U.S. patent application number 16/877053 was filed with the patent office on 2020-09-03 for systems, methods and devices for delivery systems, methods and devices for implanting prosthetic heart valves.
The applicant listed for this patent is 4C Medical Technologies, Inc.. Invention is credited to Gregory G. Brucker, Jeffrey W. Chambers, Jason S. Diedering, James E. Flaherty, Joseph P. Higgins, Karl A. Kabarowski, Saravana B. Kumar, Jeffrey R. Stone, Robert J. Thatcher.
Application Number | 20200276013 16/877053 |
Document ID | / |
Family ID | 1000004838403 |
Filed Date | 2020-09-03 |
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United States Patent
Application |
20200276013 |
Kind Code |
A1 |
Chambers; Jeffrey W. ; et
al. |
September 3, 2020 |
SYSTEMS, METHODS AND DEVICES FOR DELIVERY SYSTEMS, METHODS AND
DEVICES FOR IMPLANTING PROSTHETIC HEART VALVES
Abstract
Embodiments of delivery systems, devices and methods for
delivering a prosthetic heart valve device to a heart chamber for
expanded implementation are disclosed. More specifically, methods,
systems and devices are disclosed for delivering a self-expanding
prosthetic mitral valve device to the left atrium, with no
engagement of the left ventricle, the native mitral valve leaflets
or the annular tissue downstream of the upper annular surface
during delivery, and in some embodiments with no engagement of the
ventricle, mitral valve leaflets and/or annular tissue located
downstream of the upper annular surface by the delivered,
positioned and expanded prosthetic mitral valve device.
Inventors: |
Chambers; Jeffrey W.; (Maple
Grove, MN) ; Brucker; Gregory G.; (Maple Grove,
MN) ; Higgins; Joseph P.; (Minnetonka, MN) ;
Kumar; Saravana B.; (Minnetonka, MN) ; Diedering;
Jason S.; (Minneapolis, MN) ; Kabarowski; Karl
A.; (Maple Grove, MN) ; Thatcher; Robert J.;
(Blaine, MN) ; Flaherty; James E.; (Maple Grove,
MN) ; Stone; Jeffrey R.; (Minnetonka, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
4C Medical Technologies, Inc. |
Maple Grove |
MN |
US |
|
|
Family ID: |
1000004838403 |
Appl. No.: |
16/877053 |
Filed: |
May 18, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15874376 |
Jan 18, 2018 |
10653523 |
|
|
16877053 |
|
|
|
|
62448036 |
Jan 19, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/2439 20130101;
A61F 2/2436 20130101; A61F 2/2418 20130101; A61F 2/243
20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. A method of delivering a self-expanding prosthetic mitral valve
device comprising prosthetic mitral valve leaflets to an
implantation site within a left atrium of a patient's heart,
comprising: accessing the left atrium with a delivery catheter
having a proximal end, a distal end and a lumen therethrough,
wherein the delivery catheter comprises a curved distal portion
adapted to facilitate positioning of the self-expanding prosthetic
mitral valve device within the left atrium; loading the
self-expanding prosthetic mitral valve device in a collapsed
configuration into the lumen of the delivery catheter at the
proximal end thereof, wherein the collapsed configuration of the
prosthetic mitral valve device comprises a prosthetic mitral valve
attached thereto; delivering the collapsed prosthetic valve out of
the distal end of the delivery catheter and into the left atrium at
a location proximate the implantation site; and allowing the
delivered self-expanding prosthetic mitral valve device to expand
within the left atrium at the implantation site, wherein at least a
portion of the expanded device engages at least a portion of the
upper annular surface within the left atrium.
2. The method of claim 1, further comprising: providing a pull wire
that is attached to the distal end of the delivery catheter and
extends proximally out of the proximal end of the delivery
catheter, wherein the curved distal portion of the delivery
catheter is adapted to be curved by pulling the pull wire
proximally during at least the delivery of the prosthetic mitral
valve device; and pulling the pull wire proximally during at least
the delivery of the prosthetic mitral valve device to curve the
distal portion of the delivery catheter.
3. The method of claim 2, further comprising providing a weakened
section around at least a portion of the distal portion of the
delivery catheter and proximate to the attachment of the pull wire
to the distal end of the delivery catheter.
4. The method of claim 3, wherein the weakened section comprises a
series of cuts or serrations that extend partially through the
catheter wall of the distal portion of the delivery catheter.
5. The method of claim 3, wherein the weakened section comprises a
series of cuts or serrations that extend fully through the catheter
wall of the distal portion of the delivery catheter.
6. The method of claim 1, wherein the curved distal portion of the
delivery catheter is pre-curved.
7. The method of claim 1, further comprising: providing a plug
attached to a side of the distal portion of the collapsed
self-expanding prosthetic mitral valve device; aligning the plug
with the left atrial appendage; and engaging the left atrial
appendage with the plug when the self-expanding mitral valve device
is expanded.
8. The method of claim 7, wherein the plug further comprises a
flange that engages and seals the atrial wall around the left
atrial appendage.
9. The method of claim 1, further comprising: providing a push rod
that is connected to the collapsed prosthetic mitral valve device;
and pushing the collapsed prosthetic mitral valve device with the
push rod through the lumen of the delivery catheter for delivery
and expansion within the left atrium.
10. The method of claim 9, further comprising at least partially
collapsing the expanded prosthetic mitral valve within the lumen of
the delivery catheter by pulling proximally on the push rod.
11. The method of claim 9, further comprising: translating a
locating element through the lumen of the catheter; engaging an
open frame portion of the prosthetic mitral valve device with the
locating element; and engaging the lumen of the left upper
pulmonary vein with a distal end of the locating element before
delivering the prosthetic mitral valve device into the left
atrium.
