U.S. patent application number 15/819512 was filed with the patent office on 2018-05-24 for methods and systems for rapid retraction of a transcatheter heart valve delivery system.
The applicant listed for this patent is Neovasc Tiara Inc.. Invention is credited to Ian Fraser KERR, Randy Matthew LANE, Colin Alexander NYULI, Karen Tsoek-Ji WONG.
Application Number | 20180140419 15/819512 |
Document ID | / |
Family ID | 62144398 |
Filed Date | 2018-05-24 |
United States Patent
Application |
20180140419 |
Kind Code |
A1 |
KERR; Ian Fraser ; et
al. |
May 24, 2018 |
METHODS AND SYSTEMS FOR RAPID RETRACTION OF A TRANSCATHETER HEART
VALVE DELIVERY SYSTEM
Abstract
Methods for the rapid retraction of trans-catheter heart valve
delivery systems are provided. A rapid retraction trans-catheter
heart valve delivery system comprises a catheter based delivery
system. The delivery system has internal mechanisms that allow for
the controlled deployment of a heart valve prosthesis, as well as
mechanisms that allow for quickly closing the catheter once the
heart valve prosthesis has been implanted. This rapid retraction
ability allows for reduced procedural durations and thus reduced
risk to the patient.
Inventors: |
KERR; Ian Fraser;
(Vancouver, CA) ; WONG; Karen Tsoek-Ji; (Richmond,
CA) ; NYULI; Colin Alexander; (Vancouver, CA)
; LANE; Randy Matthew; (Langley, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Neovasc Tiara Inc. |
Richmond |
|
CA |
|
|
Family ID: |
62144398 |
Appl. No.: |
15/819512 |
Filed: |
November 21, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62424910 |
Nov 21, 2016 |
|
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|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/9517 20200501;
A61F 2/2433 20130101; A61F 2/2427 20130101; A61F 2250/0064
20130101; A61M 29/02 20130101; A61F 2/24 20130101; A61F 2/2436
20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24; A61M 29/02 20060101 A61M029/02 |
Claims
1. A method of rapidly retracting a delivery system, the method
comprising: providing a delivery system, the delivery system having
a plurality of catheters used to deliver a heart valve prosthesis;
providing a rapid retraction mechanism operably coupled with the
delivery system, the rapid retraction mechanism configured to
rapidly close the delivery system; and actuating the rapid
retracting mechanism thereby rapidly closing the delivery
system.
2. The method of claim 1, further comprising trans-apically
introducing the delivery system into an apex of a heart.
3. The method of claim 2, wherein actuating the rapid retraction
mechanism comprises actuating a button and linkage.
4. The method of claim 2, wherein the rapid retraction mechanism
comprises a screw thread and interference member, and wherein the
method further comprises constraining movement of the rapid
retraction mechanism with the screw thread and interference
member.
5. The method of claim 2, wherein the rapid retraction mechanism
comprises a flexible interference member, the method further
comprising deflecting the flexible interference member.
6. The method of claim 2, wherein the rapid retraction mechanism
comprises a pin and pin-hole link assembly, the method further
comprising removing the pin from the pin-hole link assembly.
7. The method of claim 1, further comprising trans-septally
delivering the delivery system to a heart.
8. The method of claim 7, wherein actuating the rapid retraction
mechanism comprises actuating a button and linkage.
9. The method of claim 7, wherein the rapid retraction mechanism
comprises a screw and interference member, and wherein the method
further comprises constraining movement of the rapid retraction
mechanism with the screw and interference member.
10. The method of claim 7, wherein the rapid retraction mechanism
comprises a flexible interference member, the method further
comprising deflecting the flexible interference member.
11. The method of claim 7, wherein the rapid retraction mechanism
comprises a pin and pin-hole link assembly, the method further
comprising removing the pin from the pin-hole link assembly.
12. The method of claim 1, further comprising delivering the
delivery system to the heart via a subclavian vein.
13. The method of claim 12, wherein actuating the rapid retraction
mechanism comprises actuating a button and linkage.
14. The method of claim 12, wherein the rapid retraction mechanism
comprises a screw thread and interference member, and wherein the
method further comprises constraining movement of the rapid
retraction mechanism with the screw thread and interference
member.
15. The method of claim 12, wherein the rapid retraction mechanism
comprises a flexible interference member, the method further
comprising deflecting the flexible interference member.
16. The method of claim 12, wherein the rapid retraction mechanism
comprises a pin and pin-hole linkage assembly, the method further
comprising removing the pin from the pin-hole linkage assembly.
17. The method of claim 1, further comprising delivering the
delivery system to the heart via an aorta.
18. The method of claim 17, wherein actuating the rapid retraction
mechanism comprises actuating a button and linkage.
19. The method of claim 17, wherein the rapid retraction mechanism
comprises a screw thread and interference member, the method
further comprising constraining movement of the rapid retraction
mechanism with the screw thread and interference member.
20. The method of claim 17, wherein the rapid retraction mechanism
comprises a flexible interference member, the method further
comprising deflecting the flexible interference member.
21. The method of claim 17, wherein the rapid retraction mechanism
is comprised of a pin and pin-hole linkage assembly, the method
further comprising removing the pin from the pin-hole linkage
assembly.
22. The method of claim 1, further comprising delivering the
delivery system to a heart via a right atrium or via a left
atrium.
