U.S. patent application number 17/691012 was filed with the patent office on 2022-06-23 for intra-ventricular infusion and evacuation catheter for treatment of intracerebral hemorrhage (ich).
This patent application is currently assigned to STRYKER CORPORATION. The applicant listed for this patent is STRYKER CORPORATION, STRYKER EUROPEAN OPERATIONS HOLDINGS LLC. Invention is credited to Stephen Porter, Jon Schabert.
Application Number | 20220193368 17/691012 |
Document ID | / |
Family ID | 1000006185829 |
Filed Date | 2022-06-23 |
United States Patent
Application |
20220193368 |
Kind Code |
A1 |
Porter; Stephen ; et
al. |
June 23, 2022 |
INTRA-VENTRICULAR INFUSION AND EVACUATION CATHETER FOR TREATMENT OF
INTRACEREBRAL HEMORRHAGE (ICH)
Abstract
A method of treating an anatomical cavity of a patient comprises
introducing an infusion/aspiration catheter into the patient, such
that a plurality of arms of the catheter reside within the
anatomical cavity, delivering a fluid into the at least one of a
connector, such that fluid exits the at least one fluid port of at
least one of the arms, thereby infusing the anatomical cavity with
the fluid, and aspirating the fluid into the at least one fluid
port of at least one of the arms, such that the fluid exits the
connector(s).
Inventors: |
Porter; Stephen; (Piedmont,
CA) ; Schabert; Jon; (Dublin, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
STRYKER CORPORATION
STRYKER EUROPEAN OPERATIONS HOLDINGS LLC |
Kalamazoo
Kalamazoo |
MI
MI |
US
US |
|
|
Assignee: |
STRYKER CORPORATION
Kalamazoo
MI
STRYKER EUROPEAN OPERATIONS HOLDINGS LLC
Kalamazoo
MI
|
Family ID: |
1000006185829 |
Appl. No.: |
17/691012 |
Filed: |
March 9, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
16132861 |
Sep 17, 2018 |
11298506 |
|
|
17691012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/22004 20130101;
A61M 25/0068 20130101; A61B 2018/00267 20130101; A61M 25/0074
20130101; A61B 2017/22084 20130101; A61B 2217/007 20130101; A61B
2217/005 20130101; A61M 2025/0063 20130101; A61M 25/003 20130101;
A61M 2210/0693 20130101; A61B 2017/22079 20130101; A61M 1/0058
20130101; A61M 2025/0036 20130101 |
International
Class: |
A61M 25/00 20060101
A61M025/00; A61B 17/22 20060101 A61B017/22 |
Claims
1. An infusion/aspiration catheter, comprising: an elongate
catheter body having a proximal end, a distal end, at least one
infusion lumen and an aspiration lumen extending between the
proximal end and the distal end, the aspiration lumen terminating
in a distal fluid port at the distal end of the elongate catheter
body; a plurality of arms respectively having proximal ends affixed
together at the distal end of elongate catheter body, the distal
fluid port of the elongate catheter body being disposed radially
inward from the proximal ends of the plurality of arms, the arms
having lumens in fluid communication with the at least one infusion
lumen, each of the arms having at least one fluid port in fluid
communication with the lumen of the respective arm; at least one
infusion connector affixed to the proximal end of the elongate
catheter body in fluid communication with the at least one infusion
lumen; and an aspiration connector affixed to the proximal end of
the elongate catheter body in fluid communication with the at least
one aspiration lumen.
2. The infusion/aspiration catheter of claim 1, wherein the at
least one infusion lumen comprises a plurality of infusion lumens
with which the lumens of the plurality of arms are respectively in
fluid communication in a dedicated manner, and wherein the at least
one infusion connector comprises a plurality of connectors in fluid
communication with the plurality of infusion lumens in a dedicated
manner.
3. The infusion/aspiration catheter of claim 1, wherein the at
least one infusion lumen comprises a single infusion lumen with
which the lumens of the plurality of arms are respectively in fluid
communication, and wherein the at least one infusion connector
comprises a single connector in fluid communication with the single
infusion lumen.
4. The infusion/aspiration catheter of claim 1, wherein the at
least one fluid port resides on an outwardly facing side of the
respective arm.
5. The infusion/aspiration catheter of claim 1, wherein the at
least one fluid port comprises a plurality of fluid ports extending
along a length of the respective arm.
6. The infusion/aspiration catheter of claim 5, wherein the
plurality of fluid ports extend resides on both an outwardly facing
side and an inwardly facing side of the respective arm.
7. The infusion/aspiration catheter of claim 1, wherein the number
of arms comprises at least three.
8. The infusion/aspiration catheter of claim 1, wherein the
plurality of arms are pre-shaped to expand outward in the absence
of an external force.
9. The infusion/aspiration catheter of claim 1, further comprising
a distal hub at which distal ends of the arms are affixed
together.
10. The infusion/aspiration catheter of claim 9, further comprising
an actuation wire having a distal end affixed to the distal hub and
a proximal extending from the proximal end of the elongate catheter
body, the actuator wire configured for being proximally displaced
relative to the elongate catheter body to expand the plurality of
arms outward, and for being distally displaced relative to the
elongate catheter body to straighten the plurality of arms.
11. The infusion/aspiration catheter of claim 1, wherein the at
least one infusion connector and the aspiration connector have
separate luer connections.
12. The infusion/aspiration catheter of claim 1, further comprising
a manifold assembly comprising the at least one infusion connector
and the aspiration connector.
13. The infusion/aspiration catheter of claim 1, wherein the
aspiration lumen is a central lumen, and the at least one infusion
lumen are circumferentially surrounding the central lumen.
14. The infusion/aspiration catheter of claim 13, wherein the
central lumen has a cross-sectional area greater than a
cross-section area of each of the at least one infusion lumen.
15. The infusion/aspiration catheter of claim 1, further comprising
a rigid stylet slidably disposed in the central lumen of the
elongate catheter body.
16. The infusion/aspiration catheter of claim 15, further
comprising a distal hub at which distal ends of the arms are
affixed together, wherein the distal hub comprises an aperture
through which the rigid stylet is disposed.
17. The infusion/aspiration catheter of claim 1, wherein the
elongate catheter body is sized to be introduced through a burr
hole in the cranium of a patient.
18. A catheter assembly, comprising: the infusion/aspiration
catheter of claim 1; and an introducer cannula having a lumen
through which the infusion/aspiration catheter can be introduced
into a target region of a body.
19. An infusion/aspiration system, comprising: the
infusion/aspiration catheter of claim 1; a fluid source connected
to the at least one infusion connector; and a vacuum source or
drain connected to the aspiration connector.
Description
RELATED APPLICATION DATA
[0001] The present application is a continuation of U.S. patent
application Ser. No. 16/132,861, filed Sep. 17, 2018. The foregoing
application is hereby incorporated by reference into the present
application in its entirety.
FIELD
[0002] The disclosed inventions relate generally to medical devices
and intravascular medical procedures and, more particularly, to
devices and methods for treating an intracerebral hemorrhage
(ICH).
BACKGROUND
[0003] Intracerebral hemorrhage (ICH) is a sudden bleeding into
brain tissue, which can have devastating results. It is the only
major stroke subtype without a clearly effective treatment. ICH
occurs in over 100,000 Americans yearly and is fatal in 30-50% of
all occurrences, while leaving the majority of survivors with
significant motor and cognitive disabilities.
[0004] MISTIE (Minimally Invasive Surgery Plus rt-PA for
Intracerebral Hemorrhage Evacuation) is a series of clinical trials
conducted by neurosurgeons and neurologists to investigate the
efficacy of treating ICH by quickly removing blood from the brain
through minimally invasive surgery and intermittent dosing of the
clot-busting drug, recombinant tissue plasminogen activator
(rt-PA). The premise is that by dissolving and removing the clot
faster, injury to the brain will be reduced and the patient's
prognosis improved.
[0005] MISTIE-II, a phase II set of clinical trials for the same
purpose, have shown that a blood clot in the brain, can be
successfully removed quickly and safely. These early results also
suggest that the MISTIE technique may reduce the rate of death, but
more significantly, improves the patient's neurologic functioning
and quality of life in the year following the occurrence of
ICH.
