Note: Descriptions are shown in the official language in which they were submitted.
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INTERNATIONAL PATENT APPLICATION
CLOT RETRIEVAL SYSTEM
BACKGROUND
TECHNICAL FIELD
[0001] The present invention relates to a deployable system for removing a
blood clot or other
object from a lumen of an animal.
BACKGROUND OF THE INVENTION
[0002] Acute ischemic strokes develop when a blood clot (thrombus) blocks an
artery supplying
blood to the brain. Needless to say, when a blood clot creates such a
blockage, time in removing
the clot is critical.
[0003] The removal of intracranial obstructions is limited by several factors,
such as the distance
of the intracranial obstruction from the femoral access site, the tortuosity
(twists and turns in the
artery as it enters the base of the skull) of the cervical and proximal
intracranial vasculature, the
small size of the vessels and the extremely thin walls of intracranial
vessels, which lack a
significant muscular layer. These limitations require a device to be small and
flexible enough to
navigate through tortuous vessels within a guide catheter and microcatheter,
expand after
delivery at the site of occlusion and be retrievable into the microcatheter
and yet be strong
enough to dislodge strongly adherent thrombus from the vessel wall. In
addition, the device
should distally entrap or encase the thrombus to prevent embolization to other
vessels and to
completely remove the occlusion. The device should be retrievable without the
need for proximal
occlusion of the vessel, which carries risk of further ischemia and risk of
vessel injury. The
device should be simple to use and be capable of multi-use within the same
patient treatment.
The device should not be abrasive and should not have sharp corners exposed to
the endothelial
layer of the vessel wall.
[0004] Currently available intravascular thrombus and foreign body removal
devices lack several
of these features. Currently available devices include the MERCITM RETRIEVER
clot retriever
device marketed by Concentric Medical, Inc. (Mountainvievv, CA), the
PENUMBRATm system
marketed by Penumbra Inc. (Alameda, CA) to retrieve clots, and the newer stent
retrieval
devices TREVOTm (Stryker, Kalamazoo, MI) and SOLITAIRETm (eV3 Endovascular
Inc.,
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Plymouth, MA, which is a subsidiary of Covidien). All the devices are
ineffectual at removing
organized hard thrombus that embolize to the brain from the heart and from
atherosclerotic
proximal vessels. These "hard- thrombi constitute the majority of strokes
which are refractory to
medical treatment and are therefore referred for removal by mechanical means
through an
endovascular approach. The MERCI retrieval system is comprised of coiled
spring-like metal
and associated suture material. The method of use is deployment distal to the
thrombus and by
withdrawing the device through the thrombus, the thrombus becomes entangled in
the coil and
mesh and then is retrieved. The MERCI system requires occlusion of the
proximal vessel with a
balloon catheter and simultaneous aspiration of blood while the thrombus is
being removed.
Most of the time, the device fails to dislodge the thrombus from the wall of
the vessel and often,
even when successfully dislodging the thrombus, the thrombus embolizes into
another or the
same vessel due to the open ended nature of the device.
[0005] The next attempt at a thrombus removal system was the PENUMBRA. The
PENUMBRA
is a suction catheter with a separator that macerates the thrombus which is
then removed by
suction. The device is ineffective at removing hard, organized thrombus which
has embolized
from the heart, cholesterol plaque from proximal feeding arteries and other
foreign bodies.
[0006] 'The SOLITAIRE and TREVO systems are self-expanding non-detachable
stents. The
devices are delivered across the thrombus which is then supposed to become
entwined in the
mesh of the stent and which is then removed in a manner similar to the MERCI
system. Again,
these devices are ineffectual at treating hard thrombus. In fact, the thrombus
is often compressed
against the vessel wall by the stent which temporarily opens the vessel by
outwardly pressing the
clot against the vessel wall. Upon retrieval of the devices, the clot remains
or is broken up into
several pieces which embolize to vessels further along the vessel.
[0007] Thus, there is a need for new, easy-to-use, easy-to-manufacture, safe
surgical devices for
removing obstructions, such as blood clots, from internal lumens of humans and
other animals in
a timely manner.
BRIEF SUMMARY
[0008] The present disclosure provides several systems for removing
obstructions and other
objects within a blood vessel or other lumen of an animal. The system may be
deployed in the
lumen from a distal end of a catheter and, in some embodiments, includes a
pull wire having a
proximal end and a distal end; a distal body attached to the pull wire, the
distal body comprising
an interior, an exterior, a proximal end, a distal end, a plurality of
proximal memory metal strips
located at the proximal end, a proximal hub/junction located in the distal
body interior, and a
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distal hub/junction located distal relative to the proximal hub/junction. The
distal body has a
relaxed state wherein the distal body has a first height and width and a
collapsed state wherein
the distal body has a second height and width, the second height less than
said first height, the
second width less than the first width. The system further includes a catheter
having an interior,
a proximal end leading to the interior and a distal end leading to the
interior, the catheter
comprised of a biocompatible material and configured to envelope the distal
body when the
distal body is in the collapsed state. Each of the proximal memory metal
strips has a proximal
end and a distal end and preferably, in the relaxed state, each of the
proximal ends of the
proximal memory metal strips is located proximal relative to the proximal
hub/junction.
Preferably, in the relaxed state, the proximal ends of the proximal memory
metal strips are
configured to move towards each other and towards the pull wire when an
operator moves the
proximal hub/junction distally and closer to the stationary distal
hub/junction (i.e., when the
operator decreases the distance between the hubs/junctions). Preferably, in
the relaxed state, the
proximal ends of the proximal memory metal strips are configured to move away
from each
other and away from the pull wire by moving the proximal hub/junction
proximally away from
the stationary distal hub/junction (i.e., when the operator increases the
distance between the
hubs/j unctions).
[0009] Optionally, the system further includes a plurality of memory metal
connector strips, the
plurality of memory metal connector strips each having a proximal end attached
to a proximal
memory metal strip and a distal end attached to the proximal hub/junction.
Optionally, the
connector strips are integral with the proximal hub/junction (i.e.,
optionally, the connector strips
and the proximal hub/junction are formed from the same piece of memory metal).
Optionally,
the proximal hub/junction is a tube having an aperture and the pull wire
passes through the
aperture. Optionally, in the relaxed state, the proximal hub/junction is
slideable along the pull
wire (i.e., at least a segment of the pull wire). Optionally, in the relaxed
state, the proximal
memory metal strips are distributed substantially evenly about a perimeter of
the distal body.
Optionally, the distal hub/junction is a tube having an aperture. Optionally,
the distal
hub/junction is attached to the pull wire such that the distal hub/junction is
not slideable along
the pull wire. Optionally, the distal body further comprises a lead wire
extending distally from
the distal hub/junction. Optionally, the distal body comprises a basket
comprised of a plurality
of memory metal strips distal relative to the proximal memory metal strips.
Optionally, the distal
hub/junction, the proximal hub/junction, and the distal basket are comprised
of a nitinol having
the same material composition. Optionally, the distal body further comprises
an x-ray marker.
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Optionally, the proximal memory metal strips form a claw, the claw having a
closeable proximal
end formed by the proximal ends of the proximal memory metal strips.
Optionally, between 2
and 4 proximal memory metal strips form the claw. Optionally, the distal body,
in the relaxed
state, has a tapered shape in which the distal body height and width decrease
from the proximal
end to the distal end. Optionally, the distal body, in the relaxed state, has
a bullet shape.
Optionally, the proximal hub/junction and the distal hub/junction are
generally cylindrical in
shape and each has an outer diameter and an inner diameter that forms the
apertures of the
proximal and distal hub/junctions, the outer diameters of the proximal and
distal hub/junctions
are substantially the same size, and the inner diameters of the proximal and
distal hubs/junctions
are substantially the same size. Optionally, the outer diameters of the
proximal and distal
hubs/junctions are from about 0.011 inches to about 0.054 inches, and the
inner diameters of the
proximal and distal hubs/junctions are from about 0.008 inches to about 0.051
inches.
Optionally, the pull wire is generally cylindrical and the diameter of the
pull wire is between
about 0.008 inches and about 0.051 inches. Optionally, the proximal memory
metal strips have a
length of between about 10 and about 60 millimeters. Optionally, the first
height and first width
of the distal body are between about 2 millimeters (mm) and about 6
millimeters. Optionally,
the proximal memory metal strips are configured to a separate a clot from a
blood vessel wall.
[0010] The present invention also provides a method of removing an object from
an interior
lumen of an animal, the lumen having an interior wall forming the lumen. In
some
embodiments, the method includes:
a) providing a system comprising: i) a pull wire having a proximal end and
a distal
end; ii) a distal body attached to the pull wire, the distal body comprising a
proximal end, a
distal end, and a claw, the claw comprised of a plurality of memory metal
strips, the distal body
having a relaxed state wherein the distal body has a first height and width
and a collapsed state
wherein the distal body has a second height and width, the second height less
than said first
height, the second width less than said first width; and iii) a catheter
having an interior, a
proximal end leading to the interior and a distal end leading to the interior,
the catheter
comprised of a biocompatible material and configured to envelope the distal
body when said
distal body is in said collapsed state;
b) positioning the system in the lumen;
c) deploying the distal body from the distal end of the catheter;
d) allowing the height and width of said distal body to increase; and
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e) moving the memory metal strips towards each other and the pull wire so
as to
capture the obstruction. Optionally, the claw and the memory metal
strips are located at
the proximal end of said distal body and the distal body is deployed distal to
said object.
Optionally, the proximal memory metal strips have a proximal end forming the
proximal end of
the claw and a distal end, and the method includes moving the proximal ends of
the memory
metal strips towards each other and the pull wire so as to capture the
obstruction. Optionally, the
distal body further comprises a proximal hub/junction located in the distal
body interior, and a
distal hub/junction located distal relative to the proximal hub/junction, each
of the memory metal
strips has a proximal end and a distal end, each of the proximal ends of the
memory metal strips
is located proximal relative to the proximal hub/junction, and the proximal
ends of the memory
metal strips are configured to move towards each other and towards the pull
wire by moving the
proximal hub/junction distally and closer to the distal hub/junction, and the
proximal ends of the
memory metal strips are configured to move away from each other and away from
the pull wire
by moving the proximal hub/junction proximally and away from the distal
hub/junction, and the
method further comprises moving the proximal hub/junction distally and closer
to the distal
hub/junction so as to capture the obstruction in the claw. Optionally, the
interior lumen is an
intracranial artery and the obstruction is a blood clot. Optionally, the
method further comprises
using the clot to move the proximal hub/junction toward the distal
hub/junction and exert tension
on the proximal memory metal strips. Optionally, the method further comprises
using a tube to
move the proximal hub/junction toward the distal hub/junction and exert
tension on the proximal
memory metal strips.
[0011] The present invention also provides a method of manufacturing a system
for removing
objects within an interior lumen of an animal. In some embodiments, the method
includes:
a) providing a single tube comprised of a memory metal, the single tube
having an
exterior, a hollow interior, a wall separating the exterior from the hollow
interior, a proximal
portion comprising an aperture leading to the hollow interior, a distal
portion comprising an
aperture leading to the hollow interior, and a middle portion between the
proximal portion and
the distal portion;
b) cutting the wall of the middle portion with a laser;
c) removing the pieces of the middle portion cut by the laser to form a
proximal
tube, a middle portion comprising a plurality of memory metal strips attached
to the proximal
tube and a distal tube;
d) altering the shape of the middle portion;
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e)
allowing the middle portion to expand relative to the distal tube and
the proximal
tube;
cutting the memory metal strips to form a first segment comprising the
proximal
tube and a proximal segment of the memory metal strips, and a second segment
comprising the
distal tube and a distal segment of the memory metal strips; and
joining the proximal segments to the distal segments such that the distal
segments
form the proximal end of a distal body, such that the proximal tube is located
inside an interior of
said distal body, and such that the proximal tube is located distal relative
to the proximal end.
[0012] Optionally, the method further includes placing a pull wire through the
proximal tube
such that the proximal tube is slideable along at least a segment of the pull
wire. Optionally, the
method further includes attaching the pull wire to the distal tube.
Optionally, the step of joining
the proximal segments to the distal segments comprises welding or soldering
the proximal
segments to the distal segments. Optionally, after the step of joining the
proximal segments to
the distal segments, the proximal end forms a claw comprised of between 2 and
4 memory metal
strips, the claw memory metal strips configured to move towards each by moving
said proximal
tube distally and closer to the distal tube, and the claw memory metal strips
configured to move
away from each other by moving the proximal tube proximally and away from said
distal tube.
Optionally, the method further includes not altering the shape of the proximal
and distal portions
while altering the shape of the middle portion. Optionally, the method further
includes cooling
the proximal portion, the middle portion, and the distal portion after step D)
and, after cooling,
the proximal and distal portions have substantially the same size as the
proximal and distal
portions had prior to step A). Optionally, the method of allowing said middle
portion to expand
comprises heating the middle portion. Optionally, the method of altering the
shape of the middle
portion comprises using a mandrel.
Optionally, the mandrel is tapered. Optionally, the
proximal portion and the distal portion are not cut by the laser. Optionally,
prior to cutting the
memory metal tube, the memory metal tube has an outer diameter that is from
about 0.011
inches to about 0.054 inches and an inner diameter that is from about 0.008
inches to about 0.051
inches.
[0013] In an alternate embodiment, the present disclosure provides a system
for removing
objects from an interior lumen of an animal that includes:
a pull wire having a proximal end and a distal end;
a distal body attached to the pull wire, the distal body comprising an
interior, a proximal end, a
distal end, a distal body length extending from the proximal end to the distal
end, a proximal
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hub/junction (preferably in the form of a tube) forming the proximal end of
the distal body, a
basket comprised of a plurality of cells formed by a plurality of basket
strips, a plurality of
proximal strips, and, optionally a distal hub/junction (preferably in the form
of a tube) forming a
distal end of the basket, the basket comprising a basket interior, each
proximal strip having a
proximal end attached to the proximal hub/junction, and a distal end attached
to a cell, the distal
body having a relaxed state wherein the distal body has a first height and a
first width, and a
collapsed state wherein the distal body has a second height and a second
width, the second height
less than the first height, the second width less than the first width; and
a catheter having an interior, a proximal end leading to the interior and a
distal end leading to the
interior, the catheter comprised of a biocompatible material and configured to
envelope the distal
body when the distal body is in the collapsed state,
wherein, in the relaxed state, the basket comprises a first pair of distal
crowns not attached to
another cell of the basket and pointing generally in the distal direction, the
first pair of distal
crowns located approximately the same distance from the proximal hub/junction
and
approximately 180 degrees relative to each other (e.g., between about 150
degrees and about 180
degrees relative to each other), and further wherein the basket further
comprises a second pair of
distal crowns not attached to another cell of the basket and pointing
generally in the distal
direction, the second pair of distal crowns located distally relative to, and
approximately 90
degrees relative to, the first pair of distal crowns (e.g., each distal crown
of the second pair of
distal crowns is located approximately 60 degrees to 90 degrees relative to a
distal crown of the
first pair of distal crowns), the distal crowns in the second pair of distal
crowns located
approximately the same distance from the proximal hub/junction and further
wherein each of the
distal crowns in the first and second pair of distal crowns comprises an x-ray
marker, the x-ray
maker more visible under x-ray as compared to the basket strips when the
distal body is located
in a cranial blood vessel inside the body of a human and the x-ray is taken
from outside the
human's body. Optionally, instead of a distal hub/junction, the basket
includes an open distal
end.
[0014] Optionally, the x-ray markers are comprised of a material different
than the material
forming the basket strips. Optionally, in the relaxed state, the basket
interior is substantially
hollow. Optionally, in the relaxed state, the distal body does not have
another x-ray marker that
is located approximately the same distance from the proximal hub/junction as
the first pair of x-
ray markers and the distal body does not have another x-ray marker that is
located approximately
the same distance from the proximal hub/junction as the second pair of x-ray
markers. In other
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words, the first and second pair of x-ray markers are the only markers their
respective distances
from the proximal hub/junction. Optionally, each distal crown in the first and
second pair of
distal crowns forms part of an enlarged cell and further wherein the surface
area of each enlarged
cell in the relaxed state is greater than the surface area of each of the
other individual cells of the
basket and further wherein the enlarged cells are configured to allow a
thrombus to pass
therethrough and into the basket interior. Optionally, in the relaxed state,
the distal body does
not have another free distal-pointing crown that is located approximately the
same distance from
the proximal hub/junction as the first pair of distal crowns and the distal
body does not have
another free distal-pointing crown that is located approximately the same
distance from the
proximal hub/junction as the second pair of distal crowns. Optionally, the
basket strips are
comprised of a memory metal. Optionally, each of the distal crowns in the
first pair and second
pair of distal crowns curve radially inward toward the basket interior in the
relaxed state, wherein
the distal crowns of the first pair of distal crowns are configured to contact
each other when an
exterior, external compressive force (such as a thrombus) is exerted on a
distal crown of the first
pair of distal crowns when the distal body is in the relaxed state, and
further wherein the distal
crowns of the second pair of distal crowns are configured to contact each
other when an exterior,
external compressive force (such as a thrombus) is exerted on a distal crown
of the second pair
of distal crowns when the distal body is in the relaxed state. Optionally, the
proximal
hub/junction is located approximately in the center of the first height and
first width in the
relaxed state. For example, preferably the proximal hub/junction is located
within 0.5 mm of the
center of first width and the first height. Optionally, the catheter is
comprised of a polymeric
material (i.e., one or more polymeric materials such as silicone, PVC, latex
rubber or braided
nylon). Optionally, the pull wire is comprised of a biocompatible metallic
material (e.g., a
biocompatible metal or a biocompatible metal alloy). Optionally, the proximal
end of a first
proximal strip is located at least about 65 degrees (e.g., between about 65
and about 180 degrees)
relative to the distal end of the first proximal strip, wherein the proximal
end of a second
proximal strip is located at least about 65 degrees (e.g., between about 65
and about 180 degrees)
relative to the distal end of the second proximal strip, and further wherein
the first and second
proximal strips intersect adjacent and distal to the proximal hub/junction
(e.g., within about 0
and about 4 mm of the proximal hub/junction). Optionally, each distal crown
forms part of a cell
that further comprises a proximal crown pointing generally in the proximal
direction and
connected to a memory metal strip (e.g., a proximal strip comprised of a
memory metal or a
basket strip comprised of a memory metal). In other words, the proximal crowns
are not free.
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Optionally, the basket, the proximal hub/junction and the proximal strips are
comprised of a
memory metal, wherein the proximal hub/junction comprises a proximal end and a
distal end,
and further wherein the proximal strips are integral with the distal end of
the proximal
hub/junction. Optionally, the length of the distal body from the proximal
hub/junction to the
distal hub/junction (not including any lead wire) is from about 20 mm to about
65 mm.
Optionally, the system is used in a method of removing a blood clot from a
blood vessel of an
animal the method comprising the steps of:
a) providing the system;
b) positioning the system in the lumen,
c) deploying the distal body from the distal end of the catheter;
d) allowing the height and width of the distal body to increase;
e) irradiating the distal body with x-rays;
0 moving the clot into the distal basket interior; and
g) moving the distal body proximally out of the blood vessel.
[0015] Optionally, the method further comprises irradiating the distal body
with x-rays at at least
two different angles. Optionally, at least one x-ray marker attached to the
distal crowns is distal
to the clot when the distal body is deployed from the distal end of the
catheter. Optionally, the
method further comprises applying contrast dye proximally and distally to the
clot. Optionally,
the method further comprises providing a suction catheter having a proximal
end and a distal
end, and attaching the distal end of the suction catheter to the clot by
applying suction to the
suction catheter. Optionally, the method further comprises aspirating by hand
a pre-determined
volume of fluid from the suction catheter using a syringe and then locking the
syringe at the pre-
determined volume. Optionally, the method further comprises delivering the
suction catheter
adjacent to the clot by advancing the catheter over the pull wire.
[0016] In yet another embodiment, the system includes:
a pull wire having a proximal end and a distal end;
a distal body attached to the pull wire, the distal body comprising an
interior, a proximal end, a
distal end, a distal body length extending from the proximal end to the distal
end, a proximal
hub/junction (preferably in the form of a tube) forming the proximal end of
the distal body, a
basket comprised of a plurality of cells formed by a plurality of basket
strips, a plurality of
proximal strips, and optionally a distal hub/junction (preferably in the form
of a tube) forming a
distal end of the basket, the basket comprising a basket interior, each
proximal strip having a
proximal end attached to the proximal hub/junction, and a distal end attached
to a cell, the distal
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body having a relaxed state wherein the distal body has a first height and a
first width, and a
collapsed state wherein the distal body has a second height and a second
width, the second height
less than the first height, the second width less than the first width; and
a catheter having an interior, a proximal end leading to the interior and a
distal end leading to the
interior, the catheter comprised of a biocompatible material and configured to
envelope the distal
body when the distal body is in the collapsed state,
wherein, in the relaxed state, the basket comprises a first pair of distal
crowns not attached to
another cell of the basket and pointing generally in the distal direction, the
first pair of distal
crowns located approximately the same di stance from the proximal hub/junction
and
approximately 180 degrees relative to each other (e.g., between about 150
degrees and about 180
degrees relative to each other), and further wherein the basket further
comprises a second pair of
distal crowns not attached to another cell of the basket and pointing
generally in the distal
direction, the second pair of distal crowns located distally relative to, and
approximately 90
degrees relative to, the first pair of distal crowns (e.g., each distal crown
of the second pair of
distal crowns is located approximately 60 degrees to 90 degrees relative to a
distal crown of the
first pair of distal crowns), the distal crowns in the second pair of distal
crowns located
approximately the same distance from the proximal hub/junction, wherein each
distal crown of
the first and second pair of distal crowns form a cell, each cell further
comprising a proximal
crown pointing generally in the proximal direction and connected to a memory
metal strip,
wherein each of the distal crowns in the first pair and second pair of distal
crowns curve radially
inward toward the basket interior in the relaxed state, wherein the distal
crowns of the first pair
of distal crowns are configured to contact each other when an exterior,
external compressive
force (e.g., a thrombus) is exerted on a distal crown of the first pair of
distal crowns when the
distal body is in the relaxed state, and further wherein the distal crowns of
the second pair of
distal crowns are configured to contact each other when an exterior, external
compressive force
(e.g., a thrombus) is exerted on a distal crown of the second pair of distal
crowns when the distal
body is in the relaxed state. When it is said that a proximal crown pointing
generally in the
proximal direction and is connected to a memory metal strip, it is meant that
the proximal crown
is either connected to a basket strip or a proximal strip comprised of a
memory metal (e.g.,
nitinol). Optionally, instead of a distal hub/junction, the basket includes an
open distal end.
[0017] Optionally, the proximal hub/junction is located approximately in the
center of the first
height and first width in the relaxed state. For example, preferably the
proximal hub/junction is
located within 0.5 mm of the center of first width and the first height.
