U.S. patent application number 17/307499 was filed with the patent office on 2021-08-19 for systems and methods for percutaneously supporting and manipulating a septal wall.
The applicant listed for this patent is Medtronic Vascular, Inc.. Invention is credited to Niall Duffy, James R. Keogh, Jeffrey Sandstrom.
Application Number | 20210251754 17/307499 |
Document ID | / |
Family ID | 1000005556835 |
Filed Date | 2021-08-19 |
United States Patent
Application |
20210251754 |
Kind Code |
A1 |
Duffy; Niall ; et
al. |
August 19, 2021 |
SYSTEMS AND METHODS FOR PERCUTANEOUSLY SUPPORTING AND MANIPULATING
A SEPTAL WALL
Abstract
A catheter-based system for percutaneously supporting and
articulating a septal wall of a heart includes a catheter and a
flanged device. The flanged device includes a distal anchor and a
proximal anchor, and has a radially collapsed configuration and a
radially expanded configuration. When the flanged device is in the
radially expanded configuration and disposed through a transseptal
puncture in the septal wall, the flanged device is configured to
anchor to the septal wall to permit manipulation thereof whereby an
angle between an axis through the transseptal puncture and an axis
through a native valve is reduced. The proximal anchor and the
distal anchor may each be self-expanding or balloon expandable. The
flanged device may further include a flanged device shaft. The
flanged device shaft may be releasably coupled to the catheter.
Inventors: |
Duffy; Niall; (Galway,
IE) ; Sandstrom; Jeffrey; (Scandia, MN) ;
Keogh; James R.; (Maplewood, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medtronic Vascular, Inc. |
Santa Rosa |
CA |
US |
|
|
Family ID: |
1000005556835 |
Appl. No.: |
17/307499 |
Filed: |
May 4, 2021 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
16191228 |
Nov 14, 2018 |
10993807 |
|
|
17307499 |
|
|
|
|
62586993 |
Nov 16, 2017 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/0057 20130101;
A61B 17/3423 20130101; A61B 2017/3425 20130101; A61F 2/2427
20130101; A61B 2017/00606 20130101; A61F 2/2436 20130101; A61B
2017/00867 20130101; A61B 2017/048 20130101; A61B 2017/00575
20130101; A61F 2/2433 20130101; A61B 17/0401 20130101; A61F 2/2454
20130101; A61B 2017/00243 20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24; A61B 17/00 20060101 A61B017/00; A61B 17/04 20060101
A61B017/04; A61B 17/34 20060101 A61B017/34 |
Claims
1. A catheter-based system for percutaneously supporting and
articulating a septal wall of a heart, the catheter-based system
comprising: a catheter; and a flanged device disposed at a distal
end of the catheter, the flanged device having a central lumen and
including: a distal anchor configured for engagement with a first
side of the septal wall; and a proximal anchor configured for
engagement with a second side, opposite the first side, of the
septal wall, wherein the flanged device has a radially collapsed
configuration for delivery within a vasculature and a radially
expanded configuration, and wherein when the flanged device is in
the radially expanded configuration and disposed through a
transseptal puncture in the septal wall, the flanged device is
configured to support and manipulate or articulate the interatrial
septum.
2. The catheter-based system of claim 1, wherein the septal wall is
an interatrial septum and wherein the flanged device is configured
to manipulate or articulate the interatrial septum such that when
the interatrial septum is manipulated or articulated, an angle
between a first central axis that extends through the transseptal
puncture and a second central axis that extends through a native
mitral valve is less than the angle between the first central axis
that extends through the transseptal puncture and the second
central axis that extends through the native mitral valve when the
interatrial septum is not manipulated or articulated by the flanged
device.
3. The catheter-based system of claim 1, wherein the proximal
anchor and the distal anchor each include a collapsed state
corresponding to the radially collapsed configuration of the
flanged device and an expanded state corresponding to the radially
expanded configuration of the flanged device.
4. The catheter-based system of claim 3, wherein the septal wall is
an interatrial septum and wherein when the flanged device is in the
radially expanded configuration and is disposed through the
transseptal puncture in the interatrial septum, the distal anchor
is in the expanded state and is configured to be disposed adjacent
to and engaged with the interatrial septum in a left atrium and the
proximal anchor is in the expanded state and is configured to be
disposed adjacent to and engaged with the interatrial septum in a
right atrium such that the flanged device is anchored to the
interatrial septum to permit manipulation or articulation of the
interatrial septum.
5. The catheter-based system of claim 3, wherein the distal anchor
includes a self-expanding frame such that the distal anchor is
self-expanding from the collapsed state to the expanded state.
6. The catheter-based system of claim 5, wherein the proximal
anchor includes a self-expanding frame such that the proximal
anchor is self-expanding from the collapsed state to the expanded
state.
7. The catheter-based system of claim 3, wherein the distal anchor
is a distal anchor balloon, and the distal anchor balloon is
inflatable from the collapsed state to the expanded state.
8. The catheter-based system of claim 7, wherein the proximal
anchor is a proximal anchor balloon, wherein the proximal anchor
balloon is inflatable from the collapsed state to the expanded
state.
9. The catheter-based system of claim 1, wherein the proximal
anchor is spaced from the distal anchor by a length of the flanged
device shaft.
10. The catheter-based system of claim 1, wherein the flanged
device further includes a flanged device shaft, wherein the distal
anchor is coupled to or extends from a distal portion of the
flanged device shaft and the proximal anchor is coupled to or
extends from a proximal portion of the flanged device shaft.
11. The catheter-based system of claim 10, wherein the flanged
device shaft is removably coupled to the distal end of the
catheter.
12. The catheter-based system of claim 1, wherein the flanged
device further includes a sealing mechanism configured to seal a
passageway of the flanged device shaft.
13. The catheter-based system of claim 12, wherein the sealing
mechanism is disposed within the passageway of the flanged device
shaft.
14. The catheter-based system of claim 12, wherein the sealing
mechanism is a hemostatic seal.
15.-20. (canceled)
21. A catheter-based system for percutaneously supporting and
articulating a septal wall of a heart, the catheter-based system
comprising: a catheter including an catheter shaft having a
passageway extending therethrough; and a flanged device removably
coupled to a distal end of the catheter shaft, the flanged device
having a central lumen and including: a distal anchor configured
for engagement with a first side of the septal wall; and a proximal
anchor configured for engagement with a second side, opposite the
first side, of the septal wall, wherein the flanged device has a
radially collapsed configuration for delivery within a vasculature
and a radially expanded configuration configured to be disposed
through a transseptal puncture in the septal wall, and wherein the
catheter is configured to manipulate the catheter shaft with the
flanged device coupled thereto and in the radially expanded
configuration such that the catheter and the flanged device support
and manipulate or articulate the septal wall.
22. The catheter-based system of claim 21, wherein the catheter
shaft passageway and flanged device central lumen are configured to
receive a medical device therethrough.
23. The catheter-based system of claim 21, wherein the catheter
further includes pull wires for manipulating the catheter shaft
with the flanged device coupled thereto and in the radially
expanded configuration such that the catheter and the flanged
device support and manipulate or articulate the septal wall.
24. The catheter-based system of claim 21, wherein the catheter
shaft comprises a shape memory material configured to return to a
curved shape with the flanged device coupled thereto and in the
radially expanded configuration to manipulate or articulate the
septal wall.
25. The catheter based system of claim 21, wherein: the catheter
shaft comprises an inner shaft; the catheter further includes an
outer shaft; the flanged device is disposed within the outer shaft
when in the radially compressed configuration; and the catheter
further comprises a handle including an actuator configured to
slide the outer shaft relative to the inner shaft and the flanged
device to exposed the flanged device such that the flanged device
expands from the radially compressed configuration to the radially
expanded configuration.
26. A catheter-based system for percutaneously supporting and
articulating a septal wall of a heart, the catheter-based system
comprising: a catheter including: an outer shaft including an outer
shaft lumen; an inner shaft disposed within the outer shaft lumen;
and a handle including an actuator for translating the outer shaft
relative to the inner shaft; and a flanged device removably coupled
to a distal end of the inner shaft, the flanged device having a
central lumen and including: a distal anchor; and a proximal
anchor; wherein the flanged device has a radially collapsed
configuration for delivery within a vasculature when disposed
within the outer shaft and a radially expanded configuration when
the outer shaft is retracted from the flanged device and configured
to be disposed through a transseptal puncture in the septal wall
such that the distal anchor engages a first side of the septal wall
and the proximal anchor engages as second side of the septal wall
opposite the first side, and wherein the catheter is configured to
manipulate the inner shaft with the flanged device coupled thereto
and in the radially expanded configuration such that the catheter
and the flanged device support and manipulate or articulate the
septal.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit under 35 U.S.C. .sctn.
119(e) of U.S. Provisional Application No. 62/586,993 filed Nov.
16, 2017, the contents of which are incorporated by reference
herein in their entirety.
FIELD OF THE INVENTION
[0002] The present technology relates to transseptal apparatus and
procedures utilized for delivering a prosthesis or other therapy to
the site of a native heart valve. More specifically, the present
invention relates to a catheter-based system having a flanged
device for supporting and manipulating or articulating a septal
wall, e.g., an interatrial septum, of a heart during a transseptal
approach to a native heart valve, e.g., a mitral valve.
BACKGROUND OF THE INVENTION
[0003] The human heart is a four chambered, muscular organ that
provides blood circulation through the body during a cardiac cycle.
The four main chambers include the right atria and right ventricle
which supplies the pulmonary circulation, and the left atria and
left ventricle which supplies oxygenated blood received from the
lungs to the remaining body. To ensure that blood flows in one
direction through the heart, atrioventricular valves (tricuspid and
mitral valves) are present between the junctions of the atria and
the ventricles, and semi-lunar valves (pulmonary valve and aortic
valve) govern the exits of the ventricles leading to the lungs and
the rest of the body. These valves contain leaflets or cusps that
open and shut in response to blood pressure changes caused by the
contraction and relaxation of the heart chambers. The leaflets move
apart from each other to open and allow blood to flow downstream of
the valve, and coapt to close and prevent backflow or regurgitation
in an upstream manner.
