U.S. patent application number 15/061549 was filed with the patent office on 2016-09-08 for devices for treating paravalvular leakage and methods use thereof.
The applicant listed for this patent is Mitralign, Inc.. Invention is credited to Steven Cahalane, Jason Robinson.
Application Number | 20160256269 15/061549 |
Document ID | / |
Family ID | 56849475 |
Filed Date | 2016-09-08 |
United States Patent
Application |
20160256269 |
Kind Code |
A1 |
Cahalane; Steven ; et
al. |
September 8, 2016 |
DEVICES FOR TREATING PARAVALVULAR LEAKAGE AND METHODS USE
THEREOF
Abstract
An aspect of the present teachings includes a method of
percutaneously treating a paravalvular leakage. In a preferred
embodiment, the method includes providing an anchor having an
elongate anchor member and a tensioning member, positioning the
anchor through a paravalvular leakage, deploying the anchor wherein
at least a part of the distal portion of the elongate anchor member
is on one side of the paravalvular leakage, and applying tension to
the tensioning member so that at least a part of the distal portion
of the elongate anchor member transitions from the elongate
configuration to the shortened configuration. Another aspect of the
present teachings includes a device that can be used in a method of
percutaneously treating a paravalvular leakage.
Inventors: |
Cahalane; Steven; (Pelham,
NH) ; Robinson; Jason; (Windham, NH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Mitralign, Inc. |
Tewksbury |
MA |
US |
|
|
Family ID: |
56849475 |
Appl. No.: |
15/061549 |
Filed: |
March 4, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62128997 |
Mar 5, 2015 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00004
20130101; A61B 17/12022 20130101; A61B 2017/0406 20130101; A61B
2017/00619 20130101; A61F 2250/0069 20130101; A61B 2017/00606
20130101; A61F 2/24 20130101; A61F 2220/0075 20130101; A61B
2017/0419 20130101; A61B 2017/00575 20130101; A61B 17/0057
20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. A method of percutaneously treating a paravalvular leakage
comprising the steps of: providing an anchor, wherein the anchor
comprises an elongate anchor member and a tensioning member,
wherein the elongate anchor member comprises a distal portion and a
first set of openings along a length of the elongate anchor member,
and the tensioning member passes through at least two of the first
set of openings, wherein the anchor has an elongate configuration
and a shortened configuration; positioning the anchor through a
paravalvular leakage; deploying the anchor wherein at least a part
of the distal portion of the elongate anchor member is on one side
of the paravalvular leakage; and applying tension to the tensioning
member so that at least a part of the distal portion of the
elongate anchor member transitions from the elongate configuration
to the shortened configuration.
2. The method of claim 1, wherein the elongate anchor member
comprises a proximal portion.
3. The method of claim 1, wherein the elongate anchor member
comprises a second set of openings.
4. The method of claim 2, wherein the tensioning member extends
from the proximal portion to the distal portion of the elongate
anchor member.
5. The method of any of claim 2, wherein the tensioning member
extends from the distal portion to the proximal portion of the
elongate anchor member.
6. The method of claim 5, wherein the tensioning member passes
through at least two of the first set of openings.
7. The method of claim 5, wherein the tensioning member passes
through at least two of the second set of openings.
8. The method of claim 1, wherein the elongate anchor member
comprises a first folding line and a second folding line, the first
folding line being at an angle with respect to the second folding
line.
9. The method of claim 2, further comprising the step of deploying
the anchor wherein at least a part of the proximal portion of the
elongate anchor member is on the other side of the paravalvular
leakage.
10. The method of claim 2, further comprising the step of applying
tension to the tensioning member so that at least a part of the
proximal portion of the elongate anchor member transitions from the
elongate configuration to the shortened configuration.
11. The method of claim 1, further comprising the step of
introducing a catheter approximately at the paravalvular
leakage.
12. The method of claim 11 further comprising the step of
withdrawing the catheter to deploy the anchor wherein at least a
part of the distal portion of the elongate anchor member is on one
side of the paravalvular leakage.
13. The method of claim 11, further comprising the step of
withdrawing the catheter to deploy the anchor wherein at least a
part of the proximal portion of the elongate anchor member is on
the other side of the paravalvular leakage.
14. The method of claim 1 comprising the step of locating the
paravalvular leakage.
15. The method of claim 1, wherein the elongate anchor member
comprises a plurality of panels, wherein a least one of the
plurality of panels is defined by a first folding line and a second
folding line.
16. The method of claim 18, wherein at least two of the plurality
of panels are at least one of substantially overlapping and
partially overlapping in the shortened configuration.
17. The method of claim 15, wherein the applying of tension of the
tensioning member causes at least two of the plurality of panels to
fold along one of the first and second folding line.
18. The method of claim 1, wherein the anchor comprises a second
elongate anchor member proximally to the elongate anchor
member.
19. The method of claim 18, further comprising the steps of:
deploying the anchor, wherein at least a part of the second
elongate anchor member is on the other side of the paravalvular
leakage; applying tension to the tensioning member so that at least
a part of the second elongate anchor member transitions from the
elongate configuration to the shortened configuration;
20. The method of claim 19, further comprising introducing a
catheter approximately at the paravalvular leakage.
21. The method of claim 20, further comprising the step of
withdrawing the catheter to deploy the anchor wherein at least a
part of the elongate anchor member is on one side of the
paravalvular leakage.
22. The method of claim 20, further comprising the step of
withdrawing the catheter to deploy the anchor wherein at least a
part of the second elongate anchor member is on the other side of
the paravalvular leakage.
23. An anchor for use in repairing a paravalvular leakage
comprising: an elongate anchor member, wherein the elongate anchor
member comprises two or more folding lines and two or more panels
and two of the two or more panels fold toward each other along one
of the two or more folding lines.
24. The anchor of claim 23, wherein at least two of the two or more
folding lines are parallel to each other.
25. The anchor of claim 23, wherein at least two of the two or more
folding lines are at an angle.
26. The anchor of claim 23, wherein two of the two or more panels
are substantially overlapping.
27. The anchor of claim 23, wherein two of the two or more panels
are partially overlapping.
28. The anchor of claims 23, further comprising a tensioning
member.
29. The anchor of claim 23, wherein the elongate anchor member
comprises a first set of openings and a second set of openings
along a length of the elongate anchor member, wherein the
tensioning member passes through at least two of the first set of
openings and passes through at least two of the second set of
openings.
30. A device for repairing a paravalvular leakage comprising: a
catheter and an anchor, wherein the catheter comprises a distal end
and a lumen having an opening at the distal end, and the anchor is
provided at least partially in the lumen and comprises an elongate
anchor member and a tensioning member, wherein the elongate anchor
member comprises a distal portion and a first set of openings along
a length of the elongate anchor member; and the tensioning member
passes through at least two of the first set of openings.
31. The device of claim 30, wherein the elongate anchor member
comprises a proximal portion.
32. The device of claim 30, wherein the elongate anchor member
comprises a second set of openings along a length of the elongate
anchor member.
33. The device of claim 31, wherein the tensioning member extends
from the proximal portion to the distal portion.
34. The device of claim 31, wherein the tensioning member extends
from the distal portion to the proximal portion.
35. The device of claim 32, wherein the tensioning member passes
through at least two of the second set of openings.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is based on and claims priority to U.S.