Optionally, the catheter is
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comprised of a polymeric material (i.e., one or more polymeric materials such
as silicone, PVC,
latex rubber or braided nylon). Optionally, the pull wire is comprised
of a biocompatible
metallic material (e.g., a biocompatible metal or a biocompatible metal
alloy). Optionally, in the
relaxed state, the basket interior is substantially hollow. Optionally, the
proximal end of a first
proximal strip is located at least about 65 degrees (e.g., between about 65
and about 180 degrees)
relative to the distal end of the first proximal strip, wherein the proximal
end of a second
proximal strip is located at least about 65 degrees (e.g., between about 65
and about 180 degrees)
relative to the distal end of the second proximal strip, and further wherein
the first and second
proximal strips intersect adjacent and distal to the proximal hub/junction
(e.g., within about 0
mm and about 4 mm of the proximal hub/junction). Optionally, each distal crown
in the first and
second pair of distal crowns forms part of an enlarged cell and further
wherein the surface area
of each enlarged cell in the relaxed state is at least twice as large as the
surface area of each other
individual cell of the basket and further wherein the enlarged cells are
configured to allow a
thrombus to pass therethrough and into the basket interior. Optionally, the
pull wire is attached
to the proximal hub/junction. Optionally, the basket, the proximal
hub/junction and the proximal
strips are comprised of a memory metal, wherein the proximal hub/junction
comprises a
proximal end and a distal end, and further wherein the proximal strips are
integral with the distal
end of the proximal hub/junction. Optionally, the distal body further
comprises a lead wire
extending distally from the distal hub/junction, the lead wire having a length
of from about 3 mm
to about 10 mm. Optionally, the distal hub/junction, the proximal
hub/junction, and the basket
are comprised of a nitinol having the same material composition and further
wherein the
proximal and the distal hubs/junctions are tubular and generally cylindrical
in shape and each has
an outer diameter and an inner diameter, the inner diameter forming apertures
of the proximal
and distal hubs/junctions and further wherein the outer diameters of the
proximal and distal
hubs/junctions are substantially the same size and further wherein the inner
diameters of the
proximal and distal hubs/junctions are substantially the same size.
Optionally, the length of the
distal body from the proximal hub/junction to the distal hub/junction (not
including any lead
wire) is from about 20 mm to about 65 mm.
[0018] Optionally, the system is used in a method of removing a blood clot
from a blood vessel
of an animal the method comprising the steps of:
a) providing the system;
b) positioning the system in the lumen;
c) deploying the distal body from the distal end of the catheter;
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d) allowing the height and width of the distal body to increase;
e) irradiating the distal body with x-rays;
0 moving the clot into the distal basket interior; and
g) moving the distal body proximally out of the blood vessel.
[0019] Optionally, the method further comprises irradiating the distal body
with x-rays at at least
two different angles.
100201 In still further embodiments, the present disclosure provides yet
another embodiment of a
system for removing objects from an interior lumen of an animal. The system
may include a pull
wire having a proximal end and a distal end. The system may also include a
distal body attached
to the pull wire (e.g., the distal end of the pull wire). The distal body may
include an interior, a
perimeter, a proximal end, a distal end, a distal body length extending from
the proximal end to
the distal end, a proximal junction forming the proximal end of the distal
body, a plurality of
proximal strips, a basket comprised of a plurality of cells formed by a
plurality of basket strips,
and a distal junction forming a distal end of the basket. The basket may
include a basket interior.
Each proximal strip may have a distal end attached to a cell and a proximal
end, and the
proximal ends of the proximal strips may converge at the proximal junction.
The distal body may
have a relaxed state wherein the distal body has a first height and a first
width, and a collapsed
state wherein the distal body has a second height and a second width, the
second height less than
the first height, the second width less than the first width. Optionally, in
the relaxed state, the
basket comprises a series of at least three pair of cells located on the
distal body perimeter
having a proximal crown pointing generally in the proximal direction and
attached to a memory
metal strip and a free distal crown pointing generally in the distal
direction. Optionally, in the
series, the proximal-most free distal crowns are located at the 12 and 6
o'clock positions and
located about the same distance (i.e., the same distance +/- 5 millimeters
(mm)) from the
proximal junction, the next proximal-most free distal crowns are located at
the 3 and 9 o'clock
positions and located about the same distance (i.e., the same distance +/- 5
mm) from the
proximal junction, and the succeeding proximal-most free distal crowns are
located at the 12 and
6 o'clock positions and located about the same distance (i.e., the same
distance +/- 5 mm) from
the proximal junction. Each free distal crown may form part of a different
enlarged cell that is
configured to allow a thrombus to enter the basket interior. Optionally, in
the relaxed state, the
basket comprises a plurality of distal cells distal to the distal-most free
distal crowns of the
series. The plurality of distal cells may have a proximal crown attached to
another cell of the
basket and pointing generally in the proximal direction and a distal crown
pointing generally in
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the distal direction and attached to the distal junction. Optionally, each
enlarged cell has a
proximal end, a distal end comprising a distal crown pointing generally in the
distal direction,
and a length extending from the proximal end to the distal end of the
respective enlarged cell.
Optionally, in the relaxed state, each distal cell has a length extending from
the proximal crown
to the distal crown of the respective distal cell. Optionally, in the relaxed
state, each of the
enlarged cells is longer than each of the distal cells. Optionally, for some,
most or each of the
enlarged cells, the distance from the proximal end of the enlarged cell to the
free distal crown of
the enlarged cell is less than the distance from the free distal crown of the
enlarged cell to the
distal end of the enlarged cell. Optionally, in the relaxed state, the basket
does not have any free
crowns that point generally in the proximal direction. Optionally, the distal
body, in the relaxed
state, comprises a distal tapered region in which the distal body height and
width decrease as the
basket approaches the distal junction. Optionally, each of the enlarged cells
is longer than each
of the pair of cells in the series. Optionally, in the relaxed state, each of
the enlarged cells
extends from the 6 o'clock position to the 12 o'clock position or the 3
o'clock position to the 9
o'clock position. Optionally, in the relaxed state, the basket further
comprises a plurality of
proximal cells proximal to the proximal-most free distal crowns of the series.
Optionally, the
plurality of proximal cells have a proximal crown attached to the proximal
junction and pointing
generally in the proximal direction and a distal crown pointing generally in
the distal direction
and attached to another cell of the basket. Optionally, the proximal crowns of
the cells
comprising the proximal-most free distal crowns are attached to the distal
ends of the proximal
strips. Optionally, in the relaxed state, for each of the enlarged cells, two
basket strips meet to
form the distal crown located at the distal end of the enlarged cell.
Optionally, each basket strip
has a basket strip proximal end, a basket strip distal end, and a basket strip
length extending from
the proximal end to the distal end. Optionally, for at least some, most, or
each of the enlarged
cells, the maximum angle between the two basket strips at the same location
along the distal
body length is at least 90 degrees. Optionally, in the relaxed state, for said
at least some, most or
each of the enlarged cells, two basket strips meet to form the free distal
crowns of the enlarged
cell, wherein each basket strip has a basket strip proximal end, a basket
strip distal end, and a
basket strip length extending from the proximal end to the distal end, and
further wherein the
maximum angle between the two basket strips at the same location along the
distal body length
is no more than 40 degrees. Optionally, for at least some, most or each of the
enlarged cells, the
average angle between the two basket strips is at least 90 degrees.
Optionally, for at least some,
most or each of the enlarged cells, each of the basket strip lengths are
approximately equal to 1/2
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of the distal body height and width. Optionally, from at least the proximal
crowns of the cells
comprising the next proximal-most free distal crowns to the proximal ends of
the enlarged cells
formed by the succeeding free distal crowns, the basket has no cells other
than the enlarged cells
and the cells comprising the free distal crowns. Optionally, from at least the
proximal-most free
distal crowns to the proximal ends of the enlarged cells formed by the
succeeding free distal
crowns, the basket has no cells other than the enlarged cells and the cells
comprising the free
distal crowns. Optionally, the distal crowns of the enlarged cells are
attached to another cell of
the basket. Optionally, in the relaxed state, the basket further comprises an
additional pair of
cells located about the same distance (i.e., the same distance +/- 5 mm) from
the proximal
junction as the cells comprising the proximal-most pair of free distal crowns
and located at the 9
and 3 o'clock positions. Optionally, each cell of the additional pair of cells
having a proximal
crown attached to a memory metal strip and a distal crown attached to another
cell of the basket.
Optionally, the additional pair of cells adjoin the enlarged cells formed by
the proximal-most
free distal crowns. Optionally, from at least the distal crowns of the
additional pair of cells to the
proximal ends of the enlarged cells formed by the succeeding free distal
crowns, the basket has
no cells other than the enlarged cells, the cells comprising the free distal
crowns and the
additional pair of cells. Optionally, in the relaxed state, the basket
comprises a series of bridge
memory metal strips having a proximal end attached to a distal crown of a cell
and a distal end
attached to a proximal crown of a distally-located cell. Optionally, a
proximal pair of bridge
memory metal strips are located at the 3 and 9 o'clock positions. Optionally,
a more distally-
located pair of bridge memory metal strips are located at the 12 and 6 o'clock
positions.
Optionally, each of the pair of bridge memory metal strips forms part of at
least one enlarged
cell. Optionally, the bridge memory metal strips are the sole distally-
extending basket strips
attached to the respective proximal crowns and the sole proximally-extending
basket strips
attached to the respective distal crowns. Optionally, in the relaxed state,
each of the pair of
bridge memory metal strips forms part of two enlarged cells. Optionally, the
bridge memory
metal strips are substantially parallel to the distal body length. Optionally,
the plurality of distal
cells is comprised of four cells located about the same distance (i.e., the
same distance +/- 5 mm)
from the proximal junction. Optionally, each cell has a center, and the
centers of the cells are
spaced at approximately 90 degree intervals about the distal body perimeter.
Optionally, each of
said four cells adjoins two of the other of said four cells. Optionally, each
of said four cells
comprises two lateral crowns pointing generally in a direction perpendicular
to the distal body
length and further wherein each lateral crown of one of said four cells
adjoins a lateral crown of
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an adjacent one of said four cells. Optionally, the distal body has no more
than four cells at any
location along the distal body length. Optionally, each of the enlarged cells
are approximately
the same size. Optionally, in the relaxed state, the basket interior is
substantially hollow.
Optionally, the basket comprises a series of at least five pairs of cells
located on the distal body
perimeter having a proximal crown pointing generally in the proximal direction
and attached to a
memory metal strip and a free distal crown pointing generally in the distal
direction, wherein in
the series, the next proximal-most free distal crowns after the succeeding
free distal crowns are
located at the 3 and 9 o'clock positions and located about the same distance
(the same distance
+/- 5 mm) from the proximal junction, and the distal-most free distal crowns
are located at the 12
and 6 o'clock positions and located about the same distance (the same distance
+/- 5 mm) from
the proximal junction. Optionally, the enlarged cells formed by the proximal-
most free distal
crowns are adjoining, the enlarged cells formed by the next proximal-most free
distal crowns are
adjoining and the enlarged cells formed by the succeeding free distal crowns
are adjoining.
Optionally, each of the enlarged cells formed by the next proximal-most free
distal crowns
adjoins an enlarged cell formed by a proximal-most free distal crown and an
enlarged cell
formed by a succeeding free distal crown. Optionally, the distal body further
comprises a lead
wire extending distally from the distal junction. Optionally, the system
further comprises a
catheter having an interior, a proximal end leading to the interior and a
distal end leading to the
interior, the catheter comprised of a biocompatible material and configured to
envelop the distal
body when the distal body is in the collapsed state. Optionally, for each
enlarged cell, the free
distal crown is aligned with the distal crown located at the distal end of the
enlarged cell.
Optionally, the distal body, in the relaxed state comprises a proximal tapered
region in which the
distal body height and width decrease as the proximal strips approach the
proximal junction.
Optionally, the system is used in a method of removing a blood clot from a
blood vessel of an
animal that includes: a) providing the system; b) positioning the system in
the blood vessel;
c) allowing the height and width of the distal body to increase; d) moving the
blood clot into the
basket interior; and e) moving the distal body proximally out of the blood
vessel.
[0021] Optionally, instead of three pair of cells in the series, the series
may include only two pair
of cells located on the distal body perimeter having a proximal crown pointing
generally in the
proximal direction and attached to a memory metal strip and a free distal
crown pointing
generally in the distal direction, and, in the series, the proximal-most free
distal crowns may be
located at the 12 and 6 o'clock positions and located about the same distance
(the same distance
+/- 5 mm) from the proximal junction, and the next proximal-most free distal
crowns may be
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located at the 3 and 9 o'clock positions and located about the same distance
(the same distance
+/- 5 mm) from the proximal junction. In such embodiment, the distal body and
system may
have any feature mentioned above in connection with the distal body having at
least three pairs
of cells with free distal crowns.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] FIG. IA illustrates a side, elevation view of a memory metal tube prior
to being cut by a
laser.
[0023] FIG. 1B illustrates a side, elevation view of the memory metal tube of
FIG. lA being cut
by a laser.
[0024] FIG. 2A illustrates a side, elevation view of the memory metal tube of
FIG. 1B after
being cut by a laser; in FIG. 2A, the tube is shown as though it were flat for
purposes of
illustrating the cut pattern only.
[0025] FIG. 2B illustrates a side, perspective view of the memory metal tube
of FIG. 1B after
being cut by a laser.
[0026] FIG. 2C illustrates another side, perspective view of the memory metal
tube of FIG. 1B
after being cut by a laser; in FIG. 2C, the tube is rotated as compared to
FIG. 2B.
[0027] FIGs. 3A-3H illustrate a method of manufacturing a distal body of one
embodiment of
the present invention using the laser cut memory metal tube of FIGs. 1 and 2;
in FIGs. 3A-3H,
the basket portion of the distal body is not shown for simplicity of
illustration.
[0028] FIGs. 4A-4D illustrate the welding steps of the method of manufacturing
shown in FIG.
3; in FIGs. 4A-4D, the basket portion of the distal body is not shown for
simplicity of
illustration.
[0029] FIGs. 5 and 6 illustrate different locations that connector strips may
be welded to the
proximal memory metal strips.
[0030] FIG. 7 illustrates a side, elevation view of a catheter and the distal
body of FIG. 6.
[0031] FIG. 8 illustrates a side, elevation view of a deployable system of one
embodiment of the
present invention being used to capture a blood clot; in FIG. 8, the basket
portion of the distal
body is not shown for simplicity of illustration.
[0032] FIG. 9 illustrates a side, elevation view of a claw of one embodiment
of the present
invention being closed by a claw actuator tube; in FIG 9, the basket portion
of the distal body is
not shown for simplicity of illustration.
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[0033] FIG. 10 illustrates a side, elevation view of a deployable system of
one embodiment of
the present invention being used to capture a blood clot; in FIG. 10, the
basket portion of the
distal body is not shown for simplicity of illustration.
[0034] FIG. 11 illustrates a first, perspective view of a distal body of an
alternate embodiment of
the present invention; the distal body is in what is referred to herein as
"Orientation 1".
[0035] FIG. 12A illustrates a second, perspective view of the distal body of
FIG. 11; the distal
body is in what is referred to herein as "Orientation 2".
[0036] FIG. 12B illustrates a proximal, elevation view of the proximal strips
of the distal body of
FIG. 11.
[0037] FIG. 13 illustrates a close-up, perspective view of two unattached
distal-pointing crowns
of the distal body of FIG. 11.
[0038] FIG. 14A illustrates a native memory metal tube used to manufacture the
distal body of
FIG. 11; the native tube has been rolled out flat and the lines in the tube
indicate where the tube
has been cut by a laser.
[0039] FIG. 14B illustrates a first, perspective view of the distal body
manufactured from the
native tube of FIG. 14A; the distal body is in Orientation 1.
[0040] FIG. 14C illustrates a second, perspective view of the distal body
manufactured from the
native tube of FIG. 14A; the distal body is in Orientation 2.
[0041] FIGs. 15A-G illustrate stepwise use of the distal body of FIG. 11 in
retrieving a soft clot;
the distal body is in Orientation 1.
[0042] FIGs. 16A-H illustrate stepwise use of the distal body of FIG. 11 in
retrieving a hard clot;
the distal body is in Orientation 1.
[0043] FIGs. 17A-G illustrate stepwise use of the distal body of FIG. 11 in
retrieving a soft clot;
the distal body is in Orientation 2.
[0044] FIGs. 18A-G illustrate stepwise use of the distal body of FIG. 11 in
retrieving a hard clot;
the distal body is in Orientation 2.
[0045] FIGs. 19A-N illustrate stepwise use of the distal body of FIG. 11 in
retrieving a
deformable, cohesive adherent clot; the distal body is in Orientation 2.
[0046] FIG. 20A illustrates a view of a native memory metal tube used to
manufacture a distal
body of yet another embodiment of the present invention; the native tube has
been rolled out flat,
the lines in the tube indicate where the tube has been cut by a laser, and the
distal body of FIGs.
20A-20C is slightly shorter than the distal body of FIGs. 11-19 and is meant
for use in tortuous
blood vessels.
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[0047] FIG. 20B illustrates a first, perspective view of the distal body
manufactured from the
native tube of FIG. 20A; the distal body is in Orientation 1.
[0048] FIG. 20C illustrates a second, perspective view of the distal body
manufactured from the
native tube of FIG. 20A, the distal body is in Orientation 2.
[0049] FIG. 21 shows a perspective view of a clot retrieval system that
includes the distal body
of FIGs. 20B-C being delivered in a blood vessel using a delivery catheter.
100501 FIG. 22 shows a perspective view of the distal body of FIG. 21, after
deployment of the
distal body and retraction of the delivery catheter, in a blood vessel.
[0051] FIG. 23 shows a perspective view of the distal body of FIG. 21; as
compared to FIG. 22,
the distal body has been moved proximally and tension has been exerted on the
pull wire.
[0052] FIG. 24 shows a perspective view of a suction catheter that is being
delivered over the
pull wire of the system of FIG. 21.
[0053] FIG. 25 shows a perspective view of the distal end of the suction
catheter of FIG. 24
being pushed into a clot; a syringe is sucking the clot to the suction
catheter because the user has
pulled back on the lever of the syringe.
[0054] FIG. 26 shows a perspective view of the distal end of the suction
catheter of FIG. 24
being pushed into a clot; in FIG. 26, the user has locked the syringe lever at
the desired volume.
[0055] FIG. 27 shows a perspective view of the system of FIG. 24; in FIG 27,
the suction
catheter has partially sucked the distal body and clot into the suction
catheter.
[0056] FIG. 28 shows a perspective view of the system of FIG. 24; in FIG. 28,
the suction
catheter has completely sucked the distal body and clot into the suction
catheter.
[0057] FIG. 29 shows a perspective view of the system of FIG. 24; the system,
and captured
clot, is being removed proximally from the vessel.
100581 FIG. 30 illustrates a right side perspective view of a mandrel used to
prepare unattached
distal-pointing crowns that curve radially toward the basket interior.
[0059] FIG. 31 illustrates a right side elevation view of the mandrel of FIG.
30.
[0060] FIG. 32 illustrates an alternate embodiment of a distal body; in the
distal body of FIG. 32,
the proximal strips converge and are soldered or welded at the proximal
hub/junction and the
basket strips located at the distal end of the basket converge and are
soldered or welded at the
distal hub/junction.
[0061] FIG. 33A illustrates a native memory metal tube used to manufacture a
distal body of
another embodiment of the present invention; the native tube has been rolled
out flat and the
lines in the tube indicate where the tube has been cut by a laser.
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[0062] FIG. 33B illustrates a first, perspective view of the distal body
manufactured from the
native tube of FIG. 33A; in FIG. 33B, the distal body is in Orientation 1.
[0063] FIG. 33C illustrates a second, perspective view of the distal body
manufactured from the
native tube of FIG. 33A, in FIG. 33C, the distal body is in Orientation 2.
[0064] FIG. 34A illustrates a first, perspective view of a distal body of
another embodiment of
the present invention; in FIG. 34A, the distal body is in Orientation 1.
100651 FIG. 34B illustrates a second, perspective view of the distal body of
FIG. 34A; in FIG.
34B, the distal body is in Orientation 2.
[0066] FIG. 35A illustrates a first, perspective view of a proximal portion of
a distal body of
another embodiment of the present invention; in FIG. 35A, the distal body is
in Orientation 1.
[0067] FIG. 35B illustrates a second, perspective view of the proximal portion
of the distal body
of FIG. 35A; in FIG. 35B, the distal body is in Orientation 2.
[0068] FIG. 36A illustrates a front perspective view of a distal body of
another embodiment of
the present invention; in FIG. 36A, the distal body is in the relaxed state.
[0069] FIG. 36B illustrates another front perspective view of the distal body
of FIG. 36A
without the proximal and distal hubs/junctions and pull wire.
[0070] FIG. 36C illustrates an enlarged front perspective view of the distal
body of FIG. 36A.
[0071] FIG. 36D illustrates an enlarged front perspective view of the area
labelled 36D in FIG.
36C .
[0072] FIG. 36E illustrates an enlarged front perspective view of the area
labelled 36E in FIG.
36C.
[0073] FIG. 36F illustrates an enlarged front perspective view of the area
labelled 36F in FIG.
36C.
100741 FIG. 36G illustrates an enlarged front perspective view of the area
labelled 36G in FIG.
36E.
[0075] FIG. 36H illustrates an enlarged front perspective view of the area
labelled 36H in FIG.
36F.
[0076] FIG. 361 illustrates a top plan view of the distal body of FIG. 36A.
[0077] FIG. 36J illustrates a front elevation view of the distal body of FIG.
36A.
[0078] FIG 36K illustrates a bottom plan view of the distal body of FIG 36A
[0079] FIG. 36L illustrates a rear elevation view of the distal body of FIG.
36A.
[0080] FIG. 36M illustrates a proximal elevation view of the distal body of
FIG. 36A; in FIG.
36M, the miniature clock faces illustrate the 12, 3, 6 and 9 o'clock
positions.
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[0081] FIG. 36N illustrates a distal elevation view of the distal body of FIG.
36A; in FIG. 36N,
the miniature clock faces illustrate the 12, 3, 6 and 9 o'clock positions.
[0082] FIG. 37A illustrates a front perspective view of a distal body of
another embodiment of
the present invention, in FIG. 37A, the distal body is in the relaxed state.
[0083] FIG. 37B illustrates another front perspective view of the distal body
of FIG. 37A
without the proximal and distal hubs/junctions and pull wire.
100841 FIG. 37C illustrates a top plan view of the distal body of FIG. 37A.
[0085] FIG. 37D illustrates a front elevation view of the distal body of FIG.
37A.
[0086] FIG. 37E illustrates a bottom plan view of the distal body of FIG. 37A.
