U.S. patent application number 17/685179 was filed with the patent office on 2022-06-16 for central clot stabilizer and manipulator.
The applicant listed for this patent is Hesham Morsi. Invention is credited to Hesham Morsi.
Application Number | 20220183707 17/685179 |
Document ID | / |
Family ID | 1000006169930 |
Filed Date | 2022-06-16 |
United States Patent
Application |
20220183707 |
Kind Code |
A1 |
Morsi; Hesham |
June 16, 2022 |
CENTRAL CLOT STABILIZER AND MANIPULATOR
Abstract
A clot encasement and removal device for removing a vascular
obstruction is disclosed. The encasement device comprises proximal
and distal capture members and a central stabilizer. The central
stabilizer provides several points of contact for interacting with
and manipulating an intravascular obstruction. The central
stabilizer may be coupled to the distal capture member, allowing
the central stabilizer and distal capture member to be manipulated
in unison. The central stabilizer may reside on a distinct delivery
wire, enabling independent control of proximal and distal capture
members and the central stabilizer. The proximal capture member may
comprise a furrowed delivery wire to enable retraction of at least
a portion of the central stabilizer within the proximal capture
member.
Inventors: |
Morsi; Hesham; (Houston,
TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Hesham Morsi |
Houston |
TX |
US |
|
|
Family ID: |
1000006169930 |
Appl. No.: |
17/685179 |
Filed: |
March 2, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16319231 |
Jan 18, 2019 |
11284911 |
|
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PCT/US2017/043282 |
Jul 21, 2017 |
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17685179 |
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62365472 |
Jul 22, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/22034
20130101; A61F 2/012 20200501; A61B 17/221 20130101; A61M 29/02
20130101; A61F 2/01 20130101; A61M 25/09 20130101 |
International
Class: |
A61B 17/221 20060101
A61B017/221; A61M 25/09 20060101 A61M025/09; A61M 29/02 20060101
A61M029/02; A61F 2/01 20060101 A61F002/01 |
Claims
1. A device for remove an obstruction in a lumen comprising: a
proximal capture member; and a distal capture member; wherein the
proximal capture member comprises a proximal encasement sleeve and
a hollow proximal delivery wire; wherein the distal capture member
comprises a distal encasement sleeve and a discontinuous delivery
wire; a central stabilizer bisecting the discontinuous delivery
wire into proximal and distal segments; wherein a cross-sectional
shape of at least a portion of the central stabilizer is different
from a cross-sectional shape of the distal segment of the
discontinuous delivery wire; and wherein at least a portion of the
proximal segment of the discontinuous delivery wire lies within the
hollow proximal delivery wire.
2. The device of claim 1, wherein each of the proximal and distal
capture members further comprises an open end and a tapered end, a
frame component coupled to a encasement sleeve, said encasement
sleeve extending between said open end and said tapered end.
3. The device of claim 2, wherein said proximal frame component and
distal frame component comprise a self-expanding material
configured to have a collapsed configuration and an expanded
configuration.
4. The device of claim 2, wherein the central cot stabilizer
comprises a self-expanding material configured to have a collapsed
configuration and an expanded configuration.
5. The device of claim 2, wherein the central clot stabilizer is
manually adjustable.
6. The device of claim 5, wherein an expansion state of the
manually adjustable central clot stabilizer comprises a fully
collapsed state, a fully expanded state, or any expansion state
therebetween.
7. The device of claim 3, wherein the device further comprises a
catheter.
8. The device of claim 7, wherein collapsed configurations of the
proximal capture member, distal capture member, and central
stabilizer reside within the catheter.
9. The device of any of claims 1-8, wherein at least one capture
member further comprises a support arm.
10. The device of claim 9, wherein the support arm is coupled to
the respective delivery wire and the respective frame
component.
11. The device of claim 2, wherein at least one capture member
further comprises a fastening component slidably coupled to the
respective delivery wire, allowing a coupling angle of the
respective frame component to be adjusted.
12. The device of claim 2, wherein the encasement sleeves are
devoid of any fenestrations.
13. The device of claim 2, wherein the encasement sleeves comprise
a woven material of at least one of the following: a polymer, a
metal, and any combination thereof.
14. The device of claim 2, wherein the encasement sleeves comprise
a soft and flexible material.
15. The device of claim 2, wherein the encasement sleeves comprise
a self-expanding material configured to bias the encasement sleeve
into an expanded configuration.
16. The device of claim 2, wherein each encasement sleeve covers at
least a portion of a surface of the frame component to which it is
coupled.
17. The device of claim 2, wherein at least one of the proximal
frame component, the distal frame component, or the central
stabilizer is configured to deliver a therapeutic substance to said
obstruction.
18. The device of claim 1, further comprising a radiopaque
marker.
19. The device of claim 1, wherein at least a portion of the
proximal hollow delivery wire comprises a furrowed semi-cylinder
that allows at least a portion the central stabilizer to be
withdrawn into the proximal encasement sleeve.
20. The device of claim 19, wherein the furrowed semi-cylinder
comprises a length that is equal to or greater than a central
stabilizer length to allow the entire length of the central
stabilizer to reside within the proximal encasement sleeve.
21. The device of claim 2, wherein a proximal frame component
diameter is different from a distal frame component diameter.