Provisional Patent Application 62/128,997, filed Mar. 5, 2015, the
entire contents of which is incorporated by reference herein as if
expressly set forth in its respective entirety herein.
BACKGROUND
[0002] Paravalvular leakage is a complication associated with the
implantation of a prosthetic valve. It may occur both in
traditional surgical or minimally invasive transcatheter
approaches. FIG. 1 illustrates an artificial valve 1600 that may
include, for example, a multi-leaflet structure 1602 and that may
be implemented in an appropriate manner as will be appreciated by
those of ordinary skill in the art. Additionally, a small opening
or space 1604 between the heart 1606 and the valve 1600 is shown as
may occur in some instances of valve replacement. This opening or
space 1604 results in undesired leaking during pumping of the heart
and is termed a valvular or paravalvular leak.
[0003] Accordingly, devices and methods are needed for correcting
paravalvular leakage after implantation of a stented prosthetic
valve.
BRIEF SUMMARY OF THE INVENTION
[0004] One aspect of the present teachings includes an anchor for
treating a paravalvular leakage. In various embodiments, the anchor
includes at least one elongate anchor member. In some embodiments,
the anchor includes one elongate anchor member. In some
embodiments, the anchor includes two elongate anchor members. In
yet other embodiments, the anchor includes three or more elongate
anchor members. In certain embodiments, the two, three, or more
elongate anchor members are made of a same material. In certain
other embodiments, the two, three, or more elongate anchor members
are made of different materials.
[0005] In some embodiments, the anchor has an elongate
configuration where the elongate anchor member is relaxed and
extended. In some embodiments, the anchor has a shortened
configuration when the elongate anchor member(s) is folded or
otherwise shortened. In certain embodiments, the anchor is in its
shortened configuration when deployed and/or secured.
[0006] According to various embodiments of the present teachings,
the elongate anchor member is made of a flexible material. In some
embodiments, the flexible material is a surgical grade fabric. The
elongate anchor member may also take various forms such as woven or
nonwoven fabrics, polymers, metals, other suitable materials, or
combinations thereof. For example, the surgical grade fabric used
in various embodiments of the present teachings can be constructed
from a polyester, such as Dacron.RTM., RTM, PTFE, UHMPE, HDPE,
polypropylene, polysulfone, or other biocompatible plastic.
[0007] In various embodiments, the elongate anchor member causes a
tissue response, for example, tissue growth. In some embodiments,
the surface finish of the anchor member is textured to induce
tissue response and tissue in-growth for improved stabilization. In
other embodiments, the anchor member comprises porous materials to
promote tissue in-growth.
[0008] In various embodiments, one or more of the edges and/or
other portions of the anchor member are modified, for example, to
prevent from fraying. In some embodiments, one or more of the edges
or other portions of the anchor member are coated with a material
that locks the fibers in place. Other methods can also be used to
lock the fibers at one or more edges of the anchor member in
place.
[0009] In various embodiments, the anchor includes at least one
tensioning member. In some embodiments, the tensioning member
causes both ends of the elongate anchor member to move towards each
other. This motion can create a shortened distal portion and/or a
shortened proximal portion. In certain embodiments, doing so
secures the paravalvular leakage between the distal and the
proximal portions of the elongate anchor member.
[0010] In embodiments where an anchor of the present teachings
includes two elongate anchor members, the tensioning member causes
at least one of the two elongate anchor members to move towards the
other elongate anchor member. In certain embodiments, the
tensioning member causes both of the elongate anchor members to
move towards each other. In embodiments where an anchor of the
present teachings includes three or more elongate anchor members,
the tensioning member causes at least one of the three or more
elongate anchor members to move towards another elongate anchor
member. In certain embodiments, the tensioning member causes all of
the three or more elongate anchor members to move towards one
another. This motion can create shorten elongate anchor members. In
certain other embodiments, doing so secures the paravalvular
leakage between two of the elongate anchor members.
[0011] According to various embodiments of the present teachings,
the tensioning member is in the form of a suture, as defined
herein. It will be appreciated that the tensioning member may take
forms other than a suture, such as any other small-diameter members
having a suitable tensile strength for the intended anchoring
use.
[0012] In various embodiments, one or both of the tensioning member
and the elongate anchor member are made of a resorbable polymer. In
some embodiments, such a resorbable polymer is polyactic acid,
polyglycolic acid, polycaprolactone, or a combination thereof.
Other resorbable polymers that are known to those skilled in the
art can also be used without undue experimentation and thus are
within the scope of the present teachings. In various embodiments,
the material that is used to make the anchor, i.e., the elongate
anchor member(s), the tensioning member, or both, is multilayered.
In some embodiments, the material includes a coating of resorbable
polymer. In other some embodiments, the materials includes a
semipermeable polymer that optionally is impregnated with one or
more of the compounds discussed herein. In certain embodiments, the
one or more compounds is released in a controlled manner.
[0013] In various embodiments, the anchor, including the elongate
anchor member(s), the tensioning member, or both, includes one or
more compounds that address issues associated with the product
performance. For example, one or more compounds can be embedded in
the anchor member. In certain embodiments, the one or more
compounds are released over time after implantation. These
compounds can reduce calcification, protein deposition, thrombus
formation, or a combination of some or all of these conditions. The
one or more compounds can also be used to stimulate a biological
response, for example, to induce tissue in-growth. In some
embodiments, the compound is an anti-inflammatory agent. In some
embodiments, the compound reduces tissue proliferation adjacent to
the device. One with ordinary skill in the art would understand
that numerous agents are available for the above applications and
can select such an agent without undue experimentation for each of
the applications. As such, anchors having one or more of the
numerous agents are within the scope of the present teachings.
[0014] In various embodiments, the tensioning member extends
through openings along the elongate anchor member as described
herein such that tightening the tensioning member will cause the
elongate anchor member to fold. Although certain examples of anchor
deployment are described herein, one with ordinary skill in the art
would appreciate that deployment of the anchor may take on various
forms due to the flexible nature of the anchor member, especially
when a highly flexible fabric or other materials is used. For
example, a fabric material or other similarly flexible materials
may be folded or otherwise deformed during a deployment to a
leakage site.
[0015] Another aspect of the present teachings includes methods of
treating a paravalvular leakage. In various embodiments, the method
includes providing an anchor as described herein, positioning the
anchor through a paravalvular leakage, deploying the anchor where
at least a part of the distal portion of the elongate anchor member
is on one side of the paravalvular leakage. In various embodiments,
the method includes applying tension to the tensioning member so
that at least a part of the distal portion of the elongate anchor
member transitions from the elongate configuration to the shortened
configuration. In various embodiments, the method includes
deploying the anchor wherein at least a part of the proximal
portion of the elongate anchor member is on the other side of the
paravalvular leakage. In various embodiments, the method includes
applying tension to the tensioning member so that at least a part
of the proximal portion of the elongate anchor member transitions
from the elongate configuration to the shortened configuration.
