U.S. patent application number 17/571125 was filed with the patent office on 2022-04-28 for space filling devices.
The applicant listed for this patent is W. L. Gore & Associates, Inc.. Invention is credited to Charles J. Center, Edward H. Cully, Nathan L. Friedman, Cody L. Hartman, Nichlas L. Helder, Brandon A. Lurie, Steven J. Masters, Thomas R. McDaniel, Nathan K. Mooney, Aaron L. Paris, Roark N. Wolfe.
Application Number | 20220125567 17/571125 |
Document ID | / |
Family ID | |
Filed Date | 2022-04-28 |
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United States Patent
Application |
20220125567 |
Kind Code |
A1 |
Center; Charles J. ; et
al. |
April 28, 2022 |
SPACE FILLING DEVICES
Abstract
An occlusive device includes a covering component configured to
modulate passage of blood or thrombus therethrough, and an
occlusion frame that includes a plurality of elongate occlusion
frame members. The elongate occlusion frame members are arranged to
form a generally disc-shaped member. The occlusion frame is at
least partially covered by the covering component. The device
further includes an anchor frame that includes a plurality of
elongate anchor frame members. The device further includes a first
hub component from which the elongate frame members extend, and a
second hub component from which the elongate frame members
extend.
Inventors: |
Center; Charles J.;
(Flagstaff, AZ) ; Cully; Edward H.; (Flagstaff,
AZ) ; Friedman; Nathan L.; (Flagstaff, AZ) ;
Hartman; Cody L.; (Flagstaff, AZ) ; Helder; Nichlas
L.; (Flagstaff, AZ) ; Lurie; Brandon A.;
(Flagstaff, AZ) ; Masters; Steven J.; (Flagstaff,
AZ) ; McDaniel; Thomas R.; (Flagstaff, AZ) ;
Mooney; Nathan K.; (Elkton, MD) ; Paris; Aaron
L.; (Flagstaff, AZ) ; Wolfe; Roark N.;
(Flagstaff, AZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
W. L. Gore & Associates, Inc. |
Newark |
DE |
US |
|
|
Appl. No.: |
17/571125 |
Filed: |
January 7, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14315246 |
Jun 25, 2014 |
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17571125 |
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61907326 |
Nov 21, 2013 |
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61839824 |
Jun 26, 2013 |
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International
Class: |
A61F 2/01 20060101
A61F002/01; A61B 17/12 20060101 A61B017/12; A61B 17/00 20060101
A61B017/00 |
Claims
1. An occlusive device, comprising: a covering component configured
to modulate passage of blood or thrombus through the covering
component; an occlusion frame comprising a plurality of elongate
frame members, each of which comprise a portion of a tube, the
elongate frame members arranged to form a generally disc-shaped
member when the occlusion frame assumes an expanded configuration,
each of the elongate frame members forming a petal of the generally
disc-shaped member, wherein adjacent petals of the generally
disc-shaped member at least partially overlap one another, and
wherein the occlusion frame is at least partially covered by the
covering component; an anchor frame comprising a plurality of
anchor members configured to anchor the occlusive device at an
implant location; a first hub component from which the plurality of
elongate frame members extend, the first hub component disposed
between the occlusion frame and the anchor frame; a second hub
component from which the anchor members extend, the second hub
component disposed between the occlusion frame and the anchor
frame; and a connecting member that connects the first hub
component to the second hub component.
2. The occlusive device of claim 1, wherein each anchor member of
the plurality of anchor members comprises a wire.
3. The occlusive device of claim 1, wherein each anchor member of
the plurality of anchor members comprises a portion of the
tube.
4. The occlusive device of claim 1, wherein each anchor member of
the plurality of anchor members comprises a portion of a second
tube.
5. The occlusive device of claim 1, wherein the connecting member
comprises one or more nitinol wires.
6. The occlusive device of claim 1, wherein the first hub
component, the second hub component, and the connecting member are
covered by the covering component.
7. The occlusive device of claim 1, wherein the anchor frame is at
least partially covered by the covering component.
8. The occlusive device of claim 1, wherein each of the anchor
members includes a first portion that extends generally distally
and radially from the second hub component, a second portion that
extends from the first portion in a generally distal and radial
direction, and a third portion that extends from the second portion
in a generally proximal and radial direction.
9. The occlusive device of claim 1, wherein the first portion
extends from the second hub component at an angle that is about 30
degrees distal from a directly radial direction, wherein the second
portion extends from the first portion at an angle that is about 75
degrees distal from a directly radial direction, and wherein the
third portion extends from the second portion at an angle that is
about 60 degrees proximal from a directly radial direction.
10. The occlusive device of claim 1, wherein each of the anchor
members includes a first portion that extends generally radially
from the second hub component, a second portion that extends from
the first portion in a generally proximal direction.
11. The occlusive device of claim 1, wherein the connecting member
is flexible and includes a first end portion that is attached to
the first hub component and a second end portion that is attached
to the second hub component.
12. The occlusive device of claim 1, wherein the tube comprises
nitinol.
13. An occlusive device, comprising: a covering component
configured to modulate passage of blood or thrombus through the
covering component; an occlusion frame comprising a plurality of
elongate frame members, the elongate frame members arranged to form
a generally disc-shaped member when the occlusion frame assumes an
expanded configuration, each of the elongate frame members forming
a petal of the generally disc-shaped member, wherein adjacent
petals of the generally disc-shaped member at least partially
overlap one another, and wherein the occlusion frame is at least
partially covered by the covering component; an anchor frame
comprising a plurality of anchor members, each of which comprise a
portion of a tube, wherein the anchor members are configured to
anchor the occlusive device at an implant location; a first hub
component from which the plurality of elongate frame members
extend, the first hub component disposed between the occlusion
frame and the anchor frame; a second hub component from which the
anchor members extend, the second hub component disposed between
the occlusion frame and the anchor frame; and a connecting member
that connects the first hub component to the second hub
component.
14. The occlusive device of claim 13, wherein each elongate frame
member of the plurality of elongate frame members comprises a
wire.
15. The occlusive device of claim 13, wherein each elongate frame
member of the plurality of elongate frame members comprises a
portion of the tube.
16. The occlusive device of claim 13, wherein each elongate frame
member of the plurality of elongate frame members comprises a
portion of a second tube.
17. The occlusive device of claim 13, wherein the connecting member
comprises one or more nitinol wires.
18. The occlusive device of claim 13, wherein the first hub
component, the second hub component, and the connecting member are
covered by the covering component.
19. The occlusive device of claim 13, wherein the anchor frame is
at least partially covered by the covering component.
20. The occlusive device of claim 13, wherein each of the anchor
members includes a first portion that extends generally distally
and radially from the second hub component, a second portion that
extends from the first portion in a generally distal and radial
direction, and a third portion that extends from the second portion
in a generally proximal and radial direction.
21. The occlusive device of claim 13, wherein the first portion
extends from the second hub component at an angle that is about 30
degrees distal from a directly radial direction, wherein the second
portion extends from the first portion at an angle that is about 75
degrees distal from a directly radial direction, and wherein the
third portion extends from the second portion at an angle that is
about 60 degrees proximal from a directly radial direction.
22. The occlusive device of claim 13, wherein each of the anchor
members includes a first portion that extends generally radially
from the second hub component, a second portion that extends from
the first portion in a generally proximal direction.
23. The occlusive device of claim 13, wherein the connecting member
is flexible and includes a first end portion that is attached to
the first hub component and a second end portion that is attached
to the second hub component.
24. The occlusive device of claim 13, wherein the tube comprises
nitinol.
25. An occlusive device, comprising: a covering component
configured to modulate passage of blood or thrombus through the
covering component; an occlusion frame comprising a plurality of
elongate frame members arranged to form a generally disc-shaped
member when the occlusion frame assumes an expanded configuration,
each of the elongate frame members forming a generally disc-shaped
member, wherein adjacent petals of the generally disc-shaped member
at least partially overlap one another, and wherein the occlusion
frame is at least partially covered by the covering component; an
anchor frame comprising first and second anchor arms configured to
anchor the occlusive device at an implant location, the first
anchor arm being oriented opposite the second anchor arm; a first
hub component from which the plurality of elongate frame members
extend, the first hub component disposed between the occlusion
frame and the anchor frame; a second hub component from which the
first and second anchor arms extend, the second hub component
disposed between the occlusion frame and the anchor frame; and a
flexible connecting member comprising first and second end
portions, wherein the first end portion is attached to the first
hub component and the second end portion is attached to the second
hub component.
26. An occlusive device comprising: a first portion comprising one
or more first portion elongate members that are configured to form
a first shape, a first central hub from which at least some of the
first portion elongate members extend; a second portion comprising
one or more second portion elongate members that are configured to
form a second shape; a second central hub from which at least some
of the second portion elongate members extend, wherein the second
central hub is configured to be interlocked with the first central
hub; and a covering component on at least one of the first portion
or the second portion, wherein the covering component is configured
to modulate passage of body materials through the covering
component.
27. The occlusive device of claim 26, wherein at least one of the
first or second shapes is a disc shape.
28. The occlusive device of claim 26, wherein the covering
component comprises ePTFE or PTFE.
29. An occlusive device, comprising: a covering component
configured to modulate passage of blood or thrombus through the
covering component; an occlusion frame comprising a plurality of
elongate occlusion frame members each of which comprise a portion
of a tube, the elongate occlusion frame members arranged to form an
interconnected occlusion structure, the interconnected occlusion
structure comprising a generally disc-shaped member when the
occlusion frame assumes an expanded configuration, and wherein the
occlusion frame is at least partially covered by the covering
component; an anchor frame comprising a plurality of elongate
anchor frame members each of which comprise a portion of the tube,
the anchor frame configured to anchor the occlusive device at an
implant location, the elongate anchor frame members arranged to
form an interconnected anchor structure, the interconnected anchor
structure comprising a generally cylindrical member when the anchor
frame assumes an expanded configuration; a first hub component from
which at least some of the elongate occlusion frame members extend;
and a second hub component from which at least some of the elongate
occlusion frame members extend, and from which at least some of the
elongate anchor frame members extend, the second hub component
disposed between the occlusion frame and the anchor frame.
30. The occlusive device of claim 29, wherein the anchor frame is
at least partially covered by the covering component.
31. The occlusive device of claim 29, wherein the elongate
occlusion frame members that extend from the first hub component
are first elongate occlusion frame members that bifurcate to form
bifurcated branches, and wherein the bifurcated branches join with
other bifurcated branches to form second elongate occlusion frame
members that extend from the second hub component.
40. The occlusive device of claim 32, further comprising an anchor
frame, the anchor frame comprising an anchor frame hub and one or
more anchor arms extending from the anchor frame hub, the one or
more anchor arms each defining a free end, wherein the anchor frame
hub is coupled with the hub of the frame, and wherein the free ends
of the one or more anchor arms protrude from the lateral outer
surface of the frame.
41. The occlusive device of claim 40, wherein the frame comprises a
first material and the anchor frame comprises a second material
that is different than the first material.
42. The occlusive device of claim 40, wherein the anchor frame hub
is nested within the hub of the frame.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/315,246, filed Jun. 25, 2014, which claims
the benefit of U.S. Provisional Application 61/907,326, filed Nov.
21, 2013, and also claims the benefit of U.S. Provisional
Application 61/839,824, filed Jun. 26, 2013, all of which are
incorporated herein by reference in their entireties for all
purposes.
TECHNICAL FIELD
[0002] The present disclosure relates to implantable medical
devices that may be used to occlude apertures, conduits, or
structures within a patient.
BACKGROUND
[0003] Cardiac features such as atrial appendages can contribute to
cardiac blood flow disturbance, which is associated with a number
of cardiac-related pathologies. For example, complications caused
by blood flow disturbance within the left atrial appendage (LAA)
and associated with atrial fibrillation can contribute to embolic
stroke. The LAA is a muscular pouch extending from the
anterolateral wall of the left atrium of the heart and serves as a
reservoir for the left atrium. During a normal cardiac cycle, the
LAA contracts with the left atrium to pump blood from the LAA,
which generally prevents blood from stagnating within the LAA.
However, during cardiac cycles characterized by arrhythmias (e.g.,
atrial fibrillation), the LAA often fails to sufficiently contract,
which can allow blood to stagnate within the LAA. Stagnant blood
within the LAA is susceptible to coagulating and forming a
thrombus, which can dislodge from the LAA and ultimately result in
an embolic stroke.
SUMMARY
[0004] In a first general aspect, an occlusive device includes a
covering component configured to modulate passage of blood or
thrombus through the covering component. The occlusive device also
includes an occlusion frame that includes a plurality of elongate
frame members, each of which includes a portion of a tube. The
elongate frame members are arranged to form a generally disc-shaped
member when the occlusion frame assumes an expanded configuration,
and each of the elongate frame members forms a petal of the
generally disc-shaped member. Adjacent petals of the generally
disc-shaped member at least partially overlap one another, and the
occlusion frame is at least partially covered by the covering
component. The occlusive device further includes an anchor frame
that includes a plurality of anchor members configured to anchor
the occlusive device at an implant location. The occlusive device
further includes a first hub component from which the plurality of
elongate frame members extend, where the first hub component is
disposed between the occlusion frame and the anchor frame. The
occlusive device further includes a second hub component from which
the anchor members extend, where the second hub component is
disposed between the occlusion frame and the anchor frame. The
occlusive device further includes a connecting member that connects
the first hub component to the second hub component.
[0005] Various implementations may include one or more of the
following. Each anchor member of the plurality of anchor members
may include a wire. Each anchor member of the plurality of anchor
members may include a portion of the tube. Each anchor member of
the plurality of anchor members may include a portion of a second
tube. The connecting member may include one or more nitinol wires.
The first hub component, the second hub component, and the
connecting member may be covered by the covering component. The
anchor frame may be at least partially covered by the covering
component. Each of the anchor members may include a first portion
that extends generally distally and radially from the second hub
component, a second portion that extends from the first portion in
a generally distal and radial direction, and a third portion that
extends from the second portion in a generally proximal and radial
direction. The first portion may extend from the second hub
component at an angle that is about 30 degrees distal from a
directly radial direction, wherein the second portion may extend
from the first portion at an angle that is about 75 degrees distal
from a directly radial direction, and wherein the third portion may
extend from the second portion at an angle that is about 60 degrees
proximal from a directly radial direction. Each of the anchor
members may include a first portion that extends generally radially
from the second hub component, a second portion that extends from
the first portion in a generally proximal direction. The connecting
member may be flexible and may include a first end portion that is
attached to the first hub component and a second end portion that
is attached to the second hub component. The tube may include
nitinol.
[0006] In a second general aspect, an occlusive device includes a
covering component configured to modulate passage of blood or
thrombus through the covering component, and an occlusion frame
that includes a plurality of elongate frame members. The elongate
frame members are arranged to form a generally disc-shaped member
when the occlusion frame assumes an expanded configuration, and
each of the elongate frame members forms a petal of the generally
disc-shaped member. Adjacent petals of the generally disc-shaped
member at least partially overlap one another, and the occlusion
frame is at least partially covered by the covering component. The
occlusive device also includes an anchor frame that includes a
plurality of anchor members, each of which includes a portion of a
tube, wherein the anchor members are configured to anchor the
occlusive device at an implant location. The occlusive device also
includes a first hub component from which the plurality of elongate
frame members extend, and the first hub component is disposed
between the occlusion frame and the anchor frame. The occlusive
device further includes a second hub component from which the
anchor members extend, and the second hub component is disposed
between the occlusion frame and the anchor frame. The occlusive
device further includes a connecting member that connects the first
hub component to the second hub component.
[0007] In a third general aspect, an occlusive device includes a
covering component configured to modulate passage of blood or
thrombus through the covering component, and an occlusion frame
that includes a plurality of elongate frame members arranged to
form a generally disc-shaped member when the occlusion frame
assumes an expanded configuration. Each of the elongate frame
members forms a generally disc-shaped member, wherein adjacent
petals of the generally disc-shaped member at least partially
overlap one another, and wherein the occlusion frame is at least
partially covered by the covering component. The occlusive device
further includes an anchor frame that includes first and second
anchor arms configured to anchor the occlusive device at an implant
location, where the first anchor arm is oriented opposite the
second anchor arm. The occlusive device further includes a first
hub component from which the plurality of elongate frame members
extend, and the first hub component is disposed between the
occlusion frame and the anchor frame. The occlusive device further
includes a second hub component from which the first and second
anchor arms extend, and the second hub component is disposed
between the occlusion frame and the anchor frame. The occlusive
device further includes a flexible connecting member that includes
first and second end portions, wherein the first end portion is
attached to the first hub component and the second end portion is
attached to the second hub component.
[0008] In a fourth general aspect, an occlusive device includes a
frame and a covering component attached to the frame such that the
covering component at least partially modulates passage of blood or
thrombus through at least a portion of the occlusive device. The
frame comprises a hub, a plurality of curved radial struts
extending radially outward from the hub and defining an occlusive
face of the frame, and a plurality of cells extending from the
plurality of curved radial struts and arranged in interconnected
rows of cells to define a lateral outer surface of the frame.
[0009] Various implementations of such an occlusive device may
optionally include one or more of the following features. The frame
may further comprise a plurality of anchor elements that extend
radially outward from the lateral outer surface of the frame. The
plurality of anchor elements may be at least partially positioned
in the interstitial spaces defined by at least some cells of the
plurality cells. The frame may be formed from a single tubular
piece of precursor material. The cells may be helically biased to
comprise rectangular shapes. The occlusive device may further
comprise a gathering member, wherein the gathering member is
interwoven through apices of an end-most row of cells. The
gathering member may be in tension such that each cell of the
end-most row of cells is made to be positioned nearer to the other
cells of the end-most row of cells than without the tension. In
some embodiments, the cells are diamond-shaped cells. In some
embodiments, the cells are hexagonal cells.
[0010] The details of one or more embodiments are set forth in the
accompanying drawings and the description below. Other features,
objects, and advantages will be apparent from the description and
drawings, and from the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a perspective view of an example device frame that
can be used to occlude a hole, defect, aperture, or appendage
within a body of a patient.
[0012] FIG. 2 is an exploded view of the example device frame of
FIG. 1.
[0013] FIG. 3 is side view of the example device frame of FIG.
1.
[0014] FIG. 4A is a back view of the of an example occlusive
device.
[0015] FIG. 4B is a side view of the example occlusive device of
FIG. 4A.
[0016] FIG. 5 is a side view of example disc-shaped members having
various profiles.
[0017] FIG. 6A is a side view of another example disc-shaped member
that can be used with occlusive devices provided herein.
