed off LAA
surrounds the thrombus. Unfortunately, using staples or sutures to
close off the LAA may not completely close the orifice of the LAA.
Thus, thrombus may leave the LAA and enter the patient's blood
stream, even though the LAA is closed with staples or sutures.
Additionally, closing the orifice of the LAA by using staples or
sutures may result in discontinuities, such as folds or creases, in
the endocardial surface facing the left atrium. Unfortunately,
blood clots may form in these discontinuities and can enter the
patient's blood stream, thereby causing health problems. Moreover,
it is difficult to place sutures at the orifice of the LAA and may
result in a residual appendage. For example, an epicardial approach
to ligate sutures can result in a residual appendage. Similarly,
thrombus may form in the residual appendage and enter the patient's
blood stream causing health problems.
[0010] Despite the various efforts in the prior art, there remains
a need for a minimally invasive method and associated devices for
reducing the risk of health problems (e.g., embolic stroke) related
to thrombus located in the left atrial appendage.
SUMMARY OF THE INVENTION
[0011] There is provided in accordance with one embodiment of the
present invention a method for containing emboli within a left
atrial appendage of a patient. In one embodiment, an implant that
has a frame that is expandable from a reduced cross section to an
enlarged cross section is provided, the frame extending between a
proximal hub and a distal hub. The frame is releasably coupled near
its proximal hub to a control line extending proximally away from
the proximal hub. A slider assembly is provided that is connected
to the frame, the slider assembly comprising a guide tube extending
proximally from the distal hub and an inner member slideably
received within the guide tube, the inner member being releasably
coupled to an elongate core that extends proximally through the
proximal hub, wherein movement of the inner member relative to the
frame is at least partially limited by interference between a
portion of the inner member and a portion of the guide tube.
[0012] In one embodiment, a method provides a left atrium access
path to the left atrial appendage for delivery of a device, such as
the implant discussed above. However, it will be appreciated that
any suitable device may be used. A delivery sheath having a distal
end can be distally advanced along the left atrium access path. The
distal end of the delivery sheath is distally advanced until the
delivery sheath is located proximate to an orifice of the left
atrial appendage. The method provides a delivery catheter having a
distal end that is coupled to the implant. The distal end of the
delivery catheter that is coupled the implant is distally advanced
through the delivery sheath along the left atrium access path and
the implant is delivered to the left atrial appendage of the
patient. The frame of the implant is expanded within the left
atrial appendage by providing relative movement between the control
line and the elongated core, wherein the elongated core is moveable
relative to the implant while coupled to the inner member when the
frame is positioned within the left atrial appendage.
[0013] In one embodiment, the delivery sheath is moved along the
left atrium access path, which is located within a pulmonary vein,
until the distal end of the delivery sheath is located near the LAA
of the heart.
[0014] In another embodiment, the delivery sheath is moved along
the left atrium access path, which is located through a hole in a
wall of the left atrium, until the distal end of the delivery
sheath is located near the LAA of the heart.
[0015] In another embodiment, a transseptal hole is provided and
the delivery sheath is moved along the left atrium path, which is
located within the right atrium and through the transseptal hole,
until the distal end of the delivery sheath is located near the LAA
of the heart.
[0016] In another embodiment, the left atrium is accessed by a
surgical heart procedure. The delivery sheath is moved along the
left atrium access path, which is located through the opening in
the heart, until the distal end of the delivery sheath is located
near the LAA of the heart.
[0017] In another embodiment, the left atrium is accessed by
surgical heart procedure. The implant can be distally advanced
along the left atrium access path, and the implant can be manually
delivered to the left atrial appendage of the patient.
[0018] Further, in one preferred embodiment, a user is provided
with a location of the distal end of the distally advanced delivery
sheath within the left atrium of the patient by using direct
visualization in the form of examination of the exterior surface of
the heart, visualization through the use of echocardiography,
visualization through optics including through thoracoscopes, or
the use of X-ray fluoroscopy.
[0019] In another embodiment, a method of delivering a containment
device to a left atrial appendage of a patient is provided. The
method includes providing a left atrium access path and a delivery
sheath is located along the left atrium access path. The delivery
sheath has both a delivery path and a distal end. The delivery path
extends along and within the delivery sheath. The delivery sheath
is moved to place the distal end of the delivery sheath within the
LAA of a heart. An implant is passed within the delivery sheath in
a distal direction to the distal end of the delivery sheath. The
implant is deployed by expanding a frame that is expandable from a
reduced cross section to an enlarged cross section. In one
embodiment, the implant contacts a surface of the LAA of the heart
and forms a seal between the implant and the surface of the
LAA.
[0020] It will be appreciated that any suitable device or
instrument may be delivered to the LAA along the left atrium access
path. In one embodiment, a device is delivered to the LAA as an
adjunct to a surgical heart procedure (e.g., during mitral valve
repair).
[0021] In some embodiments, a method is provide for delivering a
device to a left atrial appendage. The method comprises forming an
opening in a chest of a patient suitable for surgical heart
procedures. An implantable device is advanced through the opening
and into a left atrium. The implantable device is passed through
the left atrium and is positioned at the left atrial appendage.
[0022] In some embodiments, a method is provided for delivering a
device to a left atrial appendage. The method comprises forming an
aperture in the outer wall of a left atrium of a heart. A delivery
sheath is advanced through the aperture and into the left atrium. A
distal end of the delivery sheath is positioned proximate to an
orifice of the left atrial appendage while the delivery sheath
extends through the left atrium and the aperture. A device is
advanced through the delivery sheath and out of the distal end. The
device is implanted at the left atrial appendage.
[0023] In some embodiments, a method is provided for delivering a
device to a left atrial appendage. The method comprises providing a
delivery sheath having a lumen and a distal end and a transition
catheter having a tip configured to reduce injury to a patient. The
delivery sheath and transition catheter are advanced along the
right atrium and through a transseptal hole and into the left
atrium until a distal end of the delivery sheath is proximate to an
orifice of a left atrial appendage. The transition catheter is
removed from the delivery sheath. The device is distally advanced a
through the delivery sheath. The device is implanted at the left
atrial appendage while the distal end of the delivery sheath is
disposed within the left atrial appendage.
[0024] In some embodiments, a method is provided for delivering a
device to a left atrial appendage. The method comprises providing a
left atrium access path through a pulmonary vein to a left atrial
appendage. A delivery sheath is advanced along the left atrium
access path until the delivery sheath is located proximate to the
left atrial appendage. An implant is advanced through the delivery
sheath until the implant passes out of a distal end of the delivery
sheath. The device is implanted at the left atrial appendage.
[0025] In some embodiments, a system for delivering a device to the
left atrial appendage comprises an implant sized and configured to
prevent passage of embolic material from a left atrial appendage. A
delivery sheath defines a lumen and a distal end. A transition
catheter has an atraumatic tip and is configured to slide through
the lumen of the delivery sheath. The transition catheter is
adapted to extend from the distal end of the delivery sheath when
the distal end is proximate to the left atrial appendage. A
delivery catheter is removably coupled to the implant. The delivery
catheter and implant are configured to pass through the lumen of
the delivery sheath to the left atrial appendage.
[0026] In some embodiments, a system for delivering a device to the
left atrial appendage comprises an implant sized and configured to
prevent passage of embolic material from a left atrial appendage. A
delivery device is configured to carry the implant to the left
atrial appendage. The delivery device has a length configured to
access the left atrial appendage through an opening in a chest of a
patient. The delivery device has a length of about 80 cm or
less.
[0027] In some embodiments, a system for delivering a device into
the left atrial appendage comprises an implant sized and configured
to prevent passage of embolic material from a left atrial
appendage. A delivery device is configured to carry the implant to
the left atrial appendage. The delivery device has a length
configured to access the left atrial appendage through an opening
in a chest of a patient. The system further comprises means for
providing surgical access to the left atrial appendage through the
chest of the patient.
[0028] In some embodiments, a system for delivering a device into
the left atrial appendage of a patient comprises an implant sized
and configured to prevent passage of embolic material from a left
atrial appendage. A delivery device is configured to carry the
implant to the left atrial appendage. The delivery device has a
length configured to access the left atrial appendage through an
opening in a chest of a patient. The system further comprises a
means for performing a surgical heart procedure in the heart of the
patient.
[0029] In some embodiments, a system for delivering a device to the
left atrial appendage comprises an implant sized and configured to
prevent passage of embolic material from a left atrial appendage. A
delivery device is configured to carry the implant to the left
atrial appendage. The delivery device is sized and configured to
access the left atrial appendage through a pulmonary vein. The
delivery device has a length of about 50 cm or less.
[0030] In some, embodiments, a kit can be provided suitable for
delivering a device to the left atrial appendage. For example, the
kit can comprise the devices, apparatuses, and/or systems described
herein. The kit may optionally comprise packaging configured to
receive a system configured to deliver a device to the left atrial
appendage and/or instructions.
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] FIG. 1 is a perspective view of a containment device in
accordance with one embodiment of the present invention;
[0032] FIG. 2 is a side elevational view of the containment device
shown in FIG. 1;
[0033] FIG. 3 is a perspective view of a containment device in
accordance with an alternate embodiment of the present
invention;
[0034] FIG. 4 is a side elevational view of the embodiment shown in
FIG. 3;
[0035] FIG. 5 is a perspective view of a containment device in
accordance with a further embodiment of the present invention;
[0036] FIG. 6 is a side elevational view of the embodiment of FIG.
5;
[0037] FIG. 7 is a perspective view of a support structure for a
containment device in accordance with a further embodiment of the
present invention;
[0038] FIG. 7A is a side elevational view of the device of FIG.
7;
[0039] FIG. 7B is an end view taken along the line 7B-7B of FIG.
7A;
[0040] FIG. 8 is a schematic illustration of an inflatable balloon
positioned within the containment device of FIG. 7;
[0041] FIG. 9 is a schematic view of a pull string deployment
embodiment of the containment device of FIG. 7;
[0042] FIGS. 10 and 11 are side elevational schematic
representations of partial and complete barrier layers on the
containment device of FIG. 7;
[0043] FIG. 12 is a side elevational schematic view of an alternate
containment device in accordance with another embodiment of the
present invention;
[0044] FIG. 13 is a schematic view of a bonding layer mesh for use
in forming a composite barrier membrane in accordance with an
embodiment of the present invention;
[0045] FIG. 14 is an exploded cross sectional view of the
components of a composite barrier member in accordance with an
embodiment of the present invention;
[0046] FIG. 15 is a cross sectional view through a composite
barrier formed from the components illustrated in FIG. 14;
[0047] FIG. 16 is a top plan view of the composite barrier
illustrated in FIG. 15;
[0048] FIG. 17 is a schematic view of a deployment system in
accordance with one embodiment of the present invention;
[0049] FIG. 17A is an enlarged view of the deployment system of
FIG. 17, showing a releasable lock in an engaged configuration;
[0050] FIG. 17B is an enlarged view as in FIG. 17A, with a core
axially retracted to release the implant;
[0051] FIG. 18 is a perspective view of a flexible guide tube for
use in the configurations of FIG. 17 and/or FIG. 19;
[0052] FIG. 19 is a schematic view of an alternate deployment
system in accordance with one embodiment of the present
invention;
[0053] FIGS. 19A-19B illustrate a removal sequence for an implanted
device in accordance with one embodiment of the present
invention;
[0054] FIG. 20 is a schematic cross sectional view through the
distal end of a retrieval catheter having a containment device
removably connected thereto;
[0055] FIG. 20A is a schematic cross sectional view of the system
illustrated in FIG. 20, with the containment device axially
elongated and radially reduced;
[0056] FIG. 20B is a cross sectional schematic view as in FIG. 20A,
with the containment device drawn part way into the delivery
catheter;
[0057] FIG. 20C is a schematic view as in FIG. 20B, with the
containment device and delivery catheter drawn into a delivery
sheath;
[0058] FIG. 21 is a schematic cross sectional view of a distal
portion of an adjustable implant deployment system;
[0059] FIG. 21A is a schematic cross sectional view of a slider
assembly for use with the adjustable implant deployment system of
FIG. 21;
[0060] FIG. 21B is a cross sectional view of the slider assembly of
FIG. 21A taken along cut line 21B-21B;
[0061] FIG. 21C is a perspective view of the slider assembly of
FIG. 21 shown coupled to an axially moveable core;
[0062] FIG. 21D is a partial cut away view of the slider assembly
of FIG. 21C showing the position of the axially moveable core with
respect to the slider nut of the slider assembly;
[0063] FIG. 21E is a partial cut away view of the slider assembly
of FIG. 21 shown coupled to the frame of a detachable implant;
[0064] FIG. 22 is a schematic cross sectional view of a distal
portion of another embodiment of an adjustable implant deployment
system;
[0065] FIG. 22A is a schematic cross sectional view of a slider
assembly for use with the adjustable implant deployment system of
FIG. 22;
[0066] FIG. 23 is a schematic cross sectional view of another
embodiment of a slider assembly;
[0067] FIGS. 24 and 25 are alternative cross sectional views taken
along cut line A-A of FIG. 23;
[0068] FIG. 26 is a schematic cross sectional view of another
slider assembly for use with the adjustable implant deployment
system of FIG. 21;
[0069] FIG. 26A is a schematic cross sectional view of another
slider assembly for use with the adjustable implant deployment
system of FIG. 21;
[0070] FIG. 27 is a cross sectional view taken along cut line 27-27
of FIG. 26;
[0071] FIG. 28 is a schematic cross sectional view of a slider
assembly incorporating quick-disconnect functionality;
[0072] FIG. 29 is a schematic cross sectional view of another
slider assembly incorporating quick-disconnect functionality,
constructed in accordance with another embodiment of the present
invention;
[0073] FIG. 29A is a side elevational view of a bayonet mount
coupling the guide tube of the slider assembly of an implant to an
axial moveable core, in accordance with one embodiment of the
present invention;
[0074] FIG. 29B is a side elevational view of the axially moveable
core of FIG. 29A;
[0075] FIG. 29C is an end view of the axially moveable core of FIG.
29A;
[0076] FIG. 29D is an end view of the guide tube of the slider
assembly of the implant of FIG. 29A;
[0077] FIG. 29E is a side elevational view of one embodiment of a
maze-type slotted guide tube in accordance with one embodiment of
the present invention;
[0078] FIG. 29F is a side elevational view of another embodiment of
a maze-type slotted guide tube in accordance with one embodiment of
the present invention;
[0079] FIG. 29G is an end view of an axially moveable core in
accordance with another embodiment of the present invention;
[0080] FIG. 29H is one embodiment of a key mount coupling a first
and second portion of an axially moveable core in accordance with
one embodiment of the present invention;
[0081] FIG. 29I is a schematic cross sectional view of the key
mount of FIG. 29H taken along cut line 29I-291;
[0082] FIG. 30 is a schematic view of a deployment system
delivering an implantable containment device to the left atrial
appendage;
[0083] FIG. 31 is a schematic cross sectional view of an
implantable containment device built in accordance with one
embodiment of the present invention;
[0084] FIG. 32 is a schematic view of a delivery system constructed
in accordance with one embodiment of the present invention;
[0085] FIG. 32A is a cross sectional view of a deployment catheter
as shown in FIG. 32, taken along cut line 32A-32A.
[0086] FIG. 33 is a schematic view of the delivery system of FIG.
32, shown attached to an implantable containment device;
[0087] FIGS. 34A and 34B are a schematic cross sectional view and
an end view, respectively, of a loading collar used in the system
of FIG. 32;
[0088] FIG. 35 is a schematic view of a recapture sheath used in
the system of FIG. 32;
[0089] FIG. 36 is an enlarged partial cross sectional view of the
deployment system of FIG. 32;
[0090] FIG. 37 is a partial cross sectional view of an axially
moveable core used in the system of FIG. 32;
[0091] FIG. 37A is a cross sectional view of the axially moveable
core of FIG. 37 taken along cut line 37A-37A;
[0092] FIGS. 38A-C are a schematic view of a delivery sheath used
in combination with the system of FIG. 32;
[0093] FIG. 39 is a schematic view of a delivery sheath and a
transition catheter used in combination with the system of FIG.
32;
[0094] FIG. 40 is a view of a heart and a delivery sheath located
along the pulmonary vein;
[0095] FIG. 41 is a view of a heart and a delivery sheath through
an opening of the left atrium;
[0096] FIG. 41A is a view of an open heart and a delivery path;
[0097] FIG. 42 is a view of the heart and a delivery sheath located
within the right atrium and passing through a transseptal
puncture;
[0098] FIG. 43 a schematic view of a delivery system attached to an
implantable containment device in accordance with another
embodiment;
[0099] FIG. 44 is a cross sectional view of a deployment catheter
as shown in FIG. 43, taken along cut line 44-44;
[0100] FIG. 45 a schematic view of a delivery system attached to an
implantable containment device in accordance with another
embodiment;
[0101] FIG. 46 is a partial cross-sectional schematic view of a
delivery system attached to an implantable containment device in
accordance with another embodiment; and
[0102] FIG. 47 is a schematic view of the delivery system shown in
FIG. 46.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0103] Referring to FIGS. 1 and 2, there is illustrated one
embodiment of an occlusion or containment device 10 in accordance
with the present invention. Although the present invention will be
described primarily in the context of an occlusion device, the
present inventors also contemplate omitting the fabric cover or
enlarging the pore size to produce implantable filters or other
devices which are enlargeable at a remote implantation site. The
terms "occlusion device" or "containment device" are intended to
encompass all such devices.
[0104] The occlusion device 10 comprises an occluding member 11
comprising a frame 14 and a barrier 15. In the illustrated
embodiment, the frame 14 comprises a plurality of radially
outwardly extending spokes 17 each having a length within the range
of from about 0.5 cm to about 2 cm from a hub 16. In one
embodiment, the spokes have an axial length of about 1.5 cm.
Depending upon the desired introduction crossing profile of the
collapsed occlusion device 10, as well as structural strength
requirements in the deployed device, anywhere within the range of
from about 3 spokes to about 40 spokes may be utilized. In some
embodiments, anywhere from about 12 to about 24 spokes are
utilized, and, 18 spokes are utilized in one embodiment.
[0105] The spokes are advanceable from a generally axially
extending orientation such as to fit within a tubular introduction
catheter to a radially inclined orientation as illustrated in FIG.