23. The method of claim 22, wherein actuating the rapid retraction
mechanism comprises actuating a button and linkage.
24. The method of claim 22, wherein the rapid retraction mechanism
comprises a screw thread and interference member, the method
further comprising constraining movement of the rapid retraction
mechanism with the screw thread and interference member.
25. The method of claim 22, wherein the rapid retraction mechanism
comprises a flexible interference member, the method further
comprising deflecting the flexible interference member.
26. The method of claim 22, wherein the rapid retraction mechanism
comprises a pin and pin-hole linkage assembly, the method further
comprising removing the pin from the pin-hole linkage assembly.
27. The method of claim 1, further comprising providing a
controllable deployment mechanism, the controllable deployment
mechanism configured to preferentially release a prosthesis from
the delivery system.
28. The method of claim 27, further comprising actuating the
controllable deployment mechanism by rotating a thumbwheel operably
coupled with the delivery system.
29. A delivery device for delivering a prosthesis, said device
comprising: a delivery catheter configured to carry a prosthesis
therein; a dilator catheter disposed in the delivery catheter, the
dilator catheter having a tapered distal tip coupled thereto; a
rapid retraction mechanism for controlling movement of the delivery
catheter relative to the tapered distal tip, wherein actuation of
the rapid retraction mechanism closes the delivery device such that
a proximal end of the tapered distal tip abuts against a distal end
of the delivery catheter, thereby forming a smooth continuous outer
surface on the delivery device.
30. The device of claim 29, further comprising a first actuation
mechanism for controlling movement of the delivery catheter,
wherein actuation of the first actuation mechanism moves the
delivery catheter away from the prosthesis thereby at least
partially removing a constraint therefrom.
31. The device of claim 30, further comprising a deployment
mechanism for controlling release of the prosthesis from an
anchoring catheter, the anchoring catheter disposed at least
partially in the delivery catheter, and wherein actuation of the
deployment mechanism moves the anchoring catheter away from the
prosthesis thereby releasing a constraint therefrom.
32. The device of claim 30, wherein the first actuation mechanism
comprises a thumbwheel.
33. The device of claim 30, wherein the deployment mechanism
comprises an actuatable button with a linkage coupled thereto.
34. The device of claim 29, wherein the rapid retraction mechanism
comprises a screw thread and interference member.
35. The device of claim 29, wherein the rapid retraction mechanism
comprises a flexible interference member.
36. The device of claim 29, wherein the rapid retraction mechanism
comprises a pin and pin-hole linkage assembly.
37. A system for delivering a prosthesis, said system comprising:
the device of claim 29; and the prosthesis.
38. The system of claim 37, wherein the prosthesis comprises a
prosthetic mitral valve.
Description
CROSS-REFERENCE
[0001] The present application claims priority to U.S. Provisional
Patent Application No. 62/424,910 (Attorney Docket No.
53235-712.101), filed on Nov. 21, 2016, which is herein
incorporated by reference in its entirety.
[0002] The present application is related to: U.S. Pat. No.
8,579,964 (Attorney Docket No. 53235-703.201) filed Apr. 28, 2011;
and also related to U.S. Publication Nos. 2013/0211508 (Attorney
Docket No. 53235-704.201) filed Nov. 16, 2012; 2014/0052237
(Attorney Docket No. 53235-705.201) filed Feb. 8, 2013;
2014/0155990 (Attorney Docket No 53235-706.201) filed May 29, 2013;
2014/0257467 (Attorney Docket No. 53235-707.201) filed Mar. 3,
2014; and 2014/0343669 (Attorney Docket No. 53235-708.201) filed
Apr. 1, 2014; the entire contents of each of which is incorporated
herein by reference.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0003] Mitral regurgitation, also known as mitral insufficiency or
mitral incompetence is a heart condition in which the mitral valve
does not close properly thereby resulting in abnormal leakage of
blood retrograde from the left ventricle through the mitral valve
back upstream into the left atrium. Persistent mitral regurgitation
can result in congestive heart failure, a costly and often fatal
condition. Traditional surgical repair of the valve generally
results in a good clinical outcome but requires open heart surgery
and a lengthy and costly hospital stay along with an extended
recovery period. More recently, minimally invasive procedures have
been developed to deliver a prosthetic heart valve percutaneously
over a catheter through the patient's vasculature to the heart, or
by using a transapical procedure to introduce the prosthesis
through the chest wall and through the apex of the heart to the
treatment site. An exemplary prosthesis includes any of the
embodiments described in U.S. Pat. No. 8,579,964, the entire
contents of which are incorporated herein by reference. These
prostheses and delivery procedures appear to be promising, but
there is yet opportunity to improve procedural outcomes by
minimizing the duration of the procedure, from first contact with
the delivery system by an operator to final withdrawal of the
delivery system and wound closure in the patient. Therefore, it
would be desirable to provide improved devices, systems, and
methods that reduce the amount of time needed to remove the
delivery system from the patient, improve ease of use, speed up the
procedure, and reduce risk. At least some of these objectives will
be met by the exemplary embodiments described herein.
2. Description of the Background Art
[0004] U.S. Pat. No. 8,579,964 discloses an exemplary prosthetic
heart valve and trans-catheter delivery system, the entire contents
previously incorporated herein by reference.
