U.S. patent application number 16/147884 was filed with the patent office on 2019-01-31 for devices and methods for vascular recanalization.
The applicant listed for this patent is Covidien LP. Invention is credited to Maria Aboytes.
Application Number | 20190030305 16/147884 |
Document ID | / |
Family ID | 44507188 |
Filed Date | 2019-01-31 |
View All Diagrams
United States Patent
Application |
20190030305 |
Kind Code |
A1 |
Aboytes; Maria |
January 31, 2019 |
Devices and Methods for Vascular Recanalization
Abstract
In some embodiments, a medical device for recanalizing a vessel
having a blockage and restoring blood flow through an obstructed
blood vessel includes an expandable member coupled to a core wire
and a hypotube that are movable relative to each other to
manipulate the expandable member between various configurations.
The expandable member having a capture structure in an expanded
configuration. The expandable member can include multiple
interstices formed by woven mesh filaments or braided strands
through which the material blocking the vessel can pass. The
capture structure can include a shape on its external surface that
facilitates dislodgement and capture of the material within capture
spaces created by the expandable member. Some embodiments include a
capture sack or cap for capturing material and preventing material
from migrating downstream of the blockage. Superoxygenated blood
can be infused distal to the blockage to minimize loss of function
during an ischemic event.
Inventors: |
Aboytes; Maria; (Palo Alto,
CA) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Covidien LP |
Mansfield |
MA |
US |
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Family ID: |
44507188 |
Appl. No.: |
16/147884 |
Filed: |
October 1, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14692453 |
Apr 21, 2015 |
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16147884 |
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14666054 |
Mar 23, 2015 |
9931495 |
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14692453 |
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13033100 |
Feb 23, 2011 |
9211396 |
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14666054 |
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61306951 |
Feb 23, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/22038
20130101; A61F 2230/0076 20130101; A61B 2017/00867 20130101; A61F
2002/018 20130101; A61B 2017/00778 20130101; A61B 17/221 20130101;
A61M 25/10 20130101; A61M 29/02 20130101; A61M 2025/109 20130101;
A61F 2230/0067 20130101; A61B 2017/22054 20130101; A61B 2017/22055
20130101; A61B 2017/2215 20130101; A61B 2017/2212 20130101; A61F
2230/0069 20130101; A61F 2/013 20130101; A61M 25/0074 20130101;
A61B 17/22 20130101; A61M 2025/0681 20130101; A61M 2025/0004
20130101; A61F 2230/008 20130101; A61F 2230/0006 20130101 |
International
Class: |
A61M 29/02 20060101
A61M029/02; A61B 17/221 20060101 A61B017/221; A61B 17/22 20060101
A61B017/22; A61F 2/01 20060101 A61F002/01 |
Claims
1. A method of treating ischemic stroke comprising: delivering a
recanalization device to a neurovascular embolism that at least
partially restricts blood flow through a blood vessel, the
recanalization device including a tubular member, an elongate
member movably disposed within the tubular member, and an
expandable member constrained at a distal end to the elongate
member and at a proximal end to the tubular member; actuating the
recanalization device so that the expandable member expands
radially outward in a controlled manner from a collapsed
configuration to an expanded configuration to engage at least a
portion of the neurovascular embolism and so as to provide
controlled blood flow reperfusion through the embolism and
treatment of ischemic stroke, wherein the expandable member defines
a plurality of openings in a wall of the expandable member and an
interior region in fluid communication with the plurality of
openings so that at least a portion of the neurovascular embolism
enters through at least one opening and into the interior region as
the expandable member engages the neurovascular embolism; moving
the recanalization device and at least a portion of the
neurovascular embolism along the blood vessel; and withdrawing the
recanalization device and at least a portion of the neurovascular
embolism from the blood vessel.
2. The method of claim 1, wherein the expandable member comprises a
braid or mesh formed from a shape memory material, and wherein the
expandable member has a biased predetermined shape in the expanded
configuration.
3. The method of claim 2, wherein actuating the recanalization
device in a controlled manner comprises applying a controlled
radial force with the mesh or braid of the expandable member to
expand through the neurovascular embolism and masticate or disrupt
the neurovascular embolism.
4. The method of claim 1, wherein actuating the recanalization
device comprises retracting the elongate member proximally relative
to the tubular member so as to laterally compress the neurovascular
embolism against a wall of the blood vessel along a length of the
expandable member.
5. The method of claim 1, wherein actuating the recanalization
device comprises axially adjusting a relative position of the
tubular member constraining the expandable member at a proximal end
or the elongate member constraining the expandable member at a
distal end relative to one another so as to laterally compress the
neurovascular embolism against a wall of the blood vessel along a
length of the expandable member.
6. The method of claim 1, further comprising infusing an oxygenated
or superoxygenated blood through a lumen of the elongate member and
into the blood vessel distal to the neurovascular embolism.
7. The method of claim 1, further comprising accessing an arterial
blood vessel by advancing a microcatheter into the arterial blood
vessel and through the embolism and then inserting the
recanalization device through a lumen of the delivery catheter and
out of a distal end thereof to a position the expandable member
adjacent to or within the embolism.
8. The method of claim 1, further comprising actuating the
recanalization device to move the expandable member from the
expanded configuration to a contoured, tortuous, or helical
configuration to disrupt and capture at least a second portion of
the neurovascular embolism with the expandable member.
9. The method of claim 8, wherein actuating the recanalization
device from the expanded configuration to the contoured, tortuous,
or helical configuration comprises rotating the elongate member
relative to the tubular member, rotating the tubular member
relative to the elongate member, or rotating both the tubular
member and the elongate member in opposite directions relative to
each other.
10. A method of treating a thrombus in a circulatory blood vessel,
the method comprising; delivering a clot treatment device to a
thrombus that at least partially restricts blood flow through a
blood vessel, the clot treatment device including a tubular member,
an elongate member movably disposed within the tubular member, and
an expandable member coupled at a distal end to a distal portion of
the elongate member and at a proximal end to a distal portion of
the tubular member; actuating the clot treatment device so that the
expandable member expands radially outward in a controlled manner
from a collapsed configuration to a first expanded configuration to
engage at least a portion of the thrombus so as to restore blood
flow through the thrombus; actuating the clot treatment device so
that the expandable member moves from the first expanded
configuration to a second expanded configuration after laterally
compressing the thrombus against a wall of the blood vessel along a
length of the expandable member so as to restore blood flow; and
retrieving and removing at least a portion of the thrombus with the
expandable member in the second expanded configuration.
11. The method of claim 10, wherein actuating the clot treatment
device from the collapsed configuration to the first expanded
configuration comprises axially adjusting a relative position of
the tubular member or the elongate member relative to one another
so as to laterally compress the thrombus against a wall of the
blood vessel along the length of the expandable member.
12. The method of claim 10, wherein actuating the clot treatment
device from the first expanded configuration to the second expanded
configuration comprises rotating the elongate member relative to
the tubular member, rotating the tubular member relative to the
elongate member, or rotating both the tubular member and the
elongate member in opposite directions relative to each other so
that the expandable member is twisted into the second expanded
configuration having variable radial dimensions along the length of
the expandable member.
13. The method of claim 10, wherein the expandable member comprises
a braid or mesh formed from a shape memory material, and wherein
the expandable member has a first biased predetermined shape in the
first expanded configuration and a second biased predetermined
shape in the second expanded configuration.
14. The method of claim 10, wherein the braid or mesh comprises
sections including wires or filaments of two or more thicknesses,
wherein first sections have relatively thinner wires or filaments
having a greater density than second sections having relatively
thicker wires or filaments, such that moving the expandable member
from the first expanded configuration to the second expanded
configuration causes the expandable member to form a contoured,
tortuous, or helical shape in the second expanded configuration due
to a variation in density between the first and second sections of
the braid or mesh.
15. The method of claim 10, wherein the expandable member comprises
interstices in a wall of the expandable member and an interior
volume in fluid communication with the interstices, and further
wherein expanding the expandable member radially outward in a
controlled manner from the collapsed configuration to the first
expanded configuration captures at least a portion of the thrombus
within the interior volume via at least one interstice.
16. The method of claim 10, wherein the expandable member in the
second expanded configuration defines a plurality of annular
capture regions along an exterior surface of the expandable member,
further comprising disrupting at least a portion of the thrombus
with the expandable member in the second expanded configuration and
capturing at least a portion of the thrombus within at least one
annular capture region.
17. A method of treating a neurovascular embolism comprising:
delivering a recanalization device to a neurovascular embolism that
at least partially restricts blood flow through a blood vessel, the
recanalization device including a tubular member, an elongate
member movably disposed within the tubular member, and an
expandable member constrained at a distal end to the elongate
member and at a proximal end to the tubular member; deploying the
expandable member from a collapsed configuration to a first
expanded configuration in a controlled manner to engage at least a
portion of the neurovascular embolism and so as to provide
controlled blood flow reperfusion through the embolism; rotating
the elongate member along a longitudinal axis of the recanalization
device to twist the expandable member from the first expanded
configuration to a second expanded configuration, thereby forming a
plurality of annular capture regions along an exterior surface of
the expandable member; dislodging at least a portion of the
neurovascular embolism with the expandable member in the second
expanded configuration; capturing at least a portion of the
thrombus within at least one annular capture region; and
withdrawing the recanalization device and at least a portion of the
neurovascular embolism from the blood vessel.
18. The method of claim 17, wherein the expandable member in the
second expanded configuration includes a first portion having a
first outer perimeter, a second portion having a second outer
perimeter, and a third portion having a third outer perimeter,
wherein the second portion is disposed between the first and third
portions, and wherein the second outer perimeter is smaller than
both the first outer perimeter and the third outer perimeter such
that the expandable member defines the at least one annular capture
region between the first portion and the third portion of the
expandable member.
19. The method of claim 18, wherein the expandable member of the
recanalization device comprises a continuous mesh or braid and the
first portion, the second portion, and the third portion are
integrally formed of the mesh or braid.
20. The method of claim 17, wherein delivering the recanalization
device further comprises positioning openings in a wall of the
expandable member and the plurality of annular capture regions of
the expandable member within an axial treatment region of the
neurovascular embolism.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/692,453, filed Apr. 21, 2015, which is a
continuation of U.S. patent application Ser. No. 14/666,054, filed
Mar. 23, 2015, now issued as U.S. Pat. No. 9,931,495, which is a
continuation of U.S. patent application Ser. No. 13/033,100, filed
Feb. 23, 2011, now issued as U.S. Pat. No. 9,211,396, which claims
priority to and the benefit of U.S. Provisional Application No.
61/306,951, filed Feb. 23, 2010, the disclosure of each of which is
incorporated herein by reference in its entirety for all
purposes.
BACKGROUND
[0002] The invention relates generally to medical devices and more
particularly to expandable medical devices and methods for
increasing blood flow through an obstructed blood vessel.
[0003] Some known medical devices used for increasing blood flow
through an obstructed blood vessel include a filter trap designed
and built to trap emboli. Such filters tend to be cumbersome and
difficult to deploy. In addition, in some such devices, if the
device is not properly seated in the vessel, the device can drift
within the vessel. Some such devices are generally designed to
catch emboli greater than a particular size (limited by the
aperture size of the device walls), and are therefore not effective
for removing smaller embolic particles.
[0004] In one known filter device, a basket is carried on a
mandrel, which can be deployed and retracted through a catheter. In
another known device, a vascular filter is collapsible, and
includes a radially expandable body and proximal and distal sliders
on a mandrel. The medical device can be used to filter fluid, but
has the disadvantage of independent proximal and distal motion
control, making it difficult to coordinate precisely and
predictably a desired movement. Even if the filter trap effectively
captures dislodged material within a vessel, retracting the filter
trap into the catheter through which it was delivered can be
difficult. Some known devices use vascular suction to suction or
pull blood and clots out of the vessel.