22. A device for remove an obstruction in a lumen comprising: a
proximal capture member; a distal capture member; and a central
stabilizer wherein the proximal capture member comprises a proximal
encasement sleeve and a hollow proximal delivery wire; wherein the
distal capture member comprises a distal encasement sleeve and a
distal delivery wire; wherein the central stabilizer comprises a
central delivery wire.
23. The device of claim 22, wherein the each of the proximal and
distal capture members further comprises an open end and a tapered
end, a frame component coupled to a encasement sleeve, said
encasement sleeve extending between said open end and said tapered
end.
24. The device of claim 23, wherein said proximal frame component
and distal frame component comprise a self-expanding material
configured to have a collapsed configuration and an expanded
configuration.
25. The device of claim 23, wherein the central cot stabilizer
comprises a self-expanding material configured to have a collapsed
configuration and an expanded configuration.
26. The device of claim 23, wherein the central clot stabilizer is
manually adjustable.
27. The device of claim 25, wherein an expansion state of the
manually adjustable central clot stabilizer comprises a fully
collapsed state, a fully expanded state, or any expansion state
therebetween.
28. The device of claim 24, wherein the device further comprises a
catheter.
29. The device of claim 28, wherein collapsed configurations of the
proximal capture member, distal capture member, and central
stabilizer reside within the catheter.
30. The device of claim 29, wherein at least one capture member
further comprises a support arm.
31. The device of claim 30, wherein the support arm is coupled to
the respective delivery wire and the respective frame
component.
32. The device of claim 23, wherein at least one capture member
further comprises a fastening component slidably coupled to the
respective delivery wire, allowing a coupling angle of the
respective frame component to be adjusted.
33. The device of claim 23, wherein the encasement sleeves are
devoid of any fenestrations.
34. The device of claim 23, wherein the encasement sleeves comprise
a woven material of at least one of the following: a polymer, a
metal, and any combination thereof.
35. The device of claim 23, wherein the encasement sleeves comprise
a soft and flexible material.
36. The device of claim 23, wherein the encasement sleeves comprise
a self-expanding material configured to bias the encasement sleeve
into an expanded configuration.
37. The device of claim 2, wherein each encasement sleeve covers at
least a portion of a surface of the frame component to which it is
coupled.
38. The device of claim 2, wherein at least one of the proximal
frame component, the distal frame component, or the central
stabilizer is configured to deliver a therapeutic substance to said
obstruction.
39. The device of claim 1, further comprising a radiopaque
marker.
40. The device of claim 23, wherein a proximal frame component
diameter is different from a distal frame component diameter.
41. The device of claim 22, wherein a cross-sectional shape of at
least a portion of the central stabilizer is different from a
cross-sectional shape of the central delivery wire.
42. The device of claim 22, wherein the central delivery wire and
the distal delivery wire lie adjacently within the hollow proximal
delivery wire.
43. The device of claim 22, wherein the central delivery wire and
distal delivery wire are oriented concentrically within the hollow
proximal tube.
44. The device of claim 24, wherein at least a portion of the
central delivery wire resides within at least a portion of the
distal delivery wire.
45. The device of claim 44, wherein at least a portion of the
distal delivery wire comprises a furrowed semi-cylinder that allows
at least a portion the central stabilizer to be maneuvered into the
distal encasement sleeve.
46. The device of claim 45, wherein the furrowed semi-cylinder
length is equal to or greater than the length of central
stabilizer, enabling the entire length of the central stabilizer to
be maneuvered into the distal encasement sleeve.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. Non-Provisional
patent application Ser. No. 16/319,231 filed on Jan. 18, 2019,
which is a national phase application under 35 U.S.C. .sctn. 371
that claims priority to International Application No.
PCT/US2017/043282 filed Jul. 21, 2017, which claims priority to
U.S. Provisional Application No. 62/365,472 filed Jul. 22, 2016,
all of which are incorporated herein by reference in their
entirety.
TECHNICAL FIELD
[0002] Embodiments of the present disclosure relate generally to
medical devices and methods of using same, and more specifically,
to medical devices for treating, including treating an occluded
biological lumen, such as an embolus or clot in a blood vessel.
BACKGROUND
[0003] This section is intended to introduce various aspects of the
art, which may be associated with exemplary embodiments of the
present disclosure. This discussion is believed to assist in
providing a framework to facilitate a better understanding of
particular aspects of the present disclosure. Accordingly, it
should be understood that this section should be read in this
light, and not necessarily as any admission of prior art.
[0004] There are many reasons a blood vessel becomes blocked or
obstructed. One way is from deposition of thrombus on the walls of
the blood vessels. The buildup of these clots can restrict blood
flow. Because arterial blockages reduce blood flow through the
affected vessel, any blockage or obstruction can lead to many
serious medical complications. For instance, tissue relying on the
blood's supply of oxygen may become damaged due to the decrease in
the oxygen amount or the blockage can result in a heart attack if
the obstructed vessel supplies blood to the heart itself.
[0005] While various methods are available to treat a blockage or
obstruction through removal of the obstruction, these methods do
not sufficiently capture and retain the particulate matters from
the obstruction to prevent them from migrating to another area of
the vascular system where they can get lodged again.
[0006] The present disclosure provides solutions to long-felt needs
in the art to treat occluded vessels.
