Note: Descriptions are shown in the official language in which they were submitted.
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THROMBECTOMY CATHETER AND METHODS OF USE
CROSS REFERENCE TO RELATED APPLICATIONS
To the full extent permitted by law, the present United States Continuation-in-
Part
Patent Application hereby claims priority to and the full benefit of, U.S.
Patent Application
No. 15/964,593, filed April 27, 2018, which is entitled "Thrombectomy Catheter
and
Methods of Use," which claims priority to U.S. Provisional Application No.
62/598,436, filed
December 13, 2017, which is entitled "X-tractor Thrombectomy Catheter and
Methods of
Use," which are incorporated herein by reference in their entirety.
TECHNICAL FIELD
The disclosure relates generally to medical catheter devices and more
specifically it
relates to medical catheter devices with a deployable instrument to remove
thrombi (blood
clots).
BACKGROUND
A catheter is a medical device or apparatus made from medical grade materials
serving a broad range of functions, such as insertion into the body to treat
diseases or perform
a surgical procedure. Moreover, catheters are often of an elongated form
having manipulator
means at its distal end and utilized for surgical manipulation of matter in a
confined or
inaccessible space within a human body or animal. For example, catheters may
be utilized to
perform suturing, cutting with a knife or scissor action, or by capture and
retrieval devices
through a small arthroscopic, endoscopic incision, percutaneous, or body
aperture.
Furthermore, angioplasty, atherectomy, and deployment of stents and stent-
grafts,
procedures to treat vascular disease, often dislodge material or plaque from
the vessel walls,
which may result in the formation of clots or the release of emboli, which
enter the
bloodstream, and may be large enough to occlude smaller downstream vessels and
potentially
blocking blood flow to tissue. The result may pose a serious threat to the
health or life of a
patient if the blockage occurs in critical tissue, such as the heart, lungs,
or brain.
One previous approach includes a catheter device having a cannula with an
axial bore
wherein a remote actuator means on a proximate end activates a sliding
elastically
deformable loop to extend past the confines of the deployment opening on the
distal end
thereof to deploy the elastically deformable loop and barrier member attached
thereto and
attains its deployed configuration. One disadvantage of this approach is that
the elastically
deformable loop may over expand or linearly expand causing a tear in tissue or
a vessel in the
deployment area. Another disadvantage of this approach is that the elastically
deformable
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loop may slice or puncture the biopsy, clot, or impaling the vessel wall when
the sliding
elastically deformable loop is expanded and/or retracted back into the
deployment opening.
Moreover, such elastically deformable loop is generally incapable of
preventing material
from escaping from the filter (barrier member) during the process of
collapsing and
retraction.
Another previous approach includes a catheter device having self-expanding
vascular
device, such as a support hoop expandable to an articulation region for
supporting a sac or
mesh filter for filtering or removing matter and capturing emboli from within
a vascular
system. One disadvantage of this approach is that the mesh filter may degrade
flow through
the vessel and may result in damage to the downstream cells and tissue
normally fed by the
blocked vessel. Consequently, it may be difficult or impossible to use such
devices in small
diameter vessels.
Therefore, it is readily apparent that there is a recognizable unmet need for
a
thrombectomy catheter and methods of use thereof that functions to deploy,
scoop, collect,
and remove material, plaque, clots, and emboli from the vessel walls without
causing a tear in
tissue or a vessel, slice or puncture the biopsy, clot, or impale the vessel
wall. Also, to
prevent material from escaping from the filter (barrier member) during the
process of
collapsing and retraction, not degrade flow through the vessel and may result
in damage to
the downstream cells and tissue normally fed by the blocked vessel, and enable
operation in
small diameter vessels.
SUMMARY
Briefly described, in example embodiment, the present apparatus overcomes the
above-mentioned disadvantage, and meets the recognized need for a thrombectomy
catheter
and methods of use, by providing a catheter or delivery sheath having a dual
lumen
(passageway) extending therethrough, the catheter having a proximal segment
and a distal
segment and a linear section coupled therebetween, the distal segment
configured as a loop
(pigtail) or rim, a port or aperture formed therein said dual lumen of said
catheter, the port
positioned proximate the distal segment, and a guidewire configured to
longitudinally
traverse therethrough one of the dual lumen of the catheter, said guidewire
configured with a
mesh strainer (basket/net) configured to longitudinally traverse therethrough
the other of the
dual lumen of the catheter and exit therethrough said port and follow said
loop to form
retractable mesh strainer and, thus, functions to deploy, scoop, collect, and
remove material,
plaque, clots, and emboli from the vessel interior without causing a tear in
tissue or a vessel,
slice or puncture the biopsy, clot, or impale the vessel wall, to prevent
material from escaping
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from the filter (barrier member) during the process of collapsing and
retraction, not degrade
flow through the vessel and may result in damage to the downstream cells and
tissue
normally fed by the blocked vessel, and enable operation in small diameter
vessels.
According to its major aspects and broadly stated, the thrombectomy catheter
and
methods of use, includes a catheter or delivery sheath having a dual lumen
extending
therethrough, the catheter having a proximal segment and a distal segment and
a linear
section coupled therebetween, the distal segment configured as a loop, a port
or aperture
formed therein said dual lumen of said catheter, the port positioned proximate
the distal
segment, and a guidewire configured to longitudinally traverse therethrough
one of the dual
lumen of the catheter, said guidewire having a first end affixed to a mesh
strainer, the mesh
strainer configured to longitudinally traverse therethrough the other of the
dual lumen of the
catheter and exit therethrough said port and follow said loop to form
retractable mesh
strainer.