[0006] MISTIE-III is an international, phase III 500-patient
clinical trial designed to confirm the preliminary findings in a
larger number of patients, and has the primary goal of defining a
successful treatment for ICH.
[0007] FIG. 1 illustrates a computed tomography (CT) scan slice of
a normal brain 1' that reveals no ICH, whereas FIG. 2 illustrates a
CT scan slice of an abnormal brain 1 that reveals an ICH 2 residing
in a ventricle 3 of the brain 1'. The tools used in a MISTIE
procedure to treat the ICH 2 are simplistic. In general, a
conventional external ventricular drain (EVD) catheter 4 is placed
through a standard burr-hole access 5 in the cranium 6 into the
ventricle 3 at the site of the ICH 2, as illustrated in FIG. 3.
Image guidance may be used Magnetic Resonance (MR)/Computed
Tomography (CT), or external anatomical landmarks may be used via
standardized methods without image guidance, to target the EVD
catheter 4 into the ventricle 3 (using standard ventricular access
routes in the case of an intraventricular hemorrhage) at the site
of the ICH 2, although the EVD catheter 4 may be targeted to a
location outside of the ventricle 3 in the case of an
extra-ventricular hemorrhage. In either case, Magnetic Resonance
MR/CT imaging is used to confirm correct placement at the site of
the ICH 2.
[0008] Once correct placement of the EVD catheter 4 is confirmed,
an initial bolus of rt-PA is infused in the ventricle 3 at site of
the ICH 2 via the EVD catheter 1, and allowed to remain in place
for approximately 12-24 hours to dissolve the clot, while the EVD
catheter 4 remains open and may be allowed to drain, as illustrated
in FIG. 4. Afterwards, remaining fluid (including the rt-PA and
dissolved clot) at the site of the ICH 2 is aspirated via the same
EVD catheter 1, as illustrated in FIG. 5. This infusion and
aspiration process may be repeated at the physician's discretion.
The MISTIE procedure, although reasonably effective in treating an
ICH, has limitations that are imposed by the simple design of the
conventional EVD catheter 4, which was not designed for the purpose
of treating an ICH. In particular, the flow of fluid within the
conventional EVD catheter 4 can only occur in one direction at a
time (either infusion or aspiration, but not both), and
furthermore, the rt-PA can only be infused from the EVD catheter 4
in a direction perpendicular to a single straight axis, thereby
limiting the administration volume and increasing the diffusive
resistance of the rt-PA to reach the entire clot mass. As a result,
the time to treat the ICH may be unduly increased.
SUMMARY
[0009] In accordance with one aspect of the disclosed inventions,
an infusion/aspiration catheter comprises an elongate catheter body
having a proximal end, a distal end. The elongate catheter body
may, e.g., be sized to be introduced through a burr hole in the
cranium of a patient. The infusion/aspiration catheter further
comprises a plurality of independent lumens extending between the
proximal end and the distal end. The infusion/aspiration catheter
further comprises a plurality of arms respectively having proximal
ends affixed together at the distal end of elongate catheter body.
Each of the arms has a lumen in fluid communication with a
respective one of the independent lumens of the elongate catheter
body. Each of the arms has at least one fluid port in fluid
communication with the lumen of the respective arm. The fluid
port(s) may reside, e.g., on an outwardly facing side of the
respective arm. A plurality of fluid ports may extend along a
length of the respective arm, e.g., on both an outwardly facing
side and an inwardly facing side of the respective arm. In one
embodiment, the number of arms comprises at least three, and are
pre-shaped to expand outward in the absence of an external
force.
[0010] The infusion/aspiration catheter may further comprise at
least one connector affixed to the proximal end of the elongate
catheter body in fluid communication with the independent lumens of
the elongate catheter body. In one embodiment, the
infusion/aspiration catheter comprises a plurality of connectors in
fluid communication with the independent lumens of the elongate
catheter body. The connectors may be in fluid communication with
the respective ones of the independent lumens of the elongated
catheter body in a dedicated manner. In one embodiment, the
plurality of connectors may comprise a plurality of separate luer
connections. In another embodiment, the infusion/aspiration
catheter further comprises a manifold assembly comprising the
plurality of connectors.
[0011] In one embodiment, the infusion/aspiration catheter further
comprises a distal hub at which distal ends of the arms are affixed
together. In this case, the infusion/aspiration catheter may
further comprise an actuation wire having a distal end affixed to
the distal hub and a proximal extending from the proximal end of
the elongate catheter body. The actuator wire is configured for
being proximally displaced relative to the elongate catheter body
to expand the plurality of arms outward, and for being distally
displaced relative to the elongate catheter body to straighten the
plurality of arms.
[0012] In another embodiment, the elongate catheter body further
has a central lumen extending between the proximal end and distal
end of the elongate catheter body, and the independent lumens
circumferentially surround the central lumen. In this case, the
infusion/aspiration catheter may further comprise another connector
affixed to the proximal end of the elongate catheter body in fluid
communication with the central lumen of the elongate catheter body
in a dedicated manner. The central lumen may have a cross-sectional
area greater than a cross-section area of each of the independent
lumens. The infusion/aspiration catheter may further comprise a
rigid stylet slidably disposed in the central lumen of the elongate
catheter body. In this embodiment, the infusion/aspiration catheter
may further comprise a distal hub at which distal ends of the arms
are affixed together. The distal hub comprises an aperture through
which the rigid stylet is disposed.
[0013] In accordance with another aspect of the disclosed
inventions, the catheter assembly may itself comprise a
infusion/aspiration catheter, and an introducer cannula having a
lumen through which the infusion/aspiration catheter can be
introduced into a target region of a body.
[0014] In accordance with yet another aspect of the disclosed
inventions, an infusion/aspiration system comprises the
infusion/aspiration catheter, a fluid source connected to at least
one of the connectors, and a vacuum source or drain connected to at
least another one of the connectors.
[0015] In accordance with still another aspect of the disclosed
inventions, a method of treating an anatomical cavity of a patient
comprises introducing the infusion/aspiration catheter into the
patient (e.g., via a burr hole in the cranium of the patient), such
that the plurality of arms reside within the anatomical cavity
(e.g., in a ventricle in a head of the patient or a region where
clot has displaced brain tissue of the patient), delivering a fluid
(e.g., recombinant tissue plasminogen activator (rt-PA)) into the
connector(s), such that fluid exits the fluid port(s) of the
corresponding arms, thereby infusing the anatomical cavity with the
fluid, and aspirating the fluid into the fluid port(s) of at least
one of the arms, such that the fluid exits the connector(s). If the
patient has clot residing within the anatomical cavity, the infused
rt-PA may dissolve the clot, such that the aspirated fluid
comprises the rt-PA and the dissolved clot. In one method, a
plurality of connectors is in fluid communication with the
independent lumens of the elongate catheter body, in which case,
the fluid may be simultaneously infused into and aspirated from the
anatomical cavity via different ones of the connectors. In another
method, the fluid is sequentially infused into and aspirated from
the anatomical cavity via the same ones of the connector(s).
[0016] In one embodiment, the method further comprises expanding
the arms outward within the anatomical cavity. The method may
further comprise placing an introducer sheath within the anatomical
cavity. The plurality of arms may be pre-shaped to expand outward
in the absence of an external force. In this case, introducing the
infusion/aspiration catheter into the patient may comprise
introducing the infusion/aspiration catheter through the introducer
sheath, such that the introducer sheath applies an external force
to the plurality of arms to straighten the arms, and deploying
plurality of arms from the introducer sheath, such that the
external force is released from the plurality of arms, thereby
allowing the arms to expand outward. In an alternative method, an
actuation wire may be affixed to a distal hub of the
infusion/aspiration catheter. The method may further comprise
displacing the actuation wire distally relative to the
infusion/aspiration catheter to straighten the arms while
introducing the infusion/aspiration catheter into the anatomical
cavity, and displacing the actuation wire proximally relative to
the infusion/aspiration catheter to expand the arms outward within
the anatomical cavity. In still another method, the elongate
catheter body may further have a central lumen extending between
the proximal end and distal end of the elongate catheter body, in
which case, introducing the infusion/aspiration catheter into the
anatomical cavity may comprise disposing a rigid stylet within the
central lumen of the elongate catheter body.