[0004] Diseases associated with heart valves, such as those caused
by damage or a defect, can include stenosis and valvular
insufficiency or regurgitation. For example, valvular stenosis
causes the valve to become narrowed and hardened which can prevent
blood flow to a downstream heart chamber from occurring at the
proper flow rate and may cause the heart to work harder to pump the
blood through the diseased valve. Valvular insufficiency or
regurgitation occurs when the valve does not close completely,
allowing blood to flow backwards, thereby causing the heart to be
less efficient. A diseased or damaged valve, which can be
congenital, age-related, drug-induced, or in some instances, caused
by infection, can result in an enlarged, thickened heart that loses
elasticity and efficiency. Some symptoms of heart valve diseases
can include weakness, shortness of breath, dizziness, fainting,
palpitations, anemia and edema, and blood clots, which can increase
the likelihood of stroke or pulmonary embolism. Symptoms can often
be severe enough to be debilitating and/or life threatening.
[0005] Heart valve prostheses have been developed for repair and
replacement of diseased and/or damaged heart valves. Such heart
valve prostheses can be percutaneously delivered and deployed at
the site of the diseased heart valve through catheter-based
systems. Heart valve prostheses can be delivered while in a low
profile or compressed/collapsed arrangement so that the heart valve
prosthesis can be advanced through the patient's vasculature. Once
positioned at the treatment site, the heart valve prosthesis can be
expanded to engage tissue at the diseased heart valve region to,
for instance, hold the heart valve prosthesis in position. While
these heart valve prostheses offer minimally invasive methods for
heart valve repair and/or replacement, challenges remain to
providing effective, less invasive, smaller crossing profile valve
prosthesis delivery systems, particularly for mitral valve
replacement. For repair and replacement of a native mitral valve,
it may be desirable in some circumstances for a clinician to
utilize a transseptal approach to the native mitral valve with a
catheter-based delivery system. However, challenges exist with
maneuvering a catheter-based delivery system within the confined
space of the left atrium that may limit a clinician's ability to
properly position a heart valve prosthesis at the native mitral
valve when using a transseptal approach. More specifically, a
mitral valve prosthesis may be up to 39 mm in length and between
23F-24F in crossing profile and the length and crossing profile of
the mitral valve prosthesis retained within the delivery system can
create challenges during a transseptal approach to the native
mitral valve. Sharp bends or angles as a delivery system containing
such a mitral valve prosthesis crosses from the right atrium,
thorough a transseptal puncture in the interatrial septum, into the
left atrium and then immediately downward to the left ventricle may
be difficult to negotiate. Moreover, the sharp angle between an
axis of the transseptal puncture and the native mitral valve
require at least a distal segment of the delivery catheter that
contains the prosthesis to be articulated or bent/curved to align
with the native mitral valve, potentially tearing or otherwise
damaging the tissue of the fragile interatrial septum around the
transseptal puncture point during articulation.
[0006] Accordingly, there remains a need in the art for
catheter-based systems and methods for use with transseptal
approaches to a native mitral valve that address one or more of the
deficiencies noted above.
BRIEF SUMMARY OF THE INVENTION
[0007] Embodiment hereof are directed to a catheter-based system
for percutaneously supporting and manipulating or articulating a
septal wall of a heart. The catheter-based system includes a
catheter and a flanged device. The flanged device is disposed at a
distal end of the catheter. The flanged device is coupled to a
distal portion of the catheter and includes a proximal anchor and a
distal anchor. The flanged device has a radially collapsed
configuration for delivery within a vasculature and a radially
expanded configuration. When the flanged device is in the radially
expanded configuration and is disposed through a transseptal
puncture in the septal wall, the flanged device is configured to
support and manipulate or articulate the septal wall of the
heart.
[0008] Embodiments hereof are also directed to a method of
delivering, positioning, and manipulating or articulating a flanged
device for percutaneously supporting and manipulating or
articulating a septal wall of a heart. A distal portion of a
catheter, with the flanged device secured thereto, is advanced
through a transseptal puncture in the septal and into a first
chamber of the heart to position a distal anchor of the flanged
device within the first chamber of the heart. The distal anchor is
transitioned from a collapsed state to an expanded state. The
catheter is proximally retracted to position a proximal surface of
the distal anchor adjacent to and engaged with the septal wall in
the first chamber and to position a proximal anchor of the flanged
device within a second chamber of the heart. The proximal anchor is
transitioned from a collapsed state to an expanded state with a
distal surface of the proximal anchor being adjacent to and engaged
with the septal wall in the second chamber. The catheter may be
distally advanced such that the flanged device manipulates or
articulates the septal wall. Alternatively, or in combination with
distal advancement of the catheter, a distal end portion of the
catheter may be articulated and/or deflected such that the flanged
device manipulates or articulates the septal wall. An auxiliary
medical device may then be advanced through the catheter to treat a
native heart valve. When the treatment is complete, the auxiliary
medical device may then be removed from the catheter. The catheter
may then be proximally retracted and/or the deflection of the
distal end of the catheter is removed such that the flanged device
manipulates or articulates the septal wall to permit the septal
wall to return to a native shape.
BRIEF DESCRIPTION OF DRAWINGS
[0009] The foregoing and other features and aspects of the present
technology can be better understood from the following description
of embodiments and as illustrated in the accompanying drawings. The
accompanying drawings, which are incorporated herein and form a
part of the specification, further serve to illustrate the
principles of the present technology. The components in the
drawings are not necessarily to scale.
[0010] FIG. 1 is a sectional cut-away illustration of a heart
illustrating a transseptal approach to a native mitral valve,
wherein an angle between a first central axis of a transseptal
puncture and a second central axis of a native mitral valve is
illustrated.
[0011] FIG. 2A is a side view illustration of a catheter-based
system configured in accordance with an embodiment hereof, wherein
a flanged device is mounted at a distal portion thereof and the
flanged device is shown in a radially collapsed configuration for
delivery.
[0012] FIG. 2B is an exploded perspective view illustration of the
catheter-based system of FIG. 2A.
[0013] FIG. 2C is a side view illustration of a handle of a
catheter-based system configured in accordance with an embodiment
hereof.
[0014] FIG. 2D is a side view illustration of a distal portion of a
catheter-based system configured in accordance with an embodiment
hereof.
[0015] FIG. 2E is a side view illustration of a distal portion of a
catheter-based system configured in accordance with an embodiment
hereof.
[0016] FIG. 2F is a side view illustration of a distal portion of a
catheter-based system configured in accordance with an embodiment
hereof.
[0017] FIG. 2G is a side view illustration of a distal portion of a
catheter-based system configured in accordance with an embodiment
hereof.
[0018] FIG. 3A is a perspective illustration of the flanged device
of the catheter-based system of FIG. 2A configured in accordance
with an embodiment hereof, wherein the flanged device is in the
radially collapsed configuration.
[0019] FIG. 3B is a side view illustration of the flanged device of
FIG. 3A, wherein the flanged device is in a radially expanded
configuration.
[0020] FIG. 3C is a perspective illustration of the flanged device
of FIG. 3A, wherein the flanged device is in the radially expanded
configuration.
[0021] FIG. 3D is a perspective illustration of a flanged device
configured in accordance with an embodiment hereof, wherein the
flanged device is in the radially collapsed configuration.
[0022] FIG. 3E is an exploded perspective view illustration of
portions of a catheter-based system configured in accordance with
an embodiment hereof having the flanged device of FIG. 3D.
[0023] FIG. 3F is a side view illustration of a distal portion of
the catheter-based system of FIG. 3E, wherein the flanged device is
mounted at a distal portion thereof and the flanged device is shown
in a radially collapsed configuration for delivery.
[0024] FIG. 3G is a side view illustration of the distal portion of
the catheter-based system of FIG. 3E, wherein the flanged device is
shown in a radially expanded configuration during delivery.
[0025] FIG. 3H is a perspective illustration of the flanged device
of FIG. 3D, wherein the flanged device is in the radially expanded
configuration.
[0026] FIG. 4 is an illustration of the catheter-based system of
FIG. 2A in situ, wherein a guide catheter is positioned within a
right atrium and the catheter-based system is positioned is
positioned in the left atrium via a transseptal approach, wherein
the flanged device is in a radially collapsed configuration for
delivery thereof, in accordance with an embodiment hereof.
[0027] FIG. 5 is an illustration of the catheter-based system of
FIG. 2A in situ, wherein an outer sheath of a catheter has been
proximally retracted to release a distal anchor.
[0028] FIG. 6 is an illustration of the catheter-based system of
FIG. 2A in situ, wherein the distal anchor has expanded to an
expanded state.
[0029] FIG. 7 is an illustration of the catheter-based system of
FIG. 2A in situ, wherein the catheter-based system has been
proximally retracted to position the distal anchor adjacent the
interatrial septum within the left atrium.
[0030] FIG. 8 is an illustration of the catheter-based system of
FIG. 2A in situ, wherein the outer sheath of the catheter has been
proximally retracted to release a proximal anchor, and the proximal
anchor has expanded to an expanded state adjacent the interatrial
septum within the right atrium.
[0031] FIG. 9 is an illustration of the catheter-based system of
FIG. 2A in situ, wherein the catheter-based system has been
distally advanced to manipulate or articulate the interatrial
septum to better align a first central axis of a transseptal
puncture of the interatrial septum with a second central axis of
the native mitral valve.
[0032] FIG. 10 is an illustration of the catheter-based system of
FIG. 2A in situ, wherein an auxiliary medical device has been
advanced through the catheter-based system and into the left
atrium.
[0033] FIG. 11 is an illustration of the catheter-based system of
FIG. 2A in situ, wherein the catheter-based system has been
proximally retracted to manipulate or articulate the interatrial
septum to the native shape.
[0034] FIG. 12A is an illustration of the catheter-based system of
FIG. 2A in situ, wherein a catheter has been rotated to uncouple
the catheter from the flanged device.
[0035] FIG. 12B is an illustration of a catheter-based system
configured in accordance with an embodiment hereof, wherein a
flanged device of FIGS. 3E-3H has been uncoupled from a
catheter.
[0036] FIG. 13 is an illustration of the catheter-based system of
FIG. 2A in situ, wherein the catheter has been proximally retracted
to leave the flanged device at the transseptal puncture of the
interatrial septum.
[0037] FIG. 14A is a side view illustration of a catheter-based
system configured in accordance with another embodiment hereof,
wherein the flanged device is mounted at a distal portion thereof
and the flanged device is shown in a radially collapsed
configuration for delivery.