BRIEF SUMMARY
[0005] The present disclosure generally relates to medical systems,
devices and methods, and more particularly relates to prostheses
and delivery systems such as heart valve delivery systems that may
be used to implant a prosthesis such as a valve, including a
prosthetic mitral valve, a heart valve, or any other valve. The
present disclosure emphasizes exemplary embodiments of a prosthetic
mitral valve and delivery system, but one of skill in the art will
appreciate that this is not intended to be limiting.
[0006] In many embodiments, trans-catheter methods and systems of
deploying prosthetic heart valves and rapid retraction of the
delivery system are provided. In certain embodiments, the delivery
system comprises a trans-apical delivery system that may be used to
implant a prosthetic heart valve into anatomical position by way of
an incision in the apex of the heart. The trans-apical delivery
system may comprise a system of catheters that may be
concentrically nested upon one another and that, when combined, may
retain a compressed heart valve prosthesis. Removal of the
constraint provided by certain catheters may then facilitate
deployment of the heart valve prosthesis into the heart. Further
embodiments of the trans-apical delivery system that may be used in
any of the delivery systems disclose herein may allow for the
closure of the delivery catheters at an enhanced speed, such as by
way of translation of catheter components within each other in the
opposite direction to that required for deployment operation. The
operation of such delivery systems may be facilitated through the
use of actuator mechanisms such as button mechanisms that may be in
communication with linkage systems, or actuator mechanisms such as
button mechanisms that may be in communication with flexible
members, or even pin coupled components that simplify use.
[0007] Further embodiments herein may include delivery systems that
allow for alternative implantation pathways such as through the
inferior or superior vena cava, the aorta, or the atria.
[0008] In an aspect of the present disclosure, a method of rapidly
retracting a delivery system comprises providing a delivery system,
the delivery system having a plurality of catheters used to deliver
a heart valve prosthesis, providing a controllable deployment
mechanism, the controllable deployment mechanism having the ability
to preferentially release a prosthesis from the catheter, and
actuating the controllable deployment mechanism thereby releasing
the prosthesis from the catheter. The method may also comprise
providing a rapid retraction mechanism, the rapid retraction
mechanism having the ability to rapidly close the catheter,
actuating the rapid retracting mechanism thereby rapidly closing
the catheter.
[0009] The method may comprise trans-apically introducing the
delivery system into an apex of a heart, or transseptally
delivering the delivery system to a heart, delivering the delivery
system to the heart via a subclavian vein, delivering the delivery
system to the heart via an aorta, or delivering the delivery system
to the heart via a left atrium or a right atrium.
[0010] Actuating the rapid retraction mechanism may comprise
actuating a button and linkage. The rapid retraction mechanism may
comprise a threaded region and interference member, and the method
may further comprise constraining movement of the rapid retraction
mechanism with the threaded region and interference member. The
rapid retraction mechanism may comprise a flexible interference
member, and the method may further comprise deflecting the flexible
interference member. The rapid retraction mechanism may comprise a
pin and pin-hole link assembly, and the method may comprise
removing the pin from the pin-hole link assembly.
[0011] In another aspect of the present disclosure, a delivery
device for delivering a prosthesis comprises a first actuation
mechanism for controlling movement of a delivery catheter, wherein
the delivery catheter may be configured to carry a prosthesis
therein, and wherein actuation of the first actuation mechanism may
move the delivery catheter away from the prosthesis thereby at
least partially removing a constraint therefrom, and a deployment
mechanism for controlling release of the prosthesis from an
anchoring catheter, the anchoring catheter disposed at least
partially in the delivery catheter, and wherein actuation of the
deployment mechanism may move the anchoring catheter away from the
prosthesis thereby releasing a constraint therefrom. The delivery
system may also comprise an inner guidewire catheter having a
tapered distal tip, the inner guidewire catheter disposed in the
anchoring catheter, and a rapid retraction mechanism for
controlling movement of the delivery catheter relative to the
tapered distal tip, wherein actuation of the rapid retraction
mechanism closes the delivery device such that a proximal end of
the distal tip abuts against a distal end of the delivery catheter
thereby forming a smooth continuous outer surface of the delivery
device.
[0012] The actuation mechanism may comprise a thumbwheel. The
deployment mechanism may comprise an actuatable button with a
linkage coupled thereto. The rapid retraction mechanism may
comprise a threaded region and interference member, a flexible
interference member, or a pin and pin-hole linkage assembly.
[0013] In another aspect of the present disclosure, a system for
delivering a prosthesis comprise the delivery device described
above and a prosthesis such as a prosthetic mitral valve.
[0014] These and other embodiments are described in further detail
in the following description related to the appended drawing
figures.
INCORPORATION BY REFERENCE
[0015] All publications, patents, and patent applications mentioned
in this specification are herein incorporated by reference to the
same extent as if each individual publication, patent, or patent
application was specifically and individually indicated to be
incorporated by reference.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The novel features of the present disclosure are set forth
with particularity in the appended claims. A better understanding
of the features and advantages of the present disclosure will be
obtained by reference to the following detailed description that
sets forth illustrative embodiments, in which the principles of the
present disclosure are utilized, and the accompanying drawings of
which:
[0017] FIG. 1 shows a perspective view of a trans-apical delivery
system configured to allow for rapid retraction.