[0005] Currently, few FDA-approved treatment options exist for an
acute ischemic stroke. One option is an intravenous (IV) delivery
of Tissue Plasminogen Activator (t-PA) (Activase), which is a
thrombolytic agent. The agent is designed to dissolve the blood
clot that is blocking blood flow to the brain. IV t-PA is currently
limited in use because it must be used within a three hour window
from the onset of a stroke and can result in an increased risk of
bleeding. The second option is a thromboembolectomy device. The
device is designed to capture an embolus or clot and remove it from
the blocked vessel, thereby restoring blood flow. The device
includes a cork-screwed guidewire, but is only able to capture and
remove matter that is firm or held together by itself. In most
cases, the device is used in combination with drug therapy to
restore blood flow. A typical procedure using the device can take
2-3 hours to restore blood flow, if at all, and may take multiple
passes through the vessel to either capture, macerate or open the
vessel. In some cases, the device may capture an embolus, but then
lose grasp of it and deposit it incidentally in another area of the
neurovasculature, creating the potential for a new stroke in a new
territory. In some cases, complications such as vessel dissection,
perforation and hemorrhage arise as a result of over-manipulation
in the vessel.
[0006] Thus, there is a need for improved systems, devices and
methods for increasing blood flow through a blood vessel as
described herein.
SUMMARY OF THE INVENTION
[0007] Devices and methods for increasing blood flow through a
blood vessel are described herein. In one embodiment, an apparatus
includes an elongate member and an expandable member coupled to a
distal portion of the elongate member. The expandable member is
configured to be inserted into a blood vessel and defines multiple
openings in a wall of the expandable member. The expandable member
has a collapsed configuration for insertion into the blood vessel
and an expanded configuration in which the expandable member
defines an interior volume in fluid communication with the multiple
openings and is configured to receive therein at least a first
portion of a bodily tissue. The expandable member includes a first
portion having a first outer perimeter, a second portion having a
second outer perimeter and a third portion having a third outer
perimeter. The second outer perimeter is smaller than the first
outer perimeter and smaller than the third outer perimeter such
that the expandable member defines a capture region between the
first portion and the third portion configured to receive at least
a second portion of the bodily tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is a schematic illustration of a medical device,
according to an embodiment.
[0009] FIG. 2A is a side view of a medical device, according to an
embodiment, shown disposed within a blood vessel and in a partially
expanded configuration.
[0010] FIG. 2B is a side view of the medical device of FIG. 2A,
shown in a first expanded configuration within a blood vessel.
[0011] FIG. 2C is a side view of the medical device of FIG. 2A,
shown in a second expanded configuration within a blood vessel.
[0012] FIG. 2D is a cross-sectional view of a portion of the
medical device of FIG. 2A, taken along line 2D-2D in FIG. 2A.
[0013] FIG. 3 is a side view of a medical device, according to an
embodiment, shown in a contoured, expanded configuration.
[0014] FIG. 4A is a side view of a medical device, according to an
embodiment, shown in a collapsed configuration disposed within a
catheter.
[0015] FIG. 4B is a side view of a portion of the medical device of
FIG. 4A shown in an expanded configuration.
[0016] FIG. 5 is a side view of a portion of a medical device,
according to another embodiment, shown in an expanded
configuration.
[0017] FIG. 6 is a side view of a portion of an expandable medical
device, according to another embodiment, shown in an expanded
configuration.
[0018] FIG. 7 is a side view of a portion of a medical device,
according to another embodiment, shown in an expanded
configuration.
[0019] FIG. 8 is a side view of a portion of a medical device,
according to another embodiment, shown in an expanded
configuration.
[0020] FIG. 9 is a side view of a portion of a medical device,
according to another embodiment, shown in an expanded
configuration.
[0021] FIG. 10A is a side view of a portion of a medical device,
according to another embodiment, shown in a collapsed
configuration.
[0022] FIG. 10B is a side view of a portion of the medical device
of FIG. 10A shown in an expanded and contoured configuration.
[0023] FIG. 11A is a side view of a medical device according to
another embodiment, shown in an expanded configuration.
[0024] FIG. 11B is a side view of the medical device of FIG. 11A
shown in a partially expanded configuration and disposed within a
blood vessel.
[0025] FIG. 11C is a side view of the medical device of FIG. 11A
shown in an expanded configuration and disposed within a blood
vessel.
[0026] FIG. 11D is a side view of the medical device of FIG. 11A
shown in an expanded and contoured configuration and disposed
within a blood vessel.
[0027] FIG. 12A is a side view of a medical device according to
another embodiment, shown in an expanded configuration.
[0028] FIG. 12B is a side view of the medical device of FIG. 12A,
shown in an expanded and contoured configuration.
[0029] FIG. 13A is a side view of a medical device according to
another embodiment, shown in an expanded configuration.
[0030] FIG. 13B is a side view of the medical device of FIG. 13A,
shown partially collapsed within a delivery catheter.
[0031] FIG. 14A is a side view of a medical device according to
another embodiment, shown in a collapsed configuration and being
inserted into a blood vessel.
[0032] FIG. 14B is a side view of the medical device of FIG. 14A,
shown in an expanded configuration disposed within a blood vessel
adjacent a blockage.
[0033] FIG. 14C is a side view of the medical device of FIG. 14A,
shown in a collapsed configuration disposed within a blood
vessel.
[0034] FIG. ISA is a side view of a medical device according to
another embodiment, shown in an expanded configuration.
[0035] FIG. 15B is a side view of the medical device of FIG. 15A,
shown in a partially expanded configuration disposed within a blood
vessel adjacent a blockage.
[0036] FIG. 15C is a side view of the medical device of FIG. 15A,
shown in an expanded configuration disposed within a blood vessel
adjacent a blockage.
[0037] FIG. 16 is a side view of a medical device according to
another embodiment, shown in an expanded configuration.
[0038] FIG. 17 is a side view of a medical device according to
another embodiment, shown in an expanded configuration.
[0039] FIG. 18 is a side view of a medical device according to
another embodiment, shown in an expanded configuration.
[0040] FIG. 19 is a flowchart illustrating a method of using a
medical device for a recanalization procedure.
DETAILED DESCRIPTION
[0041] Medical devices and methods of treatment are described
herein to treat patients experiencing a blockage in a circulatory
blood vessel and the effects of that event, including ischemic
stroke and/or heart attack. In some embodiments, a delivery
apparatus, such as for example, a delivery catheter, is included
for delivering a medical device to a treatment site within a
patient. The medical devices and methods of treatment described
herein can reduce ischemic events while recanalizing a vessel. In
some embodiments, methods for retrieving and removing an
obstruction responsible for a blockage before the vessel is
re-opened are described and, in some cases, providing oxygenated
blood or superoxygenated blood distal of the blockage while the
obstruction is being cleared.
[0042] Various embodiments of a vascular recanalization device for
recanalizing a blocked vessel are described herein. The vascular
recanalization device (also referred to herein as "recanalization
device" or "medical device") can include an elongate member having
a hypotube and a core wire movably disposed therethrough, and an
expandable member formed with, for example, woven or braided
filaments in a mesh-like configuration. The terms mesh and braid
can each refer herein to a fabric or material of woven or braided
filaments or strands of wire or polymer. The expandable member of
the recanalization device can be configured to compress or collapse
for delivery into a blood vessel. In some embodiments, the
recanalization device can be inserted while in a collapsed
configuration through a delivery device, such as, for example, a
microcatheter, delivery tube or sheath. In some embodiments, the
recanalization device can be deployed without the use of such a
delivery device.
[0043] The expandable member of the recanalization device can have
a collapsed or compressed configuration such that the expandable
member has a diameter that can fit within the narrow constraints of
the neurovasculature and/or within a lumen of a delivery catheter.
The expandable member of the recanalization device can be formed
with, for example, an arrangement of strands (e.g., a mesh or braid
arrangement of strands or filaments) that can compress and expand.
The expandable member can be compressed over and/or along the
elongate core wire of the recanalization device.
[0044] In some embodiments, a recanalization device includes a core
wire movably disposed within a lumen of a hypotube. A distal
portion of an expandable member (e.g., having mesh or braid) is
attached to the core wire, and a proximal portion of the expandable
member is attached to the hypotube. The expandable member can be
moved from a collapsed configuration to an expanded configuration
while disposed within a blood vessel. Control of the expansion of
the expandable member can be achieved by axial adjustment of the
relative positions of the hypotube and core wire, and by moving the
hypotube or core wire relative to one another radially as described
in more detail herein. When the expandable member expands, it can
assume a structure that defines an interior volume through which
the core wire extends. When disposed within a vasculature, as the
expandable member expands, the expanded portion of the expandable
member can exert a radial force such that the expanded portion can
displace material in the vasculature or at the vascular wall.
[0045] While expanded, the expandable member can also be configured
to be moved or contorted to alter the contour of its external
surface. In some embodiments, contortion of the expanded expandable
member can be actuated by twisting or rotating the hypotube and
core wire in opposite directions (radial motion) to one another, or
either the hypotube or the core wire can be twisted or rotated
relative to the other while the other is maintained substantially
stationary. The changed contour of the expandable member can
include, for example, helical shelves that spiral along a length of
the core wire. The spiral shelves can have spiral edges that can be
used to carve, cut, shear or otherwise disrupt material in the
vasculature to dislodge and capture the material. Compression of
the expandable member can be actuated by opposite manipulations as
described for the expansion process. In some embodiments, the
contoured form of the expandable member can define capture spaces
or regions. In some embodiments, capture spaces or regions can be
pre-formed on an external surface of the expandable member. For
example, in some embodiments, the expandable member can be formed
with filaments of superelastic or shape memory material (such as,
e.g., nitinol alloy) and the braid or mesh can be set in a
predefined shape prior to attaching the expandable member to the
elongate member of the recanalization device. In such an
embodiment, when the expandable member expands, it assumes a biased
predetermined shape.
[0046] The recanalization devices described herein can include one
or more expandable members formed with a woven mesh or braid that
has variably sized apertures that allow various sized portions or
pieces of material (e.g., bodily tissue) to pass through the braid
wall and to rest within an interior volume defined by the
expandable member when expanded. In some embodiments, an expandable
member can be a fabric of mesh or braid formed with wires having
different diameters.
[0047] In some embodiments, an expandable member can have sections
of mesh or braid having variation in density of the filaments and
may include bands of dense filaments spaced by bands that are less
dense. The less dense braid portion can have larger openings in the
braid to capture dislodged material from a blockage. Material
(e.g., bodily tissue such as a portion of a blood clot) can be
encouraged to enter interstices of the mesh of the expandable
member and when the expandable member is compressed or collapsed it
can carry out dislodged material from the patient's body. The
sections of the expandable member having larger openings (e.g.,
less dense sections) can also provide openings for larger pieces of
material to pass into the expandable member. Thus, the expandable
member (also referred to herein as "capture sack" or "capture bag")
can capture material from a blocked vessel by encouraging the
material to enter an interior region within the expandable member.
The less dense sections can also direct the final shape of the
expandable member. For example, sections of less dense (more open)
mesh or braid can direct the effects of twisting so the less dense
areas of braid contract with the twisting, and the more dense areas
of braid form the helical shelves of a spiral shape. In some
embodiments, material can also be captured within external folds
formed on the exterior contour of the expanded member as described
in more detail herein.