[0017] In accordance with yet another aspect of the disclosed
inventions, an infusion/aspiration catheter comprises an elongate
catheter body having a proximal end, a distal end, at least one
infusion lumen. The elongate catheter body may, e.g., be sized to
be introduced through a burr hole in the cranium of a patient. The
elongate catheter body further has at least one infusion lumen and
an aspiration lumen extending between the proximal end and the
distal end. The aspiration lumen terminates in a distal fluid port
at the distal end of the elongate catheter body. The infusion
lumen(s) may circumferentially surround the central lumen. The
central lumen may have a cross-sectional area greater than a
cross-section area of each of the infusion(s).
[0018] The infusion/aspiration catheter may further comprise a
plurality of arms respectively having proximal ends affixed
together at the distal end of elongate catheter body. The distal
fluid port of the elongate catheter body is between the proximal
ends of the plurality of arms. Each of the arms has a lumen in
fluid communication with a respective one of the independent lumens
of the elongate catheter body. Each of the arms has at least one
fluid port in fluid communication with the lumen of the respective
arm. The fluid port(s) may reside, e.g., on an outwardly facing
side of the respective arm. A plurality of fluid ports may extend
along a length of the respective arm, e.g., on both an outwardly
facing side and an inwardly facing side of the respective arm. In
one embodiment, the number of arms comprises at least three, and
are pre-shaped to expand outward in the absence of an external
force.
[0019] The infusion/aspiration catheter further may comprise at
least one infusion connector affixed to the proximal end of the
elongate catheter body in fluid communication with the infusion
lumen(s), and an aspiration connector affixed to the proximal end
of the elongate catheter body in fluid communication with the
aspiration lumen(s). In one embodiment, the elongate catheter body
comprises a plurality of infusion lumens with which the lumens of
the plurality of arms are respectively in fluid communication in a
dedicated manner, a plurality of infusion connectors in fluid
communication with the plurality of infusion lumens in a dedicated
manner. In another embodiment, the elongate catheter body comprises
a single infusion lumen with which the lumens of the plurality of
arms are respectively in fluid communication, and a single
connector in fluid communication with the single infusion lumen. In
one embodiment, the infusion connector(s) and aspiration
connector(s) may comprise a plurality of separate luer connections.
In another embodiment, the infusion/aspiration catheter further
comprises a manifold assembly comprising the infusion connector(s)
and aspiration connector(s).
[0020] In one embodiment, the infusion/aspiration catheter further
comprises a distal hub at which distal ends of the arms are affixed
together. In this case, the infusion/aspiration catheter may
further comprise an actuation wire having a distal end affixed to
the distal hub and a proximal extending from the proximal end of
the elongate catheter body. The actuator wire is configured for
being proximally displaced relative to the elongate catheter body
to expand the plurality of arms outward, and for being distally
displaced relative to the elongate catheter body to straighten the
plurality of arms.
[0021] The infusion/aspiration catheter may further comprise a
rigid stylet slidably disposed in the central lumen of the elongate
catheter body. In this embodiment, the infusion/aspiration catheter
may further comprise a distal hub at which distal ends of the arms
are affixed together. The distal hub comprises an aperture through
which the rigid stylet is disposed.
[0022] In accordance with still another aspect of the disclosed
inventions, a catheter assembly comprises the infusion/aspiration
catheter, and an introducer cannula having a lumen through which
the infusion/aspiration catheter can be introduced into a target
region of a body.
[0023] In accordance with yet another aspect of the disclosed
inventions, an infusion/aspiration system comprises the
infusion/aspiration catheter, a fluid source connected to at least
one of the connectors, and a vacuum source or drain connected to at
least another one of the connectors.
[0024] In accordance with still another aspect of the disclosed
inventions, a method of treating an anatomical cavity of a patient
comprises introducing the infusion/aspiration catheter into the
patient (e.g., via a burr hole in the cranium of the patient), such
that the plurality of arms reside within the anatomical cavity
(e.g., in a ventricle in a head of the patient or a region where
clot has displaced brain tissue of the patient), delivering a fluid
(e.g., recombinant tissue plasminogen activator (rt-PA)) into the
infusion connector(s), such that fluid exits the fluid port(s) of
the corresponding arms, thereby infusing the anatomical cavity with
the fluid, and aspirating the fluid into the distal fluid port of
the elongate catheter body, such that the fluid exits the
aspiration connector. If the patient has clot residing within the
anatomical cavity, the infused rt-PA may dissolve the clot, such
that the aspirated fluid comprises the rt-PA and the dissolved
clot. In one method, the fluid may be simultaneously infused into
and aspirated from the anatomical cavity. In another method, the
fluid is sequentially infused into and aspirated from the
anatomical cavity.
[0025] In one embodiment, the method further comprises expanding
the arms outward within the anatomical cavity. The method may
further comprise placing an introducer sheath within the anatomical
cavity. The plurality of arms may be pre-shaped to expand outward
in the absence of an external force. In this case, introducing the
infusion/aspiration catheter into the patient may comprise
introducing the infusion/aspiration catheter through the introducer
sheath, such that the introducer sheath applies an external force
to the plurality of arms to straighten the arms, and deploying
plurality of arms from the introducer sheath, such that the
external force is released from the plurality of arms, thereby
allowing the arms to expand outward. In an alternative method, an
actuation wire may be affixed to a distal hub of the
infusion/aspiration catheter. The method may further comprise
displacing the actuation wire distally relative to the
infusion/aspiration catheter to straighten the arms while
introducing the infusion/aspiration catheter into the anatomical
cavity, and displacing the actuation wire proximally relative to
the infusion/aspiration catheter to expand the arms outward within
the anatomical cavity. In still another embodiment of the method,
the elongate catheter body may further have a central lumen
extending between the proximal end and distal end of the elongate
catheter body, in which case, introducing the infusion/aspiration
catheter into the anatomical cavity may comprise disposing a rigid
stylet within the central lumen of the elongate catheter body.
[0026] Other and further aspects and features of embodiments of the
disclosed inventions will become apparent from the ensuing detailed
description in view of the accompanying figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] The drawings illustrate the design and utility of preferred
embodiments of the disclosed inventions, in which similar elements
are referred to by common reference numerals. It should be noted
that the figures are not drawn to scale and that elements of
similar structures or functions are represented by like reference
numerals throughout the figures. It should also be noted that the
figures are only intended to facilitate the description of the
embodiments. They are not intended as an exhaustive description or
limitation of the scope of the disclosed inventions, which is
defined only by the appended claims and their equivalents. In
addition, an illustrated embodiments of the disclosed inventions
needs not have all the aspects or advantages shown. An aspect or an
advantage described in conjunction with a particular embodiment of
the disclosed inventions is not necessarily limited to that
embodiment and can be practiced in any other embodiments even if
not so illustrated. In order to better appreciate how the
above-recited and other advantages and objects of the disclosed
inventions are obtained, a more particular description of the
disclosed inventions briefly described above will be rendered by
reference to specific embodiments thereof, which are illustrated in
the accompanying drawings. Understanding that these drawings depict
only typical embodiments of the invention and are not therefore to
be considered limiting of its scope, and the disclosed inventions
are described and explained with additional specificity and detail
through the use of the accompanying drawings, in which:
[0028] FIG. 1 is a prior art computed tomography (CT) scan slice of
a normal brain;
[0029] FIG. 2 is a prior art CT scan slice of a brain that has
suffered an intracerebral hemorrhage (ICH);
[0030] FIG. 3 is a plan view illustrating the introduction of a
prior art external ventricular drain (EVD) catheter within a
ventricle of brain that has suffered an ICH;
[0031] FIG. 4 is a plan view illustrating the infusion of
recombinant tissue plasminogen activator (rt-PA) into the ventricle
via the EVD catheter of FIG. 3 to treat the ICH;
[0032] FIG. 5 is a plan view illustrating the draining or
aspiration of fluid including the rt-PA from the ventricle via the
EVD catheter of FIG. 3 to treat the ICH;
[0033] FIG. 6 is a plan view of one embodiment of an
infusion/aspiration system constructed in accordance with the
disclosed invention;
[0034] FIG. 7A is a perspective view of an infusion/aspiration
catheter used in the infusion/aspiration system of FIG. 6,
particularly showing the arms of the infusion/aspiration catheter
in an expanded geometry;
[0035] FIG. 7B is a perspective view of the infusion/aspiration
catheter of FIG. 7A, particularly showing the arms of the
infusion/aspiration catheter in a low-profile geometry;
[0036] FIG. 7C is a cross-sectional view of the elongate catheter
body of the infusion/aspiration catheter of FIG. 7A, taken along
the line 7C-7C;
[0037] FIG. 7D is a cross-sectional view of an arm of the
infusion/aspiration catheter of FIG. 7A, taken along the line
7D-7D;
[0038] FIG. 8 is a plan view of a valve manifold that can
alternatively be used in the infusion/aspiration system of FIG.
