U.S. patent application number 15/987583 was filed with the patent office on 2018-11-29 for assistive jet aspiration thrombectomy catheter and method of using same.
This patent application is currently assigned to ASAHI INTECC CO., LTD.. The applicant listed for this patent is ASAHI INTECC CO., LTD.. Invention is credited to Michael K. LUK, Takeshi MOGI, Satoshi NAMIMA.
Application Number | 20180338770 15/987583 |
Document ID | / |
Family ID | 63259540 |
Filed Date | 2018-11-29 |
United States Patent
Application |
20180338770 |
Kind Code |
A1 |
MOGI; Takeshi ; et
al. |
November 29, 2018 |
ASSISTIVE JET ASPIRATION THROMBECTOMY CATHETER AND METHOD OF USING
SAME
Abstract
Embodiments disclosed herein relate to an aspiration catheter
comprising a catheter body that can have a first end and a second
end and an aspiration lumen extending through the catheter body.
The aspiration lumen can have an aspiration opening located in a
distal portion of the aspiration catheter. The catheter can have an
assistive jet element extending through a wall of the aspiration
lumen. The assistive jet element can have an assistive jet channel.
The assistive jet element can be adaptable to draw blood through
the assistive jet element from a location outside of the catheter
body adjacent to the assistive jet element and into the aspiration
lumen when suction is applied to the aspiration lumen and can be
configured to break apart a thrombus or obstruction in the
aspiration lumen.
Inventors: |
MOGI; Takeshi; (Irvine,
CA) ; LUK; Michael K.; (Lake Forest, CA) ;
NAMIMA; Satoshi; (Seto-Shi, JP) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ASAHI INTECC CO., LTD. |
Nagoya-shi |
|
JP |
|
|
Assignee: |
ASAHI INTECC CO., LTD.
Nagoya-shi
JP
|
Family ID: |
63259540 |
Appl. No.: |
15/987583 |
Filed: |
May 23, 2018 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
62510193 |
May 23, 2017 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/22 20130101;
A61B 2017/22038 20130101; A61B 17/32037 20130101; A61B 2017/22084
20130101; A61M 1/008 20130101; A61B 2017/22039 20130101; A61M
2025/0098 20130101; A61B 2217/005 20130101; A61M 25/0074 20130101;
A61M 2206/20 20130101; A61B 2017/22079 20130101 |
International
Class: |
A61B 17/22 20060101
A61B017/22 |
Claims
1. An assistive jet aspiration catheter comprising: a catheter body
having a distal end, a proximal end, and an outer wall; an
aspiration lumen extending through the catheter body along an axial
length of the catheter body from the distal end of the catheter
body to the proximal end of the catheter body; a distal tip
positioned at the distal end of the catheter body, the distal tip
having an aspiration opening in communication with the aspiration
lumen; and an assistive jet element comprising an assistive jet
inlet opening extending through the outer wall in the catheter body
and in communication with the aspiration lumen; wherein the
assistive jet element is adaptable to draw fluid through the
assistive jet inlet opening from a location outside of the
aspiration lumen and to direct an assistive jet flow of the fluid
toward a blockage in the aspiration lumen distal to the assistive
jet inlet opening when suction is applied to the aspiration lumen
and when the aspiration lumen is partially or fully blocked by the
blockage distal to the assistive jet opening.
2. The aspiration catheter of claim 1, wherein an axial centerline
of the assistive jet inlet opening is positioned from approximately
2 mm to approximately 10 mm from a proximal edge of the aspiration
opening, in a proximal direction.
3. The aspiration catheter of claim 1, wherein the assistive jet
element is sized and configured to draw less than approximately 20%
by volume of the total flow aspirated through the aspiration lumen
when a flow through the aspiration window is not substantially
impeded by blockage.
4. The aspiration catheter of claim 1, wherein the assistive jet
element comprises a channel in communication with the assistive jet
inlet opening, the channel providing an enclosed lumen extending
from the assistive jet inlet opening to an assistive jet outlet
opening at a distal end of the enclosed lumen.
5. The aspiration catheter of claim 4, wherein an axial centerline
of the assistive jet inlet opening is positioned between
approximately 5 mm and approximately 50 mm from a proximal edge of
the aspiration opening.
6. The aspiration catheter of claim 4, wherein the assistive jet
outlet opening is positioned between approximately 5 mm distal to a
proximal edge of the aspiration opening to approximately 5 mm
proximal to the proximal edge of the aspiration opening
7. The aspiration catheter of claim 1, wherein the catheter body
comprises a guidewire lumen extending at least from the distal end
of the catheter body along a portion of a length of the catheter
body.
8. The aspiration catheter of claim 1, wherein the aspiration
opening is angled in a lengthwise direction of the catheter
body.
9. The aspiration catheter of claim 1, wherein the aspiration
catheter is a 3 French, 4 French, or 5 French sized catheter, and
the assistive jet inlet opening has a cross-sectional size or area
that is from approximately 20% to approximately 50% of a
cross-sectional size or area of the aspiration lumen.
10. The aspiration catheter of claim 1, wherein the aspiration
catheter is a 6 French or larger sized catheter, and the assistive
jet inlet opening has a cross-sectional size that is from
approximately 10% to approximately 40% of a cross-sectional area of
the aspiration lumen.
11. An aspiration kit, comprising the aspiration catheter of claim
1 and a syringe, the syringe being in communication with the
aspiration lumen and providing a source of suction to the
aspiration lumen.
12. An assistive jet aspiration catheter comprising: a catheter
body having a distal end, a proximal end, and an outer wall; an
aspiration lumen extending through the catheter body along an axial
length of the catheter body from the distal end of the catheter
body to the proximal end of the catheter body; a distal tip
positioned at the distal end of the catheter body, the distal tip
having an aspiration opening in communication with the aspiration
lumen; and an assistive jet inlet opening extending through the
outer wall in the catheter body and in communication with an
assistive jet channel positioned inside the aspiration lumen, the
assistive jet channel extending distally from the assistive jet
inlet opening to an assistive jet outlet opening; wherein: when the
aspiration lumen is partially or fully blocked by a thrombus or
other mass in the aspiration lumen distal to the assistive jet
outlet opening and when suction is applied to a proximal end of the
aspiration lumen, the assistive jet aspiration catheter is
configured to draw a fluid through the assistive jet inlet opening
from a location outside of the aspiration lumen and direct an
assistive jet flow of the fluid through the assistive jet channel
and toward the blockage in the aspiration lumen; and the assistive
jet aspiration catheter is configured such that such flow of fluid
through the assistive jet channel will erode or break apart the
thrombus or other mass that is blocking the aspiration lumen.
13. The aspiration catheter of claim 12, wherein the assistive jet
element is sized and configured to draw less than 20% by volume of
the total flow aspirated through the aspiration lumen when the
aspiration window is not blocked.
14. The aspiration catheter of claim 12, wherein the assistive jet
outlet opening is positioned between approximately 5 mm distal to a
proximal edge of the aspiration opening to approximately 10 mm
proximal to the proximal edge of the aspiration opening.
15. The aspiration catheter of claim 12, wherein the aspiration
opening is angled in a lengthwise direction of the catheter
body.
16. An aspiration kit, comprising the aspiration catheter of claim
12 and a syringe, the syringe being in communication with the
aspiration lumen and providing a source of suction to the
aspiration lumen.
17. An aspiration catheter comprising: an inner catheter body
having a distal end, a proximal end, and an outer wall having an
inside surface and an outside surface; an outer catheter body
having a distal end, a proximal end, and an outer wall having an
inside surface and an outside surface, the outer catheter body
being configured to slidably receive the inner catheter body
therein such that the outside surface of the outer wall of the
inner catheter body is positioned adjacent to the inside surface of
the outer wall of the outer catheter body; an aspiration lumen
extending through the inner catheter body along an axial length of
the inner catheter body from the distal end of the inner catheter
body to the proximal end of the inner catheter body; a distal tip
positioned at the distal end of the catheter body, the distal tip
having an aspiration opening in communication with the aspiration
lumen, wherein: the aspiration catheter has an inner opening
extending through the outer wall of the inner catheter and an outer
opening extending through the outer wall of the outer catheter; the
inner catheter body is movable relative to the outer catheter body
between at least a first position in which the inner and outer
openings are at least substantially in alignment with one another
and a second position in which the inner and outer openings are out
of alignment with one another such that the inner opening of the
inner catheter is at least substantially covered by the outer wall
of the outer catheter; when the inner catheter body is in the first
position, when suction is applied to the catheter, and when a
portion of the aspiration lumen distal to the inner opening in the
inner catheter body is at least partially obstructed by an
obstruction, the catheter will draw a flow of fluid from outside of
the outer catheter body through the inner and outer openings and
into the aspiration lumen; and the aspiration catheter is
configured such that such flow of fluid will assist in the removal
of the obstruction.
18. The aspiration catheter of claim 17, wherein the assistive jet
element comprises a channel in communication with the inner opening
in the inner catheter, the channel providing an enclosed lumen
extending from the inner opening to an assistive jet outlet opening
at a distal end of the enclosed lumen.
19. The aspiration catheter of claim 17, wherein the aspiration
catheter is a 3 French, 4 French, or 5 French sized catheter, and
the inner opening has a cross-sectional area that is from
approximately 20% to approximately 50% of a cross-sectional area of
the aspiration lumen.
20. The aspiration catheter of claim 17, wherein the aspiration
catheter is a 6 French or larger sized catheter, and the inner
opening has a cross-sectional area that is from approximately 10%
to approximately 40% of a cross-sectional area of the aspiration
lumen.
Description
PRIORITY CLAIM
[0001] The present application claims priority from U.S. Patent
Application No. 62/510,193, filed on May 23, 2017, titled ASSISTIVE
JET ASPIRATION THROMBECTOMY CATHETER AND METHOD OF USING SAME, the
content of which is incorporated by reference herein in its
entirety. The benefit of priority is claimed under the appropriate
legal basis including, without limitation, under 35 U.S.C. .sctn.
119(e).
BACKGROUND OF THE DISCLOSURE
Field of the Disclosure
[0002] The disclosure relates to aspiration catheters, in
particular, to aspiration catheters that have an assistive jet
element to improve aspiration of thrombus and/or emboli.
Background and Description of the Related Art
[0003] A thrombus, which is also referred to as a blood clot. can
adhere to the wall of a blood vessel and can obstruct blood flow
through healthy blood vessels. An Acute Myocardial Infarction
("AMI") is an example of an extreme condition that can obstruct
blood flow. Thrombus aspiration is a medical procedure used for the
treatment of ST-segment-elevation myocardial infarction (STEMI).
Thrombectomy refers to a procedure for removal of blood clots from
a patient's vasculature.
[0004] Aspiration catheters can be used to perform thrombectomy
procedures, but present many challenges to medical practitioners
and have many limitations to their effectiveness. Conventional
aspiration catheters currently available on the market have focused
mainly on overcoming certain design challenges such as kinking,
aspiration power in terms of flow cross-sectional area and
deliverability. However, currently available aspiration catheters
have not been able to provide an adequate solution to one of the
most critical challenges of the first generation catheters, which
is, clogging by thrombus, including high consistency thrombus.
Conventional aspiration catheters are susceptible to clogging at
the aspiration opening with thrombus that the surgeon intends to
remove. In many cases, the thrombus is larger than the diameter of
the aspiration lumen, leading to such clogging. High consistency
thrombus can present a greater risk of clogging to aspiration
catheters. Additionally, physicians may prefer to use 6 F (6
French) and 7 F (7 French) guide compatible aspiration catheters
for some patients. This generally small size can result in limited
suction power and an increased risk of becoming clogged with
thrombus or other debris or objects.
[0005] When aspiration is activated using a conventional aspiration
catheter, when the blockage in the blood vessel is severe, the flow
stream will generally mainly come in from the proximal side of the
blockage where the catheter has been advanced toward the blockage
from the proximal side of the vessel. In some cases, this will be
downstream relative to the distal end of the catheter.
[0006] When a large piece or volume of thrombus is drawn toward the
aspiration opening of a conventional aspiration catheter, the main
flow into the aspiration lumen will come from the proximal side of
the aspiration opening because flow from the distal end or side of
the aspiration opening will generally be impeded by the thrombus
inside the ruptured plaque. The constriction caused by the plaque
has a tendency to constrict the flow of blood distal to the end of
the aspiration lumen, resulting in a greater flow velocity coming
from the blood that is proximal to the distal end of the catheter.
Additionally, if the thrombus is large and dense enough to cover
and constrict the aspiration opening, a clog in the aspiration
catheter can significantly restrict if not terminate all aspiration
through the aspiration opening.
[0007] Maintaining a flow of fluid from through the aspiration
lumen during the aspiration procedure is important to effectively
and reliably removing thrombus during an aspiration procedure.
Additionally, significantly reducing or eliminating the probability
of clogging of the aspiration opening and/or aspiration catheter is
also important to effectively and reliably removing thrombus during
an aspiration procedure. In other words, it is also important to
reduce the risk of a blockage of the aspiration lumen by thrombus
plugging up the aspiration lumen, which will result in a
significant if not complete stoppage of fluid flow through the
aspiration lumen.
[0008] The negative impacts of a clogged aspiration catheter go
beyond the effectiveness of the aspiration procedure alone. A
clogged aspiration catheter can have other significant medical
impacts or present significant medical risks to the patient. When a
catheter is clogged, a physician would typically retract the
aspiration catheter out from the guide catheter to gain access to
the clogged portion (i.e. aspiration opening) of the aspiration
catheter to remove the clog from the aspiration catheter. This step
is not only inconvenient, but, can also generate emboli and
eventually lead to ischemic stroke. Emboli can be generated when
the clogged thrombus at the distal opening of the aspiration
catheter gets sheared off by the tip of the guide catheter when
passes through. If the thrombus is only partially aspirated by the
aspiration catheter due to a clog in the catheter, the remaining
portion (i.e., a portion of the thrombus not in the aspiration) of
the thrombus can be sheared by the catheter and/or can generate an
emboli. The thrombus embolus can migrate toward the brain and can
cause ischemic stroke and/or other complications. An aspiration
catheter that has a lower risk of being clogged will reduce the
overall risk of the procedure to the patient.
[0009] Using conventional aspiration catheters, physicians may not
know best the way to clear a clogged catheter as their attention is
typically directed to the monitor and not the catheter or syringe.
A physician may not even realize that the catheter system has
become clogged. Therefore, the physician may not realize that they
are not effectively aspirating thrombus. By reducing the risk of
clogging during aspiration, physicians would spend more time
removing thrombus during the procedure. Additionally, eliminating
the time consuming and risky process of clearing a clogged
aspiration lumen would also make the procedure more time efficient
and safer for the patients.
[0010] Some currently available aspiration catheters have
additional mechanisms or components such as an active saline jet
that can direct a stream of saline fluid from an external source at
the thrombus. But, such additional components or mechanisms, such
as the saline power flow components, can add significant complexity
to such systems and complications to aspiration procedures.
Additionally, such additional components or mechanisms can
negatively affect the flexibility and deliverability of the
catheter. Active flow systems can have stiffer lumen or catheter
bodies, that can reduce the overall flexibility of the catheter
system. For example, conventional active flow systems can have a
stiff tube or lumen for the supply of a saline flow, making the
catheter less flexible and potentially less suitable for tortuous
anatomy.
[0011] The addition of such mechanisms or components can also
increase the cost of the system, which can also have a significant
impact on the acceptability or feasibility of the catheter
system.
[0012] Additionally, some doctors currently use a pecking motion
technique to remove the thrombus, which is pushing and pulling the
catheter in and out repeatedly during the aspiration of thrombus.
This motion can help to prevent the catheter from clogging and also
to help to break up the thrombus. This technique can lead to
operator variations because it is difficult for different doctors
to perform this technique the same way, following the same rate of
movement, same displacement, etc. With the improved aspiration
catheters disclosed herein, doctors will be less likely to rely on
or use the pecking motion technique since the embodiments disclosed
herein present a significantly lower risk of clogging, if not
completely eliminate the risk of clogging. Reducing this operator
variation by providing an aspiration catheter that is effective for
removing thrombus at a reduced clog risk, i.e., using the
embodiments of the improved, can thereby improve the consistency
and potentially the effectiveness of aspiration thrombectomy
procedures.
[0013] Embodiments of the assistive jet catheter systems presented
herein reduce the instance or risk of the aspiration lumen of such
systems from clogging during use. Therefore, the aspiration
catheter embodiments presented herein can significantly improve
patient safety and aspiration effectiveness, as will be described
below.
SUMMARY OF SOME EMBODIMENTS
[0014] The systems, methods and devices described herein have
innovative aspects, no single one of which is indispensable or
solely responsible for their desirable attributes. Without limiting
the scope of the claims, some of the advantageous features will now
be summarized.
[0015] Some embodiments of the present disclosure are directed to
an aspiration catheter adapted to automatically remove and/or
aspirate any clogs in the aspiration lumen. As such, some
embodiments of the catheter are configured such that the catheter
will not get clogged, or will be significantly less likely to get
clogged than conventional aspiration catheters, when used in
aspiration procedures. Aspiration procedures include, but are not
limited to, procedures for ST-Elevation Myocardial Infarction
(STEMI) patients. However, any embodiments disclosed herein can be
configured to remove thrombus or clots in any suitable area of the
body, including but not limited to any coronary, neurovascular,
pulmonary, venous, and peripheral applications or areas of the
body. Some embodiments disclosed herein are directed to a new
generation of aspiration catheter that has a feature called
"assistive jet" on the distal end, which can help to unclog an
aspiration lumen blocked by thrombus.
[0016] Any of the embodiments disclosed herein can have any of the,
or any combination of any of the components, features, or details
of any of the following arrangements.
[0017] Arrangement 1: An assistive jet aspiration catheter
comprising:
[0018] a catheter body having a distal end, a proximal end, and an
outer wall;
[0019] an aspiration lumen extending through the catheter body
along an axial length of the catheter body from the distal end of
the catheter body to the proximal end of the catheter body;
[0020] a distal tip positioned at the distal end of the catheter
body, the distal tip having an aspiration opening in communication
with the aspiration lumen; and
[0021] an assistive jet element comprising an assistive jet inlet
opening extending through the outer wall in the catheter body and
in communication with the aspiration lumen;
[0022] wherein the assistive jet element can be adaptable to draw
fluid (which can be, without limitation, blood and/or other fluid
such as saline) through the assistive jet inlet opening from a
location outside of the aspiration lumen and to direct an assistive
jet flow of fluid toward a blockage in the aspiration lumen distal
to the assistive jet inlet opening when suction is applied to the
aspiration lumen and when the aspiration lumen is partially or
fully blocked by the blockage distal to the assistive jet
opening.