12. The method of claim 11, wherein the locating element extends
through an open frame section of the prosthetic mitral valve
device.
13. The method of claim 1, wherein the collapsed self-expanding
prosthetic mitral valve device further comprises: a proximal
portion; a distal portion, wherein the prosthetic mitral valve
leaflets are disposed within the distal portion; and a central
portion disposed between the proximal portion and the distal
portion, the central portion having a maximum diameter that is
smaller than a maximum diameter of the proximal portion and a
maximum diameter of the distal portion.
14. The method of claim 13, further comprising: providing a hinge
on the central portion; delivering the central portion out of the
distal end of the delivery catheter lumen to expose the hinge to
the left atrium; and rotating the distal portion toward the upper
annular surface of the left atrium; and delivering the proximal
portion out of the distal end of the delivery catheter lumen and
into the left atrium.
15. The method of claim 1, wherein the collapsed self-expanding
prosthetic mitral valve device further comprises a proximal portion
and a distal portion, wherein the prosthetic mitral valve leaflets
are disposed within the distal portion, the method further
comprising; loading an inner sheath into the catheter lumen, the
inner sheath having a distal end that engages the collapsed
self-expanding prosthetic mitral valve, wherein translation of the
inner sheath through the catheter lumen results in translation of
the collapsed self-expanding stented valve through the catheter
lumen; and wherein the inner sheath comprises a lumen therethrough
sized to receive the proximal portion of the collapsed
self-expanding prosthetic mitral valve device.
16. The method of claim 14, wherein the distal end of the inner
sheath engages the distal portion of the collapsed self-expanding
prosthetic mitral valve device, wherein the distal portion is not
received within the lumen of the inner sheath.
17. The method of claim 14, wherein the distal portion is
delivered, positioned proximate the implantation site and expanded
before the proximal portion of the collapsed self-expanding
prosthetic mitral valve device is delivered and expanded.
18. The method of claim 1, further comprising: translating an
alignment wire disposed through the lumen of the delivery catheter;
engaging an open frame portion of the prosthetic mitral valve
device with the alignment wire; and engaging the left upper
pulmonary vein with the alignment wire before delivering the
prosthetic mitral valve device into the left atrium along the
alignment wire.
19. The method of claim 1, further comprising at least one capture
wire extending through the delivery catheter lumen and engaging the
self-expanding prosthetic mitral valve device adapted to restrain
the expansion of the device to a partially expanded
configuration.
20. The method of claim 19, further comprising the at least one
capture wire further adapted to positionally orient the partially
expanded device by manipulating the at least one capture wire at
the proximal end of the delivery catheter.
21. The method of claim 20, further comprising: positionally
orienting the partially expanded device within the left atrium;
confirming proper orientation of the partially expanded device;
removing the at least one capture wire; and allowing the partially
expanded device to fully expand.
22. The method of claim 21, further comprising providing a
push/pull rod through the lumen of the delivery catheter adapted to
assist in positionally orienting the partially expanded device.
23. The method of claim 1, further comprising a lasso element
attached to the prosthetic mitral valve device adapted to be
manipulated at the proximal end of the delivery catheter;
manipulating the lasso element to positionally orient, prevent full
expansion of the prosthetic mitral device and/or allow full
expansion of the prosthetic mitral valve device within the left
atrium.
24. The method of claim 1, wherein the self-expanding prosthetic
mitral valve device further comprises an upper portion formed from
a stent comprising at least two sets of opposing subsections, at
least one set of the opposing subsections comprising a fabric
covering.
25. The method of claim 24, further comprising using the fabric
covering to capture blood flow to position the self-expanding
prosthetic mitral valve device and expanding the positioned
self-expanding prosthetic mitral valve device.
26. The method of claim 1, further comprising ensuring that the
left ventricle is not touched at any point by the expanded
prosthetic mitral valve device.
27. The method of claim 1, further comprising ensuring that the
native mitral valve leaflets are not touched at any point by the
expanded prosthetic mitral valve device.
28. The method of claim 1, wherein the left atrium is accessed
through the septum between the right and left atria.
29. The method of claim 1, further comprising: translating an
alignment wire through the lumen of the catheter and engaging an
open frame portion of the prosthetic mitral valve device; and
engaging the lumen of the left upper pulmonary vein with a distal
end of the alignment wire before delivering the prosthetic mitral
valve device into the left atrium along the alignment wire.
30. The method of claim 1, further comprising an alignment guide
wire disposed through the lumen of the catheter and engaging the
left atrial appendage.
31. A system suitable for use in a method of delivering a
self-expanding prosthetic mitral valve device to an implantation
site within a left atrium of a patient's heart, the system
comprising: the self-expanding prosthetic mitral valve device,
comprising prosthetic mitral valve leaflets; and a delivery
catheter having a proximal end, a distal end and a lumen
therethrough, wherein the delivery catheter comprises a curved
distal portion adapted to facilitate positioning of the
self-expanding prosthetic mitral valve device within the left
atrium, wherein the method comprises: accessing the left atrium
with the delivery catheter; loading the self-expanding prosthetic
mitral valve device in a collapsed configuration into the lumen of
the delivery catheter at the proximal end thereof, wherein the
collapsed configuration of the prosthetic mitral valve device
comprises a prosthetic mitral valve attached thereto; delivering
the collapsed prosthetic valve out of the distal end of the
delivery catheter and into the left atrium at a location proximate
the implantation site; and allowing the delivered self-expanding
prosthetic mitral valve device to expand within the left atrium at
the implantation site, wherein at least a portion of the expanded
device engages at least a portion of the upper annular surface
within the left atrium.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/874,376, filed Jan. 18, 2018 and entitled
SYSTEMS, METHODS AND DEVICES FOR DELIVERY SYSTEMS, METHODS AND
DEVICES FOR IMPLANTING PROSTHETIC HEART VALVES and also claims the
benefit of U.S. Provisional Ser. No. 62/448,036, filed Jan. 19,
2017 and entitled SYSTEMS, METHODS AND DEVICES FOR DELIVERY
SYSTEMS, METHODS AND DEVICES FOR IMPLANTING PROSTHETIC HEART
VALVES, the entirety of which is hereby incorporated by
reference.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] Not Applicable
INCORPORATION BY REFERENCE
[0003] All references, including but not limited to publications,
patent applications and patents mentioned in this specification are
hereby incorporated by reference to the same extent and with the
same effect as if each reference was specifically and individually
indicated to be incorporated by reference.