[0038] FIG. 14B is a cross-sectional illustration of the
catheter-based system of FIG. 14A, taken at line 14B-14B of FIG.
14A.
[0039] FIG. 15A is a perspective illustration of the flanged device
of the catheter-based system of FIG. 14A configured in accordance
with an embodiment hereof, wherein the flanged device is in the
radially collapsed configuration.
[0040] FIG. 15B is a side view illustration of the flanged device
of FIG. 15A, wherein the flanged device is in a radially expanded
configuration.
[0041] FIG. 15C is a perspective illustration of the flanged device
of FIG. 15A, wherein the flanged device is in the radially expanded
configuration.
[0042] FIG. 16 is an illustration of the catheter-based system of
FIG. 14A in situ, wherein an outer sheath of a catheter has been
proximally retracted to release a distal anchor balloon, and the
distal anchor balloon has been inflated to an expanded state.
[0043] FIG. 17 is an illustration of the catheter-based system of
FIG. 14A in situ, wherein the catheter-based system has been
proximally retracted to position the distal anchor balloon adjacent
the interatrial septum within the left atrium.
[0044] FIG. 18 is an illustration of the catheter-based system of
FIG. 14A in situ, wherein the outer sheath of the catheter has been
proximally retracted to release a proximal anchor balloon, and the
proximal anchor balloon has been inflated to an expanded state
adjacent the interatrial septum within the right atrium.
[0045] FIG. 19 is an illustration of the catheter-based system of
FIG. 14A in situ, wherein the catheter-based system has been
distally advanced to manipulate or articulate the interatrial
septum to better align an axis of a transseptal puncture of the
interatrial septum with a native mitral valve.
[0046] FIG. 20 is an illustration of the catheter-based system of
FIG. 14A in situ, wherein the catheter-based system has been
proximally retracted to manipulate or articulate the interatrial
septum to the native shape.
[0047] FIG. 21 is an illustration of the catheter-based system of
FIG. 14A in situ, wherein the distal anchor balloon and the
proximal anchor balloon have each been deflated flanged device.
[0048] FIG. 22 is an illustration of the catheter-based system of
FIG. 14A in situ, wherein the catheter-based system has been
proximally retracted.
DETAILED DESCRIPTION OF THE INVENTION
[0049] Specific embodiments of the present invention are now
described with reference to the figures, wherein like reference
numbers indicate identical or functionally similar elements. The
terms "distal" and "proximal", when used in the following
description to refer to a catheter and/or other system components
hereof are with respect to a position or direction relative to the
treating clinician. Thus, "distal" and "distally" refer to
positions distant from or in a direction away from the treating
clinician, and the terms "proximal" and "proximally" refer to
positions near or in a direction toward the treating clinician. The
terms "distal" and "proximal", when used in the following
description to refer to a native vessel or a native valve are with
reference to the direction of blood flow. Thus, "distal" and
"distally" refer to positions in a downstream direction with
respect to the direction of blood flow and the terms "proximal" and
"proximally" refer to positions in an upstream direction with
respect to the direction of blood flow.
[0050] The following detailed description is merely exemplary in
nature and is not intended to limit the present technology or the
application and uses of the present technology. Although the
description of embodiments hereof is in the context of treatment of
heart valves and particularly in the context of gaining
percutaneous access to a mitral valve via a transseptal approach,
the present technology may also be used in any other body
passageways where it is deemed useful. Furthermore, there is no
intention to be bound by any expressed or implied theory presented
in the preceding technical field, background, brief summary or the
following detailed description.
[0051] FIG. 1 is a cutaway view of a heart HE illustrating a
transseptal approach to a native mitral valve MV. A delivery system
100 includes a delivery catheter 102 and a heart valve prosthesis
104. The delivery system 100 is advanced through the vasculature of
a patient using established percutaneous transcatheter procedures.
The delivery system 100 is advanced first into a right atrium RA,
through a transseptal puncture TSP in an interatrial septum IAS,
into a left atrium LA, then downward, through the native mitral
valve MV into a left ventricle LV. The delivery system 100 must
make a sharp turn within the left atrium LA to align itself with
the native mitral valve MV. This sharp turn, bend, or curve has an
angle A.degree. that may approach 90.degree. between a first
central axis CA1 that extends through the transseptal puncture TSP
in the interatrial septum IAS and a second central axis CA2 that
extends through the native mitral valve MV, as shown in FIG. 1. The
sharpness of the turn may produce challenges in aligning the
delivery system 100 with the native mitral valve MV. Movement of
the delivery system 100 to properly align the heart valve
prosthesis 104 with the native mitral valve MV places stress on the
interatrial septum IAS at the transseptal puncture TSP as the
delivery system 100 is manipulated or articulated. This stress on
the interatrial septum IAS may result in damage to the interatrial
septum IAS such as tearing of tissue around the transseptal
puncture TSP. Moreover, proper alignment of the heart valve
prosthesis 104 is difficult, time consuming, and may jeopardize the
successful deployment of the heart valve prosthesis 104.
[0052] A catheter-based system in accordance with embodiments
hereof includes a catheter and a flanged device. The catheter
generally includes a handle, and an inner shaft. In an embodiment,
the flanged device is removably coupled to a distal end of the
inner shaft. The flanged device is configured to traverse the
septal wall, e.g. an interatrial septum, of a heart via a
transseptal puncture when the flanged device is in a radially
collapsed configuration. The flanged device is further configured
to percutaneously support the septal wall, e.g. the interatrial
septum, about the transseptal puncture when the flanged device is
in a radially expanded configuration. Once in the radially expanded
configuration, the catheter-based system is configured to
manipulate or articulate the interatrial septum of the heart to
deform the interatrial septum and establish a more favorable path
to the native mitral valve. As used herein, "more favorable path"
is meant to convey that an angle A.degree. between a first central
axis CA1 (in FIG. 1) extending through the transseptal puncture and
a second central axis CA2 (in FIG. 1) extending through the native
mitral valve with the interatrial septum manipulated or articulated
(as shown in FIG. 9) is less than the angle A.degree. between the
first central axis CA1 extending through the transseptal puncture
and the second central axis CA2 extending through the native mitral
valve when the interatrial septum is not manipulated or articulated
(as shown in FIG. 1). Moreover, with manipulation and/or
articulation of the flanged device, the overall bend radius of the
catheter can be increased such that a delivery system with a heart
valve prosthesis in a radially collapsed configuration disposed
therein can more easily traverse from the right atrium to the left
atrium and into the left ventricle of the heart through the
catheter-based system. In one embodiment, the bend radius may be
<37 mm to achieve acceptable alignment with the native mitral
valve.
[0053] FIGS. 2A-3C illustrate a catheter-based system 200 according
to an embodiment hereof. The catheter-based system 200 includes a
catheter 202 and a flanged device 204 at a distal portion thereof.
The catheter-based system 200 is configured to percutaneously
support and manipulate or articulate an interatrial septum of a
heart according to embodiments hereof.
[0054] Referring to the illustrations of FIGS. 2A and 2B, in an
embodiment, the catheter 202 includes a handle 206, an outer sheath
208, and an inner shaft 210. The catheter 202 is configured to
deliver, deploy, and manipulate or articulate the flanged device
204. The components of the catheter 202 may assume different forms
and construction based upon application requirements as described
in greater detail in, for example, U.S. Pat. No. 8,876,893 to Dwork
et al., which is incorporated by reference in its entirety,
herein.
[0055] Referring to FIG. 2B, the handle 206 includes a housing 212
and an outer sheath actuator or actuation mechanism 214 that may be
manipulated by a user. The handle 206 provides a surface for
convenient handling and grasping by a user, and while the handle
206 of FIGS. 2A and 2B is shown with a cylindrical shape, this is
by way of example and not limitation as other shapes and sizes may
be used. Further, while the handle 206 is shown with a specific
style of outer sheath actuation mechanism 214, this is also by way
of example and not limitation, and various actuation mechanisms may
be utilized including, but not limited to an axially-slidable
lever, a rotary rack and pinion gear, a button, a knob, a
thumbwheel, a switch, a toggle, or other applicable actuation
mechanisms. The handle 206 can have a variety of configurations
described in greater detail in, for example, U.S. Pat. No.
8,579,963 to Tabor, which is incorporated by reference in its
entirety, herein.
[0056] As also shown in FIG. 2B, the outer sheath 208 of the
catheter 202 includes a proximal end 216, a distal end 218, and a
lumen or passageway 220. The passageway 220 extends from the
proximal end 216 to the distal end 218 of the outer sheath 208 and
is configured to receive the inner shaft 210. The outer sheath 208
is coaxial and slidably disposed over the inner shaft 210 and the
flanged device 204. A distal portion 222 of the outer sheath 208 is
configured to retain the flanged device 204 in the radially
collapsed configuration for delivery to a treatment site, such as
the interatrial septum of the heart. While the distal portion 222
is described herein as a distal portion of the outer sheath 208, in
an embodiment the distal portion 222 may be a separate component
coupled to the distal end 218 of the outer sheath 208. Moreover,
although the outer sheath 208 is described herein as a single
component, this is by way of example and not limitation, and the
outer sheath 208 may include multiple components such as, but not
limited to proximal and distal sheaths or other components suitable
for the purposes described herein. The proximal end 216 is
configured for fixed connection to the handle 206. In an
embodiment, the proximal end 216 of the outer sheath 208 extends
proximally into the housing 212 of the handle 206, and a proximal
portion 224 of the outer sheath 208 is operably coupled to the
outer sheath actuation mechanism 214 of the handle 206. The
proximal portion 224 is operably coupled to the outer sheath
actuation mechanism 214 such that movement of the outer sheath
actuation mechanism 214 causes the outer sheath 208 and the distal
portion 222 to move relative to the inner shaft 210 and the handle
206. However, if the outer sheath actuation mechanism 214 is not
actuated and the handle 206 is manipulated, the outer sheath 208
moves with the handle 206, not relative to the handle 206. The
outer sheath 208 may be constructed or formed, either along the
entire length of the outer sheath 208 or in various segments, of
one or more materials such as, but not limited to polyurethane
(e.g. Peliethane.COPYRGT., Elasthane.TM., Texin.RTM.,
Tecothane.RTM.), polyamide polyether block copolymer (e.g.