[0023] Arrangement 2: The aspiration catheter of Arrangement 1,
wherein an axial centerline of the assistive jet inlet opening can
be positioned from approximately 2 mm to approximately 10 mm from a
proximal edge of the aspiration opening, in a proximal
direction.
[0024] Arrangement 3: The aspiration catheter of any of the
previous Arrangements, wherein the assistive jet element can be
sized and configured to draw less than approximately 20% (or,
approximately 10%) by volume of the total flow aspirated through
the aspiration lumen when a flow through the aspiration window is
not substantially impeded by blockage.
[0025] Arrangement 4: The aspiration catheter of any of the
previous Arrangements, wherein the assistive jet element can be
sized and configured to draw less than approximately 10% by volume
of the total flow aspirated through the aspiration lumen when a
flow through the aspiration window is not substantially impeded by
blockage.
[0026] Arrangement 5: The aspiration catheter of any of the
previous Arrangements, wherein the assistive jet element comprises
a channel in communication with the assistive jet inlet opening,
the channel providing an enclosed lumen extending from the
assistive jet inlet opening to an assistive jet outlet opening at a
distal end of the enclosed lumen.
[0027] Arrangement 6: The aspiration catheter of Arrangement 5,
wherein an axial centerline of the assistive jet inlet opening can
be positioned between approximately 5 mm and approximately 50 mm
from a proximal edge of the aspiration opening.
[0028] Arrangement 7: The aspiration catheter of Arrangement 5,
wherein the as sistive jet outlet opening can be positioned between
approximately 5 mm distal to a proximal edge of the aspiration
opening to approximately 5 mm proximal to the proximal edge of the
aspiration opening
[0029] Arrangement 8: The aspiration catheter of any of the
previous Arrangements, wherein the assistive jet element can be
positioned adjacent to the aspiration opening.
[0030] Arrangement 9: The aspiration catheter of any of the
previous Arrangements, wherein the catheter body comprises a
guidewire lumen extending at least from the distal end of the
catheter body along a portion of a length of the catheter body.
[0031] Arrangement 10: The aspiration catheter of any of the
previous Arrangements, wherein a distal end of the guidewire lumen
can be distal to the aspiration opening.
[0032] Arrangement 11: The aspiration catheter of any of the
previous Arrangements, wherein the aspiration opening can be angled
in a lengthwise direction of the catheter body.
[0033] Arrangement 12: The aspiration catheter of any of the
previous Arrangements, wherein the aspiration catheter is a 3
French, 4 French, or 5 French sized catheter, and the assistive jet
inlet opening has a cross-sectional size or area that can be from
approximately 20% to approximately 50% of a cross-sectional size or
area of the aspiration lumen.
[0034] Arrangement 13: The aspiration catheter of any of the
previous Arrangements, wherein the aspiration catheter is a 6
French or larger sized catheter, and the assistive jet inlet
opening has a cross-sectional size that can be from approximately
10% to approximately 40% of a cross-sectional area of the
aspiration lumen.
[0035] Arrangement 14: An aspiration kit, comprising the aspiration
catheter of any of the previous Arrangements and a syringe, the
syringe being in communication with the aspiration lumen and
providing a source of suction to the aspiration lumen.
[0036] Arrangement 15: An assistive jet aspiration catheter
comprising:
[0037] a catheter body having a distal end, a proximal end, and an
outer wall;
[0038] an aspiration lumen extending through the catheter body
along an axial length of the catheter body from the distal end of
the catheter body to the proximal end of the catheter body;
[0039] a distal tip positioned at the distal end of the catheter
body, the distal tip having an aspiration opening in communication
with the aspiration lumen; and
[0040] an assistive jet inlet opening extending through the outer
wall in the catheter body and in communication with an assistive
jet channel positioned inside the aspiration lumen, the assistive
jet channel extending distally from the assistive jet inlet opening
to an assistive jet outlet opening;
[0041] wherein: [0042] when the aspiration lumen is partially or
fully blocked by a thrombus or other mass in the aspiration lumen
distal to the assistive jet outlet opening and when suction is
applied to a proximal end of the aspiration lumen, the assistive
jet aspiration catheter can be configured to draw fluid (which can
be, without limitation, blood and/or other fluid such as saline)
through the assistive jet inlet opening from a location outside of
the aspiration lumen and direct a flow of fluid through the
assistive jet channel and toward the blockage in the aspiration
lumen; and [0043] the assistive jet aspiration catheter can be
configured such that such flow of fluid through the assistive jet
channel will erode or break apart the thrombus or other mass that
is blocking the aspiration lumen.
[0044] Arrangement 16: The aspiration catheter of Arrangement 15,
wherein the assistive jet element can be sized and configured to
draw less than 20% by volume of the total flow aspirated through
the aspiration lumen when the aspiration window is not blocked.
[0045] Arrangement 17: The aspiration catheter of any one of
Arrangements 15-16, wherein the assistive jet inlet opening can be
positioned between approximately 5 mm and approximately 50 mm from
a proximal edge of the aspiration opening.
[0046] Arrangement 18: The aspiration catheter of any one of
Arrangements 15-17, wherein the assistive jet outlet opening can be
positioned between approximately 5 mm distal to a proximal edge of
the aspiration opening to approximately 10 mm proximal to the
proximal edge of the aspiration opening.
[0047] Arrangement 19: The aspiration catheter of any one of
Arrangements 15-18, wherein the catheter body comprises a guidewire
lumen extending at least from the distal end of the catheter body
along a portion of a length of the catheter body.
[0048] Arrangement 20: The aspiration catheter of Arrangement 19,
wherein a distal end of the guidewire lumen can be distal to the
aspiration opening.
[0049] Arrangement 21: The aspiration catheter of any one of
Arrangements 15-20, wherein the aspiration opening can be angled in
a lengthwise direction of the catheter body.
[0050] Arrangement 22: An aspiration kit, comprising the aspiration
catheter of any one of Arrangements 15-121 and a syringe, the
syringe being in communication with the aspiration lumen and
providing a source of suction to the aspiration lumen.
[0051] Arrangement 23: An aspiration catheter comprising:
[0052] an inner catheter body having a distal end, a proximal end,
and an outer wall having an inside surface and an outside
surface;
[0053] an outer catheter body having a distal end, a proximal end,
and an outer wall having an inside surface and an outside surface,
the outer catheter body being configured to slidably receive the
inner catheter body therein such that the outside surface of the
outer wall of the inner catheter body is positioned adjacent to the
inside surface of the outer wall of the outer catheter body;
[0054] an aspiration lumen extending through the inner catheter
body along an axial length of the inner catheter body from the
distal end of the inner catheter body to the proximal end of the
inner catheter body;
[0055] a distal tip positioned at the distal end of the catheter
body, the distal tip having an aspiration opening in communication
with the aspiration lumen;
[0056] wherein: [0057] the aspiration catheter has an inner opening
extending through the outer wall of the inner catheter and an outer
opening extending through the outer wall of the outer catheter;
[0058] the inner catheter body can be movable relative to the outer
catheter body between at least a first position in which the inner
and outer openings are at least substantially in alignment with one
another and a second position in which the inner and outer openings
are out of alignment with one another such that the inner opening
of the inner catheter is at least substantially covered by the
outer wall of the outer catheter; [0059] when the inner catheter
body is in the first position, when suction is applied to the
catheter, and when a portion of the aspiration lumen distal to the
inner opening in the inner catheter body is at least partially
obstructed by an obstruction, the catheter will draw a flow fluid
from outside of the outer catheter body through the inner and outer
openings and into the aspiration lumen; and [0060] the aspiration
catheter can be configured such that such flow of fluid will assist
in the removal of the obstruction.
[0061] Arrangement 24: The aspiration catheter of Arrangement 23,
wherein an axial centerline of the inner opening can be positioned
from approximately 2 mm to approximately 10 mm from a proximal edge
of the aspiration opening, in a proximal direction.
[0062] Arrangement 25: The aspiration catheter of any one of
Arrangements 23-24, wherein the inner opening can be sized and
configured to draw less than approximately 20% by volume of the
total flow aspirated through the aspiration lumen when a flow
through the aspiration window is not substantially impeded by
blockage.
[0063] Arrangement 26: The aspiration catheter of any one of
Arrangements 23-25, wherein the inner opening can be sized and
configured to draw less than approximately 10% by volume of the
total flow aspirated through the aspiration lumen when a flow
through the aspiration window is not substantially impeded by
blockage.
[0064] Arrangement 27: The aspiration catheter of any one of
Arrangements 23-26, wherein the assistive jet element comprises a
channel in communication with the inner opening in the inner
catheter, the channel providing an enclosed lumen extending from
the inner opening to an assistive jet outlet opening at a distal
end of the enclosed lumen.
[0065] Arrangement 28: The aspiration catheter of Arrangement 27,
wherein an axial centerline of the inner opening can be positioned
between approximately 5 mm and approximately 50 mm from a proximal
edge of the aspiration opening.
[0066] Arrangement 29: The aspiration catheter of Arrangement 27,
wherein the assistive jet outlet opening can be positioned between
approximately 5 mm distal to a proximal edge of the aspiration
opening to approximately 5 mm proximal to the proximal edge of the
aspiration opening.
[0067] Arrangement 30: The aspiration catheter of any one of
Arrangements 23-29, wherein the catheter body comprises a guidewire
lumen extending at least from the distal end of the catheter body
along a portion of a length of the catheter body.
[0068] Arrangement 31: The aspiration catheter of Arrangement 30,
wherein a distal end of the guidewire lumen can be distal to the
aspiration opening.
[0069] Arrangement 32: The aspiration catheter of any one of
Arrangements 23-31, wherein the aspiration catheter is a 3 French,
4 French, or 5 French sized catheter, and the inner opening has a
cross-sectional area that can be from approximately 20% to
approximately 50% of a cross-sectional area of the aspiration
lumen.
[0070] Arrangement 33: The aspiration catheter of any one of
Arrangements 23-32, wherein the aspiration catheter is a 6 French
or larger sized catheter, and the inner opening has a
cross-sectional area that can be from approximately 10% to
approximately 40% of a cross-sectional area of the aspiration
lumen.
[0071] Arrangement 34: An aspiration kit, comprising the aspiration
catheter of any one of Arrangements 23-33 and a syringe, the
syringe being in communication with the aspiration lumen and
providing a source of suction to the aspiration lumen.
[0072] Arrangement 35: A method of aspirating a mass of thrombus
from a vessel, comprising:
[0073] advancing an aspiration catheter having a catheter body into
the vessel;
[0074] applying suction to the aspiration catheter;
[0075] drawing a flow of fluid through an opening in the catheter
body that is positioned adjacent to a distal end of the catheter
body;
[0076] breaking apart a thrombus positioned adjacent to or in
contact with a distal end of the catheter body with the flow of
fluid flowing through the opening, causing smaller pieces of
thrombus that can be aspirated by the aspiration catheter to break
apart.
BRIEF DESCRIPTION OF THE DRAWINGS
[0077] The foregoing and other features of the present disclosure
will become more fully apparent from the following description and
appended claims, taken in conjunction with the accompanying
drawings. Understanding that these drawings depict only several
embodiments in accordance with the disclosure and are not to be
considered limiting of its scope, the disclosure will be described
with additional specificity and detail through the use of the
accompanying drawings. Embodiments of the present disclosure will
now be described hereinafter, by way of example only, with
reference to the accompanying drawings in which:
[0078] FIG. 1 is a side view of an embodiment of an assistive jet
aspiration catheter system of an over-the-wire configuration,
showing a portion of the catheter in a loop to reduce the size of
the figure.
[0079] FIG. 2 is a side view of the assistive jet catheter body of
the embodiment of the assistive jet aspiration catheter system
shown in FIG. 1.
[0080] FIG. 3 is a top view of the assistive jet catheter body
shown in FIG. 2.
[0081] FIG. 4 is a perspective view of the assistive jet catheter
body shown in FIG. 2.
[0082] FIG. 5 is a section view of the assistive jet catheter body
shown in FIG. 2, taken through line 5-5 of FIG. 2.
[0083] FIG. 6 is a section view of the assistive jet catheter body
shown in FIG. 2, taken through line 6-6 of FIG. 3.
[0084] FIG. 7 is a section view of the assistive jet catheter body
shown in FIG. 2, illustrating aspiration of a mass of thrombus.
[0085] FIG. 8 is a section view of the assistive jet catheter body
shown in FIG. 2, illustrating aspiration of a mass of thrombus.
[0086] FIG. 9 is a side view of another embodiment of an aspiration
catheter system, this embodiment being of a rapid exchange
configuration, showing a portion of the catheter in a loop to
reduce the size of the figure.
[0087] FIG. 10 is a side view of the assistive jet catheter body of
the embodiment of the assistive jet aspiration catheter system
shown in FIG. 9.
[0088] FIG. 11 is a top view of the assistive jet catheter body
shown in FIG. 10.
[0089] FIG. 12 is a perspective view of the assistive jet catheter
body shown in FIG. 10.
[0090] FIG. 13 is a section view of the assistive jet catheter body
shown in FIG. 10, taken through line 13-13 of FIG. 10.
[0091] FIG. 14 is a section view of the assistive jet catheter body
shown in FIG. 10, taken through line 14-14 of FIG. 11.
[0092] FIG. 15 is a section view of a portion of the assistive jet
catheter body shown in FIG. 10, taken through line 15-15 of FIG.
11.
[0093] FIG. 16 is a section view of the assistive jet catheter body
shown in FIG. 10, illustrating aspiration of a mass of
thrombus.
[0094] FIG. 17 is a section view of the assistive jet catheter body
shown in FIG. 10, illustrating aspiration of a mass of
thrombus.
[0095] FIG. 18 is a side view of another embodiment of an
aspiration catheter system, showing a portion of the catheter in a
loop to reduce the size of the figure.
[0096] FIG. 19 is a side view of the assistive jet catheter body of
the embodiment of the assistive jet aspiration catheter system
shown in FIG. 18.
[0097] FIG. 20 is a top view of the assistive jet catheter body
shown in FIG. 19.
[0098] FIG. 21 is a perspective view of the assistive jet catheter
body shown in FIG. 19.
[0099] FIG. 22 is a section view of the assistive jet catheter body
shown in FIG. 19, taken through line 22-22 of FIG. 19.
[0100] FIG. 23 is a section view of the assistive jet catheter body
shown in FIG. 19, taken through line 23-23 of FIG. 20.
[0101] FIG. 24 is a section view of the assistive jet catheter body
shown in FIG. 10, illustrating aspiration of thrombus.
[0102] FIG. 25 is a section view of the assistive jet catheter body
shown in FIG. 10, illustrating aspiration of thrombus.
[0103] FIG. 26 is a perspective view of another embodiment of an
assistive channel aspiration catheter.
[0104] FIG. 27 is a side view of the assistive jet catheter body
shown in FIG. 26.
[0105] FIG. 28 is a top view of the assistive jet catheter body
shown in FIG. 26.
[0106] FIG. 29 is a section view of the assistive jet catheter body
shown in FIG. 19, taken through line 29-29 of FIG. 27.
[0107] FIG. 30 is a section view of the assistive jet catheter body
shown in FIG. 19, taken through line 30-30 of FIG. 28.
[0108] FIG. 31 is an enlargement of the section view of the
assistive jet catheter body of FIG. 30, illustrating aspiration of
thrombus.
[0109] FIG. 32 is a section view of another embodiment of an
assistive channel aspiration catheter.
[0110] FIG. 33 is a section view of another embodiment of an
assistive channel aspiration catheter.
[0111] FIG. 34 is a section view of another embodiment of an
assistive channel aspiration catheter.
[0112] FIG. 35 is a side view of another embodiment of an assistive
jet aspiration catheter, being of an over-the-wire
configuration.
[0113] FIG. 36 is a perspective view of a distal portion of the
aspiration catheter shown in FIG. 35.
[0114] FIG. 37 is a side view of a distal portion of the aspiration
catheter shown in FIG. 35.
[0115] FIG. 38 is a top view of a distal portion of the aspiration
catheter shown in FIG. 35.
[0116] FIG. 39 is a section view of the assistive jet catheter
shown in FIG. 35, taken through line 39-39 of FIG. 37.
[0117] FIG. 40 is a section view of a distal portion of the
assistive jet catheter shown in FIG. 35, taken through line 40-40
of FIG. 38.
[0118] FIG. 41 is a section view of a distal portion of the
assistive jet catheter shown in FIG. 35, illustrating aspiration of
a mass of thrombus.
[0119] FIG. 42 is a section view of a distal portion of the
assistive jet catheter shown in FIG. 35, illustrating aspiration of
a mass of thrombus.
[0120] FIG. 43 illustrates a variety of different catheter body
cross-sectional configurations that can be used with any of the
assistive jet aspiration catheter systems disclosed herein.
DETAILED DESCRIPTION
[0121] Embodiments of systems, components, methods, and details of
assembly and manufacture are described herein, with reference to
the accompanying figures, wherein like numerals refer to like or
similar elements throughout. Although several embodiments,
examples, and illustrations are disclosed below, the inventions
described herein extend beyond the specifically disclosed
embodiments, examples, and illustrations and can include other uses
of the inventions and obvious modifications and equivalents
thereof, and combinations of any of the embodiments, features, and
details of any of the embodiments disclosed herein with other of
the embodiments disclosed herein. Additionally, the descriptions of
all of the embodiments disclosed herein should be interpreted to
include any of the features, components, and other details of any
of the other embodiments disclosed here in combination with or in
the alternative to any of the features, components, and other
details explicitly described herein to form new embodiments, all of
which are included as part of this disclosure.
[0122] Additionally, the terminology used herein is not intended to
be interpreted in any limited or restrictive manner simply because
it is being used in conjunction with a detailed description of
certain specific embodiments of the inventions. Also, embodiments
of the inventions can comprise several novel features and no single
feature is solely responsible for its desirable attributes or is
essential to practicing the inventions herein described.