FIELD OF THE INVENTION
[0004] The inventions described herein relate to delivery systems,
devices and methods for delivering and/or positioning a cardiac
valve.
BACKGROUND OF THE INVENTION
[0005] The human heart comprises four chambers and four heart
valves that assist in the forward (antegrade) flow of blood through
the heart. The chambers include the left atrium, left ventricle,
right atrium and left ventricle. The four heart valves include the
mitral valve, the tricuspid valve, the aortic valve and the
pulmonary valve.
[0006] The mitral valve is located between the left atrium and left
ventricle and helps control the flow of blood from the left atrium
to the left ventricle by acting as a one-way valve to prevent
backflow into the left atrium. Similarly, the tricuspid valve is
located between the right atrium and the right ventricle, while the
aortic valve and the pulmonary valve are semilunar valves located
in arteries flowing blood away from the heart. The valves are all
one-way valves, with leaflets that open to allow forward
(antegrade) blood flow. The normally functioning valve leaflets
close under the pressure exerted by reverse blood to prevent
backflow (retrograde) of the blood into the chamber it just flowed
out of.
[0007] Native heart valves may be, or become, dysfunctional for a
variety of reasons and/or conditions including but not limited to
disease, trauma, congenital malformations, and aging. These types
of conditions may cause the valve structure to either fail to
properly open (stenotic failure) and/or fail to close properly
(regurgitant).
[0008] Mitral valve regurgitation is a specific problem resulting
from a dysfunctional mitral valve. Mitral regurgitation results
from the mitral valve allowing at least some retrograde blood flow
back into the left atrium from the right atrium. This backflow of
blood places a burden on the left ventricle with a volume load that
may lead to a series of left ventricular compensatory adaptations
and adjustments, including remodeling of the ventricular chamber
size and shape, that vary considerably during the prolonged
clinical course of mitral regurgitation.
[0009] Native heart valves generally, e.g., mitral valves,
therefore, may require functional repair and/or assistance,
including a partial or complete replacement. Such intervention may
take several forms including open heart surgery and open heart
implantation of a replacement heart valve. See e.g., U.S. Pat. No.
4,106,129 (Carpentier), for a procedure that is highly invasive,
fraught with patient risks, and requiring not only an extended
hospitalization but also a highly painful recovery period.
[0010] Less invasive methods and devices for replacing a
dysfunctional heart valve are also known and involve percutaneous
access and catheter-facilitated delivery of the replacement valve.
Most of these solutions involve a replacement heart valve attached
to a structural support such as a stent, commonly known in the art,
or other form of wire network designed to expand upon release from
a delivery catheter. See, e.g., U.S. Pat. No. 3,657,744 (Ersek);
U.S. Pat. No. 5,411,552 (Andersen). The self-expansion variants of
the supporting stent assist in positioning the valve, and holding
the expanded device in position, within the subject heart chamber
or vessel. This self-expanded form also presents problems when, as
is often the case, the device is not properly positioned in the
first positioning attempt and, therefore, must be recaptured and
positionally adjusted. This recapturing process in the case of a
fully, or even partially, expanded device requires re-collapsing
the device to a point that allows the operator to retract the
collapsed device back into a delivery sheath or catheter, adjust
the inbound position for the device and then re-expand to the
proper position by redeploying the positionally adjusted device
distally out of the delivery sheath or catheter. Collapsing the
already expanded device is difficult because the expanded stent or
wire network is generally designed to achieve the expanded state
which also resists contractive or collapsing forces.
[0011] Besides the open heart surgical approach discussed above,
gaining access to the valve of interest is achieved percutaneously
via one of at least the following known access routes: transapical;
transfemoral; transatrial; and transseptal delivery techniques.
[0012] Generally, the art is focused on systems and methods that,
using one of the above-described known access routes, allow a
partial delivery of the collapsed valve device, wherein one end of
the device is released from a delivery sheath or catheter and
expanded for an initial positioning followed by full release and
expansion when proper positioning is achieved. See, e.g., U.S. Pat.
No. 8,852,271 (Murray, III); U.S. Pat. No. 8,747,459 (Nguyen); U.S.
Pat. No. 8,814,931 (Wang); U.S. Pat. No. 9,402,720 (Richter); U.S.
Pat. No. 8,986,372 (Murray, III); and U.S. Pat. No. 9,277,991
(Salahieh); and U.S. Pat. Pub. Nos. 2015/0272731 (Racchini); and
2016/0235531 (Ciobanu).
[0013] However, known delivery systems, devices and methods still
suffer from significant flaws in delivery methodology including,
inter alia, positioning and recapture capability and
efficiency.