In an exemplary embodiment of the remotely operated surgical device includes a
flexible positioning instrument having an elongated catheter with a dual lumen
bore therein
extending from a first catheter end to a second catheter end, the dual lumen
bore having a
first lumen and a second lumen, and a pigtail attached thereto the second
catheter end, the
first lumen extends therethrough the elongated catheter and the pigtail, the
second lumen
extends therethrough the elongated catheter, a guidewire extendable
therethrough the first
lumen of the elongated catheter and the pigtail, and extendable therefrom the
pigtail, the
guidewire configured to angle the pigtail, and a retraction instrument
configured having a
proximal member and a distal member coupled to the proximal member, the distal
member
having a deformable rim and a barrier membrane affixed thereto the deformable
rim and
extendable therethrough the second lumen of the elongated catheter.
In a further exemplary embodiment of the method for removing a biomaterial
from a
patient's vessel including the steps of providing a remotely operated surgical
device having a
flexible positioning instrument, the flexible positioning instrument having an
elongated
catheter with a dual lumen bore therein extending from a first catheter end to
a second
catheter end, the dual lumen bore having a first lumen and a second lumen, and
a pigtail
attached thereto the second catheter end, the first lumen extends therethrough
the elongated
catheter and the pigtail, the second lumen extends therethrough the elongated
catheter, a
guidewire extendable therethrough the first lumen of the elongated catheter
and the pigtail,
and a retraction instrument configured having a proximal member and a distal
member
coupled to the proximal member, the distal member having a deformable rim and
a barrier
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membrane affixed thereto the deformable rim and extendable therethrough the
second lumen
of the elongated catheter, maneuvering the operated surgical device
therethrough the patient's
vessel, positioning the pigtail proximate the biomaterial, deploying the
deformable rim and
the barrier membrane therefrom the second lumen, rotating the deformable rim
and the
barrier membrane proximate the biomaterial, collecting the biomaterial therein
the barrier
membrane, retracting the deformable rim, the barrier membrane, and the
biomaterial
therethrough the second lumen.
Accordingly, a feature of the thrombectomy catheter and methods of use is its
ability
to spin the pigtail or distal segment configured as a loop multiple times
proximate the
undesirable material enabling it to scoop up clots, plaque, emboli, thrombi
(blood clots), fatty
deposit, or other undesirable material or debris therein mesh blood strainer
and extract them
from a human blood vessel.
Another feature of the thrombectomy catheter and methods of use is its ability
to
provide a mesh strainer or basket porous so that blood cells may pass through
freely while
clots, plaque, emboli, thrombi (blood clots), fatty deposit, or other
undesirable material or
debris are captured therein.
Still another feature of the thrombectomy catheter and methods of use is its
ability to
provide a dual lumen catheter where one lumen forms a passageway for the
guidewire and
the other lumen forms a passageway for the mesh strainer.
Yet another feature of the thrombectomy catheter and methods of use is the
ability to
provide a remotely operable surgical device or guidewire.
Yet another feature of the thrombectomy catheter and methods of use is the
ability to
provide a flexible a dual lumen catheter.
Yet another feature of the thrombectomy catheter and methods of use is the
ability to
provide a flexible a dual lumen catheter having a flexible pigtail having a
passageway for the
guidewire and a deployment or exit port formed proximate or at the tip end.
Yet another feature of the thrombectomy catheter and methods of use is the
ability to
provide a retractable mesh strainer that traverses therearound the distal
segment configured
as a loop to form a basket or net to scoop up clots, plaque, emboli, or other
dislodge matter
therein mesh strainer.
Yet another feature of the thrombectomy catheter and methods of use is the
ability to
provide a catheter with a deployable mesh basket, net, mesh strainer to track
around a loop,
pigtail on the distal segment of the catheter.
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Yet another feature of the thrombectomy catheter and methods of use is the
ability to
provide a vascular device that overcomes disadvantages of previously known
vascular filter
nets and thrombectomy/embolectomy devices, and employs few components.
Yet another feature of the thrombectomy catheter and methods of use is the
ability to
provide a vascular device that is capable of being contracted to a small
delivery profile, thus
permitting use of the device in small blood vessels.
Yet another feature of the thrombectomy catheter and methods of use is the
ability to
provide a vascular device without the need for specialized delivery catheters.
Yet another feature of the thrombectomy catheter and methods of use is the
ability to
provide a vascular device to provide a vascular device that reduces the risk
of clots, plaque,
emboli, thrombi (blood clots), fatty deposit, or other undesirable material or
debris escaping
from the device when the device is retracted and removed.
Yet another feature of the thrombectomy catheter and methods of use is the
ability to
provide a vascular device to percutaneously remove clots, plaque, emboli,
thrombi (blood
clots), fatty deposit, or other undesirable material or debris from human
blood vessel without
performing surgery or without giving a clot buster.