[0123] Certain terms may be used in the following description for
the purpose of reference only, and thus are not intended to be
limiting. For example, terms such as "above" and "below" may refer
to directions in the drawings to which reference is made or to a
direction relative to the orientation of the embodiment in an
operable position. Terms such as "front," "back," "left," "right,"
"rear," and "side" describe the orientation and/or location of
portions of the components or elements within a consistent but
arbitrary frame of reference which is made clear by reference to
the text and the associated drawings describing the components or
elements under discussion. Moreover, terms such as "first,"
"second," "third," and so on may be used to describe separate
components. Such terminology may include the words specifically
mentioned above, derivatives thereof, and words of similar
import.
[0124] Embodiments presented herein address significant shortcoming
or problems of the currently available aspiration catheters, which
can include clogging of the aspiration lumen of the catheter by the
thrombus that such catheters are designed to remove. As will be
discussed, some or all embodiments of the assistive jet catheter
systems presented herein produce a range of performance and
usability advantages over the presently available aspiration
catheters.
[0125] Embodiments of the assistive jet catheter systems presented
herein are configured to produce a flow of fluid flow from the
patient's bloodstream that can be used to break up thrombus within,
adjacent to, or near a distal portion of the aspiration lumen. In
any embodiments disclosed herein, saline or other suitable fluid
can be provided to the patient's vessel near the target area, and
the blood, saline, and/or other fluid can be drawn through the
assistive jet element to break apart or erode the thrombus. This
addition of the assistive jet can reduce the size of the thrombus
being aspirated by breaking the thrombus up into smaller pieces or
masses, thereby reducing the likelihood of the aspiration lumen
becoming clogged. Pieces or masses from the larger thrombus are
aspirated through the catheter's aspiration lumen as the larger
mass of the thrombus is being reduced in size.
[0126] For example, any embodiments of the assistive jet aspiration
catheter disclosed herein can have an assistive jet element that
can be used to draw blood from the patient's blood vessel and
direct the flow of blood from the patient's blood vessel at the
thrombus, thereby eroding and/or breaking apart the thrombus. In
some embodiments, the assistive jet element or assistive jet
elements can comprise any assistive jet channel features or
components, assistive jet opening features or components, and/or
other features, components, or elements adapted to draw fluid flow
(for example, blood) from the patient's vessel and direct said
fluid toward the opening of the aspiration catheter. The assistive
jet through the assistive jet element can be used to erode or break
apart thrombus positioned in contact with or adjacent to the
opening of the aspiration catheter.
[0127] In any embodiments and without limitation, the assistive jet
element can comprise an opening through the catheter body wall
positioned near the opening of the aspiration lumen, a separate
flow channel having a first or inlet opening in communication with
the patient's blood stream outside of the catheter body and a
second or outlet opening adjacent to an opening of the aspiration
lumen, or any other suitable features or combinations of features
configured to direct a flow of blood from the patient's blood
stream toward or at the opening of the aspiration lumen. In some
embodiments, the opening of the assistive jet element (which can
have a channel) can be selectively openable and/or closeable so
that a physician can have better control over the operation of the
assistive jet element.
[0128] In some embodiments, the catheter body can have any
combination of assistive jet channel and assistive jet openings
(for example, holes) in the catheter body. For example, the
catheter body can have as aspiration flow lumen in addition to one
or more aspiration flow openings that are positioned in the
catheter body distal to the opening of the aspiration flow lumen.
Fluid or blood flow through the assistive jet channel can flow
through the assistive jet channel in a direction that is opposite
to the direction of aspiration, such that the fluid or blood flow
through the assistive jet channel can be directed at the thrombus
or other debris that is positioned in contact with or adjacent to
the aspiration opening. This can increase the effect of the
assistive jet in shearing or breaking up the thrombus and,
thereafter, removal of the thrombus through the aspiration
lumen.
[0129] In any embodiments, the opening or channel of the assistive
jet element (or any of the assistive jet openings or other
assistive jet elements disclosed herein) can be adapted to provide
flow from a position that is proximal to the aspiration opening to
a position that is adjacent to, just proximal to, distal to a
distal edge of an aspiration opening (if the aspiration opening is
slanted, etc.) and/or within the aspiration opening. As used
herein, the term distal is meant to refer to a position or
direction that is closer to the handle portion of the aspiration
catheter than the distal dip of the aspiration catheter,
[0130] When aspiration is activated in the aspiration lumen, flow
can come into the aspiration lumen from multiple directions. If not
fully obstructed, flow can enter the aspiration lumen through the
aspiration lumen opening. Flow can also come through the assistive
jet channel and can break up or shear off fragments of any thrombus
in the vicinity of the end of the assistive jet channel, so that
such fragmented thrombus can be broken up into pieces or sizes that
can be aspirated by the aspiration lumen. In any embodiments
disclosed herein, though not required, the assistive jet channel or
channel can be positioned between the aspiration lumen and a
guidewire lumen, if the catheter body has a discrete guidewire
lumen. In other embodiments, though not so limited, the assistive
jet channel or channel can be positioned on an opposite side of a
guidewire lumen as compared to the aspiration lumen.
[0131] Any of the assistive jet aspiration catheter embodiments
disclosed herein can be configured to work with both rapid exchange
and over-the-wire types of catheters. These designs can also be
used for catheter with or without guidewire lumen even though most
of the catheter applications commonly used today are used with a
guidewire. Any embodiments of the assistive jet catheter systems
disclosed herein can have a guidewire lumen and a main aspiration
lumen that extends from a hub portion at a proximal end of the
catheter body to an aspiration opening that can be positioned at a
distal end of the catheter body. In any embodiments, the guidewire
lumen can extend substantially or completely the entire length of
the catheter body, or can extend along only a portion of the
catheter body, such as in a rapid exchange configuration. For
example, the guidewire lumen can extend through only the distal 15
cm of the catheter body. Any aspiration catheter embodiments
disclosed herein can also be designed to not have a guidewire
lumen.
[0132] Additionally, as mentioned above, any embodiments of the
assistive jet catheter systems disclosed herein can have one or
more side holes (referred to above as assistive jet openings) near
the aspiration opening that can also provide the assistive jet or
flow of blood toward the aspiration opening. In some embodiments, a
possible advantage of the assistive jet openings relative to
aspiration channels is that the assistive jet openings can be more
efficient than the aspiration channels. The assistive jet openings
can impart a lower pressure loss than the assistive jet channels.
This can increase the flow velocity through the aspiration lumen
when, for example and without limitation, the flow through the
aspiration opening is restricted by thrombus. An advantage of the
assistive jet channel, in some embodiments, is that the assistive
jet channel can more precisely control the direction of flow of the
assistive jet by confining the flow path of the assistive jet since
the channel will only permit the flow through the lumen of the
channel.
[0133] A guide catheter of 7 F and 8 F size typically has much more
suction power and can remove chunks of thrombus much better than a
6 F guide catheter or a 6 F compatible aspiration catheter.
However, 7 F and 8 F can be too big for some coronary arteries that
encounter acute myocardial infarction ("AMI"). 6 F or smaller
systems are typically the only aspiration catheter systems that can
be used in such anatomy. However, at least some conventional 6 F
aspiration catheters have been shown to be largely ineffective in
removing thrombus. The shearing mechanisms of the embodiments of
the assistive jet catheter systems presented herein enable the
smaller, 6 F sized catheters to have the thrombus removing
effectiveness of the larger, 7 F or 8 F aspiration catheters.
However, in any embodiments disclosed herein, the assistive jet
catheter systems can be used in catheters that are smaller than the
6 F size, including but not limited to 4 F and 5 F sizes, or in
catheters that are larger than the 6 F size, including 7 f or 8 F
or larger sizes.
[0134] Some embodiments of the assistive jet catheter devices
disclosed herein can be configured to use flexible catheter bodies,
designed to improve the flexibly and/or steerability of the
catheter systems. In any embodiments disclosed herein, all or a
portion of the catheter body can be rigid and/or formed of metal or
other rigid or semi-rigid material. For example, embodiments of the
aspiration catheter or device of the present disclosure can be
adapted for use to perform biopsy procedures. Such devices can have
all or a portion of the catheter body formed from a rigid or
semi-rigid material. The embodiments of the assistive jet catheter
devices disclosed herein can be suitable for tortuous anatomies.
Additionally, any embodiments of the assistive jet catheter devices
disclosed herein can utilize catheter bodies with coils, or coil
reinforced portions, or braiding. For example, without limitation,
the distal portion of the catheter body (the portion closest to the
end of the catheter body) can be coil and/or braid reinforced.
Embodiments of such systems can have assistive jet components or
features integrated into such coil and/or braid reinforced catheter
bodies. Additionally, in any embodiments, the catheter body can be
coil and/or braid reinforced along all or portions of the catheter
body that are proximal to the assistive jet element(s).
[0135] Any embodiments of the assistive jet catheter system
embodiments disclosed herein can be used to treat a range of
conditions, including but not limited to Acute Myocardial
Infarction ("AMI"). Any aspiration catheter embodiments disclosed
herein can be adapted for use in other parts of the body that may
also have a blood clot, such as the leg (deep vein thrombosis),
lungs, brain, and/or heart (venous thrombosis). Any aspiration
catheter embodiments disclosed herein can be adapted for removing
any loose masses that are present in the body, not just within the
blood stream.
[0136] The assistive jet catheter systems presented herein can be
easier to use and require little or no additional training for
medical practitioners familiar with known or typical thrombectomy
procedures. This can improve the safety and efficiency of the
thrombectomy system, and reduce the overall cost of using the
embodiments of the assistive jet catheter systems presented herein
as compared to more complex, or active flow systems.
[0137] Additionally, when conventional aspiration catheters become
clogged, all or a portion of the thrombus that is within the
aspiration lumen, but which has not yet reached the syringe, will
in most cases stop moving toward the syringe since the clogged
condition can terminate or significantly reduce the suction
pressure. Such clogging can also result in thrombus or other debris
positioned within the distal end of the catheter body being emitted
from the aspiration lumen back into the patient's vasculature or
anatomy, which can present significant risks to the patient.
[0138] In contrast, when large and/or high consistency thrombus are
drawn into contact with the aspiration opening or aspiration lumen
of the assistive jet catheter system embodiments disclosed herein,
at least a minimal level of aspiration flow will be maintained in
the aspiration lumen due to the fluid flow capabilities of the
assistive jet channel or opening, which can provide a fluid flow
path that bypasses a clogged portion of the aspiration opening or
lumen. Additionally and importantly, this fluid flow from the
assistive jet channel or opening can operably shear and/or break up
such thrombus, allowing large and/or high consistency thrombus that
would clog convention aspiration catheters to be aspirated by the
embodiments of the assistive jet catheter systems disclosed herein.
This can also prevent thrombus or debris within the aspiration
lumen from being ejected into the patient's vasculature, thereby
reducing the risk of an embolic condition even when the embodiments
of the assistive jet catheter systems become at least partially
clogged.
[0139] In any embodiments disclosed herein, the assistive fluid
flow path can be introduced through an assistive jet channel or
lumen that projects in a direction that is parallel with the
aspiration lumen. Fluid or blood flow through the assistive jet
channel can flow through the assistive jet channel in a direction
that is opposite to the direction of aspiration, such that the
fluid or blood flow through the assistive jet channel can be
directed at the thrombus or other debris that is positioned in
contact with or adjacent to the aspiration opening. This can
increase the effect of the assistive jet in shearing or breaking up
the thrombus.
[0140] In any embodiments, the catheter body, aspiration lumen,
aspiration opening, and/or assistive jet element(s) can be adapted
such that, when suction is applied to the aspiration lumen and
there is no obstruction from thrombus or other debris affecting
flow through the aspiration lumen, all or substantially all of the
fluid flowing into the aspiration lumen will flow through the
aspiration opening, with little to no flow through the assistive
jet element(s). In this state, the assistive jet element(s) will be
effectively disabled unless an obstruction is presented to the
aspiration lumen opening. In some embodiments, the assistive jet
element can be configured such that, as a thrombus or other mass
moves closer to the aspiration opening, the proximity of the
thrombus to the aspiration opening can cause the flow of blood
through the aspiration opening to be impeded, which obstruction to
the flow through the aspiration lumen opening can "activate" the
assistive jet element to direct fluid flow toward the aspiration
lumen opening.
[0141] In these configurations, when suction is applied through the
aspiration lumen wherein the aspiration lumen is open (i.e. not
impeded or clogged), all or substantially all of the flow of blood,
thrombus, and other debris will advance through the aspiration
opening and not through the assistive jet element. The assistive
jet element will essentially be disabled in this situation.
[0142] Additionally, in any embodiments disclosed herein, the
assistive fluid flow path can be introduced through an assistive
jet opening that is positioned in a distal region of the aspiration
catheter. For example and without limitation, the assistive jet
opening can be positioned in a side wall of the catheter body or
aspiration opening. The assistive jet opening can be a round
opening, an ovular opening, or any other suitably shaped opening
formed radially through a wall of the catheter body.
[0143] Any embodiments can have a single asisstive flow inlet
opening or multiple assistive jet inlet openings formed in the
catheter body. In some embodiments, the single opening can be
positioned at any desired radial position, for example, near a
bottom portion of the catheter body, near the lateral sides of the
catheter body, near the top of the catheter body, or otherwise. For
orientation purposes, when the aspiration lumen opening is angled,
beveled, or otherwise elongated, the distalmost portion of the
aspiration lumen can be at the bottom of the catheter body such
that an assistive jet opening positioned at a top of the catheter
body can be positioned radially opposite to the distalmost portion
of the aspiration lumen. The bottom of the lumen in this
orientation can be designated the 6 o'clock position, and the top
can be designated the 12 o'clock position. In any embodiments, the
assistive jet element inlet element or opening can be positioned
approximately at the 7 o'clock position, the 3 and/or 9 o'clock
position(s), the 12 o'clock position, or any combination of these
positions or therebetween. In embodiments having multiple assistive
jet elements, the assistive jet element inlet openings can be
positioned approximately at any combination of the 7 o'clock
position, the 3 and/or 9 o'clock position, the 12 o'clock position,
or any combination of these positions or therebetween, for example,
a first assistive jet opening can be positioned at an approximately
12 o'clock position. A second and a third assistive jet opening can
be positioned approximately between a 5 o'clock and a 6 o'clock
position, and between a 6 o'clock and a 7 o'clock position,
respectively. Some embodiments can have two assistive jet elements,
a first assistive jet element or opening can be positioned between
a 5 o'clock and a 6 o'clock position and a second assistive jet
element or opening can be positioned approximately between a 6
o'clock and a 7 o'clock position, respectively.
[0144] In any assistive jet aspiration catheter embodiments
disclosed herein, the assistive jet openings can be configured to
direct the assistive jet in any desired directions, including in
different directions. For example, in an embodiment having two
assistive jet openings, a first assistive jet opening can direct
the flow in a proximal direction (i.e., toward a proximal end of
the catheter). A second assistive jet opening can direct the flow
in a radially inward direction, or a distal direction.
[0145] A deflective or flow direction element can be positioned
inside the aspiration lumen, adjacent to the assistive jet element
opening, to direct the assistive jet through the lumen toward the
aspiration opening, such that the assistive jet can be directed
toward thrombus adjacent to or in contact with the aspiration
opening. In any embodiments, the deflective or flow direction
element can be a tab or protrusion that projects away from the
inside surface of the aspiration lumen a short distance, positioned
at an adjacent and or side of the assistive jet opening. The
deflective or flow direction element can be positioned at an angle
or can have a curved surface so as to not significantly disturb the
velocity of the assistive jet through the assistive jet
opening.
[0146] Additionally, any assistive jet aspiration catheter
embodiment disclosed herein can have multiple assistive jet
openings, each of the assistive jet openings having a different
cross-sectional size or diameter. For example, a first assistive
jet opening can have a first cross-sectional size or diameter. A
second assistive jet opening can have a second cross-sectional size
or diameter, the second cross-sectional size or diameter being
greater than, less than, or equal to the first cross-sectional size
or diameter. Additionally, the assistive jet aspiration catheter
embodiment could have a third assistive jet opening, the assistive
jet opening having a third cross-sectional size or diameter that is
greater than, equal to, or less than the cross-sectional size or
diameter of the first and/or second cross-sectional size or
diameter.
[0147] In any embodiments disclosed herein, the assistive jet
opening or the distal opening of the assistive jet channel can be
positioned adjacent to the aspiration opening. In any embodiments,
including without limitation those where the aspiration opening is
slanted, the assistive jet opening or the distal opening of the
assistive jet channel can be positioned adjacent to a top portion
or a lower portion of the aspiration opening, the top portion being
positioned further proximal of the distal end of the aspiration
catheter as compared to the lower portion of the aspiration
opening, one or both sides of the catheter body, or in any other
desired location.
[0148] In any embodiments disclosed herein, the assistive jet
channels can be small and may possibly be plugged up by the red
blood cells flowing through the assistive jet channels. Therefore,
the assistive jet openings and channels should be large enough for
blood to flow therethrough without restriction. Additionally, in
any embodiments, any channels or lumen within the aspiration
catheter, including the assistive jet channels and the aspiration
lumen, can be coated with PTFE, silicone or similar coating to
reduce the likelihood of adhesion of the blood and platelet to the
surface of the lumen that can slow down the flow through the lumen.
Coating can present a risk of peeling off and impeding flow through
the lumen, as well as reducing the flow area through the lumen.
Several new materials that have been developed involve either
having additive in the polymer itself or treating the surface of
the polymer. Examples of such additive modified materials include
Interface Biologics' s Bio Flo (or Endexo)
(http://www.interfacebiologics.com/) and Wyss Institute's
Tethered-Liquid Perfluorocarbon surface treatment
(https://wyss.harvard.edu/bioinspired-coating-for-medical-devices-repels--
blood-and-bacteria/). Any of these materials can be used to coat
any of the lumen in any of the embodiments disclosed herein.
[0149] With coronary plaque, the size of lesions typically range
from 3 mm to 3 cm. The aspiration catheter will usually be pushed
through the entire lesion length to remove the thrombus inside the
ruptured plaque. It may be useful that the assistive jet inlet
opening is located outside of the lesion during this use. On the
other hand, the location of these lesion can be from 5 cm to 15 cm
deep into the coronary arteries and ideally be outside of the guide
catheter when these locations are reached. In any embodiments
disclosed herein, the inlet opening for the assistive jet element
can be from approximately 6 to approximately 7 cm from the distal
edge of the aspiration opening, or from approximately 4 to
approximately 5 cm from the distal edge of the aspiration opening.