[0087] FIG. 37F illustrates a rear elevation view of the distal body of FIG.
37A.
[0088] FIG. 37G illustrates an enlarged front elevation view of the area
labelled 37G in FIG.
37A.
[0089] FIG. 37H illustrates a proximal elevation view of the distal body of
FIG. 37A; in FIG.
37H, the miniature clock faces illustrate the 12, 3, 6 and 9 o'clock
positions.
[0090] FIG. 371 illustrates a distal elevation view of the distal body of FIG.
37A; in FIG. 371, the
miniature clock faces illustrate the 12, 3, 6 and 9 o'clock positions.
[0091] FIG. 37J illustrates an enlarged front perspective view of the area
labelled 37J in FIG.
37A.
[0092] FIG. 37K illustrates an enlarged rear elevation view of the area
labelled 37K in FIG. 37F.
[0093] FIG. 38 illustrates a side elevation view of a distal body and an
expandable suction
catheter of another embodiment of the present invention.
[0094] FIG. 39 illustrates a side elevation view of a non-expandable suction
catheter of another
embodiment of the present invention with the suction catheter made transparent
to show the
inner blocking catheter.
[0095] FIG. 39A illustrates a side elevation of a distal end of a suction
catheter of another
embodiment of the present invention.
[0096] FIG. 39B illustrates a side elevation of a distal end of a suction
catheter of another
embodiment of the present invention.
[0097] FIG. 40 illustrates a side perspective view of a distal body and an
expandable suction
catheter of another embodiment of the present invention.
[0098] FIG. 41 illustrates a side perspective view of a distal body and an
expandable suction
catheter of another embodiment of the present invention.
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[0099] FIG. 42 illustrates a side perspective view of a distal body, a portion
of an expandable
suction catheter and a guide catheter of another embodiment of the present
invention.
[00100] FIG. 43 illustrates a side perspective view of the
distal body and suction catheter
of FIG. 42.
[00101] FIG 44A illustrates a side perspective view of the
distal body and suction catheter
of FIG. 42 being used to capture a clot in a pulmonary blood vessel; as shown
by the arrows
pointing upward, the distal body is expanding into the clot; as shown by the
arrows pointing
toward the suction catheter, a suction force is drawing the clot towards the
suction catheter.
[00102] FIG 44B illustrates a side perspective view of the
distal body and suction catheter
of FIG. 44A being used to capture the clot; as compared to FIG. 44A, in FIG.
44B, the distal
body is fully expanded (i.e., fully in its relaxed state).
[00103] FIGs. 45A-45G illustrate side perspective views of the
stepwise sequence of the
distal body and suction catheter of FIG. 42 being used to capture a clot in a
pulmonary blood
vessel, with the guide catheter also shown in FIGs. 45B-45G, and with FIG. 45G
showing how
the clot is being moved proximally out of the blood vessel.
[00104] FIG. 46A illustrates a side perspective view of a
distal body and an expandable
suction catheter of another embodiment of the present invention.
[00105] FIG. 46B illustrates a side perspective closeup view of
the distal body and
expandable suction catheter of FIG. 46A.
DETAILED DESCRIPTION
[00106] With reference to FIGs. 1-10, the present disclosure
provides a deployable
system, generally designated by the numeral 10, for removing an obstruction
such as a blood clot
12 or other object from a blood vessel 14 or other interior lumen of an
animal. In addition to a
blood clot 12, the obstruction may be, for example, extruded coils during
aneurysm treatment,
intravascular embolic material such as onyx or other obstructions requiring
mechanical
intravascular removal from small distal vessels. In the drawings, not all
reference numbers are
included in each drawing for the sake of clarity.
[00107] Referring further to FIGs. 1-10, the deployable system
10 includes a pull wire 16
that has a proximal end (not shown) and a distal end 20. Optionally, the
diameter of the pull
wire is between about 0.008 inches and about 0.051 inches. Preferably, the
pull wire 16 is
comprised of a biocompatible metallic material.
[00108] The system 10 further includes a distal body 22, which
is attached to the pull wire
16. The distal body 22 has a proximal end 24, a distal end 26, an interior 28,
and an exterior 30.
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The distal body 22 has a collapsed state, wherein the distal body 22 has a
first height and width
and is configured to fit into a catheter 50 (see FIG. 10A), and a relaxed
state wherein the distal
body 22 has a different height 32 and width and is configured to expand to
about the height and
width of a human blood vessel 14 when the distal body 22 is deployed from the
catheter 50 (see
FIGS. 10B-G). The distal body 22 further includes a proximal hub/junction 74
and a distal
hub/junction 76 that is located distal relative to the proximal hub/junction
74. In some
embodiments, the distal body 22 includes a plurality of strips 40 comprised of
a memory metal
(e.g., a memory metal alloy such as nitinol) that form the proximal end 24 of
the distal body 22.
Optionally, the proximal memory metal strips 40 each have a distal end 44 and
a proximal end
42 that forms an openable and closeable claw 46. Optionally, the proximal
memory metal strips
40 are attached to the proximal hub/junction 74 through connector memory metal
strips 48. In
such embodiments, the proximal hub/junction 74 may be slideable along at least
a segment of the
pull wire 16, in contrast to the distal hub/junction 76, which is optionally
fixed to the pull wire
16 and not slideable along the pull wire 16. Moving the proximal hub/junction
74 distally and
closer to the distal hub/junction 76 (i.e., shortening the distance 88 between
the proximal
hub/junction 74 and distal hub/junction 76 by moving the proximal hub/junction
74 distally
while keeping the distal hub/junction 76 stationary) exerts tension on the
connector memory
metal strips 48 and, in turn, the proximal memory metal strips 40. This
tension, in turn, causes
the proximal ends 42 of the proximal memory metal strips 40 to move radially
toward each other
and the pull wire 16. As the proximal ends 42 of the proximal memory metal
strips 40 move
radially toward each other and the pull wire 16, the claw 46 (formed by the
proximal memory
metal strips 40) is brought from the open position to at least a partially
closed position, which in
turn, separates the obstruction 12 from the wall of the human lumen 14 and
captures the
obstruction 12. See FIG. 3H, FIG. 8, FIG. 9F, and FIG. 1OF and 10G.
Conversely, preferably,
movement of the proximal hub/junction 74 proximally and away from the distal
hub/junction 76
(i.e., increasing the distance 88 between the hubs/junctions 74 and 76)
releases the tension in the
proximal memory metal strips 40, which in turn, causes the proximal ends 42 of
the proximal
memory metal strips 40 to move away from each other and the pull wire 16,
opening the claw
46. The claw 46 and proximal hub/junction 74 form several functions. First, as
described, closing
of the claw 46 captures the obstruction 12. Second, closing the claw 46
retracts the claw 46 from
the wall of the lumen 14 so that the claw 46 does not scrape against (and
damage) the lumen wall
while capturing the obstruction 12. Third, closing the claw 46 reduces the
height and width of
the distal body 22, which allows the distal body 22 to be re-sheathed in the
catheter 50, which
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may be desired, for example, if the operator seeks to re-deploy the distal
body 22 in another
location in the body (which may be the case if the operator originally deploys
the distal body 22
in the wrong location in the lumen 14). For purposes of the present invention,
"closing the claw"
embraces both partially closing the claw 46 (where the proximal ends 42 of the
proximal
memory metal strips 40 do not contact the pull wire 16) and fully closing the
claw 46 (where the
proximal ends 42 contact the pull wire 16).
1001091 The claw 46 may be comprised of any number of proximal
memory metal strips
40. Preferably, however, between 2 and 4 proximal memory metal strips 40
comprise the claw
46 (it being understood that the connector strips 48, if present, merely serve
to tether the claw 46
to the proximal hub/junction 74). Preferably, the proximal memory metal strips
40 have a length
of between about 10 and about 60 millimeters. The proximal memory metal strips
40 can be
thought of as arms of the claw 46.
[00110] In some embodiments, the connector strips 48 are
integral with the proximal
hub/junction 74 (i.e., formed from the same piece of memory metal). In other
embodiments, the
proximal hub/junction 74 may be welded or soldered to the connector strips 48.
Optionally, in
the relaxed state, the proximal memory metal strips 42 are distributed
substantially evenly about
a perimeter of the distal body 22.
[00111] Optionally, the distal body 22 includes a lead wire 52
extending distally from the
distal body 22. Optionally, the lead wire 52 extends distally from the distal
hub/junction 76. If
present, the lead wire 52 may be used to facilitate movement of the system 10
in the lumen 14.
[00112] Optionally, the distal body 22 includes a basket 54
distal to the proximal memory
metal strips 40, the basket 54 comprised of a plurality of memory metal strips
56 distal relative
to the proximal memory metal strips 40. The distal memory metal strips 56 may,
for example,
form a basket 54 with a plurality of mesh openings 58. Optionally, the size of
the mesh openings
58 in the basket 54 when the distal body 22 is in its relaxed state is less
(preferably significantly
less) than the diameter of an average-sized ischemic blood clot 12 so that the
blood clot 12 does
not escape from the distal basket 54 after being captured by the distal body
22. Optionally, the
basket 54 has an open proximal end 60 and a substantially closed distal end
62, which is formed
by distal tube 76. Optionally, the distal and proximal hubs/junctions 74 and
76 and the distal
basket 54 are comprised of a nitinol having the same material composition.
Optionally, the size
of the mesh openings 58 decreases from the proximal end 60 of the basket 54 to
the distal end
62. The distal basket 54 is best seen in FIG. 2 and can be comprised of a
different number of cell
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patterns. The distal basket 54 is not shown in FIGs. 3-10 for ease of
illustrating the other
components in the system 10.
[00113] Optionally, the proximal hub/junction 74 and the distal
hub/junction 76 are
cylindrical tubes comprising substantially circular apertures that span the
length of the
hubs/junctions 74 and 76 and the hubs/junctions 74 and 76 have approximately
the same inner
diameter 72 and the same outer diameter 70. Preferably, the inner diameter 72
is at least slightly
larger than the diameter of the pull wire 16 so that the pull wire 16 can
slide through the
proximal hub/junction 74. In some embodiments, the outer diameters 70 of the
proximal and
distal hubs/junctions 74 and 76 may be from about 0.011 inches to about 0.054
inches and the
inner diameters 72 of the proximal and distal hubs/junctions 74 and 76 may be
from about 0.008
inches to about 0.051 inches.
[00114] Optionally, the distal body 22 further comprises an x-
ray marker 64 that is more
visible under x-ray as compared to the proximal memory metal strips 40 when
the distal body 22
is located in a cranial blood vessel inside the body of a human and the x-ray
is taken from
outside the human's body. If the connector strips 48 are welded or soldered to
the proximal
memory metal strips 40, the x-ray markers 64 may be, for example, located at
the welding or
soldering site. In some cases, the increased thickness at the welding or
soldering site may in of
itself comprise the x-ray marker 64. Preferably, the x-ray marker 64 is
comprised of a
radiopaque material. Some examples of radiopaque materials can include, but
are not limited to,
gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded
with radiopaque
filler, and the like. Preferably, the proximal memory metal strips 40 are
comprised of nitinol and
the x-ray marker 64 is comprised of a material having a density greater than
the nitinol.
[00115] A catheter 50 with an open proximal end (not shown) and
an open distal end 66
initially envelopes the system 10. As used herein, the term "catheter"
generally refers to any
suitable tube through which the system 10 can be deployed. Preferably, the
catheter 50 is sterile
and comprised of a biocompatible material (i.e., a material that does not
irritate the human body
during the course of a 45 minute operation that involves using the system 10
to remove a clot 12
from an intracranial blood vessel 14). The catheter 50 can be any suitable
shape, including but
not limited to generally cylindrical. Preferably, the catheter 50 is a
microcatheter. For purposes
of the present invention, when it is said that the catheter 50 envelopes the
system 10, it will be
understood that the catheter 50 envelopes at least one component of the system
10 (preferably,
the distal body 22, the lead wire 52, and the pull wire 16). In some
embodiments, the catheter 50
is about 2.5 French in diameter. Optionally, the catheter 50 is delivered to
the region of the
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lumen 14 that has the obstruction 12 as follows: a guide wire is delivered to
the obstruction
region past the obstruction 12; the catheter 50 is delivered over the guide
wire; the guide wire is
removed; and the system 10 is delivered with its pull wire 16 and lead wire 52
through the
catheter 50. Optionally, the pull wire 16 is used to push the system 10
through the catheter 50 as
well as to retrieve the distal body 22 after capturing the obstruction 14 as
described below. The
system 10 may utilize a plurality of catheters 50, such as, for example, a
wider catheter that
travels to the brain and a very flexible, smaller diameter microcatheter that
is delivered from the
first catheter and travels through the small arteries of the brain.
Preferably, the catheter 50 is
comprised of a biocompatible, polymeric material (i.e., one or more polymeric
materials such as
silicone, PVC, latex rubber or braided nylon).
[00116] Optionally, in the relaxed, opened-claw state, the
distal body 22 or optionally just
the distal basket 54 has a tapered shape (e.g., substantially conical or
bullet in shape) so that the
distal body 22 or just the distal basket 54 tapers from the distal body 22 or
the distal basket's 54
proximal end to the distal end.
[00117] The proximal end of the system 10 is shown at the left
end of FIGs. 1 and 3-10
and the distal end of the system 10 is shown at the right end of FIGs. 1 and 3-
10 because a
principal use of the system 10 is to remove a blood clot 12 from a human
intracranial artery 14,
in which case the system 10 generally will enter the artery 14 at its proximal
end by the surgeon
entering the patient's body near the groin and pushing the catheter 50 towards
the brain. The
diameter of human arteries 14 generally decrease from their proximal end to
their distal end.
However, when used in other types of lumens, the distal body 22 may be located
proximally
relative to the catheter 50 as the term proximally and distally are used in
that lumen.
[00118] The surgeon may deploy the distal body 22 by, for
example, moving the catheter
50 proximally so as to unsheathe the distal body 22 or by pushing the distal
body 22 out of the
catheter 50.
[00119] Use of the system 10 will now be described to remove a
blood clot 12 from an
intracranial artery 14 of a human ischemic stroke patient, however, it will be
appreciated that the
system 10 may be used to remove other objects from other interior lumens.
[00120] A catheter 50, which contains the collapsed distal body
22 is positioned in the
lumen 14 distal to the clot 12. See FIG 10A.
[00121] The distal body 22 is deployed from the catheter 50 and
the height and width of
the distal body 22 expand to about the height and width of the blood vessel
14. See FIG. 10B.
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[00122] The catheter 50 is pulled proximally and a claw-
actuator tube 90 is deployed into
the blood vessel 14. See FIG. 10C.
[00123] The distal body 22 is moved proximally so that the clot
12 is located in the
interior 28 of the distal body 22. See FIGs. 10D and 10E.
[00124] The claw-actuator tube 90 is moved distally, which
pushes the proximal
hub/junction 74 distally so that the distance 88 between the proximal
hub/junction 74 and the
distal hub/junction 76 (which is fixed to the pull wire 16 and kept
stationary) decreases. Distal
movement of the proximal hub/junction 74 exerts tension on the connector and
proximal
memory metal strips 40 and 48, which in turn, closes the claw 46. See FIG. 1
OF. (The claw
actuator tube 90 should float on the pull wire 16 ¨ i.e., have an aperture
extending the tube's
length that has a diameter larger than the diameter of the pull wire 16 ¨ and
the aperture of the
claw actuator tube 90 should be smaller than the diameter of the proximal
hub/junction 74 so that
the claw actuator tube 90 pushes the proximal hub/junction 74).
[00125] The system 10 is withdrawn proximally and removed from
the body. See FIG.
10G.
[00126] To test the efficacy of the system 10, a distal body 22
with a distal basket 54,
proximal and distal hubs/junctions 74 and 76, and a claw 46 comprised of three
proximal
memory metal strips 42 was tested in a flow model that included a tube and a
moist cotton ball
located in the tube. The cotton ball was used to simulate a blood clot. The
system 10 was
deployed distal to the cotton ball. The claw 46 was closed by moving the
proximal hub/junction
74 distally to capture the cotton ball. The system 10 and cotton ball were
withdrawn proximally
in the tube.
[00127] In some embodiments; the distal body 22 is prepared by
a process that includes
one or more of the following steps, as illustrated in FIGs. 1-4
a) providing a single tube 68 comprised of a memory metal such as nitinol,
the single tube
68 having an exterior, a substantially hollow interior, a wall separating the
exterior from the
substantially hollow interior, an open proximal end 74, an open distal end 76,
a middle portion
78 between the open proximal end 74 and the open distal end 76 (see FIG. 1A);
b) cutting the wall of the middle portion 78 with a laser 80 (see FIG. 1B);
c) removing the pieces of the middle portion 78 cut by the laser 80 to form
a proximal tube
74, a distal tube 76 and a middle portion 78 comprising a plurality of memory
metal strips 82
attached to the proximal tube 74;
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d) altering the shape of the middle portion 78 using a mandrel and allowing
the middle
portion 78 to expand relative to the distal tube 76 and proximal tube 74 to
form the distal basket
54;
e) quenching the middle portion 78 at room temperature,
0 removing the mandrel from the middle portion 78 (see FIGs. 2
and 3A);
g) mechanically or chemically electropolishing the middle portion 78 to
remove oxides;
h) cutting the memory metal strips 82 to form a first segment 84 comprising
the proximal
tube 74 and a proximal segment of the memory metal strips 82 and a second
segment 86
comprising the distal tube 76 and a distal segment of the memory metal strips
82 (see FIG. 3B);
and
i) joining the proximal segments to the distal segments such that the
distal segments form
the proximal end 24 of the distal body 22, such that the proximal tube 74 is
located inside the
interior 28 of the distal body 22, and such the proximal tube 74 is located
distal relative to the
distal body proximal end 24 (see FIGs. 3C-3E).
[00128] In some embodiments, the method further includes
placing the pull wire 16
through the proximal tube 74 so that the proximal tube 74 is slideable along
at least a segment of
the pull wire 16.
[00129] In some embodiments, the method further includes
attaching the pull wire 16 to
the distal tube 76 so that the distal tube 76 is not slideable along the pull
wire 16 but instead the
distal tube 76 moves with the pull wire 16.
[00130] In some embodiments, after step i, the proximal end 24
of the distal body 22
forms a claw 46 comprised of between 2 to 4 proximal memory metal strips 40,
the claw
proximal memory metal strips 40 configured to move towards each other and the
pull wire 16 by
moving the proximal tube 74 distally and toward the distal tube 76 (i.e.,
decreasing the distance
88 between the tubes 74 and 76) and the claw memory metal strips 40 configured
to move away
from each other and away from the pull wire (i.e., increasing the distance 88
between the tubes
74 and 76) by moving the proximal tube 76 proximally and away from the distal
tube 76 (as
described previously).
[00131] In some embodiments, the middle portion 78 is expanded
by heating the mandrel
and the middle portion 78 by, for example, placing the mandrel and the middle
portion 78 in a
fluidized sand bath at about 500 C for about 3 to about 7 minutes. As the
middle portion 78 is
heated, the heating causes the crystalline structure of the memory metal tube
68 to realign.
Preferably, the mandrel is tapered (e.g., substantially conical or bullet in
shape) so that the distal
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basket 54 formed from the middle portion 78 tapers from the proximal end 60 to
the distal end
62. Preferably, the proximal and distal ends of the tube 74 and 76 are not
shape set by the
mandrel and are not cut by the laser 80 so that the proximal and distal ends
74 and 76 do not
change in shape and only slightly expand in size under heating and return to
the size of the native
tube 68 after the heat is removed. Preferably, the laser cuts are programmed
via a computer. To
ensure that the laser cuts only one surface of the tube wall at the time (and
not the surface
directly opposite the desired cutting surface), the laser 80 is preferably
focused between the inner
and outer diameter of the desired cutting surface and a coolant is passed
through the memory
metal tube 68 so that the laser 80 cools before reaching the surface directly
opposite the desired
cutting surface.
[00132] The portions of the wall not cut by the laser 80 create
the distal basket 53,
proximal and distal tubes 74 and 76, and memory metal strips 40, 48 and 56, as
described.
[00133] Preferably, the memory metal selected for the native
tube 68 has a heat of
transformation below average human body temperature (37 C) so that the distal
body 22 has
sufficient spring and flexibility after deployment from the catheter 50 in the
human blood vessel
14.
[00134] In some embodiments, the native tube 68 (and hence the
distal and proximal tubes
74 and 76) have an outer diameter of less than about 4 French, e.g., a
diameter of about 1 to
about 4 French. In some embodiments, the diameter of the pull wire 16 is
between about 0.008
inches and about 0.051, as noted above, and in such embodiments, the diameter
of the pull wire
16 may be approximately equal to the inner diameter 72 of the native nitinol
tube 68.
[00135] Without being bound by any particular theory, it is
believed that manufacturing
the distal body 22 from a single memory metal tube 68 provides ease of
manufacturing and
safety from mechanical failure and provides tensile strength necessary for the
system 10 to
remove hard thrombus 12 and other obstructions.
[00136] The embodiments of Fi2tires 11-29
[00137] Figures 11-29 illustrate an alternate embodiment 200
that includes one or more of
the following additional features, as described below: twisting proximal
strips/tethers 252,
unattached/free distal-pointing crowns 258 that optionally curve inward and
have x-ray markers
244, and enlarged openings/drop zones 262 in the basket 246 immediately distal
to the
unattached, distal-pointing crowns 258 that allow the obstruction or other
object 270 to enter the
distal basket interior 222.