Yet another feature of the thrombectomy catheter and methods of use is the
ability to
provide a vascular device to capture clots, plaque, emboli, thrombi (blood
clots), fatty
deposit, or other undesirable material or debris from human blood vessel just
by spinning the
pigtail, loop, or distal segment configured as a loop multiple times proximate
the undesirable
material.
Yet another feature of the thrombectomy catheter and methods of use is the
ability to
remove the net, basket, deployable mesh basket, or mesh strainer multiple
times through the
dual lumen catheter without losing position of the pigtail, loop, or distal
segment configured
as a loop adjacent to the working area.
Yet another feature of the thrombectomy catheter and methods of use is the
ability to
provide a vascular device with aspiration or suction via an aspiration device
to collect and
remove clots, plaque, emboli, thrombi (blood clots), fatty deposit, or other
undesirable
material or debris from human blood vessel by suctioning undesirable material
(aspiration
thrombectomy) therein a distal end of a lumen proximate the undesirable
material and
drawing such down the lumen channel.
These and other features of the thrombectomy catheter and methods of use will
become more apparent to one skilled in the art from the following Detailed
Description of the
Embodiments and Claims when read in light of the accompanying drawing Figures.
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BRIEF DESCRIPTION OF THE DRAWINGS
The present thrombectomy catheter and methods of use will be better understood
by
reading the Detailed Description of the embodiments with reference to the
accompanying
drawing figures, in which like reference numerals denote similar structure and
refer to like
elements throughout, and in which:
FIG. 1A is a top perspective view of an exemplary embodiment of a thrombectomy
catheter;
FIG. 1B is a perspective cross-sectional view of an exemplary embodiment of a
dual
lumen elongated catheter of the thrombectomy catheter of FIG. 1A;
FIG. 1C is a perspective cross-sectional view of an exemplary embodiment of a
single lumen pigtail of the thrombectomy catheter of FIG. 1A;
FIG. 2 is a top perspective view of an exemplary embodiment of the
thrombectomy
catheter of FIG. 1A, shown with a guidewire passing therein a first lumen
elongating the
pigtail;
FIG. 3 is a top perspective view of an exemplary embodiment of vascular
medical
instrument;
FIG. 4A is a top perspective view of an exemplary embodiment of a thrombectomy
catheter of FIG. 1, shown with a guidewire traversing therein first lumen, and
retractable
instrument traversing therein second lumen;
FIG. 4B is a perspective cross-sectional view of the elongated catheter of a
thrombectomy catheter of FIG. 1, shown with a guidewire and a retractable
instrument
traversing therethrough;
FIG. 5A is a top perspective view of an exemplary thrombectomy catheter of
FIG. 1
with retractable instrument deployed therebetween pigtail;
FIG. 5B is a front perspective view of thrombectomy catheter of FIG. 5A with
vascular medical instrument, shown netting undesirable material or debris for
retrieval;
FIG. 6 is a top view of thrombectomy catheter of FIG. 5A passing through the
heart
and deployed in a vascular vessel of the lung with retractable instrument
shown netting
undesirable material or debris for retrieval;
FIG. 7 is a flow diagram of a method deploying, using, and retrieving
thrombectomy
catheter of FIGs. 1-6 to remove undesirable material or debris from a vascular
vessel;
FIG. 8 is a top perspective view of an exemplary embodiment of a thrombectomy
catheter with aspiration device;
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FIG. 9 is a top perspective view of an exemplary thrombectomy catheter of FIG.
8
with undesirable material being drawn therein lumen distal end; and
FIG. 10 is a flow diagram of a method deploying, using, and retrieving
thrombectomy
catheter of FIGs. 1-6 and 8-9 to remove undesirable material or debris from a
vascular vessel
via aspiration.
It is to be noted that the drawings presented are intended solely for the
purpose of
illustration and that they are, therefore, neither desired nor intended to
limit the disclosure to
any or all of the exact details of construction shown, except insofar as they
may be deemed
essential to the claimed invention.
DETAILED DESCRIPTION
In describing the exemplary embodiments of the present disclosure, as
illustrated in
FIGS. 1A, 1B, 1C, 2, 3, 4A, 4B, 5A, 5B, 6 7, 8, 9, and 10 specific terminology
is employed
for the sake of clarity. The present disclosure, however, is not intended to
be limited to the
specific terminology so selected, and it is to be understood that each
specific element
includes all technical equivalents that operate in a similar manner to
accomplish similar
functions. Embodiments of the claims may, however, be embodied in many
different forms
and should not be construed to be limited to the embodiments set forth herein.
The examples
set forth herein are non-limiting examples, and are merely examples among
other possible
examples.
Referring now to FIGs. 1A, 1B, 1C, by way of example, and not limitation,
there is
illustrated an example embodiment of a flexible surgical positioning
instrument 10. Surgical
positioning instrument 10 may include a base section, such as hand grip 36,
having first
rotation flap 37 and second rotation flap 38, as coupled to a longitudinal
linear member,
cannula, housing, catheter, or sheath, such as elongated catheter 20 extending
linearly
therefrom hand grip 36. Preferably, elongated catheter 20 may include two or
dual axial
bores therethrough or space created inside elongated catheter 20 and extending
from first
catheter end 21 to second catheter end 22. Moreover, two or dual axial bores
therethrough
may include first lumen 31 and second lumen 32 separated by divider 33.