[0016] In various embodiments, the method includes providing an
anchor as described herein, positioning the anchor through a
paravalvular leakage, deploying the anchor where at least a part of
a first elongate anchor member is on one side of the paravalvular
leakage. In various embodiments, the method includes applying
tension to the tensioning member so that at least a part of the
first elongate anchor member transitions from the elongate
configuration to the shortened configuration. In various
embodiments, the method includes deploying the anchor wherein at
least a part of a second elongate anchor member is on the other
side of the paravalvular leakage. In various embodiments, the
method includes applying tension to the tensioning member so that
at least a part of the second elongate anchor member transitions
from the elongate configuration to the shortened configuration. And
in these embodiments, the anchor used in repairing a paravalvular
leakage can include two or more elongate anchor members and a
tensioning member can pass through one, two, or more of the
elongate anchor members.
[0017] In various embodiments, anchors of the present teachings is
used percutaneously. For example, the anchors are delivered
percutaneously. In other embodiments, anchors of the present
teachings are used in minimally invasive surgeries. In yet other
embodiments, anchors of the present teachings are used in
open-heart surgeries.
[0018] In various embodiments, the method includes introducing a
catheter approximately at the paravalvular leakage site. In some
embodiments, the method includes withdrawing the catheter to deploy
the anchor where at least a part of the distal portion of the
elongate anchor member is on one side of the paravalvular leakage.
In some embodiments, the method includes withdrawing the catheter
to deploy the anchor wherein at least a part of the proximal
portion of the elongate anchor member is on the other side of the
paravalvular leakage. In some embodiments, the method includes
withdrawing the catheter to deploy the anchor where at least a part
of a first elongate anchor member is on one side of the
paravalvular leakage. In some embodiments, the method includes
withdrawing the catheter to deploy the anchor wherein at least a
part of a second elongate anchor member is on the other side of the
paravalvular leakage.
[0019] In various embodiments, a clinician deploys a plurality of
anchors in a paravalvular leakage, when necessary and
practical.
[0020] In various embodiments, upon deployment, at least half
number of the folds is distal to the paravalvular leakage and the
rest of the folds are proximal to the paravalvular leakage. In
other embodiments, upon deployment, less than half of the folds are
distal to the paravalvular leakage and the rest of the folds are
proximal to the paravalvular leakage. In yet other embodiments,
upon deployment, more than half of the folds are distal to the
paravalvular leakage and the rest of the folds are proximal to the
paravalvular leakage.
[0021] In various embodiments, upon deployment, at least some of
the folds is distal to the paravalvular leakage. In various
embodiments, upon deployment, at least some of the folds are
proximal to the paravalvular leakage. In other embodiments, upon
deployment, less than half of the folds are distal to the
paravalvular leakage. In other embodiments, upon deployment, less
than half of the folds are proximal to the paravalvular leakage. In
yet other embodiments, upon deployment, more than half of the folds
are distal to the paravalvular leakage. In yet other embodiments,
upon deployment, more than half of the folds are proximal to the
paravalvular leakage.
[0022] In various embodiments, upon deployment, at least one of the
folds is in the paravalvular leakage. In some embodiments, upon
deployment, at least some of the folds are distal to the
paravalvular leakage and at least one of the folds is in the
paravalvular leakage. In some embodiments, at least some of the
folds are proximal to the paravalvular leakage and at least one of
the folds is in the paravalvular leakage. In certain embodiments,
upon deployment, at least some of the folds are distal to the
paravalvular leakage, at least one of the folds is in the
paravalvular leakage, and at least some of the folds are proximal
to the paravalvular leakage.
[0023] In various embodiments, upon deployment, at least a part of
a first anchor member is distal to the paravalvular leakage. In
various embodiments, upon deployment, at least a part of a second
anchor member is proximal to the paravalvular leakage. In various
embodiments, upon deployment, at least a part of an anchor member
is in the paravalvular leakage. In some embodiments, upon
deployment, at least a part of a first anchor member is distal to
the paravalvular leakage and at least a part of a second anchor
member is proximal to the paravalvular leakage. In certain
embodiments, upon deployment, at least a part of a first anchor
member is distal to the paravalvular leakage, at least a part of a
second anchor member is proximal to the paravalvular leakage, and
at least a part of a third anchor member is in the paravalvular
leakage.
[0024] In various embodiments, the elongate anchor member also
includes a marker. The marker can be in the form of threads, beads,
or other forms. Without limiting the scope of the present
teachings, the marker allows the anchor member to be visualized by
using a radiographic imaging equipment using x-ray, magnetic
resonance, ultrasound, fluoroscopic, or other visualization
techniques. In some embodiments, markers are attached to the anchor
member. For example, the markers can be wrapped, laminated, and/or
bonded through a welding process. An adhesive such as cyanoacrylate
or other adhesives known to those skilled in the art can also be
used to attach a marker to the anchor member.
[0025] In some embodiments, the marker is a radiopaque marker. In
certain embodiments, the radiopaque marker is made of titanium,
tungsten, platinum, irridium, gold, an alloy of any of these
materials, or a composite having any of the above materials. Other
materials that are known to those skilled in the art can also be
used.
[0026] In some embodiments, the marker is a paramagnetic marker. In
certain embodiments, the paramagnetic marker is made of a material
containing gadolinium, iron, platinum, manganese, cobalt, fluorine,
or other paramagnetic materials. In yet other embodiments, the
markers each comprises other MR visible materials that are known to
those skilled in the arts.
[0027] In some embodiments, the marker is an echogenic marker. In
certain embodiments, the echogenic marker is made of a material
that is capable of reflecting increased ultrasound waves. Some
echogenic materials are described herein elsewhere.
[0028] In various embodiments, the marker protrudes out of or is
flush with the anchor. In various embodiments, the markers are
arranged on the implant in a pattern.
[0029] In various embodiments, the anchor or a component thereof is
treated so that the anchor or a part thereof is visible under a
visualization technique. In some embodiments, the visualization
technique is based on ultrasound. For example, the visualization
technique is echocardiography. In some embodiments, an elongate
anchor member of the present teachings is treated so that it is
visible in a visualization technique. In certain embodiments, a
part of the elongate anchor member is treated so that it is visible
in a visualization technique. In some embodiments, a marker of the
present teachings is treated so that it is visible in a
visualization technique. In some embodiments, the treatment is
performed on a surface of an anchor or a component thereof. In
certain embodiments, a surface of at least a part of the elongate
anchor member is treated so that the elongate anchor member is
visible in a visualization technique. In certain embodiments, a
surface of at least a part of the marker is treated so that the
marker is visible in a visualization technique.
[0030] In various embodiments, the treatment is performed with an
echogenic material. For example, the material can contain fluorine
element. In some embodiments, the material includes a perfluoro
compound. In certain embodiments, the material includes perflutren.
In certain embodiments, the material includes perflexane. In
certain embodiments, the material includes sulfur hexafluoride. In
other embodiments, the material includes another echogenic material
known to persons with ordinary skill in the art.
[0031] In various embodiments, the method includes locating a
paravalvular leakage. For example, a paravalvular leakage can be
detected and/or located by using echocardiography, computed
tomography (CT), or cardiac magnetic resonance. In some
embodiments, the method includes locating a paravalvular leakage by
using echocardiography.
[0032] Yet another aspect of the present teachings includes a
device used to treat a paravalvular leakage. In various
embodiments, the device includes a catheter and an anchor as
described herein. In some embodiments, the catheter includes a
distal end and a lumen having an opening at the distal end. In some
embodiments, the anchor is provided at least partially in the
lumen.