[0014] In addition, known "replacement" heart valves are intended
for full replacement of the native heart valve. Therefore, these
replacement heart valves physically engage the annular throat
and/or valve leaflets, thereby eliminating all remaining
functionality of the native valve and making the patient completely
reliant on the replacement valve. Generally speaking, it is a
preferred solution that maintains and/or retains the native
function of a heart valve, thus supplementation of the valve is
preferred rather than full replacement. Obviously, there will be
cases when native valve has either lost virtually complete
functionality before the interventional implantation procedure, or
the native valve continues to lose functionality after the
implantation procedure. The preferred solution is delivery and
implantation of a valve device that will function both as a
supplementary functional valve as well as be fully capable of
replacing the native function of a valve that has lost most or all
of its functionality. However, the inventive solutions described
infra will apply generally to all types and forms of heart valve
devices, unless otherwise specified.
[0015] Finally, known solutions for, e.g., the mitral valve
replacement systems, devices and methods require 2-chamber
solutions, i.e., there is involvement and engagement of the
implanted replacement valve device in the left atrium and the left
ventricle. Generally, these solutions include a radially expanding
stent in the left atrium, with anchoring or tethering (disposed
downward through the annular through) connected from the stent
device down through the annular throat, with the sub-annular
surface within the left ventricle, the left ventricular chordae
tendineae and even into the left ventricle wall surface(s).
[0016] Such 2-chamber solutions are unnecessary bulky and therefore
more difficult to deliver and to position/recapture/reposition from
a strictly structural perspective. Further, the 2-chamber solutions
present difficulties in terms of making the ventricular anchoring
and/or tethering connections required to hold position. Moreover,
these solutions interfere with the native valve functionality as
described above because the device portions that are disposed
within the left ventricle must be routed through the annulus,
annular throat and native mitral valve, thereby disrupting any
remaining coaptation capability of the native leaflets. In
addition, the 2-chamber solutions generally require an invasive
anchoring of some of the native tissue, resulting in unnecessary
trauma and potential complication.
[0017] It will be further recognized that the 2-chamber mitral
valve solutions require sub-annular and/or ventricular engagement
with anchors, tethers and the like precisely because the atrial
portion of the device fails to adequately anchor itself to the
atrial chamber and/or upper portion of the annulus. Again, the
inventive solutions described herein are readily applicable to
single or 2-chamber solutions, unless otherwise indicated.
[0018] Various embodiments of the several inventions disclosed
herein address these, inter alia, issues.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0019] FIG. 1 illustrates a side cutaway view of one embodiment of
the present invention.
[0020] FIG. 2A illustrates a side view of one embodiment of the
present invention.
[0021] FIG. 2B illustrates a side cutaway view of one embodiment of
the present invention.
[0022] FIG. 3A illustrates a side cutaway view of one embodiment of
the present invention.
[0023] FIG. 3B illustrates a side cutaway view of one embodiment of
the present invention.
[0024] FIG. 4 illustrates a side cutaway view of one embodiment of
the present invention.
[0025] FIG. 5A illustrates a side cutaway view of one embodiment of
the present invention.
[0026] FIG. 5B illustrates a side cutaway view of one embodiment of
the present invention.
[0027] FIG. 6A illustrates a side cutaway view of one embodiment of
the present invention.
[0028] FIG. 6B illustrates a side cutaway view of one embodiment of
the present invention.
[0029] FIG. 6C illustrates a side cutaway view of one embodiment of
the present invention.
[0030] FIG. 7A illustrates a side cutaway view of one embodiment of
the present invention.
[0031] FIG. 7B illustrates a side cutaway view of one embodiment of
the present invention.
[0032] FIG. 8A illustrates a top view of one embodiment of the
present invention.
[0033] FIG. 8B illustrates a side and partially exploded view of
one embodiment of the present invention.
[0034] FIG. 9A illustrates a side cutaway view of one embodiment of
the present invention.
[0035] FIG. 9B illustrates a side cutaway view of one embodiment of
the present invention.
[0036] FIG. 9C illustrates a side cutaway view of one embodiment of
the present invention.
[0037] FIG. 9D illustrates a side cutaway view of one embodiment of
the present invention.
[0038] FIG. 10A illustrates a side cutaway view of one embodiment
of the present invention.
[0039] FIG. 10B illustrates a side cutaway view of one embodiment
of the present invention.
[0040] FIG. 10C illustrates a side cutaway view of one embodiment
of the present invention.
[0041] FIG. 11 illustrates a side cutaway view of one embodiment of
the present invention.
[0042] FIG. 12 illustrates a side view of one embodiment of the
present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0043] Various embodiments of the present invention are disclosed
in the Figures for providing percutaneous access to the valve of
interest via one of at least the following known access routes:
transapical; transfemoral; transatrial; and transseptal delivery
techniques. Each of these access routes may be used for the
embodiments disclosed herein.
[0044] Thus, FIG. 1 illustrates one embodiment of a prosthetic
valve device 100 with a 2-part frame in collapsed configuration.
The distal portion 102 of the collapsed device comprises the valve
with prosthetic leaflets with a portion of the supporting frame,
and is longitudinally translatably and rotatably confined within
the lumen of an outer sheath 104 having a first outer diameter D.
The proximal portion 106 of the collapsed device 100 comprises the
remaining supporting frame which is in operative connection with
the distal portion 102 of collapsed device 100 and in
longitudinally translatably and rotatably confined within the lumen
of an inner sheath 108 that is at least longitudinally translatable
relative to the outer sheath 104 and wherein the outer sheath 104
is at least longitudinally translatable relative to the inner
sheath 108. The inner and/or outer sheath 108, 104 may also be
rotationally translatable relative to the other sheath. The inner
sheath 108 is disposed within the lumen of the outer sheath 104
and, therefore, the inner sheath 108 comprises a second outer
diameter D' that is smaller than the outer sheath's outer diameter
D.