Furthermore, second catheter end 22 of surgical positioning instrument 10 may
be
configured as a loop, open ended loop, or enclosure, such as pigtail 50 formed
thereon or
attached thereto second catheter end 22. It is contemplated herein that
pigtail 50 may be
formed in a variety of sizes and configurations and include first pigtail
section 51 and second
pigtail section 52 with first pigtail section 51 affixed thereto second
catheter end 22 of
elongated catheter 20 and second pigtail section 52 forming an enclosure that
loops around
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back to a position proximate second catheter end 22. It is contemplated herein
that elongated
catheter 20 and pigtail 50 may preferably be configured or constructed of
plastic, polymeric
material includes polytetrafluorethylene, polyurethane, polyethylene, Teflon,
and the like as
such materials offers a variety of forms, shapes, ease of manufacture, and
flexibility;
however, other suitable materials may be utilized provided such material has
sufficient
strength, flexibility, and/or durability as would meet the purpose described
herein. The
material of elongated catheter 20, second lumen 32 pigtail 50, second lumen or
medical
instrument exit aperture 25 may be reinforced with fibers, rings, or
longitudinal ribs, for
example, to enable it to withstand the forces exerted on it by retractable
instrument 60 while
it is constrained within second lumen 32 and deformed by elongated catheter
20.
First lumen 31 may extend therethrough hand grip 36, elongated catheter 20,
and
pigtail 50, beginning with an entrance hole, such as first lumen or guidewire
entrance
aperture 24 and exit therefrom pigtail 50 proximate pigtail end 53 through an
exit or
deployment hole opening to the environment, such as first lumen or guidewire
exit aperture
26.
Second lumen 32 may extend therethrough hand grip 36 and elongated catheter 20
beginning with an entrance hole, such as first instrument aperture 23 and exit
therefrom
elongated catheter 20 proximate second catheter end 22 through an exit or
deployment hole,
such as second instrument aperture 25 proximate second catheter end 22.
Referring now to FIGs. 2, by way of example, and not limitation, there is
illustrated
an example embodiment of guidewire 40 for deployment and retraction use
therein first
lumen 31 of elongated catheter 20 and pigtail lumen 31B of pigtail 50.
Guidewire 40 may
include first guidewire end 41 and second guidewire end 42. In use, a path or
vessel guiding
device, such as guidewire 40 may be extended therethrough first lumen 31 of
elongated
catheter 20 and pigtail lumen 31B of pigtail 50 beginning with an entrance
hole, such as first
lumen entrance aperture 24 and exiting therefrom pigtail 50 proximate pig tail
end 53 through
an exit or deployment hole opening to the environment, such as first lumen
exit aperture 26 to
a position beyond or extend and extendable therefrom pigtail 50 to assist or
guide second
catheter end 22 and pigtail 50 therethrough a blood vessel V, turn, fork or
other vascular
maneuverability. First guidewire end 41 extends through the deployment
opening, such as
guide wire aperture 26 and is remotely controlled from second guidewire end
42. Moreover,
as guidewire 40 passes therethrough pigtail 50, pigtail 50 may angled or
straighten (as shown
in FIG. 2) or angle, such as pigtail angle A (from approximately 0-270 degrees
relative to
perpendicular thereto elongated catheter 20, 9 o'clock counterclockwise to 12
o'clock),
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depending on the flexibility or rigidity of first guidewire end 41 passing
therethrough.
Furthermore, first rotation R1 of elongated catheter 20 causes or results in
similar rotation,
such as rotation R2 of pigtail 50. Both pigtail angle A and rotation R2 enable
a variety of
positions of first guidewire end 41 to assist or guide or position guidewire
40, pigtail 50, and
second catheter end 22 therethrough a blood vessel V, turn, fork or other
vascular
maneuverability. Still furthermore, movement of or moving guidewire 40, such
as push/pull
P1 of second guidewire end 42 causes first guidewire end 41 to move in and out
therefrom
guide wire aperture 26 to assist or guide or position guidewire 40, pigtail
50, and second
catheter end 22 therethrough a blood vessel, turn, fork or other vascular V
maneuverability.
Alternatively, first lumen 31 and pigtail lumen 31B may be utilized as an
access for
additional laparoscopic or endoscopic devices, and/or fluid access or
withdrawal, lighting,
video, and like medical instruments 40A. Such an endoscope can also provide
surgical
implements such as lasers, scalpels, irrigation and aspiration means,
visualization means, and
the like 40A. The specific configuration and dimensions of first lumen 31 and
pigtail lumen
31B will vary with the intended use of surgical positioning instrument 10, and
whether access
for additional medical instruments 40A is provided. In general the axial bore
of first lumen 31
may have an internal diameter of 6-12 F (French=1/3 mm), however other
diameters are
contemplated herein to accommodate a working channel of an endoscope.
Referring now to FIG. 3, by way of example, and not limitation, there is
illustrated an
example embodiment of a retractable instrument 60, for use with surgical
positioning
instrument 10. Retractable instrument 60 may include a proximal or elongated
member or
operator, such as proximal member 64 having a first member end 65 and a second
member
end 66. First member end 65 may be configured having a loop, enclosure, or
basket, pigtail
such as deformable rim 67 configured thereon and proximate second member end
66. It is
contemplated herein that deformable rim 67 may be configured in a variety of
sizes and
shapes preferably matching pigtail 50 in size and shape.