[0018] FIG. 6B is an end view of the disc-shaped member of FIG.
6A.
[0019] FIG. 7A is a side view of another example disc-shaped member
that can be used with occlusive devices provided herein.
[0020] FIG. 7B is an end view of the disc-shaped member of FIG.
7A.
[0021] FIG. 8A is another example disc-shaped member, shown in a
collapsed configuration, that can be used with occlusive devices
provided herein.
[0022] FIG. 8B is a side view of the example disc-shaped member of
FIG. 8A shown in an expanded configuration.
[0023] FIG. 9A is a side view of another example disc-shaped member
that can be used with occlusive devices provided herein.
[0024] FIG. 9B is an end view of the disc-shaped member of FIG.
9A.
[0025] FIG. 10 is a side view of another example disc-shaped member
that can be used with occlusive devices provided herein.
[0026] FIG. 11 is a side view of another example disc-shaped member
that can be used with occlusive devices provided herein.
[0027] FIG. 12 is a perspective view of an example anchor
frame.
[0028] FIG. 13 is a perspective view of the anchor frame of FIGS.
12A and 12B, including an example covering component.
[0029] FIG. 14 is a perspective view of an example occlusive
device.
[0030] FIG. 15 is a side view of another example occlusive device
in accordance with embodiments provided herein.
[0031] FIGS. 16A-16D are examples of anchor features that can be
used with occlusive devices provided herein.
[0032] FIG. 17 is a perspective view of an example anchor
frame.
[0033] FIG. 18 is a perspective view of another example device
frame.
[0034] FIG. 19A is a perspective view of an example occlusive
device frame.
[0035] FIG. 19B is an enlarged view of an example flexible
connector.
[0036] FIG. 20 is a perspective view of an example device
frame.
[0037] FIGS. 21A and 21B are perspective and back views,
respectively, of an example occlusive device.
[0038] FIGS. 22A and 22B are perspective and side views,
respectively, of another example device frame.
[0039] FIG. 23 shows an example tube and an example cut pattern
that can be used to cut the tube to create the frame of FIGS. 14A
and 14B.
[0040] FIG. 24 is a perspective view of another device frame.
[0041] FIG. 25 is a conceptual drawing of an example occlusive
device that includes two anchor frames.
[0042] FIG. 26 is a perspective view of an example ring hub
component and an example collar lock component.
[0043] FIG. 27 is a view of various example hub components.
[0044] FIG. 28 is a perspective view of another example hub
component.
[0045] FIG. 29 shows views of various applications of the hub
components of FIG. 27 (or FIG. 28).
[0046] FIGS. 30A, 31A, and 32A are views of an example cutting
patterns that can be used in cutting a tube (or a portion of a
tube) to create an anchor frame.
[0047] FIGS. 30B, 31B, and 32B are views showing portions of anchor
frames created using the cutting patterns of FIGS. 30A, 31A, and
32A.
[0048] FIG. 33A is a top view of another example occlusive device
in accordance with embodiments provided herein.
[0049] FIG. 33B is a perspective side view of the example occlusive
device of FIG. 33A.
[0050] FIG. 33C is a bottom view of the example occlusive device of
FIG. 33A.
[0051] FIG. 34A is a cutting pattern that can be used to cut a tube
(or a portion of a tube) to create the frame of the occlusive
device of FIGS. 33A-33C.
[0052] FIG. 34B is a cutting pattern that can be used to cut a tube
(or a portion of a tube) to create the frame of the occlusive
device of FIGS. 35A, 35B, 36A, and 36B.
[0053] FIG. 35A is a perspective view of the frame of another
example occlusive device in accordance with embodiments provided
herein.
[0054] FIG. 35B is a side view of the frame of the occlusive device
of FIG. 35A.
[0055] FIG. 36A is a side view of the occlusive device of FIGS. 35A
and 35B with a covering on the frame of the occlusive device.
[0056] FIG. 36B is an end view of the occlusive device of FIG.
36A.
[0057] FIG. 37A is a perspective view of a frame of another example
occlusive device in accordance with embodiments provided
herein.
[0058] FIG. 37B is a perspective view of another example occlusive
device in accordance with embodiments provided herein.
[0059] FIG. 37C is a perspective view of another example occlusive
device in accordance with embodiments provided herein.
[0060] FIG. 38 is a perspective view of another example anchor
frame that can be used with embodiments of the occlusive devices
provided herein.
[0061] FIG. 39A is a perspective view of the frame of another
example anchor frame that can be used with embodiments of the
occlusive devices provided herein.
[0062] FIG. 39B is a perspective view of the frame of FIG. 39A with
the addition of a covering component.
[0063] FIG. 40 is a perspective view of another example anchor
frame that can be used with embodiments of the occlusive devices
provided herein.
[0064] FIG. 41A is a perspective view of the frame of another
example anchor frame embodiment that can be used with some
embodiments of the occlusive devices provided herein.
[0065] FIG. 41B is an end view of the frame of FIG. 41A.
[0066] FIG. 42 is a side view illustration of a portion of another
example occlusive device in accordance with embodiments provided
herein.
[0067] FIG. 43A is an end view illustration of an example design of
the occlusive device portion of FIG. 42.
[0068] FIG. 43B is an end view illustration of another example
design of the occlusive device portion of FIG. 42.
[0069] FIG. 43C is an end view illustration of another example
design of the occlusive device portion of FIG. 42.
[0070] FIGS. 44A-44D are a series of illustrations depicting the
deployment of an example occlusive device in accordance with
embodiments provided herein.
[0071] FIGS. 45A-45C are examples of design configurations whereby
the hubs of some occlusive device embodiments provided herein can
be coupled together.
[0072] FIG. 46 is a perspective view of another example occlusive
device in accordance with embodiments provided herein.
[0073] FIG. 47A is a perspective view of another example occlusive
device in accordance with embodiments provided herein.
[0074] FIG. 47B is an end view of the occlusive device of FIG.
47A.
[0075] FIG. 48 is a side view of another example occlusive device
in accordance with embodiments provided herein.
[0076] FIG. 49 is a depiction of an occlusive device deployed in a
body conduit to seal an opening in the conduit.
[0077] FIG. 50A is a top view of a frame of another example
occlusive device embodiment.
[0078] FIG. 50B is a side view of the frame of the occlusive device
of FIG. 50A.
[0079] FIG. 50C is a top perspective view of the occlusive device
of FIG. 50A with a covering component on the frame.
[0080] FIG. 50D is a side view of the occlusive device of FIG. 50A
with a covering component on the frame.
[0081] FIG. 51 is a perspective view of another example occlusive
device in accordance with embodiments provided herein.
[0082] FIG. 52 is a perspective view of another example occlusive
device in accordance with embodiments provided herein.
[0083] FIG. 53 is a perspective view of another example occlusive
device in accordance with embodiments provided herein.
[0084] FIG. 54 is a cutting pattern that can be used to cut a tube
(or a portion of a tube) to create the frame of the occlusive
device of FIG. 56.
[0085] FIG. 55 is a side view of another example occlusive device
in accordance with embodiments provided herein.
[0086] FIG. 56 is a perspective view of another example occlusive
device in accordance with embodiments provided herein.
[0087] FIG. 57 is a perspective view of another example occlusive
device in accordance with embodiments provided herein.
[0088] FIG. 58 is a perspective view of another example occlusive
device in accordance with embodiments provided herein.
[0089] FIG. 59 is a cutting pattern that can be used to cut a tube
(or a planar sheet of material) to create the frame of the
occlusive device of FIG. 58.
[0090] FIG. 60 is a perspective view of another example occlusive
device in accordance with embodiments provided herein.
[0091] FIG. 61 is a schematic illustration of another example
occlusive device in accordance with embodiments provided
herein.
[0092] FIG. 62A is a perspective view of another example occlusive
device in accordance with embodiments provided herein.
[0093] FIG. 62B is a side view of the example occlusive device of
FIG. 62A.
[0094] Like reference symbols in the various drawings indicate like
elements.
DETAILED DESCRIPTION
[0095] This document describes devices, systems and methods that
are useful, for example, for fully, partially, or substantially
occluding spaces, holes, defects, apertures, appendages, vessels or
conduits within a body of a patient. An additional use, in some
implementations, can include filtering. Several implantable medical
devices are described herein, and in general any of the features
described with respect to a particular device may also be used with
any of the other devices described herein. In some examples, one or
more features described with respect to a particular device may
replace or be substituted for one or more features of another
device. In some examples, one or more features described with
respect to a particular device may be added to or included with
another device. Also, various combinations or sub-combinations of
any of the features described herein may generally be used with any
of the devices described herein.
[0096] For example, devices described herein can include an
occlusion portion and an anchor portion, and several different
types of occlusion portions and anchor portions are described.
While a particular embodiment may include a particular occlusion
portion and a particular anchor portion, in general, any of the
occlusion portions described herein can be used with any of the
anchor portions described herein, and vice versa, in various
embodiments. In similar fashion, for devices where the occlusion
portion and the anchor portion are not integral, several types of
connecting members or techniques are described for combining an
occlusion portion with an anchor portion to form an occlusion
device, and in general any of the connecting members or techniques
described herein may be used with any combination of an occlusion
portion and an anchor portion. In some examples, the occlusion
portion and the anchor portion may be constructed separately and
then combined to form the device. In some examples, the occlusion
portion and the anchor portion may be constructed
simultaneously.
[0097] In general, any of the implantable medical devices described
herein can be delivered to, and deployed at, an in vivo deployment
site within a body of a patient using various minimally invasive
transcatheter deployment techniques. For example, any of the
implantable medical devices described herein may be releasably
attached to a delivery catheter, and the device and delivery
catheter may be loaded into a delivery sheath. The delivery sheath
may be introduced to the vasculature of the patient and advanced
through the vasculature, until a distal end of the delivery sheath
is located at or near the target in vivo deployment site. The
implantable medical device may be deployed at the deployment site,
for example by pushing the device out the distal end of the
delivery sheath using the delivery catheter and detaching the
device from the delivery catheter. In some examples, the device can
be deployed by retracting the delivery sheath while maintaining (or
advancing) a position of the delivery catheter and the implantable
medical device, and then detaching the device from the delivery
catheter. In some implementations, a first portion of the device
(e.g., an anchor portion) is released from the delivery sheath
while a second portion of the device (e.g., an occlusion portion)
remains constrained by the delivery sheath, a positioning of the
first portion of the device is verified, and then the second
portion of the device is released from the delivery sheath. The
delivery catheter and delivery sheath can then be withdrawn or
retracted from the body of the patient. In some examples, a
retrieval element such as a tether, suture, or cable, is releasably
attached to a portion of the device. The retrieval element can be
used to retrieve or recapture the device after deployment, if
desired.
[0098] Some embodiments of the implantable medical devices
described herein can be used to occlude a left atrial appendage
(LAA) of a human heart. The implantable medical devices can be
delivered in an endovascular manner through or over a catheter
system to a delivery site, such as the LAA or other appropriate
delivery site, and deployed at the site. The implantable medical
devices can be deployed within the LAA and/or across the ostium of
the LAA to isolate the LAA from the main chamber of the left atrium
(left atrial chamber), for example. This may prevent thrombus
formation within the LAA and/or thrombus exit from the LAA. In this
manner, a risk of stroke may be reduced or minimized.
[0099] Without limitation devices described here can be used to
occlude spaces, holes, defects, apertures, vessels, conduits, or
appendages within a body of a patient, including the heart, such as
right or left atrial appendages, fistulas, aneurysms, patent ductus
arteriosus, atrial septal defects, ventricular septal defects,
paravalvular leaks, arteriovenous malformations, or body vessels
including but not limited to the GI tract. For example, in some
embodiments the occlusive devices provided herein can be used to
occlude an opening in the wall of a body vessel such as the colon.
The occlusive devices provide a frame that is compliant enough to
conform to a wide variety of opening geometries and sizes, and
offer a high degree of conformability to conform to various
structural geometries at the deployment site. Particularly,
embodiments of the devices can provide a left atrial appendage
occlusion device frame that provides firm, secure anchoring with
significantly reduced clinical sequela from piercing or without
traumatic piercing of the left atrial appendage tissue.
[0100] In some implementations, the devices described herein can
assume two or more configurations. For example, while the device is
being delivered to the deployment site within the delivery sheath,
the device may assume a collapsed or delivery configuration.
Following deployment of the device, the device may assume an
expanded or deployed configuration. While the device is being
deployed, for example, the device may assume one or more partially
expanded or partially deployed configurations.
[0101] FIG. 1 is a perspective view of an example device frame 100
that can be used to occlude a hole, defect, aperture, or appendage
within a body of a patient. The device frame 100 includes two
sub-frames: an occlusion frame 102 and an anchor frame 104, each of
which is also shown in FIG. 2, which is an exploded view of the
device frame 100 of FIG. 1. While the device frames discussed
herein will generally be described as including an occlusion frame
because the examples are generally described with reference to
occlusion applications, for filtering applications where occlusion
is not desired, the occlusion frame may be referred to as a filter
frame. That is, any of the described occlusion frames may also be
filter frames, for example. As will be described further below, at
least a portion of the occlusion frame 102 can be covered by a
covering component (not shown) that is configured to modulate the
passage of blood or thrombus through the covering component, i.e.,
to substantially occlude the flow of blood and/or thrombus through
the covering component. In some embodiments, the anchor frame 104
is not covered by the covering component. In some embodiments, a
portion of the anchor frame 104 is covered by the covering
component, and in some embodiments the anchor frame is
substantially covered by the covering component (or by a second
covering component).
[0102] The occlusion frame 102, in this example, includes twelve
elongate frame members 106. In other examples, the occlusion frame
102 can include two, three, four, five, six, seven, eight, nine,
ten, or more elongate frame members 106. Each of the elongate frame
members 106 is configured to form a petal 108 (see e.g., petal 108a
and petal 108b) of the occlusion frame 102, and together the petals
108 form a generally disc-shaped member 110 (see FIG. 3) of the
occlusion frame 102. As can be seen with reference to FIG. 1,
adjacent petals (e.g., petal 108a and petal 108b) of the occlusion
frame 102 partially overlap with one another in some embodiments.
The generally disc-shaped member 110 may have a generally circular
shape in some embodiments, and in other embodiments may have an
oval or a generally elliptical shape, or other appropriate shape
for occluding according to the intended purpose. In some
embodiments, the generally disc-shaped member is symmetric about a
longitudinal axis of the device. In some embodiments, the generally
disc-shaped member is asymmetric or eccentric about a longitudinal
axis of the device. This example disc-shaped member 110 having
elongate frame members 106 that are configured to form petals is
one type of disc-shaped member and many others that do not include
petals are also envisioned, including but not limited to those
described in reference to FIGS. 6A-10 and 34B-36B.
[0103] The anchor frame 104 includes, in this example, five
elongate anchor members 114 that can be used to secure the device
to tissue and anchor the occlusion device 100 at an implant
location. In other examples, the anchor frame 104 can include two,
three, four, six, seven, eight, nine, ten, or more anchor members
114. The elongate anchor members 114 can have various shapes,
sizes, and configurations. Each of the elongate anchor members 114
in this example includes a first anchor arm 116a and a second
anchor arm 116b. By including two anchor arms (116a and 116b) for
each anchor member 114, radial opposition force of the anchor
members 114 may be increased. In some cases, a lateral stiffness
may also be increased. In other examples, the elongate anchor
members 114 may include a single anchor arm.
[0104] The elongate frame members 106 extend from a first hub
component 118, and the elongate anchor members 114 extend from a
second hub component 120. The first hub component 118 and the
second hub component are each disposed between the occlusion frame
102 and the anchor frame 104. A connecting member 122 (see FIG. 2)
connects the first hub component 118 and the second hub component.
In some embodiments, connecting member 122 is flexible. In this
context `flexible` means being easily moved under application of
little force. In other embodiments, connecting member 122 may be
relatively inflexible. In some of the discussion that follows, it
may be assumed that connecting member 122 is flexible. For example,
the flexible connecting member 122 can include a first end that is
connected to the first hub component 118, and a second end that is
connected to the second hub component 120. The flexible connecting
member 122 may permit articulation between the occlusion frame 102
and the anchor frame 104. For example, the flexible connecting
member 122 can provide an articulation joint between the occlusion
frame 102 and the anchor frame 104. Flexible connecting member 122
of FIG. 2 includes a ball end (e.g., a laser-welded ball) at its
first end, and the ball end may be received by the first hub
component 118. In other examples, the flexible connecting member
can also include a second ball on its second end, and the second
ball can be received by the second hub component 120. The ball ends
(or other retaining feature) may function to retain the first and
second hub components 118, 120, in various embodiments. In some
examples, the connecting member 122 can have a helical shape, or a
coiled shape. In some examples, connecting member 122 can include a
linkage. In some examples, connecting member includes a beaded
chain.
[0105] In some examples, the second hub component 120 can be
attached to the first hub component 118 with the flexible
connecting member 122 and a collar lock component 123. The collar
lock component 123 can optionally be used as an engagement feature,
and may be attached to the first hub component 118 with tab
features or other means of a mechanical stop. For example, the
collar lock 123 can include a groove on an inside surface of the
collar lock, and the first hub component 118 can include tab
features that can lock into the groove of the collar lock. As such,
the collar lock 123 may facilitate a snap-fit assembly of the
device, for example.
[0106] Referring again to the occlusion frame 102 and elongate
frame members 106, occlusion frame 102 is formed by cutting a tube
of material. For example, a tube is cut according to a prescribed
pattern to form elongate frame members 106, where a first end of
the elongate frame members 106 extend from the first hub component
118. A third hub component 124 terminates the other end of the
elongate frame members 106 in the depicted example. The first hub
component 118 and the third hub component 124 may be cylindrical
portions of the tube. First hub component 118, third hub component
124, and elongate frame members 106 may all be considered portions
of a tube, as they comprise the remaining portions of the tube
following the cutting process. In some embodiments, the elongate
frame members 106 extend helically between the first hub component
118 and the third hub component 120.
[0107] The tube used to form the occlusion frame 102 (and the
frames of the other devices provided herein) can be made of nitinol
(NiTi), L605 steel, stainless steel, or any other appropriate
biocompatible material. In some embodiments, bioresorbable or
bioabsorbable materials may be used, for example a bioresorbable or
bioabsorbable polymer. The tube of material may be cut in variety
of ways. For example, the tube may be cut by a laser.
Alternatively, the tube may be cut by a blade, by a water jet, or
electrochemically milled, to list just a few examples.