6;
[0039] FIG. 9 is a flow diagram illustrating one method of using
the infusion/aspiration system of FIG. 6 to treat an ICH within a
brain of a patient;
[0040] FIGS. 10A-10D are plan views illustrating the use of the
infusion/aspiration system of FIG. 6 to treat the ICH within the
brain of the patient in accordance with the method of FIG. 9;
[0041] FIG. 11 is a plan view of another embodiment of an
infusion/aspiration system constructed in accordance with the
disclosed invention;
[0042] FIG. 12A is a perspective view of an infusion/aspiration
catheter used in the infusion/aspiration system of FIG. 11,
particularly showing the arms of the infusion/aspiration catheter
in an expanded geometry;
[0043] FIG. 12B is a perspective view of the infusion/aspiration
catheter of FIG. 12A, particularly showing the arms of the
infusion/aspiration catheter in a low-profile geometry;
[0044] FIG. 12C is a cross-sectional view of the elongate catheter
body of the infusion/aspiration catheter of FIG. 12A, taken along
the line 12C-12C
[0045] FIG. 13 is a flow diagram illustrating one method of using
the infusion/aspiration system of FIG. 11 to treat an ICH within a
brain of a patient
[0046] FIGS. 14A-14D are plan views illustrating the use of the
infusion/aspiration system of FIG. 11 to treat the ICH within the
brain of the patient in accordance with the method of FIG. 13;
[0047] FIG. 15 is a plan view of still another embodiment of an
infusion/aspiration system constructed in accordance with the
disclosed invention;
[0048] FIG. 16A is a perspective view of an infusion/aspiration
catheter used in the infusion/aspiration system of FIG. 15;
[0049] FIG. 16B is a cross-sectional view of the elongate catheter
body of the infusion/aspiration catheter of FIG. 16A, taken along
the line 16B-16B;
[0050] FIG. 17 is a plan view of yet another embodiment of an
infusion/aspiration system constructed in accordance with the
disclosed inventions;
[0051] FIG. 18A is a perspective view of an infusion/aspiration
catheter used in the infusion/aspiration system of FIG. 17,
particularly showing the arms of the infusion/aspiration catheter
in an expanded geometry;
[0052] FIG. 18B is a perspective view of the infusion/aspiration
catheter of FIG. 18A, particularly showing the arms of the
infusion/aspiration catheter in a low-profile geometry;
[0053] FIG. 18C is a cross-sectional view of the elongate catheter
body of the infusion/aspiration catheter of FIG. 18A, taken along
the line 18C-18C;
[0054] FIG. 19 is a flow diagram illustrating one method of using
the infusion/aspiration system of FIG. 17 to treat an ICH within a
brain of a patient; and
[0055] FIGS. 20A-20D are plan views illustrating the use of the
infusion/aspiration system of FIG. 17 to treat the ICH within the
brain of the patient in accordance with the method of FIG. 19.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0056] Referring first to FIG. 6, an infusion/aspiration system 10
constructed in accordance with one embodiment of the disclosed
inventions will now be described. The infusion/aspiration system 10
generally comprises an introducer sheath 12 (which could be the
primary access channel and placed separately prior to introduction
of subsequent devices, or could be just a transfer sheath used to
transfer other devices into a previously placed ancillary sheath),
an infusion/aspiration catheter 14, a fluid source 16, and a vacuum
source 18.
[0057] As best shown in FIGS. 7A-7D, the introducer sheath 12
generally comprises an elongated sheath body 20 having a proximal
end 22, a distal end 24, and a lumen 26 extending therebetween. As
will be described in further detail below, the infusion/aspiration
catheter 14 is a purpose-built catheter that functions similarly to
a conventional external ventricular drain (EVD) catheter, but has
two major differences: (1) it can be delivered through the lumen 26
of the introducer sheath 12 (in the same manner as an EVD catheter)
and deployed out the distal end 24 of the elongated sheath body 20
into an anatomical cavity (or clot mass) of interest, but has
multiple lumens to allow simultaneous (or staged) infusion of the
anatomical cavity of interest with a fluid (e.g., to dissolve a
clot with recombinant tissue plasminogen activator (rt-PA)) and
aspiration of the fluid, including the dissolved clot, from the
anatomical cavity of interest; and (2) the distal portion of the
infusion/aspiration catheter 14 expands within the anatomical
cavity of interest to better distribute the infusion/aspiration
functions via multiple fluid ports. Thus, the infusion/aspiration
catheter 14 allows for a greater volume of clot to be treated with
less diffusion resistance, thereby improving the rate of action of
the procedure.
[0058] To this end, the infusion/aspiration catheter 14 generally
comprises an elongate catheter body 28 having a proximal end 30 and
a distal end 32. The elongate catheter body 28 is preferably sized
to be introduced into a patient in a minimally invasive manner,
e.g., through a burr hole (less than one-half inch in diameter) in
the cranium of a patient. The elongate catheter body 28 may be
composed of suitable biocompatible metals, metal alloys, polymers,
metal-polymer composites, and the like, or any other suitable
biocompatible material. The infusion/aspiration catheter 14 further
comprises a plurality of lumens 34 extending through the elongate
catheter body 28 between the proximal end 30 and the distal end 32.
In the illustrated embodiment, the lumens 34 are independent of
each other. That is, the lumens 34 are not in fluid communication
with each other at any point. As will be described in further
detail below, each lumen 34 may be arbitrarily selected to infuse
or aspirate fluid. For the purposes of this specification,
"aspirate" or "aspiration" means that fluid flows from a higher
pressure region to a lower pressure region. However, for the
purposes of illustration, the lumens 34 are shown divided between a
set of infusion lumens 34a and a set of aspiration lumens 34b.
[0059] In the illustrated embodiment, the set of infusion lumens
34a comprises two infusion lumens 34a, and the set of aspiration
lumens 34b comprises a single infusion lumen 34b. In alternative
embodiments, the set of infusion lumens 34a may comprise a single
infusion lumen 34a, and the set of aspiration lumens 34b comprises
two infusion lumens 34b. In other alternative embodiments where the
number of lumens 34 within the elongate catheter body 28 is greater
than three, the set of infusion lumens 34a may comprise a plural
number of infusion lumens 34a, and the set of aspiration lumens 34b
may likewise comprise a plural number of aspiration lumens 34b, or
where the number of lumens 34 within the elongate catheter body 28
is equal to two, the set of infusion lumens 34a may comprise a
single infusion lumen 34a, and the set of aspiration lumens 34b may
likewise comprise a single aspiration lumen 34b, as further
described below with respect to FIG. 11.
[0060] The infusion/aspiration catheter 14 further comprises a
plurality of arms 36 respectively having proximal ends affixed
together at the distal end 32 of the elongate catheter body 28, and
distal ends affixed together at a distal hub 42. The arms 36 may
form a unibody structure with the elongate catheter body 28, and
thus, may be composed of the same material. In the illustrated
embodiment, each of the arms 36 has a lumen 44 (shown in FIG. 7D)
in fluid communication with a respective one of the lumens 34 of
the elongate catheter body 28, such that is a one-to-one
correspondence between the lumens 34 of the elongate catheter body
28 and the arms 36, i.e., each lumen 34 of the elongated catheter
body 28 is dedicated to a respective one of the arms 36. Thus, as
with the lumens 44 in the elongate catheter body 28, each arm 36
can be arbitrarily selected to perform a fluid infusion,
aspiration, or draining function.