[0018] FIGS. 2A-2E illustrate schematic side views of an
operational sequence of a trans-apical delivery system configured
to allow for rapid retraction.
[0019] FIGS. 3A-3D illustrate partial cross-sectional breakout
views of an operational sequence of a trans-apical delivery system
configured to allow for rapid retraction.
[0020] FIGS. 4A-4B illustrate isometric partial cross-sectional
breakout views of a sequence of action of an internal mechanism
within a trans-apical delivery system configured to allow for rapid
retraction.
[0021] FIG. 5 illustrates an exploded view and internal components
of a trans-apical delivery system configured to allow for rapid
retraction.
[0022] FIGS. 6A-6E illustrate schematic side views of an
operational sequence of an alternate embodiment of a trans-apical
delivery system configured to allow for rapid retraction.
[0023] FIGS. 7A-7D illustrate schematic side views of an
operational sequence of another alternate embodiment of a
trans-apical delivery system configured to allow for rapid
retraction.
[0024] FIG. 8 illustrates a schematic diagram of an exemplary
prosthesis
[0025] FIGS. 9A-9B illustrate exemplary cross-sections of the
prosthesis in FIG. 8.
[0026] FIGS. 10A-10B illustrate a prosthesis coupled to a delivery
catheter.
[0027] FIG. 11 illustrates basic human heart anatomy.
[0028] FIGS. 12A-12C illustrate exemplary delivery methods.
[0029] FIGS. 13A-13C illustrate an exemplary method of deploying a
prosthesis in the heart.
DETAILED DESCRIPTION
[0030] In the following detailed description, reference is made to
the accompanying figures, which form a part hereof In the figures,
similar symbols typically identify similar components, unless
context dictates otherwise. The illustrative embodiments described
in the detailed description, figures, and claims are not meant to
be limiting. Other embodiments may be utilized, and other changes
may be made, without departing from the scope of the subject matter
presented herein. It will be readily understood that the aspects of
the present disclosure, as generally described herein, and
illustrated in the figures, can be arranged, substituted, combined,
separated, and designed in a wide variety of different
configurations, all of which are explicitly contemplated
herein.
[0031] Although certain embodiments and examples are disclosed
below, inventive subject matter extends beyond the specifically
disclosed embodiments to other alternative embodiments and/or uses,
and to modifications and equivalents thereof. Thus, the scope of
the claims appended hereto is not limited by any of the particular
embodiments described below. For example, in any method or process
disclosed herein, the acts or operations of the method or process
may be performed in any suitable sequence and are not necessarily
limited to any particular disclosed sequence. Various operations
may be described as multiple discrete operations in turn, in a
manner that may be helpful in understanding certain embodiments,
however, the order of description should not be construed to imply
that these operations are order dependent. Additionally, the
structures, systems, and/or devices described herein may be
embodied as integrated components or as separate components.
[0032] For purposes of comparing various embodiments, certain
aspects and advantages of these embodiments are described. Not
necessarily all such aspects or advantages are achieved by any
particular embodiment. Thus, for example, various embodiments may
be carried out in a manner that achieves or optimizes one advantage
or group of advantages as taught herein without necessarily
achieving other aspects or advantages as may also be taught or
suggested herein.
[0033] FIG. 1 shows a perspective view of a trans-apical delivery
system 1 which may be configured to allow for delivery of a
prosthesis such as a prosthetic heart valve with rapid retraction
of the delivery system after the prosthesis has been delivered,
whereby rapid retraction herein may comprise the expedient removal
of the delivery catheter 8 and dilating tip 9 from the apex of a
patient's heart (not shown) or other treatment region of the
patient. The trans-apical delivery system 1 may be comprised of a
dilating tapered tip 9 which is delivered directly into the apex of
a patient's heart (not shown), a delivery catheter 8 (sometimes
referred to as a sheath catheter), a handle assembly including a
distal handle 3, a proximal external handle 2, and an actuator
mechanism such as a thumbwheel 4 therebetween which may be
configured to actuate said delivery catheter 8 in order to cause it
to slidably translate away from the dilating tip 9 into an open
configuration or open position. When the trans-apical delivery
system is in the open position, a space for a prosthetic heart
valve 11 or any other prosthesis may be defined between the
dilating tip 9 and the distal edge of the delivery catheter 8 (best
seen in FIG. 2A). An innermost lumen can be defined between the
guidewire lumen inlet 13, located at the distal most end of the
dilating tip 9, and the guidewire lumen outlet 14 which may be
located within a connector such as a needle hub 12 having a Luer
connector at its proximal end, at the proximal most portion of the
proximal external handle 2. The guidewire lumen may extend through
the guidewire catheter (sometimes also referred to as the dilator
catheter) which may be axially and concentrically disposed under
the other catheters including bell catheter 10. The guidewire
catheter may be referred to as a guidewire catheter. Any of the
features describing the delivery catheter 8 may be applied to any
of the delivery catheter embodiments disclosed herein. Similarly,
any of the prosthetic heart valve features described for prosthetic
heart valve may apply to the prostheses disclosed herein.
[0034] Also shown in FIG. 1 is an embodiment of an actuation
mechanism 5, which can allow a user to control the final release of
a prosthesis such as a prosthetic heart valve from the delivery
system, and can enable further mechanical actions that will be
described below. The actuation mechanism 5 may be comprised of any
actuator such as a button 6, and a disposed in a housing 7 which
describes a space wherein the button 6 may translate. The
mechanical details behind the translation will be further described
below.