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[00138] More specifically, as shown in FIGs. 11-29, the system
200 may include a pull
wire 202 having a proximal end 204 and a distal end 206, as described above, a
distal body 216
attached to the pull wire 202, the distal body 216 comprising an interior 222,
a proximal end 218,
a distal end 220, a distal body length 226 extending from the proximal end 218
to the distal end
220, a distal body height 224, a proximal hub/junction 228 (preferably in the
form of a tube and
which has a proximal end 230 and a distal end 232) forming the proximal end
218 of the distal
body 216, a basket 246 comprised of a plurality of cells/openings 248 formed
by a plurality of
basket strips 291 that preferably are comprised of a memory metal, optionally
a distal
hub/junction 236 that forms the distal end of the basket 246 (preferably in
the form of a tube that
has a proximal end 238 and a distal end 240), and a plurality of proximal
strips 252 (preferably
the proximal strips 252 are comprised of a memory metal), each proximal strip
252 having a
proximal end 254 attached to the proximal hub/junction/tube 228, and a distal
end 256 attached
to a cell 248 (more specifically a proximal-pointing crown of a cell 248
located at the proximal
end of the basket 246), the basket comprising a basket interior 292, the
distal body 216 having a
relaxed state wherein the distal body 216 has a first height and width, a
collapsed state wherein
the distal body 216 has a second height and width, the second height less than
the first height, the
second width less than the first width; and a delivery catheter 208 for
delivering the distal body
216, as described above, having an interior 210, a proximal end 212 leading to
the interior 210
and a distal end 214 leading to the interior 210, the delivery catheter 208
comprised of a
biocompatible (preferably polymeric) material and configured to envelope the
distal body 216
when the distal body 216 is in the collapsed state. Optionally, the basket
interior 292 is
substantially hollow ¨ i.e., unlike U.S. Patent Publication No. 2013/0345739,
the basket interior
292 does not contain an inner elongate body. Optionally, instead of a distal
hub/junction 236,
the basket 246 includes an open distal end. Optionally, at least two cells 250
of the basket 246
comprise a proximal crown 260 pointing generally in the proximal direction and
a distal crown
258 pointing generally in the distal direction, and the distal crowns 258 of
the at least two cells
250 are not attached to another cell 248 of the basket 246. In other words,
the distal crowns 258
of at least two cells 250 are free floating and are not attached to any strip
except for the strips
forming part of the at least two cells 250; such distal crowns 258 are
referred to below as
unattached, distal-pointing crowns 258. Preferably, the distal tips of the
unattached, distal-
pointing crowns 258 terminate at an x-ray marker 244. (Cells labeled with the
numerals 250,
250A, 250B, 250C, and 250D refer to the at least two cells that include a
proximal crown 260
pointing generally in the proximal direction and an unattached, distal-
pointing crown 258, cells
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labeled with the numerals 262, 262A, 262B, 262C, and 26211 refer to the
enlarged cells/drop
zones adjacent to (preferably immediately distal to) an unattached, distal-
pointing crown 258,
and cells designated with numeral 248 refer to generally the cells of the
basket 246). (When it is
said that the enlarged cells/drop zones 262 are preferably immediately distal
to an unattached,
distal-pointing crown 258, it will be understood that at least a portion of an
enlarged cell/drop
zone 262 is immediately distal to an unattached, distal-pointing crown 258,
and that a portion of
the enlarged cell/drop zone 262 may be proximal to an unattached, distal-
pointing crown 258, as
shown in FIGs. 11-12 due to the shape of the enlarged cells/drop zones 262).
It will be
understood that part number 250 refers generally to one or more of the at
least two cells, whereas
part numbers 250A, 250B, 250C, and 25011 refer to a specific one of the at
least two cells.
Similarly, it will be understood that part number 262 refers generally to one
or more of the
enlarged cells/drop zones, whereas part numbers 262A, 262B, 262C, and 262D
refer to a specific
one of the enlarged cells/drop zones. Similarly, it will be understood that
part number 258 refers
generally to one or more of the unattached, distal-pointing crowns, whereas
part numbers 258A,
258B, 258C, and 25811 refer to a specific one of the unattached, distal-
pointing crowns.
[00139] Optionally, at least two of the unattached, distal-
pointing crowns 258 are located
approximately 180 degrees (e.g., about 150 to about 180 degrees) relative to
each other and
approximately the same distance from the proximal hub/junction/tube 228, as
best seen in FIG.
12A. Optionally, the basket 246 comprises a first pair of unattached, distal-
pointing crowns
258A and 258B, each of the first pair of unattached, distal-pointing crowns
258A and 258B is
located approximately the same distance from the proximal hub/junction/tube
228 and
approximately 180 degrees relative to each other, and the basket 246 further
comprises a second
pair of unattached, distal-pointing crowns 258C and 25811 located distally
relative to, and
approximately 90 degrees (e.g., between about 60 and about 90 degrees)
relative to, the first pair
of unattached, distal-pointing crowns 258A and 258B. Optionally, the second
pair of unattached,
distal-pointing crowns 258C and 25811 form cells 250C and 25011 that are
adjacent to, but offset
from, the cells 250A and 250B formed by the first pair of unattached, distal-
pointing crowns
258A and 258B. (In other words, optionally, the center of cell 250A is about
90 degrees relative
to the centers of cells 250C and 250D and optionally the center of cell 250B
is also about 90
degrees relative to the centers of cells 250C and 25013). Optionally, at least
one of (and
preferably all) the unattached, distal-pointing crowns 258A, 258B, 258C or
25813 comprise an x-
ray marker 244 that is more visible under x-ray as compared to the basket
strips 291 when the
distal body 216 is located in a cranial blood vessel 266 inside the body of a
human and the x-ray
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is taken from outside the human's body. Preferably, the x-ray marker 244 is a
radiopaque
material. Some examples of radiopaque materials can include, but are not
limited to, gold,
platinum, palladium, tantalum, tungsten alloy, polymer material loaded with
radiopaque filler,
and the like. Preferably, the basket strips 291 are comprised of nitinol and
the x-ray marker 244
is comprised of a material having a density greater than the nitinol. In some
embodiments, the x-
ray markers 244 comprise a heavy metal welded or soldered to the unattached,
distal-pointing
crowns 258. Optionally, the unattached, distal-pointing crowns 258 curve
subtly towards the
interior 222 of the distal basket 246, which decreases the likelihood that the
unattached, distal-
pointing crowns 258 will rub against and damage the vessel wall 268.
Optionally, the basket 246
comprises at least two cells proximal to the at least two cells 250 that
include the unattached,
distal-pointing crowns 258. Optionally, the unattached, distal-pointing distal
crowns 258 are
located about at least 5 mm (e.g., about 5 to about 30 mm) from the proximal
hub/junction/tube
228. Optionally, the unattached, distal-pointing crowns 258 are located at
least about 5 mm from
the distal hub/junction/tube 236. Optionally, the unattached, distal-pointing
crowns 258 of the at
least two cells 250 also each form part (namely a portion of the proximal
boundary) of an
enlarged cell 262 (which is the entry point of hard thrombus 270B into the
basket interior 222)
and further wherein the surface area of the enlarged cells 262 in the relaxed
state is greater than
the surface area of the other cells of the basket 246 in the relaxed state.
Optionally, the
unattached, distal-pointing crowns 258 serve several functions: 1) they form
flex points of the
basket 246, which makes it easier for the system 200 to navigate the curves of
the blood vessels
266 of the brains; 2) through the use of x-ray markers 244 on the unattached,
distal-pointing
crowns 258, they allow the operator to locate the enlarged cells 262 of the
basket 246 that form
the point at which hard thrombuses 270B enter the basket 246; and 3) they
allow the operator to
ratchet or force the object 270 into the basket 246 by moving the unattached,
distal-pointing
crowns 258 proximally and distally relative to the object 270. (As explained
below, the numeral
270 refers to clots/thrombuses and other objects generally, and 270A refers to
a soft clot, 270B
refers to a hard clot and 270C refers to a deformable, cohesive, adherent
clot). Optionally, the
proximal end 254 of a proximal strip 252 is located about 65-180 degrees
(preferably
approximately 180 degrees) relative to the distal end 256 of the same proximal
strip 252, as best
seen in FIG 12B. In other words, preferably the proximal end 254 of a first
proximal strip 252
is attached to the 12 o'clock position on the proximal tube 228 and the distal
end 256 of the first
proximal strip 252 (which terminates at a proximal cell 248 of the basket 246)
is located at the 6
o'clock position (i.e., 180 degrees from the start position), and the proximal
end 254 of a second
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proximal strip 252 is attached to the 6 o'clock position on the proximal tube
228 and the distal
end 254 (which terminates at a cell 248 of the basket 246) of the second
proximal strip 252 is
located at the 12 o'clock position (i.e., 180 degrees from the start
position). This twisting
feature serves two functions. 1) it allows the proximal strips 252 to surround
the object 270; and
2) it allows the manufacturer to insert a mandrel into the basket 246 during
the shape-setting
procedure. Optionally, the pull wire 202 is attached to the proximal tube 228
(e.g., by gluing,
welding, soldering or the like). Preferably, the pull wire 202 does not extend
through the distal
basket interior 222. Optionally, the proximal strips 252 are integral with the
distal end 232 of the
proximal tube 228 and the entire distal body 216 is created from a single tube
264 of a memory
metal. Optionally, the proximal crowns 260 of the at least two cells 250 that
include the
unattached, distal pointing-crowns 258 are each attached to another cell 248
of the basket 246.
In other words, preferably the basket 246 does not have any free-floating
proximal-pointing
crowns, as free-floating proximal-pointing crowns could damage the vessel 266
when the distal
body 216 is pulled proximally. Optionally, the system 200 further comprises a
lead wire 286
extending distally from the distal tube 236, the lead wire 286 having a length
of from about 3
mm to about 10 mm.
Optionally, the distal hub/junction/tube 236, the proximal
hub/junction/tube 228, and the basket 246 are comprised of a nitinol having
the same material
composition. In other words, as with the prior embodiment of FIGs. 1-10,
optionally the entire
distal body 216 is manufactured from a single tube of nitinol 264. Optionally,
the proximal and
distal hubs/junctions/tubes 228 and 236 comprise an x-ray marker 244 that is
more visible under
x-ray as compared to the basket strips 291 when the distal body 216 is located
in a cranial blood
vessel 266 inside the body of a human and the x-ray is taken from outside the
human's body.
Preferably, the x-ray marker 244 is a radiopaque material. Some examples of
radiopaque
materials can include, but are not limited to, gold, platinum, palladium,
tantalum, tungsten alloy,
polymer material loaded with radiopaque filler, and the like. Preferably, the
basket strips 291 are
comprised of nitinol and the x-ray marker 244 is comprised of a material
having a density greater
than the nitinol. In some embodiments, the proximal and distal
hubs/junctions/tube interiors 234
and 242 may comprise tantalum welded or otherwise attached to the interior 234
and 242 of the
proximal and distal hubs/junctions/tubes 228 and 236. Optionally, the proximal
and the distal
tubes 228 and 236 are generally cylindrical in shape and each has an outer
diameter and an inner
diameter, the inner diameter forming apertures of the proximal and distal
tubes 228 and 236 and
further wherein the outer diameters of the proximal and distal tubes 228 and
236 are
substantially the same size and further wherein the inner diameters of the
proximal and distal
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tubes 228 and 236 are substantially the same size. Optionally, the outer
diameters of the
proximal and distal tubes 228 and 236 are from about 0.011 inches to about
0.054 inches, and
further wherein the inner diameters of the proximal and distal tubes 228 and
236 are from about
0.008 inches to about 0.051 inches. Optionally, the pull wire 202 is generally
cylindrical and
further wherein the diameter of the pull wire 202 is between about 0.008
inches and about 0.051
inches. Optionally, the distal body 216 has a length of between about 10 and
about 60
millimeters. Optionally, the first height 224 and first width 226 of the
distal body 216 are
between about 2 millimeters and about 6 millimeters.
[00140] The present disclosure also provides a method of
removing a clot or other object
270 from an interior lumen 266 of an animal, the method comprising the steps
of:
a) providing the system 200 of Figures 11-29, wherein at least two cells
250 of the
basket 246 comprise a proximal crown 260 pointing generally in the proximal
direction and a
distal crown 258 pointing generally in the distal direction, and the distal
crowns 258 of the at
least two cells 250 are not attached to another cell 248 of the basket 246
(i.e., free-floating), and
further wherein at least one of the unattached, distal-pointing crowns 258
comprises an x-ray
marker 244;
b) positioning the system 200 in the lumen 266;
c) deploying the distal body 216 from the distal end 214 of the delivery
catheter 208;
d) allowing the height and width 224 and 226 of the distal body 216 to
increase;
e) irradiating the x-ray marker 244 with x-ray radiation and
moving the object 270 into the distal basket interior 222.
[00141] Optionally, the object 270 enters the distal basket
interior 222 adjacent to
(preferably adjacent and immediately distal to) at least one of the
unattached, distal-pointing
crowns 258 ¨ i.e., in the enlarged cells/drop zones 262. In some embodiments,
the distal body
216 is deployed so that at least one (e.g., preferably the two proximal 258A
and 258B) of the
unattached, distal-pointing crowns 258 is distal to the object 270. As
explained below, the x-ray
markers 244 of the unattached, distal-pointing crowns 258 are used to locate
the distal body 216
relative to the clot or other object 270. It will be appreciated that clots
270 can generally be
located in blood vessels 266 by injecting a contrast dye, for example, into
the blood vessel 266
proximal and distal to the believed area of obstruction and viewing on an x-
ray where the fluid
stops moving in the blood vessel 266. It will also be appreciated that if the
object 270 is not a
blood clot but is a radio-opaque object, the object 270 may be viewed on an x-
ray.
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[00142]
FIGs. 11 and 14B illustrate a first, perspective view of one embodiment
of a distal
body 216 with twisting proximal strips 252, unattached distal-pointing crowns
258 that subtly
curve inward and have x-ray markers 244, and enlarged openings/drop zones 262
in the basket
246 that allow the obstruction or other object 270 to enter. In FIGs. 11 and
14B, the distal body
216 is in Orientation 1. (To prepare a basket 246 with unattached distal-
pointing crowns 258
that curve inward toward the basket interior 292, a mandrel 900 such as that
illustrated in FIGs.
63 and 64 may be used. The mandrel 900 includes a generally cylindrical body
901 with tapered
proximal and distal ends 902 and 903 that slope like the ends of a pencil. The
cylindrical body
901 includes two grooves 904 that extend around the circumference of the
cylindrical body 901.
The grooves 904 include tapered portions 905 that slope towards the distal end
903, which are
designed to shape the unattached distal-pointing crowns 258. The grooves 904
are generally in
the shape of a truncated cone, as shown in FIGs. 30-31). The two proximal,
unattached distal-
pointing crowns 258A and 258B are located approximately the same distance from
the proximal
hub/junction/tube 228 and are oriented approximately 180 degrees relative to
each other. The
two distal, unattached distal-pointing crowns 258C and 258D are located
approximately the
same distance from the proximal hub/junction/tube 228 as each other (and
distal to the two
proximal, unattached distal-pointing crowns 258A and 258B) and are oriented
approximately
180 degrees relative to each other and approximately 90 degrees to the
proximal, unattached
distal-pointing crowns 258A and 258B.
For example, for purposes of FIGs. 11-29,
"approximately the same distance from the proximal hub/junction/tube 228"
means that if one
free distal crown 258A of the first pair of distal crowns 258A/258B is located
X distance from
the proximal hub/junction/tube 228, the other distal crown 258B of the first
pair of distal crowns
258A/258B is located X distance plus or minus (+/-) 3 millimeters (mm) from
the proximal
hub/junction/tube 228. Similarly, if one free distal crown 258C of the second
pair of distal
crowns 258C/258D is located Y distance from the proximal hub/junction/tube
228, the other
distal crown 258D of the second pair of distal crowns 258C/25813 is located Y
distance plus or
minus (+/-) 3 mm from the proximal hub/junction/tube 228. In a preferred
embodiment, the first
free distal crowns 258A and 258B are located the same distance +/- 0.5 mm from
the proximal
hub/junction/tube 228. Similarly, in a preferred embodiment, the second free
distal crowns
258C and 258D are located the same distance +/- 0.5 mm from the proximal
hub/junction/tube
228.
[00143]
The two proximal enlarged openings/drop zones 262A and 262B distal to
the
proximal, unattached distal pointing crowns 258A and 258B are located
approximately the same
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distance from the proximal hub/junction/tube 228 and the centers of the two
proximal enlarged
openings/drop zones 262A and 262B are oriented approximately 180 degrees
relative to each
other. (As noted above, preferably, the proximal, unattached distal-pointing
crowns 258A and
258B form part of the proximal boundary of the proximal, enlarged cells/drop
zones 262A and
262B, and the distal, unattached distal-pointing crowns 258C and 258C form
part of the
proximal boundary of the distal, enlarged cells/drop zones 262C and 26211).
The two distal,
enlarged openings/drop zones 262C and 262D distal to the distal, unattached
distal pointing
crowns 258C and 258D are located approximately the same distance from the
proximal
hub/junction/tube 228 and the centers of the distal, enlarged openings/drop
zones 262C and
26211 are oriented approximately 180 degrees relative to each other and
approximately 90
degrees relative to the proximal enlarged openings/drop zones 262A and 262B.
FIGs. 12A and
14C illustrate a second view of the distal body 216 of FIG. 11 (Orientation
2). FIG. 13 is a
close-up view of two unattached, distal-pointing crowns 262. The lines in FIG.
14 show how a
nitinol tube 264 is cut with a laser to create the distal body 216 shown in
FIG. 14B and FIG.
14C. It will be appreciated that FIG. 14B is a simplified view of the distal
body 216 and
orientation shown in FIG. 11 and FIG. 14C is a simplified view of the distal
body 216 and
orientation shown in FIG. 12A.
[00144] As described below, FIGs. 15-19 describe how the distal
body 216 is used to
retrieve, soft clots 270A, hard clots 270B, and deformable, cohesive adhesive
clots 270C in a
human intracranial artery 266. (In FIGs. 15-19, the center of the artery 266
is denominated by
the dashed line). As explained below, the distal body 216 has four rows of x-
ray markers
namely, 1) a first row of one x-ray marker, which is located inside the
proximal tube
denominated by the numeral 228, 244; 2) a second row of two x-ray markers,
which are located
at the two proximal, unattached distal-pointing crowns (the two markers are
oriented 180 degrees
relative to each other) denominated by the numerals 258A, 244 and 258B, 244;
3) a third row of
two x-ray markers, which are located at the two distal, unattached distal-
pointing crowns (these
two markers are oriented 180 degrees relative to each other and 90 degrees
relative to the two
proximal, unattached distal-pointing crowns) denominated by the numerals 258C,
244 and 2580,
244; and 4) a fourth row of one x-ray marker, which is located inside the
distal tube denominated
by the numeral 236, 244 (It will be appreciated that the first number in the
sequence describes
the position of the x-ray marker and the second number, 244, represents the
fact that the item is
an x-ray marker). As explained below, upon deploying the distal body 216 so
that the two
proximal, unattached distal-pointing crowns 258A, 244 and 258B, 244 are
immediately distal to
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the clot 270, the surgeon interventionalist (i.e., operator of the distal body
216) detects the four
rows of x-ray markers using x-ray radiation from a first vantage point and
from a second vantage
point that is offset from the first vantage point (e.g. 90 degrees). Next, the
surgeon moves the
distal body 216 proximally relative to the clot 270 and takes additional x-
rays from the first and
second vantage points. As explained in greater detail below, the surgeon uses
the x-ray markers
of the proximal and distal, unattached distal-pointing crowns. namely 258A,
244; 258B, 244;
258C, 244; and 258D, 244 (more specifically, the convergence or lack thereof
of the proximal
and distal, unattached distal-pointing crowns 258A, 244; 258B, 244; 258C, 244;
and 258D, 244
as shown on the x-ray) to determine whether the clot 270 is located inside the
distal body interior
222 or whether the clot 270 is collapsing the distal body 216.
1001451 More specifically, FIGs. 15A-G illustrate stepwise use
of the distal body 216 in
retrieving a soft clot 270A in a human intracranial artery 266. (The distal
body 216 in FIGS.
15A-15G is in Orientation 1). First, as always, the surgeon determines the
location of the clot
270A in the vessel 266 using, for example, a contrast dye injected proximal
and distal to the clot
270A. Next, the delivery catheter 208, which is enveloping the distal body
216, is positioned in
the blood vessel 266 so that the two proximal, unattached distal-pointing
crowns 258A and 258B
are immediately distal to the clot 270A. See FIG. 15B. The distal body 216 is
then deployed
from the delivery catheter 208 by moving the catheter 208 proximally. The soft
clot 270A,
which is unable to collapse the distal body 216, then enters the distal body
interior 222. See FIG.
15C. However, at this time, the surgeon is unaware that the clot 270A has
entered into the distal
body interior 222. Thus, without moving the distal body 216, the surgeon
irradiates the four
rows of x-ray markers at a first vantage point (i.e., from the front of the
distal body 216 in the
orientation shown in FIGs. 15A-G; i.e., into the page). As shown in FIG. 15D,
the first vantage
point shows four rows of x-ray markers. The first row is a single point, which
represents the x-
ray marker located in the proximal tube 228, 244; the proximal tube x-ray
marker 228, 244
always appears as a single point. The second row is a single point, which
represents the x-ray
marker located at the front, proximal, unattached distal-pointing crown 258B,
244; the reason
that this second row of markers is a single point is that the rear x-ray
marker of the second row
258A, 244 is hidden from view because it is directly behind the front x-ray
marker of the second
row 258B, 244 The third row has two points, which represents the two x-ray
markers located at
the distal, unattached distal-pointing crowns 258C, 244 and 258D, 244; the
reason that this third
row of markers has two points is that neither marker in the third row 258C,
244 and 258D, 244 is
hidden from view on the x-ray at this angle ¨ rather, one marker 258C, 244 is
located above the
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other marker 258D, 244- and as shown in FIG. 15C, the distal body 216 is not
collapsed at the
distal, unattached distal-pointing crowns 258C, 244 and 258D, 244. The fourth
row is a single
point, which represents the x-ray marker located in the distal tube 236, 244;
the distal tube x-ray
marker 236, 244 always appears as a single point. Without moving the distal
body 216, the
surgeon then irradiates the four rows of x-ray markers from a second vantage
point 90 degrees
offset from the first vantage point (i.e., from the bottom of the distal body
216 in the orientation
shown in FIG. 15A). As shown, the first row is, as always, a single point,
which represents the
x-ray marker located in the proximal tube 228, 244. The second row has two
points, which
represents the two x-ray markers located at the proximal, unattached distal-
pointing crown 258A,
244 and 258B, 244; the reason that this second row of markers shows up as two
points is that
neither marker 258A, 244 and 258B, 244 in the second row is hidden from view
on the x-ray at
this offset angle - rather, one marker 258B, 244 is located above the other
marker 258A, 244 -
and the distal body 216 is not collapsed at the proximal, unattached distal-
pointing crowns 258A,
244 and 258B, 244. The third row is a single point, which represents the x-ray
marker located at
the bottom, distal, unattached distal-pointing crown 2580, 244; the reason
that this third row of
markers is a single point is that the top x-ray marker of the third row 258C,
244 is directly
behind the bottom x-ray marker of the third row 258D, 244, and thus, hidden
from view. The
fourth row is, as always, a single point, which represents the x-ray marker
located in the distal
tube 236, 244. The surgeon, thus, concludes that neither the x-ray markers at
the second row
258A, 244 and 258B, 244 nor the x-ray markers at the third row 258C, 244 and
258D, 244 (i.e.,
the x-ray markers at both the proximal and distal unattached distal pointing-
crowns) have
converged. As shown in FIG. 15E, the surgeon then moves the distal body 216
proximally
relative to the soft clot 270A so that the distal, unattached distal-pointing
crowns 258C, 244 and
2580, 244 are immediately distal to the clot 270A and then the surgeon
irradiates the four rows
of x-ray markers again from the first vantage point and the second vantage
point. As shown in
FIG. 15F, the results are the same as FIG. 15D. With the results from FIGs.