1 and FIG. 2 following deployment from the catheter. In a
self-expandable embodiment, the spokes are biased radially
outwardly such that the occlusion member expands to its enlarged,
implantation cross-section under its own bias following deployment
from the catheter. Alternatively, the occlusion member may be
enlarged using any of a variety of enlargement structures such as
an inflatable balloon, or a catheter for axially shortening the
occlusion member, as is discussed further below.
[0106] Preferably, the spokes comprise a metal such as stainless
steel, nitinol, Elgiloy, or others which can be determined through
routine experimentation by those of skill in the art. Wires having
a circular or rectangular cross-section may be utilized depending
upon the manufacturing technique. In one embodiment, rectangular
cross section spokes are cut such as by known laser cutting
techniques from tube stock, a portion of which forms the hub
16.
[0107] The barrier 15 may comprise any of a variety of materials
which facilitate cellular in-growth, such as ePTFE. The suitability
of alternate materials for barrier 15 can be determined through
routine experimentation by those of skill in the art. The barrier
15 may be provided on either one or both axially facing sides of
the occlusion member. In one embodiment, the barrier 15 comprises
two layers, with one layer on each side of the frame 14. The two
layers may be bonded to each other around the spokes 17 in any of a
variety of ways, such as by heat bonding with or without an
intermediate bonding layer such as polyethylene or FEP, adhesives,
sutures, and other techniques which will be apparent to those of
skill in the art in view of the disclosure herein. The barrier 15
preferably has a thickness of no more than about 0.006" and a
porosity within the range of from about 5 .mu.m to about 60
.mu.m.
[0108] The barrier 15 in one embodiment preferably is securely
attached to the frame 14 and retains a sufficient porosity to
facilitate cellular ingrowth and/or attachment. One method of
manufacturing a suitable composite membrane barrier 15 is
illustrated in FIGS. 13-16. As illustrated schematically in FIG.
13, a bonding layer 254 preferably comprises a mesh or other porous
structure having an open surface area within the range of from
about 10% to about 90%. Preferably, the open surface area of the
mesh is within the range of from about 30% to about 60%. The
opening or pore size of the bonding layer 254 is preferably within
the range of from about 0.005 inches to about 0.050 inches, and, in
one embodiment, is about 0.020 inches. The thickness of the bonding
layer 254 can be varied widely, and is generally within the range
of from about 0.0005 inches to about 0.005 inches. In a preferred
embodiment, the bonding layer 254 has a thickness of about 0.001 to
about 0.002 inches. One suitable polyethylene bonding mesh is
available from Smith and Nephew, under the code SN9.
[0109] Referring to FIG. 14, the bonding layer 254 is preferably
placed adjacent one or both sides of a spoke or other frame element
14. The bonding layer 254 and frame 14 layers are then positioned
in-between a first membrane 250 and a second membrane 252 to
provide a composite membrane stack. The first membrane 250 and
second membrane 252 may comprise any of a variety of materials and
thicknesses, depending upon the desired functional result.
Generally, the membrane has a thickness within the range of from
about 0.0005 inches to about 0.010 inches. In one embodiment, the
membranes 250 and 252 each have a thickness on the order of from
about 0.001 inches to about 0.002 inches, and comprise porous
ePTFE, having a porosity within the range of from about 10 microns
to about 100 microns.
[0110] The composite stack is heated to a temperature of from about
200.degree. F. to about 300.degree. F., for about 1 minute to about
5 minutes under pressure to provide a finished composite membrane
assembly with an embedded frame 14 as illustrated schematically in
FIG. 15. The final composite membrane has a thickness within the
range of from about 0.001 inches to about 0.010 inches, and,
preferably, is about 0.002 to about 0.003 inches in thickness.
However, the thicknesses and process parameters of the foregoing
may be varied considerably, depending upon the materials of the
bonding layer 254 the first layer 250 and the second layer 252.
[0111] As illustrated in top plan view in FIG. 16, the resulting
finished composite membrane has a plurality of "unbonded" windows
or areas 256 suitable for cellular attachment and/or ingrowth. The
attachment areas 256 are bounded by the frame 14 struts, and the
cross-hatch or other wall pattern formed by the bonding layer 254.
Preferably, a regular window 256 pattern is produced in the bonding
layer 254.
[0112] The foregoing procedure allows the bonding mesh to flow into
the first and second membranes 250 and 252 and gives the composite
membrane 15 greater strength (both tensile and tear strength) than
the components without the bonding mesh. The composite allows
uniform bonding while maintaining porosity of the membrane 15, to
facilitate tissue attachment. By flowing the thermoplastic bonding
layer into the pores of the outer mesh layers 250 and 252, the
composite flexibility is preserved and the overall composite layer
thickness can be minimized.
[0113] Referring back to FIGS. 1 and 2, the occlusion device 10 may
be further provided with a bulking element or stabilizer 194. The
stabilizer 194 may be spaced apart along an axis from the occluding
member 11. In the illustrated embodiment, a distal end 190 and a
proximal end 192 are identified for reference. The designation
proximal or distal is not intended to indicate any particular
anatomical orientation or deployment orientation within the
deployment catheter. As shown in FIGS. 1 and 2, the stabilizer 194
is spaced distally apart from the occluding member 11.
[0114] For use in the LAA, the occluding member 11 has an expanded
diameter within the range of from about 1 cm to about 5 cm, and, in
one embodiment, about 3 cm. The axial length of the occluding
member 11 in an expanded, unstressed orientation from the distal
end 192 to the hub 16 is on the order of about 1 cm. The overall
length of the occlusion device 10 from the distal end 192 to the
proximal end 190 is within the range of from about 1.5 cm to about
4 cm and, in one embodiment, about 2.5 cm. The axial length of the
stabilizer 194 between distal hub 191 and proximal hub 16 is within
the range of from about 0.5 cm to about 2 cm, and, in one
embodiment, about 1 cm. The expanded diameter of the stabilizer 194
is within the range of from about 0.5 cm to about 2.5 cm, and, in
one embodiment, about 1.4 cm. The outside diameter of the distal
hub 191 and proximal hub 16 is about 2.5 mm.
[0115] Preferably, the occlusion device 10 is provided with one or
more retention structures for retaining the device in the left
atrial appendage or other body cavity or lumen. In the illustrated
embodiment, a plurality of barbs or other anchors 195 are provided,
for engaging adjacent tissue to retain the occlusion device 10 in
its implanted position and to limit relative movement between the
tissue and the occlusion device. The illustrated anchors are
provided on one or more of the spokes 17, or other portion of frame
14. Preferably, every spoke, every second spoke or every third
spoke are provided with one or two or more anchors each.
[0116] The illustrated anchor is in the form of a barb, with one on
each spoke for extending into tissue at or near the opening of the
LAA. Depending upon the embodiment, two or three barbs may
alternatively be desired on each spoke. In the single barb
embodiment of FIG. 7, each barb is inclined in a proximal
direction. This is to inhibit proximal migration of the implant out
of the left atrial appendage. In this context, distal refers to the
direction into the left atrial appendage, and proximal refers to
the direction from the left atrial appendage into the heart.
[0117] Alternatively, one or more barbs may face distally, to
inhibit distal migration of the occlusion device deeper into the
LAA. Thus the implant may be provided with at least one proximally
facing barb and at least one distally facing barb. For example, in
an embodiment of the type illustrated in FIG. 12, discussed below,
a proximal plurality of barbs may be inclined in a first direction,
and a distal plurality of barbs may be inclined in a second
direction, to anchor the implant against both proximal and distal
migration.
[0118] One or more anchors 195 may also be provided on the
stabilizer 194, such that it assists not only in orienting the
occlusion device 10 and resisting compression of the LAA, but also
in retaining the occlusion device 10 within the LAA. Any of a wide
variety of structures may be utilized for anchor 195, either on the
occluding member 11 or the stabilizer 194 or both, such as hooks,
barbs, pins, sutures, adhesives, ingrowth surfaces and others which
will be apparent to those of skill in the art in view of the
disclosure herein.
[0119] In use, the occlusion device 10 is preferably positioned
within a tubular anatomical structure to be occluded such as the
left atrial appendage. In a left atrial appendage application, the
occluding member 11 is positioned across or near the opening to the
LAA and the stabilizer 194 is positioned within the LAA. The
stabilizer 194 assists in the proper location and orientation of
the occluding member 11, as well as resists compression of the LAA
behind the occluding member 11. The present inventors have
determined that following deployment of an occluding member 11
without a stabilizer 194 or other bulking structure to resist
compression of the LAA, normal operation of the heart may cause
compression and resulting volume changes in the LAA, thereby
forcing fluid past the occluding member 11 and inhibiting or
preventing a complete seal. Provision of a stabilizer 194
dimensioned to prevent the collapse or pumping of the LAA thus
minimizes leakage, and provision of the barbs facilitates
endothelialization or other cell growth across the occluding member
11.
[0120] The stabilizer 194 is preferably movable between a reduced
cross-sectional profile for transluminal advancement into the left
atrial appendage, and an enlarged cross-sectional orientation as
illustrated to fill or to substantially fill a cross-section
through the LAA. The stabilizing member may enlarge to a greater
cross section than the (pre-stretched) anatomical cavity, to ensure
a tight fit and minimize the likelihood of compression. One
convenient construction includes a plurality of elements 196 which
are radially outwardly expandable in response to axial compression
of a distal hub 191 towards a proximal hub 16. Elements 196 each
comprise a distal segment 198 and a proximal segment 202 connected
by a bend 200. The elements 196 may be provided with a bias in the
direction of the radially enlarged orientation as illustrated in
FIG. 2, or may be radially expanded by applying an expansion force
such as an axially compressive force between distal hub 191 and
proximal hub 16 or a radial expansion force such as might be
applied by an inflatable balloon. Elements 196 may conveniently be
formed by laser cutting the same tube stock as utilized to
construct the distal hub 191, proximal hub 16 and frame 14, as will
be apparent to those of skill in the art in view of the disclosure
herein. Alternatively, the various components of the occlusion
device 10 may be separately fabricated or fabricated in
subassemblies and secured together during manufacturing.
[0121] As a post implantation step for any of the occlusion devices
disclosed herein, a radiopaque dye or other visualizeable media may
be introduced on one side or the other of the occlusion device, to
permit visualization of any escaped blood or other fluid past the
occlusion device. For example, in the context of a left atrial
appendage application, the occlusion device may be provided with a
central lumen or other capillary tube or aperture which permits
introduction of a visualizeable dye from the deployment catheter
through the occlusion device and into the entrapped space on the
distal side of the occlusion device. Alternatively, dye may be
introduced into the entrapped space distal to the occlusion device
such as by advancing a small gauge needle from the deployment
catheter through the barrier 15 on the occlusion device, to
introduce dye.
[0122] Modifications to the occlusion device 10 are illustrated in
FIGS. 3-4. The occlusion device 10 comprises an occlusion member 11
and a stabilizing member 194 as previously discussed. In the
present embodiment, however, each of the distal segments 198
inclines radially outwardly in the proximal direction and
terminates in a proximal end 204. The proximal end 204 may be
provided with an atraumatic configuration, for pressing against,
but not penetrating, the wall of the left atrial appendage or other
tubular body structure. Three or more distal segments 198 are
preferably provided, and generally anywhere within the range of
from about 6 to about 20 distal segments 198 may be used. In one
embodiment, 9 distal segments 198 are provided. In this embodiment,
three of the distal segments 198 have an axial length of about 5
mm, and 6 of the distal segments 198 have an axial length of about
1 cm. Staggering the lengths of the distal segments 198 may axially
elongate the zone in the left atrial appendage against which the
proximal ends 204 provide anchoring support for the occlusion
device.
[0123] The occlusion device 10 illustrated in FIGS. 3 and 4 is
additionally provided with a hinge 206 to allow the longitudinal
axis of the occlusion member 11 to be angularly oriented with
respect to the longitudinal axis of the stabilizing member 194. In
the illustrated embodiment, the hinge 206 is a helical coil,
although any of a variety of hinge structures can be utilized. The
illustrated embodiment may be conveniently formed by laser cutting
a helical slot through a section of the tube from which the
principal structural components of the occlusion device 10 are
formed. At the distal end of the hinge 206, an annular band 208
connects the hinge 206 to a plurality of axially extending struts
210. In the illustrated embodiment, three axial struts 210 are
provided, spaced equilaterally around the circumference of the
body. Axial struts 210 may be formed from a portion of the wall of
the original tube stock, which portion is left in its original
axial orientation following formation of the distal segments 198
such as by laser cutting from the tubular wall.
[0124] The occlusion member 11 is provided with a proximal zone 212
on each of the spokes 17. Proximal zone 212 has an enhanced degree
of flexibility, to accommodate the fit between the occlusion member
11 and the wall of the left atrial appendage. Proximal section 212
may be formed by reducing the cross sectional area of each of the
spokes 17, which may be provided with a wave pattern as
illustrated.
[0125] Each of the spokes 17 terminates in a proximal point 214.
Proximal point 214 may be contained within layers of the barrier
15, or may extend through or beyond the barrier 15 such as to
engage adjacent tissue and assist in retaining the occlusion device
10 at the deployment site.
[0126] Referring to FIGS. 5 and 6, a further variation on the
occlusion device 10 illustrated in FIGS. 1 and 2 is provided. The
occlusion device 10 is provided with a proximal face 216 on the
occlusion member 11, instead of the open and proximally concave
face on the embodiment of FIGS. 1 and 2. The proximal face 216 is
formed by providing a proximal spoke 218 which connects at an apex
220 to some or all of the distal spokes 17. The proximal spoke 218,
and corresponding apex 220 and distal spoke 17 may be an integral
structure, such as a single ribbon or wire, or element cut from a
tube stock as has been discussed.
[0127] Proximal spokes 218 are each attached to a hub 222 at the
proximal end 192 of the occlusion device 10. The barrier 15 may
surround either the proximal face or the distal face or both on the
occlusion member 11. In general, provision of a proximal spoke 218
connected by an apex 220 to a distal spoke 17 provides a greater
radial force than a distal spoke 17 alone, which will provide an
increased resistance to compression if the occlusion member 11 is
positioned with the LAA.
[0128] Referring to FIGS. 7-12, alternate structures of the
occlusion device in accordance with the present invention are
illustrated. In general, the occlusion device 10 comprises an
occluding member but does not include a distinct stabilizing member
as has been illustrated in connection with previous embodiments.
Any of the embodiments previously disclosed herein may also be
constructed using the occluding member only, and omitting the
stabilizing member as will be apparent to those of skill in the art
in view of the disclosure herein.
[0129] The occluding device 10 comprises a proximal end 192, a
distal end 190, and a longitudinal axis extending therebetween. A
plurality of supports 228 extend between a proximal hub 222 and a
distal hub 191. At least two or three supports 228 are provided,
and preferably at least about ten. In one embodiment, sixteen
supports 228 are provided. However, the precise number of supports
228 can be modified, depending upon the desired physical properties
of the occlusion device 10 as will be apparent to those of skill in
the art in view of the disclosure herein, without departing from
the present invention.
[0130] Each support 228 comprises a proximal spoke portion 218, a
distal spoke portion 17, and an apex 220 as has been discussed.
Each of the proximal spoke portion 218, distal spoke portion 17 and
apex 220 may be a region on an integral support 228, such as a
continuous rib or frame member which extends in a generally curved
configuration as illustrated with a concavity facing towards the
longitudinal axis of the occlusion device 10. Thus, no distinct
point or hinge at apex 220 is necessarily provided.
[0131] At least some of the supports 228, and, preferably, each
support 228, is provided with one or two or more barbs 195. In the
illustrated configuration, the occlusion device 10 is in its
enlarged orientation, such as for occluding a left atrial appendage
or other body cavity or lumen. In this orientation, each of the
barbs 195 projects generally radially outwardly from the
longitudinal axis, and is inclined in the proximal direction. One
or more barbs may also be inclined distally, as is discussed
elsewhere herein. In an embodiment where the barbs 195 and
corresponding support 228 are cut from a single ribbon, sheet or
tube stock, the barb 195 will incline radially outwardly at
approximately a tangent to the curve formed by the support 228.
[0132] The occlusion device 10 constructed from the frame
illustrated in FIG. 7 may be constructed in any of a variety of
ways, as will become apparent to those of skill in the art in view
of the disclosure herein. In one method, the occlusion device 10 is
constructed by laser cutting a piece of tube stock to provide a
plurality of axially extending slots in-between adjacent supports
228. Similarly, each barb 195 can be laser cut from the
corresponding support 228 or space in-between adjacent supports
228. The generally axially extending slots which separate adjacent
supports 228 end a sufficient distance from each of the proximal
end 192 and distal end 190 to leave a proximal hub 222 and a distal
hub 191 to which each of the supports 228 will attach. In this
manner, an integral cage structure may be formed. Alternatively,
each of the components of the cage structure may be separately
formed and attached together such as through soldering, brazing,
heat bonding, adhesives, and other fastening techniques which are
known in the art. A further method of manufacturing the occlusion
device 10 is to laser cut a slot pattern on a flat sheet of
appropriate material, such as a flexible metal or polymer, as has
been discussed in connection with previous embodiments. The flat
sheet may thereafter be rolled about an axis and opposing edges
bonded together to form a tubular structure.
[0133] The apex portion 220 which carries the barb 195 may be
advanced from a low profile orientation in which each of the
supports 228 extend generally parallel to the longitudinal axis, to
an implanted orientation as illustrated, in which the apex 220 and
the barb 195 are positioned radially outwardly from the
longitudinal axis. The support 228 may be biased towards the
enlarged orientation, or may be advanced to the enlarged
orientation under positive force following positioning within the
tubular anatomical structure, in any of a variety of manners.
[0134] For an example of enlarging under positive force, referring
to FIG. 8, an inflatable balloon 230 is positioned within the
occlusion device 10. Inflatable balloon 230 is connected by way of
a removable coupling 232 to an inflation catheter 234. Inflation
catheter 234 is provided with an inflation lumen for providing
communication between an inflation media source 236 outside of the
patient and the balloon 230. Following positioning within the
target body lumen, the balloon 230 is inflated, thereby engaging
barbs 195 with the surrounding tissue. The inflation catheter 234
is thereafter removed, by decoupling the removable coupling 232,
and the inflation catheter 234 is thereafter removed. The balloon
230 may be either left in place within the occlusion device 10, or
deflated and removed by the inflation catheter 234.
[0135] In an alternate embodiment, the supports 228 are radially
enlarged such as through the use of a deployment catheter 238. See
FIG. 9. Deployment catheter 238 comprises a lumen for movably
receiving a deployment element such as a flexible line 240.