Pebax.RTM., nylon 12), polyethylene, nylon, polyester, polyimide,
polyethylene terephthalate (PET), polyetheretherketone (PEEK), or
other materials suitable for the purposes of the present
disclosure. In addition, the walls of the outer sheath 208 may be
reinforced with a variety of structures, such as metal braids or
coils. Such reinforcements may be along the entire length of the
outer sheath 208 or in various segments. The proximal portion 224
of the outer sheath 208 may be coupled to the outer sheath actuator
mechanism 214 of the handle 206, for example, and not by way of
limitation, by adhesives, welding, bonding, clamping, or other
coupling methods as appropriate. In some embodiments, the handle
206 may include a numerical or graphical display of information
indicating the amount of movement the outer sheath 208 and the
distal portion 222 move relative to the inner shaft 210 and the
handle 206.
[0057] Also shown in FIG. 2B, the inner shaft 210 of the catheter
202 extends within the passageway 220 of the outer sheath 208. The
inner shaft 210 includes a lumen or passageway 226 extending from a
proximal end 228 to a distal end 230 of the inner shaft 210. The
passageway 226 is sized to receive an auxiliary medical device such
as, but not limited to a delivery system for a heart valve
prosthesis. The distal end 230 of the inner shaft 210 is coupled to
the flanged device 204, and the inner shaft 210 is configured to
manipulate the flanged device 204, coupled thereto. At least a
portion 225 of the inner shaft 210 extends within the housing 212
of the handle 206 and is coupled to the handle 206. During sliding
or longitudinal movement of the outer sheath 208 relative thereto,
the inner shaft 210 is fixed relative to the handle 206. The inner
shaft 210 may be constructed or formed, either along the entire
length of the inner shaft 210 or in various segments, of one or
more materials such as but not limited to polyurethane (e.g.
Peliethane.COPYRGT., Elasthane.TM., Texin.RTM., Tecothane.RTM.),
polyamide polyether block copolymer (e.g. Pebax.RTM., nylon12),
polyethylene, nylon, polyester, polyimide, polyethylene
terephthalate (PET), polyetheretherketone (PEEK), or other
materials suitable for the purposes described herein. In addition,
the walls of the inner shaft 210 may be reinforced with a variety
of structures, such as metal braids or coils. Such reinforcements
may be along the entire length of the inner shaft 210 or in various
segments. The inner shaft 210 may be coupled to the handle 206 by
adhesives, welding, clamping, or other coupling methods as
appropriate. The inner shaft 210 can assume a variety of
configurations described in greater detail in, for example, U.S.
Pat. No. 8,579,963 to Tabor, previously incorporated by reference
herein.
[0058] In some embodiments, the inner shaft 210 is deflectable and
the handle 206 includes one or more inner shaft deflection
actuators 215 to actuate one or more inner shaft deflection
mechanisms 217. The inner shaft deflection actuators 215 may be
manipulated by a user to deflect, for example, the distal end 230
of the inner shaft 210. While the handle 206 is shown in FIG. 2C
with a specific type of deflection actuator 215, this is by way of
example and not limitation. The deflection actuators 215 may have
any suitable form including buttons, knobs, thumbwheels, levers,
switches, toggles, or other devices. One or more deflection
mechanisms 217 may be actuated by one or more deflection actuators
215 to deflect, bend, arc, or reshape the inner shaft 210, such as
to form a curve along one or more portions of the inner shaft 210.
In addition, in some embodiments, one or more locking actuators
(not shown) may be used to actuate locking mechanisms (not shown)
to lock the inner shaft 210 in the desired shape. Locking actuators
may have any suitable form including buttons, knobs, thumbwheels,
levers, switches, toggles, or other devices. In some embodiments,
the handle 206 may include a numerical or graphical display 219 of
information indicating the degree of deflection of the inner shaft
210.
[0059] In some embodiments, one or more deflection mechanisms 217
comprise one or more cables or pullwires within the wall of the
inner shaft 210. As shown in FIG. 2D, the inner shaft 210 may
include a pullwire 272 slidably disposed in a lumen within the wall
of the inner shaft 210 extending to the distal end 230. By applying
tension to the pullwire 272 in the proximal direction, the distal
end 230 curves or deflects in the direction of the pullwire 272 as
illustrated by arrow 282. Likewise, as shown in FIG. 2E, placement
of the pullwire 274 along the opposite side of the inner shaft 210
will allow the distal end 230 to curve or deflect in the opposite
direction, as illustrated by arrow 284, when tension is applied to
the pullwire 274. Thus, referring to FIG. 2F, diametrically
opposing placement of pullwires 272, 274 within the walls of the
inner shaft 210 allows the distal end 230 to be deflected in
opposite directions. This provides a means of correcting or
adjusting a curvature. For example, if tension is applied to one
pullwire to create a curvature, the curvature may be lessened by
applying tension to the diametrically opposite pullwire. Referring
now to FIG. 2G, an additional set of opposing pullwires 272', 274'
may extend within the wall of the inner shaft 210 as shown. This
combination of pullwires 272, 272', 274, 274' allows curvature of
the distal end 230 in at least four directions illustrated by
arrows 292, 294, 296, 298.
[0060] Any number of cables or pullwires and associated lumens may
be placed in any arrangement, singly or in pairs, symmetrically or
asymmetrically. This may allow curvature in any direction and about
various axes. The cables or pullwires may be fixed at any location
along the length of the inner shaft 210 by any suitable method,
such as gluing, tying, soldering, or potting, for example. When
tension is applied to the pullwire, the curvature forms from the
point of attachment of the pullwire toward the proximal direction.
Therefore, curvatures may be formed throughout the length of the
catheter depending upon the locations of the points of attachment
of the pullwires. Typically, however, the pullwires will be
attached near the distal end 230 of the inner shaft 210.
[0061] In some embodiments, the inner shaft 210 may be pre-curved
rather than deflectable or in addition to being deflectable, the
inner shaft 210 may be comprised of a polymer or copolymer which
can be set in a desired curvature, such as by heat setting.
Likewise, the inner shaft 210 may be comprised of a shape-memory
alloy.
[0062] FIGS. 3A-3C illustrate the flanged device 204 according to
an embodiment hereof. The flanged device 204 includes a flanged
device shaft 232, a proximal anchor or umbrella 234, and a distal
anchor or umbrella 236, as shown in FIG. 3A. The flanged device 204
includes a radially collapsed configuration for delivery to the
interatrial septum of the heart, as shown in FIG. 3A. The flanged
device 204 further includes a radially expanded configuration for
supporting and manipulating or articulating the interatrial septum,
as shown in FIG. 3B. When the flanged device 204 is in the radially
expanded configuration of FIG. 3B, the proximal anchor 234 is in an
expanded state and the distal anchor 236 is in an expanded state.
More specifically, when the flanged device 204 is positioned within
a heart and is in the radially expanded configuration, the proximal
anchor 234 may be disposed within the right atrium in the expanded
state and the distal anchor 236 may be disposed within the left
atrium in the expanded state. When the flanged device 204 is in the
expanded state and positioned across an interatrial septum, the
proximal anchor 234 and the distal anchor 236 may be disposed on
opposite sides of the interatrial septum, and the flanged device
204 is configured to support and manipulate or articulate the
interatrial septum of the heart without damaging the interatrial
septum. In an embodiment, the flanged device 204 is further
configured to be removably coupled to the catheter 202. In an
embodiment, when the flanged device 204 is in the radially expanded
configuration and disposed across the interatrial septum and
uncoupled from the catheter 202, the flanged device 204 is
configured to seal the transseptal puncture in the interatrial
septum through which the flanged device 204 is disposed, as
described below.
[0063] The flanged device shaft 232 of the flanged device 204 is a
generally tubular structure with a constant outside diameter OD1,
and includes a shaft wall 238 and a central lumen or central
passageway 240, as shown in FIG. 3A. The flanged device shaft 232
includes a proximal end 242 and a distal end 244, and the central
lumen 240 extends from the proximal end 242 to the distal end 244
thereof. The central lumen 240 is sized to receive auxiliary
medical devices such as a delivery system for a mitral valve
prosthesis. The central lumen 240 is configured such that when the
flanged device 204 is removably coupled to the inner shaft 210, the
passageway 226 of the inner shaft 210 and the central lumen 240 of
the flanged device shaft 232 are aligned to form a continuous
passageway extending from the proximal end 228 of the inner shaft
210 to the distal end 244 of the flanged device shaft 232. The
flanged device shaft 232 further includes a length 262. The length
262 is disposed between the proximal and distal anchors 234, 236 to
space the proximal anchor 234 from the distal anchor 236. The
length 262 of the flanged device shaft 232 is sized to traverse a
puncture in an interatrial septum. The length 262 of the flanged
device shaft 232 is configured to support the interatrial septum at
a puncture when disposed there-through, as described below. In the
embodiment of FIG. 3A, the flanged device shaft 232 further
includes a sealing mechanism 260, described below. The sealing
mechanism 260 is disposed within the central lumen 240 and coupled
thereto. The flanged device shaft 232 may be formed of materials
such as but not limited to polyethylene, polyether block amide
(PEBA), nickel-titanium alloy (e.g. NITINOL), stainless steel, or
other materials suitable for the purposes described herein.
[0064] In the embodiments of FIGS. 2A 2B, and 3A-3C, the flanged
device shaft 232 is removably coupled to the distal end 230 of the
inner shaft 210 by a coupling mechanism 246. In an embodiment, the
coupling mechanism 246 is a threaded coupling mechanism. The
coupling mechanism 246 is configured to removably couple the distal
end 230 of the inner shaft 210 to the proximal end 242 of the
flanged device shaft 232. The coupling mechanism 246 includes a
plurality of threads 252 on an outer surface of a distal portion of
the inner shaft 210, as shown in FIG. 2B, and a corresponding
plurality of threads 254 on an inner surface of a proximal portion
of the flanged device shaft 232, as shown in FIG. 3A. The plurality
of threads 254 of the flanged device shaft 232 are configured to
receive and engage the corresponding plurality of threads 252 of
the inner shaft 210 such that the flanged device 204 may be
removably coupled to the inner shaft 210 of the catheter 202.