[0048] A recanalization device described herein can include an
expandable member coupled at a proximal end to a tubular member,
such as a hypotube, and at a distal end to an elongate member (also
referred to herein as a "core wire") that can be movably disposed
within a lumen of the tubular member. In some embodiments, the
expandable member can include an increasing radial expansion and
radial force on the proximal end of the expandable member where it
is coupled to the hypotube. To move the expandable member from a
first configuration to a second configuration, the hypotube can be
pushed and the elongate member pulled to create axial shortening
and radial expansion. Other manipulations by the practitioner using
a controller or actuator disposed at a proximal end of the
expandable medical device (usually external of the body of the
patient) are also possible.
[0049] In some embodiments, a recanalization device can be
delivered to a desired treatment site within a vasculature by
inserting the expandable medical device through a lumen of a
delivery catheter (e.g., a microcatheter). The expandable medical
device can be inserted through the delivery catheter in a collapsed
or compressed configuration. The expandable member of the
expandable medical device can be moved out through a distal end of
the delivery catheter at the treatment site (e.g., adjacent to or
within a blood clot) and moved to an expanded configuration. In
some embodiments, the delivery catheter is used to compress or
collapse the expandable member. For example, the expandable member
can be formed with a biased expanded configuration and when it is
placed within a lumen of a catheter it is compressed. When the
expandable member is moved outside of the catheter, it can assume
its biased expanded configuration.
[0050] In some embodiments, a recanalization device can be used
without a delivery catheter. For example, in some embodiments, a
recanalization device can include an elongate member or wire having
an integral expandable section that can be controlled by the
proximal end of the wire. For example, the wire can be pushed
relative to the tubular member to compress the expandable section
and pulled to expand it. A control unit at the proximal end of the
medical device can be used to push the elongate member to maintain
closure and compress the mesh or braid, and to pull the elongate
member to expand the mesh or braid once the unit is at the
blockage. In addition, the elongate member can be rotated such that
the expandable member is rotated at the blockage and provides
abrasion for scraping or loosening blockage material. Because the
expandable member is easily manipulated between configurations from
a location outside the body, the expandable member can be actuated
between various configurations without a microcatheter. In such an
embodiment, the expandable member and elongate member can have a
greater outer diameter (i.e. denser braid, or thicker filaments) if
desired.
[0051] In some embodiments, a recanalization device can include a
first expandable member formed with mesh or braid and defining an
interior region when moved to an expanded configuration, and a
second expandable member that can have a substantially parabolic
shape configured to capture vascular material as the expandable
medical device is pulled through the vessel. The second expandable
member can also be referred to herein as a "cap" or "catch basket."
In some embodiments, the second expandable medical can be disposed
distal of the first expandable member and can be used to capture
dislodged material flowing downstream of the first expandable
member. In some embodiments, the second expandable medical can be
disposed proximal of the first expandable member and can be used to
capture dislodged material moving upstream of the first expandable
member.
[0052] In some embodiments, the second expandable member can be
formed integrally or monolithically with the first expandable
member and include, for example, wires or threads connecting the
second expandable member to the first expandable member at a
non-zero or spaced distance from the first expandable member. In
some embodiments, the second expandable member can be woven or
braided using the same filaments that form the first expandable
member. To create a separation or opening between the cap and the
body, the filaments from the weave or braid of the second
expandable member (e.g., cap) are condensed (i.e., tied off) in one
or more bundles that serve as legs separating the two expandable
members, and the filaments can be organized in a continuation of a
weaving pattern to form the first expandable member. In some
embodiments, movement of the second expandable member (e.g., cap)
between a closed or collapsed configuration and an expanded or open
configuration can be controlled with wires that lead from the
second expandable member to a distal end of the device.
[0053] In some embodiments, the capture cap or basket can be formed
on the bias of woven mesh or braid so that the capture cap closes
and removes into the catheter more easily. For example, a cinch tie
along the bias (slant) of the braid can be less bulky for reentry
into the microcatheter and the braid ends can be more responsive to
the action of cinching on the bias of the woven filaments. Such an
embodiment is described in more detail herein. In some embodiments,
a core wire can be coupled to the capture cap and used to hold and
control the opening and closure of the capture cap.
[0054] In some embodiments, an expandable medical device includes
an elongate member that defines a longitudinal axis and an
expandable member is coupled to a distal portion of the elongate
member. The expandable member is configured to be inserted into a
blood vessel and defines multiple openings in a wall of the
expandable member. The expandable member defines a proximal opening
larger than the multiple openings in the wall of the expandable
member. The proximal opening is defined at an angle transverse to
the longitudinal axis of the elongate member. The expandable member
has a collapsed configuration for insertion into the blood vessel
and an expanded configuration. When in the expanded configuration,
the expandable member defines an interior volume in fluid
communication with the multiple openings. The expandable member
when in the expanded configuration is configured to capture
portions of a bodily tissue within the interior region of the
expandable member and to prevent portions of the bodily tissue from
migrating within the blood vessel past the expandable member. The
expandable member is configured to be moved to the collapsed
configuration while disposed within the blood vessel such that the
proximal opening is at least partially closed and the captured
portions of the bodily tissue are trapped within the interior
region.
[0055] In one method of using a vascular recanalization device,
super-oxygenated blood or oxygenated blood can be perfused distal
of a blockage within a vasculature to reduce or eliminate ischemia
during the procedure by providing the region cut off by blood
supply fresh oxygenated blood to keep the tissue alive.
[0056] Methods of unblocking a vessel, removing a clot, and
treating patients having blockages are described herein. In some
embodiments, a method of restoring blood flow in a blocked vessel
can include inserting an expandable member of a recanalization
device within a lumen of a delivery sheath or catheter such that
the expandable member is compressed or collapsed. A distal end
portion of the sheath can be positioned at a desired treatment
site, for example, near a blockage (e.g., blood clot) in a blocked
vessel. The sheath can be moved proximally or the expandable
medical device can be moved distally, such that the expandable
member is moved outside a distal end of the sheath, thereby
releasing the restraint on the expandable member and allowing it to
move to an expanded configuration. As the expandable member moves
to the expanded configuration, the expandable member can contact
material in the blockage. In some embodiments, as the expandable
member expands and contacts the material in the blockage, it
mechanically induces a shape change in the expandable member to
optimize contact with the material and effect displacement of
material forming the blockage.
[0057] In some embodiments, a method can further include capturing
material dislodged from the blockage; removing the captured
material; and perfusing a region distal of the blockage with
oxygenated blood during the blood flow restoration procedure. In
some embodiments, the expandable member is in the form of a braided
tube that includes fibers of a super elastic shape memory alloy, or
polymeric fibers. In some embodiments, the expandable member can
effect a shape deformation inducing a helical contour along a
longitudinal axis of the expandable member. In some embodiments,
the shape deformation can include inducing radial expansion and
axial shortening. In some embodiments, a distal end of the
expandable member can be attached to a guidewire and a proximal end
of the expandable member can be attached to a hypotube through
which the guidewire passes and inducing a shape change can be
accomplished by rotating the guidewire and/or the hypotube radially
in opposite directions.
[0058] In some embodiments, a recanalization device can include an
expandable member (e.g., a braided or mesh component) attached at a
distal end to a guide wire and at a proximal end to a hypotube
through which the guide wire passes. The expandable member can be
adapted to plastically deform for compression when disposed within
a lumen of a catheter for delivery, and to expand upon removal of
the catheter. The expanded expandable member can be capable of
changing shape by mechanical manipulation of the guide wire and/or
the hypotube. In some embodiments, the expandable member can
include a variable density braid, and be closed at a distal end and
open at a proximal end such that material (e.g., bodily tissue) can
be collected therethrough. In some embodiments, the expandable
member can have two layers of braid and can have a changed shape
adapted to capture material. In some embodiments, the changed shape
can include radial expansion or axial shortening or both. In some
embodiments, the expandable member can have interstices adapted to
capture material. In some embodiments, the filaments forming the
expandable member can include, for example, super elastic metal
alloy, polymeric fiber, and/or drawn filled tube (DFT) radiopaque
wire. In some embodiments, the expandable member can have a changed
shape that includes a helical contour on an outside surface of the
expandable member. In some embodiments, the expandable member can
include interwoven polymeric fibers and super elastic alloy
wire.
[0059] In some embodiments, a recanalization device can include a
capture cap at a distal end of the device that can have braided
fibers clipped on a bias at the proximal opening of the cap forming
an elliptical shape at the opening. The cap can thereby be adapted
for cinching closed at the elliptical opening. Such a medical
device can have a reduced diameter upon radial compression compared
to a device made by clipping the braided fibers of the capture cap
on a radial axis forming a circular opening.
[0060] In some embodiments, a recanalization device as described
herein can be used for delivering oxygenated blood to a region in
the brain during a procedure to remove a blockage in a vessel. A
method of recanalization of a blocked vessel can include, for
example, positioning an expandable mesh member affixed at a distal
end to a delivery wire at a site of a blockage in a vessel. The
expandable mesh member can be expanded at the blockage location.
The expandable mesh member can be moved to a contoured shape (while
expanded) by twisting the delivery wire counterclockwise or
clockwise. Material from the blockage can be captured within
contour variations of the outer mesh surface.
[0061] In some embodiments, a method of recanalization of a blocked
vessel includes positioning a tubular-shaped expandable mesh member
affixed at a distal end to a delivery wire at a site of blockage in
a vessel. The expandable mesh member can have a predefined variable
contour on an outer surface and a distal mesh capture bag. The
distal mesh capture bag can include a cinch on a diagonal wire of
the mesh. The expandable mesh member and the distal mesh capture
bag can be expanded such that material from the blockage that flows
distal of the expandable mesh member can be captured within the
capture bag. The capture bag can be compressed or closed by
cinching the bag, and the expandable mesh member and the capture
bag can be removed from the vessel.
[0062] The recanalization devices described herein can be used to
unblock vessels to allow the resumption of blood flow during
events, such as, for example, ischemic stroke. In some embodiments,
wire or polymer filaments can be used to form a woven mesh or
braided strands that can be expandable, and have apertures sized to
capture material disrupted by expansion of the device at a blockage
site (e.g., a blood clot). The recanalization devices can be
configured for axial compression and radial expansion. The
expandable member of the recanalization device can be configured to
have sufficient radial force to expand through material blocking
the vessel and masticate or disrupt the material with the wires of
the mesh or braid. The expandable member when expanded includes a
capture structure that defines an interior region. The capture
structure includes interstices in the mesh or braid through which
the material from the blockage can pass and be retained within the
interior region of the expanded expandable member. The expandable
member can also include an external contour for capturing material
in capture spaces or regions defined by the expanded expandable
member while disposed within the vessel. In some embodiments, the
recanalization device can also have a capture bag disposed distal
to the expandable member that can be used to catch pieces of
material that flow distally from the blockage. In some embodiments,
the recanalization device can include a capture bag disposed
proximally to the expandable member. The recanalization device can
be retrievable and can remove material captured within the
expandable member when it is compressed or collapsed for removal
from the vessel. The recanalization device can be used with or
without a microcatheter or sheath for delivery of the
recanalization device to a treatment site within a vessel.
[0063] In some embodiments, a recanalization device can include a
mesh expandable member coupled to an elongate member that includes
a hypotube and a core wire movable disposed within a lumen of the
hypotube. The expandable member can have a distal attachment to the
core wire, and a proximal attachment to the hypotube. The
expandable member can be delivered to a treatment site within a
vessel by being passed through a lumen of a delivery catheter or
sheath while in a compressed or collapsed configuration and moved
through the vessel-obstructing material. Upon withdrawal of the
catheter or sheath, the mesh expandable member expands to an open
or expanded configuration that is capable of contacting material
that forms the blockage. Further and more complete vessel clearance
can be achieved by rotating the hypotube and wire in opposite
directions (radially), which causes the expanded expandable member
to contract at distinct intervals. This creates pockets of capture
space on an external contour of the device. In some embodiments,
the region downstream of the blockage can be accessed with a
perfusion catheter or like device and perfused with oxygenated or
superoxygenated blood for the duration of the recanalization
procedure to reduce or avoid ischemic damage. Material from the
blockage can be captured within an interior region of the
expandable member through interstices of the mesh or braid of the
expandable member, or the material can be captured in the capture
spaces defined along the external contour of the expandable member.