Deployment line 240 extends in a loop 244 formed by an aperture or
slip knot 242. As will be apparent from FIG. 9, proximal retraction
on the deployment line 240 while resisting proximal movement of
proximal hub 222 such as by using the distal end of the catheter
238 will cause the distal hub 191 to be drawn towards the proximal
hub 222, thereby radially enlarging the cross-sectional area of the
occlusion device 10. Depending upon the material utilized for the
occlusion device 10, the supports 228 will retain the radially
enlarged orientation by elastic deformation, or may be retained in
the enlarged orientation such as by securing the slip knot 242
immovably to the deployment line 240 at the fully radially enlarged
orientation. This may be accomplished in any of a variety of ways,
using additional knots, clips, adhesives, or other techniques known
in the art.
[0136] A variety of alternative structures may be utilized, to open
or enlarge the occlusion device 10 under positive force. For
example, referring to FIG. 9, a pull wire 240 may be removably
attached to the distal hub 191 or other distal point of attachment
on the occlusion device 10. Proximal retraction of the pull wire
240 while resisting proximal motion of the proximal hub 222 such as
by using the distal end of the catheter 238 will cause enlargement
of the occlusion device 10 as has been discussed. The pull wire 240
may then be locked with respect to the proximal hub 222 and severed
or otherwise detached to enable removal of the deployment catheter
238 and retraction of the pull wire 240. Locking of the pull wire
with respect to the proximal hub 222 may be accomplished in any of
a variety of ways, such as by using interference fit or friction
fit structures, adhesives, a knot or other technique depending upon
the desired catheter design.
[0137] Referring to FIGS. 10 and 11, the occlusion device 10 may be
provided with a barrier 15 such as a mesh or fabric as has been
previously discussed. Barrier 15 may be provided on only one
hemisphere such as proximal face 216, or may be carried by the
entire occlusion device 10 from proximal end 192 to distal end 190.
The barrier may be secured to the radially inwardly facing surface
of the supports 228, as illustrated in FIG. 11, or may be provided
on the radially outwardly facing surfaces of supports 228, or
both.
[0138] A further embodiment of the occlusion device 10 is
illustrated in FIG. 12, in which the apex 220 is elongated in an
axial direction to provide additional contact area between the
occlusion device 10 and the wall of the tubular structure. In this
embodiment, one or two or three or more anchors 195 may be provided
on each support 228, depending upon the desired clinical
performance. The occlusion device 10 illustrated in FIG. 12 may
also be provided with any of a variety of other features discussed
herein, such as a partial or complete barrier 15. In addition, the
occlusion device 10 illustrated in FIG. 12 may be enlarged using
any of the techniques disclosed elsewhere herein.
[0139] Referring to FIG. 17, there is schematically illustrated a
further embodiment of the present invention. An adjustable implant
deployment system 300 comprises generally a catheter 302 for
placing a detachable implant 304 within a body cavity or lumen, as
has been discussed. The catheter 302 comprises an elongate flexible
tubular body 306, extending between a proximal end 308 and a distal
end 310. The catheter is shown in highly schematic form, for the
purpose of illustrating the functional aspects thereof. In one
embodiment, the catheter body will have a sufficient length and
diameter to permit percutaneous entry into the vascular system, and
transluminal advancement through the vascular system to the desired
deployment site. For example, in an embodiment intended for access
at the femoral vein and deployment within the left atrial
appendage, the catheter 302 will have a length within the range of
from about 50 cm to about 150 cm, and a diameter of generally no
more than about 15 French. Those skilled in the art recognize that
the implant deployment system 300 can be configured and sized for
various methods of deploying implant 304, as described below. The
catheter 302 can be sized and configured so that an implant 304 can
be delivered using, for example, conventional transthoracic
surgical, minimally invasive, or port access approaches. The
deployment system 300 can be used to deploy the implant 304 using
methods shown in FIGS. 40-42 and described below. Further
dimensions and physical characteristics of catheters for navigation
to particular sites within the body are well understood in the
art.
[0140] The tubular body 306 is further provided with a handle 309
generally on the proximal end 308 of the catheter 302. The handle
309 permits manipulation of the various aspects of the implant
deployment system 300, as will be discussed below. Handle 309 may
be manufactured in any of a variety of ways, typically by injection
molding or otherwise forming a handpiece for single-hand operation,
using materials and construction techniques well known in the
medical device arts.
[0141] The implant 304 may be in the form of any of those described
previously herein, as modified below. In general, the implant is
movable from a reduced crossing profile to an enlarged crossing
profile, such that it may be positioned within a body structure and
advanced from its reduced to its enlarged crossing profile to
obstruct blood flow or perform other functions while anchored
therein. The implant 304 may be biased in the direction of the
enlarged crossing profile, may be neutrally biased or may be biased
in the direction of the reduced crossing profile. Any modifications
to the device and deployment system to accommodate these various
aspects of the implant 304 may be readily accomplished by those of
skill in the art in view of the disclosure herein.
[0142] In the illustrated embodiment, the distal end 314 of the
implant 304 is provided with an implant plug 316. Implant plug 316
provides a stopping surface 317 for contacting an axially movable
core 312. The core 312 extends axially throughout the length of the
catheter body 302, and is attached at its proximal end to a core
control 332 on the handle 309.
[0143] The core 312 may comprise any of a variety of structures
which has sufficient lateral flexibility to permit navigation of
the vascular system, and sufficient axial column strength to enable
reduction of the implant 304 to its reduced crossing profile. Any
of a variety of structures such as hypotube, solid core wire,
"bottomed out" coil spring structures, or combinations thereof may
be used, depending upon the desired performance of the finished
device. In one embodiment, the core 312 comprises stainless steel
tubing.
[0144] The distal end of core 312 is positioned within a recess or
lumen 322 defined by a proximally extending guide tube 320. In the
illustrated embodiment, the guide tube 320 is a section of tubing
such as metal hypotube, which is attached at the distal end 314 of
the implant and extends proximally within the implant 304. The
guide tube 320 preferably extends a sufficient distance in the
proximal direction to inhibit buckling or prolapse of the core 312
when distal pressure is applied to the core control 332 to reduce
the profile of the implant 304. However, the guide tube 320 should
not extend proximally a sufficient distance to interfere with the
opening of the implant 304.
[0145] As will be appreciated by reference to FIG. 17, the guide
tube 320 may operate as a limit on distal axial advancement of the
proximal end 324 of implant 304. Thus, the guide tube 320
preferably does not extend sufficiently far proximally from the
distal end 314 to interfere with optimal opening of the implant
304. The specific dimensions are therefore relative, and will be
optimized to suit a particular intended application. In one
embodiment, the implant 304 has an implanted outside diameter
within the range of from about 5 mm to about 45 mm, and an axial
implanted length within the range of from about 5 mm to about 45
mm. The guide tube 320 has an overall length of about 3 mm to about
35 mm, and an outside diameter of about 0.095 inches.
[0146] An alternate guide tube 320 is schematically illustrated in
FIG. 18. In this configuration, the guide tube 320 comprises a
plurality of tubular segments 321 spaced apart by an intervening
space 323. This allows increased flexibility of the guide tube 320,
which may be desirable during the implantation step, while
retaining the ability of the guide tube 320 to maintain linearity
of the core 312 while under axial pressure. Although three segments
321 are illustrated in FIG. 18, as many as 10 or 20 or more
segments 321 may be desirable depending upon the desired
flexibility of the resulting implant.
[0147] Each adjacent pair of segments 321 may be joined by a hinge
element 325 which permits lateral flexibility. In the illustrated
embodiment, the hinge element 325 comprises an axially extending
strip or spine, which provides column strength along a first side
of the guide tube 320. The guide tube 320 may therefore be curved
by compressing or extending a second side of the guide tube 320
which is generally offset from the spine 325 by about 180.degree..
A limit on the amount of curvature may be set by adjusting the
axial length of the space 323 between adjacent segments 321. In an
embodiment having axial spines 325, each axial spine 325 may be
rotationally offset from the next adjacent axial spine 325 to
enable flexibility of the overall guide tube 320 throughout a
360.degree. angular range of motion.
[0148] Alternatively, the flexible hinge point between each
adjacent segment 321 may be provided by cutting a spiral groove or
plurality of parallel grooves in a tubular element in between what
will then become each adjacent pair of segments 321. In this
manner, each tubular element 321 will be separated by an integral
spring like structure, which can permit flexibility. As a further
alternative, the entire length of the guide tube 320 may comprise a
spring. Each of the forgoing embodiments may be readily constructed
by laser cutting or other cutting from a piece of tube stock, to
produce a one piece guide tube 320. Alternatively, the guide tube
320 may be assembled from separate components and fabricated
together using any of a variety of bonding techniques which are
appropriate for the construction material selected for the tube
320.
[0149] Various distal end 314 constructions may be utilized, as
will be apparent to those of skill in the art in view of the
disclosure herein. In the illustrated embodiment, the distal
implant plug 316 extends within the implant 304 and is attached to
the distal end of the guide tube 320. The implant plug 316 may be
secured to the guide tube 320 and implant 304 in any of a variety
of ways, depending upon the various construction materials. For
example, any of a variety of metal bonding techniques such as a
welding, brazing, interference fit such as threaded fit or snap
fit, may be utilized. Alternatively, any of a variety of bonding
techniques for dissimilar materials may be utilized, such as
adhesives, and various molding techniques. In one construction, the
implant plug 316 comprises a molded polyethylene cap, and is held
in place utilizing a distal cross pin 318 which extends through the
implant 304, the guide tube 320 and the implant plug 316 to provide
a secure fit against axial displacement.
[0150] The proximal end 324 of the implant 304 is provided with a
releasable lock 326 for attachment to a release element such as
pull wire 328. Pull wire 328 extends proximally throughout the
length of the tubular body 306 to a proximal pull wire control 330
on the handle 309.
[0151] As used herein, the term pull wire is intended to include
any of a wide variety of structures which are capable of
transmitting axial tension or compression such as a pushing or
pulling force with or without rotation from the proximal end 308 to
the distal end 310 of the catheter 302. Thus, monofilament or
multifilament metal or polymeric rods or wires, woven or braided
structures may be utilized. Alternatively, tubular elements such as
a concentric tube positioned within the outer tubular body 306 may
also be used as will be apparent to those of skill in the art.
[0152] In the illustrated embodiment, the pull wire 328 is
releasably connected to the proximal end 324 of the implant 304.
This permits proximal advancement of the proximal end of the
implant 304, which cooperates with a distal retention force
provided by the core 312 against the distal end of the implant to
axially elongate the implant 304 thereby reducing it from its
implanted configuration to its reduced profile for implantation.
The proximal end of the pull wire 328 may be connected to any of a
variety of pull wire controls 330, including rotational knobs,
levers and slider switches, depending upon the design
preference.
[0153] The proximal end 324 of the implant 304 is thus preferably
provided with a releasable lock 326 for attachment of the pull wire
328 to the deployment catheter. In the illustrated embodiment, the
releasable lock is formed by advancing the pull wire distally
around a cross pin 329, and providing an eye or loop which extends
around the core 312. As long as the core 312 is in position within
the implant 304, proximal retraction of the pull wire 328 will
advance the proximal end 324 of the implant 304 in a proximal
direction. See FIG. 17A. However, following deployment, proximal
retraction of the core 312 such as by manipulation of the core
control 332 will pull the distal end of the core 312 through the
loop on the distal end of the pull wire 328. The pull wire 328 may
then be freely proximally removed from the implant 304, thereby
enabling detachment of the implant 304 from the deployment system
300 within a treatment site. See FIG. 17B.
[0154] The implant deployment system 300 thus permits the implant
304 to be maintained in a low crossing profile configuration, to
enable transluminal navigation to a deployment site. Following
positioning at or about the desired deployment site, proximal
retraction of the core 312, or distal movement of full wire 528,
enables the implant 304 to radially enlarge under its own bias to
fit the surrounding tissue structure. Alternatively, the implant
can be enlarged under positive force, such as by inflation of a
balloon or by a mechanical mechanism as is discussed elsewhere
herein. Once the clinician is satisfied with the position of the
implant 304, such as by injection of dye and visualization using
conventional techniques, the core 312 is proximally retracted
thereby releasing the lock 326 and enabling detachment of the
implant 304 from the deployment system 300.
[0155] If, however, visualization reveals that the implant 304 is
not at the location desired by the clinician, proximal retraction
of the pull wire 328 with respect to the core 312 will radially
reduce the diameter of the implant 304, thereby enabling
repositioning of the implant 304 at the desired site. Thus, the
present invention permits the implant 304 to be enlarged or reduced
by the clinician to permit repositioning and/or removal of the
implant 304 as may be desired.
[0156] In an alternate construction, the implant may be radially
enlarged or reduced by rotating a torque element extending
throughout the deployment catheter. Referring to FIG. 19, the
elongate flexible tubular body 306 of the deployment catheter 302
includes a rotatable torque rod 340 extending axially therethrough.
The proximal end of the torque rod 340 may be connected at a
proximal manifold to a manual rotation device such as a hand crank,
thumb wheel, rotatable knob or the like. Alternatively, the torque
rod 340 may be connected to a power driven source of rotational
energy such as a motor drive or air turbine.
[0157] The distal end of the torque rod 340 is integral with or is
connected to a rotatable core 342 which extends axially through the
implant 304. A distal end 344 of the rotatable core 342 is
positioned within a cavity 322 as has been discussed.
[0158] The terms torque rod or torque element are intended to
include any of a wide variety of structures which are capable of
transmitting a rotational torque throughout the length of a
catheter body. For example, solid core elements such as stainless
steel, nitinol or other nickel titanium alloys, or polymeric
materials may be utilized. In an embodiment intended for
implantation over a guidewire, the torque rod 340 is preferably
provided with an axially extending central guidewire lumen. This
may be accomplished by constructing the torque rod 340 from a
section of hypodermic needle tubing, having an inside diameter of
from about 0.001 inches to about 0.005 inches or more greater than
the outside diameter of the intended guidewire. Tubular torque rods
340 may also be fabricated or constructed utilizing any of a wide
variety of polymeric constructions which include woven or braided
reinforcing layers in the wall. Torque transmitting tubes and their
methods of construction are well understood in the intracranial
access and rotational atherectomy catheter arts, among others, and
are not described in greater detail herein. Use of a tubular torque
rod 340 also provides a convenient infusion lumen for injection of
contrast media within the implant 304, such as through a port
343.
[0159] The proximal end 324 of the implant 304 is provided with a
threaded aperture 346 through which the core 342 is threadably
engaged. As will be appreciated by those of skill in the art in
view of the disclosure herein, rotation of the threaded core 342 in
a first direction relative to the proximal end 324 of the implant
304 will cause the rotatable core 342 to advance distally. This
distal advancement will result in an axial elongation and radial
reduction of the implantable device 304. Rotation of the rotatable
core 342 in a reverse direction will cause a proximal retraction of
the rotatable core 342, thus enabling a radial enlargement and
axial shortening of the implantable device 304.
[0160] The deployment catheter 302 is further provided with an
antirotation lock 348 between a distal end 350 of the tubular body
306 and the proximal end 324 of the implant 304. In general, the
rotational lock 348 may be conveniently provided by cooperation
between a first surface 352 on the distal end 350 of the deployment
catheter 302, which engages a second surface 354 on the proximal
end 324 of the implantable device 304, to rotationally link the
deployment catheter 302 and the implantable device 304. Any of a
variety of complementary surface structures may be provided, such
as an axial extension on one of the first and second surfaces for
coupling with a corresponding recess on the other of the first and
second surfaces. Such extensions and recesses may be positioned
laterally offset from the axis of the catheter. Alternatively, they
may be provided on the longitudinal axis with any of a variety of
axially releasable anti-rotational couplings having at least one
flat such as a hexagonal or other multifaceted cross sectional
configuration.
[0161] As schematically illustrated in FIGS. 19A and B, one or more
projections 356 on the first surface 352 may engage a corresponding
recess 358 on the second surface 354. Any of a variety of
alternative complementary surface structures may also be provided,
as will be apparent to those of skill in the art in view of the
disclosure herein. For example, referring to FIG. 19A, the
projection 356 is in the form of an axially extending pin for
engaging a complimentary recess 358 on the proximal end 324 of the
implant 304. FIG. 19B illustrates an axially extending spline 356
for receipt within a complimentary axially extending recess 358.
The various pin, spline and other structures may be reversed
between the distal end of tubular body 306 and the proximal end 324
of the implant 304 as will be apparent to those of skill in the art
in view of the disclosure herein.
[0162] Upon placement of the implantable device 304 at the desired
implantation site, the torque rod 340 is rotated in a direction
that produces an axial proximal retraction. This allows radial
enlargement of the radially outwardly biased implantable device 304
at the implantation site. Continued rotation of the torque rod 340
will cause the threaded core 342 to exit proximally through the
threaded aperture 346. At that point, the deployment catheter 302
may be proximally retracted from the patient, leaving the implanted
device 304 in place.
[0163] By modification of the decoupling mechanism to allow the
core 342 to be decoupled from the torque rod 340, the rotatable
core 342 may be left within the implantable device 304, as may be
desired depending upon the intended deployment mechanism. For
example, the distal end of the core 342 may be rotatably locked
within the end cap 326, such as by including complimentary radially
outwardly or inwardly extending flanges and grooves on the distal
end of the core 342 and inside surface of the cavity 322. In this
manner, proximal retraction of the core 342 by rotation thereof
relative to the implantable device 304 will pull the end cap 326 in
a proximal direction under positive force. This may be desirable as
a supplement to or instead of a radially enlarging bias built into
the implantable device 304.
[0164] In the embodiment illustrated in FIG. 19, or any other of
the deployment and/or removal catheters described herein, the
distal end of the tubular body 306 may be provided with a zone or
point of enhanced lateral flexibility. This may be desirable in
order allow the implant to seat in the optimal orientation within
the left atrial appendage, and not be restrained by a lack of
flexibility in the tubular body 306. This may be accomplished in
any of a variety of ways, such as providing the distal most one or
two or three centimeters or more of the tubular body 306 with a
spring coil configuration. In this manner, the distal end of the
tubular body 306 will be sufficiently flexible to allow the implant
304 to properly seat within the LAA. This distal flex zone on the
tubular body 306 may be provided in any of a variety of ways, such
as by cutting a spiral slot in the distal end of the tubular body
306 using laser cutting or other cutting techniques. The components
within the tubular body 306 such as torque rod 340 may similarly be
provided with a zone of enhanced flexibility in the distal region
of the tubular body 306.