BRIEF DESCRIPTION OF DRAWINGS
[0033] Without wishing to narrow the scope of the enclosed claims,
the present teachings may best be understood by reference to the
following description taken in conjunction with the accompanying
drawings in which:
[0034] FIG. 1 shows an artificial valve implanted into a heart
having a paravalvular leakage,
[0035] FIG. 2 is a perspective view of an exemplary anchor in
accordance with the present teachings,
[0036] FIG. 3A is a side view of an anchor positioned in a
paravalvular leakage in accordance with some embodiments of the
present teachings,
[0037] FIG. 3B is a side view similar to FIG. 3A, but illustrating
the distal portion of the exemplary anchor being moved toward the
paravalvular leakage,
[0038] FIG. 3C is a side view similar to FIG. 3B, but showing the
distal portion of the exemplary anchor fully compressed and engaged
against the paravalvular leakage,
[0039] FIG. 3D is a side view similar to FIG. 3C but illustrating
the proximal portion of the exemplary anchor being moved toward the
paravalvular leakage,
[0040] FIG. 3E illustrates the proximal and distal portions of the
exemplary anchor fully compressed against opposite sides of the
paravalvular leakage,
[0041] FIG. 3F is an enlarged cross sectional view of an exemplary
anchor fully deployed and fastened with a paravalvular leakage
between proximal and distal anchor portions,
[0042] FIG. 3G is a side view of an anchor positioned in a
paravalvular leakage in accordance with some embodiments of the
present teachings,
[0043] FIG. 3H is a side view similar to FIG. 3A, but illustrating
the distal portion of the exemplary anchor being moved toward the
paravalvular leakage,
[0044] FIG. 3I is a side view similar to FIG. 3B, but showing the
distal portion of the exemplary anchor fully compressed and engaged
against the paravalvular leakage,
[0045] FIG. 3J is a side view similar to FIG. 3C but illustrating
the proximal portion of the exemplary anchor being moved toward the
paravalvular leakage,
[0046] FIG. 3K is a side view similar to FIG. 3C but illustrating
the proximal portion of the exemplary anchor being moved toward the
paravalvular leakage,
[0047] FIG. 3L is an enlarged cross sectional view of an exemplary
anchor fully deployed and fastened with a paravalvular leakage
between proximal and distal anchor portions,
[0048] FIG. 4 is a side elevation view of an exemplary anchor in
accordance with some embodiments of the present teachings,
[0049] FIGS. 5A-5D are respective side views illustrating a
sequence of steps used for securing the anchor to a paravalvular
leakage in accordance with some embodiments of the present
teachings,
[0050] FIG. 5E is a view similar to FIG. 5D, but illustrating an
alternative tip and tensioning member arrangement in accordance
with some embodiments of the present teachings,
[0051] FIG. 6A is a front view of the elongate anchor member of an
anchor in accordance with some embodiments of the present
teachings,
[0052] FIG. 6B is a front elevation view similar to FIG. 6A, but
illustrating radiopaque markers in accordance with some embodiments
of the present teachings,
[0053] FIG. 6C is a front elevation view of an alternative elongate
anchor member having a varying width along its length in accordance
with some embodiments of the present teachings,
[0054] FIG. 6D is a side elevation view of another alternative
elongate anchor member utilizing more rigid fold sections separated
by living hinges in accordance with some embodiments of the present
teachings,
[0055] FIG. 7A is a perspective view of an anchor in accordance
with some embodiments of the present teachings,
[0056] FIG. 7B is a perspective view of an anchor in accordance
with some embodiments of the present teachings,
[0057] FIG. 7C is a perspective view of an anchor in accordance
with some embodiments of the present teachings,
[0058] FIG. 8 is a perspective view of an anchor in accordance with
some embodiments of the present teachings,
[0059] FIG. 9 is a perspective view of an anchor in accordance with
some embodiments of the present teachings,
[0060] FIG. 10A is a perspective view of an anchor in accordance
with some embodiments of the present teachings,
[0061] FIG. 10B is a side elevation view of the anchor in FIG.
10A,
[0062] FIG. 11 is a perspective view of an exemplary anchor
deployed across a paravalvular leakage in accordance with the
present teachings,
[0063] FIG. 12A is a perspective view of an anchor in accordance
with some embodiments of the present teachings,
[0064] FIG. 12B is a cross-sectional view of an anchor deployed
across a paravalvular leakage in accordance with some embodiments
of the present teachings,
[0065] FIG. 12C is a side elevation view of the anchor of FIGS.
12A-12B, and
[0066] FIG. 12D is top plan view of the anchor of FIGS.
12A-12B.
DETAILED DESCRIPTION
[0067] Certain specific details are set forth in the following
description and Figures to provide an understanding of various
embodiments of the present teachings. Those of ordinary skill in
the relevant art will understand that various features of the
present teachings may be used alone or in numerous combinations
depending on the needs and preferences of the user. Those skilled
in the art can also practice other embodiments of the present
teachings without one or more of the details described below. Thus,
it is not the intention of the present teachings to restrict or in
any way limit the scope of the appended claims to such details.
While various processes are described with reference to steps and
sequences in the following disclosure, the steps and sequences of
steps should not be taken as required to practice all embodiments
of the present teachings.
[0068] As used herein, the term "proximal" means closest to the
operator (less into the body) and "distal" means furthest from the
operator (further into the body). In positioning a medical device
from a downstream access point, distal is more upstream and
proximal is more downstream.
[0069] As used herein, the term "tensioning member" means a member
which can take forms of a suture, cable, wire, or any other small
diameter, flexible, semi-rigid or rigid material having a suitable
tensile strength for the intended use. In addition, as used herein,
the term "wire" can be a strand, a cord, a fiber, a yarn, a
filament, a cable, a thread, or the like, and these terms may be
used interchangeably.
[0070] The term "suture" used herein can be a strand, a wire, a
cord, a fiber, a yarn, a filament, a cable, a thread, or the like,
and these terms may be used interchangeably.
[0071] Unless otherwise specified, all numbers expressing
quantities, measurements, and other properties or parameters used
in the specification and claims are to be understood as being
modified in all instances by the term "about." Accordingly, unless
otherwise indicated, it should be understood that the numerical
parameters set forth in the following specification and attached
claims are approximations. At the very least, and not as an attempt
to limit the application of the doctrine of equivalents to the
scope of the claims, numerical parameters should be read in light
of the number of reported significant digits and the application of
ordinary rounding techniques.
[0072] Unless otherwise defined, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this present teachings belong.
Methods and materials similar or equivalent to those described
herein can be used in the practice or testing of the present
teachings. In case of conflict, the patent specification, including
definitions, will control. In addition, the materials, methods, and
examples are illustrative only and not intended to be limiting.
[0073] It will be appreciated that like reference numerals are used
herein to refer to like elements in all embodiments and reference
numerals with prime marks (') or double prime marks ('') refer to
like elements that have been modified in a manner as described
herein or otherwise shown in the associated Figure.
[0074] Referring first to FIG. 2, an anchor 10 constructed in
accordance with some embodiments of the present teachings generally
includes a tensioning member 12, such as a suture, extending
through spaced apart points along an elongate anchor member 14 of
flexible material, such as a surgical grade fabric. It will be
appreciated that the tensioning member 12 may take other forms
other than suture material, such as cable or any other small
diameter member having a high enough tensile strength for the
intended use. The elongate anchor member 14 may also take various
forms such as woven or nonwoven fabrics, polymers, metals, or other
suitable materials or combinations of materials. One or more
separate pledgets or other securement members (not shown) may be
used in conjunction with the elongate anchor member 14 for added
securement and/or concealing the elongate anchor member 14 and, for
example, thereby inhibiting blood clotting within or adjacent to
the folds that will be formed in the elongate anchor member 14.