Material captured within the capture spaces or within the interior
region of the expandable member, can be pulled back into the
catheter or sheath for removal from the patient.
[0064] It is noted that, as used in this written description and
the appended claims, the singular forms "a," "an" and "the" include
plural referents unless the context clearly dictates otherwise.
Thus, for example, the term "a lumen" is intended to mean a single
lumen or a combination of lumens. Furthermore, the words "proximal"
and "distal" refer to direction closer to and away from,
respectively, an operator (e.g., surgeon, physician, nurse,
technician, etc.) who would insert the medical device into the
patient, with the tip-end (i.e., distal end) of the device inserted
inside a patient's body. Thus, for example, the end inserted inside
a patient's body would be the distal end of the medical device,
while the end outside a patient's body would be the proximal end of
the medical device.
[0065] FIG. 1 is a schematic illustration of a vascular
recanalization device according to an embodiment. A vascular
recanalization device 100 (also referred to herein as
"recanalization device" or "medical device") can include a first
expandable member 126 and an optional second expandable member 128
each coupled to an actuation member 120. The actuation member 120
can include a tubular member 122 that defines a lumen and an
elongate member 124 movably disposed within the lumen of the
tubular member 122. The tubular member 122 can be, for example, a
hypotube, and the elongate member 124 can be, for example, a core
wire. The actuation member 120 can optionally be coupled on a
proximal end portion to a controller device 130, such as, for
example, a hand-held controller. The recanalization device 100 can
be used with a catheter or sheath 132 to, for example, deliver a
distal portion of the recanalization device 100 to a treatment site
within a vessel, as described in more detail herein.
[0066] The elongate member 124 can include a distal end portion
configured to be inserted into a vessel and passed through a
blockage (e.g., blood clot) at a target treatment site. In some
embodiments, the distal end portion has a blunt distal end such
that it does not damage the vessel when being inserted therein. In
some embodiments, the distal end portion of the elongate member 124
can be coiled. The controller device 130 can be used to actuate
movement of the elongate member 124 and/or the tubular member 122.
In some embodiments, the elongate member 124 and the tubular member
122 can be manually manipulated without the use of a controller
device 130. For example, a user (e.g., physician) can move or
maneuver the tubular member 122 and the elongate member 124 by
maneuvering a proximal end portion of the elongate member 124 and a
proximal end portion of the tubular member 122. For example, in
some embodiments, depending on the configuration, the elongate
member 124 is moved for and aft (e.g., longitudinally) relative to
the tubular member 122. In some embodiments, one or both of the
tubular member 122 and the elongate member 124 can be rotated.
[0067] In some embodiments, the elongate member 124 can define a
lumen extending between a proximal end portion and a distal end
portion. The lumen can be used to inject or perfuse an oxygenated
or superoxygenated blood into a blood vessel downstream of a
blockage. For example, the recanalization device 100 can be
inserted through a blockage such that a distal end of the elongate
member 122 extends beyond or distal of the blockage. Oxygenated or
superoxygenated blood can be injected into the blood vessel while
the blockage is being disrupted or cleared during a recanalization
procedure.
[0068] A distal portion of the first expandable member 126 can be
coupled to a distal portion of the elongate member 124, and a
proximal portion of the first expandable member 126 can be coupled
to a distal portion of the tubular member 122. The second
expandable member 128 can be coupled to the elongate member 124. In
some embodiments, the second expandable member 128 can also include
a cinch cord (not shown) extending from the second expandable
member 128 and outside of the patient that can be used to open and
close the second expandable member 128 as described in more detail
below.
[0069] The first expandable member 126 can be formed with a mesh or
braided material such that a wall of the first expandable member
126 defines multiple openings or interstices. The first expandable
member 126 can have a collapsed or compressed configuration and an
expanded configuration. When in the collapsed configuration, the
first expandable member 126 has a smaller outer perimeter or outer
diameter than when in the expanded configuration. The first
expandable member 126 when in the first expanded configuration
defines an interior region in fluid communication with the multiple
openings or interstices defined in the wall of the first expandable
member 126. In some embodiments, the first expandable member 126
can define more than one interior region or can include an interior
region having multiple chambers.
[0070] In some embodiments, the first expandable member 126 can be
formed with a shape-memory material, such as, for example, Nitinol,
and can be preformed to assume a desired shape. Thus, in such an
embodiment, the first expandable member 126 can be biased into an
expanded configuration and moved to a collapsed configuration by
restraining or compressing the first expandable member 126. In some
embodiments, the first expandable member 126 can be configured to
be mechanically actuated to move between a collapsed configuration
and an expanded configuration. For example, the controller device
130 can be configured to move or actuate the first expandable
member 126 between a collapsed configuration for insertion into a
body lumen and/or a catheter, and an expanded configuration for use
during a recanalization procedure.
[0071] The first expandable member 126 when in the expanded
configuration can have a variety of different shapes, sizes and
configurations. For example, in some embodiments, when the first
expandable member 126 can be substantially tubular shaped. In some
embodiments, the first expandable member 126 can have a
substantially constant outer diameter or outer perimeter along a
length of the first expandable member 126. In some embodiments, the
first expandable member 126 can include multiple portions having
varying outer perimeters or outer diameters. For example, in some
embodiments, the first expandable member 126 can include a first
portion having a first outer perimeter, a second portion having a
second outer perimeter and a third portion having a third outer
perimeter. In such an embodiment, the second outer perimeter can be
smaller than the first outer perimeter and smaller than the third
outer perimeter such that the first expandable member defines a
capture space or region between the first portion and the third
portion. A "capture region" as described herein can be a void,
space or region defined in part by the first expandable member 126
and in which a portion or portions of bodily tissue (e.g., a
portion of a blood clot) can be disposed, as described in more
detail below. The first expandable member 126 can be configured
with one or more capture regions. In some embodiments, the first
expandable member 126 can be preformed with a portion or portions
defining one or more capture regions. In some embodiments, the
first expandable member 126 can be moved to a configuration in
which the first expandable member 126 defines one or more capture
regions as described below.
[0072] In some embodiments, the first expandable member 126 can
have a compressed or collapsed configuration, a first expanded
configuration and a second expanded configuration. For example, the
first expandable member 126 can be inserted into a body lumen such
as a blood vessel while in the collapsed configuration and moved to
the first expanded configuration at a treatment site within the
body lumen. While in the first expanded configuration, the first
expandable member 126 can be moved to a second expanded
configuration in which the first expandable member 126 changes
shape. For example, the first expandable member 126 can be twisted
such that the first expandable member 126 has a contoured outer
exterior surface. In the second expanded configuration, the first
expandable member 126 can define one or more capture regions as
described herein.
[0073] The second expandable member 128 can be configured to the
same as, or similar to the first expandable member 126. For
example, the second expandable member 128 can be formed with a mesh
or braided material such that a wall of the second expandable
member 128 defines multiple openings or interstices. The second
expandable member 128 can have a collapsed or compressed
configuration and an expanded configuration. When in the collapsed
configuration, the second expandable member 128 has a smaller outer
perimeter or outer diameter than when in the expanded
configuration. The second expandable member 128 when in the
expanded configuration can define one or more interior regions in
fluid communication with the multiple openings or interstices
defined in the wall of the expandable member 128. The second
expandable member 126 can be formed with a shape memory material
such that it has a biased expanded configuration, or can be
configured to be actuated with, for example, the controller device
130, between its collapsed configuration and an expanded
configuration.
[0074] The second expandable member 128 can have a variety of
different shapes, sizes and configurations when in the expanded
configuration. The second expandable member can be the same as, or
similar to, the first expandable member 126. In some embodiments,
the second expandable member 128 can be formed such that when in
the expanded configuration the second expandable member 128 can
define a capture opening that is larger than the multiple openings
or interstices defined in the wall of the second expandable member
128. In some embodiments, the second expandable member 128 can form
a cup or parabolic shape. The capture opening can be opened or
closed with a cinch member, such as, a wire or cord coupled to the
second expandable member 128. In some embodiments, the capture
opening can be defined on a bias or angled relative to a
longitudinal axis of the recanalization device 100. In such an
embodiment, the angled capture opening can facilitate delivery and
withdrawal of the recanalization device 100 from a blood vessel due
to a reduced mass or bulk of the second expandable member 128. The
second expandable member 128 can be disposed proximal or distal to
the first expandable member 126. In some embodiments, the second
expandable member 128 can have a helical configuration when in the
expanded configuration. In some embodiments, the second expandable
member 128 can be substantially triangular shaped in a side
view.
[0075] In one example use of the recanalization device 100, a
catheter 132 can be inserted into a blood vessel and directed to a
desired treatment site near a blockage, such as, a blood clot. In
this example, the recanalization device 100 does not include a
second expandable member 128. The recanalization device 100 can be
inserted through the catheter 132 in a compressed or collapsed
configuration and moved outside through a distal end of the
catheter 132 such that the first expandable member 126 is
positioned within a portion of the blockage. As the first
expandable member 126 is moved outside of the catheter 132, it can
assume a biased expandable configuration or otherwise be actuated
to move to its expanded configuration such that the walls of the
first expandable member 126 contact at least a portion of the
blockage. The force of the first expandable member 126 contacting
the blockage can cause a portion or portions of the blockage to
pass through the openings in the wall of the first expandable
member 126 and be disposed within the interior region of the first
expandable member 126. The first expandable member 126 can
optionally be rotating while expanded and disposed within the
blockage such that further disruption of the blockage can occur and
additional portions of the blockage can enter the first expandable
member 126. In some embodiments, the first expandable member 126
can also optionally be moved to a contoured configuration while
expanded. For example, the elongate member 124 and/or the tubular
member 122 can be rotated such that the first expandable member is
twisted into a contoured (e.g., helical) shape. The twisted,
contoured shape can define capture regions in which portions of the
blockage can be disposed. When the process of breaking up or
disrupting the blockage is completed, the first expandable member
126 can be moved to its collapsed configuration by either pulling
the first expandable member 126 back into the distal end of the
catheter 132, or by actuating the first expandable member 126 to
move to its collapsed configuration depending on the particular
configuration of the first expandable member 126.
[0076] FIGS. 2A-2D illustrate another embodiment of a
recanalization device. A recanalization device 200 (also referred
to herein as "recanalization device" or "medical device") includes
an expandable member 226 coupled to an actuation member 220. The
actuation member 220 includes a tubular member 222 that defines a
lumen 223 (see e.g., FIG. 2D) between a proximal end and a distal
end of the tubular member 222, and an elongate member 224 movably
disposed within the lumen 223 of the tubular member 222. The
tubular member 222 can be, for example, a hypotube, and the
elongate member 124 can be, for example, a core wire. The actuation
member 220 can optionally be coupled on a proximal end portion to a
controller device (not shown), such as, for example, a hand-held
controller as described above. The recanalization device 200 can be
inserted through a lumen 233 (see e.g., FIG. 2D) of a catheter or
sheath 232, which will compress the expandable member 226 into a
collapsed or compressed configuration (not shown).