[0108] In some embodiments, some or all portions of the occlusion
frame 102 (and the frames of the other devices provided herein) are
coated (e.g., sputter coated) with a radiopaque coating for
enhanced radiographic visibility. For example, in some such
embodiments portions or all of the frames can be coated with a
noble metal such as, but not limited to, tantalum, platinum, and
the like.
[0109] Referring again to anchor frame 104, the elongate anchor
members 114 are formed by wires that extend from second hub
component 120. The second hub component 120 can have various
configurations. In the depicted example, the second hub component
120 has a generally ring shape, with a series of holes axially
through the wall of the ring. First ends of wires that form the
anchor members 114 can be attached to the second hub component 120,
for example by welding or by a mechanical termination. As can be
seen with reference to FIG. 3, first portions 126 of the wires that
form the anchor members 114 extend generally radially from the
second hub component 120, at an angle that is about 10 degrees
distal from a directly radial direction. Second portions 128 of the
wires that form the anchor members 114 are directed in a proximal
direction toward the disc 110.
[0110] FIG. 4A is a front view, and FIG. 4B is a perspective view,
of an example occlusive device 150. The device 150 includes an
occlusion frame 152 that is similar to the occlusion frame 102,
discussed above with reference to FIGS. 1-3, but occlusion frame
152 includes ten elongate frame members rather than twelve. The
device 150 includes an anchor frame 154 that is similar to the
anchor frame 104, discussed above with reference to FIGS. 1-3, but
anchor frame 154 includes ten elongate anchor members rather than
five.
[0111] The device 150 includes a covering component 156 that covers
the occlusion frame 152. In this example, the covering component
156 covers the occlusion frame 152 and is attached to portions of
the elongate frame members. In some embodiments, the covering
component 156 is attached to at least some portions of the elongate
frame members using an adhesive. In some embodiments, FEP
(fluorinated ethylene propylene) is used as an adhesive to attach
the covering component 156 to elongate frame members. For example,
an FEP coating can be applied to portions of the elongate frame
members, and the FEP can act as a bonding agent to adhere the
covering component 156 to the elongate frame members. In some
embodiments, a radiopaque material can be combined with the
adhesive that is used to attach the covering component 156 to the
elongate frame members. For example, in some embodiments a
radiopaque powder (e.g., tungsten powder) can be mixed with the
adhesive. When such a radiopaque material is used in conjunction
with the adhesive for attaching the covering component 156 to the
elongate frame members, the occlusive device 150 (and other devices
described herein that include such radiopaque material) can be
enhanced from a radiographic visualization standpoint (e.g., using
fluoroscopy).
[0112] In some embodiments, portions of the covering component 156
can be attached to the elongate members by banding the covering
component 156 thereto. For example, in some embodiments portions of
the covering component 156, such as but not limited to the ends of
the covering component 156, are attached to the elongate members,
or to the hub members, using banding. The banding can be a variety
of materials, including but not limited to biocompatible film
materials, suture materials, metallic materials, and the like, and
combinations thereof. Such attachment materials and techniques can
also be used for other embodiments of the occlusive devices
provided herein.
[0113] In some embodiments, the covering component 156 is attached
to selected regions of the occlusion frame 152 (and other portions
such as the anchor frame 154) and not attached to other regions of
the occlusion frame 152. This technique can facilitate enhanced
conformability of the occlusive device 150 to the topography of a
patient's anatomy at the implant site. Such techniques can also be
used with other embodiments of the occlusive devices provided
herein.
[0114] The covering component 156 is configured to modulate, and in
some examples, filter or substantially modulate or inhibit the
passage of blood and/or thrombus through the covering component
156. Some embodiments provide a covering component that is
configured to induce rapid tissue ingrowth and immediately occludes
the passage of blood and/or thrombus through the covering
component. The covering component 156 may be a porous, elastic
member that can stretch and collapse to accommodate extension and
collapse, respectively, of the elongate frame members. Pores of the
covering component 156 may be sized to substantially, or in some
examples completely, prevent passage of blood, other bodily fluids,
thrombi, and emboli. In some implementations, the covering
component 156 prevents or substantially prevents passage of blood,
other bodily fluids, thrombi, emboli, or other bodily materials
through the covering component 156. The covering component 156 can
have a microporous structure that provides a tissue ingrowth
scaffold for durable occlusion and supplemental anchoring strength
of the occlusion device 150. Some embodiments of the covering
component 156 comprise a fluoropolymer, such as an expanded
polytetrafluoroethylene (ePTFE) polymer. In some embodiments, the
covering component 156 can be a membranous covering. In some
embodiments, the covering component 156 can be a film. In some
embodiments, the covering component 156 can be a filtering
medium.
[0115] In some embodiments, the covering component 156 is
configured such that the modulation of fluid passage through the
covering component 156 is immediate and does not rely on a
thrombotic process. In some embodiments, the covering component 156
can be modified by one or more chemical or physical processes that
enhance certain physical properties of the covering component 156.
For example, a hydrophilic coating may be applied to the covering
component 156 to improve the wettability and echo translucency of
the covering component 156. In some embodiments, the covering
component 156 may be modified with chemical moieties that promote
one or more of endothelial cell attachment, endothelial cell
migration, endothelial cell proliferation, and resistance to
thrombosis. In some embodiments, the covering component 156 may be
modified with covalently attached heparin or impregnated with one
or more drug substances that are released in situ to promote wound
healing or reduce tissue inflammation. In some embodiments, the
drug may be a corticosteroid, a human growth factor, an
anti-mitotic agent, an antithrombotic agent, or dexamethasone
sodium phosphate.
[0116] In some embodiments, covering component 156 is
pre-perforated to modulate fluid flow through the covering
component, to create filtering properties, and/or to affect the
propensity for tissue ingrowth to the covering component 156. In
some embodiments, the covering component 156 is treated to make the
covering component 156 stiffer or to add surface texture. For
example, in some embodiments the covering component 156 is treated
with FEP powder to provide a stiffened covering component 156 or
roughened surface on the covering component 156. In some
embodiments, selected portions of the covering component 156 are so
treated, while other portions of the covering component 156 are not
so treated. Other covering component 156 material treatment
techniques can also be employed to provide beneficial mechanical
properties and tissue response interactions. Such materials and
techniques can be used for any of the occlusive devices provided
herein.
[0117] In some embodiments, the covering component 156 may be
formed of a fluoropolymer (e.g., expanded PTFE (ePTFE) or PTFE). In
some embodiments, the covering component 156 may be formed of a
polyester, a silicone, a urethane, or another biocompatible
polymer, or combinations thereof. In some embodiments,
bioresorbable or bioabsorbable materials may be used, for example a
bioresorbable or bioabsorbable polymer. In some embodiments, the
covering component 156 can comprise Dacron. In some embodiments,
the covering component 156 can comprise knits or fibers. The
covering component 156 may be woven or non-woven in various
embodiments. In some embodiments, the covering component 156 may be
formed of a copolymer. In some examples, a first portion of the
covering component 156 may be formed of a first material and a
second portion of the covering component 156 may be formed of a
second material. For example, the portion of the covering component
156 that covers the occlusion frame of the device may be formed of
a first material, and a portion of the covering component 156 that
covers an anchor frame of the device may be formed of a second
material.
[0118] Referring again to FIG. 1, the anchor frame 104 is referred
to as being distal of the occlusion frame 102 because, after
deployment, the position of the anchor frame 104 is generally
distal of the occlusion frame 102 with respect to the delivery
system. By contrast, the occlusion frame 102 is referred to as
being proximal of the anchor frame 104 because its deployed
position is generally proximal to the delivery system as compared
to anchor frame 104. In some examples, the anchor frame 104 is
deployed first from the delivery sheath, and the occlusion frame
102 is deployed thereafter from the delivery sheath. With respect
to a LAA, following deployment of the device, the anchor frame 104
may be generally deeper within the interior of the LAA, while the
occlusion frame 102 and the generally disc-shaped member 110 may be
oriented to face the left atrial chamber of the heart.
[0119] In the examples described thus far, the elongate frame
members of the occlusion frame have been portions of a tube, but in
other examples the elongate frame members are wires. Similarly,
while the anchor members of the anchor frame described thus far
have comprised wires, in some examples the anchor members can be
formed from a tube (e.g., either from the same tube from which the
occlusion frame is formed, or from a separate, second tube).
[0120] For embodiments where one or both of the occlusion frame
and/or the anchor frame include elongate members that are wires,
such wires may be, for example, spring wires, shape memory alloy
wires, or super-elastic alloy wires for self-expanding devices. The
elongate members can be made of nitinol (NiTi), L605 steel,
stainless steel, or any other appropriate biocompatible material.
In some embodiments, drawn wire tubes such as Nitinol tubes with a
platinum, tantalum, iridium, palladium, or the like, fill can be
used. In some embodiments, bioresorbable or bioabsorbable materials
may be used, for example a bioresorbable or bioabsorbable polymer.
The super-elastic properties of NiTi make it a particularly good
candidate material for the elongate members (e.g., NiTi wires can
be heat-set into a desired shape), according to some
implementations. NiTi can be heat-set so that an elongate member
can self-expand into a desired shape when the elongate member is
placed in a less restrictive environment, such as when it is
deployed from the delivery sheath to a body cavity. The elongate
members can provide structure and shape for the respective frame,
and for the device in general. In general, the devices described
herein include elongate members that are shaped as desired to suit
the purpose of the device. The elongate members may generally be
conformable, fatigue resistant, and elastic such that the elongate
members have a stored length. The elongate members may have a
spring nature that allows them to collapse and elongate to a
pre-formed shape (e.g., the frame of a device may have a pre-formed
shape).
[0121] In some embodiments, the diameter or thickness of the
elongate members may be within a range of about 0.008'' to about
0.015'', or about 0.009'' to about 0.030'', but in other
embodiments elongate members having smaller or larger diameters or
thicknesses may be used. In some embodiments, each of the elongate
members has the same diameter. In some embodiments, one or more
portions of the elongate members may be diametrically tapered. The
elongate members may have a round cross-sectional shape or may have
a cross-sectional shape that is not round, such as a rectangle or
other polygon. Examples of other cross-sectional shapes that the
elongate members may have include a square, oval, rectangle,
triangle, D-shape, trapezoid, or irregular cross-sectional shape
formed by a braided or stranded construct. In some embodiments, an
occlusion device may include flat elongate members. In some
examples, the elongate members may be formed using a centerless
grind technique, such that the diameter of the elongate members
varies along the length of the elongate members.
[0122] As described above, the devices discussed herein may assume
a collapsed configuration, in which the occlusion frame and anchor
frame of the device may be elongated so that the device assumes a
low crossing profile for positioning within a delivery sheath. In
some examples, the elongate frame members and anchor members are
caused to collapse or elongate as the device is pulled into the
delivery sheath. The sheath may provide a constraining environment
and may maintain the device in the delivery configuration while the
device is located within the sheath. The device may be configured
to self-expand as a result of a bias or shape-memory property of
the elongate members, where the device may self-expand upon
liberation from the constraining environment, as by exiting the
delivery sheath.
[0123] FIG. 5 shows that, in contrast to the generally flat
disc-shaped member 110 of FIG. 3, the disc-shaped member can have
different shape profiles. For example, the disc-shaped member can
have a proximally oriented concave profile 160, a distally oriented
concave profile 162, or an "S" shaped profile, where the edge
portion of the disc is generally proximally oriented concave.
Another alternative (not shown), is an "S" shaped profile, where
the edge portion of the disc is generally distally oriented
concave. In addition, in some embodiments (e.g., refer to FIGS. 4B,
6A, 7A, 8B, 9A, 10, 11, etc.) the disc-shaped member has a bulbous
shape rather than being generally planar. Such bulbous-shaped
disc-shaped members can be used with any of the occlusive devices
provided herein.
[0124] FIGS. 6A and 6B show another example embodiment of a
disc-shaped member 660 that is used with embodiments of the
occlusive devices provided herein. The disc-shaped member 660
includes a first frame portion 662, a second frame portion 664, a
peripheral member 666, and a covering 668. The peripheral member
666 is disposed at the generally circular peripheries of the first
and second frame portions 662 and 664. The covering 668 is disposed
on top of the first and second frame portions 662 and 664 and the
peripheral member 666.
[0125] The first and second frame portions 662 and 664 each include
a center hub and multiple spoke members that project radially from
the center hub. The first and second frame portions 662 and 664 can
be made of any of the frame materials described elsewhere herein.
In some embodiments, the first and second frame portions 662 and
664 have the same design configuration, but in some embodiments the
first and second frame portions 662 and 664 have different design
configurations. In the depicted embodiment, each frame portion 662
and 664 has the same design configuration with a center hub and
eight spoke members. When the first and second frame portions 662
and 664 are assembled into disc-shaped member 660, the first frame
portion 662 is simply flipped 180 degrees in relation to the second
frame portion 664, so that the first frame portion 662 is the
mirror image of the second frame portion 664. In addition, in the
depicted embodiment the first frame portion 662 is rotated about
22.5 degrees so that the spoke members of the first and second
frame portions 662 and 664 are offset from each other. In some
disc-shaped member embodiments that are configured similar to
disc-shaped member 660, different numbers of spoke members are
included, such as two, three, four, five, six, seven, nine, ten,
eleven, twelve, or more than twelve spoke members. The first and
second frame portions 662 and 664 can be made of any of the
materials of elongate members described elsewhere herein.
[0126] The peripheral member 666 is generally circumferentially
disposed around the periphery of the disc-shaped member 660. In
some embodiments, the peripheral member 666 is disposed near to and
may be in contact with the ends (e.g., tips) of the spoke members
of the first and second hubs 662 and 664, however the peripheral
member 666 is independent of the spoke members. In some
embodiments, the peripheral member 666 is a compliant outer rim
cording of the disc-shaped device 660. The peripheral member 666
can be made from materials including, but not limited to, elastic
polymeric material such as silicone, polyurethane, and the like, or
metallic wire such as NiTi wire including stranded NiTi wire or
solid NiTi wire. In some embodiments, the peripheral member 666 is
attached to the covering 668. For example, the peripheral member
666 may be sewn, adhered, clipped, and the like, to the covering
668. In some embodiments, the peripheral member 666 is sandwiched
between portions of the covering 668 that are attached together to
provide a result that is akin to upholstery piping trim.
[0127] The first and second frame portions 662 and 664, and the
peripheral member 666, can be structurally held in place by the
covering 668 to form the disc-shaped member 660. The covering 668
can be made of any of the covering materials described elsewhere
herein.
[0128] The disc-shaped member 660 can be axially elongated to a
low-profile configuration for placement within the lumen of a
delivery sheath. In the low-profile configuration, the spoke
members of the first and second frame portions 662 and 664 can fold
about 90 degrees to become general parallel with the central axis
of the disc-shaped member 660. The peripheral member 666 can be
elongated axially to become generally parallel with the central
axis of the disc-shaped member while remaining configured as a
loop. Upon deployment from the delivery sheath, the disc-shaped
member 660 can radially expand and axially contract to assume the
expanded configuration shown.
[0129] FIGS. 7A and 7B show another example embodiment of a
disc-shaped member 670 that is used with embodiments of the
occlusive devices provided herein. The disc-shaped member 670
includes a first frame portion 672, a second frame portion 674, and
a covering 678. Optionally, the disc-shaped member 670 may also
include a peripheral member (not shown) like the peripheral member
666 described above.
[0130] The first and second frame portions 672 and 674 have
petal-shaped spokes that project generally radially from the center
hubs of the first and second frame portions 672 and 674. In this
embodiment, each of the first and second frame portions 672 and 674
has five petal-shaped spokes, but in other embodiments other
numbers of petal-shaped spokes are included, such as two, three,
four, six, seven, eight, nine, ten, or more than ten petal-shaped
spokes. The first and second frame portions 672 and 674 can be made
of any of the materials of elongate members described elsewhere
herein.
[0131] The widths of the petal-shaped spokes can be selected as
desired. While in some embodiments all the petal-shaped spokes have
the same width, in some embodiments the petal-shaped spokes have
two or more different widths. Embodiments having fewer numbers of
petal-shaped spokes may have wider petal-shaped hubs, and
embodiments having greater numbers of petal-shaped spokes may have
narrower petal shaped spokes, but such a design convention is not
required. In some embodiments, adjacent petal-shaped spokes of the
first and second frame portions 672 and 674 are spaced apart from
each other (as shown), but it some embodiments adjacent
petal-shaped spokes overlap each other. While in some embodiments
petal-shaped spokes overlap only adjacent spokes, in some
embodiments petal-shaped spokes overlap adjacent and non-adjacent
petal-shaped spokes.
[0132] As described above in regard to disc-shaped member 660, in
some embodiments the first and second frame portions 672 and 674 of
disc-shaped member 670 have the same design configuration (as
shown), but the frame portions can have dissimilar design
configurations in other embodiments. In an example embodiment
having five spokes, the first frame portion 672 is flipped 180
degrees in relation to the second frame portion 674 and rotated
about 36 degrees so that the petal-shaped spokes of the first and
second frame portions 672 and 674 are off-set from each other.
[0133] The disc-shaped member 670 includes a covering 668 that can
be made of any of the covering materials and include any of the
covering material treatments described elsewhere herein. In some
embodiments, the first and second frame portions 672 and 674 can be
attached to the covering 668 using any of the techniques described
elsewhere herein, including but not limited to, sewing, adhering,
clipping, sandwiching the frame portions 672 and 674 between
multiple layers of covering 668, and so on. In some embodiments of
disc-shaped member 670, the petal-shaped spokes are at least
partially individually covered with covering 668. For example, in
embodiments that have overlapping adjacent petal-shaped spokes,
each spoke may be generally individually covered with covering 668.
Such a configuration may provide a disc-shaped member 670 that is
significantly conformable to the anatomy where the member 670 is
deployed. In some embodiments, the covering 668 may generally cover
the first and second frame portions 672 and 674 as a whole. In some
embodiments, the covering 668 may cover the petal-shaped spokes
individually. In some embodiments, a combination of individual
coverings and covering as a whole may be combined on a disc-shaped
member.
[0134] FIGS. 8A and 8B show another example embodiment of a
disc-shaped member 680. The disc-shaped member 680 includes an
elastic member 682. In some embodiments, the elastic member 682
connects the proximal and distal hubs of the disc-shaped member
680. In some embodiments, the proximal and distal hubs may be
eyelets, tubes, rings, crimp collars, and the like.