[0035] Turning now to FIG. 2A-2E, an operational sequence of a
trans-apical delivery system 1 configured to allow for rapid
retraction is presented. FIG. 2A shows the delivery system 1 in the
closed configuration where all catheters may be concentrically
disposed over one another, and the distal leading edge 22 of
delivery catheter 8 may be disposed against the proximal end of
dilating tip 9 to form a smooth continuous outer surface. A
prosthesis such as a prosthetic heart valve may be loaded and
disposed in the space 11 and constrained by the catheters. The
closed configuration may be configured for trans-apical delivery of
the prosthesis to the treatment region in the heart. FIG. 2B shows
an arrow indicating translation 20 of the distal leading edge of
the delivery catheter 22 in the proximal direction. An arrow
indicating rotation 15 of the thumbwheel 4 is also shown, and when
the thumbwheel 4 is rotated, proximal translation of the distal
leading edge of the delivery catheter 8 may occur by way of
internal component mechanical relationships, such as those
described within U.S. Pat. No. 8,579,964 (also referred to herein
as the '964 patent), which is incorporated herein by reference. For
example, FIGS. 11-15C of the '964 patent describe one exemplary
embodiment of a delivery system having features which may apply to
the present exemplary embodiment, and FIGS. 16-20 of the '964
patent describe another exemplary embodiment having features which
may apply to the present exemplary embodiment. Rotation of the
thumbwheel in the opposite direction may move the delivery catheter
8 in the opposite direction, distally.
[0036] FIG. 2C shows an arrow indicating radially inward
translation 16 of an actuator, here a button 6. An arrow indicating
proximal translation 21 of the distal leading edge 22 of the
delivery catheter 8 is also shown, and also when the button 6 is
depressed radially inwardly, the leading edge of the bell catheter
10 may translate proximally away from and off of an anchoring
catheter (sometimes referred as a hub catheter), anchoring tip 23,
as further described in the '964 patent, for example, in FIGS.
16-20. By releasing the leading edge of the bell catheter 10
(similarly referred to as a bell catheter) from the anchoring
catheter anchoring tip 23, a prosthesis such as a prosthetic heart
valve (not shown) may be preferentially released. The internal
mechanics of this component relationship will be further described
in detail below.
[0037] FIG. 2D depicts the operation of the rapid retraction
functionality of the herein disclosed trans-apical delivery system
1. By maintaining pressure on the button 6, the proximal external
handle 2 may be rotated as depicted by the arrow indicating
rotation 17. By rotating the proximal external handle 2 for one
360.degree. rotation in a first direction (clockwise with respect
to the operator), the handle can become disengaged from the middle
section of the internal handle 24 and thus may be free to translate
proximally over internal handle 24, as depicted by the arrow
indicating translation 18 (FIG. 2E). The dilator tip 9 by way of
the connector such as needle hub 12 (FIG. 5), and anchoring
catheter 50 (FIG. 5) by way of the externally threaded portion of
anchoring catheter 51 (FIG. 5) may be mated to the proximal
external handle 2. The bell catheter proximal end 68 (FIG. 5) may
be fastened to the catheter carriage 30 (FIG. 5), which may be
translated along with the proximal external handle 2, and depicted
by an arrow indicating translation 19 (FIG. 2E). This movement may
allow the proximal end of the dilator tip to butt up against the
distal end of the delivery catheter 8 to form a smooth continuous
surface when the delivery system is in a closed configuration.
[0038] FIGS. 3A-3D more clearly illustrate some of the actuation
mechanism. Turning now to FIG. 3A, there is illustrated the first
view of a sequence of views of an operational sequence of a
trans-apical delivery system that is configured to allow for rapid
retraction of the delivery system 1, depicted by way of
cross-sectional breakout. The middle section of the internal handle
24 is shown, which acts as a support structure for the proximal
external handle 2 to slide thereover. Specifically, an internal
circular rib 25 may traverse the distal-most portion of the inner
diameter of the proximal external handle 2, and in conjunction with
the external threads 27 of the middle section of the internal
handle 24 as well as an external circular flange 42, may provide
support and location for the middle section of the internal handle
24 to translate within the proximal external handle 2 (shown in
FIG. 5). In operable communication with the external threads 27 of
the middle section of the internal handle 24 may be internal
threads 28 of the proximal external handle 2, which can allow for
relative rotation and controlled translation between the two
handles without binding or cocking, prior to disengagement. An
additional feature of embodiments of this device which may be used
in any embodiment of a delivery system disclosed herein, with
specific regards to the external threads 27 of the middle section
of the internal handle 24 is an internal slot 40 (FIG. 4A), the
details of which will be described further below.