[0077] A proximal end portion of the expandable member 226 is
coupled to a distal end portion 225 of the tubular member 222 at
attachment 238, and a distal end portion of the expandable member
226 is coupled to a distal end portion 236 of the elongate member
224 at attachment 234. The expandable member 226 can be attached
with, for example, a clamp, clip, bonding, heat sealed, weld, or
other suitable coupling mechanism. The distal end portion 236 of
elongate member 224 is coiled and extends distally of the
expandable member 226 and can be used to penetrate through a
blockage B (e.g., a blood clot) within a blood vessel V.
[0078] As described above for the previous embodiment, the
expandable member 226 can be formed with a mesh or braided material
such that a wall of the expandable member 226 defines multiple
openings or interstices 235. The expandable member 226 can have a
collapsed or compressed configuration (not shown) and an expanded
configuration (see e.g., FIG. 2B). When in the collapsed
configuration, the first expandable member 226 has a smaller outer
perimeter or outer diameter than when in the expanded
configuration. When in the expanded configuration, the expandable
member 226 defines an interior region 240 (see e.g., FIG. 2B) in
fluid communication with the multiple openings 235. The expandable
member 226 can be formed with a shape-memory material such that it
is biased into its expanded configuration when not restrained as
shown in FIG. 2B and can be inserted into the lumen 233 of the
catheter 232 to move to its compressed configuration.
[0079] In use, the catheter 232 can be inserted through a blood
vessel V in a direction of the blood flow F and a distal end 237 of
the catheter 232 can be positioned near a blockage Bas shown in
FIG. 2A. The expandable member 226 can be moved out the distal end
237 of the catheter 232 by moving the actuation member 220 (i.e.,
the tubular member 222 and the elongate member 224) distally
through the blockage B where the expandable member 226 can begin to
assume its biased expanded configuration as shown in FIG. 2A. As
the expandable member 226 moves to its expanded configuration as
shown in FIG. 2B, the expandable member 226 can contact and exert a
force on the blockage B such that the blockage B is compressed and
portions of the blockage B are moved through the openings 235 of
the expandable member 226 and into the interior region 240 of the
expandable member 226.
[0080] As described above, the expandable member 226 can optionally
be rotated to further disrupt the blockage B. In addition, the
expandable member 226 can be moved to a contoured or tortuous shape
as shown in FIG. 2C. For example, the tubular member 222 and/or
elongate member 222 can be rotated relative to the other, or both
can be rotated in opposite directions such that expandable member
226 is twisted into a tortuous or helical configuration. As shown
in FIG. 2C, the expandable member 226 defines capture regions 242
that can received dislodged or disrupted portions P of blockage B.
When the disruption procedure is completed, the elongate member 224
can be pulled proximally such that the expandable member 226
partially collapses in a longitudinal direction (e.g., parallel
with an axis defined by the blood vessel V) and the portions P are
captured or trapped by the expandable member 226. The expandable
member 226 can then be pulled proximally (e.g., by pulling the
tubular member 222 and the elongate member 224) back into the lumen
233 of the catheter 232 with the trapped portions P of the blockage
B and the portions of the blockage B captured within the interior
region 240 of the expandable member 226.
[0081] FIG. 3 illustrates a variation of the recanalization device
200. A recanalization device 200' includes all the same features
and functions as described above for recanalization device 200. For
example, the recanalization device 200' includes an expandable
member 226' coupled to a tubular member 222' at attachment 238' and
coupled to an elongate member 224' at attachment 234'. The elongate
member 224' includes a distal end portion 236'. The recanalization
device 200' is shown in an expanded configuration and moved into a
contoured or tortuous shape as described above and shown in FIG.
2C. In this embodiment, the recanalization device 200' includes a
second expandable member 228 coupled to the distal end portion 236'
of the elongate member 224'.
[0082] The second expandable member 228 is coupled to the elongate
member 224' with wires or filaments 244. The second expandable
member 228 is formed with a mesh or braided material that defines
multiple openings 229. The second expandable member can be formed
with a shape-memory material such that it is biased into an
expanded or open configuration as shown in FIG. 3 and can be moved
to a compressed or closed configuration in a similar manner as
described above for expandable member 224. For example, when the
recanalization device 200' is inserted into a lumen of a catheter
(e.g., catheter 232) the second expandable member 228 can be
compressed or collapsed.
[0083] When in its expanded configuration as shown in FIG. 3, the
second expandable member 228 has a cup or parabolic shape and
defines an interior region 246 in fluid communication with the
openings 229. The second expandable member 228 also defines a
proximal opening 248 that is in fluid communication with the
interior region 246. Thus, the expandable member 228 is open at its
proximal end facing the expandable member 226'. The second
expandable member 228 can be used as a capture cap during a
recanalization procedure. For example, during a recanalization
procedure as described above for recanalization device 200, the
expandable member 228 can be used to prevent dislodged or disrupted
portions of the blockage from migrating beyond or distally of the
expandable member 228 upstream within the blood vessel. Further,
when the recanalization device 200' is moved proximally to remove
the recanalization device 200' from the blood vessel, the second
expandable member 228 can collect or capture portions of the
disrupted blockage within its interior region.
[0084] FIGS. 4A and 4B illustrate another embodiment of a
recanalization device. A recanalization device 300 (also referred
to herein as "recanalization device" or "medical device") includes
an expandable member 326 coupled to an actuation member 320. The
actuation member 320 includes a tubular member 322 that defines a
lumen (not shown) between a proximal end and a distal end of the
tubular member 322, and an elongate member 324 movably disposed
within the lumen of the tubular member 322. The actuation member
320 can optionally be coupled on a proximal end portion to a
controller device (not shown), such as, for example, a hand-held
controller as described above. The recanalization device 300 can be
inserted through a lumen not 333 of a catheter or sheath 332, which
will compress the expandable member 326 into a collapsed or
compressed configuration (as shown in FIG. 4A).
[0085] A proximal end portion of the expandable member 326 is
coupled to a distal end portion 325 of the tubular member 322 at
attachment 338, and a distal end portion of the expandable member
326 is coupled to a distal end portion 336 of the elongate member
324 at attachment 334. The expandable member 326 can be attached
with, for example, a clamp, clip, bonding, heat sealed, or other
suitable coupling mechanism.
[0086] The expandable member 326 can be formed with a shape-memory
material and has a collapsed configuration (as shown in FIG. 4A)
and a biased expanded configuration as shown in FIG. 4B. In this
embodiment, the expandable member 326 has a preformed expanded
configuration that defines a first portion 350 and a second portion
352 of the expandable member 326. The expandable member 326 can be
formed with a mesh or braided material such that a wall of the
expandable member 326 defines multiple openings or interstices 335.
When in the collapsed configuration, the first portion 350 and the
second portion 352 of the expandable member 326 each have a smaller
outer perimeter or outer diameter (as shown in FIG. 4A) than when
in the expanded configuration (as shown in FIG. 4B). When in the
expanded configuration, the expandable member 326 defines a first
interior region 354 associated with the first portion 350 and a
second interior region 356 associated with the second portion 352.
The first interior region 354 and the second interior region 356
are each in fluid communication with the openings 335. Also when in
its expanded configuration, the expandable member 326 defines an
annular capture region 342 between the first portion 350 and the
second portion 352.
[0087] In some embodiments, the shape of the expandable member 326
can be further changed by pulling the elongate member 324
proximally and holding the tubular member 322 stationary, or moving
the tubular member 322 distally and holding the elongate member
stationary, or moving the elongate member 324 proximally while
moving the tubular member 322 distally. Such action can cause the
expandable member 324 to at least partially collapse in a
longitudinal direction. In other words, the first portion 350 and
the second portion 352 of the expandable member 326 can be moved
closer to each other and the outer perimeter of the first portion
350 and the outer perimeter of the second portion 352 can be
increased.
[0088] In use, the catheter 332 can be inserted through a blood
vessel and a distal end (not shown) of the catheter 332 can be
positioned near a blockage within the blood vessel. The expandable
member 326 can be moved out the distal end of the catheter 332 by
moving the actuation member 320 (i.e., the tubular member 322 and
the elongate member 324) distally. As the expandable member 326
moves to its expanded configuration as shown in FIG. 4B, the
expandable member 326 can contact and exert a force on the blockage
such that the blockage is compressed and portions of the blockage
are moved through the openings 335 of the expandable member 326 and
into the interior regions 354 and 356. Portions of the blockage can
also be captured within the capture region 342 in a similar manner
as described above for recanalization device 200. As described
above, the expandable member 326 can optionally be rotated to
further disrupt the blockage.
[0089] When the disruption process is completed, the elongate
member 324 can be pulled proximally such that the expandable member
326 partially collapses in a longitudinal direction (e.g., parallel
with an axis defined by the blood vessel) and portions of bodily
tissue within the capture region 342 can be captured or trapped by
the expandable member 326. The expandable member 326 can then be
pulled proximally (e.g., by pulling the tubular member 322 and the
elongate member 324) back into the lumen 333 of the catheter 332
with the trapped portions of bodily tissue within the capture
region 342 and the portions captured within the interior regions
354 and 356 of the expandable member 326.
[0090] FIG. 5 illustrates a variation of the recanalization device
300. A recanalization device 400 includes all the same features and
functions as described above for recanalization device 300. For
example, the recanalization device 400 includes an expandable
member 426 coupled to a tubular member 422 at attachment 438 and
coupled to an elongate member 424 at attachment 434. The
recanalization device 400 is shown in an expanded configuration and
can be moved between a compressed or collapsed configuration and
the expanded configuration in the same or similar manner as
described above for recanalization device 300. In this embodiment,
the recanalization device 400 includes a second expandable member
428 coupled to the tubular member 422 proximal of the expandable
member 426.
[0091] The second expandable member 428 can be formed with a mesh
or braided material that defines multiple openings as described for
expandable member 426. The second expandable member 428 can be
formed with a shape-memory material such that it is biased into an
expanded or open configuration as shown in FIG. 5, and can be moved
to a compressed or closed configuration in a similar manner as
described above for expandable member 326. For example, when the
recanalization device 400 is inserted into a lumen of a catheter
(e.g., catheter 332) the second expandable member 428 can be
compressed or collapsed.
[0092] When in its expanded configuration as shown in FIG. 5, the
second expandable member 428 has an elongated shape and defines an
interior region 446 in fluid communication with the openings 429.
The second expandable member 428 also defines a distal opening 448
that is in fluid communication with the interior region 446. Thus,
the expandable member 428 is open at its distal end facing the
expandable member 426. The second expandable member 428 can be used
as a capture cap during a recanalization procedure as described
above for previous embodiments. For example, during a
recanalization procedure as described above for recanalization
device 300, the expandable member 428 can be used to prevent
dislodged or disrupted portions of the blockage from migrating
beyond or proximally of the expandable member 428 within the blood
vessel. Further, when the recanalization device 400 is moved
proximally back into the delivery catheter, the second expandable
member 428 can collapse an portions of the disrupted blockage
disposed within the interior region 446 of the second expandable
ember 428 can be captured therein.
[0093] FIG. 6 illustrates a portion of another embodiment of a
recanalization device. A recanalization device 500 (also referred
to herein as "recanalization device" or "medical device") includes
a first expandable member 526, a second expandable member 527 and a
third expandable member 528 each coupled to an actuation member
520. The actuation member 520 includes a tubular member 522 that
defines a lumen (not shown) between a proximal end and a distal end
of the tubular member 522, and an elongate member 524 movably
disposed within the lumen of the tubular member 522. As with
previous embodiments, the actuation member 520 can optionally be
coupled on a proximal end portion to a controller device (not
shown), such as, for example, a hand-held controller as described
above.
[0094] A proximal end portion of the first expandable member 526 is
coupled to a distal end portion 525 of the tubular member 522 at
attachment 538, and a distal end portion of the expandable member
526 and a proximal end portion of the second expandable member 527
are coupled to the elongate member 524 at attachment 558. A distal
end portion of the second expandable member 527 and a proximal end
portion of the third expandable member 528 are coupled to the
elongate member 524 at attachment 560, and a distal end portion of
the third expandable member 528 is coupled to a distal end portion
536 of the elongate member 524 at attachment 534.