In some embodiments, the length of the aspiration opening and the
tip can be from approximately 5 mm to approximately 12 mm long,
and/or the inlet opening of the assistive jet element can be from
approximately 3 cm to approximately 4.5 cm from a proximal edge of
the aspiration opening.
[0150] Additionally, in any of embodiments, the assistive jet from
either the assistive jet channel or the assistive jet opening can
be directed at a proximal side of the thrombus. The proximal side
of the thrombus is the side of the thrombus that is closest to the
proximal end of the aspiration catheter. A benefit of this
arrangement is that, when the assistive jet from either the
assistive jet channel or assistive jet opening is directed at a
proximal side of the thrombus, the result will be that the proximal
side of the thrombus will be sheared or broken up. This arrangement
facilitates the easy aspiration of the sheared off or broken off
pieces of the thrombus, because the sheared off or broken off
thrombus will be directly exposed to the aspiration flow through
the aspiration lumen. This can also reduce the likelihood that any
sheared off or broken off pieces of thrombus will be released into
the patient's vasculature.
[0151] The shape and size of the assistive jet inlet opening or
aperture can be varied. In any embodiments, the inlet aperture or
opening of the assistive jet element can have a round shape, a
triangular shape, an oval shape, a longitudinal slit, or
circumferential slit at the bottom of the aspiration around the
aspiration lumen opening location. The aperture can be less than
approximately 3 mm in any dimension to avoid weakening the catheter
body. Weakening the catheter body can lead to kinking of the
catheter body. A non-round geometry can increase the area of
interaction and the volume/size of the assistive jet hitting the
stuck thrombus. In some embodiments, an assistive jet opening size
of 0.3 mm to 0.6 mm diameter hole can help promote the best
mechanical integrity, and may not limit the flow through the bottom
aperture. An approximately 0.3 mm size can be, in some embodiments,
slightly superior since the velocity of the flow on the top is
higher than that of the 0.6 mm. This also means greater aspiration
power. The top and bottom jets can work together and provide better
suction and a higher velocity into the lumen in the normal state,
i.e. before clogging. For some embodiments, a 0.6 mm size can
achieve a wider and stronger flow from the aperture than a 0.3 mm
size when the aspiration lumen is in a blocked state. In some
embodiments, this flow pattern can remain unchanged when opening
sizes are above 0.6 mm.
[0152] In any embodiments, the catheter body can have an angled or
beveled distal tip. The angle can be approximately 30 degrees, or
from approximately 20 degrees to approximately 40 degrees or more,
or from approximately 10 degrees or less (as little as 5 degrees)
to approximately 50 degrees or more. In an angled configuration, an
end of the catheter tip can be truncated, blunted, and/or rounded
such that only a portion of the tip is angled or beveled. For
example, the aspiration opening can have multiple angles and
curves, ranging from 5 degrees to 45 degrees relative to the
longitudinal axis of the catheter body. The opening for the
assistive jet element can be positioned adjacent to any desired
portion of the aspiration opening or window. Additionally, in any
embodiments, an end of the aspiration catheter can have a straight
cut.
[0153] For designs of the aspiration catheter that have a guidewire
lumen (for example, the rapid exchange configurations disclosed
herein), a 0.014 in guidewire compatible aspiration catheter can
have a guidewire lumen of approximately 0.0165 in. Embodiments
adapted for coronary applications can have a lumen sized for an
approximately 0.014 in wire system. For lower limb applications,
both 0.014 in and 0.018 in guidewire compatible systems can be
used. If an 0.018 in system is used, the guidewire lumen can be
approximately 0.0205 in in diameter.
[0154] FIG. 1 is a side view of an embodiment of an assistive jet
aspiration catheter system 100 having a suction source 102 (which
can be a Vaclok 30 cc syringe, a pump system such as a Penumbra.TM.
pump, or otherwise), a stopcock or valve 104 to control the suction
and flow of fluid through the system 100, and an assistive jet
aspiration catheter 110 (also referred to herein as a assistive jet
catheter and just an aspiration catheter). The assistive jet
aspiration catheter 110 can have a catheter body 112 having a
distal end 114 in a proximal end 116. A handle or hub 120 can be
positioned at a proximal end of the catheter body. A strain relief
component (such as strain relief component 117 shown in FIG. 1) can
be positioned over the catheter body in any embodiments disclosed
herein. The strain relief component can be positioned distal to the
hub to reduce the strain experienced by the catheter body in that
region. In any embodiments disclosed herein, the hub can be coupled
directly or indirectly with a Y connector and/or the other
components of the assistive jet aspiration catheter system 100. The
Y connector can provide a sealed exit point from the aspiration
lumen for a guidewire, for example, for the over-the-wire
configuration embodiments. The catheter body can extend through the
hub. The hub 120 can be used to rotate and otherwise manipulate the
catheter body 112. FIG. 2 is a side view of the assistive jet
catheter body 112 of the embodiment of the assistive jet aspiration
catheter system 100 shown in FIG. 1. FIGS. 3 and 4 are a top view
and a perspective view, respectively, of the assistive jet catheter
body 112 shown in FIG. 2. FIG. 5 is a section view of the assistive
jet catheter 110 shown in FIG. 2, taken through line 5-5 of FIG. 2,
and FIG. 6 is a section view of the assistive jet catheter 110
shown in FIG. 2, taken through line 6-6 of FIG. 3.
[0155] With reference to the figures, in any embodiments, the
catheter body 112 can have an aspiration opening 130 and an
aspiration lumen 132 in communication with the aspiration opening
130 and extending through an entire length of the catheter body
112. In any embodiments disclosed herein, the aspiration opening
can also be referred to as an aspiration window. The catheter body
112 can also have an assistive jet element 134 configured to direct
a flow or jet of fluid (such as blood) into the aspiration lumen
adjacent to the aspiration opening, as described herein. The
assistive jet element 134 can comprise an assistive jet inlet
opening 140 (also referred to herein as an assistive jet inlet)
formed through the catheter body 112 at any desired radial and/or
longitudinal location. In the illustrated embodiment, the assistive
inlet flow opening can be positioned at a diametrically opposite
position as compared to the most proximal portion of the aspiration
opening 130. This can provide the most optimal flow of fluid toward
a thrombus that may be lodged in the aspiration opening 130 to
erode or break apart the thrombus. In any embodiments, the distal
tip can be designed to be soft or flexible and atraumatic so as to
reduce the risk of puncture and/or injury to the tissue as the
catheter body is being advanced through the patient's vessel or
passageway.
[0156] The aspiration opening 130 can have a curved profile with
rounded edges. This curved profile can optimize the aspiration
capabilities of the catheter body 112. In any other embodiments,
the aspiration opening 130 can have a flat, angled or beveled
profile, or even a square end profile. With reference to FIG. 6,
the aspiration opening 130 can define any suitable angle A1. For
example and without limitation, the angle A1 can be approximately
20.degree., or from approximately 10.degree. to approximately
30.degree.. Additionally, in any embodiments, a length of the
aspiration opening L3 can be approximately 6 mm, or from
approximately 5 mm or less to approximately 8 mm or more. The
distal most tip 114 can be rounded or blunted again to reduce the
risk of trauma to the tissue.
[0157] With reference to FIGS. 1 and 6, some embodiments of the
aspiration catheter 110 can have a length L1 from approximately 90
cm to approximately 170 cm, which can be used for most
neurological, coronary, vascular, and/or peripheral procedures for
most radial and femoral access sites. However, the length of the
catheter can be less than or greater than these values for any
suitable applications. In any embodiments, a length L2 of the
distal portion of the catheter body 112 can be approximately 7.4 mm
or more, wherein the distal portion is defined as the region of the
catheter body 112 that is unreinforced (i.e., where the catheter
body does not have a braid or coil reinforcement). With a 7 mm long
aspiration opening 130, and the assistive jet inlet 140 having a
0.3 mm diameter D1, the proximal braid section can be as close as
7.4 mm to the distal end 114. However, in any other embodiments,
the braid or coil reinforcement can terminate at point proximal to
7.4 mm to fit the needs of the application. The proximal portion
can have braids and/or coils 150 for reinforcement. The proximal
portion can extend the rest of the length of the catheter body 112
from the proximal most end of the distal portion all the way to the
proximal end 116 of the catheter body.
[0158] The location of the assistive jet inlet 140 relative to the
aspiration opening 130 can have a significant impact on the
effectiveness of the assistive jet element to provide the flow or
jet of fluid needed to break down or erode thrombus stuck in the
aspiration opening 130. For example, if the assistive jet inlet 140
is too far distal, there will be a risk that the assistive jet
opening 140 will also be clogged by a thrombus that has clogged the
aspiration opening 130. If the assistive jet inlet 140 is too far
proximal, the ability of the assistive jet inlet 140 to direct a
sufficient jet or flow of fluid at a thrombus lodged in the
aspiration opening 130 can be attenuated thereby reducing the
effectiveness of the assistive jet element 134. In some
embodiments, the assistive jet inlet 140 can be positioned such
that an axial centerline of the assistive jet inlet 140 is at a
distance L4 of approximately 1 mm, or from approximately -2 mm to
approximately 10 mm (the negative number indicates that the axial
centerline of the opening is positioned distal to the proximal edge
of the aspiration opening), or from approximately 1 mm to
approximately 3 mm, from the proximal most end of the aspiration
opening 130, or to and/or from any values within these ranges. In
some embodiments, the assistive jet inlet 140 can be positioned
such that the centerline of the assistive jet inlet 140 is
positioned distal of the proximal most end, which can increase the
impact of flow through the inlet 140 against the thrombus, assuming
that the inlet 140 is not clogged by or covered by the
thrombus.
[0159] In any embodiments disclosed herein, the assistive jet inlet
140 can have diameter D1 that is approximately 1/3 (33%) of a
diameter D2 of the aspiration lumen 132, or from approximately 10%
to approximately 15% for 3 Fr (i.e., French size) compatible
catheter, or from approximately 25% to approximately 45% of the
diameter of the aspiration lumen 132. If the diameter of the
assistive jet inlet 140 is too large relative to the aspiration
lumen, the assistive jet inlet 140 can draw more flow from the
surrounding fluid that is optimal or desired even when the
aspiration opening 130 is not clogged. The same condition can occur
if the assistive jet inlet 140 is positioned too close to the
aspiration opening 130. In any embodiments disclosed herein, the
aspiration flow inlet 140 can have a round, oblong, ovular,
triangular, or any other suitable shape.
[0160] In any embodiments, the assistive jet element can have a
plurality of holes or inlets through the catheter body to provide
additional flow or jet pathways toward a thrombus stuck in the
aspiration window. The number of holes, position of the holes, and
diameter of the holes can depend largely on the type of thrombus to
be removed. The number of holes should be optimized to provide
effective erosion of the thrombus while not significantly reducing
the amount of suction or flow through the aspiration opening 130.
Too many aspiration flow inlets in the catheter body, or the
diameter of the aspiration flow inlets is too large, can result in
too significant of a pressure drop that can reduce the
effectiveness of the assistive jet elements, basically the flow
through each of the assistive jet inlets can be too weak to
significantly erode the thrombus. Without limitation, the assistive
jet inlets can be positioned at approximately 3 o'clock and 9
o'clock, or approximately 3 o'clock, 6 o'clock, and 9 o'clock.
[0161] In any embodiments, the diameter D2 of the aspiration lumen
130 (see FIG. 6) can be any suitable value for the application and
size constraint of a particular application. For example and
without limitation, in some embodiments, for a 4.2 Fr guide sheath,
the maximum outer diameter of an aspiration catheter body that
would function optimally (i.e., draw flow from the surrounding
fluid, etc.) with such a guide sheath is approximately 1.22 mm. A
suitable assistive jet inlet diameter for this configuration is
approximately 0.26 mm, which can have an aspiration lumen having a
cross-sectional area of approximately 0.49 mm.sup.2. In some
embodiments, for a 6 Fr guide sheath, the maximum outer diameter of
an aspiration catheter body that would function optimally (i.e.,
draw flow from the surrounding fluid, etc.) with such a guide
sheath is approximately 2.16 mm, which can have an aspiration lumen
having a cross-sectional area of approximately 2.7 mm.sup.2. A
suitable assistive jet inlet diameter for this configuration is
approximately 0.62 mm. In some embodiments, for an 8 Fr guide
sheath, the maximum outer diameter of an aspiration catheter body
that would function optimally (i.e., draw flow from the surrounding
fluid, etc.) with such a guide sheath is approximately 2.82 mm,
which can have an aspiration lumen having a cross-sectional area of
approximately 4.97 mm.sup.2. A suitable assistive jet inlet
diameter for this configuration is approximately 0.84 mm.
[0162] Additionally, even though a diameter value is stated for the
assistive jet inlet, the assistive jet inlet in this and all other
embodiments disclosed herein can have a non-circular shape. For the
embodiments having a non-circular shape, the size of the
non-circular assistive jet inlets can be of an equivalent
cross-sectional area and/or size. Further, any of the values listed
in this description for the diameter of the assistive jet inlet can
be substituted for ranges extending from 20% less than the stated
value to 20% greater than the stated value, or from 10% less than
the stated value to 10% greater than the stated value. For example
and without limitation, for the 6 Fr compatible aspiration
catheter, the diameter of the assistive jet inlet can be from
approximately 0.496 mm to approximately 0.744 mm, or from 0.558 mm
to approximately 0.682 mm, while the other values of each
embodiment can be adjusted accordingly to ensure optimal fit and
performance of such embodiment.
[0163] Further, any embodiments can have one or more radiopaque
bands or markers near the aspiration opening 130 or assistive jet
inlet 140, so that a physician can identify the location of these
features under fluoroscopy. Alternatively or in combination with
such bands or markers, certain portions of the catheter 110 can
comprise a radiopaque material to improve the visibility of such
portions under fluoroscopy.
[0164] FIG. 7 is a section view of the assistive jet catheter body
112, illustrating aspiration of a mass of thrombus T that is
located distal to or upstream of the aspiration opening 130 of the
assistive jet catheter body 112. Because the flow of fluid through
the aspiration opening 130 is not impeded by thrombus or otherwise,
the flow of blood (indicated by the flow arrows) through the
assistive jet inlet 140 is significantly diminished such that all
or most of the flow through the aspiration lumen 132 will go
through the aspiration opening 130. The guidewire G can be
maintained in the aspiration lumen 132 during the aspiration
procedures, or can be withdrawn partially or completely from the
aspiration lumen prior to performing the aspiration procedures.
[0165] FIG. 8 is a section view of the assistive jet catheter shown
in FIG. 2, illustrating aspiration of a mass of thrombus T that is
located in contact with the aspiration opening 130 of the assistive
jet catheter body 112 such that the thrombus T is blocking all or
most of the flow through the aspiration opening 130. In this state,
because the flow of fluid through the aspiration opening 130 is
substantially diminished or is zero, fluid or blood can be drawn
through the assistive jet inlet 140 and into the aspiration lumen
132. The assistive jet inlet 140 can be sized and positioned to
optimally direct or exert the flow through the assistive jet inlet
toward or against the thrombus, so as to break apart or erode the
thrombus T. The jet or flow of blood through the assistive jet
inlet 140 can eventually break down the thrombus T to a small
enough size such that the thrombus T can be aspirated through the
aspiration lumen 132, thereby once again reactivating flow through
the aspiration opening 130.
[0166] FIG. 9 is a side view of another embodiment of an assistive
jet aspiration catheter system 200, this embodiment being of a
rapid exchange configuration. Any embodiments of the catheter 200
can have any of the other features, components, materials,
dimensions, and/or other details of any of the other catheter
system embodiments disclosed herein, in combination with or in
place of any of the features, components, materials, dimensions,
and/or other details disclosed with respect to the embodiments of
the catheter system 200 described below to form new embodiments.
Similarly, any of the other catheter system embodiments disclosed
herein can have any of the features, components, materials,
dimensions, and/or other details described herein with respect to
the catheter system 200 in combination with or in place of any of
the features, components, materials, dimensions, and/or other
details disclosed with respect to the embodiment of the other
catheter systems. For efficiency, a description of the components
and features that are common between the catheter system 200 and
catheter system 100 will be omitted.
[0167] FIGS. 10, 11, and 12 are a side view, a top view, and a
perspective view, respectively, of the assistive jet catheter body
212 of the embodiment of the assistive jet aspiration catheter
system 200 shown in FIG. 9. FIG. 13 is a section view of the
assistive jet catheter body 212, taken through line 13-13 of FIG.
10. FIG. 14 is a section view of the assistive jet catheter body
212, taken through line 14-14 of FIG. 11, and FIG. 15 is a section
view of the assistive jet catheter body shown in FIG. 10, taken
through line 15-15 of FIG. 11.
[0168] The assistive jet aspiration catheter system 200 can have a
suction source 202 (which can be a Vaclok 30 cc syringe, a pump
system such as a Penumbra.TM. pump, or otherwise), a stopcock or
valve 204 to control the suction and flow of fluid through the
system 200, and an assistive jet aspiration catheter 210 (also
referred to herein as an assistive jet catheter and just an
aspiration catheter) having a catheter body 212 having a distal end
214 in a proximal end 216. A handle 220 can be positioned at a
proximal end of the catheter body. A guidewire lumen 246 can extend
through a guidewire channel 248 that can extend through at least a
portion of the aspiration catheter body 212. The guidewire lumen
246 can have a first opening 247 at a distal end 214 of the
catheter body 212 and a second opening 249 proximal to the first
opening. The guidewire channel 248 can be used for rapid exchange
guidewire procedures.
[0169] With reference to the figures, in any embodiments, the
catheter body 212 can have an aspiration opening 230 and an
aspiration lumen 232 in communication with the aspiration opening
230 and extending through an entire length of the catheter body
212. The catheter body 212 can also have an assistive jet element
234 configured to direct a flow or jet of fluid (such as blood)
into the aspiration lumen adjacent to the aspiration opening, as
described herein. The assistive jet element 234 can comprise an
assistive jet inlet opening 240 (also referred to herein just as an
assistive jet inlet) formed through the catheter body 212 at any
desired radial and/or longitudinal location. In the illustrated
embodiment, the assistive inlet flow opening can be positioned at
lateral or side wall position when the catheter body is in an
upright position wherein a guidewire lumen 246 is in the downward
or vertically lowermost position. This can provide the most optimal
flow of fluid toward a thrombus that may be lodged in the
aspiration window or opening 230 to erode or break apart the
thrombus. Alternatively, the assistive jet opening 240 can be
positioned at any desired radial position on the catheter body
212.