[0045] The preferred configuration of the device of FIG. 1
comprises the collapsed device 100 consisting of one unit with a
proximal and distal portion 106,102 as shown. The outer sheath 104
may be retracted to release expose firstly the distal portion 102
from the distal end 110 of the outer sheath 104 for initial
expansion and positioning in the subject chamber of the heart.
Alternatively, the distal portion 102 of the device 100 may be
pushed distally to be released from the distal end 110 of the outer
sheath 104 in response to distal translation of the inner sheath
108, e.g., or to a push rod pushing against the proximal portion
106 of the device 100. In the case of a push rod, the proximal
portion 106 will eventually be pushed distally out of the smaller
lumen of the inner sheath 106 and into the larger lumen of the
outer sheath 104 where an interim secondary expansion of the
proximal portion 106 occurs, followed by the secondary positioning
expansion when the proximal portion 106 is eventually released from
the distal end 110 of the outer sheath 104.
[0046] If expanded within the left atrium in connection with a
prosthetic mitral valve, the lower portion of the distal portion
102 may be positioned against the upper surface of the annulus
within the left atrium.
[0047] In this configuration, if the distal portion 102 is properly
positioned and released/expanded, then the secondary release and
expansion of the proximal portion 106 of the device 100 may be
initiated and achieved according to the alternative methods
described above in connection with the initial release and
expansion of the distal portion 102. The skilled artisan will
recognize that once the initial positioning expansion of the distal
portion 102 is accomplished, then the secondary positioning
expansion of the proximal portion 106 will also be properly located
and positioned.
[0048] The configuration of FIG. 1, in its various embodiments,
enables delivery of a device 100 comprising a frame that may be
slightly oversized for the chamber, e.g., atrial, dimensions
through the two-step frame positioning expansion method. Some
frames in collapsed form may be as much as 2x in longitudinal
length than any chamber, e.g., atrial, dimension. Thus, the staged
positioning expansion method is necessary for delivery.
[0049] Turning now to FIGS. 2A and 2B a prosthetic valve device 200
comprising a supporting stent frame, with prosthetic valve attached
and/or supported therein, is provided wherein the design comprises
two portions (distal 202 and proximal 206, wherein the prosthetic
valve with leaflets 205 is held/supported within the distal portion
202) with expanded diameters that are connected by a central
portion 203 that has a smaller diameter than the expanded diameters
of the two portions 202, 206. As illustrated, the two portions 202,
206 comprise an undeformed and fully expanded spherical shape,
though other shapes may be used as the skilled artisan will readily
understand. Certain embodiments may comprise at least one of the
proximal and distal portions 206, 202 having an expanded sizing
that is slightly larger than the subject chamber's dimensions,
e.g., the left atrial dimensions to allow expansion anchoring.
Moreover, the aspect ratio of each of the two portions 206, 202 may
vary.
[0050] As shown, the collapsed stent with valve is held within the
lumen of a delivery sheath 204, with a distal portion that holds or
supports the device 200 therein being released from the end 210 of
the delivery sheath 204 with subsequent positioning expansion of
same within the subject chamber, e.g., the left atrium. When proper
positioning is confirmed, the remaining central portion 203 (if not
previously released along with the distal portion 202) and/or the
proximal portion 206 may then be released and positionally expanded
by methods described in connection with FIG. 1, including use of an
inner sheath as described above and/or a push rod to translate the
device 200 out of the distal end 210 of the outer delivery sheath
204. As with FIG. 1, this embodiment comprises a two-step or staged
delivery mechanism. Both FIG. 1 and FIG. 2A/2B sets of embodiments
may comprise a coating or covering on the distal portion 202 while
the proximal portion 206 may comprise an open frame formed from,
e.g., stent cells. In the case of FIG. 2A/2B, the central portion
202 may also comprise and open cell construction and uncovered. The
dashed lines of FIG. 2B show an alternate embodiment wherein the
expanded delivered portion 202 comprises a hinge point 212 to
assist in orienting the prosthetic valve and leaflets within distal
portion 202 downward toward the native valve.
[0051] FIGS. 3A, 3B, 3C, 5A and 5B provide further disclosure of
exemplary prosthetic valve devices with support means, e.g.,
stented and associated exemplary delivery methods. Thus FIG. 3A
shows the collapsed device 300 in the lumen of a delivery sheath
304 in operative communication with a push/pull rod 308 actuated by
the device operator that is capable of distally translating the
collapsed device 300 as in FIG. 3A out of the distal end 310 of the
delivery sheath 304 for positioning expansion and, conversely,
pulling the expanded device 300 as shown in FIG. 3B back into the
distal end 310 of the delivery sheath 304 if necessary. The
push/pull rod 308 may also allow in certain embodiments the
rotation of the collapsed device 300 within the lumen of the
delivery sheath 310 to aid in positioning prior to release and
expansion. Further, the operative communication of the push/pull
rod 308 with the collapsed device 300 may comprise a screw or clip
release mechanism 311 connected with the most proximal portion of
the collapsed device 300. The base or lower portion of the device
300 may be covered with tissue or other biocompatible material
while the upper portion of the device may comprise an open cell
construction.
[0052] Generally, the collapsed device 300 is loaded and positioned
within the delivery sheath 304 with the valve portion 305 oriented
in a downward position as shown. This allows the collapsed valve
device 305 to be pushed out of the delivery sheath 304 in a
sideways orientation as illustrated and enables the expanding valve
device 300 upon release from the delivery sheath to be properly
oriented to the native valve and subject chamber, e.g., mitral
valve and left atrium.
[0053] In certain cases, an alignment wire 315 may be translated
from the delivery sheath 304 into a pulmonary vein, e.g., the left
upper pulmonary vein PV to assist in positioning and delivery of
the device 300.