[0095] The first expandable member 526, second expandable member
527 and third expandable member 528 can be coupled to the actuation
member 520 with, for example, a clamp, clip, bonding, heat sealing,
or other suitable coupling mechanism. The first expandable member
526, second expandable member 527 and third expandable member 528
can each be formed with a shape-memory material and have a
collapsed configuration (not shown) and a biased expanded
configuration as shown in FIG. 6. When in their collapsed
configurations, the first expandable member 526, second expandable
member 527 and third expandable member 528 each have a smaller
outer perimeter or outer diameter than when in their expanded
configuration. The first expandable member 526, second expandable
member 527 and third expandable member 528 can each be formed with
a mesh or braided material.
[0096] The first expandable member 526 defines multiple openings
535 and has a preformed expanded configuration that defines an
interior region 554 in fluid communication with the multiple
openings 535. The second expandable member 527 defines multiple
openings 545 and has a preformed expanded configuration that
defines an interior region 556 in fluid communication with the
multiple openings 545. The third expandable member 527 defines
multiple openings 555 and has a preformed expanded configuration
that defines an interior region 557 in fluid communication with the
multiple openings 555.
[0097] In this embodiment, each of the interior regions 554, 556
and 557 are separate from each other. In other words, the interior
regions 554, 556 and 557 are not in fluid communication with each
other. As shown in FIG. 6, a first annular capture region 542 is
defined between the first expandable member 526 and the second
expandable member 527, and a second annular capture region 543 is
defined between the second expandable member 527 and the third
expandable member 528.
[0098] The recanalization device 500 can be used to recanalize a
vessel in a similar manner as described for previous embodiments.
For example, the recanalization device 500 can be used to disrupt a
blockage within a vessel and portions of the disrupted blockage can
enter through the openings 535, 545 and 555 and be contained within
the interior regions 554, 556 and 557. The recanalization device
500 can be rotated as previously described to further disrupt the
blockage. As described above for previous embodiments, in some
embodiments, the shape of the first expandable member 526, second
expandable member 527 and third expandable member 528 can be
further changed by pulling the elongate member 524 proximally and
holding the tubular member 522 stationary, or moving the tubular
member 522 distally and holding the elongate member stationary, or
moving the elongate member 524 proximally while moving the tubular
member 522 distally.
[0099] FIG. 7 illustrates a portion of another embodiment of a
recanalization device. A recanalization device 600 (also referred
to herein as "recanalization device" or "medical device") includes
an expandable member 626 coupled to an actuation member 620. The
actuation member 620 includes a tubular member 622 that defines a
lumen (not shown) between a proximal end and a distal end of the
tubular member 622, and an elongate member 624 movably disposed
within the lumen of the tubular member 622. The actuation member
620 can optionally be coupled on a proximal end portion to a
controller device (not shown), such as, for example, a hand-held
controller as described above.
[0100] A proximal end portion of the expandable member 626 is
coupled to a distal end portion 625 of the tubular member 622 at
attachment 638, and a distal end portion of the expandable member
626 is coupled to a distal end portion 636 of the elongate member
624 at attachment 634. The expandable member 626 can be attached
with, for example, a clamp, clip, bonding, heat sealed, or other
suitable coupling mechanism. As described above for the previous
embodiment, the expandable member 626 can be formed with a mesh or
braided material such that a wall of the expandable member 626
defines multiple openings or interstices 635. The expandable member
626 can have a collapsed or compressed configuration (not shown)
and an expanded configuration as shown in FIG. 7. When in the
collapsed configuration, the expandable member 626 has a smaller
outer perimeter or outer diameter than when in the expanded
configuration. When in the expanded configuration, the expandable
member 626 defines an interior region 640 in fluid communication
with the multiple openings 635. The expandable member 626 can be
formed with a shape-memory material such that it is biased into its
expanded configuration when not restrained and can be inserted into
a lumen of a delivery catheter to move to its compressed
configuration. In this embodiment, the expandable member 626
defines capture regions 642 along an exterior surface that are
preformed in the mesh material of the expandable member 626.
[0101] The shape of the expandable member 626 can be changed by
pulling the elongate member 624 proximally and holding the tubular
member 622 stationary, or moving the tubular member 622 distally
and holding the elongate member 624 stationary, or moving the
elongate member 624 proximally while moving the tubular member 622
distally. Such action can cause the expandable member 626 to at
least partially collapse in a longitudinal direction capturing any
portions of material within the capture regions 642. The
recanalization device 600 can be used to clear a blockage in a
recanalization procedure in the same or similar manner as described
above for previous embodiments.
[0102] FIG. 8 illustrates an embodiment of a recanalization device
including a proximal capture cap similar to the recanalization
device 400 and FIG. 9 illustrates an embodiment of a recanalization
device including a distal capture cap similar to the recanalization
device 200'. A recanalization device 700 can include all the same
features and functions as described above for recanalization device
400. For example, the recanalization device 700 includes a first
expandable member 726 coupled at a proximal end portion to a
tubular member 722 and is coupled at a distal end portion to a
distal end portion of an elongate member 724 that is movably
disposed within a lumen of the tubular member 722. The
recanalization device 700 is shown in an expanded configuration and
can be moved between a compressed or collapsed configuration and
the expanded configuration in the same or similar manner as
described above for previous embodiments. In this embodiment, the
recanalization device 700 includes a second expandable member 728
coupled to the tubular member 722 proximal of the expandable member
726 at attachment 764.
[0103] The first expandable member 726 can be configured the same
as or similar to and function the same as or similar to, for
example, the expandable member 426. The second expandable member
728 can be formed with a mesh or braided material that defines
multiple openings as described above for other embodiments. The
second expandable member 728 can be formed with a shape-memory
material such that it is biased into an expanded or open
configuration as shown in FIG. 8, and can be moved to a compressed
or closed configuration (not shown).
[0104] When in its expanded configuration as shown in FIG. 8, the
first expandable member 726 defines a capture region 742 and a
capture region 743 is defined between the first expandable member
726 and the second expandable member 728. The second expandable
member 728 is substantially cup shaped or parabolic shaped and
defines an interior region configured to receive portions of
disrupted blockage material. The second expandable member 728 also
defines a distal opening 748 that is in fluid communication with
the interior region. The second expandable member 728 can be used
as a capture cap during a recanalization procedure as described
above for previous embodiments. For example, during a
recanalization procedure as described above, the second expandable
member 728 can be used to prevent dislodged or disrupted portions
of the blockage from migrating beyond or proximally of the second
expandable member 728.
[0105] A recanalization device 800 illustrated in FIG. 9 includes a
first expandable member 826 coupled at a proximal end portion 838
to a tubular member 822 and is coupled at a distal end portion to
an elongate member 824 that is movably disposed within a lumen of
the tubular member 822. The recanalization device 800 is shown in
an expanded configuration and can be moved between a compressed or
collapsed configuration and the expanded configuration in the same
or similar manner as described above for previous embodiments. In
this embodiment, the recanalization device 800 includes a second
expandable member 828 coupled to a distal end portion 836 of the
elongate member 822 distal of the first expandable member 826.
[0106] The first expandable member 826 and the second expandable
member 828 can each be formed with a mesh or braided material that
defines multiple openings as described above for previous
embodiments. The first expandable member 826 and the second
expandable member 828 can each be formed with a shape-memory
material such that they are biased into an expanded configuration
as shown in FIG. 9, and can be moved to a compressed or closed
configuration (not shown).
[0107] When in its expanded configuration as shown in FIG. 9, a
capture region 842 is defined between the first expandable member
826 and the second expandable member 828 configured to receive
portions of disrupted blockage material. The second expandable
member 828 also defines an interior region configured to receive
portions of disrupted blockage material. The second expandable
member 828 also defines a proximal opening and can be used as a
capture cap during a recanalization procedure as described above
for previous embodiments. For example, during a recanalization
procedure as described above, the second expandable member 828 can
be used to prevent dislodged or disrupted portions of the blockage
from migrating distally of the second expandable member 828.
[0108] FIG. 10A illustrates a recanalization device 900 with an
expandable member 926 shown in a collapsed configuration, and FIG.
10B illustrates the recanalization device 900 with the expandable
member 926 shown in an expanded configuration and twisted to form a
helical contoured shape. The recanalization device 900 can be
configured the same as or similar to, and can be used in the same
or similar manner, as described above for previous embodiments.
[0109] FIGS. 11A-11D illustrate an embodiment of a recanalization
device with an expandable member formed with varying density. A
recanalization device 1000 (also referred to herein as
"recanalization device" or "medical device") includes an expandable
member 1026 coupled to an actuation member 1020. The actuation
member 1020 includes a tubular member 1022 that defines a lumen
(not shown) between a proximal end and a distal end of the tubular
member 1022, and an elongate member 1024 movably disposed within
the lumen of the tubular member 1022. The actuation member 1020 can
optionally be coupled on a proximal end portion to a controller
device (not shown), such as, for example, a hand-held controller as
described above. The recanalization device 1000 can be inserted
through a lumen (not shown) of a catheter or sheath 1032 (see e.g.,
FIGS. 11B-11D), which will compress the expandable member 1026 into
a collapsed or compressed configuration (not shown).
[0110] A proximal end portion of the expandable member 1026 is
coupled to a distal end portion of the tubular member 1022 at
attachment 1038, and a distal end portion of the expandable member
1026 is coupled to a distal end portion of the elongate member 1024
at attachment 1034.
[0111] As described above for previous embodiments, the expandable
member 1026 can be formed with a mesh or braided material such that
a wall of the expandable member 1026 defines multiple openings or
interstices. In this embodiment, the expandable member 1026 is
formed with a first mesh material that has a first density defining
multiple openings 1035 and with a second mesh material having a
second density defining multiple openings 1039. The expandable
member 1026 includes sections 1066 along a length of the expandable
member 1026 formed with the first mesh material, and sections 1068
along its length formed with the second mesh material.
[0112] The expandable member 1026 can have a collapsed or
compressed configuration (not shown) and an expanded configuration
(see e.g., FIG. 11C). When in the collapsed configuration, the
expandable member 1026 has a smaller outer perimeter or outer
diameter than when in the expanded configuration. When in the
expanded configuration, the expandable member 1026 defines an
interior region 1040 (see e.g., FIG. 11A) in fluid communication
with the multiple openings 1035 and 1039. The expandable member
1026 can be formed with a shape-memory material such that it is
biased into its expanded configuration when not restrained and can
be inserted into the lumen of the delivery catheter 1032 to move to
its compressed configuration.
[0113] In use, the catheter 1032 can be inserted through a blood
vessel Vanda distal end 1037 of the catheter 1032 can be positioned
near a blockage B (see e.g., FIG. 11B). The expandable member 1026
can be moved out the distal end 1037 of the catheter 1032 by moving
the actuation member 1020 (i.e., the tubular member 1022 and the
elongate member 1024) distally through the blockage B and the
expandable member 1026 can begin to assume its biased expanded
configuration as shown in FIG. 11B. As the expandable member 1026
moves to its expanded configuration, the expandable member 1026 can
contact and exert a force on the blockage B such that the blockage
B is compressed and portions P of the blockage B are moved through
the openings 1035 and 1039 of the expandable member 1026 and into
the interior region 1040 of the expandable member 1026, as shown in
FIG. 11C.