[0165] The implantable device 304 may also be retrieved and removed
from the body in accordance with a further aspect of the present
invention. One manner of retrieval and removal will be understood
in connection with FIGS. 20 through 20C. Referring to FIG. 20, a
previously implanted device 304 is illustrated as releasably
coupled to the distal end of the tubular body 306, as has been
previously discussed. Coupling may be accomplished by aligning the
tubular body 306 with the proximal end 324 of the deployed implant
304, under fluoroscopic visualization, and distally advancing a
rotatable core 342 through the threaded aperture 346. Threadable
engagement between the rotatable core 342 and aperture 346 may
thereafter be achieved, and distal advancement of core 342 will
axially elongate and radially reduce the implant 304.
[0166] The tubular body 306 is axially movably positioned within an
outer tubular delivery or retrieval catheter 360. Catheter 360
extends from a proximal end (not illustrated) to a distal end 362.
The distal end 362 is preferably provided with a flared opening,
such as by constructing a plurality of petals 364 for facilitating
proximal retraction of the implant 304 as will become apparent.
Petals 364 may be constructed in a variety of ways, such as by
providing axially extending slits in the distal end 362 of the
delivery catheter 360. In this manner, preferably at least about
three, and generally at least about four or five or six petals or
more will be provided on the distal end 362 of the delivery
catheter 360. Petals 364 manufactured in this manner would reside
in a first plane, transverse to the longitudinal axis of the
delivery catheter 360, if each of such petals 364 were inclined at
90 degrees to the longitudinal axis of the delivery catheter
360.
[0167] In one application of the invention, a second layer of
petals 365 are provided, which would lie in a second, adjacent
plane if the petals 365 were inclined at 90 degrees to the
longitudinal axis of the delivery catheter 360. Preferably, the
second plane of petals 365 is rotationally offset from the first
plane of petals 364, such that the second petals 365 cover the
spaces 367 formed between each adjacent pair of petals 365. The use
of two or more layers of staggered petals 364 and 365 has been
found to be useful in retrieving implants 304, particularly when
the implant 304 carries a plurality of tissue anchors 195.
[0168] The petals 364 and 365 may be manufactured from any of a
variety of polymer materials useful in constructing medical device
components such as the delivery catheter 360. This includes, for
example, polyethylene, PET, PEEK, PEBAX, and others well known in
the art. The second petals 365 may be constructed in any of a
variety of ways. In one convenient construction, a section of
tubing which concentrically fits over the delivery catheter 360 is
provided with a plurality of axially extending slots in the same
manner as discussed above. The tubing with a slotted distal end may
be concentrically positioned on the catheter 360, and rotated such
that the space between adjacent petals 365 is offset from the space
between adjacent petals 364. The hub of the petals 365 may
thereafter be bonded to the catheter 360, such as by heat
shrinking, adhesives, or other bonding techniques known in the
art.
[0169] The removal sequence will be further understood by reference
to FIGS. 20a through 20c. Referring to FIG. 20a, the radially
reduced implant 304 is proximally retracted part way into the
delivery catheter 360. This can be accomplished by proximally
retracting the tubular body 306 and/or distally advancing the
catheter 360. As illustrated in FIG. 20b, the tubular body 306
having the implant 304 attached thereto is proximally retracted a
sufficient distance to position the tissue anchors 195 within the
petals 364. The entire assembly of the tubular body 306, within the
delivery catheter 360 may then be proximally retracted within the
transseptal sheath 366 (e.g., delivery sheath) or other tubular
body as illustrated in FIG. 20c. The collapsed petals 364 allow
this to occur while preventing engagement of the tissue anchors 195
with the distal end of the transseptal sheath 366 or body tissue.
The entire assembly having the implantable device 304 contained
therein may thereafter be proximally withdrawn from or repositioned
within the patient.
[0170] In FIGS. 21-21E there is provided another embodiment of an
implant and delivery system. Adjustable implant deployment system
300 comprises catheter 302 and detachable implant 304 having a
frame 506 and anchors or barbs 195, as discussed in greater detail
above with respect to FIG. 17 and other figures. As illustrated in
FIG. 21, the deployment system 300 also includes a slider assembly
400. In the illustrated embodiment, slider assembly 400 includes a
guide tube 320 extending proximally from the distal end or distal
hub 314 of the implant, and a slider nut 402 slidably received in a
channel 430 of the guide tube 320. Slider nut 402 preferably
includes a flange 404 operable to travel within a longitudinal slot
410 that extends at least partially along the length of guide tube
320. The flange 404 of the slider nut 402 has a proximal surface
406 and a distal surface 408. Slot 410 has a proximal surface 412,
and in one embodiment, extends through the distal end of the guide
tube 320. Slot 410 may have a generally rectangular shape.
[0171] In the embodiment shown in FIG. 21, proximal movement of the
flange 404 within the slot 410, as well as proximal movement of the
slider nut 402 within the guide tube 320, is limited by
interference between the proximal surfaces 406, 412, of flange 404
and guide tube 320, respectively, as slider nut 402 is moved in the
proximal direction. As shown in FIGS. 21A, 21C and 21D, distal
movement of the flange 404 within the slot 410, as well as distal
movement of the slider nut 402 within the guide tube 320, is
limited by interference between the axially moveable core 312 and
the cross pin 318, as described in greater detail with reference to
FIG. 21A below. In addition, flange 404 prevents slider nut 402
from rotating within guide tube 320 due to the interference between
flange 404 and the side walls of the slot 410.
[0172] In one embodiment, the slot 410 of the guide tube 320 is
laser-cut, and has a length in the range between about 3 mm and 35
mm, and a width in the range between about 0.5 mm and 2 mm. In one
embodiment, the length of the guide tube 320 slot 410 is in the
range between about 0.4 in and about 0.826 in. In one embodiment,
the width of the guide tube 320 slot 410 is in the range between
about 0.02 in and about 0.04 in. In one embodiment, the slider nut
402 is a keyed polymer extrusion, and is sized so that it fits and
slides at least partially within the guide tube 320. Such material
is advantageous in that it provides a reduced friction interface
between the slider nut 402 and the guide tube 320. In other
embodiments, the slider nut 402 is made from plastic, metal, or
ceramic. In another embodiment, the slider nut 402 is made from
PEBAX, polyethylene, polyurethane, nickel titanium, or stainless
steel. Flange 404 may be integrally formed with the slider nut 402,
or may be attached to it. In one embodiment, flange 404 is made
from plastic, and is sized so that it fits and slides within the
slot 410 of the guide tube 320. The exact length of the flange 404
is selected based upon the dimensions of the slot 410, and will
vary based upon the clinical parameters of the particular
treatment.
[0173] Several views of one embodiment of the adjustable implant
deployment system 300 of FIG. 21 are shown in FIGS. 21A-21E. FIG.
21A illustrates the distal end 344 of an axially moveable core 312
similar to that described above, releasably coupled to a slider
assembly 400. Slider assembly 400 includes guide tube 320 and
slider nut 402, as described above. Slider nut 402 includes a
flange 404 as described above and a mating surface 420 for
receiving the distal end 344 of axially moveable core 312. In one
embodiment, mating surface 420 of nut 402 is an internally threaded
surface. Mating surface 420 of nut 402 engages mating surface 422
of axially moveable core 312 to provide axial coupling between the
movement of the axially moveable core 312 and the slider nut 402.
In the illustrated embodiment, mating surface 422 of axially
moveable core 312 is an externally threaded surface on a distal
section of the axially moveable core which terminates proximal to
the very distal tip of the axially moveable core 312.
[0174] In one embodiment, the axially moveable core 312 includes a
proximal shaft 576, a flexible core section 564, and a distal shaft
578 as described in greater detail below with reference to FIG. 37.
The distal shaft 578 includes a mating surface 584 (as shown on
FIG. 37), which corresponds to the mating surface 422 of the
axially moveable core 312 as shown on FIG. 21A. The mating surface
422 of axially moveable core 312 preferably is a threaded surface
to facilitate releasable attachment to the mating surface 420 of
the slider nut 402. In one embodiment, the mating surface 422
provides self-tapping functionality to the axially moveable core
312. The mating surface 422 of the axially moveable core 312
includes threads, and is self-tapping as it is inserted into the
slider nut 402 of the slider assembly 400. In one embodiment, the
slider nut 402 contains a central lumen extending axially
therethrough. In one embodiment, the mating surface 420 of the
slider nut 402 does not contain threads, but is tapped (e.g.,
mating threads are created), as the axially moveable core 312 is
inserted into, and rotated with respect to the slider nut 402.
[0175] In one embodiment, the axially moveable core 312 preferably
is attached to the slider nut 402 by rotating the axially moveable
core 312 such that the threads of the mating surface 422 of axially
moveable core 312 engage threads of the mating surface 420 of nut
402. Similarly, in one embodiment, axially moveable core 312 is
detached or decoupled from the slider nut 402 of the slider
assembly 400 by rotating the axially moveable core 312 in the
opposite direction. In one embodiment, as the axially moveable core
312 is rotated in the detachment direction, the threads of the
mating surface 422 of axially moveable core 312 disengage the
threads of the mating surface 420 of nut 402, thereby releasing the
axially moveable core 312 from the slider nut 402, slider assembly
400, and implant 304. Additional description of the axially
moveable core 312 and contemplated alternative embodiments are
provided below, including the illustration and discussion related
to FIG. 37.
[0176] In the embodiment of FIGS. 21-21E, there is illustrated the
axially moveable core 312 releasably coupled to the slider nut 402
of the slider assembly 400 of an implant 304. In the illustrated
embodiment, the mating surface 422 of axially moveable core 312 is
coupled with the mating surface 420 of nut 402 such that the distal
end surface 429 of the axially moveable core 312 and a marker 431
reside distal the slider nut 402 of the slider assembly 400. In one
embodiment, the axially moveable core 312 is coupled to the slider
nut 402 such that the marker 431 resides approximately 1 to 3 mm
distal the distal surface 418 of slider nut 402. In other
embodiments, the axially moveable core 312 is coupled to the slider
nut 402 of the slider assembly 400 such that the distal surface 429
of the axially moveable core 312 and/or the marker 431 reside
within slider nut 402. Examples of such embodiments are provided in
greater detail below with reference to FIGS. 22A, 23, and 26.
[0177] In one embodiment, axially moveable core 312 also includes a
lumen 426. The lumen 426 preferably allows visualization dye to
flow through the lumen 426 of the axially moveable core 312,
through the lumen 428 of the implant plug 316, and into the left
atrial appendage. Such usage of visualization dye is useful for
clinical diagnosis and testing of the position of the implant 304
within the left atrial appendage or other body opening, as
described in greater detail below.
[0178] The marker 431 as shown in FIGS. 21A, 21C and 21D
advantageously assists in locating the position of the distal end
344 of the axially moveable core 312. In one embodiment, marker 431
comprises a radiopaque band press fit onto the distal end 344 of
the axially moveable core 312. Marker 431 preferably is made from a
material readily identified after insertion into a patient's body
by using visualization techniques that are well known to those of
skill in the art. In one embodiment, the marker 431 is made from
gold, or tungsten, or any such suitable material, as is well known
to those of skill in the art. In another embodiment, marker 431 is
welded, soldered, or glued onto the distal end 344 of the axially
moveable core 312. In one embodiment, marker 431 is an annular band
and surrounds the circumference of the axially moveable core 312.
In other embodiments, the marker 431 does surround the
circumference of the axially moveable core 312. In other
embodiments, marker 431 includes evenly or unevenly spaced marker
segments. In one embodiment, the use of marker segments is useful
to discern the radial orientation of the implant 304 within the
body.
[0179] In the embodiment of FIG. 21A, with axially moveable core
312 threadingly engaged with slider nut 402, as axially moveable
core 312 is moved distally, distal surface 429 of axially moveable
core 312 presses against cross pin 318 to place or maintain implant
304 in a reduced diameter configuration (such as in combination
with pulling proximally on pull wire 328, as discussed above). As
tension on pull wire 328 is reduced, implant 304 assumes its
expanded diameter configuration by bending under its own bias.
Alternatively, in another embodiment, axially moveable core 312 is
moved proximally, thereby relieving pressure on cross pin 318, and
allowing implant 304 to assume its expanded diameter configuration.
Expansion and reduction of implant 304 diameter is described in
greater detail above with reference to FIG. 17, and further
below.
[0180] Once implant 304 of FIG. 21A assumes the expanded
configuration, the axially moveable core 312 and the slider nut 402
may be moved proximally until the proximal surface 406 of flange
404 interferes with the proximal surface 412 of slot 410, without
substantially affecting the shape or position of the implant 304.
Similarly, once the implant 304 assumes the expanded configuration,
the axially moveable core 312 and slider nut 402 may be moved
distally back until the distal surface 429 of the axially moveable
core 312 interferes with the cross pin 318, or implant plug 316,
without substantially affecting the shape or position of the
implant 304.
[0181] Such controllable axial decoupling between the movement of
the axially moveable core 312 and the implant 304 is useful during
delivery and expansion of the implant 304. In addition,
controllable axial decoupling is useful for testing the seal
between the implant 304 and the left atrial appendage once the
implant 304 has been delivered, but before releasing the implant
304 from the catheter 302.
[0182] For example, it is clinically advantageous to provide axial
decoupling between the axially moveable core 312 and the implant
304. Axial decoupling assures that movement of the axially moveable
core 312, as well as other components of the adjustable implant
deployment system 300 that are coupled to the axially moveable core
312 (for example, but not limited to the deployment handle 538 and
the catheter 302, described further below), do not substantially
affect the shape or position of the implant 304. Such axial
decoupling prevents inadvertent movement of the axially moveable
core 312 or deployment handle 538 from affecting the shape or
position of implant 304. For example, in one embodiment, if the
user inadvertently pulls or pushes the axially moveable core 312 or
the deployment handle, the position of the implant 304 within the
left atrial appendage preferably will not be substantially
affected. In addition, axial decoupling also preferably prevents
the motion of a beating heart from translating into movement of the
axially moveable core 312, the catheter 302, and the components
coupled to the axially moveable core 312 and catheter 302,
including the deployment handle. By decoupling the implant 304 from
the axially moveable core 312 and other components coupled to the
axially moveable core 312, the risk of accidentally dislodging the
implant 304 from the left atrial appendage during testing is
reduced.
[0183] There is illustrated in FIG. 22 another adjustable implant
deployment system 300 built in accordance with another embodiment
of the present invention. The embodiment illustrated in FIG. 22 is
similar to that illustrated in FIG. 21. Adjustable implant
deployment system 300 comprises catheter 302 and detachable implant
304 as discussed in greater detail above with respect to FIG. 17.
The system 300 also includes a slider assembly 400 having a guide
tube 320 and slider nut 402 slidably received therein. Slider nut
402 preferably includes a flange 404 operable to travel within the
longitudinal slot 410 of the guide tube 320. The flange 404 of the
slider nut 402 has a proximal surface 406 and a distal surface 408.
Slot 410 has a proximal surface 412 and distal surface 414, and
does not extend through the distal end of the guide tube 320. Slot
410 in one embodiment has a generally rectangular shape.
[0184] The slider assembly 400 of FIG. 22 functions in a similar
manner to that illustrated and described with reference to FIGS.
21-21E. However, as shown in FIG. 22A, once the implant 304 assumes
the expanded configuration, the axially moveable core 312 and
slider nut 402 may be moved distally until the distal surface 408
of flange 404 interferes with the distal surface 414 of slot 410
and/or the distal surface of slider nut 402 interferes with cross
pin 318, without substantially affecting the shape or position of
the implant 304.
[0185] In one embodiment, the axially moveable core 312 of FIG. 22A
is similar to that of FIG. 21A, except for the location of mating
surface 422. In the embodiment illustrated in FIG. 22A, the mating
surface 422 of axially moveable core 312 extends to the distal
surface 429 of axially moveable core 312. In such configuration,
the mating surface 422 of axially moveable core 312 preferably is
contained within the slider nut 402 of the slider assembly 400, as
illustrated in FIG. 22A. The marker 431 (not shown in FIG. 22A) of
the axially moveable core 312 preferably is attached to the axially
moveable core 312 such that it does not interfere with the coupling
of the mating surface 420 of nut 402 and mating surface 422 of
axially moveable core 312. For example, in one embodiment, marker
431 is pressed, welded, soldered, glued or plated onto the lumen
426 of the axially moveable core 312, the distal surface 429 of
axially moveable core 312, or circumferentially around or partially
circumferentially around the axially moveable core 312 such that
interference between mating surfaces 420, 422 does not occur. In
addition, in the embodiment of FIG. 22A, the distal end 344 of
axially moveable core 312 preferably is positioned within the
slider nut 402 of the slider assembly 400, and does not extend past
the distal surface 418 of slider nut 402.
[0186] In the embodiment illustrated in FIG. 22A, slider nut 402
includes a lumen 424 extending distally of core 312 that allows
visualization dye to flow from the lumen 426 of axially moveable
core 312 through to the lumen 428 of the implant plug 316 and into
the left atrial appendage. Such usage of visualization dye is
described in greater detail below.
[0187] An illustration of an alternative implementation of a slider
assembly is provided in FIG. 23. FIG. 23 illustrates the distal end
344 of axially moveable core 312 coupled to a slider assembly 400
similar to that described above. In FIG. 23, slider assembly 400
includes a guide tube 320 and a slider nut 402. Guide tube 320
includes a channel 430 in which slider nut 402 travels as axially
moveable core 312 is moved proximally or distally. Proximal
movement of the slider nut 402 is limited by interference between
proximal surface 416 of slider nut 402 and proximal ridge 432 of
guide tube 320. Distal movement of the slider nut 402 is limited by
interference between distal surface 418 of slider nut 402 and the
distal ridge 434 of guide tube 320. Alternatively, distal movement
of the slider nut 402 can be limited by interference between the
distal surface 418 of slider nut 402 and the cross pin 318, or the
implant plug 316, as shown in greater detail with reference to FIG.
22.
[0188] To prevent rotation of slider nut 402 within the guide tube
320, the cross-sectional shape of the channel 430 and slider nut
402 may have a non-circular shape. Examples of non-circular
cross-sectional shapes of slider nut 402 are illustrated with
reference to FIG. 24 and FIG. 25. FIG. 24 illustrates one
implementation in which the slider nut 402 and channel 430 have an
elliptical cross-sectional shape. FIG. 25 illustrates another
implementation in which the slider nut 402 and the channel 430 have
a rounded-rectangular cross-sectional shape. It is well understood
by those skilled in the art that the slider nut 402 and channel 430
may have any non-circular shape so as to prevent rotation of slider
nut 402 within the guide tube 320.