[0170] Similar to catheter body 112 described above, the catheter
body 212 can have a proximal section and a distal section. The
proximal section of the catheter body 212 can be reinforced similar
to the proximal section of the catheter body 112 described above,
the details of which are omitted herein for efficiency.
[0171] In any embodiments, the distal tip comprising a guidewire
channel 248 can be designed to be soft or flexible and atraumatic
so as to reduce the risk of puncture and/or injury to the tissue as
the catheter body is being advanced through the patient's vessel or
passageway. The guidewire lumen 246 can extend through the
guidewire channel 248 that can extend distally away from the
catheter body 212. The assistive jet inlet is optimally positioned
to pass through a side of the catheter body 212 to avoid the
guidewire channel 248.
[0172] Similar to the aspiration opening 130, the aspiration
opening 230 can have a curved profile with rounded edges. This
curved profile can optimize the aspiration capabilities of the
catheter body 212. In any other embodiments, the aspiration opening
230 can have a flat, angled or beveled profile, or even a square
end profile (except for the guidewire channel 248). The length of
the catheter body 212 can be approximately the same as or similar
to the length of the catheter body 112, including or excluding the
portion of the guidewire channel 248 that extends distally away
from the catheter body 212 distal to the aspiration opening
230.
[0173] The location of the assistive jet inlet 240 relative to the
aspiration opening 230 can have a significant impact on the
effectiveness of the assistive jet element to provide the flow or
jet of fluid needed to break down or erode thrombus stuck in the
aspiration opening 230. In some embodiments, the assistive jet
inlet 240 can be positioned such that a centerline of the assistive
jet inlet 240 is at a distance L4 of approximately 1 mm, or from
approximately 0 mm to approximately 5 mm, or from approximately 1
mm to approximately 3 mm, from the proximal most end of the
aspiration opening 230. In some embodiments, the assistive jet
inlet 240 can be positioned such that the centerline of the
assistive jet inlet 240 is positioned distal of the proximal most
end, which can increase the impact of flow through the inlet 240
against the thrombus, assuming that the inlet 240 is not clogged by
or covered by the thrombus.
[0174] In any embodiments disclosed herein, the assistive jet inlet
240 can have a diameter that is approximately 1/3 (33%) of the
diameter of the aspiration lumen 232, or from approximately 10% to
approximately 15% for 3 Fr compatible catheter, or from
approximately 25% to approximately 45% of the diameter of the
aspiration lumen 232. In any embodiments disclosed herein, the
aspiration flow inlet 240 can have a round, oblong, ovular,
triangular, or any other suitable shape.
[0175] In any embodiments, the assistive jet element can have a
plurality of holes or inlets through the catheter body to provide
additional flow or jet pathways toward a thrombus stuck in the
aspiration window. Without limitation, the assistive jet inlets can
be positioned at approximately 3 o'clock and 9 o'clock, or
approximately 3 o'clock, 6 o'clock, and 9 o'clock.
[0176] In any embodiments, a diameter of the aspiration lumen D4
(see FIG. 15) can be any suitable value for the application and
size constraint of a particular application. For example and
without limitation, in some embodiments, for a 4.2 Fr guide sheath,
the maximum outer diameter of an aspiration catheter body that
would function optimally (i.e., draw flow from the surrounding
fluid, etc.) with such a guide sheath can be approximately 1.22 mm.
A suitable assistive jet inlet diameter for this configuration can
be approximately 0.11 mm, which can have an aspiration lumen having
a cross-sectional area of approximately 0.086 mm.sup.2. In some
embodiments, for a 6 Fr guide sheath, the maximum outer diameter of
an aspiration catheter body that would function optimally (i.e.,
draw flow from the surrounding fluid, etc.) with such a guide
sheath can be approximately 2.16 mm, which can have an aspiration
lumen having a cross-sectional area of approximately 1.65 mm.sup.2.
A suitable assistive jet inlet diameter for this configuration can
be approximately 0.483 mm. In some embodiments, for an 8 Fr guide
sheath, the maximum outer diameter of an aspiration catheter body
that would function optimally (i.e., draw flow from the surrounding
fluid, etc.) with such a guide sheath can be approximately 2.82 mm,
which can have an aspiration lumen having a cross-sectional area of
approximately 3.16 mm.sup.2. A suitable assistive jet inlet
diameter for this configuration can be approximately 0.669 mm. The
foregoing values are merely examples and can vary.
[0177] Additionally, even though a diameter value is stated for the
assistive jet inlet, the assistive jet inlet in this and all other
embodiments disclosed herein can have a non-circular shape. For the
embodiments having a non-circular shape, the size of the
non-circular assistive jet inlets can be of an equivalent
cross-sectional area and/or size. Further, any of the values listed
in this description for the diameter of the assistive jet inlet can
be substituted for ranges extending from 20% less than the stated
value to 20% greater than the stated value, or from 10% less than
the stated value to 10% greater than the stated value. For example
and without limitation, for the 6 Fr compatible aspiration
catheter, the diameter of the assistive jet inlet can be from
approximately 0.386 mm to approximately 0.580 mm, or from 0.435 mm
to approximately 0.531 mm, while the other values of each
embodiment can be adjusted accordingly to ensure optimal fit and
performance of such embodiment.
[0178] Further, any embodiments can have one or more radiopaque
bands or markers 260 near the aspiration opening 230 or assistive
jet inlet 240, so that a physician can identify the location of
these features under fluoroscopy. Alternatively or in combination
with such bands or markers, certain portions of the catheter 210
can comprise a radiopaque material to improve the visibility of
such portions under fluoroscopy.
[0179] In any embodiments, a length L5 (shown in FIG. 14) of the
guidewire channel 248 can be approximately 15 cm, or can be from
approximately 10 cm to approximately 15 cm, or from approximately 5
cm to approximately 15 cm. A diameter D5 of the guidewire lumen can
be approximately 0.016 in for a system using 0.014 in guidewire.
The diameter D5 of the guidewire lumen in larger systems, such as
systems having catheters greater than 14 Fr that are configured to
use a 0.018 in guidewire can be approximately 0.020 in. The
diameter D5 of the guidewire lumen in systems having catheters
greater than 18 Fr that are configured to use a 0.035 in guidewire
can be approximately 0.037 in.
[0180] FIG. 16 is a section view of the assistive jet catheter body
212, illustrating aspiration of a mass of thrombus T that is
located distal to or upstream of the aspiration opening 230 of the
assistive jet catheter 210. Because the flow of fluid through the
aspiration opening 230 is not impeded by thrombus or otherwise, the
flow of blood (indicated by the flow arrows in FIG. 16) through the
assistive jet inlet 240 is significantly diminished such that all
or most of the flow through the aspiration lumen 232 will go
through the aspiration opening 230.
[0181] FIG. 17 is a section view of the assistive jet catheter body
212, illustrating aspiration of a mass of thrombus T that is
located in contact with the aspiration opening 230 of the assistive
jet catheter body 212 such that the thrombus T is blocking all or
most of the flow through the aspiration opening 230. In this state,
because the flow of fluid through the aspiration opening 230 is
substantially diminished or is zero, fluid or blood can be drawn
through the assistive jet inlet 240 and into the aspiration lumen
232. The assistive jet inlet 240 can be sized and positioned to
optimally direct or exert the flow through the assistive jet inlet
toward or against the thrombus, so as to break apart or erode the
thrombus T. The jet or flow of blood through the assistive jet
inlet 240 can eventually break down the thrombus T to a small
enough size such that the thrombus T can be aspirated through the
aspiration lumen 232, thereby once again reactivating flow through
the aspiration opening 230. The guidewire G can be maintained in
the aspiration lumen 232 during the aspiration procedures, or can
be withdrawn partially or completely from the aspiration lumen
prior to performing the aspiration procedures.
[0182] In some embodiments, the assistive jet element can comprise
one or more assistive jet channels that can direct a jet of fluid
against a thrombus adjacent to or plugging an aspiration opening.
The assistive jet channel can extend between a first opening and a
second opening. The first opening can be positioned closer to a
proximal end of the catheter body as compared to the second
opening. The first opening can be positioned to be in direct
contact or be directly exposed to the fluid flow within the vessel.
The first opening can extend through an outer wall of the catheter
body. In this configuration, blood can flow directly into the first
opening, through the assistive jet channel, and out through the
second opening. In some embodiments, the first opening can be
referred to as an inlet opening or aperture, and the second opening
can be referred to as an outlet opening or aperture.
[0183] The cross-sectional shape of the channel in any embodiments
can be round, square, ovular, oblong, or otherwise. Ideally, the
shape is oblong along the length, lengthening the hole by 0.5 to 3
mm, such that blood can flow into the channel with less velocity
and energy loss. In any embodiments disclosed herein, the assistive
jet channel can have an approximately oblong shape.
[0184] In any embodiments, the assistive jet catheter system can
have an embedded or integral assistive jet channel or lumen on an
inside surface of the aspiration lumen. In any embodiments, the
assistive jet channel can be radially positioned such that the
channel is adjacent to the most proximal portion or edge of the
aspiration opening. In other words, in any embodiments disclosed
herein, the assistive jet channel can be positioned adjacent or
approximately adjacent to a portion of the aspiration opening that
is closest to the proximal end of the catheter system, when the
aspiration opening is tapered or slanted. In this arrangement, if a
large mass of thrombus is drawn into the distal end of the catheter
that has a size that is larger than a cross-sectional size of the
aspiration lumen, such that the mass of thrombus cannot freely pass
through the aspiration opening or aspiration lumen (thereby,
presenting a clog or impediment to the distal end of the aspiration
catheter), blood can still be drawn into the aspiration lumen
through the assistive jet channel, which can create a jet of fluid
that can break down the thrombus. Alternatively, in any embodiments
disclosed herein, the assistive jet channel can be positioned such
that a distal opening of the channel is positioned adjacent or
approximately adjacent to a portion of the aspiration opening that
is closest to the distal end of the catheter system, or anywhere
between the proximal and distal edges of the aspiration
opening.
[0185] Blood flowing out of the second opening (or outlet) of the
assistive jet channel and into the aspiration lumen can exert a
force on the clot adjacent to or abutting the aspiration opening
that can cause the thrombus to break apart into smaller pieces that
can pass through the aspiration opening and/or aspiration lumen. In
essence, the assistive jet channel can produce a flow stream of
blood from the patient's vasculature directed at the aspiration
opening and/or thrombus or other debris that is positioned in
contact with, adjacent to, or near the aspiration opening that can
continuously break up the thrombus even when the thrombus covers up
the aspiration opening and/or the opening at the end of the
assistive jet channel.
[0186] In any embodiments, the assistive jet channel can have a
cross-sectional size or area that is approximately 10% of the
cross-sectional size or area of the aspiration lumen, or from
approximately 5% to approximately 25% or more, or from
approximately 10% to approximately 15% of the cross-sectional size
or area of the aspiration lumen. Alternatively, the assistive jet
channel can have a cross-sectional size that is larger than the
sizes listed above, though the effectiveness of the shearing force
directed to the thrombus by the assistive jet channel may be
significantly reduced by the larger cross-sectional size of the
assistive jet channel. In some embodiments, the cross-sectional
size or area of the assistive jet channel can be greater than
approximately 0.2 mm.sup.2.
[0187] Additionally, in any embodiments having a relatively smaller
catheter size (for example, from 3 Fr to 5 Fr), the assistive jet
inlet opening (for an assistive jet opening, assistive channel,
telescopic, or any other suitable configuration) can have a
cross-sectional size or area that is from approximately 20% to
approximately 50%, or from approximately 25% to approximately 35%,
of the cross-sectional size or area of the aspiration lumen. In any
embodiments having a larger catheter size (for example, 6 Fr and
larger), the assistive jet inlet opening (for an assistive jet
opening, assistive channel, telescopic, or any other suitable
configuration) can have a cross-sectional size or area that is from
approximately 10% to approximately 40%, or from approximately 20%
to approximately 40%, of the cross-sectional size or area of the
aspiration lumen.
[0188] For example and without limitation, in the 4.2 Fr compatible
aspiration catheter (i.e., which can be used with a 4.2 Fr guide
sheath), the catheter can have an outer diameter of approximately
1.22 mm or less, the cross-sectional area of the assistive jet
channel can be approximately 0.003 mm.sup.2, and a cross-sectional
area of the aspiration lumen can be approximately 0.03 mm.sup.2,
though the cross-sectional area larger may be larger than this for
optimal performance of the catheter. For a 6 F compatible
aspiration catheter, which can be used for coronary applications,
the catheter can have an outer diameter of approximately 2.16 mm,
the cross-sectional area of the assistive jet channel can be
approximately 0.09 mm.sup.2, and a cross-sectional area of the
aspiration lumen can be approximately 0.83 mm.sup.2. For an 8 F
compatible aspiration catheter, the catheter can have an outer
diameter of approximately 2.82 mm, the cross-sectional area of the
assistive jet channel can be approximately 0.18 mm.sup.2, and a
cross-sectional area of the aspiration lumen can be approximately
1.65 mm.sup.2.
[0189] Any of the values listed in this description for the
cross-sectional area of the assistive jet channel can be
substituted for ranges extending from 20% less than the stated
value to 20% greater than the stated value, or from 10% less than
the stated value to 10% greater than the stated value. For example
and without limitation, for the 6 Fr compatible aspiration
catheter, the cross-sectional area of the assistive jet channel can
be from approximately 0.0024 mm.sup.2 to approximately 0.0036
mm.sup.2, or from 0.0027 mm.sup.2 to approximately 0.0033 mm.sup.2,
while the other values of each embodiment can be adjusted
accordingly to ensure optimal fit and performance of such
embodiment. Further, for any embodiments disclosed herein, the
assistive jet channel in this and all other embodiments disclosed
herein can have a non-circular shape.
[0190] The flow channel in any embodiments set forth herein can be
in any of a variety of suitable or desired shapes (for example,
circular or non-circular, including oblong, curved oblong, ovular,
rectangular, or otherwise), sizes, and geometries. As mentioned
above, the size of the channel can be varied, but should be large
enough to permit adequate blood flow. The inlet opening should be
positioned far enough away from the aspiration opening so as to be
out of the targeted lesion to reduce the likelihood that the inlet
opening will be clogged by thrombus. However, it may not be
desirable for the inlet to be located too far away from the
aspiration opening, as this can reduce the inlet flow velocity and
volume in some embodiments.
[0191] In smaller applications, the size of the assistive jet
element should be adequate to ensure that blood will flow
substantially unimpeded through the assistive jet element, or flow
through the assistive jet element without shearing the red blood
cells. If the assistive jet element is too small, the flow of blood
through the assistive jet element can be impeded.
[0192] In applications other than the coronary arteries, using a 7
F system, the diameter of the assistive jet element in any
embodiments disclosed herein can be (without limitation) from
approximately 0.012 in to approximately 0.025 in, or from
approximately 0.010 in to approximately 0.031 in. Using, an 8 F
system, the diameter of the assistive jet element in any
embodiments disclosed herein can be (without limitation) from
approximately 0.010 to approximately 0.028 in or more, or from
approximately 0.014 to approximately 0.028 in. Using, an 9 F
system, the diameter of the assistive jet element in any
embodiments disclosed herein can be (without limitation) from
approximately 0.010 to approximately 0.032 in or more, or from
approximately 0.014 to approximately 0.032 in. In a 5 F system, the
diameter of the assistive jet element in any embodiments disclosed
herein can be (without limitation) from approximately 0.011 in to
approximately 0.015 in, or from approximately 30% to 40% of the
available lumen diameter or size.
[0193] FIG. 18 is a side view of an embodiment of an assistive
channel aspiration catheter system 300, also being of a rapid
exchange configuration. Any embodiments of the catheter 300 can
have any of the other features, components, materials, dimensions,
and/or other details of any of the other catheter system
embodiments disclosed herein, in combination with or in place of
any of the features, components, materials, dimensions, and/or
other details disclosed with respect to the embodiments of the
catheter system 300 described below to form new embodiments.
Similarly, any of the other catheter system embodiments disclosed
herein can have any of the features, components, materials,
dimensions, and/or other details described herein with respect to
the catheter system 300 in combination with or in place of any of
the features, components, materials, dimensions, and/or other
details disclosed with respect to the embodiment of the other
catheter systems. For efficiency, a description of the components
and features that are common between the catheter system 300 and
catheter system 100 or catheter system 200 will be omitted.
[0194] FIGS. 19, 20, and 21 are a side view, a top view, and a
perspective view, respectively, of an assistive channel catheter
body 312 of the embodiment of the assistive channel aspiration
catheter system 300 shown in FIG. 18. FIG. 22 is a section view of
the assistive channel catheter body 312, taken through line 22-22
of FIG. 19. FIG. 23 is a section view of the assistive channel
catheter body 312, taken through line 23-23 of FIG. 20.
[0195] The assistive channel aspiration catheter system 300 can
have a suction source 302 (which can be a Vaclok 30 cc syringe, a
pump system such as a Penumbra.TM. pump, or otherwise), a stopcock
or valve 304 to control the suction and flow of fluid through the
system 300, and an assistive channel aspiration catheter 310 (also
referred to herein as an assistive channel catheter and just an
aspiration catheter) having a catheter body 312 having a distal end
314 in a proximal end 316. A handle or hub 320 can be positioned at
a proximal end of the catheter body. A guidewire lumen 346 can have
a first opening 347 at a distal end 314 of the catheter body 312
and a second opening 349 proximal to the first opening. The
guidewire channel 348 can be used for rapid exchange guidewire
procedures.