[0114] As described above for previous embodiments, the expandable
member 1026 can optionally be rotated to further disrupt the
blockage B. In addition, the expandable member 1026 can be moved to
a contoured or tortuous shape (as shown in FIG. 11D) by rotating
the tubular member 1022 and/or elongate member 1022 relative to the
other, or both can be rotated in opposite directions. As shown in
FIG. 11D, the expandable member 1026 defines capture regions 1042
that can received dislodged or disrupted portions P of blockage B.
When the disruption procedure is completed, the elongate member
1024 can be pulled proximally such that the expandable member 1026
partially collapses in a longitudinal direction (e.g., parallel
with an axis defined by the blood vessel V) and the portions P are
captured or trapped by the expandable member 1026. The expandable
member 1026 can then be pulled proximally (e.g., by pulling the
tubular member 1022 and the elongate member 1024) back into the
lumen of the catheter 1032 with the portions P trapped within
capture regions 1042 and the portions P captured within the
interior region 1040 of the expandable member 1026.
[0115] FIGS. 12A and 12B illustrate a variation of the
recanalization device 1000. The recanalization device 1000'
includes the recanalization device 1000 with the addition of a
second expandable member 1028 in the form of a distal capture cap
coupled to a distal end portion 1036 of the elongate member 1024.
The second expandable member 1028 can be configured the same as and
function the same as or similar to the second expandable member 228
in FIG. 3. FIG. 12A shows the recanalization device 1000' in an
expanded configuration and FIG. 12B shows the recanalization device
1000' expanded and twisted or rotated to a contoured configuration.
The recanalization device 1000' can be moved to the expanded
contoured configuration in a same or similar manner as described
above for previous embodiments.
[0116] FIGS. 13A and 13B illustrate an embodiment of a
recanalization device that includes an integral capture cap at a
distal end portion of the recanalization device. A recanalization
device 1100 includes an expandable member 1126 coupled to an
actuation member 1120. The actuation member 1120 includes a tubular
member 1122 and an elongate member 1124 movably disposed within a
lumen 1123 of the tubular member 1122. As with previous
embodiments, a proximal end portion of the expandable member 1126
is coupled to a distal end portion of the tubular member 1122 at
attachment location 1138 and a distal end portion of the expandable
member 1126 is coupled to a distal end portion 1136 of the elongate
member 1124 at attachment location 1134.
[0117] The expandable member 1126 can be formed with the same
materials and include the same features and functions as previous
embodiments. In this embodiment, the expandable member 1126
includes a first portion 1150 that defines a first interior region
1154 and a second portion 1152 that defines a second interior
region 1156. The second portion 1152 is in the form of an integral
capture cap disposed at a distal end portion of the expandable
member 1126. The capture cap 1128 can be formed or woven, for
example, with the same filaments that form the expandable member
1126. A capture region 1142 is defined in the space between the
expandable member 1126 and the capture cap 1128. The first portion
1150 defines multiple openings 1135 in a wall of the first portion
1150 that are in fluid communication with the first interior region
1154 and the second portion 1152 defines multiple openings 1139
that are in fluid communication with the second interior region
1156.
[0118] The expandable member 1126 can be moved between a collapsed
configuration for insertion into a vessel and/or a lumen of a
catheter or sheath, and an expanded configuration for use during a
recanalization procedure as described herein. FIG. 13A illustrates
the expandable member 1126 in an expanded configuration and FIG.
13B illustrates the expandable member 1126 shown partially
collapsed within a lumen 1133 of a delivery catheter 1132. As shown
in FIG. 13B, portions P of bodily tissue from a blockage can be
captured within the capture region 1142, the first interior region
1154 and the second interior region 1156 and as the expandable
member 1126 is drawn back into the lumen 1133 of the catheter 1132,
the portions Pare trapped pulled therein with the expandable member
1126.
[0119] FIGS. 14A-14C illustrate an embodiment of a recanalization
device being deployed within a blood vessel without the use of a
delivery catheter. A recanalization device 1200 includes an
expandable member 1226 coupled to an actuation member 1220. The
actuation member 1220 includes a tubular member 1222 and an
elongate member 1224 movably disposed within a lumen (not shown) of
the tubular member 1222. A proximal end portion of the expandable
member 1226 is coupled to a distal end portion of the tubular
member 1222 at attachment location 1238 and a distal end portion of
the expandable member 1226 is coupled to a distal end portion 1236
of the elongate member 1224 at attachment location 1234. The
actuation member 1120 is coupled to a controller device 1230 that
can be used to control movement of the elongate member 1224
relative to the tubular member 1222 as described in more detail
below.
[0120] The expandable member 1226 can be formed with the same
materials and include the same features and functions as previous
embodiments. In this embodiment, the expandable member 1226 defines
multiple openings 1235 in fluid communication with an interior
region 1240 (see e.g., FIG. 14B). The openings 1235 can be
configured and sized to encourage material from a blockage (e.g., a
blood clot) to enter the expandable member 1226 for removal from a
vessel.
[0121] The expandable member 1226 can be moved between a collapsed
configuration for insertion into a vessel as shown in FIG. 14A, and
an expanded configuration for use during a recanalization procedure
as shown in FIG. 14B. In this embodiment, to move the expandable
member 1226 to the collapsed configuration, the operator or user of
the recanalization device 1200 can move an actuation button 1262 on
the controller 1230 distally or in a direction A (see FIG. 14A)
toward a vessel Vin which the recanalization device 1200 is being
disposed. The button 1262 is operatively coupled to the elongate
member 1224 such that when the button 1262 is moved distally, the
elongate member 1224 will move distally relative to the tubular
member 1222. Because the expandable member 1226 is coupled at its
proximal end to the tubular member 1222, this action will cause the
expandable member 1226 to elongate or collapse as shown in FIG.
14A. The user can maneuver the distal end portion 1236 to a desired
location at or near a blockage B within the vessel V.
[0122] The expandable member 1226 can then be moved to its expanded
configuration while disposed at the desired treatment site by
moving button 1262 proximally in a direction Bas shown in FIG. 14B.
As described above for previous embodiments, as the expandable
member 1226 expands, it can contact and exert a force on the
blockage B such that portions P of the blockage Bare disrupted and
pass through the openings 1240 of the expandable member 1226 as
shown in FIG. 14B. When the recanalization procedure is complete,
the expandable member 1226 can be moved to a collapsed
configuration by moving the button 1262 distally in a direction C
as shown in FIG. 14C. As the expandable member 1226 is moved to the
collapsed configuration, the portions P of the blockage B disposed
within the interior region 1240 will be captured by the expandable
member 1226. The expandable member 1226 can then be withdrawn from
the vessel V.
[0123] FIGS. 15A-15C illustrate an embodiment of a recanalization
device that can be used to perfuse an oxygenated or superoxygenated
blood distal to a blockage within a vasculature to reduce or
eliminate ischemia during the procedure by providing the region cut
off by blood supply fresh oxygenated blood to keep the tissue
alive. A recanalization device 1300 includes an expandable member
1326 coupled to an elongate member 1324. The expandable member 1326
can be configured the same as expandable members described above
for previous embodiments. For example, the expandable member 1326
can be formed with a shape memory material such that it has a
biased expanded configuration (e.g., as shown in FIG. 15A) and can
be moved to a compressed or collapsed configuration by restraining
the expandable member 1326 within a lumen of a delivery catheter.
In this embodiment, the elongate member 1326 defines a lumen
extending between a proximal end and a distal end of the elongate
member 1324 and that is in fluid communication with an opening 1364
on the distal end of the expandable member 1326 and an opening 1366
on the proximal end of the expandable member 1326. The proximal end
of the expandable member 1326 can be coupled to a source of
oxygenated or superoxygenated blood (not shown).
[0124] In use, the recanalization device 1300 can be inserted
through a lumen 1333 of a delivery catheter 1332 and inserted into
a vessel Vas shown in FIGS. 15B and 15C. The expandable member 1326
can be moved out a distal end 1337 of the delivery catheter 1332
and positioned within a blockage B to be treated. As the expandable
member 1326 is moved out of the delivery catheter 1332 it can
assume its biased expanded configuration as described above for
previous embodiments. As the expandable member 1326 expands it can
contact and compress the blockage B and portions of the blockage
can enter into an interior region of the expandable member through
openings 1335 defined in the mesh material of the expandable member
1326. While the blockage is being cleared, oxygenated blood can be
perfused through the lumen of the elongate member 1326 and out the
distal opening 1364.
[0125] FIGS. 16-18 each illustrate a different embodiment of a
recanalization device that includes a distal capture cap. A
recanalization device 1400 shown in FIG. 16 includes an expandable
member 1428 coupled at a proximal end portion to a distal end
portion of a tubular member 1422 and coupled at a distal end
portion to a distal end portion 1436 of an elongate member 1424.
The elongate member 1424 is movably disposed within a lumen 1423 of
the tubular member 1422. In this embodiment, the expandable member
1426 is formed with two layers of braid or mesh material and
defines an opening 1448 on a proximal end in fluid communication
with an interior region 1446. A looped control wire 1447 is coupled
to the expandable member 1426 adjacent the opening 1448 and extends
through the lumen 1423 of the tubular member 1422 and can be used
to move the expandable member 1426 to a collapsed configuration as
described below.
[0126] As described above for previous embodiments, the expandable
member 1426 can be moved from a collapsed configuration for
insertion into a vessel, and an expanded configuration (as shown in
FIG. 16) in which portions of a blockage within the vessel can be
captured within the interior region 1446. To move the expandable
member 1426 to the collapsed configuration, the looped control wire
1447 can be pulled proximally to cinch or close the expandable
member 1426. Thus, during a recanalization procedure as described
herein, portions of a blockage can enter through the opening 1448
and be disposed with the interior region 1446 while the expandable
member 1426 is in the expanded configuration. The expandable member
1426 can then be moved to the collapsed configuration capturing the
portions of the blockage for removal from the vessel.
[0127] FIG. 17 illustrates a recanalization device 1500 shown in an
expanded configuration. The recanalization device 1500 includes an
expandable member 1526 coupled at a distal end portion to a distal
end portion 1536 of an elongate member 1524. The elongate member
1524 can be movably disposed within a lumen of a tubular member
(not shown) as described for previous embodiments. In this
embodiment, the expandable member 1526 is formed with a braid or
mesh material and defines an opening 1548 on a proximal end portion
in fluid communication with an interior region 1546. The opening
1548 is defined on a bias of the braid or mesh material such that
the opening 1548 is disposed at an angle transverse to a
longitudinal axis A of the elongate member 1524. A control wire
1547 is coupled to the expandable member 1526 adjacent the opening
1548 and can extend proximally outside of the patient's body and
can be used to move the expandable member 1526 to a collapsed
configuration. Control of closure of the opening 1548 can be
facilitated by pulling the control wire 1547 proximally. Effecting
closure on the bias or diagonal can provide a less bulky unit,
which can make delivery and withdrawal of the recanalization device
1500 easier.
[0128] As described above for previous embodiments, the expandable
member 1526 can be moved from a collapsed configuration for
insertion into a vessel, and an expanded configuration (as shown in
FIG. 17) in which portions of a blockage within the vessel can be
captured within the interior region 1546. The expandable member
1526 can be moved to the collapsed configuration using the control
wire 1547 a described above, capturing the portions of the blockage
within the interior region 1546 for removal from the vessel.
[0129] FIG. 18 illustrates a recanalization device 1600 that
includes an expandable member 1626 coupled at a distal end portion
to a distal end portion 1636 of an elongate member 1624 and coupled
at a proximal end portion to a distal end portion of a tubular
member 1622 at attachment 1638. The elongate member 1624 is movably
disposed within a lumen 1623 of the tubular member 1622. In this
embodiment, the expandable member 1626 is formed with a braid or
mesh material and defines an opening 1648 in fluid communication
with an interior region 1646 and includes filaments or strands 1649
that extend from a perimeter of the opening 1648 to the proximal
attachment 1638. The strands 1649 can be formed with a larger
diameter than the filaments used to form the mesh or braid of the
expandable member 1626 and can have a helical configuration. The
larger diameter of the strands 1649 can assist in the closure of
the expandable member 1626.