[0061] In alternative embodiments, the number of arms 36 may not
equal the number of lumens 34 of the elongate catheter body 28, in
which case, there may not be a one-to-one correspondence between
the between the lumens 34 of the elongate catheter body 28 and the
arms 36. For example, a single lumen 34 of the elongated catheter
body 28 can be in fluid communication with more than one lumen 44
of the respective arms 36, or multiple lumens 34 of the elongate
catheter body 28 may be in fluid communication with a single lumen
44 of a respective arm 36. It is only important that the set of
infusion lumens 34a and the set of aspiration lumens 34b of the
elongated catheter body 28 be independent of each other, such that
simultaneous infusion and aspiration of fluid through the
infusion/aspiration catheter 14 can occur, as described in further
detail below.
[0062] Each of the arms 36 further has at least one fluid port 46
in fluid communication with the lumen 44 of the respective arm 36.
In the illustrated embodiment, each of the arms 36 comprise a
plurality of fluid ports 46 extending along both the outwardly
facing side and the inwardly facing side of the respective arm 36.
This can be accomplished by perforating the entire thickness of the
arm 36 to create two sets of aligned fluid ports 46 respectively
extending along the opposite sides of the arm 36. Alternatively,
the fluid ports 46 extending along the outwardly facing side and
inwardly facing side of each respective arm 36 may be offset from
each other along the length of the respective arm 36.
[0063] In the infusion/aspiration catheter 14 illustrated in FIG.
6, the number of arms 36 equals three, and are equi-distantly
spaced from each other in a circumferential manner (in this case,
spaced 120 degrees from each other), so that the entire anatomical
cavity may be equally infused with fluid, although in alternative
embodiments, the arms 36 may not be equi-distantly spaced from each
other, e.g., to infuse fluid in a particular region or regions of
the anatomical cavity in a more focused manner. Although in the
infusion/aspiration catheter 14 illustrated in FIG. 6, the number
of arms 36 equals three, it should be appreciated that arms 36 can
have any plural number, including two, as further described below
with respect to FIG. 11.
[0064] The arms 36 of the infusion/aspiration catheter 14 are
pre-shaped to expand outward in the absence of an external force.
For example, each of the arms 36 may be a shaped element or may
comprise an embedded shape memory/super-elastic forming element.
Thus, as will be described in further detail below, when the
infusion/aspiration catheter 14 is introduced through the lumen 26
of the introducer sheath 12, the arms 36 will be compressed by the
inward external force exerted by the elongated sheath body 20 onto
the arms 36, such that the arms 36 are straightened into a
low-profile geometry, as best illustrated in FIG. 7B. In contrast,
when the arms 36 are deployed out the distal end 24 of the
elongated sheath body 20, the arms 36 will outwardly expand in the
absence of the external force, thereby placing the arms 36 in an
expanded geometry to fill the anatomical cavity, as best
illustrated in FIG. 7A.
[0065] Referring back to FIG. 6, the infusion/aspiration catheter
14 further comprises connectors 56 (e.g., luer connectors) affixed
to the proximal end 30 of the elongate catheter body 28 in fluid
communication with the lumens 34 of the elongate catheter body 28.
In this embodiment, the connectors 56 are separate and
free-floating, although in alternative embodiments, the
infusion/aspiration catheter 14 may comprise a unitary manifold (or
handle) 58 comprising the connectors 56, as illustrated in FIG. 8.
Irrespective of whether the connectors 56 are free-floating or
integrated into a manifold 58, in the illustrated embodiment, the
number of connectors 56 equals the number of lumens 34 of the
elongated catheter body 28 (three, in the embodiment illustrated in
FIG. 6), and are thus, fluidly coupled to the lumens 34 in a
dedicated manner. Optionally, a valved switched manifold may be
used as well, in which case, the lumens 34 of the elongate catheter
body 28 may be switched to either the aspiration or infusion
manifold, and therefore, only two connectors 56 are needed.
[0066] In the illustrated embodiment, the connectors 56 are divided
between two infusion connectors 56a, which corresponds to the two
infusion lumens 34a, and a single aspiration connector 56b, which
corresponds to the single aspiration lumen 34b.
[0067] That is, the two infusion connectors 56a are respectively in
fluid communication with the two infusion lumens 34a of the
elongate catheter body 28, and the aspiration connector 56b is in
fluid communication with the aspiration lumen 34b of the elongate
catheter body 28. Of course, in the alternative embodiment where
two of the lumens 34 are aspiration lumens 34b, and the remaining
lumen 34 is a single infusion lumen 34a, a single infusion
connector 56a may be in fluid communication with the single
infusion lumen 34a, and two aspiration connectors 56b may be
respectively in fluid communication with the two aspiration lumens
34b.
[0068] The fluid source 16 may, e.g., take the form of a standard
hospital saline bag, and the vacuum source 18 may take the form of
a vacuum bottle, a syringe, a vacuum pump, or other suitable type
of vacuum source. For the purposes of this specification, "vacuum"
means a region of lower pressure relative to an inlet pressure. A
conventional fluid control system (not shown), including a pump and
valves, may be used to control the flow of fluid from the fluid
source 16 into the infusion/aspiration catheter 14, and the flow of
fluid from the infusion/aspiration catheter 14 into the vacuum
source 18. Exemplary fluid control systems are described in U.S.
patent application Ser. No. 15/480,354, which is expressly
incorporated herein by reference. The fluid source 16 is connected
to the two infusion connectors 56a respectively leading to the two
infusion lumens 34a within the elongate catheter body 28, whereas
the vacuum source 18 is connected to the aspiration connector 56b
leading to the aspiration lumen 34b within the elongate catheter
body 28. Thus, the fluid source 16 is fluidly coupled to the lumens
44, and thus the fluid ports 46, of two of the arms 36, whereas the
vacuum source 18 is fluidly coupled to the lumen 44, and thus the
fluid ports 46, of the remaining arm 36. Extension tubing 60 may
optionally be used to couple the fluid source 16 and vacuum source
18 to the respective infusion connectors 56a and aspiration
connectors 56b.
[0069] It should be appreciated that, although the number of
connectors 56 have been described as being equal to the number of
lumens 34 of the elongate catheter body 28, such that the
connectors 56 can be in respective fluid communication with these
lumens 34 in a dedicated manner, the number of connectors 56 may
alternatively be less than the number of lumens 34 of the elongate
catheter body 28. For example, a single infusion connector 56a can
be in fluid communication with the two infusion lumens 34a of the
elongate catheter body 28, and a single aspiration connector 56b
can be in fluid communication with the aspiration lumen 34b of the
elongate catheter body 28.
[0070] It should also be appreciated that the designation of any
particular connector 56 as an infusion connector 56a or an
aspiration connector 56b, and thus the designation of any
particular lumen (or lumens) 34 of the elongate catheter body 28 as
either an infusion lumen (or lumens) 34a or an aspiration lumen (or
lumens) 34b, may be arbitrary in that it depends on whether the
fluid source 16 or the aspiration pump 18 is connected to that
particular connector 56. That is, if the fluid source 16 is
connected to a particular connector 56, that connector 56 will be
an infusion connector 56a, and the lumen (or lumens) 34 of the
elongate catheter body 28 in fluid communication with that
connector 56a will be an infusion lumen (or lumens) 34a. Likewise,
if the vacuum source 18 is connected to a particular connector 56,
that connector 56 will be an aspiration connector 56b, and the
lumen (or lumens) 34 of the elongate catheter body 28 in fluid
communication with that connector 56b will be an aspiration lumen
(or lumens) 34b.
[0071] It should also be appreciated that, by not connecting the
fluid source 16 or the vacuum source 18 to any of the particular
connectors 56, each of these connectors 56 can function as a
drainage connector, and thus, any of the lumen (or lumens) 34 of
the elongated catheter body 28 in fluid communication with that
connector 56 can function as a drainage lumen. As such, the
infusion/aspiration catheter 14, at any particular time, can also
serve as a drainage catheter, with the expanded arms 36 associated
with such drainage lumen(s) 34 advantageously providing more
drainage locations, in addition to more infusion and aspiration
locations for the infusion/aspiration functions.