[0135] The disc-shaped member 680 is shown in a collapsed
low-profile configuration in FIG. 8A. This configuration can be
used, for example, while the disc-shaped member 680 is contained
within a delivery sheath or catheter used to deliver the occlusive
device of which disc-shaped member 680 is a part. The disc-shaped
member 680 is shown in an expanded configuration in FIG. 8B. This
is the configuration that the disc-shaped member 680 will seek when
the restraints of a delivery sheath are removed from the
disc-shaped member 680, such as when the disc-shaped member 680
emerges from the delivery sheath during a transcatheter implant
procedure.
[0136] The elastic member 682 may be optionally included on any the
disc-shaped member embodiments provided herein. In some disc-shaped
member embodiments, the elastic member 682 can cause, or encourage,
the disc-shaped member to expand to the deployed configuration as
depicted by disc-shaped member 680 in FIG. 8B. In some embodiments,
the elastic member 682 acts as an inner shaft and radial filler
when the disc-shaped member 680 is in the low-profile
configuration. In some embodiments, the elastic member 682 enhances
axial alignment between the hubs of the disc-shaped member 680, and
reduces the likelihood of the elongate members becoming engaged
with each other when the disc-shaped member 680 is in the
low-profile configuration within a delivery sheath. Keeping the
individual elongate members spaced away and not interfering with
each other inside the sheath will facilitate proper expansion of
the frame when the disc-shaped member 680 is deployed from the
delivery sheath. The elastic member 682 can also provide a tensile
force property to encourage the hubs of the disc-shaped member 680
to move towards each other during deployment to reach the intended
expanded shape in situ. The elastic member 682 can be made from a
biocompatible elastic material such as silicone, another suitable
elastomeric thermoplastic, or a polymer.
[0137] FIGS. 9A and 9B show another example embodiment of a
disc-shaped member 690 that is used with some embodiments of the
occlusive devices provided herein. The disc-shaped member 690
includes a first frame portion 692, a second frame portion 694, and
a covering 698. Optionally, the disc-shaped member 690 may also
include a perimeter member (not shown) like the peripheral member
666 described above, and/or an elastic member (not shown) like the
elastic member 682 described above.
[0138] The first and second frame portions 692 and 694 can have any
of the spoke configurations of the disc-shaped members described
elsewhere herein. For example, in some embodiments the first and
second frame portions 692 and 694 have petal-shaped spokes that
project generally radially from the center hubs of the first and
second frame portions 692 and 694. In some embodiments, the first
and second frame portions 692 and 694 may have spokes that are made
of individual elongate members. As described above in regard to
disc-shaped member 660, in some embodiments the first and second
frame portions 692 and 694 of disc-shaped member 690 have the same
design configuration (as shown), but the frame portions can have
dissimilar design configurations in other embodiments. In some
embodiments having six spokes, the first frame portion 692 is
flipped 180 degrees in relation to the second frame portion 694 and
rotated about 30 degrees so that the petal-shaped spokes of the
first and second frame portions 692 and 694 are off-set from each
other. But in some embodiments of disc-shaped members, no such
offsetting of the spokes is used. In the depicted embodiment, each
of the first and second frame portions 692 and 694 has six narrow
petal-shaped spokes, but in other embodiments other numbers of
spokes are included, such as two, three, four, five, seven, eight,
nine, ten, or more than ten spokes. The first and second frame
portions 692 and 694 can be made of any of the materials of
elongate members described elsewhere herein.
[0139] The disc-shaped member 690 includes a covering 698 that can
be made of any of the covering materials described herein and
include any of the covering material treatments described elsewhere
herein. In some embodiments, the covering 698 is a composite
material that is semi-rigid. For example, in some embodiments
multiple layers of materials are sandwiched together with FEP
bonding therebetween, to increase the rigidity of the covering 668.
In some embodiments, the spokes of the first and second frame
portions 692 and 694 are also sandwiched between the layers of
covering material. In some embodiments, the first and second frame
portions 692 and 694 are attached to the covering 698 using any of
the techniques described elsewhere herein, including but not
limited to, sewing, adhering, clipping, and the like.
[0140] In some embodiments, the free ends of some or all of the
spokes of the first and second frame portions 692 and 694 do not
extend all the way to the periphery of the disc-shaped member 690
(as shown). Such a configuration may provide a disc-shaped member
690 that is significantly conformable to the anatomy where the
member 690 is deployed, and the semi-rigid nature of the covering
698 may help facilitate the conformance. In some embodiments, the
spokes extend substantially all the way to the periphery of the
disc-shaped member 690.
[0141] FIG. 10 shows another example embodiment of a disc-shaped
member 700 that is used with some embodiments of the occlusive
devices provided herein. The disc-shaped member 700 includes a
first hub 702, a second hub 704, and a covering 708. Optionally,
the disc-shaped member 700 may also include a perimeter member (not
shown) like the peripheral member 666 described above, an elastic
member (not shown) like the elastic member 682 described above, and
frame portions with spokes, petals, or struts like any of those
embodiments described elsewhere herein.
[0142] In some embodiments, the disc-shaped member 700 is
expandable (to the general shape shown, or any other desired shape)
by inflation of the disc-shaped member 700. During transcatheter
deployment, while the disc-shaped member 700 is contained within a
delivery sheath in a low-profile configuration, the disc-shaped
member 700 is not inflated. Thereafter, when the disc-shaped member
700 has been deployed from the delivery sheath, an inflation medium
can be supplied to the disc-shaped member 700 to cause the
disc-shaped member to expand.
[0143] In some embodiments, the disc-shaped member 700 includes a
first hub 702 and a second hub 704. A covering 708 is attached to
the first and second hubs 702 and 704. The first hub 702 may
include a valve 706. In some embodiments, the valve is a one-way
valve that permits an inflation medium to enter the internal
compartment defined by the covering 708 while restricting the
inflation medium from exiting the internal compartment defined by
the covering 708. A typical duckbill-type valve system or an
umbrella valve system can be used in some implementations. The
valve may be predisposed to be in the closed position, and
increased internal pressure may contribute to its sealing
efficiency. In some embodiments, the disc-shaped member 700 can be
deflated for repositioning or retrieval purposes.
[0144] The covering 708 can be formed of one or more of a variety
of biocompatible materials and composite materials as described
elsewhere herein, including but not limited to densified PTFE or
ePTFE, silicone, or an elastomeric fluoropolymer, such as described
in one or more of U.S. Pat. Nos. 7,049,380, 7,462,675, and
8,048,440, the contents of which are each incorporated by reference
herein.
[0145] In some embodiments, the inflation medium supplied to
disc-shaped member 700 can include two or more substances. In some
embodiments, the inflation medium reacts with, combines with, or
interacts with one or more materials included in the disc-shaped
member 700 prior to delivery of the inflation medium. For example,
an inner surface of the wall of the covering 708 may be pre-imbibed
with a first filler reagent substance of a two-part filler system,
and an inflation medium that comprises a second reagent substance
may be delivered thereto. The second reagent material may activate
the first filling reagent material, in some examples. For example,
the first filling material may be a calcium-containing solution,
and the second material may be an alginate-containing solution. The
alginate-containing solution may react with the calcium-containing
solution, and they may expand. In some examples, the first and
second filling materials may differ in physical phase type. For
example, the first filling material may be one of a solid, liquid,
or gas (or other type), and the second filling material may be a
different one of a solid, liquid or gas (or other type) as compared
to the first filling material. In some examples, the filling
material comprises at least one of a bioinert material and a
biocompatible material. The inflation medium may also include
biocompatible liquids, solids, foams, gels, and gases. In some
examples, the inflation medium may be a radiopaque liquid. In some
embodiments, the inflation medium may be a saline solution. In some
embodiments, the inflation medium may include gels and/or foams. As
defined herein, the term "gel" refers to any multi-part
biocompatible substance that can be activated in situ or be caused
to swell or increase in viscosity. As defined herein, the term
"foam" refers to any substance that includes entrapped regions of
gas. Open-cell foams may be used, for example. An open-cell
polyurethane (PU) foam may be used. In some examples, the inflation
medium may be a silicone gel. In some embodiments, the inflation
medium may be a polyurethane gel. In some embodiments, the
inflation medium may be a solid material. For example, in some such
embodiments the inflation medium may be a granular solid material,
a string-like solid material, or a super-elastic wire material.
[0146] FIG. 11 shows another example embodiment of a disc-shaped
member 710 that is used with some embodiments of the occlusive
devices provided herein. The disc-shaped member 710 is illustrated
in an elongated configuration so that the arrangement of the inner
and outer frame structures can be readily visualized. The
disc-shaped member 710 includes a first nested hub assembly 712, a
second nested hub assembly 714, an outer frame structure 713, an
inner frame structure 715, and a covering 718. Optionally, the
disc-shaped member 710 may also include a perimeter member (not
shown) like the peripheral member 666 described above, and/or an
elastic member (not shown) like the elastic member 682 described
above.
[0147] Disc-shaped member 710 includes two elongate member frame
structures (the outer and inner frame structures 713 and 715) that
are nested within each other. The inner frame structure 715 is
nested inside of the outer frame structure 713. In other words, the
hubs of the inner frame structure 715 are located within the hubs
of the outer frame structure 713 at the first and second nested hub
assemblies 712 and 714. Further the elongate members of the inner
frame structure 715 (that extend between the hubs of the inner
frame structure 715) are located within the elongate members of the
outer frame structure 713 (that extend between the hubs of the
outer frame structure 713).
[0148] In some embodiments, the outer and inner frame structures
713 and 715 include elongate members that follow a spiral pattern
between a proximal and distal hub of the outer and inner frame
structures 713 and 715. In some embodiments, other types of
elongate member frame structures may be included, including, but
not limited to, spokes, struts, petals, loops, and so on. In this
embodiment, the spiral patterns of the outer and inner frame
structure 713 and 715 are not parallel to each other. Rather, in
some embodiments the elongate members of the outer and inner frame
structures 713 and 715 crisscross each other. For example, in some
embodiments, the outer and inner frame structures 713 and 715 are
formed to have reversed helical patterns. Such a relative construct
of the outer and inner frame structures 713 and 715 may facilitate
the frame structures 713 and 715 to expand from a low-profile
configuration to an expanded configuration in a balanced manner
such that frame malformations, such as twisting ("phone cording"),
can be reduced or eliminated.
[0149] FIG. 12 is a perspective view of an example anchor frame
190. Anchor members 192 extend from a second hub component 194. In
the example of FIG. 12, the anchor members 192 comprise wires, but
in other embodiments, the anchor members can be formed from a tube,
as by laser-cutting, to be discussed further below with reference
to FIG. 23. The anchor frame 190 includes twelve anchor members
192, but for clarity only six of the twelve anchor members 192 are
shown in FIG. 12. In other examples, a different number of anchor
members 192 may be used (e.g., two, three, four, five, six, seven,
eight, nine, ten, eleven, or more).
[0150] First portions 196 of the wires that form the anchor members
192 extend generally distally and radially from the second hub
component 194, at an angle that is about 30 degrees distal from a
directly radial direction. Second portions 197 of the wires that
form the anchor members 192 extend from the first portions 196 in a
generally distal and radial direction, at an angle that is about 75
degrees distal from a directly radial direction. Third portions 198
of the wires that form the anchor members 192 extend from the
second portions 197 in a generally proximal and radial direction,
at an angle that is about 60 degrees proximal from a directly
radial direction. As can be seen in FIG. 12, a profile of the
anchor frame 190 has the shape of an umbrella or a bell, formed by
first and second portions 196 and 197, with a lip formed by third
portion 198.
[0151] Each of the anchor members 192 includes one or more
generally spherically shaped member 200. The generally spherically
shaped members 200, (or ball ends) are adapted for atraumatically
engaging body tissue and securing the device in place, for example
by friction, pressure, or entanglement. In some examples, the ball
ends 200 may be formed on the end of the fixation anchor wire by
laser welding. The ball ends 200 may provide anchoring and may
reduce a potential for perforation or pericardial effusion, in some
implementations. In general, the ball ends 200 or other passive
anchor features discussed herein may cause less friction on an
inside surface of a delivery sheath as compared to some active
anchor elements with sharp edges, in some implementations, which
may reduce particulation with respect to the delivery system in
some cases.
[0152] In some embodiments, a diameter of the ball ends 200 may be
about two times the diameter of the frame anchor wire. In some
examples, the diameter of the ball end 200 may range from about
1.times. (with just a round wire end) to about 2.times. the
diameter of the frame anchor wire, for example, the diameter may be
about 1.5.times. the diameter of the frame anchor wire, or about
1.6.times., 1.7.times., 1.8.times., or 1.9.times. the diameter of
the frame anchor wire. The ball end may be created by applying a
laser pulse to the end of the frame anchor wire, for example. For
example, in some embodiments, spherical members or ball ends may be
formed directly on ends of the frame anchor wires using a precision
laser weld technique (e.g., using an Nd:YAG laser).
[0153] The ball ends 200 may serve as anchor points for anchoring
devices that include the frame anchor 190 to tissue at a deployment
site. The surface of the third portions 198 of anchor members 192
may serve as a landing zone for tissue. Additionally, the surface
of the first portions 196 may serve as a landing zone for
tissue.
[0154] FIG. 13 is a perspective view of the anchor frame 190 of
FIGS. 6A and 6B, including a covering component 210 that covers the
anchor frame 190. In this example, the covering component 210
covers substantially all of the anchor frame 190, but in other
examples the covering component 210 may cover only a portion of the
anchor frame 190.
[0155] FIG. 14 is a perspective view of an example occlusive device
230. Device 230 includes the occlusion frame 102 of FIGS. 1-3 and
the anchor frame 190 of FIG. 7. In this example, a first covering
component 156 covers the occlusion frame 102, and a second covering
component 210 covers the anchor frame 190.
[0156] FIG. 15 is an illustration of another example device 720
that can be used to occlude a hole, defect, aperture, or appendage
within a body of a patient. The device 720 includes two sub-frames:
an occlusion frame 722 (or disc-shaped member) and an anchor frame
724. While the device frames discussed herein are generally
described as including an occlusion frame because the examples are
generally described with reference to occlusion applications, for
filtering applications where occlusion is not desired, the
occlusion frame may be a filter frame. That is, any of the
described occlusion frames may also be filter frames, for example.
In some embodiments, at least a portion of the occlusion frame 722
is be covered by a covering component (not shown) that is
configured to inhibit the passage of blood and/or thrombus through
the covering component, i.e., to substantially occlude the flow of
blood and/or thrombus through the covering component. In some
embodiments, the anchor frame 724 is not covered by the covering
component. In some embodiments, a portion of the anchor frame 724
is covered by the covering component, and in some embodiments the
anchor frame 724 is substantially covered by the covering component
(or by a second covering component).
[0157] In some embodiments, the anchor frame 724 is constructed
from material that is cut and expanded. For example, in some
embodiments the anchor frame 724 is made from a tube of material
that is laser-cut and then expanded (and heat-set in some
embodiments) to the configuration substantially as shown. In some
embodiments, NiTi is used as the material, but other materials such
as stainless steel and polymers may also be used. The design of the
anchor frame 724 can facilitate the application of a radial force
from the anchor frame 724 to the surrounding tissue that can assist
with the anchoring performance of the occlusive device 720. In
addition, the configuration of the anchor frame 724 may include one
or more portions made of curved elongate members. Such curved
portions can provide axial and radial flexibility and springiness
whereby the anchor frame is resistant to device migration within
the anatomy of the patient. Further, in some embodiments the anchor
frame 724 includes multiple free ends 725 that can abut or
penetrate tissue to provide anchorage of the occlusive device 720
in relation to the surrounding tissue.
[0158] FIGS. 16A through 16D are additional example configurations
of anchor frame free ends that can be included with some
embodiments of the occlusive devices provided herein. Such anchor
frame free ends can facilitate the resilient anchorage of occlusive
devices to the tissue of a patient. FIG. 16A illustrates an anchor
frame free end 726 that is curved radially outward from the axis of
the occlusive device. As such, at least the tip of the anchor frame
free end 726 can contact tissue and provide an anchoring function
to resist migration of an occlusive device in relation to the
tissue that the anchor frame free end 726 is in contact with. FIG.
16B illustrates an anchor frame free end 727 that includes an
atraumatic tip. In this example, the atraumatic tip is a ball end
that is analogous to ball ends 200 described above. FIG. 16C
illustrates an anchor frame free end 728 that is configured to have
a sharp tip. In some implementations, such a sharp tip may
penetrate tissue to provide anchorage and resistance to migration
of the occlusive device of which the anchor frame free end 728 is a
part. FIG. 16D illustrates another example anchor frame free end
729. In this embodiment, the anchor frame free end 729 is
bifurcated to include two free ends. The two free ends of anchor
frame free end 729 are illustrated as sharpened, but in some
embodiments the two free ends may have atraumatic ends (e.g., ball
ends), or any of the other example anchor frame free ends described
herein, or combinations thereof.
[0159] FIG. 17 is a perspective view of an example anchor frame 250
that is similar to the anchor frame 190 of FIGS. 12A, 12B, and 13,
except that the anchor members 252 are not wires, but rather are
elongate members formed by laser-cutting a tube of material, in a
similar manner as described above with reference to occlusion frame
102. A second hub component 254 comprises a cylindrical portion of
the tube, and the anchor members 252 extend from the second hub
component 254. While frame 250 does not include ball end members,
in other examples a ball end member similar to ball end 200 could
be included, as could other types of anchor features.
[0160] FIG. 18 is a perspective view of another example device
frame 270. Device frame 270 includes occlusion frame 102 and anchor
frame 250, and is laser-cut from a single tube of material. That
is, both occlusion frame 102 and anchor frame 250 are laser-cut
from the same tube of material. In this example, the elongate frame
members 106 and the anchor members 252 each extend from a first hub
component 256. In this example, the anchor frame 250 is only
partially covered by a covering component 258. Covering component
258 covers the first hub component 256, the first portions 260 of
the elongate members that form the anchor members 252 and a
majority of the second portions 262 of the elongate members that
form the anchor members 252. In some embodiments, the covering
component 258 can act as a pledget in relation to the anchor
members 252. In some embodiments, supplemental pledget members can
be added to one or more of the anchor members of this embodiment
and any other occlusive device embodiment provided herein.
[0161] FIG. 19A is a perspective view of an example occlusion
device frame 300 that includes a wire-based occlusion frame 302 and
a wire-based anchor frame 304. Elongate frame members 306 of
occlusion frame 302 extend from a first hub component 308, and
anchor members 310 of anchor frame 304 extend from a second hub
component 312. The occlusion frame 302 is coupled to the anchor
frame 304 by a flexible connector 314 that couples the first hub
component 308 to the second hub component 312. The first hub
component 308 and the second hub component 312 may be laser-cut
rings in this example, and the wire-based elongate frame members
306 and wire-based anchor members 310 may be crimped, swaged,
welded or mechanically engaged to the respective first or second
hub component 308 or 312. Lengths of the anchor members 310 are
staggered, in this example.