[0130] As described above for previous embodiments, the expandable
member 1626 can be moved from a collapsed configuration for
insertion into a vessel, and an expanded configuration (as shown in
FIG. 18) in which portions of a blockage within the vessel can be
captured within the interior region 1646. To move the expandable
member 1626 to the collapsed configuration, the elongate member
1624 can be moved distally relative to the tubular member 1622
and/or the tubular member 1622 can be moved proximally relative to
the elongate member 1622 as described above for previous
embodiments.
[0131] A method of using a recanalization device as described
herein in a procedure to clear a blockage within a vessel, can
include advancing an expandable member of a recanalization device
while in a collapsed configuration to a desired treatment site
(e.g., a location of a blood clot or other blockage) within a blood
vessel. The expandable member of the recanalization device is
coupled to a core wire movably disposed within a hypotube as
described herein. The expandable member can be positioned such that
most, if not all of the openings and/or capture regions of the
expandable member are disposed within the blockage region. The core
wire is then retracted (moved proximally) within the hypotube to
expand the expandable member, and at the same time form capture
regions along an exterior of the expandable member. As the
expandable member is expanded, the blockage (e.g., blood clot) is
compressed by the expandable member against the walls of the
vessel, which can restore blood flow to the vessel. The blockage
material can be trapped within the capture regions and within an
interior of the expandable member. The core wire can be pulled
further proximally to achieve a desired structural rigidity for the
expandable member and the portions of the blockage can be trapped
between by the expandable member within the capture regions. The
recanalization device and blockage material are retrieved together
back into, for example, guide catheter for removal from the
vessel.
[0132] FIG. 19 is a flowchart illustrating another method of using
a recanalization device as described herein to perform a
recanalization procedure. The method includes at 70, inserting a
distal portion of a medical device into a blood vessel. The medical
device can include an elongate member and an expandable member
coupled to a distal portion of the elongate member. The expandable
member defines multiple openings in a wall of the expandable member
and is in a collapsed configuration during the inserting. At 72,
the distal portion of the medical device is positioned adjacent to
or within a blood clot within the blood vessel. At 74, the medical
device is actuated at a first time period to move the expandable
member from the collapsed configuration to a first expanded
configuration in which the expandable member defines an interior
region in fluid communication with the multiple openings and such
that the expandable member contacts the blood clot and at least a
first portion of the blood clot enters through at least one of the
openings and into the interior region of the expandable member.
This action can restore blood flow through the blood vessel. At 76,
the medical device is actuated at a second time period to move the
expandable member from the first expanded configuration to a second
expanded configuration in which the expandable member defines at
least one capture region configured to receive a second portion of
the blood clot therein. For example, the medical device can include
a tubular member defining a lumen and the elongate member can be
movably disposed within the lumen of the tubular member. The
actuating the medical device at the second time period can include
rotating at least one of the elongate member or the tubular member
such that the expandable member is twisted into a tortuous
configuration.
[0133] At 78, after the second time period, the medical device can
be actuated again to move the expandable member to its collapsed
configuration while disposed within the blood vessel such that at
least a portion of the blood clot is trapped within the expandable
member. At 80, the medical device can optionally be rotated while
disposed within the blood vessel and in either the first expanded
configuration or the second expanded configuration such that at
least a third portion of the blood clot is moved through at least
one of the multiple openings and into the interior volume of the
expandable member.
[0134] In some embodiments, the expandable member is a first
expandable member and the medical device can include a second
expandable member coupled to the distal portion of the elongate
member at a non-zero distance from the first expandable member. The
first expandable member and the second expandable member can define
a capture region between the first expandable member and the second
expandable member. In such an embodiment, the medical device can be
actuated such that the second expandable member is moved toward the
first expandable member and at least one of the second portion of
the blood clot or a third portion of the blood clot is trapped
between the first expandable member and the second expandable
member. In some embodiments, the elongate member can define a lumen
and the method can include infusing one of oxygenated blood and
superoxygenated blood through the lumen of the elongate member and
into the blood vessel distal to the blood clot. At 82, the medical
device can be removed from the blood vessel with captured portions
of the blood clot contained within the expandable member.
[0135] In some embodiments, the devices described herein can be
included in a kit. For example, a kit can include one or more
recanalization devices, one or more delivery catheters or sheaths,
various other devices that can assist in the stabilization or
removal of an obstruction, instructions and/or a container for the
contents of the kit.
[0136] The length of the expandable member (e.g., braid or mesh)
can be variable depending on the assessed size of the obstruction
and the amount of material to be retrieved in the case that the
device is acting as a clot retriever. In addition to being affixed
at the proximal and distal ends, the expandable member can be
constricted at one or more points along a length of the expandable
member. For example, the expandable member can be coupled along the
hypotube at more than one location and/or coupled to the elongate
member (e.g., core wire) at one more locations. If the expandable
member is made of metal wire (e.g. NiTi wire), the expandable
member may be heat treated after the expandable member is
constricted at the hypotube (generally with a band or with wrapped
wire, e.g. Platinum wire) at the one or more points. The
constriction can be done to fix the bulges of the expandable member
(e.g., the braid or mesh material) to a certain shape. The heat
treatment may be desired where the sections of the expandable
member (separated by the constriction points) are different lengths
or diameters. Heat treatment of the expandable member braided wire
may not be necessary, for example, where the tube is constricted at
regular intervals along a length of the expandable member. The core
wire can be made, for example, with any metal typically used for
medical guidewires, including stainless steel or NiTi. The hypotube
can be made, for example, with any metal or cable-formed hypotube,
such as typically used in the medical arts for constructing tubes
that carry pusher or core wires.
[0137] Constriction of the expandable member at intervals along the
length of the expandable member can be done to establish
compartments between regions of the expandable member. When
delivered to a blood vessel, the core wire can extend out from the
hypotube at the distal end and can be pushed out further distally
so that the expandable member is compressed as much as possible for
delivery. The constriction points can move along the core wire
within the hypotube. The expandable member can be passed through
the blockage, transverse to the blocking material. After the
expandable member is positioned beyond the obstruction, the core
wire can be pulled back (proximally), which begins the formation of
compartments between the regions of the expandable member. The
expandable member regions can expand outward to contact the vessel
walls and to pull the obstructing material within compartments
formed between the expandable member openings/spaces.
Provisionally, the amount of obstructing material can serve as a
guide to determine how many constriction points may be desired
along the expandable member. For example, in some embodiments, the
device can include, from 1 to about 10 constriction points.
[0138] The various devices described herein can be made of any
material suitable for the defined purpose, including, for example,
drawn filed tube DFT.RTM.. DFT is available as wire, cable or
ribbon. Drawn filed tube DFT is a metal-to-metal composite
developed to combine the desired physical and mechanical attributes
of two or more materials into a single wire or ribbon system, which
can be used for the core wire within the hypotube, or for the
expandable member.
[0139] Filaments or wires for the device (either in the elongate
member or the expandable member) can include, for example, gold,
silver, platinum, titanium, titanium alloys, nitinol, platinum
alloys, and tungsten. Outer materials for the hypotube (e.g.,
tubular member) or DFT wire can include, for example, MP35N,
stainless steel, nitinol, cobalt chromium, titanium alloys,
zirconium alloys, platinum, tantalum, and tungsten. For the braid
or mesh (e.g., the expandable members), filaments can also include,
for example, filaments of materials such as MP35N, stainless steel,
nitinol, cobalt chromium, titanium alloys, zirconium alloys,
platinum, tantalum, tungsten, polyester, polyethylene (PET),
Dacron, PEEK, vectron, and suture materials. Each strand may have a
diameter between 0.0005''-0.010'', e.g., about 0.002''. In some
embodiments, an outer material of the mesh or braid can be formed
with nitinol that is super elastic at body temperature, and an
inner material can be radiopaque, or alternatively platinum wires
may be included in the braid to provide additional radiopacity.
[0140] In some embodiments, the expandable members described herein
can be formed with tubular braid, or sheets of woven filaments
(forming a mesh, weave or fabric). The filaments can be wire or
polymer or other suitable material. The expandable members can be
braided wire (e.g. NiTi wire), and can include a mixture of wire
types and wire sizes (e.g. NiTi and Platinum wire, and e.g. 0.001''
wire braided with 0.00125'' wire). The expandable members can also
be made with polymer fibers, or polymer fibers and metal wire mixed
together.
[0141] The mesh of the expandable members can be made by a variety
of different forms, including but not limited to, braiding,
weaving, welding, or laser cutting. The mesh can have an operating
length, for example, in a range of about 0.5 mm to about 70 mm. In
some embodiments, the mesh can have a length of 30 mm. In some
embodiments, the mesh can have a diameter in a range of about
0.5-60 mm. In some embodiments, the mesh can have a diameter of
about 5 mm when expanded. The mesh can have a single density or can
have two or more densities. For example, in some embodiments, the
number of variable densities can be in a range of about 2 to about
10. For example, a first density can be about 100 PPP and a second
density can be about 40 PPL (PPI=pics per inch). The braid pattern
can be any pattern suitable, for example, a one-over-one
configuration, or two-over-one configuration, etc. Strand count for
the mesh can be in a range of about 4 strands to about 288 strands.
In some embodiments, the strand count is about 48 strands. Common
multiples of 4, 8, 16, 24, 32, 64, 72, 96, 128, 144, 192 and 288
strands for braid are available using commercial braiders.
[0142] A single expandable member can include wires of the same
size or a combination of 2 different wire sizes. For example, the
expandable member can have 24 wires of 0.001'' and 24 wires of
0.0005''. The thicker wires can impart additional strength to the
expandable member and the thinner wire can provide density. In
addition any combination of wire count, wire diameter, braid angle
or pick per inch can be used to make the mesh of the expandable
member.
[0143] A non limiting example of suitable delivery catheters that
can be used include, for example, the Excelsior line of BSCI, the
DAC catheter line of Concentric Medical and Rapidtransit of
J&J. Use of oxygenated and superoxygenated blood is described
in an article entitled Buying Time for Recanalization in Acute
Stroke: Arterial Blood Infusion Beyond the Occluding Clot as a
Neuroprotective Strategy Ribo et al, Barcelona, Spain (BA, MM),
Jan. 28, 2008. Ribo et al describe a novel neuroprotective
intra-arterial (IA) strategy that allows intermittent oxygenated
blood perfusion beyond the occluding clot. In the case studied an
almost total recovery was observed despite late complete
recanalization (12 hours after onset), which suggests a
neuroprotective effect of the technique.
CONCLUSION
[0144] While various embodiments of the invention have been
described above, it should be understood that they have been
presented by way of example only, and not limitation. Where methods
and steps described above indicate certain events occurring in
certain order, those of ordinary skill in the art having the
benefit of this disclosure would recognize that the ordering of
certain steps may be modified and that such modifications are in
accordance with the variations of the invention. Additionally,
certain of the steps may be performed concurrently in a parallel
process when possible, as well as performed sequentially as
described above. The embodiments have been particularly shown and
described, but it will be understood that various changes in form
and details may be made.
[0145] For example, although various embodiments have been
described as having particular features and/or combinations of
components, other embodiments are possible having any combination
or sub-combination of any features and/or components from any of
the embodiments described herein. The specific configurations of
the various components can also be varied. For example, the size
and specific shape of the various components can be different than
the embodiments shown, while still providing the functions as
described herein.
* * * * *