[0075] A woven or nonwoven material may contain additional
materials, such as threads, beads or other elements that cause at
least portions of the elongate anchor member 14 to be radiopaque.
Currently, a surgical grade fabric constructed from polyester, such
as Dacron.RTM., is contemplated for use in constructing the
elongate anchor member 14. One of many possible alternative
materials for use in constructing the elongate anchor member 14 is
polytetrafluoroethylene (PTFE). Anchor 10 may be partly or wholly
formed from materials that are absorbed into the patient's tissue
over time, depending on the intended use. The edges and/or other
portions of the elongate anchor member 14 may be suitably modified
to prevent fraying, such as by being coated with a material that
locks the fibers in place, or otherwise modified in a manner that
locks the fibers at least at the edges of the elongate anchor
member 14 in place.
[0076] The suture 12 may extend from a proximal portion 14a of the
elongate anchor member 14 to a distal end portion 14b and then loop
back through spaced apart points of the elongate anchor member 14
to the proximal portion 14a where a knot 16 or other stop member is
located. As will become apparent, the suture 12 extends through
spaced apart locations along the elongate anchor member 14 such
that tensioning of the suture 12 or other tensioning member will
cause the elongate anchor member 14 to form folded portions 14c
when the tensioning member 12 is placed under tension or pulled.
Thus, the elongate anchor member 14 is activated in this manner
between essentially an elongate configuration, such as shown in
FIG. 2, and a shortened configuration, such as a folded or
otherwise shortened configuration having an expanded width in at
least one dimension as compared to the elongate configuration. It
will be appreciated that the deployment orientation may take on
various forms due to the flexible nature of the elongate anchor
member 14, especially when using a highly flexible fabric or other
material. For example, a fabric material or other similarly
flexible materials may be folded or otherwise deformed for carrying
purposes within a catheter and/or during deployment to a
paravalvular leakage site and then suitably activated at the
leakage site.
[0077] More specifically referring to FIGS. 3A-3E, the elongate
anchor member 14 and attached suture 12 are initially inserted
through a paravalvular leakage site 20 as generally shown in FIG.
3A. One end or portion 12a of the suture 12 is then pulled and
thereby placed under tension. It will be appreciated that, for
catheter-based procedures, suture portion 12a may extend to a
location outside the patient's body for pulling or tensioning, or
it may be grasped by a suitable mechanism within the catheter and
pulled or tensioned. Pulling suture portion 12a may initially draw
the distal portion 14b of the elongate anchor member 14 toward the
paravalvular leakage site 20 as shown in FIG. 3B. Once the distal
portion 14b is compressed against the leakage site 20, the proximal
portion 14a begins to be drawn and compressed against a proximal
side of the paravalvular leakage site 20 as shown in FIGS. 3C-3E.
This occurs because end 12a of the suture 12 is being pulled
downwardly (as viewed for purposes of discussion in FIGS. 3C-3E)
and, since the suture 12 is looped in a reverse direction through
distal end portion 14b of the elongate anchor member 14, the knot
16 at the end of the suture 12 moves upwardly and brings the
proximal portion 14a of the elongate anchor member 14 with it. In
this manner, the proximal portion 14a of the elongate anchor member
14 is being folded and drawn along the suture 12 toward the
paravalvular leakage 20 and then firmly compressed against the
proximal side of the paravalvular leakage 20 as shown in FIG. 3E.
As further shown in FIG. 3F, a suitable locker element, such as a
crimp member 22, a knot or other element may be used to maintain
the suture 12 and elongate anchor member 14 in the positions shown
in FIG. 3F securely anchoring the proximal and distal portions 14a,
14b of the elongate anchor member 14 folded against opposite sides
of the paravalvular leakage 20.
[0078] Anchors having two or more elongate anchor members can also
be used to repair a paravalvular leakage. Thus, as shown in FIG.
3G, in various embodiments, an anchor includes a distal elongate
anchor member 14b', a proximal elongate anchor member 14a', and a
tensioning member 12 slideably connecting the distal elongate
anchor member 14b' and the proximal elongate anchor member 14a'. In
some embodiments, one end of the tensioning member passes through
the proximal elongate anchor member 14a' and the distal elongate
anchor member 14b', loops back, passes through the distal elongate
anchor member 14b' and the proximal elongate anchor member 14a',
and forms a knot 16 around the tensioning member 12. In certain
embodiments, the other end, or the proximal end 12a', of the
tensioning member extends through a delivery catheter and exists
outside of the body. The passing through an elongate anchor member
can be achieved by passing through one or two holes in the elongate
anchor member or threading through the elongate anchor member
itself.
[0079] Thus, the method of repairing a paravalvular leakage, in
some embodiments, includes, as shown in FIG. 3G, inserting the
distal elongate anchor member 14b' and attached tensioning member
12 through a paravalvular leakage 20. In some embodiments, the
method includes pulling the proximal end 12a of the tensioning
member 12. The pulling of the tensioning member, in some
embodiments, folds at least a portion of the distal elongate anchor
member 14b' and/or draws the distal elongate anchor member towards
the paravalvular leakage site 20, as shown FIG. 3H. In some
embodiments, the method includes continuing pulling the proximal
end 12a of the tensioning member 12 to compress the distal elongate
anchor member 14b' against the paravalvular leakage 20, as shown in
FIG. 3I. In some embodiments, the method includes folding at least
a portion of the proximal elongate anchor member 14a' and drawing
the proximal elongate anchor member 14a' towards the paravalvular
leakage site 20, as shown in FIG. 3J. The folding of at least a
portion of the proximal elongate anchor member 14a' and/or the
drawing of the proximal elongate anchor member 14a', in certain
embodiments, are achieved sequentially or simultaneously by
continuing pulling the proximal end 12a of the tensioning member
12. As the distal elongate anchor member 14b' and the proximal
elongate anchor member 14a' are compressed against the paravalvular
leakage 20, in some embodiments, the method includes using a
suitable locker element 22 to maintain the anchor 10 in the
deployed configuration, as shown in FIG. 3L.
[0080] FIG. 4 is a side elevation view of an anchor 70 according to
some embodiments of the present teachings. This anchor includes a
distal tip 76. In addition, this anchor includes a proximal
radiopaque band 90 and a distal radiopaque band 92. Both the
radiopaque bands can be attached to the suture 72, as shown in FIG.
4, or otherwise secured to the suture 72, at the proximal end
portion of the anchor member 74 and to either the interior or
exterior of the distal tip 76, respectively, or any other part of
the anchor 70. Without wishing to be bound by any particular
theory, under a fluoroscope, these bands or other markers 90 and 92
will indicate to the clinician that the anchor 70 has been
deployed, activated, fully compressed, and/or fastened, as
necessary during the procedure.
[0081] The tip 76 itself may alternatively be formed from a
radiopaque material. In this embodiment, the knot 94 formed in the
suture 72 or other tensioning member is a slip knot through which
another portion of the suture 72 slides during activation of the
anchor 70. It will be appreciated that this slip knot 94 may be
replaced by another element which serves substantially or
approximately the same purpose but takes the form, for example, of
a small tubular element or other feature similar in function to a
slip knot.