[0162] Similar to occlusion frame 102, described above, any
appropriate number of elongate frame members 306 can be used.
Anchor frame 304 includes six anchor members 310, but any
appropriate number of anchor members can be used in other examples.
The anchor members 310 include first and second arms of the anchor
member that join in a loop at a distal end of the anchor member
310. First portions 316 of the anchor members 310 extend generally
distally and radially from the second hub component 310 at an angle
that is about 40 degrees distal from a directly radial direction.
Second portions 318 of the anchor members 310 extend from the first
portions 316 in a generally proximal and radial direction, at an
angle that is about 45 degrees distal from a directly radial
direction.
[0163] FIG. 19B is an enlarged view of the flexible connector 314,
which includes generally spherical members 320 at first and second
ends of the flexible connector 314. In some embodiments, connector
314 may be relatively inflexible, semi-rigid, rigid, or a
combination thereof. In various implementations the spherical
member 320a at the first end of the flexible connector 314 can be
received by first hub component 308, and the spherical member 320b
at the second end of the flexible connector 314 can be received by
second hub component 312. In some examples, flexible connector 314
is a nitinol wire with ball ends 320 formed thereon. In some
examples, flexible connector 314 is a solid wire or a stranded
wire. In some examples, flexible connector 314 is a polymeric
fiber.
[0164] FIG. 20 is a perspective view of device frame 300 showing
how flexible connector 314 permits articulation between the
occlusion frame 302 and the anchor frame 304. For example, flexible
connector 314 can serve as an articulation joint between the
occlusion frame 302 and the anchor frame 304. As such, the anchor
frame 304 may rotate substantially independently of occlusion frame
302, according to some embodiments. By the same token, the
occlusion frame 302 may rotate substantially independently of
anchor frame 304, according to some embodiments. This can be
advantageous, for example, during deployment of the device, as the
anchor frame 304 can be deployed and can engage tissue, and then
subsequently the occlusion frame 302 can be deployed and, because
of the articulation permitted by the flexible connector 314, can
find its natural or preferred orientation, including by rotating if
appropriate, without consequently causing the anchor frame to
similarly rotate and perhaps tear or rip tissue at the deployment
site.
[0165] FIGS. 21A and 21B are perspective and back views,
respectively, of an example occlusive device 330 that includes the
device frame 300 of FIGS. 19A and 19B and a covering component 332
that covers the occlusion frame 302 of the device frame 300.
[0166] FIGS. 22A and 22B are perspective and side views,
respectively, of another device frame 400. Device frame 400 is cut
from a single tube of material, and includes an occlusion frame
402, a two-member anchor frame 404, and a flexible linkage 406 that
couples the occlusion frame 402 to the anchor frame 404. Occlusion
frame 402 is similar to the occlusion frame 102, described above
with reference to FIGS. 1-3. Anchor frame 404 is substantially a
two-dimensional anchor frame, and has first anchor member 408a and
second anchor member 408b. Anchor members 408a and 408b are
configured to stretch an occluded space, such as the left atrial
appendage, to flatten and minimize a profile of the occluded space.
For example, anchor members 408a and 408b can flatten and minimize
the left atrial appendage so that it substantially lays flat on the
heart, according to some implementations. Each of the anchor
members 408a and 408b includes a tine, hook or barb 410 at a crest
of the anchor members 408a, 408b for engaging tissue at the
deployment site. Penetration depth may be limited by the anchor
member 408a, 408b. In some embodiments, anchor members 408a and
408b may have a curved shape. In some examples, the anchor members
408a and 408b may have a curved shape similar to a "potato chip,"
for example. In some examples, a curved shape may improve
conformance, for example. In some examples, curved anchor members
408a and 408b may better conform to a wall of a space to be
occluded.
[0167] In some embodiments, flexible linkage 406 may permit
rotation between the occlusion frame 402 and the anchor frame 410.
For example, flexible linkage 406 may be configured to cause anchor
frame 404 to rotate a predetermined amount (e.g., about 180
degrees) when anchor frame 404 is deployed from a sheath, for
example. The anchor members 408 and/or tine/hook/barb 410 may
initially engage tissue upon deployment of the anchor frame 404,
and then as the flexible linkage 406 and the occlusion frame 402
are deployed, a torque feature configured with the flexible linkage
406 may cause the anchor frame members 408 to rotate the
predetermined amount with respect to the occlusion frame 204. For
example, as viewed in FIG. 22B where the anchor members 408a and
408b are oriented substantially vertical prior to the rotation,
following the rotation the anchor member 408a may be orientated
408a substantially out of the page, and anchor member 408b may be
oriented substantially into the page (or vice versa). Such rotation
of the anchor members 408 may cause the appendage (or other
occluded space) to flip or twist on itself, and thereby
substantially close off the appendage. The occlusion frame 402,
covered by a covering component (not shown), further occludes the
appendage. In some embodiments, flexible linkage 406 may not permit
rotation between the occlusion frame 402 and the anchor frame
410.
[0168] Optionally, a spring or elastic component (not shown), can
be included between the first hub component 410 and the cylinder
portion 412 at the distal end of the anchor frame 404. This
optional feature can increase radial force by pulling and locking
over-center, for example. FIG. 23 shows a tube 450 and a cut
pattern 452 that can be used to cut the tube 450 to create the
frame 400 of FIGS. 22A and 22B.
[0169] FIG. 24 is a perspective view of yet another device frame
500. The device includes an occlusion frame 502 and an anchor frame
504. In the depicted example, the device is mounted on an example
mandrel 506. The anchor frame includes anchor members 508. First
portions 510 of the anchor members 508 extend generally distally
and radially from a second hub component 516, at an angle that is
about 15 degrees distal from a directly radial direction. Second
portions 512 of the anchor members 508 extend from the first
portions 510 in a substantially distal direction. Third portions
514 of the anchor members 508 extend from the second portions 512
in a generally distal and inwardly radial direction, at an angle
that is about 15 degrees from a directly inwardly radial direction.
Second portions 512 of the anchor members 508 provide a relatively
flat surface for opposition to a wall of a space to be occluded,
such as the wall of the left atrial appendage. This may minimize
opportunity for penetration of the wall, for example, and may
minimize pericardial effusion.
[0170] FIG. 25 is a conceptual drawing of an example occlusive
device 600 that includes two anchor frames. A first anchor frame
602 may substantially correspond to any of the anchor frames
discussed herein, except that the anchor members 606 of the first
anchor frame may extend from a proximal end of a second hub
component 608, in some implementations. In other implementations,
the anchor members 606 may extend from a distal end of the second
hub component 608, for example. A second anchor frame 604 may be
"daisy-chained" distal of the first anchor frame 602, and may
provide for two-stage anchor deployments where the second anchor
frame 604 is initially deployed, the first anchor frame is
thereafter deployed, and the occlusion frame is then deployed.
[0171] In various embodiments, the second anchor frame 604 may
include anchor members 610 that extend from a distal end of the
second hub component 608 (not shown), or from a third hub component
612, which can be coupled to the second hub component 608, to the
first hub component 614 (or to both the second hub component 608
and the first hub component 614).
[0172] In general, any of the anchor frame designs discussed herein
can be modified so that the anchor members extend from the proximal
end of the second hub component, as shown in FIG. 25. In some
cases, modifying in this manner may shorten device length, and may
increase a radial opposition force applied by the anchor members,
for example.
[0173] In general, any of the occlusion device frames discussed
herein can optionally include a spring or elastic component that
couples a hub component at the proximal end of the occlusion device
frame (e.g., component 124 in FIG. 1) with for example the second
hub component, to provide a light tension. In some cases, such
light tension can be used to help maintain the shape of the
generally disc-shaped member and prevent the generally disc-shaped
member from assuming a bulbous shape, for example. In some
embodiments, the optional spring can be wound in a direction
opposite of the helical wind direction of the occlusion frame
elongate members, and this opposite wind direction (e.g., reverse
torsion) can help to balance deployment of the device and minimize
undesired rotation of the device during deployment, for
example.
[0174] FIG. 26 is a perspective view of a ring hub 650 that can be
used as a hub component in any of the devices discussed herein, for
example, and of a collar lock 652. The collar lock 652 is an
optional engagement feature that can include an inset groove within
the collar lock 652, tab features of the cut-tube frame that can
lock into the groove of the collar lock 652.
[0175] FIG. 27 is a view of various example hub components (e.g.,
ring hub components) 1190, 1192, 1194, and 1196. Each of the hub
components 1190-1196 has a generally ring-shaped body and defines
apertures longitudinally though a wall of the ring-shaped body.
Components 1190 and 1192 include a center lumen having a
non-circular shape, and components 1194 and 1196 include a center
aperture having a circular shape. Components 1190 and 1192 may be
considered "keyed" components because of the non-circular shape of
the center lumen, for example. The central lumen can be used for
device deployment, device maneuverability, and maintaining device
alignment during deployment, for example, as by coupling with a
component of a delivery system.
[0176] In various examples, the components 1190-1196 can have
different heights or longitudinal lengths, and in some cases two or
more components may be stacked, one on top of the other. In some
examples, wires having a ball end may couple with a component of
FIG. 27 (or of FIG. 28), where the wire passes through an aperture
of the component and the ball end prevents the end of the wire from
passing through the aperture.
[0177] FIG. 28 is a perspective view of another example hub
component 1180. In the depicted example, hub component 1180
includes a generally ring-shaped body portion 1182, which includes
twelve apertures 1184 that are disposed longitudinally through a
wall of the ring-shaped body portion 1182. In some examples, hub
component 1180 can be used with two-filar devices that include six
wires, and in some examples the hub component 1180 can be used with
single-filar devices that include twelve wires.
[0178] The apertures 1184 may be laser-cut through the wall of the
body portion 1182, in some examples. In some examples, some of the
apertures 1184 may have a first diameter, and some of the apertures
1184 may have a second, different, diameter. In some examples, the
apertures 1184 all have the same diameter. In general, the
apertures 1184 may be equidistantly spaced around the circumference
of the body member 1182.
[0179] FIG. 28 shows that six wires are used with hub component
1180, where each of the six wires respectively passes through a
first aperture 1184 of the hub component 1180 in a first
longitudinal direction, and then passes back through the hub
component 1180 in the opposite longitudinal direction via a second
aperture 1184, where the second aperture 1184 is not adjacent to
the first aperture 1184, but rather is offset by one aperture from
the first aperture. For example, if the twelve apertures are
consecutively numbered 1-12 in a clockwise direction around the
body portion 1182, a first wire passes (in different directions)
through apertures 1 and 3; a second wire passes (in different
directions) through apertures 2 and 4; a third wire passes (in
different directions) through apertures 5 and 7; a fourth wire
passes (in different directions) through apertures 6 and 8; a fifth
wire passes (in different directions) through apertures 9 and 11;
and a sixth wire passes (in different directions) through apertures
10 and 12. In some examples some of the wires may have different
sizes. For example, the first, third, and fifth wires may have a
first diameter (e.g., 0.009''), and the second, fourth, and sixth
wires may have a second diameter (e.g., 0.007''). This may allow,
for examples certain features (e.g., the device frame or sub-frame)
of the device to be formed by wires of the first diameter and other
features (e.g., anchor features or assemblies) of the device to be
formed by wires of the second diameter. In some examples, the
structural features of a device may be created with the larger wire
and, for example, anchor features of the device may be created with
the smaller wire.
[0180] FIG. 29 shows views of various applications of the hub
components 1190-1196 of FIG. 27 (or FIG. 28), and shows examples of
how wires with ball ends can be terminated by the hub components.
The balls can be formed by melting the wire ends or by other means
of manipulating the wire ends.
[0181] FIG. 30A is a view of an example cutting pattern 800 that
can be used to cut a tube (or a portion of a tube) to create an
anchor frame that includes anchor members 802 with a "spade" shaped
anchor feature 804. Each of the anchor members 802 includes first
and second anchor arms 806a and 806b. As shown in FIG. 30B, first
portions 808 of the anchor members 802 can extend generally
distally and radially from the second hub component 810, at an
angle that is about 30 degrees distal from a directly radial
direction. Second portions 812 of the anchor members 802 can extend
from the first portions 808 in a generally proximal and radial
direction, at about a 90 degree angle from the first portions 808.
A sharp tip portion of the space feature 804 may be designed to
penetrate tissue, and the flared shape of the spade feature 804 may
limit tissue penetration depth.
[0182] FIG. 31A is a view of an example cutting pattern 820 that
can be used to cut a tube (or a portion of a tube) to create an
anchor frame that includes anchor members 822 with a feature 824
that includes three prongs: an outer and inner prong and a longer
center prong between the outer prong and inner prong. The center
prong is slightly longer that the outside prongs, for example, so
that when deploying into a cylindrically shaped space, each of the
prongs may contact tissue at approximately the same time. Each of
the anchor members 822 includes first and second anchor arms. As
shown in FIG. 31B, first portions 828 of the anchor members 822 can
extend generally distally and radially from the second hub
component 830, at an angle that is about 60 degrees distal from a
directly radial direction. Second portions 832 of the anchor
members 822 can extend from the first portions 828 in a generally
proximal and radial direction, at about a 90 degree angle from the
first portions 828. FIG. 32A is a view of an example cutting
pattern 850 that can be used to cut a tube (or a portion of a tube)
to create an anchor frame that includes anchor members 852 with a
feature 854 that includes two prongs that extend at an angle from
each other. Each of the anchor members 852 includes first and
second anchor arms. As shown in FIG. 32B, first portions 858 of the
anchor members 852 can extend generally distally and radially from
the second hub component 830, at an angle that is about 45 degrees
distal from a directly radial direction. Second portions 862 of the
anchor members 852 can extend from the first portions 852 in a
generally proximal and radial direction, at about a 90 degree angle
from the first portions 852.
[0183] FIGS. 33A through 33C are a top, perspective side, and
bottom view, respectively, of another example occlusive device 730
that can be used to occlude a hole, defect, aperture, or appendage
within a body of a patient. The occlusive device 730 includes two
sub-frames: an occlusion frame 732 (or disc-shaped member) and an
anchor frame 734. In some embodiments, the occlusion frame 732 and
the anchor frame 734 are formed from the same piece of precursor
material. For example, in some embodiments the occlusion frame 732
and the anchor frame 734 can be formed from a single tube or sheet
of material that is cut and expanded to form the frame
configurations of the occlusion frame 732 and the anchor frame 734.
In such embodiments, the occlusion frame 732 and the anchor frame
734 are a unitary member. In some such embodiments, the occlusion
frame 732 and the anchor frame 734 are a seamless member. In some
embodiments, the unitary construct of the occlusive device can
include anchor features.
[0184] In some embodiments, at least a portion of the occlusion
frame 732 is covered by a covering component 738 that is configured
to modulate or inhibit the passage of blood and/or thrombus through
the covering component 738, i.e., to substantially occlude the flow
of blood and/or thrombus through the covering component 738. In
some embodiments, the anchor frame 734 is not covered by the
covering component 738. In some embodiments, a portion of the
anchor frame 734 is covered by the covering component 738 (as
shown), and in some embodiments the anchor frame 734 is
substantially covered by the covering component 738 (or by a second
covering component). More than one covering component 738 can be
used on the occlusive device 730 in some embodiments. That is, some
portions of the occlusive device 730 can be covered by a first
covering component and other portions of the occlusive device 730
can be covered by a second covering component. In some embodiments,
more than two separate covering components can be included on an
occlusive device. The separate covering components may be made of
the same material or of different materials, and may have the same
material treatments or different material treatments. The covering
component 738 can be made from any of the types of coverings, and
can include any of the treatments, described elsewhere herein.
[0185] In some embodiments, the occlusion frame 732 and the anchor
frame 724 are constructed from material that is cut and then
expanded. For example, in some embodiments the occlusion frame 732
and the anchor frame 724 are made from a tube or sheet of material
that is laser-cut and then expanded (and heat-set in some
embodiments) to the configuration substantially as shown. In some
embodiments, NiTi is used as the material, but other materials such
as stainless steel, L605 steel, and polymers may also be used. In
some embodiments, the constructions of the occlusion frame 732
anchor frame 724 can include hubs and wire elongate members as
described elsewhere herein. In some embodiments, the occlusive
devices provided herein include a combination of types of frame
constructs. For example, a portion of the frame of an occlusive
device can be formed by cutting and expanding a material, and
another portion of the frame can be made from one or more wires
that may or may not be attached to a hub or hubs (wherein hubs
include, but are not limited to, eyelets, rings, crimp collars, and
the like).
[0186] The occlusion frame 732 can have any of the configurations
of disc-shaped members, and any of the variations thereof, that are
described elsewhere herein. In the embodiment depicted, the
occlusion frame 732 is a construct of overlapping petals. In this
embodiment, ten overlapping petals are included, but in other
embodiments, two, three, four, five, six, seven, eight, nine,
eleven, twelve, or more than twelve overlapping petals are
included. In some embodiments, the petals do not overlap each
other. In some embodiments, frame members are configured into
orientations that are not petals (e.g., FIGS. 35A-36B). The
occlusion frame 732 is a conformable member. That is, the occlusion
frame 732 can readily conform in shape to the topography of the
anatomy surrounding the anchor frame 732 at the implant site.
[0187] In some embodiments, the anchor frame 734 can have one or
more rows of cells. In some embodiments, the cells have shapes such
as, but not limited to, hexagonal, diamond-shaped, parallelogram,
and the like. In the depicted embodiment, two rows of hexagonal
cells are included. In some embodiments, one, two, three, four,
five, six, or more than six rows of cells are included. The anchor
frame 734 is a conformable member. That is, the shape of the anchor
frame 734 can readily conform and assimilate to the topography of
the anatomy surrounding the anchor frame 734 at the implant site.
In some embodiments, the anchor frame 734 is generally
cylindrical.
[0188] In some embodiments, the occlusion frame 732 and the anchor
frame 724 are a unitary construct. For example, the occlusion frame
732 and the anchor frame 724 can be made from a single material
component such as a tube or sheet. In such cases, the connection
between the occlusion frame 732 and the anchor frame 724 is
confluent with the occlusion frame 732 and the anchor frame 724. In
some embodiments, the occlusion frame 732 and the anchor frame 724
are interconnected using a connecting member such as those
described elsewhere herein (e.g., FIGS. 2 3, 19A, and 19B). In some
embodiments, portions of the occlusive device 730 can include
anchoring features.