15D and 15F, the
surgeon concludes that neither x-ray markers at the second row 258A, 244 and
258B, 244 nor
the x-ray markers at the third row 258C, 244 and 2580, 244 (i.e., the x-ray
markers at both the
proximal and distal unattached distal pointing-crowns) converged at either the
original position
of the distal body 216 (FIGs. 15C and 15D) or the position after moving the
distal body 216
proximally (FIGs. 15E and 15F), and, thus, the distal body 216 was expanded in
the vessel 266
in both positions. Thus, the surgeon concludes that the clot is a soft clot
270A that has entered
into the distal body interior 222 and the surgeon removes the distal body 216
and the soft clot
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270A, captured by the distal body 216, by moving the distal body 216
proximally out of the
vessel 266, as shown in FIG. 15G.
[00146] FIGs. 16A-H illustrate stepwise use of the distal body
216 in retrieving a hard clot
270B in a human intracranial artery 266. (In FIGs. 16A-H, the distal body 216
is in Orientation
1). First, as always, the surgeon determines the location of the clot 270B in
the vessel 266 using,
for example, a contrast dye injected proximal and distal to the clot 270B.
Next, the delivery
catheter 208, which is enveloping the distal body 216, is positioned in the
blood vessel 266 so
that the two proximal, unattached distal-pointing crowns 258A and 258B are
immediately distal
to the clot 270B. See FIG. 16B. The distal body 216 is then deployed from the
delivery catheter
208 by moving the catheter 208 proximally. The hard clot 270B, which is
located above the
distal body 216, collapses the distal body 216, as shown in FIG. 16C. However,
at this time, the
surgeon is unaware that the clot 270B has collapsed the distal body 216. Thus,
without moving
the distal body 216, the surgeon in-adiates the x-ray markers at a first
vantage point (i.e., from the
front of the distal body 216; i.e., into the page). As shown in FIG. 16D, the
first vantage point
shows four rows of x-ray markers. The first row is, as always, a single point,
representing the x-
ray marker located in the proximal tube ¨ i.e., 228, 244. The second row is a
single point, which
represents the x-ray marker located at the front, proximal, unattached distal-
pointing crown
258B, 244; the reason that this second row of markers is a single point is
that the rear x-ray
marker of the second row 258A, 244 is hidden from view because it is directly
behind the front
x-ray marker of the second row 258B, 244. The third row has two points, which
represents the
two x-ray markers located at the distal, unattached distal-pointing crowns
258C, 244 and 2580,
244; the reason that this third row of markers has two points is that neither
marker in the third
row is hidden from view on the x-ray at this angle ¨ rather, one marker 258C,
244 is located
above the other marker 2580, 244 ¨ and as shown in FIG. 16C, the distal body
216 is not
collapsed at the distal, unattached distal-pointing crowns 258C, 244 and 2580,
244. The fourth
row is, as always, a single point, representing the x-ray marker located in
the distal tube 236,
244. Without moving the distal body 216, the surgeon then irradiates the
markers from a second
vantage point 90 degrees offset from the first vantage point (i.e., from the
bottom of the distal
body 216). As shown, the first row is, as always, a single point, which
represents the x-ray
marker located in the proximal tube 228, 244 The second row has two points,
which represents
the two x-ray markers located at the proximal, unattached distal-pointing
crowns 258A, 244 and
258B, 244; the reason that this second row of markers shows up as two points
is that neither
marker in the second row is hidden from view on the x-ray at this offset angle
¨ rather, one
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marker 258B, 244 is located above the other marker 258A, 244 - and although
the distal body
216 is collapsed at the proximal, unattached distal-pointing crowns as shown
in FIG. 16C, the
second row of x-ray markers have not converged because the clot 270B is on top
of the second
row of x-ray markers. The third row is a single point, which represents the x-
ray marker located
at the bottom, distal, unattached distal-pointing crown 2580, 244; the reason
that this third row
of markers is a single point is that the top x-ray marker of the third row
258C, 244 is directly
behind the bottom x-ray marker of the third row 258D, 244, and thus, hidden
from view. The
fourth row is, as always, a single point, which represents the x-ray marker
located in the distal
tube 236, 244. The surgeon, thus, concludes that neither the second row 258A,
244 and 258B,
244 nor the third row 258C, 244 and 258D, 244 of x-ray markers (i.e., the x-
ray markers at both
the proximal and distal unattached distal pointing-crowns) has converged. As
shown in FIG.
16E, the surgeon then moves the distal body 216 proximally so that the distal,
unattached distal-
pointing crowns 258C, 244 and 258D, 244 are immediately distal to the clot
270B and the
surgeon then irradiates the x-markers again from the first vantage point. As
shown in FIG. 16F,
the first row is, as always, a single point, representing the x-ray marker
located in the proximal
tube 228, 244. The second row is a single point, which represents the x-ray
marker located at the
front, proximal, unattached distal-pointing crown 258B, 244; the reason that
this second row of
markers is a single point is that the rear x-ray marker of the second row
258A, 244 is hidden
from view because it is directly behind the front x-ray marker of the second
row 258B, 244. The
third row has only one point because the clot 270B, which is on top of the
third row of x-ray
markers 258C, 244 and 2580, 244 (i.e., the markers at the distal, unattached
distal-pointing
crowns), has pushed the third row of x-ray markers 258C, 244 and 258D, 244
together. The
fourth row is, as always, a single point, representing the x-ray marker
located in the distal tube
236, 244. Without moving the distal body 216, the surgeon then irradiates the
markers from a
second vantage point 90 degrees offset from the first vantage point (i.e.,
from the bottom of the
distal body). As shown, the first row is, as always, a single point, which
represents the x-ray
marker located in the proximal tube 228, 244. The second row has two points,
which represents
the two x-ray markers located at the proximal, unattached distal-pointing
crown 258A, 244 and
258B, 244; the reason that this second row of markers shows up as two points
is that neither
marker in the second row is hidden from view on the x-ray at this offset angle
and the distal body
216 is not collapsed at the proximal, unattached distal-pointing crowns 258A,
244 and 258B,
244. The third row is a single point, which represents the x-ray marker
located at the bottom,
distal, unattached distal-pointing crown 258D, 244; the reason that this third
row of markers is a
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single point is that the bottom x-ray marker of the third row 258D, 244 is
directly in front of the
top x-ray marker of the third row 258C, 244, and thus, the top x-ray marker of
the third row
258C, 244 is hidden from view. The fourth row is, as always, a single point,
which represents
the x-ray marker located in the distal tube 236, 244. Knowing that the distal,
unattached distal-
pointing crowns 258C, 244 and 258D, 244 have converged as shown in FIG. 16F,
the surgeon
moves the distal body 216 proximally and the hard clot 270B falls into the
distal body interior
222 in the enlarged cell/drop zone 262C immediately distal to the top, distal,
unattached distal-
pointing crown 258C. See FIG. 16G. To confirm that the hard clot 270B has
entered the distal
body interior 222, the surgeon takes x-rays from the first and second vantage
points. The results
are shown in FIG. 16H. As compared to 16F, the front x-ray view of FIG. 16H
shows that the
distal, unattached distal-pointing crowns 258C, 244 and 2580, 244 are not
converged, and, thus,
the surgeon concludes that the hard clot 270B has entered the distal body
interior 222. The
surgeon then removes the distal body 216 and the hard clot 270B, captured by
the distal body
216, by moving the distal body 216 proximally out of the vessel 266.
[00147] FIGs. 17A-G illustrate stepwise use of the distal body
216 in retrieving a soft clot
270A in a human intracranial artery 266. (In FIGs. 17A-G, the distal body 216
is in Orientation
2). First, as always, the surgeon determines the location of the clot 270A in
the vessel 266 using,
for example, a contrast dye injected proximal and distal to the clot 270A.
Next, the delivery
catheter 208, which is enveloping the distal body 216, is positioned in the
blood vessel 266 so
that the two proximal, unattached distal-pointing crowns 258A and 258B are
immediately distal
to the clot 270A. See FIG. 17B. The distal body 216 is then deployed from the
catheter 208 by
moving the catheter 208 proximally. The soft clot 270A, which is unable to
collapse the distal
body 216, then enters the distal body interior 222. See FIG. 17C. However, at
this time, the
surgeon is unaware that the clot 270A has entered into the distal body
interior 222. Thus,
without moving the distal body 216, the surgeon irradiates the x-ray markers
at a first vantage
point (i.e., from the front of the distal body; into the page). As shown in
FIG. 17D, the first
vantage point shows four rows of x-ray markers. The first row is, as always, a
single point,
representing the x-ray marker located in the proximal tube 228, 244. The
second row has two
points, which represents the two x-ray markers located at the proximal,
unattached distal-
pointing crowns 258A, 244 and 258B, 244; the reason that this second row of
markers has two
points is that neither marker in the second row is hidden from view on the x-
ray at this angle ¨
rather, one marker 258A, 244 is located above the other marker 258B, 244 ¨ and
as shown in
FIG. 17C, the distal body 216 is not collapsed at the proximal, unattached
distal-pointing crowns
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258A, 244 and 258B, 244. The third row has a single point, which represents
the x-ray marker
located at the front (in Orientation 2), distal, unattached distal-pointing
crown 258C, 244; the
reason that this third row of markers is a single point is that the rear (in
Orientation 2) x-ray
marker 2580, 244 of the third row is hidden from view because it is directly
behind the front x-
ray marker 258C, 244 of the third row. The fourth row is, as always, a single
point, representing
the x-ray marker located in the distal tube 236, 244. Without moving the
distal body, the
surgeon then irradiates the markers from a second vantage point 90 degrees
offset from the first
vantage point (i.e., from the bottom of the distal body, as shown in this
view). As shown, the
first row is, as always, a single point, which represents the x-ray marker
located in the proximal
tube 228, 244. The second row is a single point, which represents the x-ray
marker located at the
bottom (in Orientation 2), proximal, unattached distal-pointing crown 258B,
244; the reason that
this second row of markers is a single point is that the top (in Orientation
2) x-ray marker of the
second row 258A, 244 is directly behind the bottom x-ray marker of the second
row 258B, 244,
and thus, hidden from view. The third row has two points, which represents the
two x-ray
markers located at the distal, unattached distal-pointing crowns 258C, 244 and
258D, 244; the
reason that this third row of markers shows up as two points is that neither
marker in the third
row is hidden from view on the x-ray at this offset angle and the distal body
216 is not collapsed
at the distal, unattached distal-pointing crowns 258C, 244 and 2580, 244. The
fourth row is, as
always, a single point, which represents the x-ray marker located in the
distal tube 236, 244. The
surgeon, thus, concludes that neither the second row 258A, 244 and 258B, 244
nor the third row
of x-ray markers 258C, 244 and 2580, 244 (i.e., the x-ray markers at both the
proximal and
distal unattached distal pointing-crowns) has converged. As shown in FIG. 17E,
the surgeon
then moves the distal body 216 proximally relative to the clot 270A so that
the distal, unattached
distal-pointing crowns 258C, 244 and 2580, 244 are immediately distal to the
clot 270A and
then the surgeon irradiates the x-markers again from the first vantage point
and the second
vantage point. As shown in FIG. 17F, the results are the same as FIG. 17D.
With the results
from FIGs. 17D and 17F, the surgeon concludes that neither the second row
258A, 244 and
258B, 244 nor the third row of x-ray markers 258C, 244 and 2580, 244 (i.e.,
the x-ray markers
at both the proximal and distal unattached distal pointing-crowns) were
converged at either the
original position of the distal body 216 (FIG. 17C and 17D) or the position
after moving the
distal body 216 proximally (FIG. 17E and 17F), and, thus, the distal body 216
was expanded in
the vessel 266 in both positions. Thus, the surgeon concludes that the clot
270A is a soft clot
270A that has entered into the distal body interior 222 and the surgeon
removes the distal body
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216 and the soft clot 270A, captured by the distal body 216, by moving the
distal body 216
proximally out of the vessel 266, as shown in FIG. 17G.
[00148] FIGs. 18A-G illustrate stepwise use of the distal body
216 in retrieving a hard clot
270B in a human intracranial artery 266. (In FIGS. 18A-G, the distal body 216
is in Orientation
2). (As described below, the primary differences between FIGs 18A-G and FIGs.
16A-G is that
the clot 270B enters the distal body interior 222 in an enlarged cell/drop
zone 262A immediately
distal to one of the proximal, unattached distal-pointing crowns 258A in FIGs.
18A-G, as
compared to FIGs. 16A-G where the clot 270B enters the distal body interior
222 in an enlarged
cell/drop zone 262C immediately distal to one of the distal, unattached distal-
pointing crowns
258C). First, as always, the surgeon determines the location of the clot 270B
in the vessel 266
using, for example, a contrast dye injected proximal and distal to the clot
270B. Next, the
delivery catheter 208, which is enveloping the distal body 216, is positioned
in the blood vessel
266 so that the two proximal, unattached distal-pointing crowns 258A and 258B
are immediately
distal to the clot 270B. See FIG. 18B. The distal body 216 is then deployed
from the catheter
208 by moving the catheter 208 proximally. The hard clot 270B, which is
located above the
distal body 216, collapses the distal body 216, as shown in FIG. 18C. However,
at this time, the
surgeon is unaware that the clot 270B has collapsed the distal body 216. Thus,
without moving
the distal body 216, the surgeon irradiates the x-ray markers at a first
vantage point (i.e., from the
front of the distal body in Orientation 2; into the page). As shown in FIG.
18D, the first vantage
point shows four rows of x-ray markers. The first row is, as always, a single
point, representing
the x-ray marker located in the proximal tube 228, 244. The second row has
only one point
because the clot 270B, which is on top of the second row of x-ray markers
258A, 244 and 258B,
244 (i.e., the markers at the proximal, unattached distal-pointing crowns).
has pushed them
together. The third row has only one point, which represents the x-ray marker
located at the
front (in Orientation 2), proximal, unattached distal-pointing crown 258C,
244; the reason that
this third row of markers is a single point is that the rear (in this view) x-
ray marker of the third
row 258D, 244 is hidden from view because it is directly behind the front x-
ray marker of the
third row 258C, 244. The fourth row is, as always, a single point,
representing the x-ray marker
located in the distal tube 236, 244. Without moving the distal body, the
surgeon then irradiates
the markers from a second vantage point 90 degrees offset from the first
vantage point (i.e., from
the bottom of the distal body 216). As shown, the first row is, as always, a
single point, which
represents the x-ray marker located in the proximal tube 228, 244. The second
row has a single
point because the top (in Orientation 2) x-ray marker of the second row 258A,
244 is located
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behind the bottom (in Orientation 2) x-ray marker 258B, 244 and thus, the top
x-ray marker of
the second row 258A, 244 is hidden from view. The third row has two points,
which represents
the x-ray markers located at the distal, unattached distal-pointing crowns
258C, 244 and 258D,
244, in this x-ray view neither of the x-ray markers of the third row is
hidden from view. The
fourth row is, as always, a single point, which represents the x-ray marker
located in the distal
tube 236, 244. The surgeon, thus, concludes that the second row of x-ray
markers 258A, 244
and 258B, 244 (i.e., the x-ray markers at the proximal, unattached distal
pointing-crowns) has
converged. As shown in FIG. 18E, the surgeon then moves the distal body 216
proximally so
that the distal, unattached distal-pointing crowns 258C, 244 and 258D, 244 are
immediately
distal to the clot 270B. Unbeknownst to the surgeon, the clot 270B enters the
distal body interior
222 immediately distal to the top (in Orientation 2), proximal unattached
distal-pointing crown
258A and the distal body 216 is no longer collapsed. The surgeon then
irradiates the x-markers
again from the first vantage point. As shown in FIG. 18F, the first row is, as
always, a single
point, representing the x-ray marker located in the proximal tube 228, 244.
The second row has
two x-ray markers because the distal body 216 is not collapsed and neither the
top (in
Orientation 2) 258A, 244 nor the bottom 258B, 244 (in Orientation 2) x-ray
marker of the second
row (i.e., the marker at the proximal, unattached distal-pointing crowns) is
hidden from view.
The third row has only one point because the rear (in Orientation 2), distal
unattached distal-
pointing crown 258D, 244 is hidden behind the front (in Orientation 2),
distal, unattached distal
pointing-crown 258C, 244. The fourth row is, as always, a single point,
representing the x-ray
marker located in the distal tube 236, 244. Without moving the distal body
216, the surgeon then
irradiates the markers from a second vantage point 90 degrees offset from the
first vantage point
(i.e., from the bottom of the distal body 216). As showwu the first row is, as
always, a single
point, which represents the x-ray marker located in the proximal tube 228,
244. The second row
has a single point because the x-ray marker at the top (in Orientation 2),
proximal, unattached
distal-pointing crown 258A, 244 is hidden behind the bottom (in Orientation
2), proximal,
unattached-distal pointing crown 258B, 244. The third row has two points
because neither the
front nor the rear x-ray markers at the distal, unattached, distal-pointing
crowns 258C, 244 and
258D, 244 is hidden from view. The fourth row is, as always, a single point,
which represents
the x-ray marker located in the distal tube 236, 244. Based on the information
from FIGs. 18D
and 18F, the surgeon concludes that the clot 270B has entered into the distal
body interior 222.
The surgeon then removes the distal body 216 and the hard clot 270B, captured
by the distal
body 216, by moving the distal body 216 proximally out of the vessel 266, as
shown in FIG.
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18G. Upon comparing FIGs. 16A-G and FIGs. 18A-G it will be appreciated that
the orientation
of the enlarged cells/drop zone 262A-D relative to the orientation of a hard
clot 270B determine
which enlarged cell/drop zone 262A, 262B, 262C, or 262D, the hard clot 270
enters the distal
body interior 222 through. For example, in FIG. 16C, the hard clot 270B is
located above the
distal body 216, and thus, the hard clot 270B must enter through the enlarged
cell/drop zone
located at the top of the distal body, which in the orientation of the distal
body shown in FIGs.
16A-G, is the enlarged cell/drop zone 262C immediately distal to the top,
distal, unattached,
distal-pointing crown 258C. In FIG. 18C, the hard clot 270B is again located
above the distal
body and, thus, the hard clot 270B must enter through the enlarged cell/drop
zone located at the
top of the distal body. However, in FIG. 18C, the enlarged cell/drop zone
located at the top of
the distal body 216, in the orientation of the distal body 216 shown in FIGs.
18A-G, is the
enlarged cell/drop zone 262A immediately distal to the top, proximal,
unattached, distal-pointing
crown 258A.
[00149] FIGs. 19A-N illustrate stepwise use of the distal body
216 in retrieving a
deformable cohesive, adherent clot 270C¨ i.e., a clot that is difficult to
break up and is tightly
adhered to the vessel wall 268 - in a human intracranial artery 266. (In FIGS.
19A-N, the distal
body 216 is in Orientation 2). First, as always, the surgeon determines the
location of the clot
270C in the vessel 266 using, for example, a contrast dye injected proximal
and distal to the clot
270C. Next, the delivery catheter 208, which is enveloping the distal body
216, is positioned in
the blood vessel 266 so that the two proximal, unattached distal-pointing
crowns 258A and 258B
are immediately distal to the clot 270C. See FIG. 19B. The distal body 216 is
then deployed
from the catheter 208 by moving the catheter 208 proximally. The deformable,
cohesive
adherent clot 270C, which is located above the distal body 216, collapses the
distal body 216, as
shown in FIG. 19C. However, at this time, the surgeon is unaware that the clot
270C has
collapsed the distal body 216. Thus, without moving the distal body 216, the
surgeon irradiates
the x-ray markers at a first vantage point (i.e., from the front of the distal
body; i.e., into the
page). As shown in FIG. 19D, the first vantage point shows four rows of x-ray
markers. The
first row is, as always, a single point, representing the x-ray marker located
in the proximal tube
228, 244. The second row has a single point, corresponding to the top (in
Orientation 2) and
bottom (in Orientation 2), proximal, unattached distal-pointing crowns 258A,
244 and 258B,
244, which have converged because the clot 270C is collapsing the distal body
216. The third
row has a single point, which represents the x-ray marker located at the front
(in Orientation 2),
distal, unattached distal-pointing crown 258C, 244; the x-ray marker located
at the rear, distal,
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unattached distal-pointing crown 258D, 244 is hidden from view. The fourth row
is, as always, a
single point, representing the x-ray marker located in the distal tube 236,
244. Without moving
the distal body 216, the surgeon then irradiates the markers from a second
vantage point 90
degrees offset from the first vantage point (i.e., from the bottom of the
distal body). As shown,
the first row is, as always, a single point, which represents the x-ray marker
located in the
proximal tube 228, 244. The second row has a single point, which corresponds
to the bottom (in
Orientation 2), proximal, unattached distal-pointing crown 258B, 244; the top
(in Orientation 2),
proximal, unattached distal-pointing crown 258A, 244 is located behind the
bottom, proximal,
unattached distal-pointing crown 258B, 244 and hidden from view. The third row
has two
points, which correspond to the front (in Orientation 2) 258C, 244 and rear
258D, 244 (in
Orientation 2), distal, unattached distal-pointing crowns, neither of which is
blocked in this view.
The fourth row is, as always, a single point, which represents the x-ray
marker located in the
distal tube 236, 244. As shown in FIG. 19E, the surgeon then moves the distal
body 216
proximally (i.e., slightly withdraws the distal body 216). The surgeon then
irradiates the x-
markers again from the first and second vantage points. As shown in FIG. 19F,
the results are
exactly the same as in FIG. 19D. Based on the observation that the proximal,
unattached distal-
pointing crowns 258A, 244 and 258B, 244 have converged at both the original
position (FIGs.
19C and 19D in which the proximal, unattached distal-pointing crowns 258A, 244
and 258B,
244 are immediately distal to the clot 270C) and the second position (FIGs.
19E and 19F), the
surgeon concludes that the clot 270C is a deformable cohesive, adherent clot
270C. The surgeon
then oscillates the distal body 216 proximally and distally a small distance
(e.g., about lmm to
about 2 mm) in the vessel 266, and the clot 270C begins to enter the distal
body 216, as shown in
FIG. 19G. The surgeon then irradiates the x-markers again from the first and
second vantage
points. As shown in FIG. 19H, the results are exactly the same as in FIG. 19D
and FIG. 19F
except that the second row of markers 258A, 244 and 258B, 244 (at the
proximal, unattached
distal-pointing crowns) are beginning to move apart. The surgeon then moves
the distal body
216 proximally again, as shown in FIG. 191. The surgeon then irradiates the x-
markers again
from the first and second vantage points. As shown in FIG. 19J, the results
are exactly the same
as in FIGs. 19D and 19F, as the clot 270C has caused the second row of markers
258A, 244 and
258B, 244 to re-converge. The surgeon then oscillates the distal body 216
proximally and
distally a small distance (e.g., about lmm to about 2 mm) in the vessel 266,
and the clot 270C
begins to further enter the distal body interior 222, as shown in FIG. 19K.