Moreover, deformable rim 67 may be configured of one or two components, such
as
first deformable section 61 and second deformable section 62 and may
alternatively include
one or more pivot joint 68 therebetween first deformable section 61 and second
deformable
section 62. Deformable rim 67 is preferably made of a flexible, elastic, or
shape memory
material or alloy biocompatible material capable of flexing, bending, or
collapsing to a
configuration which may enter and exit first instrument aperture 23, traverse
axial bore of
second lumen 32, expanding to deployed net after passing therethrough second
instrument
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aperture 26, and collapsing to re-enter second instrument aperture 26 to
extract biomaterial
therefrom a blood vessel or other vascular channel or conduit V.
It is further contemplated herein that deformable rim 67 may include one or
more
joints or hinges, such as pivot point 68 positioned therearound deformable rim
67 or between
first deformable section 61 and second deformable section 62 to enable
deformable rim 67,
first deformable section 61, and second deformable section 62 to linearly
collapse or fold and
traverse therethrough first instrument aperture 23, axial bore of second lumen
32, and second
instrument aperture 25. It is still further contemplated herein that
deformable rim 67 may
form an opening, such as rim inlet 69.
When expanded, deformable rim 67 may have a diameter of from about 1 cm or
less
to about 3 cm but other sizes are contemplated herein. Moreover, a barrier
membrane or other
sifting or filtering membrane, such as mesh strainer 63 preferably runs,
spans, or is affixed
thereto deformable rim 67 loosely, forming a rounded open end capture net
across rim inlet
69. Mesh strainer 63 may be utilized to filter or capture clots, plaque,
emboli, thrombi (blood
clots), fatty deposit, or other undesirable material or debris from within
human blood vessels
V.
The specific configuration and dimensions of axial bore of second lumen 32
will vary
with the use of surgical positioning instrument 10, the parameters of
retractable instrument
60, such as insertion/retraction member 64 and sized to receive deformable rim
67 having
first deformable section 61 and second deformable section 62 in a constrained
configuration
with mesh strainer 63 furled around first deformable section 61, second
deformable section
62, and insertion/retraction member 64. In general, the axial bore of second
lumen 32 may
have an axial bore or internal diameter of 6-12 F (French=1/3 mm) to
accommodate
retractable instrument 60 in a constrained configuration, however other
diameters are
contemplated herein.
Alternatively, second lumen 32 may be utilized as an access for additional
laparoscopic or endoscopic devices, and/or fluid access or withdrawal,
lighting, video, and
like medical instruments 40A. Such an endoscope can also provide surgical
implements such
as lasers, scalpels, irrigation and aspiration means, visualization means, and
the like 40A.
Referring again to FIG. 1A, the outer diameter of the catheter 20 may vary
with the
application, the size of first lumen 31 and second lumen 32, the size of
deformable rim 67 of
retractable instrument 60 having first deformable section 61 and second
deformable section
62, whether access for additional laparoscopic or endoscopic devices, and/or
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withdrawal, lighting, video, and the like 40A, and whether additional lumens
are included in
surgical positioning instrument 10.
Referring now to FIGs. 4A and 4B, by way of example, and not limitation, there
is
illustrated an example embodiment of retractable instrument 60 for deployment
and retraction
use therein second lumen 32 of surgical positioning instrument 10. Moreover,
second
guidewire end 42 may be pulled and as guidewire 40 retracts therethrough
pigtail 50, pigtail
50 may return to pigtail or loop configuration as shown in FIGs. 1 and 4A.
In use, deformable rim 67 of first member end 65 may be preferably collapsed
and
mesh strainer 63 may be furled or wrapped therearound deformable rim 67 and/or
first
member end 65 of retractable instrument 60. Collapsed deformable rim 67 and
furled mesh
strainer 63 may be inserted therein first instrument aperture 23 of second
lumen 32.
Collapsed deformable rim 67 and furled mesh strainer 63 may be disposed
within, extended,
and traverse therethrough second lumen 32 of elongated catheter 20 and exit or
deploy
therethrough or extendable therefrom. Upon deformable rim 67 and furled mesh
strainer 63
exit thereof second lumen 32, deformable rim 67 expands to deployed deformable
rim 67
with mesh strainer 63 unfurled to an expanded collection state positioned
proximate pigtail
50. When deployed first deformable section 61 and second deformable section 62
of
deformable rim 67 expand back to a non-compressed position as shown in FIG. 5
to create
expanded deformable rim 67 having rim inlet 69 and mesh strainer 63, where
expanded
deformable rim 67 preferably mates up with or may be positioned proximate or
within pigtail
50, as shown in FIG. 5.
Referring now to FIG. 5A and 5B, by way of example, and not limitation, there
is
illustrated an example embodiment of retractable instrument 60 shown deployed
therefrom
second lumen 32 of surgical positioning instrument 103 In use, push/pull P1 of
second
member end 66 may deploy or extend deformable rim 67 within pigtail 50 or past
the
confines of second instrument aperture 25 on the distal end thereof second
catheter end 22 to
deploy deformable rim 67 and mesh strainer 63 attached thereto and attains its
deployed
configuration. Rotation R3 of second member end 66 causes or results in
similar rotation,
such as rotation R4 of deformable rim 67 having rim inlet 69 and mesh strainer
63, which in
turn causes deformable rim 67 having rim inlet 69 and mesh strainer 63 of
retractable
instrument 60 to scoop up or collect or capture clots, plaque, emboli, thrombi
(blood clots),
fatty deposit, biomaterial, or other undesirable material or debris M from
blood vessel V.