[0082] In various embodiments, the elongate anchor member 74 may be
about 40 mm long by about 3 mm wide. This may be desirable to
achieve a lower profile. These embodiments may lead to more
versatile applications, lower incidents of blood clotting, easier
use, etc. Of course, any other desired dimensions and shapes may be
used, depending on application needs.
[0083] As further shown in FIGS. 4 and 6A, the tensioning member or
suture 72 can advantageously extend through respective fold
portions 74c of the elongate anchor member 74 in essentially an
hourglass configuration. Specifically, adjacent portions of the
suture 72 located near the proximal and distal end portions 74a,
74b of the anchor member 74 are spaced farther apart than the
adjacent portions of the suture 72 in the middle of the anchor
member 74.
[0084] As further shown in FIG. 6B, radiopaque markers, such as
distinct areas of dots 95, may be used for enabling the clinician
to visualize the folds of the elongate anchor member 74 during
deployment and securement of the elongate anchor member 74. These
dots or other radiopaque markers may be printed on the anchor
member 74. For example, dots 95 or other markers may be formed with
a platinum powder base ink or other suitable material that is
radiopaque and biologically compatible. This radiopaque material
may also add stiffness to the fold sections 74c thereby helping to
maintain the fold sections 74c flat and increasing retention force
on the paravalvular leakage. Meanwhile, the fold lines 74d between
fold sections 74c can remain highly flexible to create tight radius
fold lines.
[0085] As further shown in FIG. 6A, each of the holes 96 that the
tensioning member or suture 72 is received through may be marked by
circles 98 surrounding each hole 96 or other markers for
visualizing purposes during assembly of the tensioning member or
suture 72 with the elongate anchor member 74. Optionally, holes 96
may be eliminated and the suture 72 may be threaded with a needle
through the anchor member 74. One could also, for example, choose
different sets of holes 96 along anchor member 74 for receiving the
tensioning member or suture 72 thereby changing the width of the
folds and/or number of folds and/or shape of the folds depending on
the application needs or desires of the clinician.
[0086] The tensioning member or suture 72 may be threaded or
otherwise attached along the anchor member 74 in any number of
manners including, for example, x-patterns or other crossing
patterns, zig-zag patterns, etc. that may alter the folded or
otherwise shortened or compressed footprint of the anchor into
various beneficial shapes, such as flower shapes, circular shapes
or other rounded shapes, ball shapes or other configurations.
Modifications of the manner in which the tensioning member or
suture 72 is threaded or otherwise attached along the length of
anchor member 74 may result in higher or lower tensioning force
being required to compress the anchor and/or higher or lower
friction holding force that may help maintain the anchor in the
compressed or shortened configuration.
[0087] The width of the elongate anchor member 74' may be varied
along its length, such as by tapering, stepping, or forming an
hourglass shape or shapes along the length of the anchor member 14.
For example, as illustrated in FIG. 6C, having proximal and distal
end portions 75, 77 of wider dimension than an intermediate or
middle portion or portions 79 along the length of anchor member 74'
will allow these wider portions 75, 77 may cover over the more
intermediate folded portions 79 and prevent unnecessary contact
with adjacent tissue during use.
[0088] The elongate anchor member 74 may have variable stiffness
including, for example, a relatively rigid perimeter or relatively
rigid edges 74e, 74f (FIG. 6A) or intermittent relatively rigid
sections 74c'' separated by flexible sections such as living hinges
74d'' (FIG. 6D) that may aid in folding and securing the elongate
anchor member 74'' into a folded condition.
[0089] FIGS. 5A-5D illustrate a series of steps for deploying and
securely fastening the anchor 70 to a paravalvular leakage site 100
according to some embodiments of the present teachings. Generally,
as shown in FIG. 5A, the combination of the elongate anchor member
74 and tensioning member or suture 72 is deployed through the
paravalvular leakage site 100. One end or portion 72a of the suture
72 that extends through the slip knot 94 is then pulled. This
causes the distal portion 74b of the elongate anchor member 74 to
fold and compress against the distal side of the paravalvular
leakage 100. As shown in FIG. 5B, further pulling the tensioning
member 72 causes the slip knot 94 to ride upwardly or distally
along the suture 72 and against a proximal portion 74a of the
elongate anchor member 74, thereby folding and compressing the
proximal portion 74a against the proximal side of the paravalvular
leakage 100 as shown in FIG. 5C. As shown in FIG. 5D, a suitable
crimp or locking element 102 may be used to securely lock the slip
knot 94 in place relative to the suture or tensioning member
segment which extends therethrough. This will lock the entire
anchor 70 in place with the respective proximal and distal folded
anchor member portions 74a, 74b securely retaining the paravalvular
leakage 100 therebetween. FIG. 5D shows the tip 76 acting as a
retainer on top of the distal end portion 74b to assist in holding
the distal end portion 74b in place.
[0090] FIG. 5E shows an alternative in which the tensioning member
is threaded through at least one hole 76a more centrally located in
the tip. Yet another alternative would be to thread the tensioning
member through two centrally located holes instead of through the
proximal end of the tip 76 and one centrally located hole 76a as
shown in FIG. 5E. These alternatives allow the tip 76 to act more
like a "T"-bar with forces acting in a more perpendicular or normal
manner relative to the distal end portion 74b of the anchor member
74.
[0091] FIG. 7A illustrates an exemplary anchor of the present
teachings. In various embodiments, the elongate anchor member has a
rectangle profile as illustrated in FIG. 7A. In other embodiments,
the elongate anchor member has an hour glass profile as illustrated
in FIG. 7B. One skilled in the art would understand that the
elongate anchor member can have other profiles, and accordingly,
the embodiments discussed herein are not limiting to the scope of
the present teachings.
[0092] Referring to FIG. 7A, an anchor 200 constructed in
accordance with some embodiments of the present teachings generally
includes a tensioning member 201 extending from a proximal end
portion 212 of an elongate anchor member 210 to a distal end
portion 214. In some embodiments, the tensioning member 201 loops
back and extends from the distal end 214 to the proximal end
portion 212. In some embodiments, the tensioning member 201 passes
through a plurality of openings along the elongate anchor member
210. In some embodiments, one end of the tensioning member 201,
after it extends from the proximal end to the distal end and loops
back to the proximal end of the anchor member 210, forms a knot 220
around the other end portion of the tensioning member 201. In some
embodiments, the knot 220 slides along the other end portion of the
tensioning member 201 in such way that it pulls the free end of the
tensioning member 201 proximally, causing the knot 220 moving
distally and shortening the longitudinal length of the anchor
member 210. By doing so in these embodiments, the elongate anchor
member 210 is folded and the ends of the anchor member 210 are
drawn toward each other. In certain embodiments, the elongate
anchor member 210 also can include at least one pre-set folding
line (not shown) which allows the elongate anchor member 210 to be
fold at the pre-set folding line.
[0093] In various embodiments, an anchor, such as that referred to
as anchor 200, shortens at one of the proximal and distal ends. For
example, when the tensioning member 201 is pulled, at least a part
of the distal portion 214 folds first while the proximal end 212
substantially maintains its elongated configuration. In some
embodiments, this occurs when the distal portion 214 is deployed.