The surgeon then
irradiates the x-markers again from the first and second vantage points. As
shown in FIG. 19L,
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the results are the same as in FIG. 19H. The surgeon then moves the distal
body 216 again
proximally, and, instead of collapsing the second row of markers 258A, 244 and
258B, 244, the
clot 270C fully enters the distal body interior 222, as shown in FIG. 19M. The
surgeon then
irradiates the x-markers again from the first and second vantage points. As
shown in FIG. 19N,
the results show that the second row of markers 258A, 244 and 258B, 244 (at
the proximal,
unattached distal-pointing crowns) have moved apart. Satisfied that the x-ray
markers in the
second row 258A, 244 and 258B, 244 (at the proximal, unattached distal-
pointing crowns) are
sufficiently far apart and that the x-ray markers in the third row (at the
distal, unattached distal-
pointing crowns) 258C, 244 and 258D, 244 have stayed far apart, the surgeon
concludes that the
deformable cohesive, adherent clot 270C has been sufficiently captured by the
distal body 216
and the surgeon then removes the distal body 216 and the clot 270C, captured
by the distal body
216, by moving the distal body 216 proximally out of the vessel 266.
[00150] Several observations can be made from FIGs. 15-19, as
indicated above. For
example, the x-ray markers at the proximal and distal, unattached distal-
pointing crowns 258A-
D, 244 provide the surgeon feedback concerning the interaction between the
distal body 216 and
the clot 270 in the blood vessel 266. In addition, the guiding principle of a
soft clot 270A is that
the soft clot 270A does not collapse the distal body 216, and thus, x-ray
markers at the proximal
and distal, unattached distal-pointing crowns 258A-D, 244 always appear as two
points except
when a marker is hidden behind another marker (due to the view). When it comes
to a hard clot
270B, the hard clot 270B is generally able to enter the distal body interior
222 without needing
to oscillate the distal body 216 proximally and distally (unlike a deformable
cohesive, adherent
clot 270C). However, to capture the hard clot 270B, the hard clot 270B must be
oriented
properly relative to the enlarged cell/drop zones 262A, 262B, 262C, or 26211.
(This is the reason
that the distal body 216 has four enlarged cells/drop zones: one enlarged
cells/drop zone at 0
degrees 262B, one enlarged cells/drop zone at 90 degrees 262C, one enlarged
cells/drop zone at
180 degrees 262A and one enlarged cells/drop zone at 270 degrees 262D). As a
guiding
principle, an enlarged cell/drop zone 262A, 262B, 262C, or 262D is properly
oriented to the clot
270B when the x-ray markers at the proximal, unattached distal-pointing crowns
258A, 244 and
258B, 244 or the distal, unattached distal pointing crowns 258C, 244 and 258D,
244 are
together at both a first x-ray view and a second x-ray view 90 degrees
relative to the first x-ray
view, and the hard clot 270B can enter the enlarged cell/drop zone 262A, 262B,
262C, or 262D
by moving the distal body 216 proximally. See FIG. 16F and 18D. Finally, the
guiding
principal of retrieval of deformable cohesive, adherent clots 270C is that
oscillation of the distal
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body 216 causes the deformable cohesive, adherent clots 270C to gradually
enter the distal
basket interior 222 over time.
[00151] FIGs. 20A, 20B and 20C show a distal body 216 that is
similar to the distal body
216 of FIGs. 14A, 14B and 14C except that the distal body 216 of FIGs. 20A,
20B and 20C is
slightly shorter and its unattached, distal-pointing crowns 258A, 258B, 258C,
and 258D are
closer to the proximal tube 228. The shortened distal body 216 of FIGs. 20A,
20B and 20C is
particularly adapted for tortuous blood vessels 266. FIG. 21-29 show stepwise
deployment of
the distal body 216 of FIGs. 20A, 20B and 20C in use with a manual (i.e., hand-
operated),
volume-dependent (i.e. volume locked) suction catheter 272 that is locked at
between about 10 to
about 60 cubic centimeters (cc). Optionally, the suction catheter 272 has an
outer diameter of
between about 0.05 inches and about 0.09 inches and its outer diameter is
substantially larger
than the outer diameter of the delivery catheter 208. The clot 270 is located
in the vessel 266
through the use of, for example, contrast dye injected proximal and distal to
the clot 270. As
shown in FIG. 21, a delivery catheter 208 containing the distal body 216 of
FIGs. 20A, 20B and
20C is positioned in the tortuous vessel 266 distal to the clot 270. The
delivery catheter 208 is
withdrawn, deploying the distal body 216. See FIG. 22. The distal body 216 is
moved
proximally relative to the clot 270 and tension is exerted on pull wire 202.
See FIG. 23. While
maintaining tension on the pull wire 202, a suction catheter 272 having a
proximal end 274 and a
distal end 276 is delivered over the pull wire 202 that is attached to the
distal body 216. See
FIG. 24. (The reason for exerting tension on the pull wire 202 is that the
pull wire 202 serves as
the guide/track for the movement of the suction catheter 272 and without
tension, the suction
catheter 272 and pull wire 202 could end up in the ophthalmic artery 288). The
distal end 276 of
the suction catheter 272 is positioned against the clot 270. A syringe 278 is
attached to the
suction catheter 272 using a rotating hemostatic valve 290, which allows the
surgeon to aspirate
while a pull wire 202 is in the system. The surgeon aspirates the syringe 278
by pulling back on
the lever 280 to a mark on the base 282 corresponding to between about 10 and
about 60 cubic
centimeters of fluid. The surgeon then locks the lever 280 (and attached
plunger) into place,
leaving the suction catheter 272 under suction. The surgeon captures the clot
270 in the distal
body 216 using the techniques described in FIGs. 15-19. The distal body 216
and clot 270
become captured by the suction catheter 272. See FIGs. 27 and 28. The surgeon
then removes
the suction catheter 272 and the distal body 216 and the clot 270, captured by
the suction
catheter 272, by moving the suction catheter 272 proximally out of the vessel
266. See FIG. 29.
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It is believed that the suction catheter 272 would be helpful in the event
that a small portion of
the clot 270 breaks off when retrieving the clot 270 using the distal body
216.
[00152] To examine effectiveness of the systems 200, the
systems 200 of FIGs. 11-20,
without the use of a suction catheter 272, were used to retrieve soft and hard
clots 270A and
270B induced in a pig weighing between 30 to 50 kg. The weight of the pig was
chosen so that
the size of its vessels 266 would be approximate to the size of a human
vessel. The pig was
anesthetized. Several hard clots 270B were prepared by mixing pig blood and
barium and
incubating the mixture for 2 hours. Several soft clots 270A were prepared by
mixing pig blood,
thrombin and barium and incubating the mixture for 1 hour. The clots 270A and
270B, each of
which had a width of 4 to 6 mm and a length of 10 to 40 mm, were then inserted
into a vessel
266 having a diameter of 2 to 4 mm. (Only one clot 270A and 270B was located
in the vessel
266 at a time). Angiograms were then performed to confirm occlusion. After
waiting ten
minutes after confirming occlusion, the distal bodies 216 of FIGs. 11-20 were
then delivered
distal to the clots 270A and 270B as described above and were used to retrieve
the clots 270A
and 270B as described in FIGs. 11-19. In each case, the distal bodies 216 were
successful in
retrieving the clots 270A and 270B. As shown, the distal body height in the
relaxed state
tapers/decreases as the proximal strips 252 approach the proximal
hub/junction/tube 228 and also
tapers/decreases as the basket strips 291 located at the distal end 220 of the
basket 246 converge
at the distal hub/junction/tube 236.
[00153] The alternate embodiment of FIG. 32
[00154] FIG. 32 shows a distal body 216 in which the proximal
strips proximal ends 254
converge and are soldered or welded at the proximal hub/junction 228 and the
basket strips 291
located at the distal end 220 of the basket 246 converge and are soldered or
welded at the distal
hub/junction 236. To create such an embodiment, the distal body 216 may be
prepared from a
single tube, as described above, and the proximal and distal tubes may be
clipped and the
proximal ends 254 of the proximal strips 252 soldered or welded together (and
optionally to the
pull wire 202) and the basket strips 291 located at the distal end 220 of the
basket 246 may also
be welded or soldered or welded together. Optionally, the proximal and distal
hubs/junctions
228 and 236 may include x-ray markers 244 as described above.
[00155] The alternate embodiments of FIGs. 33-35
[00156] FIGs. 33A-33C and FIGs. 34A-34B (and the close-up views
shown in FIGs. 35A
and 35B) show an alternate embodiment in which no cells are proximal to the
proximal-most
cells 250A and 250B that have a free distal crown 258A and 258B. (FIGs. 33A-
35B do not
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show the pull wire or catheter, both of which are preferably used with the
distal body 216 and
shown elsewhere, e.g., in FIGs. 11-20, and FIGs. 33B-33C and FIG. 35A-35B do
not show the
proximal hub 228). FIGs. 33A-33C has four pair of cells (only a few such cells
are labelled with
250 or 250B and visible) with free distal-pointing crowns 258A-258H, which
create four pairs of
enlarged openings 262A-262H. FIGs. 34A-34B has five pair of cells (again not
all labelled)
with free distal-pointing crowns 258A-258J, which create five pairs of
enlarged openings 262A-
262J. More particularly, like FIGs. 11-20, in FIGs. 33A-33C and FIGs. 34A-34B,
the distal
body 216 has a proximal pair of free distal crowns 258A and 258B that have x-
ray markers 244
and are located approximately the same distance from the proximal junction 228
and between
150 degrees and 180 degrees apart and then a second pair of free distal crowns
258C and 258D
that have x-ray markers 244, and are located distal to the proximal pair of
free distal crowns
258A and 258B. Like FIGs. 11-20, in FIGs. 33A-33C and FIGs. 34A-34B, the
second pair of
distal crowns 258C and 25SD are located approximately the same distance from
the proximal
junction 228, are located between 150 degrees and 180 degrees apart and are
located between
about 60 degrees and about 90 degrees relative to the proximal pair of free
distal crowns 258A
and 258B.
[00157] The embodiments of FIGs. 33A-33C, FIGs. 34A-34B and
FIGs. 35A-35B have
several additional features. For example, in FIGs. 33A-33C, FIGs. 34A-34B, and
FIGs. 35A-
35B, the proximal pair of cells 250A and 250B having free distal crowns 258A
and 258B each
have a proximal crown 297A and 297B attached to a proximal strip 252. In FIGs.
33A-33C and
FIGs. 34A-34B, distal to the second pair of free distal crowns 258C and 2580,
the distal body
216 has a third pair of free distal crowns 258E and 258F that have x-ray
markers 244, are located
approximately the same distance from the proximal junction 228 and are located
between 150
degrees and 180 degrees apart and are located between about 60 degrees and
about 90 degrees
relative to the second pair of free distal crowns 258C and 2580. In FIGs. 33A-
33C and FIGs.
34A-34B, distal to the third pair of free distal crowns 258E and 258F, the
distal body 216 also
has a fourth pair of free distal crowns 258G and 258H that have x-ray markers
244, are located
approximately the same distance from the proximal junction 228 and are located
between 150
degrees and 180 degrees apart and are located between about 60 degrees and
about 90 degrees
relative to the third pair of free distal crowns 258E and 258F. In FIGs. 34A-
34B, distal to the
fourth pair of free distal crowns 258G and 258H, the distal body 216 also has
a fifth pair of free
distal crowns 2581 and 258J that have x-ray markers 244, are located
approximately the same
distance from the proximal junction 228 and are located between 150 degrees
and 180 degrees
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apart and are located between about 60 degrees and about 90 degrees relative
to the fourth pair of
free distal crowns 258G and 258H. An advantage having eight unattached distal-
pointing
crowns 258A-258H that are sequentially offset (as in FIGs. 33A-33C) and ten
unattached distal-
pointing crowns 258A-258J that are sequentially offset (as in FIGs. 34A-34B)
is that each free
distal crown 258A-258J creates an enlarged cell 262A-262J. Thus, in FIGs. 33A-
33C and FIGs.
34A-34B, eight and ten, respectively, sequentially offset enlarged cells 262A-
262H are formed,
creating multiple clot entry points. In FIG. 34A-34B, with the exception of
the enlarged cells
262A-262H, all of the cells located between the cells 250A and 250B (250A is
hidden in FIGs.
34A-34B but shown in FIGs. 35A-35B) having the proximal pair of free distal
crowns 258A and
258B and the cells having the distal-most pair of free distal crowns 2581 and
2583 have free
distal crowns. Indeed, with the exception of the enlarged cells 262A-262H, all
of the cells
located between proximal-most free-distal crowns 258A and 258B and distal-most
free crowns
2581 and 258J have free distal crowns 258C-258H. By contrast, the distal body
216 of FIGs.
33A-33C has an intermediate group of cells 248 (i.e., a stent-like structure)
with non-free distal
crowns (distal crowns that are attached to a basket strip 291) between the
second pair of enlarged
openings 262C and 262D and the third pair of enlarged openings 262E and 262F.
In FIG. 34A-
34B, all of the cells 248 having distal crowns that are attached to a basket
strip 291 are located at
the distal end of the distal body 216 (i.e., distal to the distal-most
enlarged openings 262G and
262H) to create a substantially closed distal end of the basket 246 to capture
the clot.
[00158] In addition, in FIGs. 33A-33C, 34A-34B, FIGs. 35A-35B,
the distal body 216 has
two proximal three-dimensional openings 293 that are located 180 degrees
apart, as best seen in
FIG. 33C and FIG. 34A and the close-up views of FIGs. 35A and 35B. (The
proximal three-
dimensional openings 293 are aligned and create a continuous void). One such
three-
dimensional opening 293 has a proximal end at the intersection point 294 of
the proximal strips
252 and a distal end at a distal crown 299 attached to a first strut 295
located (lengthwise)
approximately the same distance from the proximal hub/junction 228 as the free
distal crowns
258A and 258B of the first pair of free distal crowns. The other such three-
dimensional opening
293 is on the other side of the distal body 216 and has a proximal end at the
intersection point
294 of the proximal strips 252 and a distal end at another distal crown 298
attached to a second
strut 296 that is also located (lengthwise) approximately the same distance
from the proximal
hub/junction 228 as the free distal crowns 258A and 258B of the first pair of
free distal crowns.
The second strut 296 is located 180 degrees from the first strut 295. As shown
in FIG. 35A, the
intersection point 294 of the proximal strips 252 may be located approximately
in the widthwise
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and heightwise center of the distal body 216 and the proximal crowns 297A and
297B of the
proximal-most cells 250A and 250B having the free distal crowns 258A and 258B
may be
located approximately 150 degrees to 180 degrees apart (e.g., at the 12
o'clock and 6 o'clock
positions as shown in FIG. 35A and the 3 o'clock and 9 o'clock positions in
FIG. 35B) and at the
maximum height/width of the distal body 216. The proximal crowns 297A and 297B
of the
proximal-most cells 250A and 250B having the free distal crowns 258A and 258B
also are
attached to the proximal strips 252 as shown in FIGs. 35A and 35B. Similarly,
the bridge
memory metal strips (distal struts) 295 and 296 may be located approximately
150 degrees to
180 degrees apart (e.g., at the 3 o'clock and 9 o'clock positions as shown in
FIG. 35A and the 12
o'clock and 6 o'clock positions in FIG. 35B), at the maximum height/width of
the distal body
216, and approximately 60 degrees to 90 degrees relative to the free distal
crowns 258A and
258B.
[00159] The Embodiments of FIGs. 36-37
[00160] FIGs. 36A-36N and 37A-37K (also referred to herein as
FIGs. 36-37 for brevity)
show alternate embodiments of distal bodies 216 that are similar to the
embodiments of FIGs.
11-35. The distal bodies 216 may be made by any method known in the art
including but not
limited to those described in U.S. Patent No. 9,566,412, the entire contents
of which are
incorporated herein by reference.
[00161] FIGs. 36-37 are CAD drawings drawn to scale. However,
it will be appreciated
that other dimensions are possible.
[00162] More particularly, FIGs. 36-37 provide a system for
removing objects from an
interior lumen of an animal. The system may include, as previously described,
a pull wire 202
having a proximal end (not shown in FIGs. 36-37) and a distal end 206. The
system of FIGs. 36-
37 also includes a distal body 216 that may be attached to the pull wire 202,
preferably the pull
wire distal end 206. As with the prior embodiments of FIGs. 11-35, the distal
body 216 may
include an interior 222, a perimeter 300, a proximal end 218, a distal end
220, a distal body
length 226 extending from the proximal end 218 to the distal end 220, a
proximal
junction/hub/tube 228 that may be attached to the pull wire 202 and may form
the proximal end
218 of the distal body 216, a plurality of proximal strips 252, a basket 246
comprised of a
plurality of cells formed by a plurality of basket strips 291, and a distal
junction/hub/tube 236
forming a distal end 302 of the basket 246. As with the prior embodiments of
FIGs. 11-35, the
basket 246 may include a basket interior 346, each proximal strip 252 may have
a distal end 256
attached to a cell and a proximal end 254, the proximal ends 254 of the
proximal strips 252 may
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converge at the proximal junction 228. As with the prior embodiments of FIGs.
11-35, the distal
body 216 may have a relaxed state wherein the distal body 216 has a first
height 224 and a first
width 225, and a collapsed state (not shown in FIGs. 36-37) wherein the distal
body 216 has a
second height and a second width, the second height less than the first height
224, the second
width less than the first width 225. As with prior embodiments, in the
embodiments of FIGs. 36-
37, the proximal strips 252 and the basket strips 291 are preferably comprised
of a memory
metal.
[00163] Like the embodiments of FIGs. 33-35, in the embodiments
of FIGs. 36-37, in the
relaxed state, the basket 246 may include a series of at least three pair of
cells 250A-250F
located on the distal body perimeter 300 having a proximal crown 260 pointing
generally in the
proximal direction and attached to a memory metal strip (either a proximal
strip 252 or basket
strip 291) and a free distal crown 258A-258F pointing generally in the distal
direction.
Optionally, as shown in FIGs. 36-37, in the series, the proximal-most free
distal crowns 258A,
258B are located at the 12 and 6 o'clock positions and located about the same
distance from the
proximal junction 228, the next proximal-most free distal crowns 258C, 258D
are located at the
3 and 9 o'clock positions and located about the same distance from the
proximal junction 228,
and the succeeding proximal-most free distal crowns 258E, 258F are located at
the 12 and 6
o'clock positions (i.e., substantially aligned with proximal-most free distal
crowns 258A, 258B)
and located about the same distance from the proximal junction 228.
Optionally, each free distal
crown 250A-250F forms part of a different enlarged cell 262A-262F that is
configured to allow
a thrombus to enter the basket interior 346. In other words, like the prior
embodiments, the
enlarged cells 262A-262F are designed to capture a clot/thrombus. In the
proximal and distal
end views of FIGs. 36M, 36N, 37H, and 371, miniature clocks with clock hands
are used to
illustrate the 12, 3, 6 and 9 o'clock positions.
[00164] For purposes of FIGs. 36-37, when it is said that a
component, such as a free
distal crown 258A-258J, is located "about the same distance from the proximal
junction" 228, if
one component (e.g., one free distal crown 258A of the pair of proximal-most
free distal crowns
258A/258B) is located X distance from the proximal junction 228, the other
component (e.g., the
other free distal crown 258B of the pair of proximal-most free distal crowns
258A/258B) is
located X distance plus or minus (+/-) 5 millimeters (mm) from the proximal
junction 228. In a
preferred embodiment, the other component is located X distance plus or minus
(+/-) 3 mm from
the proximal junction 228, more preferably X distance plus or minus (+/-) 0.5
mm from the
proximal junction 228. (The same relationship will hold true for the other
pairs of free distal
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crowns 258C-258F in the series ¨ e.g., if one free distal crown 258C of the
next proximal-most
pair of free distal crowns 258C/258D is located Y distance from the proximal
junction 228, the
other free distal crown 258D of the next proximal-most pair of free distal
crowns 258C/258D is
located Y distance plus or minus (+/-) 5 inm from the proximal junction 228.
Again, more
preferably the other component is located Y distance plus or minus (+/-) 3 mm
from the
proximal junction 228, more preferably Y distance plus or minus (+/-) 0.5 mm
from the proximal
junction 228. The same relationship holds true from 258E and 258F.
[00165] In FIG. 37, like the embodiment of FIG. 34, the series
includes at least five pair of
cells 250A-250J located on the distal body perimeter 300 having a proximal
crown 260 pointing
generally in the proximal direction and attached to a memory metal strip
(either a proximal strip
252 or basket strip 291) and a free distal crown 258A-258J pointing generally
in the distal
direction, and in the series, after the succeeding free distal crowns 258E,
258F, the next
proximal-most free distal crowns 258G, 258H are located at the 3 and 9 o'clock
positions and
located about the same distance from the proximal junction 228 and form
enlarged cells 262G,
262H, and the distal-most free distal crowns 2581, 258J are located at the 12
and 6 o'clock
positions and located about the same distance from the proximal junction 228
and form the most
distally-located enlarged cells 2621, 262J. Again, about the same distance
from the proximal hub
228, means the same distance +/- 5 mm from the proximal junction 228. In a
preferred
embodiment, 258G/258H are located the same distance +/- 3 mm from the proximal
junction
228, more preferably the same distance +/- 0.5 mm from the proximal junction.
The same
relationship holds true from 2581 and 258J.
[00166] As with prior embodiments, FIGs. 36-37 illustrate that
in the relaxed state, the
basket 246 may comprise a plurality of distal cells 248D distal to the distal-
most free distal
crown (i.e. 258E, 258F in FIG. 36 and 2581, 258J in FIG. 37) that have a
proximal crown
attached to another cell of the basket 246 and pointing generally in the
proximal direction and a
distal crown pointing generally in the distal direction and attached to the
distal junction 236. In
other words, the distal cells 248D are designed to retain a clot/thrombus in
the basket interior
346.
[00167] As with prior embodiments, FIGs. 36-37 illustrate that,
in the relaxed state, each
enlarged cell 262A-262J may have a proximal end 308 that may be comprised of
two proximal
crowns pointing generally in the proximal direction, a distal end 310 that may
comprise a distal
crown pointing generally in the distal direction, and a length 312 extending
from the proximal
end 308 to the distal end 310 of the respective enlarged cell 262A-262J.
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[00168] As with prior embodiments, El-Gs. 36-37 illustrate that
in the relaxed state, each
distal cell 24811 may have a length 314 extending from the proximal crown to
the distal crown
307 of the respective distal cell 24811.