[0189] FIG. 34A illustrates a material cutting pattern 740 that can
be used to form the occlusive device 730. The portions of the
cutting pattern 740 that will form the occlusion frame 732 and the
anchor frame 724 are identified. Using pattern 740, the occlusion
frame 732 and the anchor frame 724 can be formed as a unitary
member, or as separate members that are connected as components of
an assembled occlusive device 730. In some cases, the material
cutting pattern 740 can be utilized for laser-cutting a tube of
material. In some such cases, the occlusion frame 732 and the
anchor frame 724 can be a unitary and seamless construct. Or, in
some cases a planar sheet of material can be cut as shown and the
sheet can thereafter be formed into a tube. Any of the materials
described herein can be used.
[0190] FIG. 34B illustrates a material cutting pattern 750 that can
be used to form another example occlusive device (refer to
occlusive device 760 of FIGS. 35A, 35B, 36A, and 36B). The portions
of the cutting pattern 750 that will form the occlusion frame 762
and the anchor frame 764 are identified. Using pattern 750, the
occlusion frame 762 and the anchor frame 764 can be formed as a
unitary member, or as separate members that are connected as
components of an assembled occlusive device 750. In some cases, the
material cutting pattern 750 can be utilized for laser-cutting a
tube of material. In some such cases, the occlusion frame 762 and
the anchor frame 764 can be a unitary and seamless construct. Or,
in some cases a planar sheet of material can be cut as shown and
the sheet can thereafter be formed into a tube. Any of the
materials described herein can be used. The occlusion frame 762 is
an example of a construct that does not have petals. The occlusion
frame 762 is one such example, and other non-petal constructs are
also envisioned within the scope of this disclosure.
[0191] FIGS. 35A, 35B, 36A, and 36B are illustrations of another
example occlusive device 760 that can be used to occlude a hole,
defect, aperture, or appendage within a body of a patient. FIGS.
35A and 35B show just the two sub-frames: an occlusion frame 762
(or disc-shaped member) and an anchor frame 764. FIGS. 36A and 36B
show the occlusive device 760 with a covering component 768. In
some embodiments, the occlusion frame 762 and the anchor frame 764
are formed from the same piece of precursor material. For example,
in some embodiments the occlusion frame 762 and the anchor frame
764 can be formed from a single tube or sheet of material that is
cut and expanded to form the frame configurations of the occlusion
frame 762 and the anchor frame 764. In such embodiments, the
occlusion frame 762 and the anchor frame 764 are a unitary member.
In some such embodiments, the occlusion frame 762 and the anchor
frame 764 are a seamless member. In some embodiments, the unitary
construct of the occlusive device can include anchor features. Such
frame construction techniques can also be used for the formation of
the other occlusive devices provided herein.
[0192] While the device frames discussed herein are generally
described with reference to occlusion applications, for filtering
applications where substantial occlusion is not desired, the
occlusion frame may be referred to as a filter frame. That is, any
of the described occlusion frames may also be filter frames, for
example.
[0193] In some embodiments, the occlusion frame 762 and the anchor
frame 764 are both substantially covered by a covering component
768 that is configured to modulate or inhibit the passage of blood
and/or thrombus through the covering component 768. In some
embodiments, some but not all portions of the occlusion frame 762
are covered by a covering component 768. In some embodiments, some
or all portions of the anchor frame 764 are not covered by the
covering component 768. In some embodiments, a portion of the
anchor frame 764 is covered by the covering component 768, and in
some embodiments (as shown) the anchor frame 764 is substantially
covered by the covering component 768 (or by a second covering
component). More than one covering component 768 can be used on the
occlusive device 760 in some embodiments. That is, some portions of
the occlusive device 760 can be covered by a first covering
component and other portions of the occlusive device 760 can be
covered by a second covering component. In some embodiments, more
than two separate covering components can be included on an
occlusive device. The separate covering components may be made of
the same material or of different materials, and may have the same
material treatments or different material treatments.
[0194] In some embodiments, the occlusion frame 762 and the anchor
frame 764 are constructed from material that is cut and expanded
(refer to FIG. 34B). For example, in some embodiments the occlusion
frame 762 and the anchor frame 764 are made from a tube or sheet of
material that is laser-cut and then expanded (and heat-set in some
embodiments) to the configuration substantially as shown. In some
embodiments, NiTi is used as the material, but other materials such
as stainless steel and polymers may also be used. In some
embodiments, the constructions of the occlusion frame 762 anchor
frame 764 can include hubs and wire elongate members as described
elsewhere herein. In some embodiments, the occlusive devices
provided herein include a combination of types of frame constructs.
For example, a portion of the frame of an occlusive device can be
formed by cutting and expanding a material, and another portion of
the frame can be made from one or more wires that may or may not be
attached to a hub or hubs (wherein hubs include, but are not
limited to, eyelets, rings, crimp collars, and the like).
[0195] The construction of example occlusion frame 762 is as
follows (as shown in FIG. 34B). Elongate members extend from the
proximal hub 763 of the occlusion frame 762. The elongate members
extending from the proximal hub 763 bifurcate to create two
bifurcated branches. Each bifurcated branch then joins with another
bifurcated branch that originated from an adjacent elongate member
that extends from the proximal hub 763. Then the joined bifurcated
branches (which comprise a single elongate member) extend to the
connecting hub 765. The elongate occlusion frame members are
thereby arranged to form an interconnected occlusion structure. In
some embodiments the interconnected occlusion structure comprises a
generally disc-shaped member. This construction of the occlusion
frame 762 provides a highly stable structure that is resistant to
malformations of the occlusion frame 762 during deployment and in
situ. The example occlusion frame 762 does not include
independently moving petals. Other types of occlusion frame
constructs that do not include petals are also envisioned within
the scope of this disclosure, and occlusion frame 762 is one
example of such. The occlusion frame 762 is a conformable member.
That is, the occlusion frame 762 can readily conform in shape to
the topography of the anatomy surrounding the anchor frame 762 at
the implant site. In addition, the anchor frame 764 is a
conformable member. That is, the shape of the anchor frame 764 can
readily conform and assimilate to the topography of the anatomy
surrounding the anchor frame 764 at the implant site.
[0196] In some embodiments, the anchor frame 764 can have one or
more rows of cells. In some embodiments, the cells have shapes such
as, but not limited to, hexagonal, diamond-shaped, parallelogram,
and the like. In the depicted embodiment, two rows of hexagonal
cells are included. In some embodiments, one, two, three, four,
five, six, or more than six rows of cells are included. The cells
are defined by elongate members of the anchor frame 764 that are
arranged to form an interconnected anchor structure. In some
embodiments the interconnected anchor structure comprises a
generally cylindrical member. The anchor frame 764 is a conformable
member. That is, the shape of the anchor frame 764 can readily
conform and assimilate to the topography of the anatomy surrounding
the anchor frame 764 at the implant site. In some embodiments, the
anchor frame 764 is generally cylindrical.
[0197] FIG. 37A is another example occlusive device 770. The
example occlusive device 770 may include a covering component (not
shown) as with other embodiments of occlusive devices described
herein. The occlusive device 770 is an example of an anchor frame
that includes one row of hexagonal cells. Additionally, the
occlusive device 770 includes mid-point anchors 771 that are free
ends located on the periphery and near the axial-midpoint of the
anchor frame. In some embodiments, the occlusive device 770 is a
unitary frame construct (including the mid-point anchors 771). In
some embodiments, the occlusive device 770 is made from a
combination of frame component parts that were formed distinctly
from each other.
[0198] FIG. 37B is another example occlusive device 772. The
occlusive device 772 includes free ends 773 that extend from the
cells of the anchor frame. In some embodiments, the free ends 773
are angled generally radially and include ball-ends. It should be
understood that any of the other types of free ends described
herein (e.g., refer to FIGS. 16A-16D) may be substituted for the
free ends 773. In addition, in some embodiments a combination or
sub-combination of types of anchors and/or types free ends can be
included on a single occlusive device. For example, the mid-point
anchors of occlusive device 770 can be combined with the distally
located ball-end anchors of occlusive device 772.
[0199] FIG. 37C is another example occlusive device 774. The
occlusive device 774 includes free ends 775 that extend from the
cells of the anchor frame. In some embodiments, the free ends 775
are curled to provide atraumatic free ends 775. It should be
understood that any of the other types of free ends described
herein (e.g., refer to FIGS. 16A-16D) may be substituted for the
free ends 775.
[0200] FIG. 38 is another example of an anchor frame 780. The
anchor frame 780 is generally cylindrical. This anchor frame 780
can be used in conjunction with any of the disc-shaped occlusion
frame portions described herein. Anchor frame 780 includes double
free ends 781a and 781b extending from the distal end of each cell
of the distal-most row of cells. It should be understood that any
of the other types of free ends described herein (e.g., refer to
FIGS. 16A-16D) may be substituted for the free ends 773.
[0201] FIGS. 39A and 39B are another example of an anchor frame
784, shown as an uncovered frame and a covered frame, respectively.
The anchor frame 784 includes a covering component 788 in FIG. 39B.
This provides an example of how, in some embodiments, the covering
component 788 can be tailored to terminate with the diagonal
pattern of the ends of the distal-most cells. In FIG. 39A, a
cupping or concavity at the proximal end (the top as viewed in FIG.
39A) of the anchoring frame 784 is shown. In some embodiments, when
implanted in a patient such cupping can advantageously create an
axial bias towards the occlusive disc member, and to reduce the
spacing between the anchor frame and the occlusive disc-shaped
member. This configuration can help to seal the occlusive device to
the surrounding tissue by keeping the occlusive device biased
toward the ostium after the anchors are set. This cupping is also
seen in FIGS. 40, 41A, and 41B, and can be incorporated with any of
the occlusive devices provided herein. FIG. 40 is another example
of an anchor frame 790 with a covering component 792 that is
tailored to terminate with the diagonal pattern of the ends of the
distal-most cells.
[0202] FIGS. 41A and 41B are a perspective view and an end view of
another example anchor frame 794. This embodiment of anchor frame
794 has a structure that can provide a substantial radial force to
surrounding tissue to thereby resist device migration.
[0203] Referring now to FIGS. 42 through 49, as described
previously, the occlusive devices provided herein can be used to
occlude spaces, holes, defects, apertures, appendages, vessels or
conduits within a body of a patient. As will be explained further,
FIGS. 42 through 49 provide example occlusive device embodiments
that are especially well-suited to occluding holes, apertures, and
other such tissue defects so as to inhibit the passage of body
materials. For example, the occlusion and sealing of an opening
(e.g., a hole, perforation, tear, fistula, etc.) of a body conduit
such as the colon, blood vessels, intestines, and other body
conduits can be treated using such devices and techniques. In such
cases, the occlusive device can inhibit the passage of body
materials (e.g., fecal matter, bile, digestive fluids, blood,
thrombus, and the like).
[0204] The example occlusive devices of FIGS. 42-49 are well-suited
for use in the gastrointestinal (GI) tract, and other areas. For
example, the devices can be used to occlude and seal a lumen wall
opening resulting from an endoscopic full thickness resection
(EFTR). In addition, in some embodiments the devices can be used to
treat a gastrointestinal fistula or diverticulum. The use of
occlusive devices in the environment of the GI tract calls for
occlusive devices that provide substantially continuous lumen wall
contact with apposition force for effective occlusion performance
during peristaltic motion. Peristaltic motion can result in the
application of large dynamic, asymmetric, and non-planar
displacements to the occlusive devices in some circumstances, as
well as normal and shear stresses from material transport. In some
embodiments, the occlusive devices provided herein provide
substantially continuous lumen wall contact with conformability and
apposition force for effective occlusion and sealing performance
during such conditions caused by peristaltic motion. In addition,
the intra-lumenal and extra-lumenal pressures in the GI tract are
often unbalanced, so the occlusive devices provided herein are
resistant to such a pressure gradient. In some embodiments, the
occlusive devices provided herein substantially do not interfere
with the healing response of the body, to allow the defect area in
the GI tract to close (heal). In some embodiments, the occlusive
devices provided herein are removable after the defect area has
healed. Therefore, in some such embodiments the occlusive devices
are configured to not allow tissue ingrowth and are designed for
atraumatic withdrawal. For example, in some embodiments the
occlusion device's provision of apposition force without the use of
barbs or prongs allows the device to resist migration, seal, and be
safely removed. Further, in some embodiments the occlusive devices
provided herein also have low profiles to reduce risk of puncture,
adhesion, or stricture of the GI tract lumen or surrounding
organs.
[0205] FIG. 42 is a side view of one portion 900 of a two-part
occlusive device that is well-suited for use in the GI tract and
other areas. In some embodiments, the other portion of the two-part
device (not shown) may be configured the same as portion 900,
except the hubs may include dissimilar structures by which the
portions of the two-part device can couple together. However, in
some embodiments the portions of a two-part device are configured
differently, and may include differences such as, but not limited
to, diameters of the elongate members, patterns of the elongate
members, coverings on the portions, and the like. In some
embodiments, the portion 900 may be symmetrical, and in some
embodiments the portion 900 may be asymmetrical.
[0206] In some embodiments, the portion 900 of the two-part
occlusive device includes a frame 901 formed of elongate members,
and an eyelet 902 that is formed of the same elongate members of
the frame 901. In some embodiments, the eyelet 902 is a different
type of hub, such as a ring, crimp collar, tube, and the like. In
some embodiments, the portion 900 may be formed from a single
elongate member. In some embodiments, more than one elongate member
is used to form the frame 901. The elongate members terminate at
the eyelet 902. The elongate members may be formed from any of the
frame materials described elsewhere herein. In some embodiments, a
ring hub may be used instead of the spiral-wound eyelet 902. In
some embodiments, the portion 900 may be made from a cut tube or
planar material.
[0207] The frame 901 includes a dish-shaped profile. As will be
described later, the dish-shaped profile helps to establish and
maintain a resilient and compliant seal of the defect being
treated, and to resist device migration.
[0208] FIGS. 43A through 43C show alternative frame patterns 904,
906, and 908. The frame patterns of any of the disc-shaped members
described elsewhere herein may be used for the frame 900. For
example, pattern 904 includes petal-shaped spokes and a
circumferential member; pattern 906 includes petals that do not
overlap; and pattern 908 includes overlapping petals. It should be
understood that these frame patterns are non-limiting examples, and
various other types of frame patterns (including, ovular, oblong,
non-circular, irregular, non-uniform and asymmetrical shapes) are
within the scope of this disclosure.
[0209] In some embodiments, the frame patterns include two or more
elongate members that can have different cross-sectional diameters.
The use of such elongate members with dissimilar diameters can be
used advantageously to provide suitable bending stiffness
properties in particular portions of the frame. For example,
elongate members with dissimilar diameters can be used to construct
a disc frame with overlapping petals where one or more petals are
made with larger diameter wire than others such that the disc frame
has a lower bending force in one plane versus another. The same
result can be accomplished with an elongate member of variable
diameter along its length so that areas of larger or smaller
diametrical cross-section can be strategically placed to provide
differing bending strength in different planes. Therefore, in some
embodiments the elongate members making up the frame can have a
variable diameter. That is, a first portion of an elongate member
may have a small diameter than another portion of the same elongate
member.
[0210] In some embodiments, at least one of the portions of the
two-part occlusive device includes a covering component. For
example, the portion of the two-part occlusive device that is on
the inside of a conduit (e.g., the colon) may have a covering
component. In some embodiments, both portions of the two-part
occlusive device include a covering component, while in other
embodiments just one portion of the two-part device includes a
covering component (e.g., refer to FIG. 46).
[0211] FIGS. 44A through 44D illustrate an example deployment
process of a two-part occlusive device 910 to occlude a tissue
opening 909. The first and second portions 912 and 914 can be
collapsed to low-profile configurations and loaded into a delivery
sheath 911. The distal end portion of the delivery sheath 911 can
be positioned within the opening 909.
[0212] Each of the first and second portions 912 and 914 can be
attached to a control catheter 913 and 915 respectively. In some
embodiments, the control catheters 913 and 915 are configured
co-axially. The control catheters 913 and 915 allow independent
axial and rotational control of the position of the first and
second portions 912 and 914. In some embodiments, the control
catheters 913 and 915 can also be used to transport fluid,
adhesives, energy, and the like.
[0213] The first portion 912 can be deployed by pushing the control
catheter 913 distally as shown in FIG. 44B. The second portion 914
can be deployed by pushing the control catheter 915 distally and
retracting the delivery sheath 911 as shown in FIG. 44C. In FIG.
44D, the eyelets of the first and second portions 912 and 914 are
engaged together such that the first and second portions 912 and
914 are interlocked. In that configuration, the first and second
portions 912 and 914 are clamping the tissue and sealing the
opening 909. Then the control catheters 913 and 915 can be
disengaged from the first and second portions 912 and 914, and the
control catheters 913 and 915 and delivery sheath 911 can be
withdrawn from the patient.
[0214] FIGS. 45A through 45C provide examples techniques for
coupling the eyelets (or other types of hubs such as rings, tubes,
crimp collars, and the like, in some embodiments) of the first and
second portions of a two-part occlusive device together. In FIG.
45A, the first and second eyelets can be coupled to form an
assembly 980 using a lock loop 981. In some embodiments, the lock
loop can be made of a super-elastic material such as NiTi. In FIG.
45B, the eyelets are locked together to form an assembly 982 using
barbs 983 that are disposed on one or both of the eyelets. In FIG.
45C, the eyelets are coupled together to form an assembly 984 using
a frictional or interference fit. In other embodiments, threaded
engagement, magnetic engagement, and adhesives can be used. In some
embodiments, heat by way of electrical resistance, or RF, can be
delivered down the control catheter to weld the eyelets
together.
[0215] FIG. 46 provides an example two-part occlusive device 920.
The two-part occlusive device 920 includes a first portion 922 and
a second portion 924. In this example, the first portion 922 does
not include a covering component and the second portion 924 does
include a covering component 928. The eyelets of the first and
second portions 922 and 924 are concentrically interlocked.
[0216] FIGS. 47A and 47B provide another example of a two-part
occlusive device 930 in perspective views and end views
respectively. A first portion 932 includes a covering component 938
disposed on the frame of the first portion 932. The frame of the
first portion 932 is comprised of overlapping petals. The hub of
the first portion 932 is interlocked with the hub of the second
portion 934. The second portion 934, in this example embodiment
930, does not include a covering component. The frame of the second
portion 934 is also comprised of overlapping petals.
[0217] FIG. 48 is another example two-part occlusive device 940 in
accordance with some embodiments provided herein. Both portions 942
and 944 of the two-part occlusive device 940 include a covering
component 948, and have frames comprised of overlapping petals.