[0072] Having described the structure and operation of the
infusion/aspiration system 10, one method 100 of operating it to
treat an anatomical cavity 82 of a patient will now be described
with respect to FIG. 9, as well as FIGS. 10A-10D. In this exemplary
method, the anatomical cavity 82 is a ventricle within the cranium
84 of the patient, and the patient 80 has suffered a hemorrhagic
stroke of the brain 80 (i.e., an ICH), resulting in a clot 86
within the ventricle 82, such that the treatment of the patient
involves infusing fluid comprising rt-PA into the ventricle 82 to
dissolve the clot 86, and the rt-PA fluid, along with the dissolved
clot 86, is aspirated out from the ventricle 82.
[0073] To this end, the method 100 comprises introducing the
introducer sheath 12 into the ventricle 82 via a bore hole 88
conventionally formed through the cranium 84 (step 102) (see FIG.
10A). The introducer sheath 12 may be tracked over an image-guide
access probe along a pre-determined non-linear path to minimize
potential damage to eloquent tissue. Next, the infusion/aspiration
catheter 14 is introduced into the lumen 26 of the introducer
sheath 12, such that the introducer sheath 12 applies an external
force to the arms 36 of the infusion/aspiration catheter 14 (shown
partially in phantom), thereby straightening the arms 36 out into a
low-profile geometry (step 104) (see FIG. 10B).
[0074] Next, the arms 36 of the infusion/aspiration catheter 14 are
deployed from the distal end 24 of the introducer sheath 12 into
the ventricle 82, such that the external force is released from the
arms 36, thereby allowing the arms 12 to expand outward into an
expanded geometry (step 106) (see FIG. 10C). This can be
accomplished by, e.g., pushing the infusion/aspiration catheter 14
in the distal direction while maintaining the same position of the
introducer sheath 12, or pulling the introducer sheath 12 in the
proximal direction while maintaining the same position of the
infusion/aspiration catheter 14. Next, the fluid source 16 and the
vacuum source 18 are connected to the respective infusion
connector(s) 56a and aspiration connector(s) 56b of the
infusion/aspiration catheter 14 (step 108). Although this step is
illustrated as occurring after deployment of the arms 36 into the
ventricle 82, this step can occur any time prior to the
infusion/aspiration process, including prior to introduction of the
introducer sheath 12 into the ventricle 82.
[0075] Fluid comprising rt-PA is then simultaneously infused into
and aspirated from the ventricle 82 (step 110) (see FIG. 10D). That
is, rt-PA fluid will flow from the fluid source 16 into the
infusion connector(s) 56a, through the two infusion lumens 34a
within the elongate catheter body 28, through the lumens 44, and
out the fluid ports 46, of two of the arms 36, thereby dissolving
the clot 86, and simultaneously, the rt-PA fluid and any dissolved
clot 86, will flow into the fluid ports 46, and through the lumen
44, of the remaining arm 36, through the aspiration lumen 34b
within the elongate catheter body 28, out of the aspiration
connector(s) 56b, and into the vacuum source 18. Alternatively,
other forms of treatment, which may include or not include the
administration of rt-PA, may be administered via the lumens 44 of
the elongated catheter body 28. Such alternative treatments can,
e.g., include saline lavage, which removes unwanted potentially
toxic substances, which may arise due to the presence of the clot,
and could be the primary cause of tissue damage; introduction of
hyperosmotic solution to help reduce local edema; introduction of
some unknown therapeutic agent that "fixes brain," etc.
[0076] The method 100 may optionally comprise draining the fluid by
disconnecting one or both of the fluid source 16 and aspiration
pump 18 from one or more of the connectors 56. That is, fluid will
drain into the fluid ports 46, and through the lumen(s) 44, of the
arm(s) 36, through the lumen(s) 34 within the elongate catheter
body 28, out of the connector(s) 56, and into a basin under
atmospheric pressure. Optionally, an automated system may be used
to infuse, aspirate, and/or drain according to a predetermined
schedule or in response to a measured input, such as the patient
intracranial pressure (ICP) or the static pressure measured from
the catheter body 28 (which may be a direct measure of the
ICP).
[0077] After the procedure is completed (i.e., the clot 86 has been
completely (or sufficiently) evacuated from the ventricle 82), the
arms 36 of the infusion/aspiration catheter 14 can be proximally
withdrawn into the introducer sheath 12 or the introducer sheath 12
can be distally displaced to re-sheath the arms 36, such that the
introducer sheath 12 again applies an external force to the arms 36
of the infusion/aspiration catheter 14, thereby straightening the
arms 36 back out into a low-profile geometry (step 112). The
introducer sheath 12, along with the infusion/aspiration catheter
14, can then be removed from the patient (step 114).
[0078] Referring now to FIG. 11, an infusion/aspiration system 10'
constructed in accordance with another embodiment of the disclosed
inventions will now be described. As best shown in FIGS. 12A-12C,
the infusion/aspiration system 10' is similar to the
infusion/aspiration system 10 illustrated in FIG. 6, with the
exception that it comprises an infusion/aspiration catheter 14'
that comprises only two arms 36. In this embodiment, the two arms
36 are circumferentially spaced from each other by one hundred
eighty degrees, although the two arms 36 may be spaced from each
other at an angle different from one hundred eight degrees, e.g.,
to focus infusion of the fluid in only one region of the anatomical
cavity.
[0079] In this embodiment, the set of infusion lumens 34a comprises
a single infusion lumen 34a, and the set of aspiration lumens 34b
likewise comprises a single infusion lumen 34b. In the illustrated
embodiment, the lumen 44 of each of the arms 36 in fluid
communication with a respective one of the lumens 34 of the
elongate catheter body 28, such that is a one-to-one correspondence
between the lumens 34 of the elongate catheter body 28 and the arms
36, i.e., each lumen 34 of the elongated catheter body 28 is
dedicated to a respective one of the arms 36.
[0080] In alternative embodiments, the number of arms 36 may not
equal the number of lumens 34 of the elongate catheter body 28, in
which case, there may not be a one-to-one correspondence between
the between the lumens 34 of the elongate catheter body 28 and the
arms 36. For example, multiple lumens 34 of the elongate catheter
body 28 may be in fluid communication with a single lumen 44 of a
respective arm 36. Again, it is only important that the set of
infusion lumens 34a and the set of aspiration lumens 34b of the
elongated catheter body 28 be independent of each other, such that
simultaneous infusion and aspiration of fluid through the
infusion/aspiration catheter 14 can occur, as described in further
detail below.
[0081] A single infusion connector 56a and a single aspiration
connector 56b are affixed to the proximal end 30 of the elongate
catheter body 28 in fluid communication with the respective
infusion lumen 34a and aspiration lumen 34b of the elongate
catheter body 28. In the embodiment illustrated in FIG. 11, the
connectors 56 are separate and free-floating, although in
alternative embodiments, the infusion/aspiration catheter 14' may
comprise a unitary manifold (similar to the manifold 58 illustrated
in FIG. 8) comprising the connectors 56. Irrespective of whether
the connectors 56 are free-floating or integrated into a manifold,
the fluid source 16 is connected to the infusion connector 56a
leading to the infusion lumen 34a within the elongate catheter body
28, whereas the vacuum source 18 is connected to the aspiration
connector 56b leading to the aspiration lumen 34b within the
elongate catheter body 28. Thus, the fluid source 16 is fluidly
coupled to the lumens 44, and thus the fluid ports 46, of one arm
36, whereas the vacuum source 18 is fluidly coupled to the lumen
44, and thus the fluid ports 46, of the remaining arm 36.
[0082] In the infusion/aspiration catheter 14' illustrated in FIG.
11, instead of, or in addition to, pre-shaping the arms 36 to
expand outward in the absence of an external force, the
infusion/aspiration catheter 14' further comprises an actuation
wire 48 slidably disposed within an additional lumen (not shown)
within the elongated catheter body 28, as best shown in FIGS.
12A-12C. The actuation wire 48 (best shown in FIG. 12A) has a
distal end affixed to the distal hub 42 of the elongated catheter
body 28 and a proximal end extending out of the proximal end 30 of
the elongated catheter body 28 for manipulation by a physician to
alternately place the arms 36 between a low-profile geometry and an
expanded geometry. That is, by proximally displacing the actuation
wire 48 within the lumen (not shown) relative to the elongate
catheter body 28, the arms 36 will expand outward into the expanded
geometry (see FIG. 12A), and by distally displacing the actuation
wire 48 within the lumen relative to the elongate catheter body 28,
the arms 36 will straighten back out into the low-profile geometry
(see FIG. 12B).