SUMMARY
[0007] The foregoing has outlined rather broadly the features and
technical advantages of the embodiments of the present disclosure
in order that the detailed description of these embodiments that
follows may be better understood. Additional features and
advantages of the embodiments of the present disclosure will be
described hereinafter which form the subject of the claims of the
present disclosure. It should be appreciated by those skilled in
the art that the conception and specific embodiment disclosed may
be readily utilized as a basis for modifying or designing other
structures for carrying out the same purposes of the present
disclosure. It should also be realized by those skilled in the art
that such equivalent constructions do not depart from the spirit
and scope of the present disclosure as set forth in the appended
claims. The novel features which are believed to be characteristic
of the present disclosure, both as to its organization and method
of operation, together with further objects and advantages will be
better understood from the following description when considered in
connection with the accompanying figures. It is to be expressly
understood, however, that each of the figures is provided for the
purpose of illustration and description only and is not intended as
a definition of the limits of the present disclosure.
[0008] The term "coupled" is defined as connected, although not
necessarily directly, and not necessarily mechanically. The terms
"a" and "an" are defined as one or more unless this disclosure
explicitly requires otherwise. The term "substantially" is defined
as being largely but not necessarily wholly what is specified (and
include wholly what is specified) as understood by one of ordinary
skill in the art. In any disclosed embodiment, the term
"substantially" may be substituted with "within [a percentage] of"
what is specified, where the percentage includes 0.1, 1, 5, and 10
percent. The terms "comprise" (and any form of comprise, such as
"comprises" and "comprising"), "have" (and any form of have, such
as "has" and "having"), "include" (and any form of include, such as
"includes" and "including") and "contain" (and any form of contain,
such as "contains" and "containing") are open-ended linking verbs.
As a result, an encasement sleeve that "comprises," "has,"
"includes" or "contains" one or more elements possesses those one
or more elements, but is not limited to possessing only those one
or more elements Likewise, an element of a system or composition
that "comprises," "has," "includes" or "contains" one or more
features possesses those one or more features, but is not limited
to possessing only those one or more features. Furthermore, a
structure or composition that is configured in a certain way is
configured in at least that way, but may also be configured in ways
that are not listed. Metric units may be derived from the English
units provided by applying a conversion and rounding to the nearest
millimeter. The feature or features of one embodiment may be
applied to other embodiments, even though not described or
illustrated, unless expressly prohibited by this disclosure or the
nature of the embodiments. Any embodiment of any of the disclosed
container assemblies and compositions can consist of or consist
essentially of--rather than comprise/include/contain/have--any of
the described elements and/or features and/or steps. Thus, in any
of the claims, the term "consisting of" or "consisting essentially
of" can be substituted for any of the open-ended linking verbs
recited above, in order to change the scope of a given claim from
what it would otherwise be using the open-ended linking verb.
Details associated with the embodiments described above and others
are presented below.
[0009] Embodiments of the disclosure are directed towards a clot
encasement and removal device. In particular embodiments, the
device comprises proximal and distal capture members within which a
clot or other obstruction may be sequestered. In specific aspects,
the device further comprises a central stabilizer for direct
contact, stabilization, and manipulation of a vascular obstruction.
The central stabilizer may be used at least in part to effectively
grab an obstruction. The central stabilizer may be operated in
unison with the proximal capture member, or it may be independently
operated. In some embodiments, the proximal capture member features
a furrowed section for allowing at least a portion of the central
stabilizer to be withdrawn into the proximal capture member.
[0010] The clot encasement device is configured to offer a
multitude of options for capturing and manipulating obstructions.
Upon making contact and stabilizing an obstruction, the central
stabilizer may be pulled into the proximal capture member, the
stabilizer may be pushed into the distal capture member, or either
or both of the capture members may be directed to encase at least a
portion of the central stabilizer. The central stabilizer may hold
an obstruction in place, and the proximal and/or distal capture
members may be manipulated to encase the obstruction. Both proximal
and distal capture members may come together to provide an encasing
volume for the obstruction. The proximal and distal capture members
may comprise frame components at open ends with the same or
different diameters. The diameters may be selected such that one
frame fits within the other frame, at least in part. In this
fashion, the proximal and distal capture members can provide a
tight seal around an obstruction, thereby preventing obstruction
outflow or escape.
[0011] In some embodiments, a device for removal of an obstruction
in a lumen comprises a proximal capture member and a distal capture
member. In specific embodiments, the proximal capture member
comprises a proximal encasement sleeve and a hollow proximal
delivery wire, and the distal capture member comprises a distal
encasement sleeve and a discontinuous delivery wire. In some
embodiments, the a central stabilizer is included and bisects the
discontinuous delivery wire into proximal and distal segments.
[0012] The shape of the central stabilizer is different from the
shape of the delivery wire to which it is coupled. In some
embodiments, a cross-sectional shape of at least a portion of the
central stabilizer is different from a cross-sectional shape of the
distal segment of the discontinuous delivery wire. In some aspects,
at least a portion of the proximal segment of the discontinuous
delivery wire lies within the hollow proximal delivery wire.
[0013] In some embodiments, each of the proximal and distal capture
members further comprises an open end and a tapered end, and a
frame component coupled to a encasement sleeve. The encasement
sleeve extends between the open end and tapered end. The proximal
frame component, distal frame component, and/or central stabilizer
may comprise a self-expanding material. In some embodiments, the
proximal frame component, distal frame component, and/or central
stabilizer have a collapsed configuration and an expanded
configuration. The device may further comprises a catheter, within
which the proximal frame component, distal frame component, and
central stabilizer reside in the respective collapsed
configurations.