Stated more plainly, the coupling mechanism 246 is configured such
that rotation of the inner shaft 210 in a first direction couples
the inner shaft 210 to the flanged device 204, and rotation of the
inner shaft 210 in a second direction opposite the first direction
uncouples the inner shaft 210 from the flanged device 204. While
the inner shaft 210 and the flanged device shaft 232 are each shown
with a specific number, pitch, and handedness of the plurality of
threads 252, 254, respectively, this is not meant to limit the
invention, and the plurality of threads 252, 254 of the inner shaft
210 and the flanged device shaft 232, respectively, may be of a
greater or lesser number, with a greater or lesser pitch, and a
different handedness.
[0065] In another embodiment, a coupling; mechanism 246E can
include one or more coupling arms 223 and matching coupling grooves
225, as shown in FIGS. 3D-3H in which features unchanged from prior
embodiments retain the same reference numbers. A flanged device
204E may include a flanged device shaft 232E having one or more
arms 223 extending proximal of a proximal anchor 234 of the flanged
device 204E. As shown in FIGS. 3E-3G, a distal end 230E of an inner
shaft 210E can include one or more grooves 225 matching the shape
of proximal ends 242E of the arms 223. Preferably the number of
grooves 225 of the inner shaft 210E matches the number of arms 223
of the flanged device 204E. As illustrated in FIG. 3F, when the
flanged device 204E is located within the outer sheath 208, the
proximal ends 242E of the arms 223 are set within the grooves 225
of the inner shaft 210E, thereby releasably attaching the flanged
device 204E to the inner shaft 210E.
[0066] In some embodiments, the coupling mechanism 246 can include
one or more elongate tension members, such as one or more sutures,
chords, or filaments, extending the length of the inner shaft 210
(not shown). The elongate tension members can be slidably disposed
in one or more lumens within the wall of the inner shaft 210 and
the elongate tension members can be used to couple the flanged
device shaft 232 to the distal end 230 of the inner shaft 210. The
elongate tension members can be looped through the flanged device
shaft 232 so that tensioning the elongate tension members fixedly
couples the flanged device 204 to the inner shaft 210. To release
the flanged device 204 from the inner shaft 210, one end of each of
the elongate tension members is released and the other end is
pulled until the elongate tension members are removed from the
flanged device 204 thus releasing the flanged device 204 from the
inner shaft 210.
[0067] In some embodiments, coupling mechanism 246 may include a
snap fit mechanism, a friction fit mechanism, or any other coupling
mechanism suitable to removably couple the inner shaft 210 to the
flanged device shaft 232 for the purposes described herein.
[0068] The proximal anchor 234 of the flanged device 204 includes a
proximal surface 256 and a distal surface 258, as shown in FIG. 3B.
The proximal anchor 234 includes a collapsed state, wherein the
proximal anchor 234 is radially collapsed for delivery to the
interatrial septum of the heart, as shown in FIG. 3A. The proximal
anchor 234 further includes the expanded state, as shown in FIGS.
3B and 3C. When in the expanded state, the proximal anchor 234
radially expands to a general disc or flat cylindrical shape, as
shown in FIG. 3C. The distal surface 258 of the proximal anchor 234
is configured for engagement with a second side, opposite the first
side, of the septal wall, which in this embodiment is the
interatrial septum of the right atrium, when the proximal anchor
234 is in the expanded state and the flanged device 204 is disposed
at a transseptal puncture in the interatrial septum. The proximal
anchor 234 in the expanded state and engaged with the interatrial
septum in the right atrium is further configured to support the
interatrial septum and to transmit forces applied to the proximal
anchor 234 of the flanged device 204 across a large surface area of
the interatrial septum engaged with the distal surface 258 of the
proximal anchor 234. The proximal anchor 234 is coupled to or
extends from an outer surface of a proximal portion of the shaft
wall 238 of the flanged device shaft 232 proximal of and spaced
from the distal anchor 236. The proximal anchor 234 is formed of a
shape memory material with a pre-set shape in the expanded state.
The proximal anchor 234 is of a suitable diameter D1, such that
forces applied to the proximal anchor 234 may be distributed over a
large surface area of the adjacent interatrial septum such that the
interatrial septum is not damaged during manipulation or
articulation. In a non-limiting example, the diameter D1 of the
proximal anchor 234 may be from 10 mm up to 30 mm. The proximal
anchor 234 is self-expanding from the collapsed state to the
expanded state. "Self-expanding" as used herein means that a
structure/component has a mechanical memory to return to the
expanded or deployed configuration or state as described herein. In
some embodiments, the proximal anchor 234 may be coupled to the
flanged device shaft 232 by methods such as, but not limited to,
adhesives, bonding, fusing, welding, or other suitable methods.
[0069] In an embodiment, the proximal anchor 234 is formed of a
frame 268, as best shown in FIG. 3C. In some embodiments, the frame
268 is part of or an extension of the flanged device shaft 232. The
flanged device shaft 232 and the frame 268 can be constructed from
a shape memory material that is configured to self-deploy or
self-expand when released from the outer sheath 208 of the catheter
202 (not shown in FIGS. 3A-3C). When the proximal anchor 234 is in
the expanded state, the frame 268 is configured to provide
structural rigidity to the proximal anchor 234 such that forces
applied to the proximal anchor 234 may be distributed over the
large surface area of the adjacent interatrial septum such that the
interatrial septum is not damaged during articulation. While the
frame 268 is shown in FIG. 3C with a radial spoke configuration,
this is by way of example and not limitation, and the frame 268 may
have other configurations, such as, but not limited to various
lattice configurations. In some embodiments, the frame 268 may be
covered by a braided mesh covering, a woven fabric covering, and/or
a tissue covering (not shown in FIG. 3C). The shape-memory of the
frame 268 of the proximal anchor 234 may be accomplished with
various shape-memory materials, such as, but not limited to a
nickel-titanium alloy (e.g. NITINOL), polymers, or other materials
suitable for the purposes described herein. A braided mesh covering
may be formed of materials such as, but not limited to a
nickel-titanium alloy (e.g. NITINOL), stainless steel, or other
materials suitable for the purposes described herein. A woven
fabric covering may be formed of materials such as, but not limited
to a woven Dacron material, a woven polymer material, or other
materials suitable for the purposes described herein. A tissue
covering may be formed of materials such as, but not limited to a
pericardial tissue, a bovine tissue, a porcine tissue, or other
materials suitable for the purposes described herein.
[0070] The distal anchor 236 is similar to the self-expanding
proximal anchor 234 described previously. Accordingly, the distal
anchor 236 includes a proximal surface 264 and a distal surface
266, as shown in FIG. 3B. Further, the distal anchor 236 includes a
collapsed state, wherein the distal anchor 236 is radially
collapsed for delivery to a septal wall, e.g., the interatrial
septum, of the heart, as shown in FIG. 3A. The distal anchor 236
further includes an expanded state, as shown in FIGS. 3B and 3C.
When the distal anchor 236 is in the expanded state, the distal
anchor 236 radially expands to a general disc or flat cylindrical
shape, as shown in FIG. 3C. The proximal surface 264 of the distal
anchor 236 is configured for engagement with a first side of the
septal wall, which in this embodiment is the interatrial septum of
the left atrium, when the distal anchor 236 is in the expanded
state and the flanged device 204 is disposed at the transseptal
puncture of the interatrial septum. The distal anchor 236 is
coupled to or extends from the outer surface of a distal portion of
the shaft wall 238 of the flanged device shaft 232 distal of and
spaced from the proximal anchor 234. Similar to the proximal anchor
234 described previously, the distal anchor 236 is of a suitable
diameter D1 such that forces applied to the distal anchor 234 may
be distributed over a large surface area of the adjacent
interatrial septum such that the interatrial septum is not damaged
during articulation. In the embodiment of FIGS. 3A-3C, the distal
anchor 236 includes a frame 270. The frame 270 is similar to the
frame 268 described previously with reference to the proximal
anchor 236. Therefore, details of the construction and alternatives
of the frame 270 of the distal anchor 236 will not be repeated. The
distal anchor 236 and the frame 270 are shaped and formed of
materials and by methods similar to the proximal anchor 234 and the
frame 268 described previously. For example, in some embodiments,
similar to the frame 268, the frame 270 can be part of or an
extension of the flanged device shaft 232.
[0071] In some embodiments, the flanged device 204E includes the
one or more arms 223 that can be self-expanding from a collapsed
configuration or state, as shown in FIG. 3D, to an expanded
configuration or state, as shown in FIG. 3H. The arms 223 can
include a collapsed state, wherein the arms 223 are radially
collapsed for delivery to a septal wall, e.g., the interatrial
septum, of the heart, as shown in FIG. 3F. The arms 223 further can
include an expanded state wherein the arms 223 radially expand to a
flat shape, as shown in FIG. 3H. In the expanded state when the
flanged device 204E is fully deployed at a transseptal puncture in
the interatrial septum, the arms 223 are configured to engage the
proximal surface of the proximal anchor 234.
[0072] In an embodiment, the flanged device 204 further includes a
sealing mechanism 260 disposed within the central lumen 240 of the
flanged device shaft 232. The sealing mechanism 260 is disposed
distal of the coupling mechanism 246 such that the sealing
mechanism 260 does not interfere with the coupling mechanism 246.
In an embodiment, the sealing mechanism 260 is a hemostatic seal.
The sealing mechanism 260 is configured to receive an auxiliary
medical device (not shown in FIGS. 3A-3H) there through, and
provide a hemostatic seal with the auxiliary medical device
received there through. The sealing mechanism 260 is further
configured such that when no auxiliary medical device is received
there through, the sealing mechanism 260 does not permit fluid to
flow through the central lumen 240. Stated more plainly, the
sealing mechanism 260 is configured to seal or occlude the central
lumen 240 of the flanged device shaft 232 to prevent fluid flow
there-through.
[0073] With an understanding of the components of the
catheter-based system 200, the interaction of the various
components is now described with reference to FIGS. 3F-13. The
flanged device 204 of the catheter-based system 200 is manipulated
to the radially collapsed configuration and restrained in the
radially collapsed configuration by the outer sheath 208 of the
catheter 202 that surrounds the flanged device 204, as shown in
FIGS. 2A and 3F.