[00169] As with prior embodiments, FIGs. 36-37, and
particularly FIG. 36J, illustrate that
in the relaxed state, each of the enlarged cells 262A-262J may be longer than
each of the distal
cells 2481).
1001701 As with prior embodiments, FIGs. 36-37, and
particularly FIG. 36J, illustrate that
in the relaxed state, for each of the enlarged cells 262A-262J, the distance
316 from the proximal
end 308 of the enlarged cell 262A-262J to the free distal crown 258A-258J of
the enlarged cell
262A-2623 may be less than the distance 318 from the free distal crown 258A-
258.1 of the
enlarged cell 262A-262J to the distal end 310 of the enlarged cell 262A-262J.
In other words,
the free distal crowns 258A-258J do not protrude far enough into the enlarged
cells 262A-262J
to prevent a clot from entering the basket interior 346 through the enlarged
cells 262A-262J.
[00171] As with prior embodiments, FIGs. 36-37 illustrate that
the distal body 216 may
further comprise a lead wire 286 extending distally from the distal junction
236. As with prior
embodiments but not shown in FIGs. 36-37, the system may further comprise a
catheter having
an interior, a proximal end leading to the interior and a distal end leading
to the interior, the
catheter comprised of a biocompatible material and configured to envelop the
distal body 216
when the distal body 216 is in the collapsed state. Deployment and use of the
system may be as
shown in FIGs. 15-29.
[00172] As with prior embodiments, FIGs. 36-37 illustrate that
in the relaxed state, the
basket 246 preferably does not have any free crowns that point generally in
the proximal
direction, as free proximal crowns could damage the vessel as mentioned
previously.
1001731 As with prior embodiments, FIGs. 36-37 illustrate that
the distal body 216, in the
relaxed state, may comprise a distal tapered region 322 in which the distal
body height 224 and
width 225 decrease as the basket 246 approaches the distal junction 236.
[00174] As with prior embodiments, FIGs. 36-37 illustrate that
the distal body 216, in the
relaxed state may comprise a proximal tapered region 320 in which the distal
body height 224
and width 225 decrease as the proximal strips 252 approach the proximal
junction 228. It will be
appreciated that the tapering of the proximal region 320 may take on a variety
of shapes as
shown in FIGs. 36 and 37.
[00175] As with prior embodiments. FIGs. 36-37 illustrate that
in the relaxed state, each
of the enlarged cells 262A-262J may be longer than each of the pair of cells
250A-250J.
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[00176] As with prior embodiments, FIGs. 36-37 illustrate that
in the relaxed state, each
of the enlarged cells 262A-262J may extend from the 6 o'clock position to the
12 o'clock
position or the 3 o'clock position to the 9 o'clock position, as best seen in
the close-up views of
FIGs. 36C, 36E and 36F and 37G but also shown in FIGs. 36A-36B, 36I-36L, 37A-
37F.
[00177] As with the prior embodiments of FIGs. 11-19 and 21-32,
FIG. 36 illustrates that
in the relaxed state the basket 246 may further comprise a plurality of
proximal cells 342
proximal to the proximal-most free distal crowns 258A, 258B, the plurality of
proximal cells 342
having a proximal crown attached to the proximal junction 228 and pointing
generally in the
proximal direction and a distal crown pointing generally in the distal
direction and attached to
another cell of the basket 246. However, such proximal cells 342 are optional
and not shown in
FIG. 37, due to the length of the basket 246 which includes ten enlarged cells
262A-262J. If the
proximal cells 342 are not included, optionally, as with the prior embodiments
of FIGs. 20 and
33-35, FIG. 37 illustrates that in the relaxed state the proximal crowns of
the cells 250A, 250B
comprising the proximal-most free distal crowns 258A, 258B may be attached to
the distal ends
256 of the proximal strips 252. Without being bound by any particular theory,
a purpose of the
proximal cells 342 may be to allow the clot to rest on the proximal cells 342
prior to entering
through the enlarged cells 262A-262J.
[00178] In preliminary clot capture animal studies using a
swine thrombectomy model, it
has been observed the distal body 216 of FIG. 37 is particularly adept at
capturing a clot.
(Preliminary clot capture animal studies were performed using conditions
similar to that
described in Ulm et al., Preclinical Evaluation of the NeVaTM Stent Retriever:
Safety and
Efficacy in the Swine Thrombectomy Model, Intery Neurol. 2018 Apr;7(5):205-
217). Without
being bound by any particular theory, it is believed that the clot capture
ability of the distal body
216 of FIG. 37 is due to the minimal interference at the enlarged cells 262A-
262J (i.e., that the
basket strips 291 are flared apart at the distal crowns located at the distal
ends 310 of the
enlarged cells 262A-262J).
[00179] Thus, as shown in FIG. 37, in the relaxed state, for at
least some enlarged cells
262A-262J (preferably for most, more preferably for each enlarged cell 262A-
262J), two basket
strips 291 meet to form the distal crown located at the distal end 310 of the
enlarged cell 262A-
262J, and the two basket strips 291 form an angle 328 greater than 65 degrees,
more preferably
greater than 70 degrees, more preferably greater than 75 degrees, more
preferably greater than 80
degrees, more preferably greater than 85 degrees, more preferably greater than
90 degrees, more
preferably greater than 95 degrees, more preferably greater than 100 degrees
at the respective
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distal crown located at the distal end 310 of the enlarged cell 262A-262J.
Preferably, the angle
328 is less than 150 degrees. It is believed that the flared nature of the
basket strips 291 meeting
at the distal crown at the distal end 310 of the enlarged cells 250A-250J
assists in allowing the
clot to enter the basket interior 346. By comparison, the basket strips 291
meeting to form the
free distal crowns 258A-258J may have a much smaller angle 326 at the
respective free distal
crown 258A-258J, given that cells 250A-250J are not intended to be clot
capture cells. For
example, the angle 326 at the respective free distal crown 258A-258J may be
less than 50
degrees, more preferably less than 45 degrees, more preferably less than 40
degrees. In other
words, for some, most or all enlarged cells 262A-262J, the angle 328 at the
distal crown at the
distal end 310 may be at least 2 times (more preferably at least 2.5 times,
more preferably at least
3 times) as large as the angle 326 at the free distal crown 258A-258J.
Preferably, angle 328 is
no more than 5 times as large as angle 326. Due to the symmetry of the distal
body 216, the
angle 326 at free distal crown 258A may be substantially the same as the angle
326 at free distal
crown 258B, the angle 326 at free distal crown 258C may be substantially the
same as the angle
326 at free distal crown 258D, the angle 326 at free distal crown 258E may be
substantially the
same as the angle 326 at free distal crown 258F, the angle 326 at free distal
crown 258G may be
substantially the same as the angle 326 at free distal crown 258H, the angle
326 at free distal
crown 2581 may be substantially the same as the angle 326 at free distal crown
258J. Similarly,
the angle 328 at the distal crown at the distal end 310 of enlarged cell 262A
may be substantially
the same as the angle 328 at the distal crown of enlarged cell 262B, the angle
328 at the distal
crown at the distal end 310 of enlarged cell 262C may be substantially the
same as the angle 328
at the distal crown of enlarged cell 262D, the angle 328 at the distal crown
at the distal end 310
of enlarged cell 262E may be substantially the same as the angle 328 at the
distal crown of
enlarged cell 262F, the angle 328 at the distal crown at the distal end 310 of
enlarged cell 262G
may be substantially the same as the angle 328 at the distal crown of enlarged
cell 262H, and the
angle 328 at the distal crown at the distal end 310 of enlarged cell 2621 may
be substantially the
same as the angle 328 at the distal crown of enlarged cell 262J.
1001801 Because the basket strips 291 may be non-linear, the
angles 326 and 328 may be
determined as if the basket strips 291 were straight from their proximal ends
330 to their distal
ends 332. (See dashed lines 350 and 355 in FIG 37K). In other words, the
angles 326 and 328
may be the average (mean) angle between the basket strips 291 along the basket
strip lengths. In
such measurements, the angles 326 and 328 are measured by drawing an arc
between a point on
each basket strip 291 at the same position along the distal body length 226.
Alternatively, the
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angles 326 and 328 may be the maximum angle between the basket strips 291
along the basket
strip lengths, drawing an arc between a point on each of the two basket strips
291 at the same
position along the distal body length 226. See FIG. 37A, 37E, 37F, 37G for
showing how arcs
are drawn and maximum angles 326 and 328 are measured.
[00181] As an example, the maximum angles 328 between the
basket strips 291 forming
the distal crowns at the distal ends 310 of the enlarged cells 262C, 262F, and
262G. as illustrated
in FIGs. 37E-37G, are approximately 100 degrees, whereas the maximum angles
326 between
the basket strips 291 forming free distal crowns 258C, 258F, and 258G, as
illustrated in FIGs.
37E-37G, by comparison are about 40 degrees. (It should be noted that the
maximum angle 328
between the basket strips 291 forming the distal crown at the distal end 310
of distal-most
enlarged cell 262J, as illustrated in FIG. 37E, is approximately 80 degrees,
showing that there
may be variability in the angles 326, 328).
[00182] Relatedly, optionally, in the relaxed state, each of
the basket strips 291 meeting at
the distal crown at the distal end 310 of some or all of the enlarged cells
250A-250J extends
proximally from the respective distal crown at the distal end 310 at an angle
348 of at least 32.5
degrees, more preferably at least 35 degrees, more preferably at least 37.5
degrees, more
preferably at least 40 degrees, more preferably at least 42.5 degrees, more
preferably at least 45
degrees, more preferably at least 47.5 degrees, more preferably at least 50
degrees relative to a
line bisecting the respective distal crown that is parallel to the distal body
length 226 as best seen
in FIG 37K. The angle 348 may be determined by measuring the basket strip 291
as if it were
straight from the proximal end 330 to the distal end 332. Thus, for example,
each basket strip
length, as measured from drawing a straight line from the proximal end 330 to
the distal end 332
of the basket strip 291 may be at least 32.5 degrees, more preferably at least
35 degrees, more
preferably at least 37.5 degrees, more preferably at least 40 degrees, more
preferably at least 42.5
degrees, more preferably at least 45 degrees, more preferably at least 47.5
degrees, more
preferably at least 50 degrees relative to a line bisecting the respective
distal crown that is
parallel to the distal body length 226 (as well as an adjacent bridge memory
metal strip 336,
which as explained herein may be substantially parallel to the distal body
length 226). See FIG.
36K (dotted line 350 representing basket strip length, dotted line 226 drawn
through the
respective distal crown that is parallel to the distal body length 226, and
angle 348 between the
lines 350 and 226 measuring 45 degrees). Relatedly, for some, most or all the
free distal crowns
258A-258J, the basket strip lengths, as measured from drawing a straight line
from the proximal
end 330 to the distal end 332 of the basket strip 291 may be less than 25
degrees, more
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preferably less than 22.5 degrees, more preferably less than 20 degrees
relative to a line that
bisects the free distal crowns 258A-258J and is parallel to the distal body
length 226. See FIG.
36K (dotted line 355 representing basket strip length, dotted line 226 drawn
through distal crown
258H that is parallel to the distal body length 226, and angle 354 between the
lines 355 and 226
measuring 18 degrees at free distal crown 258H). Thus, for some, most or each
enlarged cell
262A-262J, angle 348 at free distal crowns 258A-258J may be twice, more
preferably 2.5 times,
more preferably 3 times the size of angle 354.
[00183] Relatedly, in FIG. 37E, which shows a top plan view,
the distal ends 332 of the
basket strips 291 forming the distal crown of enlarged cell 262J are located
approximately in the
center of the distal body width 225 and the proximal ends 330 of the basket
strips 291 are located
approximately at the front and rear of the distal body 216. The proximal end
330 and distal ends
332 of the basket strips 291 meeting to form the distal crown located at the
distal end 310 of
enlarged cell 262H are also shown in the perspective view of FIG. 37G.
Optionally, the lengths
of each basket strip 291 meeting at the distal crown at the distal end 310 of
some or all of the
enlarged cells 250A-250J, as measured from their proximal ends 330 to their
distal ends 332,
may be approximately equal to 1/2 of the distal body width 225 and height
224.
[00184] Relatedly, optionally, as shown in the embodiment of
FIG. 37 and best seen in
FIG. 37G and 37K, in the relaxed state, for at least some enlarged cells 262A-
262J (preferably
for each enlarged cell 262A-262J), in the relaxed state, the two basket strips
291 meeting to form
the distal crown located at the distal end 310 of the enlarged cell 262A-262J
may have distal
ends 332 meeting at the respective distal crown and located approximately in
the center of the
distal body height 224 or width 225 and a proximal end 330 attached to another
cell of the basket
246 and located approximately at the top, bottom or front side, or rear side
of the distal body
216. In other words, in FIGs. 37F and 37K, which show front and rear elevation
views, the distal
ends 332 of the basket strips 291 forming the distal crown of enlarged cells
262G and 262H are
located approximately in the center of the distal body height 224 and the
proximal ends 330 of
the basket strips 291 are located approximately at the top and bottom of the
distal body 216.
[00185] As with the prior embodiments of FIGs. 34A-34B, in the
distal body 216 of FIG.
37, as seen in FIGs. 37E-37F for example, in the relaxed state, due to the
space occupied by the
ten enlarged cells 250A-250J, from at least the proximal crowns 260 of the
cells 250C, 250D
comprising the next proximal-most free distal crowns 258C, 258D to the
proximal ends 308 of
the enlarged cells 2621, 262J formed by the distal-most pair of free distal
crowns 2581, 258J, the
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basket 246 has no cells other than the enlarged cells 262A-262J and the cells
250C-250J
comprising the free distal crowns 258C-258J.
[00186] In the distal body 216 of FIG. 36, in the relaxed
state, due to the space occupied
by the six enlarged cells 250A-250F, as seen in FIGs. 37E-37F for example,
from at least the
proximal crowns 260 of the cells 250C, 250D comprising the next proximal-most
free distal
crowns 258B, 258C to the proximal ends 308 of the enlarged cells 262E, 262F
formed by the
succeeding pair of free distal crowns 258E, 258F the basket 246 has no cells
other than the
enlarged cells 250A-250F and the cells 262C-262F comprising the free distal
crowns 258C-
258F.
[00187] The distal bodies 216 may be substantially symmetrical
from front to rear and
bottom to top, as shown in FIGS. 36I-36L and 37C-37F for example.
[00188] As with prior embodiments, FIGs. 36-37 illustrate that
in the relaxed state, the
distal crowns located at the distal end 310 of the enlarged cells 250A-250J
may be attached to
another cell of basket 246 (i.e., are not free floating).
[00189] Optionally, as with prior embodiments, in the
embodiment of FIG. 36, as best
seen in FIGs. 36J and 36L, in the relaxed state, the basket 246 further
comprises an additional
pair of cells 344 located about the same distance from the proximal junction
228 as the cells
250A, 250B comprising the proximal-most pair of free distal crowns 258A, 258B
and located at
the 9 and 3 o'clock positions, each cell of the additional pair of cells 344
having a proximal
crown attached to a memory metal strip (either a basket strip 291 or a
proximal strip 252) and a
distal crown attached to another cell of the basket 246 (i.e., a non-free
floating distal crown).
Again, about the same distance means the same distance from the proximal hub
228 +/- 5 mm.
(In preferred embodiments, the additional pair of cells 344 are located the
same distance +/- 3
mm, more preferably the same distance +/- 0.5 mm, from the proximal hub 228).
As best seen in
FIGs. 36J and 36L, the additional pair of cells 344 may adjoin the enlarged
cells 262A, 262B
formed by the proximal-most free distal crowns 258A, 258B. Optionally, from at
least the distal
crowns of the additional pair of cells 344 to the proximal ends of the
enlarged cells 262E, 262F
formed by the succeeding free distal crowns 258E, 258F, the basket 246 has no
cells other than
the enlarged cells 262A-262F, the cells 250A-250F comprising the free distal
crowns 258A-
258F and the additional pair of cells 344
[00190] As with prior embodiments, FIGs. 36-37 illustrate that
in the relaxed state, the
basket 246 may comprise a series of struts/bridge memory metal strips 295
haying a proximal
end 334 attached to a distal crown of a cell and a distal end 336 attached to
a proximal crown of
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a distally-located cell. The proximal-most pair of bridge memory metal strips
295 may be
located at the 3 and 9 o'clock positions, the next proximal-most pair of
bridge memory metal
strips 295 may be located at the 12 and 6 o'clock positions, the succeeding
proximal-most pair of
bridge memory metal strips may be located at the 3 and 9 o'clock positions, so
that the bridge
memory strips 295, like the free distal crowns 258A-258J, alternate along the
distal body length
226. Each of the pair of bridge memory metal strips 295 may form part of at
least one enlarged
cell 262A-262J. Optionally, the bridge memory metal strips 295 are the sole
distally-extending
basket strips 291 attached to the respective proximal crowns and the sole
proximally-extending
basket strips 291 attached to the respective distal crowns.
[00191] As with prior embodiments, FIGs. 36-37 illustrate that
in the relaxed state, each
of the pair of bridge memory metal strips 295 may form part of two enlarged
cells 262A-262J.
As with prior embodiments, FIGs. 36 and 37 illustrate that in the relaxed
state the bridge
memory metal strips 295 may be substantially parallel to the distal body
length 226.
[00192] As with prior embodiments, FIGs. 36-37 illustrate that
in the relaxed state, the
plurality of distal cells 248D may be comprised of four distal cells 248D
located about the same
distance from the proximal junction 228, each cell having a center 340, and
the centers 340 of
the cells 248D may be spaced at approximately 90 degree intervals about the
distal body
perimeter 300, and each of said four distal cells 248D may adjoin two of the
other of said distal
four cells 248D, as best seen in FIGs. 36C and 36D. Again, about the same
distance means the
same distance from the proximal hub 228 +/- 5 mm. (In preferred embodiments,
the four distal
cells 248D are located the same distance +/- 3 mm, more preferably the same
distance +/- 0.5
mm, from the proximal hub 228). Optionally, in the relaxed state, as best seen
in FIGs. 36C and
36D, each of the four distal cells 24811 comprises two lateral crowns 338
pointing generally in a
direction perpendicular to the distal body length 226 and each lateral crown
338 of one of said
four cells 248D adjoins a lateral crown 338 of an adjacent of said four cells
248D.
[00193] As with prior embodiments, FIGs. 36-37 illustrate that
the distal body 216
preferably has no more than four cells at any location along the distal body
length 226.
[00194] As with prior embodiments, FIGs. 36-37 illustrate that
each of the enlarged cells
260A-260J may be approximately the same size.
[00195] As with prior embodiments, FIGs. 36-37 illustrate that
in the relaxed state, the
basket interior 346 may be substantially hollow.
[00196] As with prior embodiments, FIGs. 36-37 illustrate that
in the relaxed state, the
enlarged cells 262A, 262B formed by the proximal-most free distal crowns 258A,
258B may be
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adjoining, the enlarged cells 262C, 262D formed by the next proximal-most free
distal crowns
258C, 258D may be adjoining and the enlarged cells 262E, 262F formed by the
succeeding free
distal crowns 258E, 258F may be adjoining. Optionally, as shown in the
illustrations of FIGs.
36-37, in the relaxed state each of the enlarged cells 262C, 262D formed by
the next proximal-
most free distal crowns 258C, 258D adjoins an enlarged cell 262A, 262B formed
by a proximal-
most free distal crown 258A, 258B and an enlarged cell 262E, 262F formed by a
succeeding free
distal crown 258E, 258F.
[00197] As with prior embodiments, FIGs. 36-37 illustrate that
in the relaxed state, for at
least some enlarged cells 262A-262J (preferably for each enlarged cell, as
shown in the
illustrations), the free distal crown 258A-258J may be aligned with the distal
crown 307 located
at the distal end MO of the enlarged cell 262A-262J.
[00198] As with prior embodiments, FIGs. 36-37 illustrate that
in the relaxed state, the
distal cells 248D may be substantially the same size and attached to the
distal junction 236 by a
basket strip 291 having a proximal end attached to a distal crown of a distal
cell 248D and a
distal end attached to the distal junction 236.
[00199] As with prior embodiments, FIGs. 36-37 illustrate that
in the relaxed state, the
cells 250A-250J comprising the free distal crowns 258A-258J may be
substantially the same
size.
[00200] As with prior embodiments, the system of FIGs. 36-37
may be used in a method
of removing a blood clot from a blood vessel of an animal the method
comprising the steps of: a)
providing the system; b) positioning the system in the blood vessel; c)
allowing the height 224
and width 225 of the distal body 216 to increase; d) moving the blood clot
into the basket interior
346; and e) moving the distal body 216 proximally out of the blood vessel.
1002011 As with prior embodiments, in FIGs. 36-37, not all
parts are labelled in every
drawing for clarity.
[00202] The embodiments of FIGs. 36-37 may include any feature
described or shown
with the prior embodiments. For example, as illustrated in FIGs. 36-37, the
proximal junction
228 and distal junction 236 may be located approximately in the center of the
distal body width
225 and distal body height 224 in the relaxed state. Additionally, as
illustrated in FIGs. 36-37,
each pair of enlarged cells 262A/262B; 262C/26211; 262E/262F; 262G/262H;
262I/262J may
be substantially aligned such that each pair of enlarged cells 262A/262B;
262C/262D;
262E/262F; 262G/262H; 262I/262J and the substantially hollow interior 346
create a void
extending from one side of the basket 246 through the substantially hollow
interior 346 to the
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opposite side of the basket 246. In addition, FIGs. 36-37 illustrate the
previously mentioned and
shown twisting proximal strips 252. For example, the proximal end 254 of a
first proximal strip
252 may be located at least about 65 degrees relative to the distal end 256 of
the first proximal
strip 252, the proximal end 254 of a second proximal strip 252 may be located
least about 65
degrees relative to the distal end 256 of the second proximal strip 252, and
the first and second
proximal strips 252 may intersect adjacent and distal to the proximal junction
228 and the
intersection may be located approximately in the center of the first height
224 and first width 225
in the relaxed state. In addition, FIG. 37 illustrate that the distal body 216
may have a void
located between the proximal junction 228 and the cells 250A, 250B comprising
the proximal-
most free distal crowns 258A, 258B. In addition, FIGs. 36-37 illustrate that
the basket 246 has a
non-uniform outward radial force from the proximal strips 252 to the basket
distal end 302. As
with prior embodiments, in the embodiments of FIGs. 36-37, the free distal
crowns of each pair
of free distal crowns 258A/258B; 258C/2581); 258E/258F; 258G/258H; 258I/258J
may be
configured to contact each other when an exterior, external compressive force
is exerted on the
free distal crowns 258A-258J when the distal body 216 is in the relaxed state.