[0083] Having described the structure and operation of the
infusion/aspiration system 10', another method 100' of operating it
to treat the anatomical cavity 82 of a patient 80 will now be
described with respect to FIG. 13, as well as FIGS. 14A-140. As
with the previous exemplary method 100, in this method 100', the
anatomical cavity 82 is a ventricle within the cranium 84 of the
patient 80, and the patient 80 has suffered a hemorrhagic stroke,
resulting in a clot 86 within the ventricle 82, such that the
treatment of the patient 80 involves infusing fluid comprising
rt-PA, into the ventricle 82 to dissolve the clot 86, and the rt-PA
fluid, along with the dissolved clot 86, is aspirated out from the
ventricle 82.
[0084] To this end, the method 100' comprises introducing the
introducer sheath 12 into the ventricle 82 via a bore hole 88
conventionally formed through the cranium 84 (step 102') (see FIG.
14A). The introducer sheath 12 may be tracked over an image-guide
access probe along a pre-determined non-linear path to minimize
potential damage to eloquent tissue. Next, the infusion/aspiration
catheter 14 is introduced into the lumen 26 of the introducer
sheath 12, while the actuation wire 48 is displaced distally within
the additional lumen (not shown) relative to the elongate catheter
body 28 to straighten the arms 36 into the low-profile geometry
(step 104') (see FIG. 14B). Next, the arms 36 of the
infusion/aspiration catheter 14 are deployed from the distal end 24
of the introducer sheath 12 into the ventricle 82, and the
actuation wire 48 is displaced proximally within the additional
lumen relative to the elongate catheter body 28 to expand the arms
36 outward into the expanded geometry (step 106') (see FIG. 14C).
Next, the fluid source 16 and the vacuum source 18 are connected to
the respective infusion connector 56a and aspiration connector 56b
of the infusion/aspiration catheter 14 (step 108').
[0085] Fluid comprising rt-PA (or another therapeutic solution) is
then simultaneously infused into and aspirated from the ventricle
82 (step 110) (see FIG. 14D). That is, rt-PA fluid will flow from
the fluid source 16 into the infusion connector 56a, through the
single infusion lumen 34a within the elongate catheter body 28,
through the lumen 44, and out the fluid ports 46, of one of the
arms 36, thereby dissolving the clot 86, and simultaneously, the
rt-PA fluid and any dissolved clot 86, will flow into the fluid
ports 46, and through the lumen 44, of the remaining arm 36,
through the aspiration lumen 34b within the elongate catheter body
28, out of the aspiration connector 56, and into the vacuum source
18.
[0086] The method 100' may optionally comprise aspirating by
draining the fluid by disconnecting one or both of the fluid source
16 and aspiration pump 18 from one or more of the connectors 56.
That is, fluid will drain into the fluid ports 46, and through the
lumen(s) 44, of the arm(s) 36, through the lumen(s) 34 within the
elongate catheter body 28, out of the connector(s) 56, and into a
basin under atmospheric pressure (or optionally using an automated
system to infuse, aspirate, and/or drain).
[0087] After the procedure is completed, the actuation wire 48 is
displaced distally within the additional lumen relative to the
elongate catheter body 28 to straighten the arms 36 back out into
the low-profile geometry (step 112'), and the arms 36 of the
infusion/aspiration catheter 14 can be proximally withdrawn into
the introducer sheath 12 or the introducer sheath 12 can be
distally displaced to re-sheath the arms 36. Alternatively, the
elongate catheter body 28 can be retracted directly into the
introducer sheath 12, with the actuation wire 48 left free to slide
distally as the elongated catheter body 28 is resheathed into the
introducer sheath 12. The introducer sheath 12, along with the
infusion/aspiration catheter 14, can then be removed from the
patient (step 114').
[0088] Referring now to FIG. 15, an infusion/aspiration system 10''
constructed in accordance with still another embodiment of the
disclosed inventions will now be described. The infusion/aspiration
system 10'' is similar to the infusion/aspiration system 10'
illustrated in FIG. 6, with the exception that it comprises an
infusion/aspiration catheter 14'' that has a central aspiration
lumen 34b extending through the elongated catheter body 28 between
the proximal end 30 and the distal end 32, with the other three
lumens 34b serving as infusion lumens that circumferentially
surround the aspiration lumen 34b, as best illustrated in FIG. 16.
The aspiration lumen 34b terminates in a distal fluid port 62 at
the distal end 32 of the elongate catheter body 28 between the
proximal ends of the arms 36. In the embodiment illustrated in FIG.
16, the central aspiration lumen 34b has a cross-sectional area
greater than the cross-section area of each of the surrounding
infusion lumens 34a, thereby lending itself well to aspiration.
[0089] In the same manner described above with respect to the
infusion/aspiration catheter 14' in FIG. 6, the connectors 56 are
affixed to the proximal end 30 of the elongate catheter body 28 in
fluid communication with the lumens 34 of the elongate catheter
body 28, and can be free-floating, as illustrated in FIG. 15, or
may be incorporated into a unitary manifold 58 in a similar manner
illustrated in FIG. 8. The number of connectors 56 equals the
number of lumens 34 of the elongated catheter body 28 (four, in the
embodiment illustrated in FIG. 15), and are thus, fluidly coupled
to the lumens 34 in a dedicated manner. Alternatively, a single
connector 56 and a single lumen 34 of the elongated catheter body
28 may be fluidly coupled to the lumens 44 of the three arms
36.
[0090] In the illustrated embodiment, the connectors 56 are divided
between three infusion connectors 56a, which corresponds to the
three surrounding infusion lumens 34a, and a single aspiration
connector 56b, which corresponds to the single central aspiration
lumen 34b. That is, the three infusion connectors 56a are
respectively in fluid communication with the three infusion lumens
34a of the elongate catheter body 28, and the aspiration connector
56b is in fluid communication with the aspiration lumen 34b of the
elongate catheter body 28. Of course, just as with the
infusion/aspiration catheter 10 of FIG. 6, the designation of any
particular connector 56 as an infusion connector 56a or an
aspiration connector 56b, and thus the designation of any
particular lumen (or lumens) 34 of the elongate catheter body 28 as
either an infusion lumen (or lumens) 34a or an aspiration lumen (or
lumens) 34b, may be arbitrary in that it depends on whether the
fluid source 16 or the aspiration pump 18 is connected to that
particular connector 56.
[0091] The fluid source 16 is connected to the three infusion
connectors 56a respectively leading to the three infusion lumens
34a within the elongate catheter body 28 (or a single infusion
connector leading to a single infusion lumen within the elongate
catheter body 28), whereas the vacuum source 18 is connected to the
aspiration connector 56b leading to the aspiration lumen 34b within
the elongate catheter body 28. Thus, the fluid source 16 is fluidly
coupled to the lumens 44, and thus the fluid ports 46, of the three
arms 36, whereas the vacuum source 18 is fluidly coupled to the
lumen 44, and thus the distal fluid port 62 between the proximal
ends of the arms 36.
[0092] It should be appreciated that, although the number of
connectors 56 have been described as being equal to the number of
lumens 34 of the elongate catheter body 28, such that the
connectors 56 can be in respective fluid communication with these
lumens 34 in a dedicated manner, the number of connectors 56 may
alternatively be less than the number of lumens 34 of the elongate
catheter body 28. For example, a single infusion connector 56a can
be in fluid communication with the three surrounding infusion
lumens 34a of the elongate catheter body 28, and a single
aspiration connector 56b can be in fluid communication with the
central aspiration lumen 34b of the elongate catheter body 28.