[0074] The catheter-based system 200 is advanced to a septal wall
of a heart, in this embodiment the interatrial septum IAS of the
heart, to position the flanged device 204 through or across the
interatrial septum, as shown in FIG. 4. Thereafter, the outer
sheath 208 of the catheter 202 is proximally retracted to release
the distal anchor 236 of the flanged device 204 from the outer
sheath, as shown in FIG. 5. The distal anchor 236 radially expands
from the collapsed state to the expanded state within a first
chamber of the heart, in this embodiment the left atrium LA, as
shown in FIG. 6. With the distal anchor 236 in the expanded state,
the catheter-based system 200 is proximally retracted to position
the proximal surface 264 of the distal anchor 236 adjacent the
interatrial septum IAS and to engage the tissue of the interatrial
septum within the left atrium, as shown in FIG. 7. With the
proximal surface 264 of the distal anchor 236 engaged with the
interatrial septum IAS within the left atrium LA, the outer sheath
208 is again proximally retracted to release the proximal anchor
234 within a second chamber of the heart, in this embodiment the
right atrium RA, as shown in FIG. 8. The proximal anchor 234
expands from the collapsed state to the expanded state adjacent the
interatrial septum within the right atrium, and the distal surface
258 of the proximal anchor 234 engages tissue of the interatrial
septum IAS within the right atrium RA. Thus with the flanged device
204 in the radially expanded configuration, a portion of the
interatrial septum IAS of the heart HE is disposed or sandwiched
between and supported by the proximal and the distal anchors 234,
236 of the flanged device 204.
[0075] In some embodiments wherein the flanged device 204E includes
one or more coupling arms 223, the outer sheath 208 is proximally
retracted just enough to release the proximal anchor 234 but not
enough to release the arms 223 from the inner shaft 210E, as shown
in FIG. 3G.
[0076] With the septal wall, and more specifically the interatrial
septum IAS supported on each side by the flanged device 204, the
catheter-based system 200 may be distally advanced and/or
deflected, as described above, to manipulate or articulate the
flanged device 204 and the interatrial septum IAS sandwiched
there-between, as shown in FIG. 9. It will be understood that the
catheter-based system 200 may be deflectable by various methods
understood by those knowledgeable in the pertinent art such as, but
not limited to pull wires or other suitable methods, e.g., as
described above. The flanged device 204 and the interatrial septum
IAS are manipulated or articulated such that the first central axis
CA1 that extends through the transseptal puncture TSP in the
interatrial septum IAS is more closely aligned with the second
central axis CA2 that extends through the native mitral valve MV.
Stated another way the angle A.degree. between the first central
axis CA1 extending through the transseptal puncture and the second
central axis CA2 extending through the native mitral valve with the
interatrial septum manipulated or articulated is less than the
angle A.degree. (shown in FIG. 1) between the first central axis
CA1 extending through the transseptal puncture and the second
central axis CA2 extending through the native mitral valve when the
interatrial septum is not manipulated or articulated. Thus,
manipulation and/or articulation of the flanged device 204 and the
interatrial septum reduces the angle A.degree. between the central
axes of the transseptal puncture TSP and the native mitral valve
MV. Moreover, when the interatrial septum has been manipulated or
articulated by the flanged device 204, the bend radius or curve of
the catheter-based system 200 is increased and forms a softer, more
favorable, and less tortuous path through which a heart valve
delivery catheter or other treatment device may be tracked.
[0077] An auxiliary medical device 900, such as a heart valve
delivery catheter for delivering, for example, a prosthetic mitral
valve in a radially collapsed configuration may now be advanced
through the passageway 226 of the inner shaft 210 and the aligned
central lumen 240 of the flanged device 204 to treat the native
mitral valve, as shown in FIG. 10.
[0078] Once the desired treatment has been completed, the auxiliary
medical device 900 may be proximally retracted from the
catheter-based system 200. As a distal tip of the auxiliary medical
device 900 travels proximal of the sealing mechanism 260, the
sealing mechanism 260 seals the central lumen 240 of the flanged
device shaft 232. More precisely, the sealing mechanism 260 seals
the central lumen 240 such that fluid will not flow through the
central lumen 240 of the flanged device shaft 232.
[0079] With the auxiliary medical device 900 removed from the
catheter-based system 200 and the sealing mechanism 260 sealing the
central lumen 240 of the flanged device shaft 232, the
catheter-based system 200 may be proximally retracted to manipulate
or articulate the flanged device 204 and the interatrial septum IAS
sandwiched there-between, as shown in FIG. 11.
[0080] In some embodiments, when the interatrial septum IAS has
returned to its native shape and the central lumen 240 of the
flanged device shaft 232 is sealed by the sealing mechanism 260,
the catheter 202 is rotated, as shown in FIG. 12A, such that the
plurality of threads 252 at the distal portion 248 of the inner
shaft 210 disengage from the plurality of threads 254 of the
flanged device 204 to uncouple the inner shaft 210 from the flanged
device 204.
[0081] In some embodiments, wherein the flanged device 204E
includes one or more coupling arms 223, when the interatrial septum
IAS has returned to its native shape and the central lumen 240 of
the flanged device shaft 232E is sealed by the sealing mechanism
260, the outer sheath 208 of the catheter 202 is proximally
retracted to release the coupling arms 223 from the distal end 230E
of the inner shaft 210E, as shown in FIG. 12B, such that the
proximal ends 242E of the arms 223 disengage from the plurality of
grooves 225 of the distal end 230E of the inner shaft 210E to
uncouple the flanged device 204E from the inner shaft 210E.
[0082] In some embodiments, wherein the coupling mechanism 246
includes one or more sutures, when the interatrial septum IAS has
returned to its native shape and the central lumen 240 of the
flanged device shaft 232 is sealed by the sealing mechanism 260,
tension within the sutures can be released and the sutures removed
thus uncoupling the flanged device 204 from the inner shaft
210.
[0083] Once the coupling mechanism 246 has been actuated or
manipulated to release or uncouple the flanged device 204 from the
inner shaft 210, the catheter 202 is proximally retracted, as shown
in FIG. 13. The flanged device 204 is configured to remain within
the patient, as shown in FIG. 13. The proximal and distal anchors
234, 236 may include a biological or pharmacological substance for
example, and not by way of limitation, to promote tissue ingrowth,
to prevent infection, to prevent thrombosis, or other substances or
combinations of substances suitable for the purposes described
herein.
[0084] While the sealing mechanism 260 of the flanged device 204 is
described as a hemostatic seal disposed within the central lumen
240 of the flanged device shaft 232, alternatively the central
lumen 240 of the flanged device shaft 232 may be sealed by other
sealing mechanisms such as, but not limited to flap mechanisms,
iris mechanisms, or any other sealing mechanisms as appropriate. In
some embodiments, the sealing mechanism 260 may be configured to
seal permanently. Alternatively, the sealing mechanism 260 may be
configured to allow future passage of one or more devices following
the release of the flanged device 204 from the catheter 202.
[0085] FIGS. 4-13 are sectional cut-away views of a heart HE
illustrating a transseptal approach for supporting and manipulating
or articulating an interatrial septum IAS of the heart HE using the
catheter-based system 200, for example one shown in FIGS. 2A-3H in
accordance with embodiments hereof. With reference to FIG. 4, a
guide catheter GC is shown having been introduced into the
vasculature via a percutaneous entry point, such as with the
Seldinger technique, and tracked through the vasculature and into a
right atrium RA of the heart HE such that a distal end of the guide
catheter GC is positioned within the right atrium RA. Intravascular
access to the right atrium RA may be achieved via a percutaneous
access site to femoral venous access up to the inferior venal cava,
or other known access routes. Thereafter, a guidewire (not shown in
FIGS. 4-13) is directed into the right atrium RA, traverses the
right atrium RA and is made to puncture, with the aid of a
transseptal needle or pre-existing hole, the interatrial septum
IAS, thereby entering the left atrium LA. Once the guidewire (not
shown in FIGS. 4-13) is positioned, the endoluminal entry port and
the interatrial septum IAS are dilated to permit entry of the
catheter-based system 200 into the left atrium LA. Although
described as a transfemoral antegrade approach for percutaneously
accessing the left atrium LA, the guide catheter GC may be
positioned within the desired area of the heart HE via other
different methods such as a transseptal antegrade approach via a
thoracotomy.
[0086] Referring again to FIG. 4, and in a next deployment step,
the clinician advances the catheter-based system 200 with the
flanged device 204 in the radially collapsed configuration
restrained within the outer sheath 208 of the catheter 202 through
the guide catheter GC, through the puncture in the interatrial
septum IAS, and into the left atrium LA using established
percutaneous transcatheter procedures. The catheter-based system
200 is distally advanced until at least the distal anchor 236 of
the flanged device 204 is disposed within the left atrium LA.
[0087] When the distal anchor 236 of the flanged device 204 is
disposed within the left atrium LA, the outer sheath 208 is
proximally retracted to expose the distal anchor 236, as shown in
FIG. 5. More particularly, the outer sheath actuator mechanism 214
(not shown in FIGS. 4-13) of the handle 206 (not shown in FIGS.
4-13) of the catheter 202 is manipulated to proximally retract the
outer sheath 208. When proximally retracted, the outer sheath 208
releases the distal anchor 236 and the distal anchor 236
self-expands, and transitions from the collapsed state to the
expanded state within the left atrium LA, as shown in FIG. 6.
[0088] When the distal anchor 236 is in the expanded state within
the left atrium LA, the catheter-based system 200 is proximally
retracted to position the proximal surface 264 of the distal anchor
236 adjacent to and engaged with the interatrial septum IAS within
the left atrium LA, as shown in FIG. 7.
[0089] Referring to FIG. 8, when the distal anchor 236 is engaged
with the interatrial septum IAS within the left atrium LA, the
outer sheath actuator mechanism 214 (not shown in FIGS. 4-13) of
the handle 206 (not shown in FIGS. 4-13) is again manipulated to
proximally retract the outer sheath 208 to release the proximal
anchor 234 within the right atrium RA. When the proximal anchor 234
is released from the outer sheath 208, the proximal anchor 234
self-expands and transitions from the collapsed state to the
expanded state within the right atrium RA. The distal surface 258
of the proximal anchor 234 engages the interatrial septum IAS
within the right atrium RA such that the flanged device 204 is
anchored to the interatrial septum IAS.