Moreover, rotation R1 of elongated catheter 20 results in rotation R2 of
pigtail 50 which in
turn results in rotation R4 of deformable rim 67 having rim inlet 69 and mesh
strainer 63 due
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to abutting or contact therebetween pigtail 50 and deformable rim 67
(deformable rim 67
abuts pigtail 50), which in turn causes deformable rim 67 having rim inlet 69
and mesh
strainer 63 of retractable instrument 60 to scoop up or collect or capture
clots, plaque, emboli,
thrombi (blood clots), fatty deposit, biomaterial, or other undesirable
material or debris M
from blood vessel V. Undesirable material or debris M may be removed from
blood vessel V
by extracting retractable instrument 60 and deformable rim 67 having rim inlet
69 and mesh
strainer 63 containing undesirable material or debris M back therein second
instrument
aperture 25 collapsing deformable rim 67 and pulling retractable instrument 60
down second
lumen 32 of surgical positioning instrument 10 and out first instrument
aperture 23, as shown
in FIGs. 4A and 4B. Push/pull P1 of second member end 66 may retrieve
deformable rim 67
by collapsing deformable rim 67 and mesh strainer 63 may be furled or wrapped
therearound
deformable rim 67 and/or first member end 65, and retractable instrument 60
with
undesirable material or debris M may be pulled therethrough second instrument
aperture 25
and exit out first instrument aperture 23.
It is contemplated herein that deformable rim 67 and pigtail 50 may be similar
or
matched in size and shape, such as circumference and/ or diameter, to enable
abutting or
contact therebetween pigtail 50 and deformable rim 67 (deformable rim 67 abuts
pigtail 50).
Referring now to FIG. 6, by way of example, and not limitation, there is
illustrated an
example embodiment of surgical device, the combination of retractable
instrument 60 and
surgical positioning instrument 10. In use, surgical positioning instrument
10, shown with
pigtail 50 inserted into a patient and serpentinely deployed therethrough
blood vessel V, heart
H, lung L, and into lung blood vessel V. It is contemplated herein that
surgical positioning
instrument 10 may be deployed therein any fluid-carrying vessels where debris
needs to be
removed.
In use, push/pull P1 of guidewire 40 may be extended therethrough pigtail 50,
causing pigtail 50 to straighten or elongate (as shown in FIG. 2) or angle,
such as pigtail
angle A, therein blood vessel V depending on the flexibility or rigidity of
first guidewire end
41 passing therethrough. Furthermore, first rotation R1 of elongated catheter
20 causes pigtail
50 to similarly rotate, rotation R2 therein blood vessel V. Both pigtail angle
A and rotation
R2 enable a variety of positions of first guidewire end 41 to assist or guide
or position
guidewire 40, pigtail 50, and second catheter end 22 therethrough or therein
blood vessel V,
heart H, lung L to serpentine, turn, maneuver a fork of or other vascular
maneuverability to
precisely maneuver and position pigtail 50 therein blood vessel V. The
objective of surgical
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positioning instrument 10 is to preferably position pigtail 50 in a specific
location within a
patient's vessel.
Push/pull P1 of second member end 66 results in exit or deployment of
deformable
rim 67 having rim inlet 69 and mesh strainer 63 therethrough second instrument
aperture 25
proximate a junction between second catheter end 22, and expanding to deployed
deformable
rim 67 with mesh strainer 63 after passing therethrough second instrument
aperture 25 to a
position proximate pigtail 50 therein blood vessel V.
Moreover, rotation R3 of second member end 66 results in rotation R4 of
deformable
rim 67 within blood vessel V having rim inlet 69 and mesh strainer 63, which
in turn causes
deformable rim 67 having rim inlet 69 and mesh strainer 63 of retractable
instrument 60 to
scoop up or collect or capture clots, plaque, emboli, thrombi (blood clots),
fatty deposit,
biomaterial, or other undesirable material or debris M from blood vessel V.
Furthermore, rotation R1 of elongated catheter 20 results in rotation R2 of
pigtail 50
within blood vessel V which in turn results in rotation R4 of deformable rim
67 having rim
inlet 69 and mesh strainer 63 due to abutting or contact therebetween pigtail
50 and
deformable rim 67, which in turn causes deformable rim 67 having rim inlet 69
and mesh
strainer 63 of retractable instrument 60 to scoop up or collect or capture
clots, plaque, emboli,
thrombi (blood clots), fatty deposit, biomaterial, or other undesirable
material or debris M
from blood vessel V.
Push/pull P1 of second member end 66 results in collapsed deformable rim 67
having
rim inlet 69 and mesh strainer 63 being retracted or entry therein second
instrument aperture
and traversing therethrough second lumen 32 to first instrument aperture 23 to
remove
undesirable material or debris M captured therein mesh strainer 63 from blood
vessel V. It is
contemplated herein that such capture and retrieval of undesirable material or
debris M may
25 be
accomplished multiple times with multiple passes, deployment, retract, and
retrieval of
retractable instrument 60 therethrough second lumen 32 of surgical positioning
instrument
10.