[0039] As previously described, a button 6 may be provided which
when pushed as depicted by the arrow indicating translation 16 of
the button 6, may transmit force and motion along the shaft of the
button 6, and through a linkage arm 31, thereby applying it to the
catheter carriage 30 and causing it to translate proximally, as
depicted by the arrow indicating translation 43 of the catheter
carriage 30. Directional control of the translation of the button 6
may be provided by the button housing 7, which may be cylindrically
shaped and acts as a piston chamber to guide the similarly
cylindrically shaped, piston-like button 6. Functionally, the
combination of button 6, linkage arm 31 and catheter carriage 30
may behave as a mechanical linkage. The transmission of force and
motion between these components can be achieved through
pin-and-hole connection of each successive component to the next;
whereas a plurality of button pins 46 (FIG. 5) on one end of the
button 6 may be concentrically mated with the distal pin-holes 32
of the linkage arm 31, and a plurality of catheter carriage pins 47
(FIG. 5) on one end of the catheter carriage 30 may be
concentrically mated with the proximal pin-holes 33 of the linkage
arm 31. The catheter carriage 30 has several characteristics that
may assist in its ability to translate smoothly without binding or
cocking within the proximal external handle 2. For example, the
catheter carriage 30 may have a plurality of support bosses 36
(best seen in FIG. 4A) that can allow the carriage to slide within
the proximal external handle 2 by contacting the inner surface of
said proximal external handle 2. The catheter carriage 30 may also
have a plurality of support fins 35 that can also assist the
sliding of the carriage within the proximal external handle 2 by
contacting the inner surface of said proximal external handle 2.
Additionally, the plurality of support fins 35 may also provide
locations for the plurality of catheter carriage pins 47 (FIG.
5).
[0040] In order to provide the necessary return force for
appropriate valve-capturing ability through the distal end of the
bell catheter 10, a cylindrical retaining nut 38 may be in contact
with both the catheter carriage 30 and a compression spring 39.
This compression spring 39 can act to push the catheter carriage 30
and bell catheter 10 proximal end 68 and distal end towards the
dilating tip 9 when the button is released due to the bias provided
by the compression spring 39 causing the bell catheter distal end
10 to slide over top of the anchoring catheter anchoring tip
23.
[0041] Continuing on through the sequence of views of an
operational sequence of a trans-apical delivery system that is
configured to allow for rapid retraction of the delivery system 1,
by turning to FIG. 3B it is shown that further rotation of the
proximal external handle 2 as depicted by the arrow indicating
rotation 17, may allow the external threads 27 of the middle
section of the internal handle 24 and internal threads 28 of the
proximal external handle 2 to further become disengaged. If this
rotation is continued (arrow indicating continued rotation 41 of
the proximal external handle 2, FIG. 3C), the above mentioned
threads may eventually completely disengage, as illustrated in FIG.
3D. Once the above mentioned threads are completely disengaged, the
proximal external handle 2 may be free to translate away from the
distal handle 3 when pulled proximally by an operator, as depicted
by the arrow indicating translation 18 of the proximal external
handle 2. The proximal end of the dilator tip may now be butted up
against the distal end of the delivery catheter 8 forming a smooth
continuous outer surface, and all catheters may be nested within
one another. This can complete the rapid retraction process,
whereupon the device can safely be removed from the apex of a
patient's heart (not shown) or another treatment site. It should be
noted that the internal circular rib 25 located on the distal end
of the proximal external handle 2 may acts as a rigid, physical
stop upon contact with the external circular flange 42 located at
the proximal end of the middle section 24 of the internal handle.
This limits the translation of the proximal external handle 2 and
associated components relative to the internal handle, ensuring the
handles do not become fully detached from one another.
[0042] As mentioned previously, there is an internal slot 40 (FIG.
4A) located at the proximal-most end of the middle section of the
internal handle 24. The purpose of this internal slot 40 is to
provide space wherein a rectangular tab 34 of the linkage arm 31
may be placed to prevent unwanted rotation of the proximal external
handle 2 relative to the inner handle 24 or distal handle 3, and
the relationships between these components is more easily
appreciated when witnessed as depicted in FIG. 4A. The rectangular
tab may be biased to rest in the slot when the button remains
undepressed. One further feature of the mechanical linkage defined
by the button 6, linkage arm 31 and catheter carriage 30 that must
be appreciated may be realized by the pressing of the button 6,
whereupon the rectangular tab 34 of the linkage arm 31 becomes
fully removed from the internal slot 40, and full rotation of the
proximal external handle 2 relative to the inner handle 24 is thus
enabled.
[0043] Turning now to FIG. 5, there is illustrated an exploded view
with internal components of a trans-apical delivery system
configured to allow for rapid retraction of delivery system 1.
While many of the elements of FIG. 5 have been previously described
herein, additional detail will now be given with emphasis to
certain elements used to anchor components within the handle. The
proximal external handle 2 may be comprised of two handle halves,
specifically an upper section 44 and a lower section 45 which may
be fastened together by way of commonly used medical device
adhesives such as cyanoacrylate UV cure adhesives that may be
applied to a plurality of pegs 58 for mating of said proximal
external handle sections 44, 45. Other means for coupling the two
handle halves together include but are not limited to press fits,
screws, ultrasonic welding, etc. The pegs 58 are illustrated as
being located within the lower section 45 of the proximal external
handle 2, and each peg may have a complementary boss having an
aperture into which it fits in the upper section 44, although it is
not shown. The relative positions of the pegs and bosses may be
transposed. At the proximal-most end of each of the sections (upper
44, and lower 45) of the proximal external handle 2 there is
illustrated a plurality of rectangular slots 60 that may act to
securely locate and retain the body 59 of the connector such as
needle hub 12. Additionally, a plurality of pockets 56 for
retaining the needle hub flange 57 may be provided in close
proximity to the plurality of rectangular slots 60, in order to
retain and locate a specific fastening feature of the needle hub
12, being primarily the needle hub flange 57. Also found within the
upper section 44 and lower section 45 of the proximal external
handle 2 may be a plurality of rectangular pockets 55, which serve
to locate and retain the anchoring nut 48 and also provide location
for an adhesive bond that secures the anchoring nut into the handle
sections. It will be remembered that the anchoring nut 48 may
provide mechanical fastening and location of the anchoring catheter
50 by way of an externally threaded portion 51 on the anchoring
catheter 50 and an internally threaded portion 52 within the
anchoring nut 48.