[0189] Another implementation of one embodiment of the present
invention is provided with reference to FIG. 26. FIG. 26
illustrates the distal end 344 of axially moveable core 312
removably coupled to a slider assembly 400. As shown in FIG. 26,
proximal movement of slider nut 402 is limited by interference
between proximal surface 416 of slider nut 402 and proximal ridge
432 of guide tube 320. Distal movement of slider nut 402 is limited
by interference between distal surface 429 of axially moveable core
312 and cross pin 318. The distal end 344 of the axially moveable
core 312 is shown having a first diameter 433, a second diameter
435, and a step 437 therebetween. In other embodiments, the distal
end 344 of the axially moveable core 312 does not include such
first diameter 433, second diameter 435, and step 437. In one
embodiment, the axially moveable core 312 is screwed into the
slider nut 402 of the slider assembly 400 until the proximal
surface 416 of slider nut 402 interferes with the step 437 of the
axially moveable core 312. In another embodiment, the axially
moveable core 312 is advanced distally into the slider nut 402 of
the slider assembly 400 as far as the mating surface 420 of nut 402
and mating surface 422 of axially moveable core 312 permit. Axial
rotation of slider nut 402 with respect to the guide tube 320 may
be limited by providing slider nut 402 with a non-circular
cross-sectional shape, as described in greater detail above. An
example of slider nut 402 having a non-circular cross-sectional
shape is illustrated in FIG. 27. FIG. 27 shows the sectional view
along cut line 27-27 of FIG. 26.
[0190] In another embodiment described with reference to FIG. 26A,
a slider assembly 400 does not include a slider nut 402. Instead,
the distal end 600 of an axially moveable core 312 includes an
externally threaded, enlarged diameter, distal portion 602, and the
proximal end 604 of a guide tube 320 includes an internally
threaded, reduced diameter, proximal portion 606. The axially
moveable core 312 is coupled to the guide tube 320 of the implant
304 by screwing the externally threaded, enlarged diameter, distal
portion 602 of the axially moveable core 312 into the internally
threaded, reduced diameter, proximal portion 606 of the guide tube
320. Once coupled, the implant 304 is delivered to the desired
deployment site within the patient as described in further detail
herein. The axially moveable core 312 is then further manipulated
(e.g., rotated in a clockwise direction), until the externally
threaded, enlarged diameter, distal portion 602 of the axially
moveable core 312 enters the guide tube 320 of the implant 304, and
becomes decoupled from the internally threaded, reduced diameter,
proximal portion 606 of the guide tube 320, as shown in FIG.
26A.
[0191] Thereafter, proximal movement of the axially moveable core
312 with respect to the implant 304 is limited by interference
between a proximal surface 608 of the external threads of the
enlarged diameter, distal portion 602 of the axially moveable core
312, and a distal surface 610 of the internal threads of the
reduced diameter, proximal portion 606 of the guide tube 320.
Distal movement of the axially moveable core 312 with respect to
the implant 304 is limited by interference between a distal surface
612 of the external threads of the enlarged diameter, distal
portion 602 of the axially moveable core 312, and a cross pin 318,
as described in greater detail herein. Alternatively, distal
movement of the axially moveable core 312 with respect to the
implant 304 can be limited by interference between the distal
surface 429 of axially moveable core 312 and the cross pin 318, as
described in greater detail herein.
[0192] To remove the axially moveable core 312, the axially
moveable core 312 is moved proximally with respect to the implant
304 and manipulated (e.g., rotated counter-clockwise), until the
external threads of the enlarged diameter, distal portion 602 of
the axially moveable core 312 engage the internal threads of the
reduced diameter, proximal portion 606 of the guide tube 320. The
axially moveable core 312 is then further manipulated (e.g.,
rotated counter-clockwise), until the external threads of the
enlarged diameter, distal portion 602 of the axially moveable core
312 disengage the internal threads of the reduced diameter,
proximal portion 606 of the guide tube 320 such that the axially
moveable core 312 may thereafter be removed from the patient while
leaving the implant 304 in place.
[0193] In the embodiment of FIG. 26A described above, transverse
movement of at least a portion of the axially moveable core 312
with respect to the guide tube 320 and the implant 304 is decoupled
over a limited range. As illustrated, transverse movement is
permitted by the outside diameter of the axially moveable core 312
being substantially smaller than the inside diameter of the
proximal portion of the guide tube 320. This permits the core 312
to move transversely within the space defined by the proximal
portion of the guide tube. In other embodiments, transverse
movement is permitted by controlling the relative dimensions of the
inside diameter of the guide tube 320, the inside diameter of the
proximal portion of the guide tube 320, the outside diameter of the
axially moveable core 312, the outside diameter of the slider nut
402, or a combination of any of the above, to provide space between
corresponding parts of the device. It will be appreciated by those
of skill in the art that transverse movement may be provided with
any of the embodiments described herein, including those that
incorporate a slider nut 402 as part of the slider assembly 400. In
one embodiment, as at least a portion of the axially moveable core
312 is moved in a direction transverse to the guide tube 320, the
axially moveable core 312 can also be positioned at an angle with
respect to the longitudinal axis of the guide tube 320 and implant
304.
[0194] FIG. 28 illustrates another implementation of a slider
assembly 400. The slider assembly 400 provides quick-disconnect
functionality, and the ability to release the axially moveable core
312 from the guide tube 320 without using rotational forces. Such
configuration is advantageous in that rotational forces applied to
the axially moveable core 312 to unscrew it from the guide tube 320
can, in some clinical situations, cause the implant 304 to rotate
within or dislodge from the left atrial appendage. By using
quick-disconnect functionality, such as that illustrated in the
embodiment of FIG. 28, the operator may decouple the axially
moveable core 312 from the guide tube 320 of the slider assembly
400 by applying axial force instead of rotational force. An axial
force may be particularly advantageous because in certain
embodiments, the anchors 195 of the implant may provide greater
resistance to axial movement than to rotational movement, and thus
be better able to withstand axial decoupling of the axially
moveable core 312 from the slider assembly 400 than rotation
decoupling.
[0195] In the illustrated embodiment of FIG. 28, slider assembly
400 includes a guide tube 320, shown coupled to an axially moveable
core 312. Guide tube 320 includes a slot 410, as described in
greater detail above with reference to FIG. 21. Axially moveable
core 312 is preferably hollow and includes a bending plug 436 near
its distal end, a port 440 provided in the core 312 adjacent plug
436, with a retractable lock 438 extending through the lumen of the
core 312. After axially moveable core 312 is inserted into the
guide tube 320, retractable lock 438 is advanced distally relative
to the core 312 until it is guided by bending plug 436 through the
port 440 of axially moveable core 312. When properly positioned, a
distal tip 442 of retractable lock 438 extends into the slot 410 of
the guide tube 320. The distal tip 442 of retractable lock 438
limits axial movement of the axially moveable core 312 relative to
the guide tube 320 by interference between the distal tip 442 of
retractable lock 438 and the proximal and distal surfaces 412, 414
of slot 410. Retractable lock 438 is made from a material or
materials flexible enough to bend as provided by bending plug 436,
yet stiff enough to limit the motion of the axially moveable core
312 by interfering with proximal and distal surfaces 412, 414 of
slot 410. In one embodiment, retractable lock 438 includes a spiral
cut, transverse slots, or changes in material or thickness to
control flexibility. In one embodiment, the distal tip 442 of
retractable lock 438 comprises a material that is stiffer, or less
flexible than the retractable lock 438.
[0196] In one embodiment, the retractable lock 438 is made from a
flexible wire, such as a nickel titanium or stainless steel.
Alternatively, retractable lock 438 is made from metal hypotube,
plastic, or other biocompatible material. In one embodiment,
bending plug 436 is made from metal, such as nickel titanium or
stainless steel. Alternatively, bending plug 436 is made from
plastic, or other biocompatible material.
[0197] An alternative embodiment of a slider assembly 400 is shown
in FIG. 29. The slider assembly 400 of FIG. 29 also provides
quick-disconnect functionality for release of axially moveable core
312 from guide tube 320 by using non-rotational forces. As
illustrated, slider assembly 400 includes a guide tube 320, which
comprises at least one slot 410. Two opposing slots 410 are shown
in the embodiment of FIG. 29. Axially moveable core 312 is coupled
to guide tube 320 by quick-disconnect functionality.
[0198] Axially moveable core 312 in this embodiment includes a
retractable lock 438 in the form of an elongate key 439 extending
through the lumen of the core 312, and two opposing ports 440 in
axially moveable core 312 through which two tabs 444 extend. The
distal tip 442 of the key 439 includes a contact surface 446
operable to engage contact surfaces 448 of the tabs 444. The key
439 is moveable relative to the axially moveable core 312, and can
be moved distally such that contact surface 446 engages contact
surfaces 448 of tabs 444, translating into radial movement of tabs
444. Radial movement of tabs 444 causes them to project into slots
410 of the guide tube 320 by bending radially outwardly, and
extending in a substantially radial direction. In one embodiment,
the key 439 is secured in place relative to the axially moveable
core 312, so that the tabs 444 remain projected into the slots 410
of the guide tube 320. With the tabs 444 secured in place, axial
movement of axially moveable core 312 preferably is limited by
interference between the tabs 444 and the proximal and distal
surfaces 412, 414 of guide tube 320.
[0199] In one embodiment, the key 439 is made from an elongate
wire, rod, or tube flexible enough for delivery through the
adjustable implant deployment system 300 described above, and
strong enough to apply enough force to tabs 444 to achieve the
functionality described above. In one embodiment, the key 439 is
made from stainless steel. The key 439 preferably is locked in
place relative to the axially moveable core 312 by using a control,
such as a thumbswitch or other such device as is well known to
those of skill in the art. For example, in one embodiment, the
axially moveable core 312 is secured to the proximal portion of a
deployment handle (not shown) such that the position of the axially
moveable core 312 is fixed with respect to the deployment handle. A
key 439 preferably is inserted inside of the axially moveable core
312 such that it may slide axially within the axially moveable core
312. The proximal portion of the key 439 preferably is coupled to a
control, such as, for example, a thumbswitch. The thumbswitch
preferably is provided such that it may slide axially with respect
to the deployment handle (and therefore with respect to the axially
moveable core 312) over a predetermined range. By coupling the
thumbswitch to the proximal portion of the key 439, axial movement
of the key 439 with respect to the axially moveable core 312 is
achieved over the predetermined range. In addition, by locking the
thumbswitch in place (by using mechanisms well known to those of
skill in the art, such as release buttons, tabs, or their
equivalents), the key 439 may be locked in place with respect to
the axially moveable core 312. Alternatively, switches, levers,
buttons, dials, and similar devices well known to those of skill in
the art may be used instead of a thumbswitch as the control for the
retractable lock 438.
[0200] To decouple axially moveable core 312 from the guide tube
320, retractable lock 438 is released by moving key 439 proximally
relative to axially moveable core 312, thereby removing radial
forces from contact surfaces 448 of tabs 444. In one embodiment,
tabs 444 are biased to bend inward upon the removal of the radial
forces from their contact surfaces 448. For example, tabs 444
preferably are constructed from a spring material, or a shape
memory metal, such as, for example, nickel titanium. Alternatively,
in another embodiment, key 439 is moved distally to decouple
axially moveable core 312 from the guide tube 320. For example, in
one embodiment, key 439 includes a cutout, notch, or slot along at
least a portion of its distal end. In one embodiment, as the key
439 is moved distally, the cutout, notch, or slot is moved such
that it engages the tabs 444, allowing them to flex inwardly
preferably under their own bias. In another embodiment, tabs 444
are biased to bend outward upon removal of a radial force from a
contact surface 448, and bend inward upon application of a radial
force to contact surface 448. In such embodiment, the key 439
preferably is advanced distally to apply force on a contact surface
448 such that tabs 444 are directed inward. In one embodiment, the
key 439 is advanced proximally to apply force on a contact surface
448 such that tabs 444 are directed inward.
[0201] Alternative mechanisms for coupling the axially moveable
core 312 to the slider assembly 400 may be used in addition to or
instead of those described above. In one embodiment, the mating
surface 420 of nut 402 and mating surface 422 of axially moveable
core 312 may include at least one slot and at least one pin,
respectively, such that axially moveable core 312 couples with the
slider nut 402 by a bayonet mount. In one such embodiment, axially
moveable core 312 is proximally advanced until the at least one
slot of its mating surface 422 receives the at least one pin of the
mating surface 420 of the nut 402. Axially moveable core 312 is
subsequently rotated to lock the axially moveable core 312 with
respect to the slider nut 402. Axially moveable core 312 may be
decoupled from slider nut 402 by rotating it in the opposite
direction.
[0202] Referring to FIGS. 29A-G, in one embodiment, the axially
moveable core 312 is coupled to the guide tube 320 of the slider
assembly 400 with a bayonet mount 450. In one embodiment, the
bayonet mount 450 includes a guide tube 320, which includes an
un-threaded channel 430, and a maze-type slot 452. In one
embodiment, the maze-type slot 452 includes at least one entry
portion 454 extending in an axial direction, and at least one keyed
portion 456 extending at least partially in a non-axial direction.
In one embodiment, the maze-type slot 452 extends from the proximal
edge 458 of the guide tube 320 in the distal direction, then
extends in a direction substantially transverse the axis of the
guide tube 320, and then extends axially, either in the proximal or
distal direction, or both, such as shown for example, in FIGS. 29E
and 29F. The mating surface 422 of the axially moveable core 312
includes a flange 460, pin, or equivalent structure, which engages
the maze-type slot 452 of the guide tube 320. An example of one
such flange 460 is illustrated in FIG. 29B. By manipulating the
flange 460 of the axially moveable core 312 with respect to the
maze-type slot 452 of the guide tube 320 according to a
predetermined sequence, the axially moveable core 312 may be
coupled to the detachable implant 304. In addition, the shape of
the maze-type slot 452 may provide limited axial decoupling between
the axially moveable core 312 and the detachable implant 304 along
the keyed portion 456 of the maze-type slot 452, such as described
above with respect to the slider assembly 400 of FIGS. 21-21E.
[0203] In another embodiment, the maze-type slot 452 of the bayonet
mount 450 is provided on the axially moveable core 312, and the
flange 460 of the bayonet mount 450 is provided on the guide tube
320 of the slider assembly 400. The flange 460 may extend in a
radial outward direction, such as shown in FIG. 29C, or may extend
in a radial inward direction, such as shown in FIG. 29G. In another
embodiment, the flange 460 extends in both radial outward and
radial inward directions.
[0204] In other embodiments, a slider assembly need not be
connected to the implant, and for example, can be provided as part
of the axially moveable core, or even the deployment handle in
order to decouple axial movement between the implant and delivery
system. For example, in one embodiment, an axially moveable core
may include two concentric or axially aligned tubes, slidably
moveable with respect to one another, such as, for example, an
outer tube and an inner tube. The outer tube may include a mating
surface on or near its distal end to engage a mating surface on the
distal hub, or elsewhere on the implant. The outer tube slidably
engages an inner tube, which enters the outer tube at the outer
tube's proximal end. In one embodiment, a solid core is used
instead of an inner tube. Relative proximal and distal movement of
the inner and outer tube is preferably limited by a motion limit.
In one embodiment, the motion limit includes at least one cross
pin. In other embodiments, the motion limit includes at least one
flare, annular ring, bump, or other suitable mechanism as is well
known to those of skill in the art. The inner tube extends
preferably to a handle as described above for operating the axially
moveable core. The engagement of the outer tube and the inner tube
of the axially moveable core may occur anywhere between the handle
and the implant along the length of the core.
[0205] In another embodiment, the inner tube includes a mating
surface on its distal end to engage a mating surface on the distal
hub of the implant. The inner tube slidably engages an outer tube,
which at least partially covers the inner tube at the inner tube's
proximal end. Relative proximal and distal movement of the inner
and outer tube is preferably limited by a motion limit as described
above, with the outer tube extending outside of the patient and
operably connected to a handle.
[0206] In another embodiment as shown in FIGS. 29H-I, a first
portion 462 of the axially moveable core 312, and a second portion
464 of the axially moveable core 312 are coupled to one another
with a key mount 462. The second portion 464 includes a flange 468,
pin, or equivalent structure, which engages a maze-type slot 470 of
the first portion 462 of the axially moveable core 312. By pulling,
rotating, and pushing the first portion 462 with respect to the
second portion 464 according to a predetermined sequence, limited
axial decoupling between the first portion 462 and second portion
464 is achieved.
[0207] In one embodiment, the first portion 462 comprises a
proximal portion of the axially moveable core 312, and the second
portion 464 comprises a distal portion of the axially moveable core
312. In another embodiment, the first portion 462 comprises a
distal portion of the axially moveable core 312, and the second
portion 464 comprises a proximal portion of the axially moveable
core 312. In one embodiment, the flange 468 extends in an outward
radial direction, such as shown in FIG. 29I. In another embodiment,
the flange 468 extends in an inward radial direction, or in both,
radially outward and inward directions.
[0208] Alternatively, in another embodiment, a slider assembly can
be provided as part of a deployment handle. In one embodiment, the
distal portion of an axially moveable core includes a mating
surface to engage a mating surface of the distal hub of the
implant. The deployment handle can include a guide tube and an
internally slideable nut, or other slider assembly such as
described above, for receiving the proximal end of the axially
moveable core.
[0209] FIG. 30 illustrates a deployment system 300, having an
implant 304 and a delivery system 500, in accordance with one
embodiment of the present invention. In a preferred embodiment, the
implant 304 is a transluminally delivered device designed to
occlude or contain particles within the left atrial appendage 502
(LAA 502) and prevent thrombus from forming in, and emboli from
originating from, the LAA 502. The deployment system as described
herein incorporates a slider assembly 400 such as described with
respect to FIGS. 21-21E above.
[0210] The delivery system 500 preferably may be used to deliver
the implant 304 to occlude or block the LAA 502 in a patient with
atrial fibrillation. The delivery system 500 preferably is
compatible for use with a delivery sheath 504 (e.g., a transseptal
sheath), shown in FIGS. 38A-38C. The delivery system 500 and
implant 304 preferably are designed to allow the implant 304 to be
positioned, repositioned, and retrieved from the LAA 502 if
necessary. Injection ports 546, 548, as shown in FIGS. 32 and 33,
preferably are provided in the delivery system 500 to allow
contrast injection proximally and distally of the implant 304 to
facilitate in-vivo assessment of the positioning and seal quality
of the implant 304.