It is contemplated herein that second lumen 32 angioplasty, atherectomy, and
deployment of stents and stent-grafts, procedures to treat vascular disease
may be deployed
therethrough second lumen 32. Such instruments often dislodge material or
plaque from the
vessel walls of blood vessel V, which may result in the formation of clots or
the release of
emboli, biomaterial, such as undesirable material or debris M, which enter the
bloodstream,
and may be large enough to occlude smaller downstream vessels and potentially
blocking
blood flow to tissue. The result may pose a serious threat to the health or
life of a patient if
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the blockage occurs in critical tissue, such as the heart, lungs, or brain.
Retractable instrument
60 may be utilized herein to traverse second lumen 32 to capture and remove
undesirable
material or debris M from blood vessel V.
It is further contemplated herein that pigtail 50 encircling of deformable rim
67 may
protect blood vessel V when deformable rim 67 expands preventing contact
therewith blood
vessel V preventing a tear in tissue or a vessel in the deployment area.
It is still further contemplated herein that pigtail 50 encircling of
deformable rim 67
may protect blood vessel V when deformable rim 67 expands or retracts
preventing contact
therewith blood vessel V preventing slice or puncture the biopsy, clot, or
impaling the vessel
wall of blood vessel V.
It is yet further contemplated herein that second lumen 32 may be utilized for
delivery
of other medical instrument(s), such as a suture to conduct a biopsy or other
medical
instrument to meet the needs of the medical application being performed with
surgical
positioning instrument 10.
It is yet further contemplated herein that second lumen 32 may be sized or
configured
adjustable to accommodate different diameter or sized medical instruments 60.
Referring now to FIG. 7, there is illustrated a flow diagram 700 of utilizing
surgical
positioning instrument 10 and retractable instrument 60 to remove clots or the
release of
emboli, biomaterial, such as undesirable material or debris M from blood
vessel V. In block
or step 710, providing surgical positioning instrument 10 having elongated
member 20 with
two or dual axial bores therethrough, such as first lumen 31 and second lumen
32, and pigtail
50 on one end and integral retractable instrument 60 having deformable rim 67
and mesh
strainer 63 as described above in FIGS. 1-6 including (collapsing deformable
rim 67 and
wrapping mesh strainer 63 therearound first member end 65 and insertion
therein first
instrument aperture 23 of second lumen 32) and (traversing first instrument
aperture 23
(push/pull P1 of second member end 66) to second instrument aperture 25 of
second lumen
32).
In block or step 715, manipulating or moving guidewire 40 (push/pull P1 of
guidewire 40 or rotate R1 elongated member 20) to alter the position of
pigtail 50 for a path
or vessel guiding device to maneuver or advance surgical positioning
instrument 10
therethrough blood vessel V, turn, fork or other vascular maneuverability and
positioning
pigtail 50 proximate material or debris M.
In block or step 720, deploying retractable instrument 60 via expanding
deployed
deformable rim 67 with mesh strainer 63 after passing therethrough second
instrument
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aperture 25 to a position proximate pigtail 50 (deploying deformable rim 67
and mesh
strainer 63 therefrom second lumen 32). When deployed first deformable section
61 and
second deformable section 62 of deformable rim 67 expands back to a non-
compressed
position.
In block or step 730, rotating deformable rim 67 and mesh strainer 63
proximate
material or debris M via rotating second member end 66 of retractable
instrument 60, rotation
R3, results in rotation R4 of deformable rim 67 having rim inlet 69 and mesh
strainer 63,
which in turn causes expanded deformable rim 67 having rim inlet 69 and mesh
strainer 63 of
retractable instrument 60 to scoop up or collect or capture clots, plaque,
emboli, thrombi
(blood clots), fatty deposit, biomaterial, or other undesirable material or
debris M from blood
vessel V.
In block or step 730, rotating deformable rim 67 and mesh strainer 63
proximate
material or debris M via rotating elongated catheter 20, rotation R1, results
in rotation R2 of
pigtail 50 which in turn results in rotation R4 of deformable rim 67 having
rim inlet 69 and
mesh strainer 63 due to abutting or contact therebetween pigtail 50 and
deformable rim 67,
which in turn causes deformable rim 67 having rim inlet 69 and mesh strainer
63 of
retractable instrument 60 to scoop up or collect or capture clots, plaque,
emboli, thrombi
(blood clots), fatty deposit, biomaterial, or other undesirable material or
debris M from blood
vessel V.
In block or step 735, collecting material or debris M therein mesh strainer 63
via
scooping up or collecting or capturing clots, plaque, emboli, thrombi (blood
clots), fatty
deposit, biomaterial, or other undesirable material or debris M from blood
vessel V therein
mesh strainer 63.
In block or step 740, retracting deformable rim 67, mesh strainer 63, and
material or
debris M therethrough second instrument aperture 25 of second lumen 32 via
collapsing
deformable rim 67 by push/pull P1 of second member end 66 to retrieve
collapsing
deformable rim 67 and mesh strainer 63 may be furled or wrapped therearound
deformable
rim 67 and/or first member end 65, and retractable instrument 60 with
undesirable material or
debris M may be pulled therethrough or entry therein second instrument
aperture 25 and exit
out first instrument aperture 23.