[0196] With reference to the figures, in any embodiments, the
catheter body 312 can have an aspiration window or opening 330 and
an aspiration lumen 332 in communication with the aspiration
opening 330 and extending through an entire length of the catheter
body 312. The catheter body 312 can also have an assistive jet
element 334 configured to direct a flow or jet of fluid (such as
blood) into the aspiration lumen adjacent to the aspiration
opening, as described herein. The assistive jet element 334 can
comprise an assistive channel inlet or channel opening 340 (also
referred to herein just as an assistive channel inlet) formed
through the catheter body 312 at any desired radial and/or
longitudinal location. In the illustrated embodiment, the assistive
inlet flow opening can be positioned at a top wall position when
the catheter body is in an upright position wherein a guidewire
lumen 346 is in the downward or vertically lowermost position so
that the assistive flow element 334 is closest to a proximal edge
of the aspiration opening 330. This can provide the most optimal
flow of fluid toward a thrombus that may be lodged in the
aspiration opening 330 to erode or break apart the thrombus.
Alternatively, the assistive channel opening 340 can be positioned
at any desired radial position on the catheter body 312.
[0197] Similar to catheter body 112 described above, the catheter
body 312 can have a proximal section and a distal section. The
proximal section of the catheter body 312 can be reinforced similar
to the proximal section of the catheter body 112 described above,
the details of this and other features or characteristics of the
catheter body that are the same as or similar to those of the other
catheter bodies described herein are omitted herein for efficiency
but considered to be included in these embodiments.
[0198] In any embodiments, the distal tip comprising a guidewire
channel 348 can be designed to be soft or flexible and atraumatic
so as to reduce the risk of puncture and/or injury to the tissue as
the catheter body is being advanced through the patient's vessel or
passageway. The guidewire lumen 346 can extend through a guidewire
channel 348 that can extend distally away from the catheter body
312. The assistive channel inlet is optimally positioned to pass
through a side of the catheter body 312 to avoid the guidewire
channel 348.
[0199] Similar to the aspiration opening 130, the aspiration
opening 330 can have a curved profile of an arcuate, parabolic, or
other geometry. The edges can be rounded to improve pushability of
the catheter and to reduce trauma to the tissue or other risks. The
profile of the aspiration opening can optimize the aspiration
capabilities of the catheter body 312. In any other embodiments,
the aspiration opening 330 can have a flat, angled or beveled
profile, or even a square end profile (except for the guidewire
channel 348). The length of the catheter body 312 can be
approximately the same as or similar to the length of the catheter
body 112, including or excluding the portion of the guidewire
channel 348 that extends distally away from the catheter body 312
distal to the aspiration opening 330.
[0200] The location of the assistive channel inlet 340 relative to
the aspiration opening 330 can have an impact on the effectiveness
of the assistive jet element to provide the flow or jet of fluid
needed to break down or erode thrombus stuck in the aspiration
opening 330. With reference to FIG. 23, in some embodiments, the
assistive channel inlet 340 can be positioned such that a distance
L5 from a proximal edge of the aspiration opening 330 to the closer
edge of the of the assistive channel inlet 340 is approximately 5
mm to approximately 100 mm, or from approximately 20 mm to
approximately 60 mm. In the illustrated embodiment, the distance L5
also approximately represents the length of an assistive jet
channel 342 and an assistive jet channel lumen 344. For coronary
applications, the length of the channel 342 (represented by L5) can
be from approximately 30 mm to approximately 50 mm.
[0201] It is important that the assistive channel inlet 340 be
positioned far enough away from the distal end 314 of the catheter
body 312 so to not be clogged or impeded by plaque, thrombus, or
other debris or tissue near the lesion, but yet close enough to the
distal end 314 of the catheter body 312 so that it can clear the
end of the guide catheter. Additionally, a shorter assistive jet
channel will present less resistance and have less pressure loss
than a longer assistive jet channel.
[0202] In any embodiments disclosed herein, the assistive channel
inlet 340 can have a diameter or size that approximately matches
the diameter or size (which can be defined in terms of area) of the
assistive jet channel diameter or size. In any embodiments, the
assistive channel inlet 340 can have a diameter or size that is
approximately 1/3 (33%) of the diameter of the aspiration lumen
332, or from approximately 10% to approximately 15% for 3 Fr
compatible catheter, or from approximately 25% to approximately 45%
of the diameter of the aspiration lumen 332. In any embodiments
disclosed herein, the aspiration flow inlet 340 can have a round,
oblong, ovular, triangular, or any other suitable shape. In any
embodiments disclosed herein, the assistive channel inlet 340 can
have a diameter or size that is approximately 0.5 mm to
approximately 3 mm, or from approximately 1 mm to approximately 2
mm.
[0203] In any embodiments disclosed herein, the lumen 344 of the
assistive jet channel 342 can have a diameter or cross-sectional
size that is approximately 25% of the diameter or cross-sectional
size of the aspiration lumen 332, or from approximately 10% to
approximately 40% of the diameter or cross-sectional size of the
aspiration lumen 332. The lumen 344 of the assistive jet channel
342 can, in some embodiments, have a cross-sectional area that is
approximately 0.04 mm.sup.2, or from approximately 0.02 mm.sup.2 to
approximately 0.3 mm.sup.2. For example, for a 4.2 Fr
[0204] In any embodiments, a diameter D7 of the aspiration lumen
332 (see FIG. 22) can be any suitable value for the application and
size constraint of a particular application. For example and
without limitation, in some embodiments, for a 4.2 Fr guide sheath,
the maximum outer diameter of an aspiration catheter body that
would function optimally (i.e., draw flow from the surrounding
fluid, etc.) with such a guide sheath can be approximately 1.22 mm.
A suitable assistive jet channel area for this configuration can be
approximately 0.02 mm.sup.2, which can have an aspiration lumen
having a cross-sectional area of approximately 0.22 mm.sup.2. In
some embodiments, for a 6 Fr guide sheath, the maximum outer
diameter of an aspiration catheter body that would function
optimally (i.e., draw flow from the surrounding fluid, etc.) with
such a guide sheath is approximately 2.16 mm, which can have an
aspiration lumen having a cross-sectional area of approximately
1.48 mm.sup.2. A suitable assistive jet channel cross-sectional
area for this configuration is approximately 0.16 mm.sup.2. In some
embodiments, for an 8 Fr guide sheath, the maximum outer diameter
of an aspiration catheter body that would function optimally (i.e.,
draw flow from the surrounding fluid, etc.) with such a guide
sheath is approximately 2.82 mm, which can have an aspiration lumen
having a cross-sectional area of approximately 2.74 mm.sup.2. A
suitable assistive channel inlet diameter for this configuration is
approximately 0.30 mm.sup.2. The foregoing values are merely
examples and can vary.
[0205] Flow rate is a key consideration for the size of the
assistive jet channel or lumen size. The channel should not be too
small as the size of the lumen may restrict the flow of the viscous
blood, which can have other implications. Additionally, flow that
is too slow through the channel lumen can also hinder the
effectiveness of the assistive jet element, as the slow flow may be
unable to effectively erode and break up the thrombus. Conversely,
the channel (and also the aspiration lumen itself) should not be so
large as to drain blood too quickly from the patient, which can
cause hypothermia. The risk of hypothermia may be increased when a
pump system is used for the aspiration, such as the Penumbra.TM.
pump.
[0206] In any embodiments, the size or diameter of the inlet
opening 340 for the assistive jet channel can the approximately the
same as or similar to the diameter or size (which can be defined in
terms of area) of the assistive jet channel diameter or size. In
any embodiments, the assistive jet element can have a plurality of
channels and inlets through the catheter body to provide additional
flow or jet pathways toward a thrombus stuck in the aspiration
window. Without limitation, the assistive jet channels and inlets
can be positioned at approximately 3 o'clock and 9 o'clock, or
approximately 3 o'clock, 6 o'clock, and 9 o'clock.
[0207] Proximal to the assistive jet channel, the aspiration lumen
can occupy a larger cross-sectional area than the distal section.
In any catheter embodiments disclosed herein, the walls of the
catheter body can have a thickness of from approximately 0.003 in
to approximately 0.005 in. For example and without limitation,
interior walls can have a thickness of approximately 0.003 in, and
the exterior walls can have a thickness of approximately 0.005 in.
The exterior wall thickness adjacent to the assistive jet channel
can be approximately 0.003 in.
[0208] Further, any embodiments can have one or more radiopaque
bands or markers (not illustrated) near the aspiration opening 330
or assistive channel inlet 340, so that a physician can identify
the location of these features under fluoroscopy. Alternatively or
in combination with such bands or markers, certain portions of the
catheter 310 can comprise a radiopaque material to improve the
visibility of such portions under fluoroscopy.
[0209] In any embodiments, a length of the guidewire channel 348
can be approximately 15 cm, or can be from approximately 10 cm to
approximately 15 cm, or from approximately 5 cm to approximately 15
cm. A diameter D5 of the guidewire lumen can be approximately 0.016
in for a system using 0.014 in guidewire. The diameter D5 of the
guidewire lumen in larger systems, such as systems having catheters
greater than 14 Fr that are configured to use a 0.018 in guidewire
can be approximately 0.020 in. The diameter D5 of the guidewire
lumen in systems having catheters greater than 18 Fr that are
configured to use a 0.035 in guidewire can be approximately 0.037
in.
[0210] FIG. 24 is a section view of the assistive jet catheter body
312, illustrating aspiration of a mass of thrombus T that is
located distal to or upstream of the aspiration opening 330 of the
assistive jet catheter 310. Because the flow of fluid through the
aspiration opening 330 is not impeded by thrombus or otherwise, the
flow of blood (indicated by the flow arrows in FIG. 16) through the
assistive channel inlet 340 is significantly diminished such that
all or most of the flow through the aspiration lumen 332 will go
through the aspiration opening 330.
[0211] FIG. 25 is a section view of the assistive jet catheter body
312, illustrating aspiration of a mass of thrombus T that is
located in contact with the aspiration opening 330 of the assistive
jet catheter body 312 such that the thrombus T is blocking all or
most of the flow through the aspiration opening 330. In this state,
because the flow of fluid through the aspiration opening 330 is
substantially diminished or is zero, fluid or blood can be drawn
through the assistive channel inlet 340, flow through the assistive
jet channel 342, out an assistive jet outlet 345, and be directed
at the thrombus. Such flow through the channel 342 can be aspirated
by the aspiration lumen 332. The assistive channel inlet 340 can be
sized and positioned to optimally direct or exert the flow through
the assistive jet inlet toward or against the thrombus, so as to
break apart or erode the thrombus T. The jet or flow of blood
through the assistive channel inlet 340 can eventually break down
the thrombus T to a small enough size such that the thrombus T can
be aspirated through the aspiration lumen 332, thereby once again
reactivating flow through the aspiration opening 330.
[0212] Any embodiments disclosed herein can have multiple assistive
flow channels supported by or integrally formed with the aspiration
lumen. Where there are multiple assistive jet channels, the
channels can be radially arranged about the aspiration lumen.
Embodiments having multiple assistive jet channels can increase the
effectiveness and efficiency of break up and removal of thrombus
via aspiration. Embodiments having multiple assistive jet channels
can be more effective in clearing thrombus than conventionally
available aspiration catheters. Having multiple assistive jet
elements (which can comprise assistive jet channels or just
assistive jet openings) can have a synergistic effect on the
breakdown and removal of thrombus. Multiple assistive jet streams
can work together to break down the thrombus at the aspiration
opening very efficiently.
[0213] In embodiments having multiple assistive jet channels, the
inlets can be lined up at the same axial point or region, or can be
staggered along the length of the catheter. With aspiration usually
done with the aspiration catheter tip at 5 cm to 15 cm deep into
the coronary arteries (past the distal end of the guide catheter),
the assistive jet inlet holes can be positioned within 5 cm from
the tip to increase the likelihood that the holes are exposed to
blood to feed the flow and not hidden inside the guide catheter.
This design can also be executed as a telescopic assistive jet
stream design as described herein and can, therefore, have any of
the features, components, or other details of the telescopic
assistive jet catheter system of any of the embodiments disclosed
herein in combination with any other features disclosed herein.
Impeding the flow can occur if the clearance between an inside
surface of the guide catheter and an outside surface of the
catheter body is too small, e.g., less than approximately 0.003 in.
Additionally, the inlet hole may also be pressing against the wall
of the guide catheter and impede or prevent flow through the
assistive jet channel if the inlet opening is located on a bend in
the catheter (which can cause the guide catheter and catheter body
to press together).
[0214] Alternatively, in some embodiments having assistive jet
channels, the inlet opening positioned over a greater distance or
range of the catheter body as compared to the through hole
assistive jet design because the channel will always have an
outflow point dictated by the position of the end of the channel
and not the position of the inlet of the channel. In such
arrangements, the inlet opening for the channel can be positioned
significantly further away from the aspiration window as compared
to the through hole assistive jet design, and can be positioned on
a portion of the aspiration catheter that is inside the guide
catheter, if the clearance between guide catheter and the assistive
jet aspiration catheter is greater than a threshold amount. For
example and without limitation, a threshold amount can be above
approximately 0.003 in, in some embodiments.
[0215] Additionally, any embodiments or variations of the assistive
channel aspiration catheter system 300 disclosed herein can be
adapted for use as an over-the-wire catheter configuration. In some
embodiments, this can be achieved by, without limitation, omitting
the guidewire channel and adjusting the cross-section of the
catheter body accordingly. This can permit the aspiration lumen
and/or the assistive jet channel to have a larger cross-sectional
size without increasing the overall size of the catheter body. One
embodiment of an over-the-wire assistive jet aspiration catheter
having an assistive channel jet is described below.
[0216] In any embodiments disclosed herein, the channel outlet can
be designed with openings at different angles. For example and
without limitation, the outlet opening of the assistive jet channel
can have a downard angle of approximately 45.degree. to enhance the
shearing of the thrombus in front of it without pushing the
thrombus away from the aspiration lumen. Additionally, the outlet
opening of the assistive jet channel can have a straight opening.
The 45.degree. angle of the outlet opening can help reduce the
chance of getting the outlet plugged up by the thrombus. In any
embodiments, outlet opening of the assistive jet channel can have a
90.degree. downward angle, which can further minimize the risk of
clogging. This outlet opening shape and orientation can be
effective when a portion of the thrombus is inside the lumen
already. The outlet opening of the assistive jet channel can have a
135.degree. angle or any angle past 90.degree., which can help to
push the thrombus in, but may not have much shearing effect on
thrombus positioned adjacent to or in contact with the aspiratin
opening, as the others above.
[0217] Finally, in any embodiments, the outlet can be recessed
(approximately 0.5 to 2 mm) from a proximal end of the aspiration
opening to reduce the chance of clogging. Recessing the outlet or
outlow opening too far can result in overly attenuating the flow
velocity and shearing force of the assistive jet relative to the
thrombus. FIG. 33 is a section view of another embodiment of an
assistive channel aspiration catheter 470 of an over-the-wire
configuration having a catheter body 472, and assistive jet channel
474, and an aspiration lumen 476. With reference to FIG. 33, a
distal end 477 of the assistive jet channel 474 can be recessed in
a proximal direction away from a proximal end of the aspiration
window 478 by a distance (represented by L6 in FIG. 33) that can be
approximately 2 mm, or from approximately 0.5 mm or less to
approximately 3 mm or more, or from approximately 0.5 mm to
approximately 1.5 mm, depending on the sizes and details of the
features of the assistive jet catheter body 472.
[0218] FIG. 34 is a section view of another embodiment of an
assistive channel aspiration catheter 480 of a rapid exchange
guidewire configuration having a catheter body 482, and assistive
jet channel 484, and an aspiration lumen 486. With reference to
FIG. 34, a distal end 487 of the assistive jet channel 484 can be
recessed in a proximal direction away from a proximal end of an
aspiration window 488 by a distance (represented by L7 in FIG. 34)
that can be approximately 2 mm, or from approximately 0.5 mm or
less to approximately 3 mm or more, or from approximately 0.5 mm to
approximately 1.5 mm, depending on the sizes and details of the
features of the assistive jet catheter body 482.
[0219] FIG. 26 is a perspective view of an embodiment of an
assistive channel aspiration catheter 410, being of an
over-the-wire configuration. Any embodiments of the aspiration
catheter 410 can have any of the other features, components,
materials, dimensions, and/or other details of any of the other
aspiration catheter embodiments disclosed herein, in combination
with or in place of any of the features, components, materials,
dimensions, and/or other details disclosed with respect to the
embodiments of the aspiration catheter 410 described below to form
new embodiments. This includes, without limitation, that the
assistive channel aspiration catheter 410 can be configured for use
with a rapid exchange guidewire system by adding any of the
features or components disclosed herein or suitable for use in a
rapid exchange guidewire
[0220] Similarly, any of the other aspiration catheter embodiments
disclosed herein can have any of the features, components,
materials, dimensions, and/or other details described herein with
respect to the aspiration catheter 410 in combination with or in
place of any of the features, components, materials, dimensions,
and/or other details disclosed with respect to the embodiment of
the other aspiration catheters. Further, the embodiments of the
aspiration catheter 410 described herein can be configured to work
with any of the aspiration catheter system embodiments described
herein and/or components thereof. For efficiency, a description of
the components and features that are common between the embodiments
of the aspiration catheter 410 and the embodiments of the
aspiration catheter 310 and/or other aspiration catheter
embodiments disclosed herein, as well as the components that can be
used with the embodiments of the aspiration catheter 410, will be
omitted.
[0221] FIGS. 27 and 28 are a side view and a top view,
respectively, of an assistive channel catheter body 412 shown in
FIG. 26. FIG. 29 is a section view of the assistive jet catheter
body 412 shown in FIG. 19, taken through line 29-29 of FIG. 27.
FIG. 30 is a section view of the assistive jet catheter body shown
in FIG. 19, taken through line 30-30 of FIG. 28.
[0222] With reference to the figures, in any embodiments, the
catheter body 412 can have an aspiration window or opening 430 and
an aspiration lumen 432 in communication with the aspiration
opening 430 and extending through an entire length of the catheter
body 412. Because the assistive catheter embodiment 410 is
configured for over-the-wire use, the size of the aspiration lumen
432 extending through the catheter body 412 can be greater than the
aspiration lumen 332 of the assistive catheter embodiment 310,
which is configured for rapid exchange guidewire procedures. The
size of the aspiration lumen 432 can be generally similar to or the
same as the aspiration lumen 132 of any of the embodiments of the
assistive jet catheters 110 disclosed above, with the exception of
the size of the assistive jet channel 442 that is formed in a
distal portion of the aspiration lumen 432. Further, in any
embodiments, the length, diameter, and other sizes of the assistive
jet channels 442 can be generally the same as or similar to any of
the assistive jet channels 342 or other assistive jet channels
disclosed herein.