[0211] As shown in FIG. 31, the implant 304 preferably is available
in a range of sizes to accommodate the anatomy of a patient's LAA
502. The implant 304 preferably comprises a frame 506 and a
membrane (not shown) on a proximal face of the implant, such as
described above. The frame 506 preferably is constructed of
self-expanding nitinol supports. The membrane preferably is
constructed of a fabric covering, such as one made of ePTFE, or an
ePTFE/PE laminate. To attach the membrane to the frame 506, a PE
mesh preferably is placed against the supports, with one sheet of
ePTFE preferably placed over the PE mesh and another sheet of ePTFE
preferably placed on an opposite side of the supports. The membrane
preferably is heated on both sides causing the PE to melt into both
sheets of ePTFE, thereby surrounding a portion of the frame 506.
The nitinol supports allow the implant 304 to self-expand in the
appendage 502, covering the orifice with the laminated fabric. The
porous ePTFE/PE lamination facilitates rapid endothelialization and
healing.
[0212] As shown in FIGS. 30 and 31, the implant 304 preferably
extends from a proximal end or hub 324 to a distal end or hub 314.
In some embodiments, the proximal hub 324 is coupled with a
crosspin 329 as described above. In some embodiments the distal hub
314 is coupled with a slider assembly 400 as described above. The
distal hub 314 preferably is coupled with an implant plug 316. In
one embodiment, the implant plug 316 comprises an atraumatic tip,
such that contact between the atraumatic tip and the inside surface
of the LAA 502 does not cause significant damage to the LAA 502.
The implant 304 preferably is expandable and collapsible. The
implant 304 preferably comprises anchors 195 that extend from the
frame 506 when the implant 304 is expanded as described above.
[0213] As shown in FIGS. 32 and 33, the delivery system 500
preferably comprises a peel-away sheath 512, a recapture sheath
514, a deployment catheter 516, and an axially moveable core 312,
each described further below. In addition, FIG. 32 illustrates the
deployment system without a loading collar 510, and FIG. 33
illustrates the deployment system with a loading collar 510, with
the system operably connected to an implant 304.
[0214] The deployment catheter 516, which is analogous to
deployment catheter 302 described above, preferably comprises a
deployment handle 538 and a multi-lumen shaft 540. As shown in
FIGS. 32 and 33, the deployment handle 538 preferably comprises a
control knob 542, a release knob 544, a proximal injection port 546
and a distal injection port 548. The multi-lumen shaft 540
preferably comprises a four-lumen shaft shown in FIG. 32A. The
multi-lumen shaft 540 preferably comprises a core lumen 550 for
holding an axially moveable core 312, a control line lumen 552 and
two proximal injection lumens 554 in communication with proximal
injection port 546.
[0215] An axially moveable core 312 preferably extends from the
deployment handle 538 through the core lumen 550 of the catheter
516 and couples the implant 304 to the delivery system 500 through
a slider assembly 400 as described above. Referring to FIGS. 30, 33
and 36, a control line 328 (referred to previously as a pull wire
328) preferably extends through the control line lumen 552 and
preferably couples a proximal hub 324 of the implant 304 to the
deployment handle control knob 542, allowing for implant 304
expansion and collapse. The control line 328 preferably extends
around a portion of the axially movable core 312 near the proximal
hub 324 of the implant 304, and is coupled to the implant 304 by
crosspin 329, as described above.
[0216] As shown in FIG. 36 (which is similar to FIG. 21), the
deployment catheter 516 preferably comprises a flexible catheter
section 562 at its distal end, which in some embodiments is a
spiral cut tubular section housed in a polymer sleeve 566. The
flexible catheter section 562 may be coupled to a distal end of
multilumen shaft 540.
[0217] As shown in FIGS. 36 and 37, the axially moveable core 312
preferably includes a hollow proximal shaft 576 and a hollow distal
shaft 578 with a flexible hollow core section 564 therebetween, all
co-axially aligned and connected. In one embodiment, the proximal
end of the distal shaft 578 is attached to the distal end of the
flexible core section 564, and the proximal end of the flexible
core section 564 is attached to the distal end of the proximal
shaft 576. In some embodiments, the flexible core section 564 has a
spring coil section 568 housed in a polymer sleeve 570, the spring
coil section 568 preferably coupled with the shafts 576 and 578 on
first and second ends 572, 574.
[0218] The axially moveable core 312 preferably is disposed within
the deployment catheter 516 such that the flexible core section 564
may be linearly co-located with the flexible catheter section 562
at a distal portion 560 of the delivery system 500 during
appropriate times during a procedure, as shown in FIG. 36. When the
flexible core section 564 is aligned and linearly co-located with
the flexible catheter section 562, the sections preferably
cooperate to form a delivery system flexible segment 558. As shown
in FIGS. 32, 33, and 36, the delivery system flexible segment 558
preferably is located toward a distal end 560 of the delivery
system 500.
[0219] In one embodiment, shown in FIG. 37, the distal shaft 578,
flexible core section 564, and proximal shaft 576 are attached by
welding. Small windows 580 may be provided to allow welding
materials to flow between the shafts 564, 576 and 578 and provide
stronger bonding therebetween. In another embodiment, solder, glue,
or press-fitting is used to attach shafts 564, 576, and 578 to one
another, as is well known to those of skill in the art. In another
embodiment, the shafts 564, 576 and 578 are formed from a single
tube, for example, a laser-cut tube. In other embodiments, more
than one tube may be used to form each of the shafts 564, 576 and
578. For example, FIG. 37 illustrates proximal shaft 576 comprising
two tubes connected by welding such as described above.
[0220] Referring to FIG. 37A, distal contrast media preferably can
be injected through a lumen 582 in the shafts 576 and 578 for
determining the placement of the implant 304. This lumen may be in
fluid communication with distal injection port 548, shown in FIGS.
32 and 33. The distal shaft 578 preferably comprises a mating
surface 584 and a radiopaque marker 586, such as described above.
In one embodiment, the mating surface 584 is a threaded surface.
The distal shaft 578 preferably is releasably coupled through the
implant 304 with the slider assembly 400, such as described
above.
[0221] When the delivery system 500 is assembled, the recapture
sheath 514 is preferably loaded over the deployment catheter 516,
distal to the handle 538, as shown in FIGS. 32 and 33. The
recapture sheath 514 preferably is designed to allow recapture of
the implant 304 prior to its final release such as described with
respect to retrieval catheter 360 above. Recapture petals or flares
528 preferably are provided on the distal end 530 of the recapture
sheath 514 to cover the anchors 195 of the implant 304 during
retrieval into the delivery sheath 504, as described above with
respect to FIGS. 20A-20C, and further below. A Touhy-Borst adapter
or valve 532 preferably is attached to the proximal end 534 of the
recapture sheath 514. The recapture sheath 514 preferably comprises
a radiopaque marker 536 on its distal end 530 near the recapture
flares 528. The recapture sheath 514 preferably comprises a
recapture sheath injection port 588 for delivering fluid proximal
the implant 304.
[0222] The peel-away sheath 512 preferably is provided over a
portion of the recapture sheath 514, between Touhy-Borst valve 532
and recapture flares 528. The peel-away sheath 512 preferably is
used to introduce the delivery system 500 into a delivery sheath
504 shown in FIGS. 38A-38C, described below. As shown in FIGS. 32
and 33, the peel-away sheath 512 preferably comprises a locking
collar 522, a peel-away section 524, and a reinforced section 526.
The locking collar can be unlocked relative to peel-away section
524, and preferably includes a threaded hub 523 that releasably
engages tabs 525 of the peel-away section 524.
[0223] The loading collar 510 preferably is located over a portion
of the peel-away sheath 512 and a portion of the recapture sheath
514 with its proximal end being located over the peel-away sheath
512 at its distal end loaded over recapture sheath 514. The loading
collar 510 preferably accommodates loading a collapsed implant 304
into the peel-away sheath 512 as described below. As shown in FIGS.
33 and 34, the loading collar 510 preferably comprises a first end
portion 518 adapted to receive and extend over a collapsed implant
304, and a second end portion 520 configured to guide the collapsed
implant 304 into the peel-away sheath 512. The loading collar 510
preferably is made of stainless steel.
[0224] To assemble the delivery system, the axially movable core
312 and control line 328 preferably are fed into the multi-lumen
shaft 540 of the deployment catheter 516. The multi-lumen shaft 540
preferably is then coupled with components of the deployment handle
538 and the injection port components 546, 548. The peel-away
sheath 512 and the loading collar 510 preferably are slid onto the
recapture sheath 514, and the recapture sheath 514 is slid onto the
deployment catheter 516. The implant 304 preferably is then loaded
on an end of the axially movable core 312 and coupled with the
control line 328. In one embodiment, the implant 304 is loaded on
an end of the axially movable core 312 by screwing the axially
movable core 312 into the slider nut 402 of the slider assembly
400. The control knob 542 and outer casing of the deployment handle
538 preferably are then coupled with the system.
[0225] The deployment system 300 preferably is used in connection
with a delivery sheath 504 to advance the implant 304 for
deployment in a patient. As shown in FIGS. 30 and 38A-38C, the
delivery sheath 504 is a tubular device that in one embodiment can
be advanced over a guidewire (not shown) for accessing the LAA 502
of a patient. Delivery sheath 504 in one embodiment has a permanent
bend 594, as shown in the views of FIGS. 38A and 38B. A hemostasis
valve 596 is provided at the proximal end of transseptal sheath. A
fluid injection port 598 is also provided at the proximal end to
deliver fluid such as contrast media through the transseptal
sheath. Systems and methods for implanting the device 304 in the
LAA 502 are described further below.
[0226] In one embodiment, the system and method preferably allows
for access and assessment of the LAA 502. A guidewire (not shown)
preferably is used to access the superior or inferior vena cava
through groin access. For example, a delivery sheath 504 preferably
is advanced over the guidewire and into the superior vena cava. The
guidewire preferably is removed and replaced with a transseptal
needle (not shown). The delivery sheath 504 preferably is retracted
inferiorly so that the bend 594 in delivery sheath directs the
distal tip of the delivery sheath 504 toward the fossa ovalis. The
needle preferably is advanced to puncture the fossa ovalis. The
delivery sheath 504 preferably is advanced to establish access to
the LAA 502 and the needle preferably is retracted. Further details
or disclosure are provided in copending U.S. patent applications
Ser. Nos. 09/435,562 and 10/033,371, the entireties of which are
hereby incorporated by reference. In one embodiment, the implant
304 can be deployed within the LAA 502 as an adjunct to surgical
heart procedures, as described below. The delivery sheath 504 for
establishing access to the LAA 502 can be generally straight and
can have a length less than the length of the delivery sheath 504
which is advanced through the superior or inferior vena cava.
[0227] After properly preparing a delivery sheath 504 for LAA 502
access, the size of the neck diameter and morphology of the LAA 502
preferably is determined by advancing the delivery sheath 504 to
the distal portion of the LAA 502 and injecting contrast media to
obtain an initial left atrial appendogram. The neck diameter
preferably is measured approximately 5 mm in from the ostium of the
LAA 502 at end diastole.
[0228] In one embodiment, the system and method preferably allows
for selection and preparation of a deployment system 300. A
deployment system 300 preferably comprises an implant 304 of an
appropriate size for placement in a patient. Initially, the implant
304 preferably is in an expanded configuration, with axially
moveable core 312 engaging slider assembly 400, as described above.
The recapture sheath 514 preferably is positioned so it covers and
supports the flexible segment 558 of the delivery system 500,
wherein the flexible catheter section 562 of deployment catheter
302 and flexible core section 564 of axially moveable core 312 are
aligned. The Touhy-Borst valve 532 preferably is tightened over the
deployment catheter 516 to prevent relative movement between
recapture sheath 514 and deployment catheter 516. The loading
collar 510 and peel-away sheath 512 preferably are positioned so
they are at the base of the recapture flares 528, proximal
thereto.
[0229] The delivery system 500 preferably is loaded by rotating the
control knob 542 counterclockwise until the implant 304 is fully
collapsed. Preferably, at least a portion of the control line 328
is coupled with the control knob 542 such that rotation of the
control knob 542 in the counterclockwise direction retracts at
least a portion of the control line 328. Retraction of the control
line 328 preferably places tension on the proximal hub 324 of the
implant 304, because a portion of the control line 328 preferably
is coupled with the proximal hub 324 by a pin 329. While the distal
portion of the axially moveable core 312 engages slider assembly
400 and applies a distal force to distal hub 314 of the implant
304, tension in the control line 328 preferably causes the proximal
hub 324 of the implant 304 to move proximally relative the axially
moveable core 312, thereby collapsing the implant 304.
[0230] The diameter of the implant 304 preferably is reduced to
approximately 1/3.sup.rd or less of its original diameter when
collapsed. The loading collar 510 and peel-away sheath 512 are then
advanced distally over the flares 528 and implant 304 until the
distal tip of the implant 304 is aligned with the distal end of the
peel-away sheath 512 and the distal end of the loading collar is
about 1.5 cm from the distal tip of the implant At this point, the
flares 528 partially cover the implant. The loading collar 510
preferably is removed and discarded.
[0231] With the implant 304 partially within the recapture sheath
514 and retracted within the peel-away sheath 512, the entire
system preferably is flushed with sterile heparinized saline after
attaching stopcocks to the recapture sheath injection port 588, the
proximal injection port 546 and distal injection port 548 of the
delivery system 500. The recapture sheath 514 and the Touhy-Borst
valve 532 are first thoroughly flushed through port 588. Then the
distal injection port 548 and the proximal injection port 546 of
the deployment handle 538 are preferably flushed through. The
distal injection port 548 is in fluid communication with lumen 426
of axially moveable core 312, and proximal injection port 546 is in
fluid communication with injection lumens 554 of multilumen shaft
540. The delivery sheath 504 placement preferably is reconfirmed
using fluoroscopy and contrast media injection.
[0232] The delivery system 500, as described above, with implant
304 inserted therein, preferably is then inserted into the proximal
end of the delivery sheath 504. To avoid introducing air into the
delivery sheath 504 during insertion of the delivery system 500, a
continual, slow flush of sterile heparinized saline preferably is
applied through the proximal injection port 546 of the deployment
handle 538 to the distal end of the deployment catheter 516 until
the tip of the peel-away sheath 512 has been inserted into, and
stops in, the hemostatic valve of the delivery sheath 504.
Preferably, the distal tip of the peel-away sheath 512 is inserted
approximately 5 mm relative to the proximal end of the delivery
sheath 504.
[0233] Under fluoroscopy, the recapture sheath 514 and deployment
catheter 516 preferably are advanced, relative to the peel-away
sheath 512, approximately 20-30 cm from the proximal end of the
transseptal sheath, and the system 500 preferably is evaluated for
trapped air. The peel-away sheath 512 is preferably not advanced
into the delivery sheath 504 due to the hemostasis valve 596
blocking its passage. If air is present in the system 500, it may
be removed by aspirating through the distal injection port 548,
recapture sheath injection port 588, or proximal injection port
546. If air cannot be aspirated, the deployment catheter 516 and
recapture sheath 514 preferably are moved proximally and the
delivery system 500 preferably is removed from the delivery sheath
504. All air preferably is aspirated and the flushing/introduction
procedure preferably is repeated.
[0234] The peel-away sheath 512 preferably is manually slid
proximally to the proximal end 534 of the recapture sheath 514. The
Touhy-Borst valve 532 preferably is loosened and the deployment
catheter 516 preferably is advanced distally relative to the
recapture sheath 514 until the deployment handle 538 is within
about 2 cm of the Touhy-Borst valve 532 of the recapture sheath
514. This causes the implant 304 to be advanced distally within the
delivery sheath 504 such that the recapture sheath 514 no longer
covers the implant 304 or the flexible section 558. The Touhy-Borst
valve 532 preferably is tightened to secure the deployment catheter
516 to fix relative movement between the deployment catheter 516
and recapture sheath 514.
[0235] Under fluoroscopy, the implant 304 preferably is advanced to
the tip of the delivery sheath 504 by distal movement of the
delivery catheter 302. The distal hub 314 of implant 304 preferably
is aligned with a delivery sheathtip radiopaque marker 590. Under
fluoroscopy, the sheath 504 positioning within the LAA 502
preferably is confirmed with a distal contrast media injection.
[0236] The position of the implant 304 preferably is maintained by
holding the deployment handle 538 stable. The delivery sheath 504
preferably is withdrawn proximally until its tip radiopaque marker
590 is aligned with the distal end of the deployment catheter
flexible segment 558. This preferably exposes the implant 304.
[0237] Under fluoroscopy, the implant 304 preferably is expanded by
rotating the control knob 542 clockwise until it stops. Rotating
the control knob 542 preferably releases tension on the control
line 328, preferably allowing the implant 304 to expand. The
implant 304 preferably is self-expanding. After expansion, any
tension on the LAA 502 preferably is removed by carefully
retracting the deployment handle 538 under fluoroscopy until the
radiopaque marker 586 on the axially movable core 312 moves
proximally approximately 1-2 mm in the guide tube 320. The position
of the implant 304 relative the LAA 502 preferably is not altered
because the axially movable core 312 preferably is coupled with the
slider assembly 400 allowing for relative movement between the
implant 304 and the axially movable core 312. The slider assembly
400 preferably allows for the distal portion of the axially movable
core 312 to be slightly retracted proximally from the distal hub
314 of the implant 304, thereby removing any axial tension that may
be acting on the implant 304 through the axially movable core 312.
The radiopaque marker 586 preferably is about 1-2 mm proximal from
the implant 304 distal hub 314, and the delivery sheath 592 tip
preferably is about 2-3 mm proximal from the implant proximal hub
324, thereby indicating a neutral position.
[0238] Under fluoroscopy, the expanded diameter (.O slashed. in
FIG. 30) of the implant 304 preferably is measured in at least two
views to assess the position of the implant within the LAA 502. The
measured implant diameter .O slashed. preferably is compared to the
maximum expanded diameter.
[0239] Preferably, the labeled proximal and distal injection ports
546, 548 of the deployment handle 538 shown in FIG. 32, correlate
with the proximal and distal contrast media injections. The
proximal contrast media injections are delivered through the
delivery catheter lumen 554 to a location proximal to the implant
304. The distal contrast media injections are delivered through the
axially movable core 312 to a location distal to the implant 304.