[0054] FIG. 4 illustrates a sideways delivery of device 300 during
expansion and just after delivery from the outer end 310 of the
delivery sheath 304, wherein the delivered device is oriented
substantially vertically and aligned for positioning over the
native valve.
[0055] Thus, as shown best in FIGS. 5A and 5B, the prosthetic valve
device 500 may be delivered sideways (with the valve portion 505
oriented on the bottom as shown), asymmetrically and may comprise a
locating element 515 in operative connection with the prosthetic
valve device 500 and that extends from the delivery sheath 503 with
at least a distal end of the locating element 515 or push tube
disposed within a pulmonary vein PV, e.g., the left upper pulmonary
vein as shown. This system provides a self-centering system that
may expand upon releasing/translating the collapsed prosthetic
valve device 500 from the distal end 510 of the delivery sheath
504. As shown a push tube 508 and associated connector 511 may be
used to assist in manipulating the orientation of the prosthetic
valve device 500 once it is delivered from the distal end 510 of
the delivery sheath 504.
[0056] Turning now to FIGS. 6A-6C, a the prosthetic valve device
600 is delivered using a delivery catheter or sheath 604 comprises
either a pre-curved distal portion 620 or a distal portion adapted
to be able to be curved 620 to present a substantially straight
distal section within the atrium. FIG. 6A provides a pre-curved
embodiment, curved to enable loading of a prosthetic valve device
600 in a configuration that places the valved bottom portion 605 in
the proper location on release from the distal end 610 of the
pre-curved distal portion 620 of the delivery catheter or sheath,
more specifically from the straightened distal section distal to
the pre-curved distal portion 620. Thus, as shown, the valve
supported portion 605 of the collapsed and expandable frame/stent
is distal-most within the lumen of the delivery catheter/sheath
604. The pre-curved portion 620 enables easy orienting of the
valved portion 605 with an exemplary mitral valve and/or upper
surface of the annulus thereof.
[0057] Thus, the delivery system with a curved distal portion as in
FIG. 6A enables the prosthetic valve device 600 to be positioned
over the annulus and native valve leaflets. When positioned over
the annulus and native valve leaflets, the curved delivery catheter
or sheath 604 may be withdrawn proximally, alone or in combination
with a push rod 608 or similar device on the proximal side of the
prosthetic valve device 600, to release and deliver the prosthetic
valve device 600 into the left atrium and expand the delivered
device 600. It is noteworthy that the curved delivery catheter or
sheath 604 comprises in some embodiments a straight distal end
within the left atrium and located distal to the curved section 620
wherein the compressed prosthetic valve device 600 is translated
and manipulated around the curved portion 620 of the curved
delivery catheter or sheath 604. The compressed prosthetic valve
device 600 may be assisted in translating around the curved portion
620 of the curved delivery catheter or sheath by including a suture
attachment to the distal end of the implant, a pull wire attached
to the distal end of the implant extending to the proximal end of
the delivery catheter or sheath, or by taking advantage of the
natural flexion point in the arrangement of FIG. 1 between the
proximal and the distal portions of the prosthetic valve device
and/or by a hinging point as in FIG. 2.
[0058] FIGS. 6B and 6C comprise an alternative approach to creating
the curved portion 620 by enabling curving of the distal portion of
the delivery sheath or catheter 604 by providing a series of cuts
or serrations 609 along a bottom portion surface of the sheath or
catheter, resulting in a weak region susceptible to bending. As
shown a pull wire 625 is attached to the distal end 610 of the
catheter 604 along this bottom weak cut or serrated region and is
disposed through the catheter/sheath lumen to an operator who may
pull the wire with force F proximally to achieve the desired
curvature prior to release of the collapsed prosthetic valve
structure 600 which is oriented in collapsed form as in FIG. 6A and
released for positioning expansion virtually directly on the
subject valve or upper annular surface. The cuts 609 may extend
through the catheter/sheath wall completely or may only be sections
that have a catheter/sheath wall that is thinner than the rest of
the catheter/sheath walls. The cuts 609 shown are uniform and
generally square, though any depth, shape and uniform or
non-uniform spacing of same may be used to achieve the weakened
region.
[0059] FIGS. 7A and 7B illustrate delivery systems for an exemplary
prosthetic valve, e.g., mitral valve replacement or supplement, to
a heart chamber, e.g., the left atrium using a delivery catheter or
sheath 704 as shown in FIG. 7A with transseptal access and in
combination with an additional guidance tool 728 used to help guide
the expanding valved device (not shown) as it is released from the
distal end 710 of the catheter or sheath 704 using methods or
devices described herein. The additional guidance tool 728 may be
disposed within the upper pulmonary vein PV, for example. The
guidance tool 728 may be hingedly or rotatingly attached to the
catheter or sheath 704 enabling the tool 728 to rotate into
position. A pull wire similar to that shown in FIGS. 6B and 6C may
be used to connect to and manipulate the tool 728 into
position.
[0060] FIG. 7B illustrates two delivery systems, a first delivery
system 800 for alignment and deployment and a second delivery
system 850 for recapture and repositioning if needed. One of the
delivery systems, either the first 800 or the second 850, may
access the subject heart chamber via a transfemoral access method
while the other delivery system may access the subject heart
chamber via another transvenous access method. The first delivery
system 800 may thus comprise a delivery catheter or sheath 804 as
described elsewhere herein while the second delivery system may
comprise a recapture and repositioning catheter or sheath 854,
similar in structure to the delivery catheter/sheath 804.