[0218] FIG. 49 shows an example two-part occlusive device 950 that
has been implanted to seal an opening in the wall of a body conduit
951. As shown, the outer diameter of the portion of the two-part
sealing device 950 that includes a covering component is larger
than the size of the opening. The second portion of the two-part
sealing device 950 is inside of the body conduit 951 and therefore
not visible in this view. The second portion may also include a
covering.
[0219] FIGS. 50A through 50D are illustrations of another example
occlusive device 960 that can be used to occlude a hole, defect,
aperture, or appendage within a body of a patient. FIGS. 50A (top
view) and 50B (side view) show the two sub-frames: an occlusion
frame 962 (or disc-shaped member) and an anchor frame 964. FIGS.
50C (top perspective view) and 50D (side view) show the frames 962
and 964 of the occlusive device 960 with a covering component
968.
[0220] In some embodiments, the occlusion frame 962 and the anchor
frame 964 are formed from the same piece of precursor material. For
example, in some embodiments the occlusion frame 962 and the anchor
frame 964 can be formed from a single tube or sheet of material
that is cut and expanded to form the frame configurations of the
occlusion frame 962 and the anchor frame 964. In some such
embodiments, the occlusion frame 962 and the anchor frame 964 are a
unitary member. In some such embodiments, the occlusion frame 962
and the anchor frame 964 are a seamless member. In some
embodiments, the unitary construct of the occlusive device 970 can
include anchor features. Such frame construction techniques can
also be used for the formation of the other occlusive devices
provided herein. In some embodiments, frames 962 and 964 can be
formed from wound elongate member such as wires. Hubs, such as
rings, crimp collars, eyelets and the like, can be incorporated
into the frame construct. Such frame construction techniques can
also be used for the formation of the other occlusive devices
provided herein. In some embodiments, the occlusive devices
provided herein include a combination of types of frame constructs
in a single occlusive device. For example, a portion of the frame
of an occlusive device can be formed by cutting and expanding a
material, and another portion of the frame can be made from one or
more wires that may or may not be attached to a hub or hubs
(wherein hubs include, but are not limited to, eyelets, rings,
crimp collars, and the like).
[0221] While the device frames discussed herein are generally
described with reference to occlusion applications, for filtering
applications where substantial occlusion is not desired, the
occlusion frame may be referred to as a filter frame. That is, any
of the described occlusion frames may also be filter frames, for
example.
[0222] The occlusion frame 962 is another example of a non-petal
shaped disc-shaped occlusive frame. The construction of example
occlusion frame 962 is as follows. Elongate members extend from the
proximal hub 961 of the occlusion frame 962. The elongate members
bifurcate at about the axial midpoint between the proximal hub 961
and the connecting hub 963. Each of the bifurcated branch elongate
members then joins with another elongate member that extends to the
connecting hub 963. This construction of the occlusion frame 962
provides a highly stable structure that is conformable to the
topography of surrounding tissue and is resistant to malformations
of the occlusion frame 962 during deployment and in situ. The
example occlusion frame 962 does not include petals. Other types of
occlusion frame constructs that also do not include petals are also
envisioned within the scope of this disclosure, and occlusion frame
962 is one example of such.
[0223] The occlusion frame 962 is a conformable member. That is,
the occlusion frame 962 can readily conform in shape to the
topography of the anatomy surrounding the anchor frame 962 at the
implant site. In addition, the anchor frame 964 is a conformable
member. That is, the shape of the anchor frame 964 can readily
conform and assimilate to the topography of the anatomy surrounding
the anchor frame 964 at the implant site.
[0224] In some embodiments, the example anchor frame 964 includes a
chevron-shaped cell structure 965, as shown in FIG. 50B. This
structure provides a conformable and stable anchor frame 962. The
chevron-shaped cell structure 965 can also facilitate collapsing
the anchor frame 962 to a low-profile for placement within a
delivery sheath. In some embodiments, the anchor frame 964 can have
one or more rows of chevron-shaped cells. In the depicted
embodiment, one row of chevron-shaped cells is included. In some
embodiments, two, three, four, five, six, or more than six rows of
chevron-shaped cells are included. The anchor frame 964 is a
conformable member. That is, the shape of the anchor frame 964 can
readily conform and assimilate to the topography of the anatomy
surrounding the anchor frame 964 at the implant site. In some
embodiments, the anchor frame 964 is generally cylindrical. In some
embodiments, the anchor frame 964 can include a combination of
shapes of cell structures. For example, a single occlusive device
can include two or more shapes of cell structures (e.g.,
diamond-shaped, chevron-shaped, hexagonal, and the like).
[0225] In some embodiments, the occlusive device 960 includes a
covering component 968 that covers some or all of the occlusion
frame 962. In this example, the covering component 968 covers the
occlusion frame 962 and is attached to portions of the elongate
frame members of the occlusion frame 962. In some embodiments, the
covering component 968 is at least partially attached to portions
of the elongate frame members using an adhesive, such as but not
limited to FEP. In some embodiments, portions of the covering
component 968 can be attached to the elongate members by banding
the covering component 968 thereto, such as at hubs 961 and 963.
The banding can be a variety of materials, including but not
limited to biocompatible film materials, suture materials, metallic
materials, and the like, and combinations thereof. Such attachment
materials and techniques can also be used for other embodiments of
the occlusive devices provided herein.
[0226] In some embodiments, the covering component 968 is attached
to selected regions of the occlusion frame 962 (and other portions
such as the anchor frame 964) and not attached to other regions of
the occlusion frame 962. This technique can facilitate enhanced
conformability of the occlusive device 960 to the topography of a
patient's anatomy at the implant site. Such techniques can also be
used with other embodiments of the occlusive devices provided
herein.
[0227] The covering component 968 is configured to modulate, and in
some examples, filter, or substantially inhibit the passage of
blood and/or thrombus through the covering component 968. Some
embodiments include a covering component 968 that is configured to
induce rapid tissue ingrowth and to occlude the passage of blood
and/or thrombus through the covering component. The covering
component 968 may be a porous, elastic member that can stretch and
collapse to accommodate extension and collapse, respectively, of
the elongate frame members. Pores of the covering component 968 may
be sized to substantially, or in some examples completely, prevent
passage of blood, other bodily fluids, thrombi, and emboli. The
covering component 968 can have a microporous structure that
provides a tissue ingrowth scaffold for durable occlusion and
supplemental anchoring strength of the occlusion device 960. Some
embodiments of the covering component 968 comprise a fluoropolymer,
such as an expanded polytetrafluoroethylene (ePTFE) polymer. In
some embodiments, the covering component 968 can be a membranous
covering. In some embodiments the covering component 968 can be a
film. In some embodiments, the covering component 968 can be a
filtering medium.
[0228] In some embodiments, the covering component 968 is
configured such that the modulation of fluid passage through the
covering component 968 is immediate and does not rely on a
thrombotic process. In some embodiments, the covering component 968
can be modified by one or more chemical or physical processes that
enhance certain physical properties of the covering component 968.
For example, a hydrophilic coating may be applied to the covering
component 968 to improve the wettability and echo translucency of
the covering component 968. In some embodiments, the covering
component 968 may be modified with chemical moieties that promote
one or more of endothelial cell attachment, endothelial cell
migration, endothelial cell proliferation, and resistance to
thrombosis. In some embodiments, the covering component 968 may be
modified with covalently attached heparin or impregnated with one
or more drug substances that are released in situ to promote wound
healing or reduce tissue inflammation. In some embodiments, the
drug may be a corticosteroid, a human growth factor, an
anti-mitotic agent, an antithrombotic agent, or dexamethasone
sodium phosphate.
[0229] In some embodiments, covering component 968 is
pre-perforated to modulate fluid flow through the covering
component, to create filtering properties, and/or to affect the
propensity for tissue ingrowth to the covering component 968. In
some embodiments, the covering component 968 is treated to make the
covering component 968 stiffer or to add surface texture. For
example, in some embodiments the covering component 968 is treated
with FEP powder to provide a stiffened covering component 968 or
roughened surface on the covering component 968. In some
embodiments, selected portions of the covering component 968 are so
treated, while other portions of the covering component 968 are not
so treated. Other covering component 968 material treatment
techniques can also be employed to provide beneficial mechanical
properties and tissue response interactions. Such materials and
techniques can be used for any of the occlusive devices provided
herein.
[0230] In some embodiments, the covering component 968 may be
formed of a fluoropolymer (e.g., expanded PTFE (ePTFE) or PTFE). In
some embodiments, the covering component 968 may be formed of a
polyester, a silicone, a urethane, or another biocompatible
polymer, or combinations thereof. In some embodiments,
bioresorbable or bioabsorbable materials may be used, for example a
bioresorbable or bioabsorbable polymer. In some embodiments, the
covering component 968 can comprise Dacron. In some embodiments,
the covering component 968 can comprise knits or fibers. The
covering component 968 may be woven or non-woven in various
embodiments. In some embodiments, the covering component 968 may be
formed of a copolymer. In some examples, a first portion of the
covering component 968 may be formed of a first material and a
second portion of the covering component 968 may be formed of a
second material. For example, the portion of the covering component
968 that covers the occlusion frame 962 of the device may be
comprised of a first material, and a portion of the covering
component 968 that covers the anchor frame 964 of the device may be
comprised of a second material.
[0231] FIGS. 51-53, 55-58, and 60 illustrate additional example
occluder devices 970, 980, 990, 1010, 1020, 1030, 1040, and 1060
respectively. In some embodiments, the occluder devices 970, 980,
990, 1010, 1020, 1030, 1040, and 1060 can serve as anchor frames in
a manner like that of anchor frames 780, 784, 790, and 794 of FIGS.
38, 39B, 40, and 41A. In some such embodiments, the occluder
devices 970, 980, 990, 1010, 1020, 1030, 1040, and 1060 can coupled
to any of the occlusion frames described herein to provide occluder
devices that include an occlusion frame and an anchor frame (e.g.,
refer to FIGS. 33B, 36A, 37B, 37C, and 50D). Any of the mechanisms
described herein for coupling an occlusion frame with an anchor
frame can be used to couple the occluder devices 970, 980, 990,
1010, 1020, 1030, 1040, and 1060 to any of the occlusion frames
provided herein. For example, such coupling mechanisms include, but
are not limited to, a unitary connecting hub (e.g., connecting hub
765 of FIG. 35B), a flexible connector (e.g., flexible connector
314 of FIG. 20), a flexible linkage (e.g., flexible linkage 406 of
FIG. 22A), a nested hub/ring arrangement (e.g., FIG. 26), and so
on, and combinations of such mechanisms.
[0232] In some embodiments, the occluder devices 970, 980, 990,
1010, 1020, 1030, 1040, and 1060 as shown can serve as occluder
devices in and of themselves. As such, the occluder devices 970,
980, 990, 1010, 1020, 1030, 1040, and 1060 can be described as
"plug-type" occluder devices. The depicted occluder devices 970,
980, 990, 1010, 1020, 1030, 1040, and 1060 are generally
cylindrical when in an unrestrained expanded or deployed
configuration (as shown). In some embodiments, the occluder devices
970, 980, 990, 1010, 1020, 1030, 1040, and 1060 have shapes other
than generally cylindrical such as, but not limited to, conical,
frusto conical, spherical, pyramidal, truncated pyramidal, and the
like.
[0233] In some embodiments, the occluder devices 970, 980, 990,
1010, 1020, 1030, 1040, and 1060 are constructed from material that
is cut and then expanded. For example, in some embodiments the
occluder devices 970, 980, 990, 1010, 1020, 1030, 1040, and 1060
are made from a tube or sheet of material that is laser-cut and
then expanded (and heat-set in some embodiments) to the
configuration substantially as shown. In some embodiments, NiTi is
used as the material, but other materials such as stainless steel,
L605 steel, polymers, and bioabsorbable polymers may also be used.
In some embodiments, the constructions of the occluder devices 970,
980, 990, 1010, 1020, 1030, 1040, and 1060 can include hubs and
wire elongate members as described elsewhere herein. In some
embodiments, the occluder devices 970, 980, 990, 1010, 1020, 1030,
1040, and 1060 include a combination of types of frame constructs.
For example, a portion of the frame of the occluder devices 970,
980, 990, 1010, 1020, 1030, 1040, and 1060 can be formed by cutting
and expanding a material, and another portion of the frame can be
made from one or more wires that may or may not be attached to a
hub or hubs (wherein hubs include, but are not limited to, eyelets,
rings, crimp collars, and the like). In some embodiments, frames of
the occluder devices 970, 980, 990, 1010, 1020, 1030, 1040, and
1060 comprise one or more rows of cell structures. In some such
embodiments, the cell structures can be of various shapes
including, but not limited to, diamond-shaped, chevron-shaped,
hexagonal, polygonal, and the like. In some embodiments, a single
occlusive device can include a combination of shapes of cell
structures (e.g., sizes and shapes). For example, a single
occlusive device can include two or more shapes of cell structures
(e.g., diamond-shaped, chevron-shaped, hexagonal, and the
like).
[0234] In some embodiments, at least portions of the occluder
devices 970, 980, 990, 1010, 1020, 1030, 1040, and 1060 include a
covering that is configured to modulate, reduce, or inhibit the
passage of blood and/or thrombus through the covering, i.e., to
substantially occlude the flow of blood and/or thrombus through the
covering. The covering(s) used with the occluder devices 970, 980,
990, 1010, 1020, 1030, 1040, and 1060 can include one or more of
any feature, material, treatment, method of attachment to frame
members, coverage of frame members, etc. as described elsewhere
herein in regard to coverings such as, but not limited to, covering
component 156, covering component 768, covering component 968, and
all others. In some embodiments, the covering component is attached
to the frame members so that the covering component is disposed on
the inside of the occluder devices 970, 980, 990, 1010, 1020, 1030,
1040, and 1060. In some embodiments, the covering component is
attached to the frame members so that the covering component is
disposed on the outside of the occluder devices 970, 980, 990,
1010, 1020, 1030, 1040, and 1060. In some embodiments, the covering
component is attached to the frame members so that the covering
component is disposed on the inside and on the outside of the
occluder devices 970, 980, 990, 1010, 1020, 1030, 1040, and
1060.
[0235] As described above, in some embodiments the covering
component is configured to induce rapid tissue ingrowth. For
example, pores of the covering component may be sized to provide a
tissue ingrowth scaffold, while preventing formation of thrombi.
The covering component can thereby provide supplemental occlusion
device migration resistance and enhanced sealing. In some
implementations, the covering component prevents or substantially
prevents passage of blood, other bodily fluids, thrombi, emboli, or
other bodily materials through the covering component. Some
embodiments of the covering component comprises a fluoropolymer,
such as an expanded polytetrafluoroethylene (ePTFE) polymer. In
some embodiments, the covering component can be a membranous
covering. In some embodiments, the covering component can be a
film. In some embodiments, the covering component can be a
filtering medium. Any and all combinations and sub-combinations of
such features (and other features) can be included in the occlusive
devices provided herein, including in the occluder devices 970,
980, 990, 1010, 1020, 1030, 1040, and 1060.
[0236] FIG. 51 illustrates a perspective view of an example
occluder device 970. The depicted embodiment of occluder device 970
includes a hub 972, radial struts 974, a covering component 978,
and cells 976. The radial struts 974 extend generally radially from
the hub 972 to form an occlusive face of the occluder device 970.
The radial struts 974 bifurcate to join with adjacent bifurcated
radial struts 974 to form the cells 976. The depicted embodiment of
occluder device 970 includes five rows of the cells 976 that are
hexagonal cells. In some embodiments, fewer than five or more than
five rows of cells 976 can be included in the occluder device 970;
for example, the occluder device 970 may include one, two, three,
four, five, six, seven, eight, or more than eight rows of cells
976. In the depicted embodiment, the occluder device 970 is
radially symmetric. As such, the occluder device 970 is
structurally balanced. Because of the structural balance of the
occluder device 970, the occluder device 970 can have advantageous
deployment reliability, durability, and conformability.
[0237] FIG. 52 illustrates a perspective view of an example
occluder device 980. The depicted embodiment of occluder device 980
includes a hub 982, radial struts 984, a covering component 988,
and cells 986. The radial struts 984 extend generally radially from
the hub 982 to form an occlusive face of the occluder device 980.
The radial struts 984 bifurcate to join with adjacent bifurcated
radial struts 984 to form the cells 986. The depicted embodiment of
occluder device 980 includes five rows of the cells 986 that are
hexagonal cells. In some embodiments, fewer than five or more than
five rows of cells 986 can be included in the occluder device 980;
for example, the occluder device 980 may include one, two, three,
four, five, six, seven, eight, or more than eight rows of cells
986.
[0238] While the constructions of occluder device 970 and occluder
device 980 are similar, the depicted occluder device 970 is a
smaller occluder device than the depicted occluder device 980.
Therefore, it should be understood that the occlusive devices
provided herein are scalable to a broad range of sizes so that the
occlusive devices can be used in a variety of different anatomies,
implant sites, and types of implementations.
[0239] FIG. 53 illustrates a perspective view of an example
occluder device 990. The depicted embodiment of occluder device 990
includes a hub 992, radial struts 994, cells 996, a covering
component 999, and anchors 998. The radial struts 994 extend
generally radially from the hub 992 to form an occlusive face of
the occluder device 990. The radial struts 984 bifurcate to join
with adjacent bifurcated radial struts 984 to form the cells 996.
The depicted embodiment of occluder device 980 includes five rows
of the cells 996 that are hexagonal cells. In some embodiments,
fewer than five or more than five rows of cells 996 can be included
in the occluder device 990; for example, the occluder device 990
may include one, two, three, four, five, six, seven, eight, or more
than eight rows of cells 996.
[0240] In the depicted embodiment of occluder device 990, the
anchors 998 extend within the interstitial spaces defined by
particular cells 996 and extend radially outward from the
cylindrical profile of the occluder device 990 to terminations at
free ends of the anchors 998. As such, at least the tips of the
anchors 998 can contact tissue and provide an anchoring function to
resist migration of the occluder device 990 in relation to the
tissue that the free ends of the anchors 998 is in contact with.
While the depicted embodiment of occluder device 990 includes six
anchors 998, in some embodiments one, two, three, four, five,
seven, eight, nine, ten, eleven, twelve, or more than twelve
anchors 998 are included. While the free ends of the anchors 998 of
the depicted embodiment of occluder device 990 are terminations of
elongate members that curve radially outward from the axis of the
occlusive device 990, in some embodiments one or more of the
anchors 998 include an atraumatic tip (e.g., refer to FIG. 16B). In
some embodiments, one or more of the anchors 998 include a sharp
tip (e.g., refer to FIG. 16C). In some embodiments, one or more of
the anchors 998 include a bifurcated tip (e.g., refer to FIG. 16D).