In block or step 745, repeating steps 715-740.
Referring now to FIG. 8, by way of example, and not limitation, there is
illustrated an
example embodiment of a flexible surgical positioning instrument 10. Surgical
positioning
instrument 10 may include access hub or port, such as aspiration port 90
positioned
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proximate hand grip 36 or first catheter end 21. Aspiration port 90 may
provide access, may
be connected, in communication thereto first lumen 31 running the length
thereof elongated
catheter 20, pigtail lumen 31B of pigtail 50, and thereto pigtail end 53.
Moreover, surgical
positioning instrument 10 may include a side arm or conduit, such as
aspiration tube 80
which may include a distal end, such as first tube end 81 and a proximate end,
or second tube
end 82. Second tube end 82 may be affixed or removeably affixed thereto
aspiration port 90.
Aspiration tube 80 may include three way stop cock valve 84 with cock bar 85.
Cock bar 85
may be rotated (rotational) between open position for passage therethrough and
for suction,
diversion position to divert debris M to threaded port and cap 83, and closed
position to seal
second tube end 82. Furthermore, surgical positioning instrument 10 may
include a suction,
vacuum or negative pressure device, such as aspiration device 70. Aspiration
device 70 may
include a syringe having a housing or body such as syringe barrel 72, plunger
71 positioned
therein and drawn or moved, such as as movement M therein syringe barrel 72,
and adapter
port 73 provides an exit or entrance thereto syringe barrel 72. Aspiration
device 70 or more
specifically adapter port 73 may be connected, in communication, or removeably
connected
thereto first tube end 81 preferably to perform aspiration, vacuum, or suction
S therethrough
aspiration tube 80, aspiration port 90, lumen 31 of elongated catheter 20,
pigtail lumen 31B
of pigtail 50, and therethrough pigtail end 53.
Referring now to FIG. 9, by way of example, and not limitation, there is
illustrated an
example embodiment of pigtail 50 shown proximate clots, plaque, emboli,
thrombi (blood
clots), fatty deposit, biomaterial, or other undesirable material or debris M
within blood
vessel V. Moreover, aspiration or suction thereby aspiration device 70
preferably results in
debris M being suctioned in or drawn or pulled (pulls/suctions) or collected
or captured
therein pigtail end 53. Furthermore with continued aspiration or suction
(aspiration
thrombectomy) thereby aspiration device 70 debris M may be pulled or traverse
pigtail lumen
31B of pigtail 50, lumen 31 of elongated catheter 20, aspiration port 90, and
aspiration tube
80, thereto aspiration device 70 whereby debris M has been removed therefrom
blood vessel
V.
It is contemplated herein that pigtail 50 may be in an extended configuration
as shown
in FIG. 2 rather than in a curled configuration as shown in FIGs. 5 during
aspiration or
suction (aspiration thrombectomy) of debris M.
Referring now to FIG. 10, there is illustrated a flow diagram 1000 of
utilizing
surgical positioning instrument 10 and retractable instrument 60 to remove
clots or the
release of emboli, biomaterial, such as undesirable material or debris M from
blood vessel V
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via aspiration or suction. In block or step 1010, providing surgical
positioning instrument 10
having elongated member 20 with two or dual axial bores therethrough, such as
first lumen
31 and second lumen 32, and pigtail 50 on one end and aspiration port 90,
aspiration tube 80,
and aspiration device 70 as described above in FIGS. 8-9.
In block or step 1015, manipulating or moving first catheter end 21 to alter
the
position of pigtail 50 for a path or vessel guiding device to maneuver or
advance surgical
positioning instrument 10 therethrough blood vessel V, turn, fork or other
vascular
maneuverability and positioning pigtail 50 proximate material or debris M,
block or step
1020.
In block or step 1030, operating aspiration device 70 (aspirating or
suctioning) for
collecting, capturing, debris M therein pigtail end 53. Furthermore with
continued aspiration
or suction step 1040 (aspiration thrombectomy) thereby aspiration device 70
debris M may
be pulled or traverse pigtail lumen 31B of pigtail 50, lumen 31 of elongated
catheter 20,
aspiration port 90, and aspiration tube 80, thereto aspiration device 70 step
1050 whereby
debris M has been removed therefrom blood vessel V.
The foregoing description and drawings comprise illustrative embodiments of
the
present disclosure. Having thus described exemplary embodiments, it should be
noted by
those ordinarily skilled in the art that the within disclosures are exemplary
only, and that
various other alternatives, adaptations, and modifications may be made within
the scope of
the present disclosure. Merely listing or numbering the steps of a method in a
certain order
does not constitute any limitation on the order of the steps of that method.
Many
modifications and other embodiments of the disclosure will come to mind to one
ordinarily
skilled in the art to which this disclosure pertains having the benefit of the
teachings
presented in the foregoing descriptions and the associated drawings. Although
specific terms
may be employed herein, they are used in a generic and descriptive sense only
and not for
purposes of limitation. Moreover, the present disclosure has been described in
detail, it
should be understood that various changes, substitutions and alterations can
be made thereto
without departing from the spirit and scope of the disclosure as defined by
the appended
claims. Accordingly, the present disclosure is not limited to the specific
embodiments
illustrated herein, but is limited only by the following claims.
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