[0093] It should also be appreciated that, just as with the
embodiment illustrated in FIG. 6, the designation of any particular
connector 56 as an infusion connector 56a or an aspiration
connector 56b, and thus the designation of any particular lumen (or
lumens) 34 of the elongate catheter body 28 as either an infusion
lumen (or lumens) 34a or an aspiration lumen (or lumens) 34b, may
be arbitrary in that it depends on whether the fluid source 16 or
the aspiration pump 18 is connected to that particular connector
56. That is, if the fluid source 16 is connected to a particular
connector 56, that connector 56 will be an infusion connector 56a,
and the lumen (or lumens) 34 of the elongate catheter body 28 in
fluid communication with that connector 56a will be an infusion
lumen (or lumens) 34a. Likewise, if the vacuum source 18 is
connected to a particular connector 56 that connector 56 will be an
aspiration connector 56b, and the lumen (or lumens) 34 of the
elongate catheter body 28 in fluid communication with that
connector 56b will be an aspiration lumen (or lumens) 34b.
[0094] Furthermore, in an alternative embodiment, the number of
lumens 34 of the elongate catheter body 28 may not match the number
of lumens 44 of the arms 36. For example, it may be advantageous to
have only one infusion lumen 34a that is in fluid communication
with the three lumens 44 of the arms 36 via a coupling at the
proximal ends or the distal ends of the arms 36. In this manner,
the cross-sectional size of the aspiration lumen 34b may be
maximized. Furthermore, in an optional embodiment where the
aspiration lumen 34b is large enough to be capable of ingesting
large clot masses, and thus, also being capable to be clogged, the
infusion/catheter 10'' may comprise a maceration tool (not shown),
e.g., a rotary cutter/impeller, ultrasound probe, reciprocating
wire, etc., that resides in the aspiration lumen 34b.
[0095] The method of operating the infusion/catheter system 10'' is
similar to the operation of the infusion/catheter system 10 of FIG.
6 (see FIGS. 10A-10D), with the exception that the previously
infused rt-PA fluid and dissolved clot 86 will flow into the distal
fluid port 62 at the distal end 32 of the elongate catheter body 28
(instead of into the fluid ports 46 of the arm(s) 36, through the
central aspiration lumen 34b within the elongate catheter body 28,
out of the aspiration connector 56b, and into the vacuum source
18.
[0096] Referring now to FIG. 17, an infusion/aspiration system 10''
constructed in accordance with yet another embodiment of the
disclosed inventions will now be described. The infusion/aspiration
system 10'' is similar to the infusion/aspiration system 10''
illustrated in FIG. 15, with the exception that the arms 36 of the
infusion/aspiration catheter 14'' are made smaller to better serve
as a filter to prevent, or at least minimize, aspiration of tissue
into the distal fluid port 62 of the elongate catheter body 28, as
best illustrated in FIG. 18. The infusion/aspiration catheter 14''
further optionally comprises a rigid stylet 64 removably disposed
within the central aspiration lumen 34b of the elongate catheter
body 28. The distal hub 42 of the infusion/aspiration catheter 14'
comprises an aperture 66 through which the rigid stylet 64 is
disposed to straighten the arms 36 out into a low-profile geometry.
Thus, as it will be described in further detail below, the rigid
stylet 64 may aid placement of the infusion/aspiration catheter
14'' within the anatomical cavity, with or without the use of the
introducer sheath 12. The rigid stylet 64 may be removed from the
infusion/aspiration catheter 14'', so that the central aspiration
lumen 34b may subsequently be used to aspirate fluid from the
anatomical cavity.
[0097] Having described the structure and operation of the
infusion/aspiration system 10'', one method 100'' of operating it
to treat an anatomical cavity 82 of a patient 80 will now be
described with respect to FIG. 19, as well as FIGS. 20A-20D. As
with the previous exemplary method 100, in this method 100'', the
anatomical cavity 82 is a ventricle within the cranium 84 of the
patient 80, and the patient 80 has suffered a hemorrhagic stroke,
resulting in a clot 86 within the ventricle 82, such that the
treatment of the patient 80 involves infusing fluid comprising
rt-PA, into the ventricle 82 to dissolve the clot 86, and the rt-PA
fluid, along with the dissolved clot 86, is aspirated out from the
ventricle 82.
[0098] This method 100'' does not require the use of an introducer
sheath 12, and therefore, such introducer sheath 12 is not
introduced into the ventricle 82. Instead, the rigid stylet 64 is
inserted through the central aspiration lumen 34b of the
infusion/aspiration catheter 14'', and then the distal end of the
rigid stylet 64 is introduced through the aperture 66 of the distal
hub 42 to straighten the arms 12 into the low-profile geometry
(step 102'') (see FIG. 20A). Next, the infusion/aspiration catheter
14'', along with the rigid stylet 64, is introduced into the
ventricle 82 through the conventional bore hole 88 formed through
the cranium 84 (step 104''') (see FIG. 20B). Next, the rigid stylet
64 is removed from the central aspiration lumen 34b of the
infusion/aspiration catheter 14'', thereby allowing the arms 12 to
expand outward into the expanded geometry (step 106'') (see FIG.
20C). Next, the fluid source 16 and the vacuum source 18 are
connected to the respective infusion connector(s) 56a and
aspiration connector 56b of the infusion/aspiration catheter 14
(step 108'').
[0099] Fluid comprising rt-PA (or other therapeutic solution) is
then simultaneously infused into and aspirated from the ventricle
82 (step 110'') (see FIG. 20D). That is, rt-PA fluid will flow from
the fluid source 16 into the infusion connector(s) 56a, through the
three infusion lumens 34a within the elongate catheter body 28,
through the lumens 44, and out the fluid ports 46, of the three
arms 36, thereby dissolving the clot 86, and simultaneously, the
rt-PA fluid and any dissolved clot 86, will flow into the distal
fluid port 80, through the central aspiration lumen 34b, within the
elongate catheter body 28, out of the aspiration connector 56b, and
into the vacuum source 18.
[0100] The method 100'' may optionally comprise aspirating by
draining the fluid by disconnecting one or both of the fluid source
16 and aspiration pump 18 from one or more of the connectors 56.
That is, fluid will drain into the fluid ports 46, and through the
lumen(s) 44, of the arm(s) 36, and/or into the distal port 80,
through the lumen(s) 34 within the elongate catheter body 28, out
of the connector(s) 56, and into a basin under atmospheric pressure
(or optionally using an automated system to infuse, aspirate,
and/or drain).
[0101] After the procedure is completed, the rigid stylet 64 is
reinserted through the central aspiration lumen 34b of the
infusion/aspiration catheter 14'' until the distal end of the rigid
stylet 64, and then the distal end of the rigid stylet 64 is
introduced through the aperture 66 of the distal hub 42 to
straighten the arms 12 into the low-profile geometry. The
infusion/aspiration catheter 14 can then be removed from the
patient.
[0102] Although the embodiments described herein lend themselves
well to the simultaneous infusion and aspiration of fluid into and
out of an anatomical cavity, it should be appreciated that in some
circumstances, such simultaneous infusion and aspiration of fluid
may not be needed. In this case, the infusion and aspiration of the
fluid into and out of the anatomical cavity can be staged (i.e.,
performed serially). For example, with respect to the
infusion/aspiration catheters 10, 10', and 10'', all three lumens
34 of the elongated catheter body 28 can be used as infusion lumens
to deliver the rt-PA (or other therapeutic solution) into the
anatomical cavity, and then all three lumens 34 of the elongated
catheter body 28 can be used as aspiration lumens to aspirate the
rt-PA (or other therapeutic solution) from the anatomical cavity.
Thus, all of the lumens 34 may be configured for infusion at once,
and likewise, all of the lumens 34 may be configured for aspiration
at once. In this manner, infusion out of the lumens 44 of all three
of the arms 36 will advantageously deliver the rt-PA to a larger
more spread out region. The lumens 34 may also be switched between
aspiration and infusion into any configuration at will or via an
automated control system. In this case, a single connector 56 can
be affixed to the proximal end 30 of the elongate catheter body 28
in fluid communication with the lumens 34 of the elongate catheter
body 28, such that the fluid source 16 can be connected to the
single connector 56, and after the infusion process is completed,
the aspiration pump 18 can be connected to the same connector
56.
[0103] Although particular embodiments of the disclosed inventions
have been shown and described, it will be understood that it is not
intended to limit the disclosed inventions to the preferred
embodiments, and it will be obvious to those skilled in the art
that various changes and modifications may be made without
departing from the scope of the disclosed inventions as defined by
the claims.
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