[0044] FIGS. 6A-6E provide illustration of an operational sequence
of an alternate embodiment of a trans-apical delivery system 1
configured to allow for rapid retraction. FIG. 6A depicts the first
view of an operational sequence, showing another embodiment of a
proximal external handle 65. In this embodiment of a proximal
external handle 65, rapid retraction may be provided by way of a
similar fashion as previously described herein, but with
alternative means for disengagement of the proximal external handle
65 from another embodiment of a distal handle section 66.
Specifically, the actuator mechanism in this embodiment may include
latching buttons 49 (FIG. 6A-6C) which may be used to maintain this
embodiment of the distal handle section 66 coupled to this
embodiment of the proximal external handle 65. The latching buttons
49 may be in continuous and flexible connection with this
embodiment of the distal handle section 66, but may be typically
located within a recess of the proximal external handle embodiment
65. Thus, an interfering edge 63 of the latching buttons may be
registered against another interfering edge 62 that is within the
proximal external handle embodiment 65, prior to engagement. As
depicted in FIG. 6D, once both the latching buttons 49 are
depressed (illustrated by arrows 61 indicating translation/bending
of the cantilevered latching buttons 49) the interfering edge 63 of
the buttons may achieve clearance of the interfering edge 62 of the
proximal external handle 65 by bending flexion (FIG. 6E). Clearance
between the components may allow for translation of this embodiment
of the proximal external handle 65 away from this embodiment of the
distal handle 66, as depicted by directional arrow 67 indicating
translation of the proximal external handle embodiment 65 (FIG.
6E). The remaining internal and external elements of this
embodiment (FIG. 6A-6E) of a trans-apical delivery system 1 may be
configured to allow for rapid-retraction are as that of the
delivery system described in the '964 patent.
[0045] FIGS. 7A-7D provide illustration of an operational sequence
of yet another alternate embodiment of a trans-apical delivery
system 1 configured to allow for rapid retraction. FIG. 7A depicts
the first view of an operational sequence, showing yet another
embodiment of a proximal external handle 72. In this embodiment of
a proximal external handle 72, rapid retraction may be provided by
way of a similar fashion as previously described herein, but with
alternative means for disengagement of the proximal external handle
72 from yet another embodiment of a distal handle section 73. In
the embodiment illustrated in FIG. 7A, a retaining pin/latch style
of handle retention similar to what may be seen in the modern
hand-grenade may be provided. Specifically, a retaining pin 71
which may be comprised of a preferential shaped wire-form having a
grasping portion 76 and shafts 75 (FIG. 7C) may be used to pin a
proximal external handle section embodiment 72 to a distal handle
embodiment 73 by disposing the shafts 75 in receiving pin holes 77
(located on the proximal end of the distal handle embodiment 73)
and pin holes 78 (located on the proximal handle embodiment 72). A
recess 74 (FIG. 7B) in the handle for the retaining pin 71 may
provide a location for the pin to sit flush with the outer surface
of the proximal handle embodiment 72, preventing the snagging of
sterile gloves that may be adorned by the clinical user (not
shown). Operation of the actuation mechanism here having a
retaining pin 71 may be as follows: after final deployment of a
prosthetic heart valve (not shown) by sustained rotation of the
thumbwheel 4 (FIG. 7B), the user may then grasp the retaining pin
71 and pull it out of the recess 74 as depicted by directional
arrow 69 indicating translation of the retaining pin 71. Once the
retaining pin shafts 75 are entirely removed from the pin holes 77,
78, the proximal external handle embodiment 72 may become free to
translate away from the distal handle embodiment 73 as depicted by
directional arrow 70 indicating translation of the proximal
external handle embodiment 72. The remaining internal and external
elements of this embodiment (FIG. 7A-7D) of a trans-apical delivery
system 1 may be configured to allow for rapid-retraction are as
that of the delivery system described in '964 patent.
[0046] Prosthesis
[0047] FIG. 8 illustrates a schematic diagram of an exemplary
prosthesis 802 which may be used with any of the delivery catheters
disclosed herein. The prosthesis 802 is preferably a prosthetic
valve such as a prosthetic mitral valve, although it may be a
prosthetic valve for any other region in the body such as a
prosthetic triscuspid valve, a prosthetic aortic valve, or a
prosthetic pulmonary valve. Or it may be a prosthetic venous valve,
or any other prosthetic valve, or prosthetic device. The prostheses
802 preferably includes an expandable frame 804 with a prosthetic
valve mechanism 806 and preferably includes an anchor mechanism
808. The expandable frame may be balloon expandable or
self-expanding and the frame expands into engagement with the
native valve. The prosthetic valve mechanism 806 may include one,
two, three, or more prosthetic valve leaflets which have an open
position which allows antegrade fluid flow therepast, and a closed
configuration where the prosthetic valve leaflets coapt with one
another to prevent or minimize retrograde fluid flow therepast. The
fluid may be blood or another body fluid. The prosthetic leaflets
may be pericardial tissue or other tissues, or they may be formed
from synthetic materials such as polymers or metals. The anchor
mechanism may be any structure configured to help enagage tissue
and anchor the prosthesis with the native valve.