In certain embodiments, this occurs when the distal portion 214 is
deployed and the proximal portion 212 is not deployed, for example,
because the proximal portion 212 is restrained in a delivery
catheter (not shown). In other embodiments, when the tensioning
member 201 is pulled, at least a part of the proximal portion 212
folds first while the distal portion 214 substantially maintains
its elongated configuration. It will be appreciated by a person
with ordinary skill in the art that an anchor of the present
teachings may also be folded in a sequential manner under other
circumstances.
[0094] As seen in FIG. 7A, in various embodiments, the elongate
anchor member has two sets of openings 225, 226 (first openings 225
and second openings 226). In some embodiments, the tensioning
member 201 extends from the proximal end portion 212 of the anchor
member 210 to the distal end portion 214 of the anchor member 210
through the first set of openings 225. Upon reaching the distal end
of the elongate anchor member 210, in some embodiments, the
tensioning member 201 loops back and further extends from the
distal end portion of the anchor member 210 to the proximal end of
the anchor member through the second set of openings 226.
[0095] In certain embodiments, as shown in FIG. 7A, the tensioning
member 201 extends from the proximal end of the anchor member 210
distally, travels from one side of the anchor member 210 to another
side by passing through the first opening 225 closest to the
proximal end of the anchor member 210 in the first set of openings
225; the tensioning member 201 further extends distally, passes
through the next opening 225 distal to the first opening 225 in the
first set of openings 225. The tensioning member extends further
distally repeating above steps until it passes through the last
opening 225 in the first set of openings 225 and reaches the distal
end of the anchor member 210. In one embodiment of the present
teachings, there are ten openings 225 in the first set of openings
225. Anchor members 210 having between four and twelve openings 225
in the first set of openings can be made and used by one with
ordinary skill in the art without undue experimentation.
[0096] In various embodiments of the present teachings, upon
reaching the distal end of the anchor member 210, the tensioning
member 201 loops back, extends proximally, travels from one side of
the anchor member 210 to another side by passing through the first
opening 226 closest to the distal end of the anchor member 210 in
the second set of openings 226. The tensioning member 201 further
extends proximally, travels to the first side of the anchor member
210 by passing through the next opening 226 proximal to the first
opening 226 in the second set of openings 226. The tensioning
member 201 extends further proximally repeating the above steps
until it passes through the last opening 226 in the second set of
openings 226 and reaches the proximal end of the anchor member 210.
In some embodiments of the present teachings, there are ten
openings 226 in the second set of openings 226. Elongate anchor
members 210 having between four and twelve openings 226 in this set
can be made and used by one with ordinary skill in the art without
undue experimentation.
[0097] In various embodiments of the present teachings, as
illustrated in FIG. 7A, the tensioning member 201 extends from one
side of the anchor member 210 distally, loops back, and ends on the
same side of the anchor member 210. In other embodiments, the
tensioning member 201 extends from one side of the anchor member
210 distally, loops back, and ends on a different side of the
anchor member 210.
[0098] In various embodiments of the present teachings, the number
of openings 225 in the first set and the number of openings 226 in
the second set are the same as illustrated in FIG. 7A. In other
embodiments, the number of openings 225 in the first set and the
number of openings 226 in the second set are different.
[0099] In some embodiments, the first and second sets of openings
225, 226 are different as illustrated in FIG. 7A. In other
embodiments, the first and second sets of openings 225, 226 share
at least one opening as illustrated in FIG. 7C. This common opening
is identified with reference character 227 in FIG. 7C.
[0100] As mentioned above, the anchor member 210 can have an hour
glass profile as illustrated in FIG. 7B. In this embodiment, the
anchor member 210 has a pair of sections 229 of increased width
(with one being located at the proximal end portion 212 and one at
the distal end portion 214).
[0101] According to various embodiments of the present teachings,
at least one opening 225 in the first set of openings 225 has a
corresponding opening 226 in the second set of openings 226 and
together they form a pair of openings on the anchor members 210. In
some embodiments, at least one pair of openings 225, 226 form a
line perpendicular to the longitudinal axis of the anchor member
210. In other embodiments, at least one pair of the openings 225,
226 forms a line parallel to the longitudinal axis of the anchor
member 210. In yet other embodiments, at least one pair of the
openings 225, 226 form a line that forms an angle with the
longitudinal axis of the anchor member 210. In some embodiments,
lines formed by all of the pairs of openings 225, 226 are in the
same orientation with one another. For example, they can be
parallel to one another and/or perpendicular to the longitudinal
axis of the anchor member 210 as illustrated in FIG. 7A. In another
embodiment, they can all be parallel to the longitudinal axis of
the anchor member 210. In yet other embodiments, the lines formed
by all the pairs of openings 225, 226 can have random
directions.
[0102] In various embodiments, the two openings 225, 226 in a pair
are 2-3 mm apart from each other. In some embodiments, the distance
between two opening 225, 226 is the same in each pair. In some
embodiments, the distance between two openings 225, 226 is
different from one pair to another.
[0103] In various embodiments, the distance between two adjacent
openings 225, 225 (or 226, 226) in the same set, defined by the
distance from one opening to the next closest one in the same set
of openings (either 225 or 226), is about 5-12 mm. In some
embodiments, the distances between each adjacent openings 225, 225
(or 226, 226) is the same as each other. In some embodiments, the
distances between each adjacent openings is different from each
other.
[0104] In various embodiments, at least one pair of the openings
225, 226 are at the lateral center of the anchor member. In some
embodiments, all the pairs of openings 225, 226 are at the lateral
center of the anchor member. In some embodiments, at least one pair
of the openings 225, 226 is biased toward one side of the anchor
member 210. In some embodiments, all the pairs of openings 225, 226
are biased toward the same side of the anchor member. In some
embodiments, each of the pairs of openings is biased toward
different sides of the anchor member 210.
[0105] In various embodiments, all the openings 225, 226 in at
least one set of openings, or in both the sets of openings, form a
straight line. In various embodiments, all the openings in at least
one set of the openings, or in both the sets of openings, form a
curved line.
[0106] FIGS. 8 illustrates an exemplary elongate profile of an
exemplary anchor 300 that includes an elongate anchor member 310
and wherein the openings 225 in the first set of openings 225 form
a straight line parallel to the longitudinal axis of the anchor
member 310, and the openings 226 in the second set of openings 226
form another straight line parallel to the longitudinal axis of the
anchor member 310 and at a distance from the line formed by the
first set of openings 225.
[0107] FIG. 9 illustrates an exemplary elongate profile of an
exemplary anchor 400 that includes an elongate anchor member 410.
The openings 225 in the first set of openings form a curve with the
openings 225 in the middle portion of the anchor member closest to
the lateral center of the anchor member 410, and the openings 226
in the second set of openings form another curve with the openings
226 in the middle portion of the anchor member 410 closest to the
lateral center of the anchor member 410, and the two curves have a
lateral distance from each other and together form an "hour glass"
shape.
[0108] FIGS. 10A and 10B illustrate an exemplary elongate profile
of an exemplary anchor 500 that includes an elongate anchor member
510. All openings 225, 226 in both sets of the openings are aligned
with each other forming a straight line parallel to the
longitudinal axis of the anchor member 510. FIG. 10B is a side
elevation view of the anchor member 510 showing the routing of the
tensioning member 201 through the anchor member 510.