[0090] Once the flanged device 204 is in the radially expanded
configuration and anchored to the interatrial septum IAS with the
proximal and distal anchors 234, 236 of the flanged device 204
engaged with opposing sides of the interatrial septum IAS, the
catheter-based system 200 is distally advanced and/or deflected to
manipulate, articulate or move the interatrial septum IAS,
deforming the interatrial septum IAS, as shown in FIG. 9.
Manipulation or articulation of the flanged device 204 and the
interatrial septum IAS reduces the angle A.degree. between the
first central axis CA1 extending through the transseptal puncture
and the second central axis CA2 extending through the native mitral
valve.
[0091] With reference to FIG. 10, when the interatrial septum IAS
has been manipulated or articulated by the flanged device 204, an
auxiliary medical device 900 may be advanced through the
catheter-based system 200 to effect desired treatment on the native
mitral valve MV. Once the treatment of the native mitral valve MV
is complete, the auxiliary medical device 900 is retracted from the
catheter-based system 200. As the auxiliary medical device is
retracted proximal of the sealing mechanism 260 of the flanged
device shaft 232, the central lumen 240 is sealed by the sealing
mechanism 260.
[0092] Directing attention next to FIG. 11, when the central lumen
240 of the flanged device shaft 232 has been sealed by the sealing
mechanism 260, the catheter-based system 200 is proximally
retracted. The catheter-based system 200 is proximally retracted to
return the interatrial septum IAS to the native shape.
[0093] In an embodiment, when the interatrial septum IAS is in the
native shape, the handle 206 (not shown in FIGS. 4-13) of the
catheter 202 is rotated in a direction of arrow 280, as shown in
FIG. 12. The catheter 202 is rotated until the catheter 202
uncouples from the flanged device 204. In an alternative
embodiment, when the interatrial septum IAS is in the native shape,
the outer sheath actuation mechanism 214 (not shown in FIGS. 4-13)
is again manipulated to proximally retract the outer sheath 208 to
fully release or deploy the flanged device 204 from the catheter
202. In another alternative embodiment, when the interatrial septum
IAS is in the native shape, one or more elongate tension members
are removed (not shown in FIGS. 4-13) thus uncoupling the flanged
device 204 from the catheter 202.
[0094] With reference to FIG. 13, once the coupling mechanism 246
has been actuated or manipulated to uncouple the flanged device 204
from the catheter 202, the catheter 202 is proximally retracted,
leaving the fully deployed flanged device 204 disposed in the right
and left atriums, and extending through the interatrial septum
IAS.
[0095] Image guidance, e.g., intracardiac echocardiography (ICE),
fluoroscopy, computed tomography (CT), intravascular ultrasound
(IVUS), optical coherence tomography (OCT), or another suitable
guidance modality, or combination thereof, may be used to aid the
clinician's delivery, positioning, and manipulation and/or
articulation of the flanged device 204 and the interatrial septum
IAS. In another embodiment, selected outer surfaces of the flanged
device 204 may be treated to enhance the echogenicity of the
flanged device 204. In some embodiments, image guidance components
(e.g., IVUS, OCT) may be coupled to a distal segment of the
catheter 202 to provide three-dimensional images of the
vasculature/heart to facilitate positioning, orienting, and
manipulation and/or articulation of the flanged device 204 and the
interatrial septum IAS.
[0096] When the catheter 202 has been removed from the patient, the
guide catheter GC may be removed using established percutaneous
transcatheter procedures. The flanged device 204 remains in the
radially expanded configuration at the interatrial septum IAS,
sealing the transseptal puncture TSP.
[0097] FIGS. 14A-15C illustrate a catheter-based system 300
according to another embodiment hereof. The catheter-based system
300 includes a catheter 302 and a flanged device 304. The
catheter-based system 300 is configured to percutaneously support
and manipulate or articulate an interatrial septum of a heart
according to an embodiment of the present invention. In the
embodiment of FIGS. 14A-15C, a proximal anchor of the flanged
device 304 is a proximal anchor balloon 350 and a distal anchor of
the flanged device 304 is a distal anchor balloon 342.
[0098] Referring to the illustrations of FIGS. 14A and 14B, the
catheter 302 includes a handle 306, and outer sheath 308, an inner
shaft 310, a first inflation lumen 312, and a second inflation
lumen 314, as shown in FIG. 14A. The catheter 302 is configured to
deliver, deploy, and manipulate or articulate the flanged device
304 across a transseptal puncture of the interatrial septum of the
heart. The handle 306, the outer sheath 308, and the inner shaft
310 are similar to the handle 206, the outer sheath 208, and the
inner shaft 210 described previously. Therefore similar
construction and alternative details will not be repeated. However,
with the catheter 302 of FIGS. 14A and 14B, the inner shaft 310
includes the first and the second inflation lumen 312, 314 for
transitioning the flanged device 304 between radially collapsed and
radially expanded configurations. While the catheter 302 is shown
as including the outer sheath 308 operably coupled to the handle
306, this is by way of example and not limitation, and it will be
understood that in embodiments hereof the outer sheath 308 is
optional and may be omitted.
[0099] The first inflation lumen 312 extends through the inner
shaft 310, as shown in FIG. 14A, and in an embodiment may be
defined by the inner shaft 310, as shown in the cross-sectional
view of the catheter 302 in FIG. 14B. The first inflation lumen 312
includes a proximal end 336 and a distal end 338 in fluid
communication with a distal anchor balloon inflation port 340, as
shown in FIG. 14A. The distal anchor balloon inflation port 340 is
in fluid communication with an interior of the distal anchor
balloon 342 of the flanged device 304.
[0100] The second inflation lumen 314 also extends through, and may
be defined by, the inner shaft 310, as shown in FIG. 14A and the
cross-sectional view of the catheter 302 of FIG. 14B. The second
inflation lumen 314 includes a proximal end 344 and a distal end
346 in fluid communication with a proximal anchor balloon inflation
port 348. The proximal anchor balloon inflation port 348 is in
fluid communication with an interior of the proximal anchor balloon
350 of the flanged device 304.
[0101] In the embodiment shown, the first inflation lumen 312 and
the second inflation lumen 314 are configured such that the distal
anchor balloon 342 and the proximal anchor balloon 350 of the
flanged device 304 inflate/deflate independent of each other. The
proximal ends 336, 344 of the first and second inflation lumen 312,
314, respectively, allow inflation fluid received through inflation
ports (not shown in FIGS. 14A and 14B) of the handle 306 to be
delivered to the distal and proximal anchor balloons 342, 350
respectively. The handle 306 provides a luer hub or other type of
fitting that may be connected to a source of inflation fluid and
may be of another constructional configuration without departing
from the scope of the present invention. The tool catheter 302 may
have alternate configurations known to one skilled in the art.
Moreover, while described herein with a first and a second
inflation lumen 312, 314, this is by way of example and not
limitation and in another embodiment the catheter 302 may include
only one inflation lumen in fluid communication with both the
proximal and the distal anchor balloons 350, 342.
[0102] FIGS. 15A-15C illustrate the flanged device 304 according to
an embodiment hereof. The flanged device 304 includes the proximal
anchor balloon 350 and the distal anchor balloon 342. The flanged
device 304 includes a radially collapsed configuration for delivery
to an interatrial septum of a heart, wherein the proximal anchor
balloon 350 and the distal anchor balloon 342 are each in a
collapsed state, as shown in FIG. 15A. The flanged device 304
further includes a radially expanded configuration for supporting
and articulating the interatrial septum about a transseptal
puncture, wherein the proximal anchor balloon 350 and the distal
anchor balloon 342 are each in an expanded state, as shown in FIGS.
15B and 15C. More precisely, when the flanged device 304 is in the
radially expanded configuration, the distal anchor balloon 342 is
adjacent to and engaged with the interatrial septum in the left
atrium and the proximal anchor balloon 350 is adjacent to and
engaged with the interatrial septum in the right atrium. Thus, when
the flanged device 304 is in the radially expanded configuration,
the interatrial septum IAS is disposed between the proximal anchor
balloon 350 and the distal anchor balloon 342 and the flanged
device 304 provides support to, and the ability to manipulate or
articulate the interatrial septum.
[0103] The distal anchor balloon 342 is coupled to the inner shaft
310 and includes a proximal surface 352 and a distal surface 354,
as shown in FIG. 15B. The distal anchor balloon 342 is disposed at
a distal portion of the inner shaft 310 and spaced from, the
proximal anchor balloon 350. The distal anchor balloon 342 has a
collapsed state wherein the distal anchor balloon 342 is not
inflated, as shown in FIG. 15A. The distal anchor balloon 342 has
an expanded state, wherein the distal anchor balloon 342 is
inflated via inflation fluid delivered through the first inflation
lumen 312 (as shown in phantom in FIGS. 15A and 15B) to the
interior of the distal anchor balloon 342. When in the expanded
state, the distal anchor balloon 342 radially expands to a general
disc or flat cylindrical shape, as shown in FIGS. 15B and 15C. The
proximal surface 352 of the distal anchor balloon 342 is configured
to engage a wall/surface of the interatrial septum within the left
atrium when the distal anchor balloon 342 is in the expanded state
and the flanged device 304 is disposed at a transseptal puncture in
the interatrial septum. The distal anchor balloon 342 in the
expanded state and engaged with the interatrial septum in the left
atrium is further configured to support the interatrial septum and
to transmit forces applied to the distal anchor balloon 342 across
a large surface area of the interatrial septum engaged with the
proximal surface 352 of the distal anchor balloon 342. The distal
anchor balloon 342 is of a suitable diameter D2 such that forces
applied to the distal anchor balloon 342 may be distributed over a
large surface area of the adjacent interatrial septum such that the
interatrial septum is not damaged during articulation. In a
non-limiting example, the diameter D2 of the distal anchor balloon
342 may be from 10 mm up to 30 mm. The distal anchor balloon 342
may be a non-compliant or semi-compliant balloon constructed of any
suitable material such as, but not limited to polyethylene
terephthalate (PET), nylon, or polyurethane.
[0104] The proximal anchor balloon 350 is coupled to the inner
shaft 310 and includes a proximal surface 356 and a distal surface
358, as shown in FIG. 15B. The proximal anchor balloon 350 is
disposed proximal of, and spaced from, the distal anchor balloon
342. The proximal anchor balloon 350 has a collapsed state wherein
the proximal anchor balloon 350 is not inflated, as shown in FIG.