[0014] In some aspects, at least one of the distal or proximal
capture members comprises a support arm. The support arm may be
coupled to the respective delivery wire and the respective frame
component. The proximal or distal capture members may further
comprise a fastening component slidably coupled to the respective
delivery wire, thereby allowing a coupling angle of the respective
frame component to be adjusted.
[0015] In some aspects, the encasement sleeves comprise a woven
material of at least one of the following: a polymer, a metal, and
any combination thereof. In some embodiments, the encasement
sleeves are devoid of any fenestrations. The encasement sleeves may
be made of a soft and flexible material. In some aspects, the
encasement sleeves comprise a self-expanding material configured to
bias the encasement sleeve into an expanded configuration. In some
aspects, each encasement sleeve is configured to cover at least a
portion of a surface of the frame component to which it is coupled.
In some aspects, at least one of the proximal frame component, the
distal frame component, or the central stabilizer may be configured
to deliver a therapeutic substance to said obstruction.
[0016] The clot encasement device may comprise at least one
radiopaque marker. In some aspects, each delivery wire comprises at
least one radiopaque marker. In further aspects, each delivery wire
comprises at least two radiopaque markers.
[0017] The clot encasement device may be configured to allow the
central stabilizer to be withdrawn into the proximal capture
member. In some aspects, at least a portion of the proximal hollow
delivery wire comprises a furrowed semi-cylinder that allows at
least a portion the central stabilizer to be withdrawn into the
proximal encasement sleeve. In some embodiments, the furrowed
semi-cylinder comprises a length that is equal to or greater than a
central stabilizer length to allow the entire length of the central
stabilizer to reside within the proximal encasement sleeve. In some
embodiments, a proximal frame component diameter is different from
a distal frame component diameter, thereby allowing one frame
component to fit within the other frame component.
[0018] Some aspects of the disclosure are directed towards a clot
encasement device comprising, a proximal capture member coupled to
a proximal delivery wire, a distal capture member coupled to a
distal delivery wire, and a central stabilizer coupled to a central
delivery wire that is distinct from the distal delivery wire,
thereby allowing independent manipulation of the proximal and
distal capture members and the central stabilizer. In some aspects,
each of the proximal and distal capture members further comprises
an open end and a tapered end, a frame component coupled to a
encasement sleeve, with the encasement sleeve extending between the
open and tapered ends. In some embodiments, the proximal frame
component, distal frame component, and/or central stabilizer
comprise a self-expanding material configured to have a collapsed
configuration and an expanded configuration. The device comprises a
catheter, within which the proximal frame component, distal frame
component, and central stabilizer reside in their respective
collapsed configurations.
[0019] In some embodiments, at least a portion of the central
stabilizer comprises a cross-sectional shape that is different from
a cross-sectional shape of the central delivery wire. In some
embodiments, the central delivery wire and the distal delivery wire
lie adjacent to each other within the hollow proximal delivery
wire. In other embodiments, the central delivery wire and distal
delivery wire are oriented concentrically within the hollow
proximal tube. In some embodiments, at least a portion of the
central delivery wire resides within at least a portion of the
distal delivery wire. In some aspects, at least a portion of the
hollow proximal delivery wire or the distal delivery wire comprises
a furrowed semi-cylinder that allows at least a portion the central
stabilizer to be maneuvered into the respective encasement sleeve.
In some embodiments, the furrowed semi-cylinder length is equal to
or greater than the length of central stabilizer, enabling the
entire length of the central stabilizer to be maneuvered into the
proximal or distal encasement sleeve.
[0020] In some embodiments of the clot encasement device, at least
one capture member is coupled to a support arm. The support arm may
be coupled to the respective delivery wire and the respective frame
component. At least one capture member may further comprise a
fastening component slidably coupled to the respective delivery
wire, thereby allowing a coupling angle of the respective frame
component to be adjusted.
[0021] In some aspects, the encasement sleeves comprise a woven
material of at least one of the following: a polymer, a metal, and
any combination thereof. In some embodiments, the encasement
sleeves are devoid of any fenestrations. The encasement sleeves may
be made of a soft and flexible material. In some aspects, the
encasement sleeves comprise a self-expanding material configured to
bias the encasement sleeve into an expanded configuration. In some
aspects, each encasement sleeve is configured to cover at least a
portion of a surface of the frame component to which it is coupled.
In some aspects, at least one of the proximal frame component, the
distal frame component, or the central stabilizer may be configured
to deliver a therapeutic substance to said obstruction.
[0022] The clot encasement device may comprise at least one
radiopaque marker. In some aspects, each delivery wire comprises at
least one radiopaque marker. In further aspects, each delivery wire
comprises at least two radiopaque markers.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] The following drawings illustrate by way of example and not
limitation. For the sake of brevity and clarity, every feature of a
given structure may not be labeled in every figure in which that
structure appears.
[0024] FIG. 1 is a side perspective view of a first embodiment of
the clot encasement and removal system. The central clot stabilizer
is in the form of a brush and is coupled to the distal capture
member.
[0025] FIG. 2 is a side perspective view of a second embodiment of
the clot encasement and removal system. The central clot stabilizer
is in the form of a coil and is coupled to the distal capture
member.
[0026] FIG. 3 is a side perspective view of a third embodiment of
the clot encasement and removal system. The central clot stabilizer
is in the form of a lemniscate and is coupled to the distal capture
member.