[0048] FIGS. 9A-9B illustrates taken along the line A-A in FIG. 8
and show possible cross-sections of the frame 804. FIG. 9A shows
that the prosthesis may have a circular cross-section, and in
preferred embodiments, preferably for the mitral valve, the
prosthesis may have a D-shaped cross-section so that the prosthesis
conforms to the native anatomy. Additional details about exemplary
embodiments of a prosthesis are disclosed in the '964 patent
previously incorporated herein by reference.
[0049] FIGS. 10A-10B illustrate a prosthesis 1008 such as the one
described in FIG. 8 coupled to a delivery catheter 1002. In FIG.
10A, the prosthesis is in a collapsed configuration and being
carried and constrained by the delivery catheter 1002. The delivery
catheter 1002 may be any of the delivery catheters described
herein. An outer sheath 1004 constrains the prosthesis 1008 and
keeps it in the collapsed configuration and disposed over an inner
shaft 1006 slidably disposed in the outer sheath 1004. The inner
shaft 1006 may be any of the inner shafts disclosed herein
including the bell catheter previously disclosed. Other optional
shafts in the delivery catheter are not illustrated for
convenience. As the outer sheath 1004 is retracted proximally, or
the bell catheter is advanced distally, the prosthesis becomes
unconstrained from the outer sheath and begins to self-expand as
seen in FIG. 10B. Once the prosthesis is completely unconstrained,
is self-expands into position, preferably into engagement with a
native valve.
[0050] Delivery
[0051] FIG. 11 illustrates basic human heart anatomy. The heart
includes four chambers, the right atrium RA, the right ventricle
RV, the left atrium LA, and the left ventricle LV. Several valves
prevent retrograde blood flow. The tricuspid valve TV controls flow
from the right atrium to the right ventricle, and the pulmonary
valve PV controls flow out of the right ventricle RV. The mitral
valve MV controls flow between the left atrium LA and the left
ventricle LV, and the aortic valve AOV controls flow out of the
aorta AO. The major vessels coupled to the heart include the vena
cava VC which brings venous blood back to the right atrium RA, and
the pulmonary artery brings blood from the right ventricle RV to
the lungs (not illustrated). Oxygenated blood from the lungs
returns to the left atrium LA via the pulmonary veins PVE, and
blood is delivered out of the left ventricle LV to the body by the
aorta AO.
[0052] FIG. 12A illustrates one exemplary delivery method for
treating mitral valve MV. In this embodiment, the delivery catheter
C which may be any of the delivery devices disclosed herein and may
have any of the prostheses disclosed herein is advanced typically
from a femoral vein in the groin up into the vena cava VC into the
right atrium RA and then transseptally across the atrial septal
wall into the left atrium LA and then downward into disposition
across or adjacent the native mitral valve MV where the prosthesis
may be deployed as described herein.
[0053] FIG. 12B illustrates another exemplary delivery method for
treating a mitral valve MV. In this embodiment, the delivery
catheter C which may be any of the delivery devices disclosed
herein and may have any of the prostheses disclosed herein is
advanced typically from a femoral artery or other artery (e.g.
radial artery) up into the aorta AO in to the left ventricle LV and
then across the mitral valve MV or adjacent thereto for deployment
of the prosthesis as described herein.
[0054] FIG. 12C illustrates another exemplary delivery method for
treating a mitral valve MV. In this embodiment, the delivery
catheter C which may be any of the delivery devices described
herein and may have any of the prostheses disclosed herein is
typically advanced transapically from outside the body, through the
chest well, into the apex of the heart into the left ventricle LV
and then adjacent or across the mitral valve MV where the
prosthesis is then deployed as disclosed herein.
[0055] FIGS. 13A-13C illustrate an exemplary method of deploying a
prosthesis P in the heart using a delivery catheter C which may be
any of the delivery devices disclosed herein. The prosthesis is
preferably a mitral valve prosthesis but may be any of the
prostheses disclosed herein. In FIG. 13A, the delivery catheter is
preferably delivered transapically to the mitral valve MV. In FIG.
13B, once the prosthesis P has been properly positioned relative to
the native mitral valve MV, the outer sheath is retracted
proximally (or the inner bell shaft is advanced distally) so that
the prosthesis is unconstrained and allowed to self-expand into
engagement with the native mitral valve and anchor into position.
After the prosthetic valve has been deployed and properly
positioned and anchored, the delivery catheter is then retracted
proximally and removed from the heart as seen in FIG. 13C. The
prosthetic valve now takes over the function of the native mitral
valve allowing antegrade flow from the left atrium to the left
ventricle and preventing or minimizing regurgitation of blood from
the left ventricle to the left atrium.
[0056] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that methods and structures
within the scope of these claims and their equivalents be covered
thereby.
* * * * *