Proximal contrast media injections preferably are completed in two
views. If the injection rate is insufficient, the recapture sheath
injection port 588 may be used independently or in conjunction with
the proximal injection port 546 to deliver fluid to a location
proximal to the implant 304.
[0240] If satisfactory results are seen, any transverse tension on
the LAA 502 preferably is released by exposing the flexible segment
558 of the delivery system 500. The flexible catheter section 562
and the flexible core section 564 preferably are linearly
co-located to cooperate as the flexible segment 558 of the delivery
system 500. This preferably is accomplished by retracting the
delivery sheath 504 proximally approximately 2 cm to expose the
flexible segment. By exposing the flexible segment 558, the
flexible segment 558 preferably will flex to allow the implant 304
to sit within the LAA 502 free from transverse forces that may be
created, for example, by contractions of the heart acting against
the delivery sheath 504 or deployment catheter 516.
[0241] Once the flexible segment 558 is exposed, distal contrast
media injections preferably are completed in at least two views to
verify proper positioning of the implant 304. A flush of saline
preferably is used as needed between injections to clear the
contrast media from the LAA 502. Following the contrast media
injections, the delivery sheath 504 preferably is advanced distally
to cover the flexible segment 558.
[0242] If implant 304 position or results are sub-optimal, the
implant 304 preferably may be collapsed and repositioned in the LAA
502. To achieve this, under fluoroscopy, the deployment handle 538
preferably is advanced distally to place the radiopaque marker 586
of the axially moveable core 312 at the distal hub 314 of the
implant 304. The distal end of the delivery sheath 504 preferably
is aligned with the distal end of the flexible segment 558. The
control knob 542 preferably is rotated until the implant 304 has
been collapsed to approximately 1/3.sup.rd or less of its expanded
diameter. The control knob 542 preferably acts on the control line
328 to place tension on the proximal hub 324 of the implant 304,
pulling the proximal hub 324 of the implant 304 proximally relative
the distal hub 314 of the implant 304 to collapse the implant 304.
The implant 304 preferably can be repositioned and re-expanded.
[0243] The stability of the implant 304 preferably is verified in
several views. Stability tests preferably are preformed in the
following manner. A contrast media filled syringe preferably is
connected to the distal injection port 548 of the deployment handle
538. Under fluoroscopy, at least about a 10 mm gap between the tip
of the delivery sheath 504 and the proximal hub 222 of the implant
304 is preferably confirmed.
[0244] The stability of the implant 304 in the LAA 502 preferably
is evaluated using fluoroscopy and echocardiography. The recapture
sheath Touhy-Borst valve 532 preferably is loosened. Then the
deployment handle 538 preferably is alternately retracted and
advanced about 5-10 mm while maintaining the position of the
delivery sheath 504 and simultaneously injecting contrast media
through the distal injection port 548. This tests how well the
implant is held within the LAA 502.
[0245] If the implant stability tests are unacceptable, the implant
304 preferably may be collapsed and repositioned as described
above. If repositioning the implant 304 does not achieve an
acceptable result, the implant 304 preferably may be collapsed and
recaptured as described further below.
[0246] The implant 304 preferably meets the following acceptance
criteria, associated with the assessment techniques listed below,
prior to being released. The assessment techniques to be evaluated
preferably include 1) residual compression; 2) implant location; 3)
anchor engagement; 4) seal quality; and 5) stability. For residual
compression, the implant diameter .O slashed., as measured by
fluoroscopic imaging, preferably is less than the maximum expanded
diameter of the implant 304. For implant location, the proximal
sealing surface of the implant 304 preferably is positioned between
the LAA 502 ostium and sources of thrombus formation (pectinates,
secondary lobes, etc.) (preferably imaged in at least two views).
For anchor engagement, the implant frame 506 preferably is
positioned within the LAA 502 so as to completely engage a middle
row of anchors 195 in an LAA 502 wall (preferably imaged in at
least two views). For seal quality, the contrast injections
preferably show leakage rated no worse than mild (preferably
defined as a flow of contrast media, well defined, and filling
one-third of the LAA 502 during a proximal injection over a period
of up to about five ventricular beats, preferably imaged in at
least two views). For stability, there preferably is no migration
or movement of the implant 304 relative to the LAA 502 wall as a
result of the Stability Test.
[0247] If implant recapture is necessary, because a different size
implant 304 is necessary or desired, or if acceptable positioning
or sealing cannot be achieved, the implant 304 preferably is fully
collapsed as described above. Once the implant 304 is collapsed,
the locking collar 522 of the peel away sheath 512 preferably is
unlocked. The peel-away portion 524 of the peel-away sheath 512
preferably is split up to the reinforced section 526 and removed.
The reinforced section 526 of the peel-away sheath 512 preferably
is slid proximally to the hub of the recapture sheath 514. The
Touhy-Borst valve 532 on the proximal end of the recapture sheath
514 preferably is slightly loosened to allow smooth movement of the
sheath 514 over deployment catheter 516 without allowing air to
enter past the Touhy-Borst valve 532 seal. By removing the
peel-away portion 524 of peel-away sheath 512, the recapture sheath
514 can now be advanced further distally relative to the
transseptal sheath.
[0248] While holding the deployment catheter 516 and delivery
sheath 504 in place, the recapture sheath 514 preferably is
advanced distally into the delivery sheath 504 until a half marker
band 536 on the recapture sheath 514 is aligned with a full marker
band 590 on the delivery sheath 504. This preferably exposes the
recapture flares 528 outside the transseptal sheath.
[0249] The collapsed implant 304 preferably is retracted into the
recapture sheath 514 by simultaneously pulling the deployment
handle 538 and maintaining the position of the recapture sheath 514
until approximately half the implant 304 is seated in the recapture
sheath 514. The Touhy-Borst valve 532 on the recapture sheath 514
preferably is tightened over the deployment catheter 516. The
recapture sheath 514 and implant 304 preferably are retracted into
the delivery sheath 504 by pulling on the recapture sheath 514
while maintaining the position of the delivery sheath 504,
preferably maintaining left atrial access. The recapture flares 528
of the recapture sheath 514 preferably cover at least some of the
anchor elements 195 on the implant 304 as the implant is retracted
proximally into the delivery sheath 504. Further details are
described above with respect to FIGS. 20A-20C.
[0250] If the implant's position and function are acceptable, and
implant recapture is not necessary, the implant 304 preferably is
released from the delivery system 500. Under fluoroscopy, the
delivery sheath 504 preferably is advanced to the proximal hub 324
of the implant 304 for support. The release knob 544 on the
proximal end of the deployment handle 538 preferably is rotated to
release the implant 304. Rotating the release knob 544 preferably
causes a threaded portion 584 of the distal shaft 578 of the
axially movable core 312 to rotate with respect to the slider
assembly 400 such that the threaded section 584 preferably is
decoupled from the slider assembly 400. Under fluoroscopy, after
the axially movable core 312 is decoupled from the implant 304, the
release knob 544 preferably is retracted until the distal end 578
of the axially movable core 312 is at least about 2 cm within the
delivery sheath 504.
[0251] Under fluoroscopy, while assuring that transseptal access is
maintained, the delivery system 500 preferably is retracted and
removed through the delivery sheath 504. Under fluoroscopy, the
delivery sheath 504 position preferably is verified to be
approximately 1 cm away from the face of the implant 304. Contrast
injections, fluoroscopy and/or echocardiography preferably may be
used to confirm proper positioning and delivery of the implant 304
and containment of the LAA 502. The delivery sheath 504 preferably
is withdrawn.
[0252] In addition to the aforementioned techniques, an implant as
described above can be delivered, e.g., using conventional
transthoracic surgical, minimally invasive, or port access
approaches. Delivery can be made or done in conjunction with
surgical procedures. Implant 304, for example, can be used in
conjunction with various surgical heart procedures related to the
heart (e.g., mitral valve repair) or surgical procedures in the
region surrounding the heart. The delivery system 500 and delivery
sheath 504 can be used to locate and deploy the implant 304 in
order to prevent the passage of embolic material from the LAA, such
that thrombus remains contained in the LAA 502. Thrombus remains
contained in the LAA 502 because the implant 304 inhibits thrombus
within the LAA 502 from passing through the orifice of the LAA 502
and into the patient's blood stream. Additionally, the deployed
implant 304 located in the LAA 502 can provide a smooth,
non-thrombogenic surface facing the left atrium. Preferably, the
smooth, non-thrombogenic surface facing the left atrium will not
promote blood clots to form proximate to the LAA 502. Access to the
heart may be provided by surgical procedures in order to deploy the
implant 304 in the LAA 502. That is, the implant 304 can be
deployed as an adjunct to surgical procedures. Access to the left
atrium is provided in one embodiment by obtaining a left atrium
access path. The delivery sheath 504 can be located along the left
atrium access path to define a delivery path. The delivery system
500 can be used to deliver the implant 304 along the delivery path
to a position for deployment. The implant 304 located in the
position for deployment can be deployed to block the LAA 502. There
are many methods of delivering and deploying the implant 304 as
described in further detail below.
[0253] In particular, access to the heart of a patient can be
provided by various techniques and procedures so that implant 304
can delivered and deployed in the heart. For example, minimally
invasive surgery techniques, laparoscopic procedures and/or open
surgical procedures can provide the left atrium access path to the
heart. In one embodiment, access to the LAA can be provided by
access through the chest of the patient, and may include, without
limitation, conventional transthoracic surgical approaches, open
and semi-open heart procedures, laparoscopic, and port access
techniques. Such surgical access and procedures preferably will
utilize conventional surgical instruments for accessing the heart
and performing surgical procedures on the heart, for example,
retractors, rib spreaders, trocars, laparoscopic instruments,
forceps, scissors, shears, rongeurs, clip appliers, staplers,
sutures, needle holders, bulldogs, clamps, elevators, cauterizing
instruments or substances, electrosurgical pens, suction
apparatuses, approximators, and/or the like. The implant can be
conveniently deployed as an adjunct to a surgical heart procedure,
such that the implant can be delivered at the LAA without
performing additional complicated procedures for gaining access to
the LAA. As used herein the phrase "surgical heart procedure" is a
broad phrase and is used in accordance with its ordinary meaning
and may include, without limitation, open procedures, semi-open
procedures, laparoscopic procedures, open heart surgery and may
include procedures for replacing and/or repairing portions of the
heart. In one non-limiting exemplifying embodiment, surgical heart
procedures include treatment of the heart, such as aortic valve
repair, mitral valve repair, pulmonary valve repair, and/or
replacement of a heart valve (e.g., a diseased aortic, mitral, or
pulmonary valve) with an artificial valve or prosthesis. The known
conventional surgical instruments for accessing the heart and
performing surgical procedures on the heart can be used in
combination with instruments used for these heart treatments. For
example, sizing rings, balloons, calipers, gages, and the like can
be employed to match an implant/device (such as artificial valve or
prosthesis) to an anatomical structure of the heart.
[0254] Many times, the access techniques and procedures can be
performed by the surgeon and/or a robotic device, such as robotic
systems used for performing minimally invasive heart surgery. Those
skilled in the art recognize that there are many different ways the
heart can be accessed.
[0255] In one embodiment, the access to the left atrium can be
obtained by creating a left atrium access path. The left atrium
access path is a path the can be used to locate the delivery sheath
into a patient's body for implant 304 delivery. The left atrium
access path can be obtained before, during, or after another
surgical heart procedure (e.g., mitral valve repair), which many
times can provide the left atrium access path. The left atrium
access path can be sized to allow the passing of the delivery
sheath 504 along the left atrium access path without injuring the
patient. The techniques and procedures for obtaining the left
atrium access path can be performed by the surgeon and/or a robotic
device.
[0256] The left atrium access path can be disposed in various
locations in the patient's body. For example, the left atrium
access path can be located within the pulmonary vein and to the
left atrium. In another embodiment, the left atrium access path can
be located outside of the heart and through the wall of the left
atrium and into the left atrium. In another embodiment, the left
atrium access path is located within the right atrium through a
transseptal puncture and passes into the left atrium. In another
embodiment, the left atrium access path is located through an
opening, for example obtained during an open heart procedure, in
the wall of left atrium and into the left atrium. Those skilled in
the art recognize that the left atrium access path can be located
in various other positions.
[0257] The delivery sheath 504 can be positioned along the left
atrium access path and can define a delivery path for the delivery
of the implant 304. The delivery path is disposed within and along
the delivery sheath 504. The delivery sheath 504 is sized to permit
the implant 304 to pass along the delivery path through the
delivery sheath 504 and out of a distal end 702 of the delivery
sheath 504 (as shown in FIG. 30). The delivery sheath 504 can be
configured for particular left atrium access paths, which are
described herein. The delivery sheath 504, of course, can be used
with the delivery system 500 and 300, as described above.
[0258] In the illustrated embodiment of FIG. 40, the implant 304
can be delivered along a delivery path 901 that passes through the
pulmonary vein 904 and through the left atrium to the LAA 502,
e.g., the distal end 702 of the delivery sheath 504 can be
positioned for delivery and deployment of the implant 304. The
delivery path 901 can be positioned by inserting the distal end 702
of the delivery sheath 504 into the pulmonary vein 904 and
advancing the distal end 702 of the delivery sheath 504 along the
pulmonary vein 904 towards the wall of the left atrium. The sheath
504 can be delivered to the pulmonary vein, for example, in a
surgical heart procedure, such as in conventional open procedure
through the chest of a patient, or in a laparoscopic approach
through the chest using trocars and other instruments to direct the
delivery sheath 504 to the pulmonary vein. The distal end 702 of
the delivery sheath 504 can pass through the chamber of the left
atrium such that the distal end 702 of the delivery sheath 504 is
proximate to the orifice of the LAA 502. The implant 304 can be
delivered through the delivery sheath 504 and along the delivery
path 901 as indicated by the arrows. Thus, the delivery sheath 504
defines the delivery path 901 that passes through the pulmonary
vein 904, the chamber of the left atrium, and is used to deliver
the implant 304 to the LAA 502. Delivery and deployment of the
implant 304 can be accomplished using the techniques as described
above, or other suitable techniques. In some non-limiting
exemplifying embodiments, the delivery sheath 504 has length that
is greater than about 15 cm. In some non-limiting exemplifying
embodiments, the delivery sheath 504 has a length of about 50 cm or
less, and even more preferably about 45 cm or less, about 40 cm or
less, about 35 cm or less, about 30 cm or less, about 25 cm or
less, about 20 cm or less, about 15 cm or more, or even ranges
encompassing such lengths. The delivery sheath 504 can have a
length suitable for allowing the surgeon to easily position the
delivery sheath 504 through the pulmonary vein (or along other
delivery paths described below). For example, in an open procedure,
one hand of the surgeon can position the delivery sheath 504 in the
heart and the other hand of the surgeon can hold and position the
proximal end of delivery sheath 504 outside of chest cavity. Thus,
a person can manually position the delivery sheath 504 to deliver
the implant into the LAA. Many times, conventional sheaths are long
and therefore awkward to stabilize and may be difficult to position
both ends of the conventional sheath. Alternatively, the delivery
sheath 504 can be positioned by a robotic system, multiple
surgeons, and/or other suitable means for positioning.
[0259] In the illustrated embodiment of FIG. 41, the implant 304
can be delivered along a delivery path 910 that passes directly
through an opening 912 in the wall of the left atrium. In some
embodiments, the opening 912 is formed in an outer wall 913 of the
left atrium. The outer wall 913 forms a portion of the outer
surface 915 of the heart. The opening 912 is preferably spaced from
the LAA 502 so that the delivery sheath 504 can be easily
positioned near the LAA 502. For example, the opening 912 can be
spaced from the orifice of the LAA 502 by a distance of about 1 to
10 cm, more preferably about 5 cm. However, the opening 912 can be
formed at any point along the outer wall 913. For example, the
opening 912 can be formed in the wall of the LAA 502. The opening
912 is configured and sized to receive the delivery sheath 504. In
some exemplifying non-limiting embodiments, the cross sectional
area of the delivery sheath 504 is equal to or more than about 30%
of the area of the opening 912. The cross-sectional area of the
delivery sheath 504 can be equal to or more than 40%, 50%, 60%,
70%, 80%, 90%, and ranges encompassing such percentages of the area
of the opening 912. Thus, the delivery sheath 504 can be
conveniently inserted through the opening 912 and maneuvered within
the left atrium.
[0260] The illustrated delivery path can be positioned by passing
the distal end 702 of the delivery sheath 504, which is located
outside of the heart, through the wall 913 of the left atrium and
into the chamber of the left atrium. It will be appreciated that
the sheath 504 may be steered or turned to the desired location.
The delivery sheath preferably has a length suitable for accessing
the opening 912 and the LAA 502 from outside the heart and outside
the patient, more preferably about 80 cm or less, and even more
preferably about 70 cm or less, about 50 cm or less, about 30 cm or
less, about 10 cm or less, or even ranges encompassing these
lengths. As discussed above, the surgeon can easily position the
delivery sheath 504. The delivery sheath 504 is distally advanced
to a position for deployment, such that the distal end 702 of the
delivery sheath 504 is proximate to the orifice of the LAA 502. The
implant 304 can be delivered through the delivery sheath 504 and
along the delivery path 910 as indicated by the arrows. Thus, the
delivery sheath 504 defines the delivery path that passes directly
through the wall of the left atrium and is used to deliver the
implant 304 to the LAA 502.
[0261] In the illustrated embodiment of FIG. 42, the implant 304
can be delivered along a delivery path 920 that passes through the
right atrium, a transseptal puncture 930, and the left atrium. The
delivery path can be positioned by passing the distal end 702 of
the delivery sheath 504 through the right atrium and towards the
transseptal puncture 930. The transseptal puncture is sized and
located to allow the distal end 702 of the delivery sheath 504 to
pass through the transseptal puncture 930 and into the left atrium.
The distal end 702 of the delivery sheath 504 is moved proximate to
the orifice of the LAA 502 for the delivery and deployment of
implant 304 by distally advancing the delivery sheath 504 through
the right atrium and the transseptal puncture 930. The implant 304
can be delivered through the delivery sheath 504 and along the
delivery path 920 as indicated by the arrows. Thus, the delivery
sheath 504 defines a delivery path that passes through the right
atrium, the transseptal puncture 930, and the left atrium. Access
can be gained to the right atrium, for example, through the
superior vena cava (as discussed above) or through the inferior
vena cava. Access to the right atrium through the inferior vena
cava can be obtained by advancing the delivery sheath 504 over the
guidewire disposed within the inferior vena cava and the right
atrium. Thus, the delivery sheath 504 can define a delivery path
920 that passes through the superior or inferior vena cava, the
right atrium, and the transseptal puncture 930 and into the left
atrium. Alternatively, the delivery path can comprise a
pre-existing septal defect such as a hole (an atrial septal defect)
or a tunnel (a patent foramen ovale).