[0027] FIG. 4 is a side perspective view of a fourth embodiment of
the clot encasement and removal system. The central clot stabilizer
is in the form of a brush. The central clot stabilizer and distal
capture member are coupled to distinct delivery wires.
[0028] FIG. 5 is a perspective view of a hollow proximal delivery
wire with a furrowed semi-cylinder. The furrow allows at least a
portion the central stabilizer to be withdrawn into the proximal
encasement sleeve.
[0029] FIGS. 6A-6C depict three views of a proximal hollow delivery
wire with a furrowed semi-cylinder. FIG. 6A is a top view of the
distal delivery wire residing within the hollow proximal delivery
wire. FIG. 6B is a cross-sectional view of the distal delivery wire
residing within a non-furrowed section of the hollow proximal
delivery wire. FIG. 6C is a cross-sectional view of the distal
delivery wire residing within a furrowed section of the hollow
proximal delivery wire.
[0030] FIGS. 7A-7B depict one embodiment of the clot encasement and
removal system wherein the central clot stabilizer is manually
adjustable. FIG. 7A depicts the manually adjustable central clot
stabilizer in a partially-collapsed state. FIG. 7B depicts the
manually adjustable central clot stabilizer in an expanded
state.
DETAILED DESCRIPTION
[0031] Embodiments of the present disclosure provide for minimally
invasive removal of accumulated material, such as a clot or
embolism, disposed in a patient's (mammalian, including human or
otherwise) vascular system. Certain embodiments of the present
disclosure are particularly applicable for extraction of material
in distal, narrow, tortuous segments of the neuro-blood vessels. In
a general embodiment, the endovascular device of the present
disclosure includes two opposing capture members that are slidably
coupled to each other. Each capture member preferably comprises an
open end and a tapered end, where the open end of each capture
member face one another. In one embodiment, the endovascular device
can be delivered to the site of the material deposit using a
catheter. The capture members can be placed on each side of the
material deposit with the open ends facing the material deposit.
Preferably, the majority of the material deposit is moved into the
capture members when the capture members progresses toward one
another. In one closed configuration, the open end of the capture
members meet one another to form an enclosure to capture and retain
the material deposit contained therein. The capture members can be
withdrawn in this closed configuration and/or be pulled into a
catheter, thereby removing the material deposit.
[0032] FIGS. 1-6 show certain specific embodiments according to the
aspects of the present invention. FIGS. 1-3 depict a side
perspective view of three embodiments of the clot encasement and
removal system. The three embodiments differ in the shape of the
central clot stabilizer. The embodiment depicted in FIG. 1 includes
a brush-like central clot stabilizer. The embodiment depicted in
FIG. 2 includes a coil-shape central clot stabilizer. The
embodiment depicted in FIG. 3 includes a lemniscate-shaped central
clot stabilizer.
[0033] As shown in FIG. 1, the clot encasement and removal system
comprises two capture members 110 and 112. Capture member 112 is
the distal capture member and capture member 110 is the proximal
member. The proximal and distal qualifiers describe the relative
distances from a care provider (e.g., physician) who may be using
the clot encasement device.
[0034] Proximal capture member 110 comprises a proximal encasement
sleeve 114 and a hollow proximal delivery wire 116. Distal capture
member 112 comprises a distal encasement sleeve 118 and a
discontinuous delivery wire 120. The discontinuous delivery wire
120 is divided into distal segment 120a and proximal segment 120b.
Distal and proximal segments of the discontinuous delivery wire 120
are bisected by a central stabilizer 122. Bisection of the
discontinuous delivery wire 120 by the central stabilizer 122 does
not necessarily divide distal and proximal segments of the
discontinuous delivery wire 120 into two equal parts, such that the
distal and proximal segments 120a and 120b may of different
lengths.
[0035] At least a portion of the central stabilizer 122 comprises a
cross-sectional shape that is different from the cross-sectional
shape of the distal segment 120a of the discontinuous delivery wire
120. In some embodiments, the cross-sectional shape of the distal
segment of the discontinuous delivery wire is circular. The
cross-sectional shape of central stabilizer 122 may be constant or
may vary along the length of the central stabilizer 122. The
cross-sectional shape at least one point along the length of the
central 122 is different from the cross-sectional shape of the
distal segment 120a of the discontinuous delivery wire 120.
[0036] At least a portion of the proximal segment 120a of the
discontinuous delivery wire 120 resides within the hollow proximal
delivery wire 116. The inclusion of two distinct delivery wires,
hollow proximal delivery wire 116 and the discontinuous delivery
wire 120, allows the proximal and distal capture members to be
maneuvered independently. The proximal capture member 110 and the
distal capture member 112 may also be maneuvered in unison.
[0037] As depicted in FIG. 5, the hollow proximal delivery wire 516
may comprise a furrowed semi-cylinder. The furrow allows at least a
portion of the central stabilizer to be withdrawn into the proximal
encasement sleeve. The length of the furrow may be selected based
upon the particular application. In some embodiments, the furrow
may be of a length that allows a portion of the central stabilizer
to be withdrawn into the proximal encasement sleeve. In other
embodiments, the furrow may be of a length that allows the entire
length of the central stabilizer to be withdrawn into the proximal
encasement sleeve. The furrow provides the hollow proximal delivery
wire with an open section through which the central stabilizer may
pass. In this fashion, the open furrowed area prevents the central
stabilizer from collapsing to fit within the proximal delivery wire
hollow.