[0109] In various embodiments, at least one pre-set folding line is
created between two pairs of the openings 225, 226, as illustrated
in FIG. 12A. The pre-set folding line can be made by heat setting
with or without a mold. One skilled in the art would understand
that other methods can also be used to create pre-set folding lines
without undue experimentations. In some embodiments, the pre-set
folding lines allow the elongate anchor member to fold at
pre-defined places. In certain embodiments, a pre-set folding line
is created between every two pairs of the openings 225, 226, for
example, as illustrated in FIGS. 8-10.
[0110] According to various embodiments of the present teachings,
the elongate anchor member (e.g., anchor member 210) shortens and
creates folds as illustrated in FIG. 11. In some embodiments, the
number of the folds in the anchor in its deployed profile ranges
from 4 to 12. In various embodiments, the number of the folds is
the same as the number of the openings in at least one set of the
openings 225, 226. In other embodiments, the number of the folds
has no particular relationship with the number of the openings in
either set of the openings 225, 226. In various embodiments, the
number of the folds is the same as the number of the pre-set
folding lines plus one. In other embodiments, the number of the
folds has no particular relationship with the number of the pre-set
folding lines.
[0111] FIGS. 12A-D illustrate an exemplary embodiment of the
present teachings. Specifically, FIGS. 12A and 12D illustrate an
exemplary elongate profile and an exemplary deployed profile,
respectively, of an anchor 600 of the present teachings. The anchor
600 includes an elongate anchor member 610. As shown in FIG. 12A,
the elongate anchor member 610 has two sets of openings 225, 226
through which the tensioning member 201 weaves. The tensioning
member 201 weaves through the first set of openings 225 as it
extends from the proximal end to the distal end of the anchor
member 610 and weaves through the second set of openings 226 as it
returns from the distal end to the proximal end of the anchor
member 610.
[0112] In various embodiments of the present teachings, at least
one opening in the first set of openings corresponds with another
opening in the second set of openings and together they form a pair
of openings on the anchor member. As shown in FIG. 12A, there are 5
pairs of openings 225, 226 in the distal portion of the anchor
member, and 3 pairs of openings 225, 226 in the proximal portion of
the anchor member 510. As shown in FIG. 12A, each pair of the
openings 225, 226 in the distal end section of the distal portion
of the anchor member form an imaginary line and the imaginary lines
from the opening pairs 225, 226 in the distal portion of the anchor
member 610 are parallel to one another and perpendicular to the
longitudinal axis of the anchor member 610, and at the lateral
center of the anchor member 610; all openings 225, 226 in the
proximal end section of the distal portion of the anchor member 610
align with one another and form an imaginary straight line that is
parallel to the longitudinal axis of the entire distal portion of
the anchor member 610, and at the lateral center of the entire
distal portion of the anchor member 610. Thus, in the proximal
portion of the anchor member 610, all openings 225, 226 from both
set of openings align with one another and form an imaginary
straight line that is parallel to the longitudinal axis of the
anchor member 610 and at the lateral center of the anchor member
610. One skilled in the art should understand that the amount of
pairs of opening in distal and/or proximal portions of the anchor
member 610 can be of any number other than what has been described
here.
[0113] FIG. 12A further illustrates exemplary pre-set folding lines
in an elongate anchor member of the present teachings. As shown in
FIG. 12A, the folding lines (indicated in the drawings as "L") in
the proximal portions and the distal end portion of the distal
portion of the anchor member 610 are parallel to one another and
perpendicular to the longitudinal axis of the anchor member 610.
The pre-set folding lines L between the distal end section and
proximal end section of the distal portion of the anchor member 610
are angled to the other pre-set folding lines L. Although specific
pre-set folding patterns is shown in FIG. 12A, one with ordinary
skill in the art would understand that other patterns, numbers can
be incorporated to form pre-set folding lines L. For example, the
both distal and proximal portions of the anchor member 610 are
parallel to one another and perpendicular to the longitudinal axis
of the anchor member 610, and only a middle portion 615 between the
distal and proximal portions of the anchor member 610 are angled,
so as to forming a transitional section across the paravalvular
leakage upon deployment. Therefore what is shown in FIG. 12A should
not be considered as being limiting.
[0114] FIG. 12A further illustrates an exemplary narrow section in
the distal end portion of the anchor member. This narrow section is
the result of radiopaque marker being crimped onto the anchor
member. As described above, there are other ways of putting one or
more radiopaque markers onto the anchor member. Thus, what is shown
in this Figure should not limit the scope of the present
teachings.
[0115] FIG. 12B illustrates an exemplary deployment profile of an
embodiment of the present teachings across a paravalvular leakage
site. There are 8 folds in the deployed anchor as shown in FIG.
12B, among which 5 are distal to the paravalvular leakage and 3 are
proximal to the leakage. One skilled in the art would understand
that the number of folds in each side of the paravalvular leakage
should not be viewed as limiting. As shown in FIG. 12B, the folded
panels at the proximal portion of the anchor member and at the
proximal end section of the distal portion of the anchor member
orientate in one direction, and the folded panels in the distal end
portion of the anchor member orientate in another direction that is
perpendicular to folded panels in the other direction. The
transitional folds between the distal and proximal end section of
the distal portion of the anchor member are located at the angled
pre-set folding line. In this specific embodiment shown in FIG.
12B, the transitional folds are distal to the paravalvular leakage
and are generally indicated with the reference character 601 (in
other words, the change in folding direction is identified at 601).
One skilled in the art should understand that the transitional
folds can be proximal to the paravalvular leakage, or across the
paravalvular leakage, and thus what has be illustrated here should
not be viewed as limiting.
[0116] FIG. 12C is a view of the exemplary anchor shown in FIGS.
12A and B in its deployed configuration. The distal deployed anchor
portion has a width "x" established by the width of the anchor and
a length "y" determined by the distance between two pairs of the
openings. The proximal deployed anchor portion has a width "y"
established by the distance between the two pairs of the openings
and a length "x" established by the width of the anchor. As shown
in this view, the configuration in the exemplary embodiment shown
in FIGS. 12A-D increases the overall width of the deployed anchor.
This configuration prevents the tensioning member from cutting the
panel and the paravalvular leakage and increases the retention
force of the anchor against the leakage site.
[0117] In other words as shown in FIG. 12D, at least two adjacent
anchor panels 603, 605 are disposed in a crisscrossed manner in
that the longitudinal axes of the adjacent anchor panels 603, 605
are disposed perpendicular to one another as shown.
[0118] Other arrangements can be incorporated into the two sets of
openings. For example, all the openings from both sets of openings
in the distal portion of the anchor member can align with each
other to form an imaginary straight line that is parallel to the
longitudinal axis of the anchor member, and/or each pair of the
openings in the proximal portion of the anchor member can form an
imaginary line and all the imaginary lines so formed are parallel
to one another and perpendicular to the longitudinal axis of the
anchor member. One skilled in the art would understand that
openings in either or both set of the openings can form any
configuration so long as it serves the intended purpose.
[0119] Although the present teachings have been described with
reference to preferred embodiments, persons ordinarily skilled in
the art will recognize that changes can be made in form and detail
without departing from the spirit and scope of the present
disclosure.
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