Such a bifurcated tip design may have individual tips that are
sharpened, atraumatic ends (e.g., ball ends), or any of the other
example anchor frame free ends described herein, or combinations
thereof.
[0241] In some embodiments, the anchors 998 (and other anchors
provided herein) are designed to be flexible and resilient such
that the anchors 998 can be folded to a low-profile delivery
configuration for containment within a delivery sheath, and can be
translated within the delivery sheath without significant dragging
resistance. When deployed from the delivery sheath, the anchors 998
revert to a curved configuration (e.g., as shown, or similar to as
shown) that engages with the surrounding tissue at the deployment
site. In some implementations, the anchors 998 pierce the
surrounding tissue while the other parts of the frame 990 act as a
pledget to limit the penetration depth of the anchors 998. In
addition, in some embodiments the covering component can provide a
seal around the penetration site. In such ways, the risk of
pericardial effusion related to penetration of the anchors 998 can
be mitigated. In some implementations, the anchors 998 engage the
surrounding tissue without penetration.
[0242] FIG. 55 illustrates a perspective view of an example
occluder device 1010. The depicted embodiment of occluder device
1010 includes a hub 1012, radial struts 1014, a covering component
1018, and hexagonal cells with a helical bias 1016. The radial
struts 1014 extend generally radially from the hub 1012 to form an
occlusive face of the occluder device 1010. The radial struts 1014
bifurcate to join with adjacent bifurcated radial struts 1014 to
form the hexagonal cells with a helical bias 1016. The depicted
embodiment of occluder device 1010 includes five rows of the
hexagonal cells with a helical bias 1016. In some embodiments,
fewer than five or more than five rows of hexagonal cells with a
helical bias 1016 can be included in the occluder device 1010; for
example, the occluder device 1010 may include one, two, three,
four, five, six, seven, eight, or more than eight rows of hexagonal
cells with a helical bias 1016. FIG. 56 illustrates a perspective
view of an example occluder device 1020. The depicted embodiment of
occluder device 1020 includes a hub 1022, curved struts 1024, a
covering component 1028, and hexagonal cells with a helical bias
1026. The curved struts 1024 extend along a curved path from the
hub 1022 to form an occlusive face of the occluder device 1020. The
curved struts 1024 bifurcate to join with adjacent bifurcated
curved struts 1024 to form the hexagonal cells with a helical bias
1026. The depicted embodiment of occluder device 1020 includes five
rows of the hexagonal cells with a helical bias 1026. In some
embodiments, fewer than five or more than five rows of hexagonal
cells with a helical bias 1026 can be included in the occluder
device 1020; for example, the occluder device 1020 may include one,
two, three, four, five, six, seven, eight, or more than eight rows
of hexagonal cells with a helical bias 1026.
[0243] The occlusive devices 1010 and 1020 can have advantageous
properties owing to the curved struts 1024 and cells with helical
bias 1016 and 1026. Such advantageous properties can include, but
are not limited to, enhanced conformability (at the occlusive face
and along the sides of the devices 1010 and 1020), enhanced sealing
capabilities, enhanced durability and fatigue resistance, and a low
delivery profile.
[0244] FIG. 54 illustrates a material cutting pattern 1028 that can
be used to form the occlusion device 1020. The portions of the
cutting pattern 1028 that will form the hub 1022, the curved struts
1024, and the hexagonal cells with a helical bias 1026 are
identified. Using pattern 1028, the frame of the occluder device
1020 can be formed as a unitary member. In some cases, the material
cutting pattern 1028 can be utilized for laser-cutting a tube of
material. In some such cases, the frame of the occluder device 1020
is a unitary and seamless construct. Or, in some cases a planar
sheet of material can be cut as shown and the sheet can thereafter
be formed into a tube. In some embodiments, chemical etching,
machining, water jet cutting, or other techniques can be used to
create the frame of the occluder device 1020 in accordance with the
material cutting pattern 1028.
[0245] FIG. 57 illustrates a perspective view of an example
occluder device 1030. The depicted embodiment of occluder device
1030 includes a hub 1032, radial struts 1034, cells 1036, a
covering component 1039, and anchors 1038. The radial struts 1034
extend generally radially from the hub 1032 to form an occlusive
face of the occluder device 1030. The radial struts 1034 bifurcate
to join with adjacent bifurcated radial struts 1034 to form the
cells 1036. The depicted embodiment of occluder device 1030
includes four rows of the cells 1036 that are hexagonal. In some
embodiments, fewer than four or more than four rows of cells 1036
can be included in the occluder device 1030; for example, the
occluder device 1030 may include one, two, three, four, five, six,
seven, eight, or more than eight rows of cells 1036.
[0246] In the depicted embodiment of occluder device 1030, the
anchors 1038 extend within the interstitial spaces defined between
particular groups of cells 1036, and extend radially outward from
the cylindrical profile of the occluder device 1030 to terminations
at free ends of the anchors 1038. In comparison to the occluder
device 990 that has anchors 998 (refer to FIG. 53), the anchors
1038 can be made longer than the anchors 998. That is the case
because the length of the anchors 998 are limited to the size of
open space of individual cells 996. In contrast, the occluder
device 1030 is configured to include larger open spaces between the
particular groups of cells 1036 in which the anchors 1038 are
located. Therefore, in some embodiments the anchors 1038 can be
made longer than the anchors 998.
[0247] At least the tips of the anchors 1038 can contact tissue and
provide an anchoring function to resist migration of the occluder
device 1030 in relation to the tissue that the free ends of the
anchors 1038 is in contact with. While the depicted embodiment of
occluder device 1030 includes six anchors 1038, in some embodiments
one, two, three, four, five, seven, eight, nine, ten, eleven,
twelve, or more than twelve anchors 1038 are included. While the
free ends of the anchors 1038 of the depicted embodiment of
occluder device 1030 are terminations of elongate members that
curve radially outward from the axis of the occlusive device 1030,
in some embodiments one or more of the anchors 1038 include an
atraumatic tip (e.g., refer to FIG. 16B). In some embodiments, one
or more of the anchors 1038 include a sharp tip (e.g., refer to
FIG. 16C). In some embodiments, one or more of the anchors 1038
include a bifurcated tip (e.g., refer to FIG. 16D). Such a
bifurcated tip design may have individual tips that are sharpened,
atraumatic ends (e.g., ball ends), or any of the other example
anchor frame free ends described herein, or combinations
thereof.
[0248] In some embodiments, the anchors 1038 (and other anchors
provided herein) are designed to be flexible and resilient such
that the anchors 1038 can be folded to a low-profile delivery
configuration for containment within a delivery sheath, and can be
translated within the delivery sheath without significant dragging
resistance. When deployed from the delivery sheath, the anchors
1038 revert to a curved configuration (e.g., as shown, or similar
to as shown) that engages with the surrounding tissue at the
deployment site. In some implementations, the anchors 1038 pierce
the surrounding tissue while the other parts of the frame 1030 act
as a pledget to limit the penetration depth of the anchors 1038. In
addition, in some embodiments the covering component can provide a
seal around the penetration site. In such ways, the risk of
pericardial effusion related to penetration of the anchors 1038 can
be mitigated. In some implementations, the anchors 1038 engage the
surrounding tissue without penetration.
[0249] FIG. 58 illustrates a perspective view of an example
occluder device 1040. The depicted embodiment of occluder device
1040 includes a hub 1042, curved struts 1044, a covering component
1048, and cells 1046. The curved struts 1044 extend along a curved
path from the hub 1042 to form an occlusive face of the occluder
device 1040. The curved struts 1044 bifurcate to join with adjacent
bifurcated curved struts 1044 to form the cells 1046. The depicted
embodiment of occluder device 1040 includes four rows of the cells
1046 that are hexagonal. In some embodiments, fewer than four or
more than four rows of cells 1046 can be included in the occluder
device 1040; for example, the occluder device 1040 may include one,
two, three, four, five, six, seven, eight, or more than eight rows
of cells 1046.
[0250] The occlusive device 1040 can have advantageous properties
owing to the curved struts 1044. Such advantageous properties can
include, but are not limited to, enhanced conformability (e.g., at
the occlusive face of the device 1040), enhanced sealing
capabilities, enhanced durability and fatigue resistance, and a low
delivery profile.
[0251] FIG. 59 illustrates a material cutting pattern 1048 that can
be used to form the occlusion device 1040. The portions of the
cutting pattern 1048 that will form the hub 1042, the curved struts
1044, and the hexagonal cells 1046 are identified. Using pattern
1048, the frame of the occluder device 1040 can be formed as a
unitary member. In some cases, the material cutting pattern 1048
can be utilized for laser-cutting a tube of material. In some such
cases, the frame of the occluder device 1020 is a unitary and
seamless construct. Or, in some cases a planar sheet of material
can be cut as shown and the sheet can thereafter be formed into a
tube. In some embodiments, chemical etching, machining, water jet
cutting, or other techniques can be used to create the frame of the
occluder device 1040 in accordance with the material cutting
pattern 1048.
[0252] FIG. 60 illustrates a perspective view of an example
occluder device 1060. The depicted embodiment of occluder device
1060 includes a hub 1062, radial struts 1064, a covering component
1068, and cells 1066. The radial struts 1064 extend generally
radially from the hub 1062 and then bifurcate into a first radial
strut portion 1064a and a second radial strut portion 1064b. The
radial struts 1064 in combination with the first radial strut
portion 1064a and the second radial strut portion 1064b form an
occlusive face of the occluder device 1060. The first radial strut
portion 1064a joins with an adjacent second radial strut portion
1064b such that the cells 1066 can be defined. The depicted
embodiment of occluder device 1060 includes five rows of the cells
1066 that are hexagonal. In some embodiments, fewer than five or
more than five rows of cells 1066 can be included in the occluder
device 1060; for example, the occluder device 1060 may include one,
two, three, four, five, six, seven, eight, or more than eight rows
of cells 1066.
[0253] The occluder device 1060 can have advantageous properties
owing to the design of the radial struts 1064. The design of the
radial struts 1064 combines some features of the radially
symmetrical designs (e.g., FIGS. 51 and 52) with their advantageous
deployment reliability, durability, and conformability, along with
the curved strut designs (e.g., FIGS. 56 and 58) with their
advantageous conformability, sealing capabilities, durability and
fatigue resistance, and low delivery profile.
[0254] FIG. 61 schematically depicts an occluder device 1070
including an occlusion frame 1072 and an anchor frame 1076. The
occlusion frame 1072 includes a hub 1074, and the anchor frame 1076
includes a hub 1078. The occlusion frame 1072 can comprise one or
more rows of cells in some embodiments; for example, the occlusion
frame 1072 may include one, two, three, four, five, six, seven,
eight, or more than eight rows of cells.
[0255] FIG. 61 is drawn to highlight particular frame features that
can be incorporated into the designs of the occlusive devices
provided herein. For example, the designs of the hubs 1074 and 1076
and/or other frame features are highlighted. It should be
understood that one or more of the features that are highlighted in
this figure can be included in any of the occlusive devices
described elsewhere herein, and that such features (and other
features described herein) can be mixed and matched to create
hybrid designs that are entirely within the scope of this
disclosure. In this figure, no covering component is shown and some
portions of the frames are not shown so that the highlighted frame
features are more readily visible. It should be understood that the
occlusive device of FIG. 61 can be combined with a covering
component in some embodiments. The covering component can share any
or all of the features, characteristics, properties, etc. as
described above in reference to the covering component 156 and/or
any other exemplary covering components described herein.
[0256] In the depicted embodiment of occluder device 1070, the
occlusion frame 1072 and the anchor frame 1076 are both
individually formed by cutting material (e.g., laser cutting
tubular materials (e.g., NiTi) or planar materials). The hub 1074
of the formed occlusion frame 1072 and the hub 1078 of the formed
anchor frame 1076 are then coupled together in a nested
arrangement. The hubs 1074 and 1078 can be coupled by being
press-fit together, welded together, adhered together, mechanically
interlocking, and the like, and combinations thereof.
[0257] The occluder device 1070 can provide advantageous features
owing to the construction of the device 1070. For example, because
the occlusion frame 1072 and the anchor frame 1076 are only coupled
at their hubs 1074 and 1078 in the depicted embodiment, substantial
independence of movement between the occlusion frame 1072 and the
anchor frame 1076 is facilitated. In addition, the occlusion frame
1072 and the anchor frame 1076 can be formed from differing
materials, differing elongate element sizes, and so on, so that the
properties of the occlusion frame 1072 and the anchor frame 1076
can be independently selected as desired. For example, in some
embodiments the anchor frame 1076 can be a bioabsorbable polymer
while the occlusion frame 1072 is NiTi. Any and all such
above-described variations, combinations, permutations, and
sub-combinations of: materials, components, constructions,
features, and configurations of the occlusion frame 1072 and the
anchor frame 1076 are envisioned within the scope of this
disclosure.
[0258] In the depicted embodiment of occluder device 1070, the
anchor frame 1076 is within the occlusion frame 1072, except that
the free ends of the anchor frame 1076 extend beyond the outer
lateral profile of the occlusion frame 1072. In some embodiments,
the occlusion frame 1072 is within the anchor frame 1076 such that
the hub 1074 within the hub 1078.
[0259] FIGS. 62A and 62B illustrate another example occluder device
1080. The frame of the occluder device 1080 can be constructed, for
example, like any of the occluder devices 970, 980, 990, 1010,
1020, 1030, 1040, and 1060 described above. For example, the
occluder device 1080 includes a hub (not shown), radial struts
1084, and multiple rows of diamond-shaped cells 1086 (and may also
include anchors, etc.). However, the occluder device 1080 is
distinct from the depicted embodiments of the occluder devices 970,
980, 990, 1010, 1020, 1030, 1040, and 1060 in that the distal end
of the occluder device 1080 is gathered to form an apex 1088. The
gathering of the frame to form the apex 1088 can be accomplished,
for example, by weaving a gathering member (e.g., a suture or wire)
through the apices of the distal-most row of diamond-shaped cells
1086, and fixing the gathering member such that the distal-most row
of diamond-shaped cells 1086 are gathered together to a desired
extent. In some embodiments, in some embodiments the same shape is
attained by heat-setting rather than gathering. The advantage is
that the frame will endure less strain than the gathering (more
fatigue resistant).
[0260] The gathering of the frame of occluder device 1080 to form
the apex 1088 has the effect of reshaping the occluder device 1080
to create a tapered outer profile and more a rounded proximal end.
In result, the following advantages may potentially be realized: 1)
tucking apical points into a condensed blunt and flattened distal
end may make the distal end of the occluder device 1080 more
atraumatic; 2) the distal end of occluder device 1080 is made
stiffer (potentially helping to improve anchor retention with
greater radial force); 3) the gathered distal end creates structure
that helps organize and radially balance the frame for enhanced
deployment reliability, because the frame is allowed to compress
more evenly without allowing the frame to flare or pleat--thereby
helping with catheter loading, deployment, and repositioning; 4)
the shape may conform better with a LAA. In some embodiments, the
gathered distal end can be replaced or enhanced by the addition of
a film disc (to provide further coverage of the distal end) and/or
an internal solid hub component (to improve alignment of all distal
apices).
[0261] In general, for any of the designs described as being
laser-cut from a tube, the designs may similarly be cut from a
planar sheet of material, and the sheet may thereafter be formed
into a tube.
[0262] In addition to the materials previously discussed wires for
the frames or tubes for the frames can be made from a variety of
suitable materials. For example, the wires or tubes can be made of
nitinol (NiTi), L605 steel, MP35N steel, stainless steel, a
polymeric material, Pyhnox, Elgiloy, or any other appropriate
biocompatible material.
[0263] In general, the frames for any of the devices described
herein may be constructed from one or more elongate members. For
frames or sub-frames comprising wires, the frames or sub-frames may
be constructed using a modular tool, in some examples, or by using
a jig apparatus in other examples.
[0264] While the occlusion devices have been described with respect
to an LAA, in some embodiments, the occlusion devices can be used
to occlude or seal other apertures within a body of a patient, such
as a right atrial appendage, a fistula, a patent ductus arteriosus,
an atrial septal defect, a ventricular septal defect, a
paravalvular leak, an arteriovenous malformation, or a body
vessel.
[0265] The examples discussed herein have focused on occlusion
devices, but it is contemplated that the features described herein
may also be used with other types of medical devices or
accessories. Examples of implantable devices and accessories
include, without limitation, occlusion and closure devices, filters
(e.g., inferior vena cava filter or an embolic protection filter),
catheter based grabbers or retrieval devices, temporary filtration
devices, stents, stent-grafts, and vessel sizers. For embodiments
where the device is designed to filter, the covering component may
be porous, where the pores are sized to generally permit blood to
pass through the pores, but are sized to prevent emboli or thrombi
from passing through the pores of the covering component.
[0266] For additional examples of hub features that can be used
with the devices discussed herein, see the provisional application
titled "Joint Assembly for Medical Devices," having inventors Coby
C. Larsen, Steven J. Masters, and Thomas R. McDaniel, filed on 16
Nov. 2012, and which is herein incorporated by reference in its
entirety for all purposes, and see also the provisional application
titled "Space Filling Devices," having inventors Coby C. Larsen,
Brandon A. Lurie, Steven J. Masters, Thomas R. McDaniel, and
Stanislaw L. Zukowski, filed on 15 Mar. 2013, and which is herein
incorporated by reference in its entirety for all purposes. For
additional examples of delivery system devices, systems, and
techniques that can be used to deliver, deploy, reposition, and
retrieve the devices discussed herein, see the provisional
application titled "Implantable Medical Device Deployment System,"
having inventors Steven J. Masters and Thomas R. McDaniel, filed on
16 Nov. 2012, and which is herein incorporated by reference in its
entirety for all purposes.
[0267] Several characteristics and advantages have been set forth
in the preceding description, including various alternatives
together with details of the structure and function of the devices
and/or methods. The disclosure is intended as illustrative only and
as such is not intended to be exhaustive. It will be evident to
those skilled in the art that various modifications may be made,
especially in matters of structure, materials, elements,
components, shapes, sizes, and arrangements of parts including
combinations within the principles described herein, to the full
extent indicated by the broad, general meaning of the terms in
which the appended claims are expressed. To the extent that these
various modifications depart from the spirit and scope of the
appended claims, they are intended to be encompassed therein. All
references, publications, and patents referred to herein, including
the figures and drawings included therewith, are incorporated by
reference in their entirety.
* * * * *