[0038] The hollow proximal delivery wire 116 and discontinuous
delivery wire 120 may comprise a radiopaque material. Non-limiting
examples of a radiopaque material include platinum or tantalum DFT
Nitinol. The radiopaque material provides a radiopaque marker that
may be used to aim and maneuver different sections of the clot
encasement. The embodiment depicted in FIG. 1 includes four
distinct radiopaque markers which are located on the hollow
proximal delivery wire 116 and discontinuous delivery wire 120. The
discontinuous delivery wire 120 comprises radiopaque markers 134a
and 134b. The hollow proximal delivery wire 116 comprises
radiopaque markers 134c and 134d. In this embodiment, the
radiopaque markers are located at open and tapered sections of
proximal encasement sleeve 114 and distal encasement sleeves 118.
The location and number of radiopaque markers is not limited to the
location and number of radiopaque markers depicted in FIG. 1.
Radiopaque markers may be located at any location on the clot
encasement device. Any number of radiopaque markers may be
incorporated into the clot encasement device. For example, a clot
encasement device may include 0, 1, 2, 3, 4, 5, 6, or more
radiopaque markers.
[0039] Proximal capture member 110 and distal capture member 112
may further comprise a frame component. The frame component may be
coupled to an open end of the encasement sleeve. The frame
component may be coupled to the capture member delivery wire. The
frame component aids in providing rigidity for maintaining the
shape and size of open ends of encasement sleeves in expanded
configurations. Frame components are preferably circular in shape
to match the shape of the target blood vessel. In other
embodiments, however, frame components can have any shape in the
expanded configuration desired, such as circular, oval, rectangular
or any other regular or irregular shapes that may be suitable to
the particular application. In the embodiment depicted in FIG. 1,
distal frame component 128 is coupled to the open end of distal
encasement sleeve 118 and to hollow proximal delivery wire 116.
Proximal frame component 126 is coupled to the open end of proximal
encasement sleeve 114 and to the distal segment 120a of
discontinuous delivery wire 120.
[0040] The angle between a frame component and a delivery wire may
be fixed or may be adjustable. Proximal capture member 110 and/or
distal capture member 112 may further comprise a fastening
component slidably coupled to the respective delivery wire. The
fastening component allows a coupling angle of the respective frame
component to be adjusted. In the embodiment depicted in FIG. 1.,
proximal capture member 110 comprises proximal fastening component
130, which is coupled to hollow proximal delivery wire 116 and
proximal frame component 126. Distal capture member 112 comprises
distal fastening component 132, which is coupled to the distal
segment 120a of distal delivery wire 120 and distal frame component
128.
[0041] The size and shape of the proximal and distal frame
components may be the same or different. In one embodiment, the
proximal frame component 126 and distal frame component 128 are
both circular in shape. The diameter of proximal frame component
126 is different from the diameter of distal frame component 128.
The diameters (or other size for a non-circular frame) of the
proximal and distal frame components may be selected such that one
frame component fits within the other frame component. This allows
the frame components, and the encasement sleeves to which they are
coupled, to fit within one another, thereby providing an encasement
volume within which an obstruction may be captured. The sized of
the proximal and distal frame components may be selected to provide
a tight junction between open ends of respective capture
members.
[0042] Frame components preferably comprises a superelastic and/or
self-expanding material. In particular, the superelastic and/or
self-expanding material preferably have properties that allow it to
have a deformed shape under one condition and to recover its
original shape prior to deformation, which can also be referred to
as an expanded configuration, in response to exposure to an
activation mechanism. Preferably, the material can include a
memory-shaped heated alloy such as nitinol, or nickel titanium,
which is a metal alloy of nickel and titanium. Nitinol alloys
exhibit two closely related and unique properties: shape memory and
superelasticity. Shape memory refers to the ability of nitinol to
undergo deformation at one temperature, then recover its original,
un-deformed shape upon heating above its "transformation
temperature." That is, nitinol alloy has a biased expanded
condition and may be compressed into a collapsed or deformed
condition before use. During use, it may be exposed to temperature
above the transformation threshold, thereby causing it to revert
back to its un-deformed and/or original shape. Frame components can
also comprise any flexible and/or elastic material that allows
frame components to be compressed, or deformed by a radial force,
to fit into a catheter, such as catheter 124 shown in FIG. 1,
without sustaining any damage and revert back to its original shape
once released from the catheter.
[0043] In one embodiment, the diameter of frame components 126 and
128 ranges between about 10 microns to 500 microns. In a preferred
embodiment, the diameter of frame components 126 and 128 ranges
between about 80 microns to about 120 microns. In another preferred
embodiment, the diameter of frame components 126 and 128 ranges
between about 95 microns to about 105 microns.
[0044] The diameter of at least one of frame components 126 and 128
in the expanded configuration, and capture member open ends, is
preferably configured to substantially match the diameter of the
particular lumen or blood vessel of interest in which the target
material deposit, e.g., clot, is disposed. In such an expanded
configuration, frame components 126 and/or 128 preferably contact
the inner wall of the target blood vessel gently, e.g., without
exerting significant force that can damage the blood vessel. This
allows at least one capture member 110 or 112 to extend across the
interior, or lumen, of the blood vessel where effectively most or
all the fluid and material flowing through the target blood vessel
are directed through the respective extended capture member 110 or
112. In one embodiment, the diameter of at least one encasement
sleeve open end is in a range of about 1.5 mm to about 6 mm, and
preferably in a range of about 2 mm to about 4.5 mm. In another
preferred embodiment, the diameter of at least one encasement
sleeve open end is between about 2.5 mm and about 3 mm.