[0061] FIGS. 8A and 8B illustrate embodiments designed to
facilitate accurate positioning of a prosthetic heart valve within
a chamber, e.g., the left atrium, including but not limited to
self-centering and fluoroscopy techniques. In this embodiment of a
prosthetic stented valve device 900, with the prosthetic valve and
leaflets 905 supported proximate the bottom portion of the valve
device, the upper portion 909 of the device 900 may be divided into
subsections as shown from the top in FIG. 8A. The illustrated case
provides 4 subsections, though other numbers of subsections may
certainly be useful and are within the scope of the present
invention. As shown, opposing subsections are either open cell or
open wire construction 907 or are comprised of a fabric in the form
of a type of sail 908. Upon delivery of this device 900 to a
subject heart chamber, the fabric sails 908 will catch and use the
natural force of blood flow to maneuver the device frame 900 into
proper positioning with subsequent release and expansion when
positioning is confirmed.
[0062] FIG. 8B is a related concept, but also includes an annulus
spacer 919 that may be delivered first via a delivery
catheter/sheath as described previously herein and in certain
embodiments, the spacer may be directed into position with a
guidewire positioned within the lumen of the delivery
catheter/sheath and further moved out of the distal end of the
delivery catheter/sheath and either proximate to (on the proximal
side) of the chamber upper annular surface or may be disposed at
least partway within the annular throat. Once released from the
lumen and distal end of the delivery catheter/sheath, the annular
spacer 919 may expand from a delivered collapsed form and
positioned on the upper annular surface which may space the
prosthetic valve and leaflets 905 from the upper annular surface.
Subsequently, the prosthetic valve device, as described herein and
which may, or may not, comprise sails 908 as in FIG. 7A, is
delivered from the delivery catheter/sheath and positionally
expanded to connect with the previously positioned spacer 919.
[0063] We next describe positional orienting delivery structures in
FIGS. 9A-9D. Generally, each of these prosthetic valved devices are
designed for use in the left atrium and make use of the left atrial
appendage (LAA) as an orienting mechanism. FIG. 9A therefore
comprises an LAA plug 1006 disposed on a side surface of the
collapsed device 100 within the delivery sheath 1004 lumen and, in
FIG. 9B, the LAA plug 1006 is positioned at least partially within
the LAA. Once the LAA is engaged by the LAA plug 1006, the operator
has confirmation that the valved prosthetic device 1000 is in
correct position. This device may be used in combination with any
of the previously described devices and methods, including but not
limited to the staged 2-step delivery devices and methods, whereby
an initial positioning expansion would result in orienting the LAA
plug into the LAA, then the secondary positioning expansion of the
rest of the device initiated by release from the distal end of a
delivery sheath.
[0064] An additional benefit of certain embodiments of FIGS. 9A and
9B may be to employ the LAA plug 1006 as a device to prevent
clotting within the LAA, wherein the LAA plug 1006 fills the LAA
entirely and/or an outer flange 1008 covers the LAA opening
entirely to prevent any blood clots from forming and/or moving out
of the heart to potentially cause a stroke.
[0065] FIG. 9D shows a slightly different mechanism whereby a
guidewire 1020 is disposed through a delivery sheath 1004 and into
the LAA to provide orienting guidance for the positioning expansion
(1 step or staged) of the collapsed prosthetic valved device (not
shown) within the lumen of delivery sheath 1004. The sheath 1004
may be pulled back to deploy/release the valved device (not shown)
from the distal end of the sheath 1004 for positioning expansion or
a push rod may be used to push the valved device out of the
sheath's distal end as previously described. In these cases, the
guidewire 1020 positioned within the LAA provides a key orienting
guidance parameter so that the operator knows positioning will be
proper on expansion. The guidewire 1020 may comprise an atraumatic
tip to prevent damaging the tissue of the LAA.
[0066] FIG. 9C illustrates another alignment/orienting system
wherein the delivery catheter/sheath 1004 is introduced via a
pulmonary vein PV, e.g., the upper pulmonary vein, into the left
atrium and a guidewire 1020 disposed through the lumen of the
delivery catheter/sheath 1004 and into, or proximate, the annulus,
i.e., the annular throat, as a guide for the to-be-delivered valved
device (not shown but compressed and self-expanding as previously
described). When the sheath 1004 is pulled back, or a push rod is
used to push the collapsed valved device out of the distal end of
the delivery catheter or sheath 1004, the expanding valved device
may slide down over the pre-positioned guidewire 1020 to a proper
position when fully expanded.
[0067] FIG. 10A illustrates a partially expanded stented valved
device 1100 released from the delivery catheter sheath. At least
one capture wire 1030 (shown radially wrapped around the device
1100, but may take other wrapping positions) is shown and which
restrains the expandable device 1100 from fully expanding until
properly positioned within the subject heart chamber, e.g., the
left atrium. When proper position is confirmed, the capture wire
1030 may be removed by cutting and withdrawal distally through the
delivery sheath 1004 lumen or by disconnecting a connector pin or
latch 1032 or equivalent to enable full expansion of the device
1100 at the proper positional location. FIG. 10B is similar with an
alignment wire 1130 that assists in positional orientation as it
feeds out of the distal end of the delivery catheter/sheath 1104
while in connection with the partially expanding sheath at 2 or 3
or more stabilization points 1034 until proper position is
confirmed. The stabilization point 1134 connections may hold the
partially expanded device in that state until proper position is
confirmed, then the connections may be removed, either by cutting
(as in the case of a releasable suture) or by disconnecting a
connector pin or latch, to enable the full expansion at the proper
positional location or by provision of a secondary over the wire
cutter introduced via the delivery catheter/sheath 1104 to clip
alignment wire 1130.
[0068] FIG. 10C provides an alternative prosthetic heart valve
device shown in a positionally expanded position after release from
the distal end of the delivery catheter/sheath 1104 and comprising
at least one attachment point 1032 located within the stented heart
valve device as well as two or more pull/push wires 1130 with a
first end connected to the at least one attachment point 1032 and a
second end attached to points 1033 around the stent frame. This
arrangement may function in several different ways to facilitate
recapture, repositioning and/or redeployment.