As with prior
embodiments, in the embodiments of FIGs. 36-37, the proximal junction 228 and
distal junction
236 may be in the form of tubes. In addition, the distal body 216 may include
the three-
dimensional openings 293 mentioned previously. As with the prior embodiments,
in the
embodiments of FIGs. 36 and 37, some or all of the free distal crowns 258A-
258J, as well as
proximal and distal junctions 228 and 236, may include x-ray markers, as
previously described.
[00203] The Embodiments of FIGs. 38-46
[00204] FIGs. 38-46 illustrate yet another clot retrieval
system 400 in accordance with the
present invention. The system 400 of FIGs. 38-46 is particularly adapted to
capture a clot 402
(e.g., a pulmomary embolism) in a pulmonary blood vessel 404, which taper in
diameter less
gradually than cranial vessels. The system 400 includes a suction catheter
(also known as an
aspiration catheter) 436 that optionally passes into the interior 422 of a
cage 408 and includes
one or more suction openings 444 so that when the suction catheter 436 is
connected to a
suction source (such as a syringe or pump that is proximal to the suction
opening 444 and located
adjacent to the suction catheter proximal end 440) that applies a proximal
suction force (i.e., a
suctional force in the proximal direction such as shown in FIGs. 44A and 44B
where the arrows
generally point in the proximal direction), the surgeon is able to use the
suction opening 444 to
draw a clot 402 into the interior 422 of the cage 408. Nonetheless, the system
of FIGs. 38-46
may be used to retrieve other objects in other lumens of the body.
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[00205] In the embodiment of FIGs. 38-46, the system 400 may
include a distal body,
which may be in the form of a cage 408 comprising a cage proximal end 410 that
may comprise
a proximal junction 412, a cage distal end 414, a cage length 416 extending
from the cage
proximal end 410 to the cage distal end 414, a cage height 418 perpendicular
to the cage length
416, a cage width perpendicular to the cage length 416 and cage height 418, a
cage interior 422
and a cage perimeter (not specifically labelled but denoted in other
embodiments with numeral
300) comprised of a plurality of memory metal strips 426. Optionally, the cage
408 has a
relaxed state wherein the cage has a first height 428 and a first width, and a
collapsed state
wherein the cage has a second height 432 and a second width, the second height
432 of the cage
408 less than the first height 428 of the cage 408, the second width of the
cage 408 less than the
first width of the cage 408. In some embodiments, as shown in FIGs. 38 and 40-
41 and 46, the
cage 408 is in the form of a stent retriever with a plurality of cells 480 and
is similar in design to
the distal bodies of the previous embodiments. In other embodiments, as shown
in FIGs. 42-45
the cage 408 may take a slightly different design.
[00206] The system 400 may also include a suction catheter 436
comprising a generally
hollow interior 438, a proximal end 440 located proximal to the cage proximal
end 410, and a
distal end 442. The suction catheter 436 may be attached to the cage proximal
end 410 and may
pass into the cage interior 422. In some embodiments, the suction catheter 436
may be attached
to the cage distal end 414, as shown in FIG. 38. In other embodiments, the
suction catheter
distal end 442 may be proximal to the cage distal end 414, as shown in FIGs.
40-46. Within the
cage interior 422, the suction catheter 436 may comprise at least one suction
opening 444, which
preferably is located between the cage proximal end 410 and the cage distal
end 414, and leads to
the suction catheter generally hollow interior 438. The at least one suction
opening 444 allows
the suction catheter 436 to apply suction force to draw the clot 402 from
outside the cage interior
422 into the cage interior 422, as shown in FIGs. 44A-44B, for example.
[00207] In some embodiments, the suction catheter 436 is not
expandable, as shown in
FIG. 39. In other embodiments, the suction catheter 436 may comprise an
expandable distal tip
446, which may be comprised of a memory metal. In such embodiments, the
suction catheter 436
may comprise an expandable distal tip 446 that is located adjacent to the
suction catheter distal
end 442 and is comprised of a memory metal framework 448 and, optionally, a
film/coating 450
attached to the memory metal framework 448. Optionally, the expandable distal
tip 446 has a
relaxed state wherein the expandable distal tip 446 has a first height 452 and
a first width, and a
collapsed state wherein the expandable distal tip 446 has a second height 456
and a second
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width, the second height 456 of the expandable distal tip 446 is less than the
first height 452 of
the expandable distal tip 446, as best seen comparing FIG. 45E with FIG. 45D.
Optionally, the
first height 452 of the expandable distal tip 446 is less than the first
height 428 of the cage 408
and the first width of the expandable distal tip 446 is less than the first
width of the cage 408, as
shown in FIG. 38, and FIGs. 40-45.
[00208] Optionally, in the relaxed state, the expandable distal
tip 446 of the suction
catheter 436 is tapered in shape (e.g., in the shape of a funnel) in the
relaxed state, as shown in
FIGs. 40-45. Optionally, the distal end 442 of the suction catheter 436 forms
the maximum
height and width of the expandable distal tip 446 in the relaxed state, as
shown in FIGs. 40-45.
Optionally, the distal end 442 of the suction catheter 436 is flared inward,
as shown in FIGs. 39A
and 39B.
[00209] Optionally, the cage 408 comprises a width and a height
418 of between about 15
and about 35 millimeters in the relaxed state. Optionally, the suction
catheter 436 comprises a
non-expandable proximal segment 460, which is comprised of a different
material than the
expandable distal tip 446, is located immediately proximal to the expandable
distal tip 446, and
the non-expandable proximal segment 460 is configured to maintain
substantially the same
height and same width when the expandable distal tip 446 moves between the
collapsed state and
the relaxed state. Optionally, the expandable distal tip 446 comprises a
maximum width in the
relaxed state that is between about 2 and about 6 times greater than the width
of the proximal
segment. Optionally, the expandable distal tip 446 comprises a maximum height
in the relaxed
state that is between about 2 and about 6 times greater than the height of the
proximal segment.
[00210] FIGs. 46A and 46B show drawings (drawn to scale) of a
prototype of a particular
embodiment of an expandable distal tip 446 that was made. In FIGs. 46A and
46B, the proximal
ends 474 of the proximal memory metal strips 470 are attached to the outer
wall/outer
circumference of the non-expandable proximal segment 460. In addition, the
expandable distal
tip 446 is comprised of a film 450 chemically bonded to the proximal memory
metal strips 470 at
least partially along the length of the proximal memory metal strips 470
(e.g., a distance of at
least 2 millimeters). The device of FIGs. 46A and 46B was made by dipping the
proximal
memory metal strips 470 (made of nitinol) and the film 450 in the same polymer
and then
brushing a solvent on the proximal memory metal strips 470 and film 450 to
attach/chemically
bond the proximal memory metal strips 470 and the film 450. This process
created several
advantages including having a covered area in the expandable distal tip
portion 474 that is able
to expand and collapse in its height 452 and width 456 with the cage 408 ¨
i.e., as the cage
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expands and collapses in height. In other words, as depicted in FIG-s. 46A and
46B, the
expanded distal tip 446 may be co-extensive with a proximal portion of the
cage 408, with the
film 450 present for a portion (e.g., between about 5% and about 50%, more
preferably between
about 5% and about 33%, more preferably between about 5% and about 25%, more
preferably
between about 15% and about 25%) of the cage length 416. For example the film
450 may have
a length 451 (parallel to the cage length 416) of from about 2 millimeters to
about 30
millimeters, more preferably from about 5 to about 25 millimeters, more
preferably from about 5
millimeters to about 20 millimeters, more preferably from about 10 millimeters
to about 15
millimeters. In addition, the cage 408 was designed to have larger cells 480A
distal to the
expandable distal tip 446 (to allow for clot to enter the cage interior 422)
and smaller cells 480B
at the distal portion of the cage 408 to prevent captured clot from escaping
out of the cage distal
end 414. In exemplary embodiments, the larger cells 480A have a surface area
that is between
about 150% and about 500% of the surface area of the smaller cells 480B in the
relaxed state.
However, other dimensions are possible. In effect, the suction opening 444 is
located at the
distal end of the expandable distal tip 446 (and proximal to the large cells
480A as well as distal
to the cage proximal end 410) and allows the suction force from the syringe or
other suction
source to be applied to draw the clot through the large cells 480A. In
addition, as visible from
viewing FIGs. 46A and 46B, which is depicted in the relaxed state, the first
height 452 of the
expandable distal tip 446 is equal to the first height 428 of the cage 408 and
the first width of the
expandable distal tip 446 is equal to the first width of the cage 408.
[00211] Optionally, the memory metal framework 448 is comprised
of woven/braided
linear memory metal strands 462, as shown in FIGs. 38 and 40-46. Examples of
woven/braided
linear memory metal strands with films/coatings are known in the art. For
example, the
Anaconda suction catheters with such frameworks and films/coatings are sold by
Anaconda
Biomed SL (Barcelona, Spain) and described in European Patent Application
EP3634768, where
it is described that the woven/braided linear strands may be dipped into a
polymeric coating or
sprayed onto the strands and that the film/coating may create a watertight
compartment.
Woven/braided linear strands also are described in Applicant's own U.S. Patent
Nos. 10,321,925
and 10,226,268, for example. The contents of the aforementioned European
Patent Application
and U.S. Patents are incorporated herein by reference. Optionally, each woven
linear strand may
rotate about the distal portion perimeter relative to the cage
length/longitudinal axis a plurality of
times in a helical fashion. Optionally, the suction catheter expandable distal
tip 446 may be
flexible and invertible, as with the Anaconda suction catheter.
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[00212] Optionally, the at least one suction opening 444 is
located at the distal end 442 of
the suction catheter 436, as shown in FIGs. 39B, and 40-46. Alternatively, the
distal end 442 of
the suction catheter 436 may be closed, as shown in FIGs. 38-39 and 39A.
[00213] Optionally, as shown in FIGs. 38-40, the at least one
suction opening 444 is
located in the film 450 proximal to the suction catheter distal end 442. It
will be understood that
the term -at least one suction opening" allows for the suction catheter 436 to
have multiple
suction openings 444 within the cage interior 422, as shown in FIG. 38, 39B
and 40 for example.
Optionally, if one side of the suction catheter 436 (e.g., the top) includes a
suction opening 444,
preferably the opposite side (e.g., the bottom) also includes an aligned
suction opening 444, as
best seen in FIG. 38 and 39B. This can also be inferred in FIG. 40, for
example, because there is
no film 450 on the side opposite of the suction opening 444 visible. In other
words, optionally,
the centers of the suction openings 444 are aligned longitudinally and located
between 150 and
180 degrees apart.
[00214] Optionally, the cages 408 comprise a plurality of x-ray
markers 524 located
between the suction catheter distal end 442 and the cage distal end 414, as
best seen in FIGs. 42-
44. Optionally, as best seen in FIGs. 42-44, the x-ray markers 524 are aligned
longitudinally
(i.e., each of the x-ray markers 524 is located approximately the same
distance from the cage
proximal end 410). Without being bound by any particular theory, the plurality
of x-ray markers
524 may inform the operator/surgeon the location of the cage 408 relative to
the clot 402 so that
the operator deploys the cage 408 in the correct location in the vessel 404.
[00215] Optionally the proximal end 440 of the suction catheter
436 is connected to a
syringe or a pump, not shown but well-known in the art.
[00216] Optionally, the cage 408 is not free floating on the
suction catheter 436 but
instead the attachment of the suction catheter 436 to the cage 408 is
configured to allow an
operator to pull the cage 408 proximally by pulling the suction catheter 436
proximally and to
push the cage 408 distally by pushing the suction catheter 436 distally. In
other words, the
surgeon may be able to move the cage 408 proximally and distally by moving the
suction
catheter 436 proximally and distally.
[00217] Optionally, the proximal 440 end of the suction
catheter 436 comprises a tapered
(e.g., funnel shaped) hub/coupler 468 configured to connect the proximal end
440 to a suction
source, as shown in FIG. 38, 40, 41 and 43 and 46 for example.
[00218] Optionally, in the relaxed state, the cage 408
comprises a tapered proximal region
528 in which the cage height 418 and the cage width decrease as the memory
metal strips 426
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located at the proximal end of the cage 408 approach the cage proximal end
410, as shown in
FIGs. 38, and 40-46.
[00219] Optionally, in the relaxed state, the cage 408
comprises a tapered distal region
530 in which the cage height 418 and the cage width decrease as the memory
metal strips 426
located at the distal end of the cage 408 approach the cage distal end 414, as
shown in FIGs. 38,
and 40-46.
1002201 Optionally, the cage 408 further comprises a cage
proximal junction 412 located
at the cage proximal end 410 and a plurality of proximal strips 470, each
proximal strip 470
having a distal end 472 and a proximal end 474, the proximal ends of the
proximal strips 470
converging at the cage proximal junction 412, and further wherein the suction
catheter 436
passes through the cage proximal junction 412, as shown in FIG. 38.
[00221] Optionally, as shown in FIGs. 38 and 40-45, the cage
408 further comprises a
cage distal junction 532 located at the cage distal end 414 and a plurality of
distal strips 534,
each distal strip 534 having a distal end 536 and a proximal end 538, the
distal ends 536 of the
distal strips 534 converging at the cage distal junction 532.
[00222] Optionally, the suction catheter 436 is attached to the
cage distal junction 532, as
shown in FIG. 38. Optionally, the suction catheter distal end 442 may extend
distally beyond the
cage distal end 414. Optionally, the suction catheter 436 is not attached to
the cage distal end
414.
[00223] Optionally, the suction catheter 436 has a length of
from about 60 centimeters to
about 150 centimeters.
[00224] Optionally, the suction catheter 436 comprises a
plurality of suction openings 444
and at least some of the plurality suction openings 444 are located proximal
to the suction
catheter distal end 442, as shown in FIGs. 38-40.
[00225] Optionally, as shown in FIGs. 38 and 40-41 the cage 408
is comprised of a
framework 478 comprising a plurality of cells 480 formed by the plurality of
memory metal
strips 426. Optionally, in the relaxed state, at least one of the suction
openings 444 located
proximal to the suction catheter distal end 442 is aligned with a cell 480 to
allow the operator to
use the suction opening 444 to move the clot through the cell 480 and into the
cage interior 422.
For example, as shown in FIGs. 38 and 40-41, the heightwise center of the
suction opening 422
may be aligned with the heightwise center of the cell 480 so that the suction
force is centered in
the cell 480. Optionally, in the relaxed state, as shown in FIGs. 38 and 40-
41, the framework
478 comprises at least one pair of distal crowns 482 not attached to another
cell 480 and pointing
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generally in the distal direction, the distal crowns 482 in the at least one
pair of distal crowns 482
located approximately the same distance from the cage proximal end 410 and
located between
150 degrees and 180 degrees relative to each other. Optionally, each distal
crown in the at least
one pair of distal crowns 482 forms part of a different enlarged cell 484,
each enlarged cell 484
having a center. Optionally, the centers of the enlarged cells 484 of the at
least one pair of distal
crowns 482 are between 150 degrees and 180 degrees relative to each other.
Optionally, the
enlarged cells 484 are configured to allow a clot 402 to pass therethrough and
into the cage
interior 422. Optionally, one or more of the suction openings 444 located
proximal to the
suction catheter distal end 442 is aligned with an enlarged cell 484.
Optionally, as shown in
FIG. 38, as with prior embodiments, the enlarged cells 484 are sequentially
offset (e.g., the
proximal-most pair of enlarged cells 484 are offset 60-90 degrees from the
next proximal most
pair of enlarged cells 484, which are offset 60-90 degrees from the succeeding
proximal-most
pair of enlarged cells and so forth) and the suction openings 444 are likewise
sequentially offset.
[00226] Optionally, as shown in FIG. 38, the cage 408 further
comprises a cage proximal
junction 412 located at the cage proximal end 410 and a plurality of proximal
strips 470, each
proximal strip 470 having a distal end 472 attached to a proximal crown 540 of
a cell of the cage
408 and a proximal end 474, the proximal ends of the proximal strips 470
converging at the cage
proximal junction 412.
[00227] Optionally, as shown in FIG. 45E, the system 400
further comprises a delivery
catheter 488 having an interior, a proximal end (not shown) leading to the
interior and a distal
end 494 leading to the interior, the delivery catheter 488 comprised of a
biocompatible material
and configured to envelop the cage 408 and the suction catheter 436 prior to
deployment from
the delivery catheter 488. The system 400 may also include a guide catheter
542 as shown in
FIGs. 42 and 45E and 45F.
[00228] Optionally, as shown in FIG. 39, the system 400 may
include an inner blocking
catheter 498 located in the suction catheter generally hollow interior 438 and
moveable
proximally and distally in the suction catheter generally hollow interior 438,
the inner blocking
catheter 498 comprising an open proximal end 500, an open distal end 502 and a
generally
hollow interior. Without being bound by any particular theory, the inner
blocking catheter 498
may be used to block a suction hole(s) 444 in the suction catheter 436, as
shown in FIG 39
where the proximal suction holes 444 are blocked. Optionally, the inner
blocking catheter 498
and the suction catheter 436 each comprise an outer diameter and an inner
diameter and further
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wherein the outer diameter of the inner blocking catheter 498 is between about
85% to about
99.9% of the size of the inner diameter of the suction catheter 436.
[00229] Optionally, the heightwise/widthwise center of the
suction catheter 436 is located
approximately in the heightwise/widthwise center of the cage 408 in the
relaxed state, as shown
in FIGs. 38 and 40-45.
[00230] Optionally, though not shown, the cage 408 may further
include scaffolding
memory metal strips 426 extending from the cage perimeter inwardly to the
suction catheter 436
to help maintain the suction catheter 436 in the center of the cage 408.
[00231] Optionally, in the relaxed state, the cage 408 has a
minimum height 418 and
width at the cage proximal end 410, as shown in FIGs 40-46.
[00232] Optionally, except for the suction catheter 436, the
cage interior 422 is hollow.
[00233] Optionally, as shown in FIG. 38, the cage proximal end
410 is in the form of a
tube.
[00234] Optionally, as shown in FIGs. 38-46, the suction
catheter 436 is fixedly attached
to at least some of the cage memory metal strips 426.
[00235] Optionally, as shown in FIG. 38 and FIGs. 40-41 and 46,
in the relaxed state, the
cage 408 is comprised of a plurality of cells 480 but does not have any free
proximal crowns 540
pointing generally in the proximal direction but does have free distal crowns
482 pointing
generally in the distal direction.
[00236] Optionally, the system further includes a lead wire 512
extending distally from
the cage distal end 414.
[00237] Generally, as exemplified in FIGs. 44A and 44B, and 45A-
45G, the system 400
may be used in a method of removing a blood clot 402 from an animal the method
comprising
the steps of:
[00238] a) providing a delivery catheter 488 having an
interior, a proximal end and a
distal end 494, the delivery catheter 488 enveloping the cage 408 (see FIG.
45C);
[00239] b) deploying the cage 408 from the delivery catheter
distal end 494 so the
cage 408 moves from the collapsed state to the relaxed state (see FIGs. 45D
and 45E);
[00240] c) applying suction to the suction catheter 436 to
move the blood clot 402
into the cage interior 422 (see FIG 45F as well as FIGs. 44A and 44B); and
[00241] d) moving the cage 408 and blood clot 402 proximally
out of the animal (see
FIG. 45G) e.g., by pulling proximally on the suction catheter 436.
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[00242] Optionally, the method further comprises connecting a
syringe or a pump (not
shown but known in the art) to the suction catheter proximal end 440 and using
the syringe or the
pump to apply suction to the suction catheter 436.
[00243] Optionally, as shown in FIG. 39, the method further
comprises, before step c),
providing an inner blocking catheter 498 located in the suction catheter
generally hollow interior
438 and moving the inner blocking catheter 498 proximally or distally in the
suction catheter
generally hollow interior 438 to cover a suction opening 444 in the suction
catheter 436.
[00244] Optionally, steps b) and c) occur in a lung of the
animal.
[00245] Without being bound by any particular theory, FIGs. 44A
and 44B and 45D and
45E show how the cage 408 may gradually move from the collapsed state to the
relaxed state.
Unlike the prior embodiment as best seen in FIG. 22, where the distal body is
deployed distally
to the clot 402, in the embodiment of FIGs. 38-45, the cage 408 may be
deployed at the site of
the clot 402, as best seen in FIGs. 44A-44B and 45D and 45E where the cage
proximal end 410
is distal to the clot's 402 proximal end and the cage distal end 414 is
proximal to the clot's 402
distal end. In addition to a delivery catheter 488, a guide catheter 542
having a larger diameter
than the delivery catheter 488 may also be used, as shown in FIGs. 45C-45G.
After clot 402
capture, the suction catheter 436, the cage 408 and the clot 402 may be moved
(fully or partially)
into the guide catheter 542, as shown in FIG. 45G.
[00246] PARTS LIST
Clot retrieval system 400
Clot 402
Pulmonary blood vessel 404
Distal body 406
Cage 408
Cage proximal end 410
Cage proximal junction 412
Cage distal end 414
Cage length 416
Cage height 418
Cage width Not shown
Cage interior 422
Plurality of memory metal strips 426
Cage first height 428
Cage first width Not shown
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Cage second height 432
Cage second width Not shown
Suction catheter 436
Suction catheter hollow interior 438
Suction catheter proximal end 440
Suction catheter distal end 442
Suction opening 444
Suction catheter expandable distal tip 446
Memory metal framework 448
Film 450
Film length 451
Expandable distal tip first height 452
Expandable distal tip second height 456
Suction catheter non-expandable proximal
segment 460
Woven linear memory metal strands 462
Plurality of braided mesh openings 464
Tapered hub 468
Plurality of proximal strips 470
Proximal strip distal end 472
Proximal strip proximal end 474
Cell 480
Free distal crowns 482
Enlarged cell 484
Delivery catheter 488
Delivery catheter distal end 494
Inner blocking catheter 498
Inner blocking catheter open proximal end 500
Inner blocking catheter open distal end 502
Lead wire 512
Plurality of x-ray markers 524
Tapered proximal region 528
Tapered distal region 530
Cage distal junction 532
Cage distal strips 534
Cage distal strips distal ends 536
Cage distal strips proximal ends 538
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Proximal crown 540
Guide catheter 542
[00247] Having now described the invention in accordance with
the requirements of the
patent statutes, those skilled in the art will understand how to make changes
and modifications to
the disclosed embodiments to meet their specific requirements or conditions.
Changes and
modifications may be made without departing from the scope and spirit of the
invention, as
defined and limited solely by the following claims. In particular, although
the system has been
exemplified for use in retrieving blood clots, the system may be used to
retrieve other objects
from animal lumens. In addition, the steps of any method described herein may
be performed in
any suitable order and steps may be performed simultaneously if needed.
[00248] Terms of degree such as "substantially", "about" and
"approximately" as used
herein mean a reasonable amount of deviation of the modified term such that
the end result is not
significantly changed. For example, these terms can be construed as including
a deviation of at
least 5% of the modified term if this deviation would not negate the meaning
of the word it
modifies.
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