[0045] The clot encasement device comprises a central stabilizer.
In some embodiments, the central stabilizer comprises a
self-expanding material configured to have a collapsed
configuration and an expanded configuration. The central stabilizer
functions to provide one or more points of contact with an
obstruction, e.g., a clot. Contacting an obstruction with the
central stabilizer allows the central stabilizer to exert a
stabilizing force on the obstruction. Obstruction stabilization is
especially useful for long clots (>5 mm). The central
stabilizer/obstruction contact may occur at either end of the
obstruction, between ends of the obstruction, or along the entire
length of the obstruction. Contacting an obstruction with the
central stabilizer allows the obstruction to be stabilized, or held
in place. The obstruction may be stabilized by the central
stabilizer while moving one or both capture members over the
obstruction surface to encapsulate the obstruction without
significant compression and/or deformation. Contacting an
obstruction with the central stabilizer may be used to apply a
dragging force uniformly at one or more points along the length of
the obstruction. In this fashion, the central stabilizer may be
used to effectively manipulate the obstruction at least partially
inside one or both capture members. Manipulation of an obstruction
may be accomplished without significant compression and deformation
of the clot.
[0046] In further embodiments, the central stabilizer is manually
adjustable. Manual adjustment of the central stabilizer allows the
user to control the central stabilizer expansion state. The central
stabilizer may reside within the hollow proximal delivery wire in a
fully or partially collapsed state. Upon being directed or
manipulated out of the hollow proximal delivery wire, the central
stabilizer may remain in a fully collapsed state. The central
stabilizer may include one or more radiopaque markers to assist in
delivery and placement of the central stabilizer relative to an
obstruction. The expansion state of the central stabilizer may be
manually adjusted from fully collapsed to fully expanded, or any
expansion state therebetween. FIG. 7A depicts the manually
adjustable central clot stabilizer in a partially-collapsed or
partially-expanded state. FIG. 7B depicts the manually adjustable
central clot stabilizer in an expanded state. The expansion state
of the central clot stabilizer may be selected and adjusted to
optimally position, grasp, prod, penetrate, pierce, nudge, envelop,
clasp, and/or retrieve an obstruction.
[0047] The central stabilizer 122 may be at least partially
withdrawn into the proximal encasement sleeve. The hollow proximal
delivery wire may comprise a furrow whose shape and size are
selected to allow at least a portion of the central stabilizer to
overlap at least a portion of the length of the hollow proximal
delivery wire 116. In this fashion, the central stabilizer may be
withdrawn into the proximal encasement sleeve. The central
stabilizer 122 may be provided with or have incorporated within it
a radiopaque material. The central stabilizer 122 may comprise one
or more radiopaque markers.
[0048] The size and shape of the central stabilizer may be selected
depending on the blood vessel and obstruction. The central
stabilizer size may be selected such that a portion of, or the
entirety of the central stabilizer fits within at least one
encasement sleeve. The orthogonal size of the central stabilizer
may range from about 1 to about 6 mm, and preferably from about 2
mm to about 3 mm. The orthogonal size refers to the dimension of
the central stabilizer that is orthogonal to the line created by
the delivery wires. The length of the central stabilizer may range
between about 5 mm to about 40 mm, and preferably from about 10 mm
to about 20 mm. The central stabilizer may comprise a superelastic
and/or self-expanding material. In particular, the superelastic
and/or self-expanding material preferably have properties that
allow it to have a deformed shape under one condition and to
recover its original shape prior to deformation, which can also be
referred to as an expanded configuration, in response to exposure
to an activation mechanism. The central stabilizer material can
include a memory-shaped metal or alloy such as nitinol, or nickel
titanium, which is a metal alloy of nickel and titanium. In some
embodiments, the central stabilizer may be made of a polymer. In
further embodiments, the central stabilizer is made of a
combination of a polymer and a memory-shaped metal or alloy.
[0049] The central stabilizer is provided in a shape that is
different from the delivery wire shape. In some embodiments, the
cross-sectional shape of at least a portion of the central
stabilizer is different from a cross-sectional shape of the distal
segment of the discontinuous delivery wire. A discontinuous
delivery wire cross-sectional shape may be square, round, oval,
rectangular, etc. The central stabilizer is shaped such that at
least a portion of the central stabilizer's cross-sectional shape
is different from the discontinuous delivery wire cross-sectional
shape. In comparison to the delivery wire, the central stabilizer
shape provides a different or additional surface area for engaging
an obstruction. The central stabilizer shape may be a helix, a
double helix, a lemniscate, a coil or spring, or a brush with
projections emanating from a base. A helix, double helix, or coil
or spring may have ring coils with the same or different diameters.