[0069] First, one embodiment may comprise the two or more pull/push
wires 1130 of a length that is slightly smaller than the chamber,
e.g., left atriam, dimensions to ensure proper positioning. Once
position is confirmed as proper, the pull/push wires 1130 may be
released by, e.g., a secondary over the wire cutter or other means
to disengage the pull/push wire connection between the at least one
attachment point 1032 and the two or more pull/push wires 1130,
thereby enabling the full expansion of the properly positioned
frame within the chamber. As with other embodiments described
herein, the fully expanded frame may be slightly larger than at
least one dimension to facilitate anchoring.
[0070] Another embodiment may further comprise a push rod disposed
translationally within the delivery catheter/sheath 1104 lumen and
that also provides a distally extending releasable connector
attached to the at least one attachment point 1032 within the
stented heart valve frame for disengaging the attachment between
the at least one attachment point 1032 and the two or more
push/pull wires 1130 once proper positioning is confirmed. This
embodiment provides the further benefit of using a distally
extending releasable connector tool to pull proximally on the at
least one attachment point wherein the attachment point and the
push/pull wires are connected to points on the stent frame that,
when proximal force is applied to the attachment point, cause the
stent frame to collapse slightly or fully, to enable repositioning.
Once repositioned, distal force is applied to the releasable
connector tool to fully expand the prosthetic valve frame.
[0071] Yet another embodiment may comprise the attachment point
1132, push/pull wires 1130, and/or the connection of the push/pull
wires to the stent frame to be formed of a material that dissolves
over a short time period.
[0072] FIG. 11 illustrates a prosthetic valve device 1200
comprising a ball and socket relationship between the support frame
(socket or partial socket), with the prosthetic valve and leaflets
1253 disposed therein (ball or partial ball). In this embodiment,
the outer frame 1250 is, as illustrated, a partial sphere having a
radiusing and a central point 1252, with the central point 1252
disposed generally around the native valve and annulus. The outer
frame 1250 may comprise a radially extending flange 1254 to connect
and seal with the upper annular surface and may further comprise
wall elements 1256 extending upward from at least portions of the
radially extending flange 1252 to connect with and seal against the
chamber, e.g., left atrial, walls. The radially extending flange
1252 may comprise an expandable stent-like construction to provide
radial expansive force to assist in anchoring the device 1200.
Alternative constructions may comprise any of the prosthetic
stented valve frames described herein, e.g. and without limitation,
an upper open expandable frame with a lower expandable frame
covered with tissue.
[0073] The prosthetic valve further comprises an inner partial
sphere 1253 with a radiusing that matches, or is complementary
with, the radiusing of the outer frame's partial sphere 1250, but
with a smaller radius that the outer frame 1250 as the inner
partial sphere 1253 resides within the outer frame's partial sphere
1250. The prosthetic leaflets are supported within the inner
partial sphere 1253. The inner partial sphere 1253 may comprise a
friction fit with the outer frame's partial sphere 1250 so that
some movement is possible in all dimensions, including rotational,
without losing the proper valve position relative to the native
valve and/or annulus. Alternatives may allow a looser friction fit
so that the inner partial sphere essentially floats within the
outer frame's partial sphere, thereby allowing a fuller range of
motion than a tighter friction fit.
[0074] FIG. 12 illustrates an implant frame with prosthetic valve
device 1300 attached thereto connected via a connector element 1302
to a lasso structure 1304 that is, in turn, operatively connected
with a manipulation wire 1306, that may comprise a single wire or
two wires, that extends proximally to the operator who is then able
to manipulate the lasso 1304 and connector element 1302. The lasso
structure 1304 may comprise two distal wires, W1, W2, or more than
two distal wires, in operative connection with the connector
element 1302. If the manipulation wire 1306 comprises two wires W1,
W2, then a first of the two wires may be connected with wire 1 and
the second of the two wires may be connected with wire 1. Wires W1,
W2 may be disconnected from the connector element 1302 by the
operator's pulling of one, or both, of the manipulation wire(s) W1,
W2. The lasso structure 1304 may, as shown, be expandable to a
diameter that is larger than the inner diameter of the catheter's
1305 lumen and is disposed through the implant frame structure with
the connector element 1302 in operative connection with the lasso
1304 and the device frame 1300 generally in the middle of the
implant structure. This configuration allows the operator to steer
the device 1300 with the lasso structure 1304 during deployment and
also allows retrieval back into the catheter's 1305 lumen if
necessary. The connector element 1302 may be configured together
with the device's 1300 frame structure to enable collapsing of the
device's 1300 frame structure to allow pullback of the device's
1300 structure into the catheter's 1305 lumen. The connector
element 1302 may also be disconnected by the operator from the
device's 1300 frame, whereby one, or both, of the wires W1, W2 are
disconnected and the lasso structure 1304 retracted proximally
through the catheter 1305. In other embodiments, the connector
element 1302 may remain attached to the device's 1300 frame
structure when the operator disconnects wires W1, W2 from the
connector element 1302 and pulls the lasso structure 1304
proximally through the catheter sheath 1305.
[0075] The description of the various inventions, embodiments
thereof and applications as set forth herein is illustrative and is
not intended to limit the scope of the invention. Features of
various embodiments may be combined with other embodiments within
the contemplation of these inventions. Variations and modifications
of the embodiments disclosed herein are possible, and practical
alternatives to and equivalents of the various elements of the
embodiments would be understood to those of ordinary skill in the
art upon study of this patent document. These and other variations
and modifications of the embodiments disclosed herein may be made
without departing from the scope and spirit of the inventions.
* * * * *