[0223] The catheter body 412 can also have an assistive jet element
434 configured to direct a flow or jet of fluid (such as blood)
into the aspiration lumen adjacent to the aspiration opening, as
described herein. The assistive jet element 434 can comprise an
assistive channel inlet or channel opening 440 (also referred to
herein just as an assistive channel inlet) formed through the
catheter body 412 at any desired radial and/or longitudinal
location. In the illustrated embodiment, the assistive inlet flow
opening can be positioned at a top wall position when the catheter
body is in an upright position so that the assistive flow element
434 is closest to a proximal edge of the aspiration opening 430.
Alternatively, the assistive channel opening 440 can be positioned
at any desired radial position on the catheter body 412.
[0224] In any embodiments, the aspiration opening 430 can have a
flat but angled profile, a curved profile of an arcuate, parabolic,
or other geometry, a square profile, or otherwise. The edges can be
rounded to improve pushability of the catheter and to reduce trauma
to the tissue or other risks. The length of the catheter body 412
can be approximately the same as or similar to any other catheter
body embodiments disclosed herein, including the embodiments of the
catheter body 112.
[0225] With reference to FIGS. 30 and 31, any embodiments of the
assistive jet elements 434 can comprise a deflector or cover
element 447 positioned at a distal end of the assistive jet channel
442. The deflector element 447 can block or shield the opening 445
of the assistive channel lumen 444 from blockage or obstruction
that may be caused by a thrombus or other debris that may come into
contact with the assistive jet channel 442, thereby reducing the
likelihood that the opening 445 of the assistive channel lumen 442
will become blocks during aspiration. Additionally, the deflector
element 447 can also be configured to direct the jet or flow of
fluid flowing through the jet channel lumen 444 in a downward
direction. For example without limitation, the deflector element
447 can be configured to direct the jet or flow of fluid flowing
through the jet channel lumen 444 at an angle that is approximately
45.degree. relative to the longitudinal axis of the jet channel
lumen 444, or from approximately 30.degree. to approximately
60.degree., or from approximately 15.degree. to approximately
90.degree. or more, relative to the jet channel lumen 444.
[0226] FIG. 32 illustrates an embodiment of an aspiration catheter
460 having a catheter body 462 that has an assistive jet channel
464 formed therein, and a deflector element 467 that is configured
to direct the jet or flow of fluid flowing through the jet channel
lumen 464 at a greater downward direction. For example without
limitation, the deflector element 467 can be configured to direct
the jet or flow of fluid flowing through the jet channel lumen 464
at an angle that is approximately 90.degree. relative to the
longitudinal axis of a jet channel lumen 444, or from approximately
60.degree. to approximately 90.degree. or more, or from
approximately 75.degree. to approximately 90.degree., relative to
the jet channel lumen 464.
[0227] In the illustrated embodiment, the distal end of the jet
channel lumen 444 and the deflector element 447 are positioned
adjacent to the proximal most end of the aspiration opening 430. In
any other embodiments disclosed herein, all or a portion of the
assistive jet channel 442 can be recessed such that the distal end
of the jet channel lumen 444 and the deflector element 447 are
recessed by from approximately 1 mm to approximately 5 mm within
the aspiration lumen 432.
[0228] FIG. 31 is a section view of the assistive jet catheter body
412, illustrating aspiration of a mass of thrombus T that is
located in contact with the aspiration opening 430 of the assistive
jet catheter body 412 such that the thrombus T is blocking all or
most of the flow through the aspiration opening 430. In this state,
because the flow of fluid through the aspiration opening 430 is
substantially diminished or is zero, fluid or blood can be drawn
through the assistive channel inlet 440, flow through the lumen 444
of the assistive jet channel 442, the deflector downward by the
deflector element 447, and out the assistive jet outlet 445. Such
flow through the channel 442 can be aspirated by the aspiration
lumen 432. The deflector element 447 can help prevent the lumen 444
of the assistive jet channel 442 from being clogged by the thrombus
T. Additionally, imparting the assistive flow or jet at a downward
angle can, in some embodiments, optimize the shearing force of the
assistive jet on the thrombus T.
[0229] FIG. 35 is a side view of another embodiment of an assistive
jet aspiration catheter 510, being of an over-the-wire
configuration. Any embodiments of the aspiration catheter 510 can
have any of the other features, components, materials, dimensions,
and/or other details of any of the other aspiration catheter
embodiments disclosed herein, in combination with or in place of
any of the features, components, materials, dimensions, and/or
other details disclosed with respect to the embodiments of the
aspiration catheter 510 described below to form new embodiments.
Similarly, any of the other aspiration catheter embodiments
disclosed herein can have any of the features, components,
materials, dimensions, and/or other details described herein with
respect to the aspiration catheter 510 in combination with or in
place of any of the features, components, materials, dimensions,
and/or other details disclosed with respect to the embodiment of
the other aspiration catheters. For efficiency, a description of
the components and features that are common between the aspiration
catheter 510 and the other aspiration catheter embodiments
disclosed herein will be omitted.
[0230] Further, the embodiments of the aspiration catheter 510
described herein can be configured to work with any of the
aspiration catheter system embodiments described herein and/or
components thereof. For efficiency, a description of the components
and features that are common between the embodiments of the
aspiration catheter 510 and the embodiments of the aspiration
catheter 310 and/or other aspiration catheter embodiments disclosed
herein, as well as the components that can be used with the
embodiments of the aspiration catheter 510, will be omitted.
[0231] FIGS. 36, 37, and 38 are a perspective view, a side view,
and a top view, respectively, of the assistive jet catheter 510
shown in FIG. 35. FIG. 39 is a section view of the assistive jet
catheter 510 shown in FIG. 35, taken through line 39-39 of FIG. 37,
and FIG. 40 is a section view of a distal portion of the assistive
jet catheter 510 shown in FIG. 35, taken through line 40-40 of FIG.
38.
[0232] The assistive jet aspiration catheter 510 (also referred to
herein as an assistive jet catheter and just an aspiration
catheter) can have a first or outer catheter body 512 having a
distal end 514 in a proximal end 516. A first handle 520 can be
positioned at a proximal end of the first catheter body 512. The
aspiration catheter 510 can also have a second or inner catheter
body 513 having a distal end 515 in a proximal end 517. The second
catheter body 513 can be configured to slide within the inner
diameter of the outer catheter body 512 and can have a second
handle 521 at a proximal end thereof. When the aspiration catheter
510 is in an operable position, the proximal end 517 of the inner
catheter body 513 will extend proximal of the proximal end 516 of
the outer catheter body 512 so that the surgeon can manipulate the
inner catheter body 513 relative to the outer catheter body 512 by
grasping the second handle 521 coupled with the inner catheter body
513 and the first handle 520 and advancing or withdrawing the
handle 521 relative to the first handle 520 and the outer catheter
body 512. This relative movement will simultaneously advance or
withdraw the inner catheter 513 relative to the outer catheter body
512.
[0233] With reference to the figures, in any embodiments, the first
or outer catheter body 512 can have an aspiration opening 530 at a
distal end thereof and a first aspiration lumen 532 in
communication with the aspiration opening 530 and extending through
an entire length of the outer catheter body 512. The second or
inner catheter body 513 can have an aspiration opening 531 at a
distal end thereof and a second aspiration lumen 533 in
communication with the aspiration opening 531 and extending through
an entire length of the catheter body 513. The length of the outer
catheter body 512 can be generally the same as or similar to any of
the other catheter body embodiments disclosed herein, while the
inner catheter body 513 can be longer than the outer catheter body
512 so that the inner catheter body 513 can extend in a proximal
direction beyond the proximal end of the outer catheter body
512.
[0234] The first or outer catheter body 512 can be configured to
aspirate fluid and thrombus, as well as to slidably receive the
second or inner catheter body 513 therethrough. The first and
second catheter bodies 512, 513 can be configured to minimize the
gap between an outer surface of the inner catheter body 513 and an
inner surface of the outer catheter body 512, to maximize space and
to limit blood or fluid flow between the inner and outer catheter
bodies 512, 513. The inner and outer catheter bodies 512, 513 can
be configured such that the gap therebetween is from approximately
0.0015 in to approximately 0.003 in.
[0235] In some embodiments, the first and/or second catheter bodies
512, 513 can have indexing features to maintain the catheter bodies
in a radial alignment. Additionally, some embodiments of the first
and/or second catheter bodies 512, 513 can have stops or other
features to limit how far the distal end 515 of the inner catheter
body 513 can be advanced relative to the outer catheter body 512.
This can facilitate alignment of the first and second catheter
bodies 512, 513 in an axial direction when the second catheter body
513 advanced to the point of reaching the stop or axial limit. As
will be described, this can facilitate alignment of the openings
540, 541 of an assistive jet element 534.
[0236] In some embodiments, when the inner catheter body 513 is
advanced in a distal direction to a first position, wherein the
inner catheter body 513 is advanced as far distally as possible
relative to the outer catheter body 512, the assistive jet element
534 will be in an open or activated state, which is shown in FIG.
40 and FIG. 42. The assistive jet element 534 can be moved to a
closed state, which is shown in FIG. 41, by withdrawing the inner
catheter body 513 relative to the outer catheter body 512. Any
embodiments of the aspiration catheter 510 can have stops or other
features that limit a movement of the inner catheter body 513
relative to the outer catheter body 512 between the first and
second positions. In any embodiments, the distance between the
first and second positions can be from, for example and without
limitation, approximately 5 mm to approximately 10 mm.
[0237] With reference to the figures, the assistive jet element 534
can be configured to direct a flow or jet of fluid (such as blood)
into the aspiration lumen adjacent to the aspiration opening, as
described herein. The assistive jet element 534 can comprise an
assistive channel inlet or channel opening 540 (also referred to
herein just as an assistive channel inlet) formed through the inner
catheter body 513 at any desired radial and/or longitudinal
location. Other embodiments having an inner catheter body and an
outer catheter body, such as described above, can have an assistive
jet element that does not have a channel. In the illustrated
embodiment, the assistive inlet flow opening 540 can be positioned
at a top wall position when the catheter body 513 is in an upright
position so that the assistive flow element 534 is closest to a
proximal edge of the aspiration opening 530. Alternatively, the
assistive channel opening 540 can be positioned at any desired
radial position on the catheter body 513. Additionally, the opening
541 can be formed in the outer catheter body 512 which can align
with the opening 540 formed in the inner catheter body 513 when the
inner catheter body 513 is in the first position, as shown in FIG.
40 and FIG. 42. In any embodiments, the opening 541 in the outer
catheter body 512 can be the same size as or slightly larger (by,
for example and without limitation, approximately 10%-20%) than the
opening 540 in the inner catheter body 513. The openings 540, 541
can be circular, ovular, oblong, or any desired shape.
[0238] In this configuration, the user can selectively activate and
deactivate the assistive jet element 534 by advancing the inner
catheter body 513 to the first position, so as to activate the
assistive jet element 534, and withdrawing or pulling the inner
catheter body 513 in a proximal direction relative to the outer
catheter body 512 to the second position, or any position where the
openings 540, 541 are out of alignment wherein the outer catheter
body 512 essentially seals the opening 540, to deactivate the
assistive jet element 534. In some embodiments, the aspiration
catheter 510 can be configured such that the user activate and
deactivate the assistive jet element 534 by rotating the inner
catheter body 513 relative to the outer catheter body 512, thereby
causing the openings 540, 541 to be out of alignment.
[0239] FIG. 41 is a section view of a distal portion of the
assistive jet catheter 510 shown in FIG. 35, illustrating
aspiration of a mass of thrombus T that is located distal to or
upstream of the aspiration opening 530 of the assistive jet
catheter 510. The flow of fluid through the aspiration opening 530
is not substantially impeded by thrombus or otherwise. The user has
not activated the assistive jet element 534, so little to no blood
or fluid is flowing through the assistive jet element 534. All or
most of the flow through the aspiration lumen 533 goes through the
aspiration opening 530.
[0240] FIG. 42 is a section view of a distal portion of the
assistive jet catheter 510 shown in FIG. 35, illustrating
aspiration of a mass of thrombus T that is located in contact with
the aspiration opening 530 of the assistive jet catheter body 512
such that the thrombus T is blocking all or most of the flow
through the aspiration opening 530. In this state, the flow of
fluid through the aspiration opening 530 is substantially
diminished or is zero. As the user applies suction to the catheter
510, when the assistive jet element 534 is activated by advancing
the inner catheter body 513 to the first position, fluid or blood
can be drawn through the assistive channel inlets 540, 541, flow
through the lumen 544 of the assistive jet channel 542, out the
assistive jet outlet 545, and be directed at the thrombus. Such
flow through the channel 542 can break down the thrombus T and can
be aspirated by the aspiration lumen 533 formed in the inner
catheter body 513.
[0241] The assistive channel inlet 540 can be sized and positioned
to optimally direct or exert the flow through the assistive jet
inlet toward or against the thrombus, so as to break apart or erode
the thrombus T. The jet or flow of blood through the assistive
channel inlet 540 can eventually break down the thrombus T to a
small enough size such that the thrombus T can be aspirated through
the aspiration lumen 533, thereby once again reactivating flow
through the aspiration opening 530. Once this is achieved, the user
can deactivate the assistive jet element 534 by withdrawing the
inner catheter body 513 to the second position. Of course, in any
embodiments, deactivation can be achieved by advancing the inner
catheter body 513 distally, such that the operation of the catheter
body 510 to activate and deactivate the assistive flow element 534
will be opposite or different than as described above.
[0242] Any embodiments disclosed herein can have multiple assistive
flow channels supported by or integrally formed with the aspiration
lumen. Where there are multiple assistive jet channels, the
channels can be radially arranged about the aspiration lumen.
Embodiments having multiple assistive jet channels can increase the
effectiveness and efficiency of break up and removal of thrombus
via aspiration. Embodiments having multiple assistive jet channels
can be more effective in clearing thrombus than conventionally
available aspiration catheters. Having multiple assistive jet
elements (which can comprise assistive jet channels or just
assistive jet openings) can have a synergistic effect on the
breakdown and removal of thrombus. Multiple assistive jet streams
can work together to break down the thrombus at the aspiration
opening very efficiently.
[0243] Additionally, in some embodiments, having multiple assistive
jet channels inside of the aspiration lumen can constrict or narrow
the flow area of the aspiration lumen, which can create a fluid
dynamics advantage called the Venturi effect. The Venturi effect
can increase the flow velocity of the blood through the constricted
portion of the aspiration lumen to increase the suction force
exerted on the thrombus that is broken down at the aspiration
opening.
[0244] In some embodiments, the aspiration lumen can also have a
constricted portion adjacent to the assistive jet opening. The
constricted portion of the aspiration lumen can have a
cross-sectional area that is approximately 30% less than a
cross-sectional area of the unconstricted portion of the aspiration
lumen proximal to the constricted portion, or from approximately
35% to approximately 50% less than a cross-sectional area of the
unconstricted portion of the aspiration lumen proximal to the
constricted portion. Additionally, an entrance profile of the
assistive jet opening through the catheter body wall can be angled,
so as to direct the assistive jet at an angle relative to the
vertical orientation. In the illustrated embodiment, the entrance
profile of the assistive jet opening is configured to direct the
assistive jet at an angle in a proximal direction relative to the
vertical orientation (i.e., toward the proximal end of the catheter
body). In other embodiments, not illustrated, the entrance profile
of the assistive jet opening can be configured to direct the
assistive jet at an angle in a distal direction relative to the
vertical orientation (i.e., toward the distal end of the catheter
body), or can be configured to direct the assistive jet straight
into the aspiration lumen (parallel with the vertical
direction).
[0245] The constricted portion of the aspiration lumen can cause a
substantial increase in the flow velocity of fluid and debris
through the constricted portion. The high velocity flow rate can
increase a suction force applied to thrombus, and can increase a
shear force applied to a thrombus in the aspiration lumen from the
assistive jet. In some embodiments, the location and/or size of the
assistive jet opening(s) and the size of the constriction can be
optimized to provide optimal suction through the constricted
portion without excessively reducing the flow through the
aspiration lumen. Additionally, the angle and relative positions of
the side holes can also be sized and configured to optimize the
Venturi effect and also to optimize the shearing effect on the
thrombus.
[0246] In some embodiments, the constricted portion can be created
by a thicker wall portion of the aspiration catheter body. The wall
portion adjacent to the constricted portion of the aspiration lumen
can be tapered. In some embodiments, the taper can extend further
in the distal direction than in a proximal direction. The side hole
can be positioned at a leading edge of the constriction.
[0247] In any embodiments disclosed herein, the one or more
constrictions can have a tapered profile, or a double tapered
profile. For example and without limitation, any constriction
disclosed herein can have a middle portion, a leading portion that
is upstream relative to the flow direction through the aspiration
lumen or distal to the middle portion, and a trailing portion that
is downstream or proximal to the middle portion and the leading
portion. In some embodiments, a length or thickness of the
protrusion of the middle portion can be greater than the leading or
trailing portion, such that the middle portion projects further
into the flow stream within the aspiration lumen than either the
leading or trailing portion.
[0248] The leading and/or trailing portion of the constriction can
have an angled, tapered, or curved shape or profile along a length
thereof (the length being along the axial length of the catheter
body), or have any other desired shape or profile along the length
thereof. Additionally, in any embodiments, the leading portion can
have a first shape or profile along the length thereof, and the
trailing portion can have a second shape or profile along the
length there, the second shape or profile being different than the
first shape or profile. For example and without limitation, a
surface of the leading edge can be formed at an angle relative to
the outer wall of the catheter body having an orientation of
approximately 35 degrees, or from approximately 30 degrees to
approximately 40 degrees, or from approximately 20 degrees or less
to approximately 45 degrees or more. Additionally, a surface of the
trailing edge can be formed at an angle relative to the outer wall
of the catheter body having an orientation of approximately 25
degrees, or from approximately 20 degrees to approximately 30
degrees, or from approximately 15 degrees or less to approximately
35 degrees or more. In any embodiments, an angular orientation or
pitch of the leading portion can be greater than an angular
orientation or pitch of the trailing portion. The length of each
portion can vary such that the length of the leading portion and
the trailing portion can be different.