The ring coil diameters may be constant along the central
stabilizer length or they may be variable. The ring coil diameters
may increase or taper in size. The ring coil diameters may be of
alternating diameters. The helix, spring, or coil may be wound
clockwise or counterclockwise. The coil pitch may be tight, for
example, 0.5 mm. The coil pitch may be intermediate, for example 1
mm to 2 mm. The coil pitch may be loose, for example 3 mm and
above. The coil pitch may vary from about 0.5 mm to about 5 mm. The
coil rings may be touching or they may be separated. A double helix
may comprise two component helices with the same or different
dimensions. In some embodiments, a central stabilizer comprises a
plurality of component wires. In some embodiments, a central
stabilizer comprises a braided shape, for example, a bi-axial or
higher-order braid. In central stabilizer embodiments comprising a
plurality of component wires, the wires may be separate from each
other or may be attached to each other at one or more points. In a
brush-shaped central stabilizer, the projections may be of uniform
length or of varying length. The distance between the projections
may be constant or may vary. In some embodiments, the distance
between projections varies from about 0.5 mm to about 3 mm. The
projection angle may vary from acute to obtuse. In a preferred
embodiment, the projection angle is 90 degrees. In some
embodiments, a central stabilizer may comprise a combination of
different shapes.
[0050] The distal and proximal encasement sleeves may be formed of
any material which is flexible and compatible with bodily fluids
such as blood. Non-limiting examples of suitable materials include
polymeric film materials, such as, but not limited to,
polyurethane, polyolefin, polyester, and silicone polymers. In an
embodiment using such polymeric film material, distal and/or
proximal encasement sleeve tapered ends can further include
apertures of sufficient size to allow fluids to flow through distal
and/or proximal encasement sleeve while retaining the captured
material deposit. In some embodiments, distal and/or proximal
encasement sleeves comprise a polymeric net-like material having a
plurality of apertures throughout the material, such as, but not
limited to, a woven mesh of polymeric material, metal, and/or other
superelastic, self-expanding, and/or memory shape alloy such as
nitinol. In certain embodiments, the woven mesh can comprise a
combination of polymers, metals, and/or metal alloys. While the
figures may depict body members formed of a film material, it is
intended to be exemplary and not limiting, as it is understood that
such body members can be made of net-like material without
departing from certain aspects of the present invention. In one
embodiment, the material of distal and/or proximal encasement
sleeve can comprise material similar to that of the material of
frame component, providing it a biased shape in the expanded
configuration that allows distal and/or proximal encasement sleeve
to remain open as it extends away from its respective frame
component. In some embodiments, the total length of distal and
proximal encasement sleeves is between about 5 mm and about 30 mm.
In a preferred embodiment, the total length of both distal and
proximal encasement sleeves is between about 8 mm and about 20. In
another preferred embodiment, the total length of distal and
proximal encasement sleeves is between about 10 mm and 12 mm. In
yet another preferred embodiment, the total length of distal and
proximal encasement sleeves is about 10 mm.
[0051] In one embodiment, a user can hold hollow proximal delivery
wire 116 static, thereby keeping proximal capture member 110 in one
position, while pushing or pulling distal guide member 120 to
adjust the position of distal capture member 112. In another
embodiment, the user can hold distal guide member 120 constant,
thereby keeping distal capture member 112 in one position, while
pushing or pulling hollow proximal delivery wire 116 to adjust the
position of proximal capture member 110. In yet another embodiment,
both delivery wires 116 and 120 can be adjusted at the same time to
achieve the desired positions of capture members 110 and 112 and
central stabilizer 122.
[0052] The body of either delivery wire 116 or 118 preferably has a
length sufficient to extend through the vascular system of a
patient to reach the target accumulation and place endovascular
device in the desired deployment location. In one embodiment,
either delivery wire 116 or 118 has a length of between about 50 cm
and about 250 cm, more preferably a length of about 125 cm and
about 175 cm. The diameter of either delivery wire 116 or 118 may
be constant or may vary along the length of the respective delivery
wire 116 or 118. For example, the diameter of one guide member
toward the proximal end away from the user may be between about 0.2
mm and about 1 mm, and preferably about 0.3 mm and about 0.4 mm,
while the diameter near the distal end near the clot may be between
about 0.05 mm and about 1 mm, and more preferably about 0.1 mm and
about 0.2 mm. Accordingly, the diameter of either guide member 116,
118 may taper from the proximal end to the distal end.
[0053] Referring to FIG. 4, some embodiments of a clot encasement
device may comprise a proximal capture member coupled to a hollow
proximal delivery wire, a central stabilizer coupled to a central
delivery wire and a distal capture member coupled to a distal
delivery wire. The central and distal delivery wires are distinct
wires which allow independent control of the respective central
stabilizer and distal capture member. At least a portion of the
central and distal delivery wires reside within the hollow proximal
delivery wire, and are controlled by manipulation through the
interior of the hollow proximal delivery wire. Each of the
proximal, central, and distal delivery wires may comprise at least
one radiopaque marker. The radiopaque marker enables visualization
of the respective delivery wire to which the marker is coupled. The
proximal, central, and distal delivery wires may be independently
controlled for independent manipulation of the respective proximal
capture member, central stabilizer, and distal capture member.
[0054] Although the embodiments of the present disclosure and their
advantages have been described in detail, it should be understood
that various changes, substitutions and alterations can be made
herein without departing from the spirit and scope of the invention
as defined by the appended claims. Moreover, the scope of the
present application is not intended to be limited to the particular
embodiments of the process, machine, manufacture, composition of
matter, means, methods and steps described in the specification. As
one of ordinary skill in the art will readily appreciate from the
present disclosure, processes, machines, manufacture, compositions
of matter, means, methods, or steps, presently existing or later to
be developed that perform substantially the same function or
achieve substantially the same result as the corresponding
embodiments described herein may be utilized according to the
present disclosure. Accordingly, the appended claims are intended
to include within their scope such processes, machines,
manufacture, compositions of matter, means, methods, or steps.
* * * * *