15A. The proximal anchor balloon 350 further has an expanded state,
wherein the proximal anchor balloon 350 is inflated via inflation
fluid delivered through the second inflation lumen 314 (shown in
phantom in FIGS. 15A and 15B) to the interior of the proximal
anchor balloon 350. When in the expanded state, the proximal anchor
balloon 350 radially expands to a general disc or flat cylindrical
shape, as shown in FIG. 15C. The distal surface 358 of the proximal
anchor balloon 350 is configured to engage a wall/surface of the
interatrial septum within the right atrium when the proximal anchor
balloon 350 is in the expanded state and the flanged device 304 is
disposed at a transseptal puncture in the interatrial septum. The
proximal anchor balloon 350 in the expanded state and engaged with
the interatrial septum in the right atrium is further configured to
support the interatrial septum and to transmit forces applied to
the proximal anchor balloon 350 across a large surface area of the
interatrial septum engaged with the distal surface 358 of the
proximal anchor balloon 350. The proximal anchor balloon 350 is of
a suitable diameter D2 such that forces applied to the proximal
anchor balloon 350 may be distributed over a large surface area of
the adjacent interatrial septum such that the interatrial septum is
not damaged during articulation. Similar to the distal anchor
balloon 342, in a non-limiting example, the diameter D2 of the
proximal anchor balloon 350 may be from 10 mm up to 30 mm. The
proximal anchor balloon 350 may be a non-compliant or
semi-compliant balloon constructed of any suitable material such
as, but not limited to polyethylene terephthalate (PET), nylon, or
polyurethane.
[0105] The interaction of the components of the catheter-based
system 300 to deliver and manipulate or articulate the flanged
device 304 and to further support and manipulate or articulate the
interatrial septum of a heart are similar to the interaction of the
components of the catheter-based system 200 described previously.
However, with the catheter-based system 300, the distal anchor
balloon 342 and the proximal anchor balloon 350 are each inflated
to the expanded state. More specifically, when the distal anchor
balloon 342 is disposed within the left atrium, inflation fluid
under pressure is pumped thorough the first inflation lumen 312,
through the distal anchor balloon inflation port 340 and into the
interior of the distal anchor balloon 342 to transition the distal
anchor balloon 342 from the collapsed state to the expanded state,
as shown in FIG. 16. Similarly, when the proximal anchor balloon
350 is disposed within the right atrium, inflation fluid under
pressure is pumped thorough the second inflation lumen 314, through
the proximal anchor balloon inflation port 348 and into the
interior of the proximal anchor balloon 350 to transition the
proximal anchor balloon 350 from the collapsed state to the
expanded state, as shown in FIG. 18.
[0106] Further, when the desired treatment has been effected and an
auxiliary medical device 900 (not shown in FIGS. 14A-22) has been
proximally retracted from the catheter-based system 300, inflation
fluid may be withdrawn from the anchor balloons 342, 350 to deflate
the anchor balloons 342, 350. In an embodiment, release of
inflation fluid pressure permits inflation fluid to flow out of the
distal and the proximal anchor balloons 342, 350 through the
respective first and second inflation lumen 312, 314 such that the
distal and the proximal anchor balloons 342, 350 transition from
the expanded state to the collapsed state. Accordingly, the flanged
device 304 transitions from the radially expanded configuration to
the radially collapsed configuration, as shown in FIG. 21. The
catheter-based system 300 may then be retracted to remove the
catheter-based system 300 from the patient. A septal occluder
device may be utilized to seal the transseptal puncture in the
interatrial septum.
[0107] FIGS. 16-22 show schematically an embodiment of a method of
delivering, and articulating the flanged device 304 and further
supporting and articulating an interatrial septum IAS of a heart HE
with the catheter-based system 300 of the present disclosure. The
catheter-based system 300 and the flanged device 304 are similar to
the catheter-based system 200 and the flanged device 204 described
previously. However, in the embodiment of FIGS. 16-22, the flanged
device 304, and more precisely the distal anchor balloon 342 and
the proximal anchor balloon 350 must be inflated to transition to
the expanded state. Therefore, details of the method up to the step
of tracking and positioning the catheter-based system within the
left atrium will not be repeated.
[0108] Referring next to FIG. 16, when the distal anchor balloon
342 is positioned within the left atrium, inflation fluid under
pressure is pumped into the first inflation lumen 312 (not shown in
FIGS. 16-22) to transition the distal anchor balloon 342 from the
collapsed state to the expanded state within the left atrium LA. If
the catheter-based system 300 includes the optional outer sheath
308 (not shown in FIGS. 16-22), prior to inflation of the distal
anchor balloon 342, the outer sheath actuator mechanism 318 (not
shown in FIGS. 16-22) of the handle 306 (not shown in FIGS. 16-22)
is manipulated to proximally retract the outer sheath 308 (not
shown in FIGS. 16-22) to release the distal anchor balloon 342.
[0109] When the distal anchor balloon 342 is in the expanded state
within the left atrium LA of the heart HE, the catheter-based
system 300 is proximally retracted to position the proximal surface
352 of the distal anchor balloon 342 adjacent to and engaged with
the interatrial septum IAS within the left atrium LA, as shown in
FIG. 17.
[0110] Referring to FIGS. 17 and 18, when the distal anchor balloon
342 is engaged with the interatrial septum IAS in the left atrium
LA and the proximal anchor balloon 350 is disposed within the right
atrium RA, inflation fluid under pressure is pumped into the second
inflation lumen 314 (not shown in FIGS. 16-22) to transition the
proximal anchor balloon 350 from the collapsed state to the
expanded state within the right atrium RA. When the proximal anchor
balloon 350 transitions from the collapsed state to the expanded
state, the distal surface 358 of the proximal anchor balloon 350,
adjacent the interatrial septum IAS, engages the interatrial septum
IAS within the right atrium RA. If the catheter-based system 300
includes the optional outer sheath 308 (not shown in FIGS. 16-22),
prior to inflating the proximal anchor balloon 350, the outer
sheath actuator mechanism 318 (not shown in FIGS. 16-22) of the
handle 306 (not shown in FIGS. 16-22) is again manipulated to
further proximally retract the outer sheath 308 (not shown in FIGS.
16-22) to release the proximal anchor balloon 350 within the right
atrium RA.
[0111] With the flanged device 304 in the radially expanded
configuration, and the proximal anchor balloon 350 engaged with the
interatrial septum IAS in the right atrium RA and the distal anchor
balloon 342 engaged with the interatrial septum IAS in the left
atrium LA, the catheter-based system 300 is distally advanced
and/or deflected, if the catheter-based system 330 includes a
deflection mechanism, to manipulate or articulate the interatrial
septum IAS. More specifically, the catheter-based system 300 is
distally advanced and/or deflected such that the flanged device
304, supporting the interatrial septum IAS, manipulates or
articulates the interatrial septum, thereby deforming the
interatrial septum IAS, as shown in FIG. 19. The catheter-based
system 300 is distally advanced to decrease the angle A.degree.
between the first central axis CA1 extending through the
transseptal puncture and the second central axis CA2 extending
through the native mitral valve from an angle A.degree. (as shown
in FIG. 1) when the interatrial septum is not manipulated or
articulated.
[0112] When the interatrial septum IAS has been manipulated or
articulated by the flanged device 304, an auxiliary medical device
may be advanced through the catheter-based system 300 to effect
desired treatment on the native mitral valve MV. When the treatment
of the native mitral valve MV is complete, the auxiliary medical
device is retracted from the catheter-based system 300.
[0113] When the auxiliary medical device has been removed from the
catheter-based system 300, the catheter-based system 300 is
proximally retracted to return the interatrial septum IAS to the
native shape or orientation, as shown in FIG. 20.
[0114] Referring to FIG. 21, when the interatrial septum IAS has
returned to the native shape or orientation, the inflation fluid
pressure is removed from the first and the second inflation lumen
312, 314 (not shown in FIGS. 16-22), to transition the distal and
proximal anchor balloons 342, 350 each to the collapsed state. In
an embodiment, a vacuum is placed on the first and second inflation
lumen 312, 314 to retain the distal and proximal anchor balloons
342, 350 each in the collapsed state. In embodiments with an outer
sheath 308 (not shown in FIGS. 16-22), when the proximal and the
distal anchor balloons 350, 342 are each in the collapsed state,
the outer sheath 308 is distally advanced to encapsulate the
uninflated proximal and distal anchor balloons 350, 342.
[0115] The catheter-based system 300 with the flanged device 304
may then be proximally retracted to remove them from the patient
using established percutaneous transcatheter procedures, as shown
in FIG. 22. With the flanged device 304 removed from the patient,
the transseptal puncture TSP in the interatrial septum IAS may be
sealed by known methods.
[0116] Image guidance, e.g., intracardiac echocardiography (ICE),
fluoroscopy, computed tomography (CT), intravascular ultrasound
(IVUS), optical coherence tomography (OCT), or another suitable
guidance modality, or combination thereof, may be used to aid the
clinician's delivery, positioning, and manipulation and/or
articulation of the flanged device 304 and the interatrial septum
IAS. In another embodiment, selected outer surfaces of the flanged
device 304 may be treated such that the echogenicity of the flanged
device 304 is enhanced. In some embodiments, image guidance
components (e.g., IVUS, OCT) may be coupled to a distal segment of
the catheter 302 to provide three-dimensional images of the
vasculature to facilitate positioning, orienting, and manipulation
and/or articulation of the flanged device 304 and the interatrial
septum IAS.
[0117] While various embodiments have been described above, it
should be understood that they have been presented only as
illustrations and examples of the present technology, and not by
way of limitation. It will be apparent to persons skilled in the
relevant art that various changes in form and detail may be made
therein without departing from the spirit and scope of the present
technology. Thus, the breadth and scope of the present technology
should not be limited by any of the above-described embodiments,
but should be defined only in accordance with the appended claims
and their equivalents. It will also be understood that each feature
of each embodiment discussed herein, and of each reference cited
herein, may be used in combination with the features of any other
embodiment. All patents and publications discussed herein are
incorporated by reference herein in their entirety.
* * * * *