[0249] Further, in any assistive jet aspiration catheter
embodiments disclosed herein, the assistive jet aspiration catheter
can have one or more constrictions that are asymmetrically
positioned or formed in the aspiration lumen. For example and
without limitation, any assistive jet aspiration catheter
embodiments can have a protrusion formed on one side of the
aspiration lumen, or one both of two sides of an aspiration lumen,
with the assistive jet openings formed on one or both of a leading
edge of the constrictions. In any embodiments disclosed herein, the
constrictions formed on the aspiration lumen can be radially
symmetrical or uniform about the inner circumference of the
aspiration lumen or can be positioned on only a portion or multiple
separate and discrete portions of the circumference of the inner
surface of the aspiration lumen.
[0250] In any embodiments, the assistive jet element can be
monolithically formed with all or a portion of the other features
of the catheter body, or can be separately formed and coupled with
the other components or features of the catheter body. Any catheter
body embodiments can have a proximal portion or section (closer to
the user) and a distal portion or section (further away from the
user). In any catheter body embodiments disclosed herein, the
distal portion can comprise any suitable material, including a
polymer such as thermoplastic polyurethane, Pebax, nylon,
polyester, polyethylene, polycarbonate, polytetrafluoroethylene, or
any other suitable extrudable thermoplastic material. Where
multiple lumen or channels are needed, such portions of the
catheter can be made using a multi-lumen extrusion tube.
Additionally, in any embodiments, the proximal portion can comprise
a braid or coil reinforced polymer laminated tube. For small
catheters, the braid thickness can be approximately 0.0007 inch.
For a 6 Fr catheter, the braid or coil can have a thickness of
approximately 0.001 in. For larger catheters, the braid or coil can
have a thickness of approximately 0.002 in or less. In any
embodiments, the braid or coil reinforcement can extend all the way
to the proximal portion, or even up to a point that is just
proximal of the inlet opening of the assistive jet element.
[0251] Any of the components of any of the embodiments disclosed
herein can be made from any materials commonly used for aspiration
catheters, or which are suitable for the construction of aspiration
catheters. Additionally, in any embodiments disclosed herein, the
lumen or channels of the catheter can be coated to reduce or
eliminate blood cell adhesion in the flow channel, or to improve
the flow rate of blood, thrombus, and other debris or objects
through the flow channel.
[0252] Any components of any of the embodiments disclosed herein
can be made from any suitable materials. Such materials can include
thermoplastic polymers, including but not limited to nylon,
polyurethane, Pebax, HDPE, PE, polyolefin and the like, and/or
metal alloys such as stainless steel, Nitinol, and others.
Stainless steel metal wire can be used for reinforcement. The wire
can be fabricated into a braid mesh or coil embedded within the
polymer layer to provide stiffness, flexibility and kink resistance
properties. Braid can use approximately 0.001 in, approximately
0.0015 in, or approximately 0.002 in wires formed into a mesh using
a PIC count of from approximately 15 to approximately 30.
Alternatively, such wires can be formed into coils at the distal
section where the assistive jet channel is located. Then, the wire
coils can transition into wire braiding with or without an overlap
of 1 to 2 mm proximal to the assistive jet channel. With the
limited wall space at the assistive jet channel section of the
catheter at the distal end, the use of wire coil can give better
flexibility and conserve more space for the aspiration lumen and
assistive jet flow channel in this distal end. Similarly and
alternatively, polymer fiber such as Radel.TM., Dacron.TM., and
Kevlar.TM. can also be used for reinforcement.
[0253] The catheter embodiments disclosed herein can be sized to
suit the needs of any particular applications, including
neurological procedures, vascular procedures, aortic procedures,
coronary procedures, peripheral procedures of any kind, and
otherwise. For example, for neurological procedures, the
approximate outer diameters of the embodiments of the aspiration
catheters disclosed herein that can be used for a 4 Fr guide
catheter, a 5 Fr guide catheter, and a 6 Fr guide catheter are 1.22
mm, 1.42 mm, and 1.75 mm, respectively, though it may be possible
to use slightly larger or slightly smaller aspiration catheters
than these. For coronary procedures, the approximate outer
diameters of the embodiments of the aspiration catheters disclosed
herein that can be used for a 4 Fr guide catheter, a 5 Fr guide
catheter, a 6 Fr guide catheter, a 7 Fr guide catheter, and an 8 Fr
guide catheter are 1.22 mm, 1.42 mm, 1.75 mm, 2.01 mm, and 2.24 mm,
respectively, though it may be possible to use slightly larger or
slightly smaller aspiration catheters than these. For vascular
procedures, the approximate outer diameters of the embodiments of
the aspiration catheters disclosed herein that can be used for a 6
Fr guide catheter, a 7 Fr guide catheter, an 8 Fr guide catheter, a
9 Fr guide catheter, and a 10 Fr guide catheter are 1.75 mm, 2.01
mm, 2.24 mm, 2.44 mm, 2.73 mm, respectively, though it may be
possible to use slightly larger or slightly smaller aspiration
catheters than these. For aortic procedures, the approximate outer
diameter of the embodiments of the aspiration catheters disclosed
herein that can be used for a 14 Fr guide catheter is 4.39 mm,
though it may be possible to use a slightly larger or slightly
smaller aspiration catheter than this. For peripheral procedures,
the approximate outer diameters of the embodiments of the
aspiration catheters disclosed herein that can be used for a 3 Fr
sheath, a 5 Fr sheath, 6 Fr sheath, a 7 Fr sheath, an 8 Fr sheath,
a 9 Fr sheath, and a 10 Fr sheath are 0.91 mm, 1.88 mm, 2.16 mm,
2.49 mm, 2.82 mm, 2.44 mm, and 2.74 mm, respectively, though it may
be possible to use slightly larger or slightly smaller aspiration
catheters than these.
[0254] Any embodiments can have a distal tip, which can be made
from a polyurethane polymer or nylon polymer with or without
tungsten loaded resin. The tip can comprise a tungsten loaded resin
to provide a signal to the user under x-ray of the location of the
tip. In some embodiments, the proximal shaft can use a Grilamid L25
to provide a stiff end for pushing. A middle section of the
catheter body can transition to Pebax 72D, Pebax 70D, Pebax 63D,
Pebax 55D and have Pebax 40D and 35D for the distal end soft
section, which can comprise about 10-15 cm of the distal end. If
the catheter is used for other areas such as lower limb
vasculature, stiffer polymers instead of 40D or 35D Pebax can be
used to achieve a stiffer distal end. Thermoplastic polymers,
nylon, polyurethane, Pebax, HDPE, PE, polyolefin and the like can
be used. But this can be done in metal tube with the configuration
will work too.
[0255] Any of the aspiration catheter embodiments disclosed herein
can be used in the coronary applications as part of the
percutaneous coronary intervention (PCI) procedure for STEMI
patients and for any other aspiration procedures. Currently, using
conventional aspiration catheters, a procedure to remove thrombus
in the coronary heart attack situation will typically require a few
minutes. With any of the embodiments disclosed herein, it is
expected that the amount of time needed to aspirate thrombus in the
coronary heart attack situation will be shorter, which can have
significant health and safety benefits to the patient.
[0256] When aspiration procedures are performed, an introducer or a
guide sheath is typically used to guide the catheter embodiments
disclosed herein to the desired location. Because a guide sheath
may block any inlet openings in the assistive jet elements
disclosed herein, the aspiration catheter should be advanced past
the distal end of the guide sheath far enough such that the one or
more in the openings of the assistive jet elements are positioned
distal of the distal end of the guide sheath. Because a guide
sheath is used in many procedures, the size of the aspiration
catheter may be limited by the inner diameter of the guide sheath,
wherein the size of the aspiration catheter may be chosen to ensure
proper clearance and fit within the guide sheath.
[0257] Any of the aspiration catheter embodiments disclosed herein
can be configured to be either an over-the-wire configuration, or a
rapid exchange configuration, or any other suitable configuration.
With an over-the-wire configuration, after a guidewire has been
advanced into the patient's vasculature or vessels, the catheter
can be advanced over the guidewire by passing the proximal end of
the guidewire, outside of the patient's body, through the
aspiration lumen of the catheter body. The guidewire can then be
directed out a side port so as to not interfere with the suction
source. For the rapid exchange catheter configurations disclosed
herein, the catheters can be advanced over the guidewire by passing
the guidewire through the guidewire lumen in the rapid exchange
catheter. For a comparable outer diameter of the catheter body, the
over-the-wire configuration can have a larger aspiration lumen
compared to a similar rapid exchange configuration of the
aspiration catheter embodiments disclosed herein. Note that, in any
embodiments disclosed herein, the guidewire can be withdrawn
partially or completely before aspiration procedures have begun so
that the guidewire does not interfere with the aspiration.
[0258] FIG. 43 illustrates a variety of different catheter body
cross-sectional configurations that can be used with any of the
assistive jet aspiration catheter systems disclosed herein. The
embodiment of a catheter body 700 illustrated therein can be
configured for over-the-wire use, or can be modified for rapid
exchange guidewire use. The catheter body 700 can have an assistive
jet lumen 702 and an aspiration lumen 704. The assistive jet lumen
702 can have a semicircular shape and can comprise approximately
20%, or from approximately 10% to approximately 30% or more, of the
cross-sectional area of the catheter body 700.
[0259] The embodiment of the catheter body 710 illustrated therein
can be configured for over-the-wire use, or can be modified for
rapid exchange guidewire use. Catheter body 710 can have an
assistive jet lumen 712 and an aspiration lumen 714. The assistive
jet lumen 712 can have a circular shape and can comprise
approximately 10%, or from approximately 5% to approximately 20% or
more, of the cross-sectional area of the catheter body 710.
[0260] The embodiment of the catheter body 720 illustrated therein
has been designed to be usable for over-the-wire use, or for rapid
exchange guidewire use. Catheter body 720 can have one or more
assistive jet lumens 722, each having a curved, oblong shape and an
aspiration lumen 724, and a guidewire lumen 726. The assistive jet
lumens 722 can, collectively, comprise approximately 10%, or from
approximately 5% to approximately 20% or more, of the
cross-sectional area of the catheter body 720.
[0261] The embodiment of a catheter body 730 illustrated therein
can have any of the same properties or features as the catheter
body 710, and is configured for rapid exchange guidewire use. The
catheter body 730 can have an assistive jet lumen 732, an
aspiration lumen 734, and a guidewire lumen 736. The assistive jet
lumen 732 can have a semicircular shape and can comprise
approximately 20%, or from approximately 10% to approximately 30%
or more, of the cross-sectional area of the catheter body 730.
[0262] The embodiment of a catheter body 740 illustrated therein
can have any of the same properties or features as the catheter
body 730, and is configured for rapid exchange guidewire use. The
catheter body 740 can have an assistive jet lumen 742, an
aspiration lumen 744, and a guidewire lumen 746. The assistive jet
lumen 742 can have a circular shape and can comprise approximately
10%, or from approximately 5% to approximately 20% or more, of the
cross-sectional area of the catheter body 740.
[0263] Any of the catheter embodiments disclosed herein can be used
in many parts of the anatomy with early stage thrombus like
substances. The catheter embodiments disclosed herein may be
suitable for any vessels that are slightly larger (such as a few
millimeters larger) than the outer diameter of the catheter body.
For example, coronary arteries are mostly from approximately 2 mm
to approximately 6 mm, while an aspiration catheter having an outer
diameter of approximately 1.73 mm could be used, which would
provide a space between the outside of the catheter body and the
inside of the vessel wall of approximately 0.27 mm to approximately
4.27 mm for blood to flow to provide the necessary fluid for the
assistive jet elements of the embodiments disclosed herein.
Similarly, in Above-the-Knee cases, vessels typically have an
inside diameter of approximately 7 mm to 8 mm, while the catheters
that are typically used have an outside diameter of approximately
1.4 mm, leaving a space of approximately 5.6 mm for the blood flow.
The inner diameter or size of neurovascular vessels accessed by
catheter are typically about 2 mm to 3 mm, while catheters used for
such vessels are usually about 1 mm.
[0264] The following is a non-limiting example of a procedure that
any of the aspiration catheter embodiments disclosed herein can be
used for. A 6 F aspiration catheter can be used for this
application. The aspiration catheter can be loaded on a 0.014''
guidewire, then slowly inserted into the guiding catheter. The
physician can have the guiding catheter inserted at a radial
(either left or right, though mostly right) entry point or at the
common femoral location using an introducer sheath of compatible
size. The aspiration catheter can have markings on the proximal
shaft to let physician know the tip reaches the tip of the guiding
catheter. The catheter can also be connected to a vacuum syringe at
the hub end. With diagnostic imaging or angiogram, lesion location
is identified.
[0265] A physician or medical practitioner can park the catheter
just proximal to the lesion and activate the vacuum syringe
connected to the catheter. The aspiration catheter can then be
slowly advanced over the wire into the lesion and then slowly
retracted out. This motion can be repeated with the catheter over
the wire the entire time for a few times or until the thrombus
inside the ruptured plaque is removed. The physician may use the
aspiration catheter to inject contrast dye to diagnose section
beyond the lesion. Upon completion, the physician can keep the
guidewire and the guide catheter in place and slowly pull out the
aspiration catheter.
[0266] While certain embodiments have been described, these
embodiments have been presented by way of example only, and are not
intended to limit the scope of protection. Indeed, the novel
methods and systems described herein may be embodied in a variety
of other forms. Furthermore, various omissions, substitutions and
changes in the form of the methods and systems described herein may
be made. Those skilled in the art will appreciate that in some
embodiments, the actual steps taken in the processes illustrated
and/or disclosed may differ from those shown in the figures.
Depending on the embodiment, certain of the steps described above
may be removed, others may be added. Accordingly, the scope of the
present disclosure is intended to be defined only by reference to
the claims of the utility application. The accompanying claims and
their equivalents are intended to cover such forms or modifications
as would fall within the scope and spirit of the protection.
Furthermore, the features and attributes of the specific
embodiments disclosed above may be combined in different ways to
form additional embodiments, all of which fall within the scope of
the present disclosure. Although the present disclosure provides
certain embodiments and applications, other embodiments that are
apparent to those of ordinary skill in the art, including
embodiments which do not provide all of the features and advantages
set forth herein, are also within the scope of this disclosure.
Accordingly, the scope of the present disclosure is intended to be
defined only by reference to the appended claims or claims that
will be added in the future.
[0267] Accordingly, although the present disclosure includes
certain embodiments, examples and applications, it will be
understood by those skilled in the art that the present disclosure
extends beyond the specifically disclosed embodiments to other
alternative embodiments and/or uses and obvious modifications and
equivalents thereof, including embodiments which do not provide all
of the features and advantages set forth herein. Accordingly, the
scope of the present disclosure is not intended to be limited by
the specific disclosures of preferred embodiments herein, and may
be defined by claims as presented herein or as presented in the
future. Finally, as used herein and unless otherwise stated, the
term approximately is meant to represent a range of +/-10% of the
stated value.
[0268] It should be emphasized that many variations and
modifications may be made to the herein-described embodiments, the
elements of which are to be understood as being among other
acceptable examples. All such modifications and variations are
intended to be included herein within the scope of this disclosure
and protected by the following claims. Moreover, any of the steps
described herein can be performed simultaneously or in an order
different from the steps as ordered herein. Moreover, as should be
apparent, the features and attributes of the specific embodiments
disclosed herein may be combined in different ways to form
additional embodiments, all of which fall within the scope of the
present disclosure.
[0269] Conditional language used herein, such as, among others,
"can," "could," "might," "may," "e.g.," and the like, unless
specifically stated otherwise, or otherwise understood within the
context as used, is generally intended to convey that certain
embodiments include, while other embodiments do not include,
certain features, elements and/or states. Thus, such conditional
language is not generally intended to imply that features, elements
and/or states are in any way required for one or more embodiments
or that one or more embodiments necessarily include logic for
deciding, with or without author input or prompting, whether these
features, elements and/or states are included or are to be
performed in any particular embodiment.
[0270] Moreover, the following terminology may have been used
herein. The singular forms "a," "an," and "the" include plural
referents unless the context clearly dictates otherwise. Thus, for
example, reference to an item includes reference to one or more
items. The term "ones" refers to one, two, or more, and generally
applies to the selection of some or all of a quantity. The term
"plurality" refers to two or more of an item. The term "about" or
"approximately" means that quantities, dimensions, sizes,
formulations, parameters, shapes and other characteristics need not
be exact, but may be approximated and/or larger or smaller, as
desired, reflecting acceptable tolerances, conversion factors,
rounding off, measurement error and the like and other factors
known to those of skill in the art. The term "substantially" means
that the recited characteristic, parameter, or value need not be
achieved exactly, but that deviations or variations, including for
example, tolerances, measurement error, measurement accuracy
limitations and other factors known to those of skill in the art,
may occur in amounts that do not preclude the effect the
characteristic was intended to provide.
[0271] Numerical data may be expressed or presented herein in a
range format. It is to be understood that such a range format is
used merely for convenience and brevity and thus should be
interpreted flexibly to include not only the numerical values
explicitly recited as the limits of the range, but also interpreted
to include all of the individual numerical values or sub-ranges
encompassed within that range as if each numerical value and
sub-range is explicitly recited. As an illustration, a numerical
range of "about 1 to 5" should be interpreted to include not only
the explicitly recited values of about 1 to about 5, but should
also be interpreted to also include individual values and
sub-ranges within the indicated range. Thus, included in this
numerical range are individual values such as 2, 3 and 4 and
sub-ranges such as "about 1 to about 3," "about 2 to about 4" and
"about 3 to about 5," "1 to 3," "2 to 4," "3 to 5," etc. This same
principle applies to ranges reciting only one numerical value
(e.g., "greater than about 1") and should apply regardless of the
breadth of the range or the characteristics being described. A
plurality of items may be presented in a common list for
convenience. However, these lists should be construed as though
each member of the list is individually identified as a separate
and unique member. Thus, no individual member of such list should
be construed as a de facto equivalent of any other member of the
same list solely based on their presentation in a common group
without indications to the contrary. Furthermore, where the terms
"and" and "or" are used in conjunction with a list of items, they
are to be interpreted broadly, in that any one or more of the
listed items may be used alone or in combination with other listed
items. The term "alternatively" refers to selection of one of two
or more alternatives, and is not intended to limit the selection to
only those listed alternatives or to only one of the listed
alternatives at a time, unless the context clearly indicates
otherwise.
* * * * *
References