[0262] As discussed above, the delivery sheath 504 can have various
configurations that facilitate the delivery and deployment of the
implant 304. For example, the delivery sheath 504 used for defining
the delivery path through the pulmonary vein and the left atrium
may have different shape and size than the delivery sheath 504 used
for defining a delivery path directly through the wall of the left
atrium. In particular, the length of the delivery sheath 504, which
is used by passing the delivery sheath 504 through the pulmonary
vein, may be different than the length of the delivery sheath 504,
which is used by passing the delivery sheath 504 through the wall
of the left atrium. Thus, the configuration of the delivery sheath
504 can ensure that the implant 304 can be delivered to the proper
location in the heart even though a plurality of left atrium access
paths can be used to deliver the implant 304 to the LAA 502. The
delivery sheath 504 can have various cross sectional profiles,
curves, shapes and sizes to ensure that the implant 304 can be
properly delivered and deployed. For example, a distal portion of
the delivery sheath 504 can be configured to deliver the implant
304 within the LAA 502. Preferably, the distal portion of the
delivery sheath 504 can be configured (e.g., having pre-shaped or
permanent curves) in order to locate the distal end 702 of the
delivery sheath 504 within the LAA 502. The curvature of the distal
end 702 of delivery sheath 504 can be similar to the curvature of
the LAA 502 such that the distal end 702 can be distally advanced
within the LAA 502. Further, the distal portion of the delivery
sheath 504 can be an atraumatic soft-tip to prevent injury to the
patient.
[0263] As shown in FIG. 39, a transition catheter or member 704 can
be used with the delivery sheath 504 for easy handling and
preventing injuries. The transition catheter 704 can be disposed
within the delivery sheath 504 so that distal end 702 of the
delivery sheath 504 is proximate to the distal end of the
transition catheter 704. While the transition catheter 704 is
disposed within the delivery sheath 504, the delivery sheath 504
can be put into the patient to define the delivery path for the
implant 304. In one embodiment, the distal end of the transition
catheter 704 can be a smooth, round top. The smooth, round top can
prevent damage to the distal end 702 of the delivery sheath 504,
for example, by providing structural support to the distal end 702
of the delivery sheath 504. Additionally, the smooth, round top can
prevent injury to the patient by providing an atraumatic surface
that contacts the patient thereby preventing contact between the
distal end 702. After the delivery sheath 504 is properly located,
the transition catheter 704 can be removed from the delivery sheath
504. Then the implant 304 can be inserted into the sheath 504 and
delivered, as described above.
[0264] In one embodiment, the delivery sheath 504 can be advanced
over a guidewire, not shown, for accessing the LAA 502 of a
patient. For example, the guidewire can be disposed directly
through the wall of the left atrium, e.g., along a left atrium
access path through the wall of the left atrium. The delivery
sheath 504 can be advanced over the guidewire and directly through
the wall of the left atrium and towards the LAA 502. Additionally,
the positioning of the delivery sheath 504 can be aided by various
techniques, such as direct visualization from the exterior surface
of the heart, visualization through the use of echocardiography
(e.g., Intracardiac Echo or Transsesophogeal Echo), visualization
through optics including through thoracoscopes, or through the use
of X-Ray fluoroscopy. These techniques can aid the surgeon to
properly advance and locate the delivery sheath 504.
[0265] After the delivery sheath 504 is in the desired position,
the implant 304 can be deployed as described above. Generally, once
the delivery sheath 504 is in deployment position, the delivery
catheter 360 can be inserted into the delivery sheath 504. The
delivery catheter has an appropriate length corresponding to the
length of the delivery sheath, as selected for a desired access
technique. For example, in a procedure through the wall of the left
atrium or in an open procedure, as described herein, the delivery
catheter, like the delivery sheath, may have a length of about 110
cm or less, and even more preferably about 80 cm or less, about 50
cm or less, about 30 cm or less, or even about 20 cm or less. In
some embodiments, the delivery catheter has a length that is
slightly greater than the delivery sheath. For example, the
delivery catheter can have a length that is about 10 cm to about 30
cm greater than the length of the delivery sheath. For example, the
delivery catheter can have a length that is about 10 cm greater
than the length of the delivery sheath, about 15 cm greater than
the length of the delivery sheath, about 20 cm greater than the
length of the delivery sheath, about 25 cm greater than the length
of the delivery sheath, about 30 cm greater than the length of the
delivery sheath, and ranges encompassing these lengths. The implant
304 is collapsed and then the loading collar 510 and the peel-away
sheath 512 are advanced distally over the flares 528 and the
implant 304 until the distal tip of the implant 304 is aligned with
the distal end of the peel-away sheath 512 and the distal end of
the loading collar 510. The loading collar 510 can then be removed
resulting in the collapsed implant 304 located partially within the
recapture sheath 514 and retracted within the peel-away sheath 512,
and the entire system is flushed.
[0266] The implant 304 is inserted in the delivery sheath 504 and
is advanced through the delivery sheath 504 by distal movement of
the delivery catheter 360. The implant 304 is aligned and
positioned for deployment. Preferably, the implant 304 can maintain
proper position by holding the deployment handle 538 in a
particular position. The delivery sheath 504 can move proximally
until the implant 304 is exposed. The surgeon can adjust the
position of the implant 304 by collapsing the implant 304 and
repositioning the implant 304, and the repositioned implant 304 can
be re-expanded. The implant 304 can be released from the delivery
system 500 after the implant 304 is properly positioned because
recapture may not be necessary. The delivery system 500 preferably
is retracted and removed through the delivery sheath 504. There are
various techniques (e.g., contrast injections, fluoroscopy,
thoracoscopy, and/or echocardiography) to confirm proper
positioning and delivery of the implant 304 and containment of
thrombus within the LAA 502. The delivery sheath 504 preferably is
withdrawn along the left atrium access path.
[0267] Thus, the delivery system 500 can be configured and sized to
locate and deploy the implant 304 in the LAA 502 as an adjunct to
many surgical procedures which may or may not be related to the LAA
502. Depending on the surgical procedure, one of the various
embodiments of the delivery system 500 may be more conveniently
used than other embodiments of the delivery system 500 to deploy
the implant 304.
[0268] In the illustrated embodiment of FIG. 41A, the implant 304
can be delivered along a delivery path 910A that passes through an
open left atrium. A surgical procedure, such as open heart valve
surgery, provides the open left atrium for convenient access to the
LAA 502. The surgical procedure can form an opening in the chest of
a patient suitable for open heart procedures. For example, the
opening in the chest can be formed by a sternotomy incision. In one
embodiment, the delivery path 910A can be positioned by passing the
distal end 702 of the delivery sheath 504 through the opening in
the left atrium obtained for open heart surgery. The delivery
sheath 504 in this embodiment may have a length of about 80 cm or
less, about 70 cm or less, about 50 cm or less, about 30 cm or
less, or even about 10 cm or less. In one embodiment, the delivery
sheath has a length of about 1 to 10 cm. As discussed above, the
surgeon can easily manually position the delivery sheath 504. Thus,
the delivery system 500 can be used to locate and deploy the
implant 304 to occlude the LAA 502. During open heart surgery, the
delivery system 500 can be used without the recapture sheath 514
because of the accessibility of the LAA 502 and convenience of
deploying the implant 304. Those skilled in the art recognize that
various catheters (e.g., delivery sheath 504 and/or recapture
sheath 514) can be used with the delivery system 500. If the
delivery sheath 504 is used during open heart surgery, the delivery
sheath 504 is preferably generally straight and has a length less
than the length of the delivery sheath 504 used, e.g., for implant
304 delivery through the femoral vein. Similarly, the length of the
delivery system 500 used for delivering the implant 304 along the
delivery path 910A is preferably less than the length of the
delivery system 500 used to deliver the implant 304 through the
femoral vein.
[0269] In one embodiment, a deployment catheter 516A (shown in FIG.
43) is used in conjunction with open heart surgery. In one
embodiment, the deployment catheter 516A is used without a delivery
sheath. The deployment catheter 516A has the deployment handle 538
connected to a shaft 603. The implant 304 is located near a distal
end 605 of the shaft 603. The core 312 extends axially throughout
the length of the shaft 603 and can be attached at its distal end
to the implant 304. The pull wire or control line 328 extends
proximally throughout the length of the shaft 603 to the deployment
handle 538. The shaft 603 can be sized and configured so that the
implant 304 can be easily located and deployed within the LAA 502.
In one embodiment, for example, shaft 603 has a length in the range
of about 5 cm to 15 cm, more preferably in the range of about 9 cm
to 11 cm. It will be appreciated that the shaft 603 may have any
suitable length for access the LAA in an open procedure, such as
about 80 cm or less, about 70 cm or less, about 50 cm or less, or
about 30 cm or less. The shaft 603 can be a multi-lumen shaft,
similar to the shaft 540 shown in FIG. 32A. The shaft 603
preferably comprises the core lumen 550 for holding the axially
moveable core 312, the control line lumen 552 and two proximal
injection lumens 554 in communication with proximal injection port
546. The control line 328 preferably extends through the control
line lumen 552 and preferably couples to the proximal hub 324 of
the implant 304 to the deployment handle control knob 542, allowing
for implant 304 expansion and collapse. Thus, during open heart
surgery, for example, the implant 304 can be passed directly into
the left atrium of the open heart and along the delivery path 910A
and into the LAA 502. Implant 304 is collapsed, preferably before
it is passed through the left atrium and into the LAA 502, by
rotating the control knob 542 counterclockwise until the implant
304 is fully collapsed. The counterclockwise motion of the control
knob 542 retracts at least a portion of the control line 328 and
places tension on the proximal hub 324 of the implant 304. While
the distal portion of the axially moveable core 312 engages slider
assembly 400 and applies a distal force to the distal hub 314 of
the implant 304, tension in the control line 328 preferably causes
the proximal hub 324 of the implant 304 to move proximally relative
to the axially moveable core 312, thereby collapsing the implant
304. In one embodiment, the deployment catheter 516A comprises a
multi-lumen shaft 603A (shown in FIGS. 44 and 45 without the
control line 328) comprising the core lumen 550 for holding the
axially moveable core 312 and the control line lumen 552. Although
not illustrated, the deployment catheter 516A can be used with a
delivery sheath 504 to aid in the delivery and deployment of the
implant 304.
[0270] As shown in FIG. 45, an insertion tool 538A comprises the
shaft 603A connected to a handle 610 having a lever or trigger 612.
The trigger 612 can be moved towards the handle 610 thereby causing
the implant 304 to collapse. In one embodiment, the control line
328 is coupled to the trigger 612 such that movement of the trigger
612 towards the handle 610 retracts at least a portion of the
control line 328, thereby placing tension on the proximal hub 324
of the implant 304. The tension in the control line 328 causes the
proximal hub 324 of the implant 304 to move proximally relative to
the axially moveable core 312, thereby collapsing the implant 304.
As tension on the pull wire 328 is reduced by moving the trigger
612 away from the handle 610, the implant 304 assumes its expanded
diameter configuration by bending under its own bias.
Advantageously, the insertion tool 538A can facilitate proper
placement of the implant 304, and the grip 310 can be shaped to
conveniently fit the hand of a user. In one embodiment, for
example, shaft 603A has a length in the range of about 5 cm to 15
cm, more preferably in the range of about 9 cm to 11 cm, so that
the implant 304 can be easily located and deployed in the LAA 502.
Those skilled in the art recognize that the various catheters
(e.g., delivery sheath 504 and/or recapture sheath 514) can be used
with the delivery system 500 shown in FIG. 45.
[0271] The implant 304 can also be manually deployed in the LAA
502, preferably during open heart surgery. Thus, the implant 304
can be positioned and deployed within the LAA 502 without the use
of a delivery system. For example, the surgeon can manually hold
the implant 304 and pass the implant 304 into the opened heart,
through the left atrium, and into the LAA 502. The surgeon can
manually apply an inward radial force to the frame 14 to collapse
the implant 304 for convenient positioning at the desired site.
After the implant 304 is placed within the LAA 502, the implant 304
can assume its expanded configuration by bending under its own
bias. Of course, to move the implant 304 into the LAA 502, the
surgeon can provide a distal force on the proximal hub 324 of the
implant 304 in the direction of the LAA 502. For example, because
of the open access to the left atrium during open heart surgery,
the surgeon's thumb can be conveniently used to push on the
proximal hub 324 of the implant 304 to move the implant 304 into
the LAA 502, even though the implant 304 engages with the wall of
the LAA 502 because of the implant 304 biasing to the expanded
configuration. The surgeon can manually apply an inward radial
force to the implant 304 to collapse the implant 304 for convenient
repositioning or removal of the implant 304.
[0272] As illustrated in the partial cross-sectional view of FIG.
46 and FIG. 47, in another embodiment of a delivery system a
delivery sheath 1002 surrounds the implant 304 and a portion of a
push rod 1010. The sheath 1002 has a sheath wall 1003 defining an
inner surface 1008 that engages with the implant 304 to keep the
implant 304 in the collapsed position. The push rod 1010 has a
distal end 1012 that can contact the proximal hub 324 of implant
304. When the push rod 1010 is moved in the distal direction the
distal end 1012 contacts and causes the implant 304 to move in the
distal direction. Those skilled in the art recognize that the
distal end 1012 may or may not be coupled to the proximal hub 324.
When the implant 304 moves out of the sheath 1002, the implant 304
can expand and assume its expanded diameter configuration by
bending under its own bias. Preferably, the implant 304 is passed
through the sheath 1002 and deployed in the LAA 502 as an adjunct
to open heart surgery. For example, during open heart surgery, the
surgeon can hold and move the proximal end 1013 of the push rod
1010 in the distal direction. The push rod 1010 and implant 304
move together in the distal direction towards a distal end 1004 of
the sheath 1002. As the implant 304 moves out of an opening 1005 of
the sheath 1002, the implant 304 can expand under its own bias.
Preferably, the distal end 1004 of the sheath 1002 is located
proximate to the opening of the LAA 502 so that the implant 304
expands within the LAA 502 upon exiting the sheath 1002. After the
implant 304 is expanded in the LAA 502, the sheath 1002 and the
push rod 1010 can be removed from the open heart. Of course, the
surgeon can adjust the position of the implant 304 within the LAA
502. For example, as discussed above, the surgeon can manually
provide a distal or proximal force on the proximal hub 324 to move
the implant 304 relative to the LAA 502.
[0273] To inhibit migration of the implant 304 out of the LAA 502,
the implant 304 can have barbs or anchors 195 that face proximally
as described above. The anchors 195 can engage with adjacent tissue
to retain the implant 304 in its implanted position and can limit
relative movement between the tissue and the implant 304. Further,
after the implant 304 is deployed, various techniques can be
performed to ensure that the implant 304 is properly located in the
LAA 502. For example, the left atrium or LAA may change shape or
expand after the implant 304 is deployed. The orifice of the LAA
502 can be sutured while the implant 304 is within the LAA 502 to
further fix the implant 304 into the LAA 502.
[0274] It will be appreciated that the delivery systems for the
implant 304 described above can be used in combination with
conventional instruments used in open surgical procedures or other
procedures performed through the chest of a patient and any
procedures that are being performed as an adjunct with the delivery
of the implant 304 to the LAA. For example, when the implant is to
be delivered through the chest, one embodiment of the invention
includes a delivery sheath or catheter as described above, an
implant sized and configured to prevent passage of embolic material
from the left atrial appendage, and means or instruments for
providing surgical access through the chest of the patient or for
performing surgical procedures on the heart, e.g., retractors, rib
spreaders, forceps, scissors, shears, rongeurs, clip appliers,
staplers, sutures, needle holders, bulldogs, clamps, elevators,
cauterizing instruments or substances, electrosurgical pens,
suction apparatus, approximators, and/or the like. When the implant
is to be delivered through an outer wall of the left atrium,
another embodiment of the invention includes a delivery sheath or
catheter as described above, an implant sized and configured to
prevent passage of embolic material from the left atrial appendage,
and means or instruments for providing access through the left
atrium wall, e.g., trocars, port instruments, and the like. When
the implant is to be delivered as an adjunct to another surgical
procedure, another embodiment of the invention includes a delivery
sheath or catheter as described above, an implant sized and
configured to prevent passage of embolic material from the left
atrial appendage, and means for performing surgical heart
procedures, e.g., conventional surgical instruments (such as those
described herein) for accessing the heart and performing surgical
procedures on the heart. Thus, conventional surgical instruments
can be used in conjunction with the delivery of the implant, e.g.,
when the implant is delivered through the atrial wall of the heart,
through the wall of LAA, etc.
[0275] Optionally, various procedures and instruments can be used
in conjunction with the delivery of the implant, especially if the
implant is delivered as an adjunct to an open surgical procedure or
other surgical heart procedure. For example, one or more verres
needles, trocars, cannulas, insufflators, laparoscopes, light
sources, video monitors, forceps, scissors, clip appliers, sutures,
needle holders, clamps, retractors, elevators, morcellators,
cauterizing instruments or substances, electrosurgical cutting or
grasping instruments, suction apparatuses, approximators, and/or
the like can be used before, during, and/or after the surgical
procedures and/or delivery of the implant in the LAA.
[0276] Throughout this application the terms implant and occlusion
device have been used. One of ordinary skill in the art will
appreciate that all of the disclosures herein are applicable to a
wide variety of structures that include both implants that may or
may not also be occlusion devices. Routine experimentation will
demonstrate those limited circumstances under which certain
disclosures and combinations thereof are not beneficial.
[0277] Further details regarding left atrial appendages devices and
related methods are disclosed in U.S. Pat. No. 6,152,144, titled
"Method and Device for Left Atrial Appendage Occlusion," filed Nov.
6, 1998, U.S. patent application Ser. No. 09/435,562, filed Nov. 8,
1999, U.S. patent application Ser. No. 10/033,371, titled
"Adjustable Left Atrial Appendage Occlusion Device," filed Oct. 19,
2001. The entirety of each of these is hereby incorporated by
reference in their entirety.
[0278] While particular forms of the invention have been described,
it will be apparent that various modifications can be made without
departing from the spirit and scope of the invention. Accordingly,
it is not intended that the invention be limited, except as by the
appended claims.
* * * * *