U.S. patent application number 14/743652 was filed with the patent office on 2016-02-25 for devices and systems for access and navigation of cerebrospinal fluid space.
The applicant listed for this patent is Minnetronix, Inc.. Invention is credited to Abhi Vase.
Application Number | 20160051801 14/743652 |
Document ID | / |
Family ID | 55347377 |
Filed Date | 2016-02-25 |
United States Patent
Application |
20160051801 |
Kind Code |
A1 |
Vase; Abhi |
February 25, 2016 |
Devices and Systems for Access and Navigation of Cerebrospinal
Fluid Space
Abstract
The present disclosure relates to accessing, removing,
exchanging and recirculating cerebrospinal fluid (CSF). Devices,
systems and methods disclosed herein are used to safely and
efficiently navigate the space at and around the brain and spinal
cord where the CSF flows through the body, also known as the CSF
space.
Inventors: |
Vase; Abhi; (Los Altos
Hills, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Minnetronix, Inc. |
St. Paul |
MN |
US |
|
|
Family ID: |
55347377 |
Appl. No.: |
14/743652 |
Filed: |
June 18, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62038998 |
Aug 19, 2014 |
|
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|
Current U.S.
Class: |
604/8 |
Current CPC
Class: |
A61B 5/00 20130101; A61M
25/0045 20130101; A61M 2025/1079 20130101; A61M 25/0068 20130101;
A61M 25/1011 20130101; A61M 25/0067 20130101; A61M 27/006 20130101;
A61B 17/12 20130101; A61M 25/0053 20130101; A61M 25/0097 20130101;
A61M 25/0041 20130101; A61M 2025/0059 20130101; A61B 17/221
20130101; A61M 25/0026 20130101; A61B 2017/2215 20130101; A61M
25/0043 20130101; A61M 2025/0042 20130101; A61B 2090/064 20160201;
A61M 2025/0031 20130101; A61M 2210/0693 20130101; A61M 25/0032
20130101; A61B 2017/22034 20130101; A61M 25/003 20130101; A61M
25/007 20130101; A61B 2017/22051 20130101; A61M 2025/0002 20130101;
A61M 2025/0681 20130101; A61M 2205/3331 20130101 |
International
Class: |
A61M 27/00 20060101
A61M027/00; A61M 25/00 20060101 A61M025/00; A61M 25/01 20060101
A61M025/01 |
Claims
1. A system for access and navigation of a cerebrospinal fluid
(CSF) space, the system comprising an introducer sheath configured
to access and align with the cerebrospinal fluid space; an
introducer coupled to a proximal end of the introducer sheath; and
a catheter having multiple lumens that is configured to be received
in the introducer, wherein, the catheter is configured to be
positioned to access and navigate the cerebrospinal fluid space
upon delivery of the catheter through the introducer and the
introducer sheath.
2. The system of claim 1, wherein the introducer is configured to
enable the catheter to make a bend having a radius of between
approximately 0 mm and approximately 10 mm.
3. The system of claim 2, wherein the introducer is configured to
enable the catheter to make a bend having a radius of between
approximately 1 mm and approximately 10 mm.
4. The system of claim 3, wherein the catheter includes a spring
loaded tip in a pre-deployed position during delivery through the
introducer sheath and in a deployed position after exiting the
introducer sheath.
5. The system of claim 1, further comprising at least two
transducers positioned on or about the catheter, wherein at least
one transducer is a pressure sensor and at least one transducer is
a flow sensor.
6. The system of claim 1, wherein the introducer comprises a
plurality of ports, each of the plurality of ports including a
check valve operably associated therewith.
7. The system of claim 1, further comprising a strain relief and
kink resistance feature formed as a sleeve and disposed on the
catheter.
8. The system of claim 7, wherein the strain relief and kink
resistance feature is a coiled wire embedded in a tube constructed
from medical grade catheter material.
9. The system of claim 8, wherein said medical grade catheter
material is flexible.
10. The system of claim 7, wherein the strain relief and kink
resistance feature is a braided wire embedded in a tube constructed
from medical grade catheter material.
11. The system of claim 1, further comprising a plurality of
openings defined within an outer circumferential wall of the
catheter to increase fluid flow through the system.
12. The system of claim 11, wherein the plurality of openings has a
total cross-sectional surface area of at least approximately 0.6
mm.sup.2.
13. The system of claim 11, wherein the plurality of openings is
positioned generally linearly along or parallel to a horizontal
line defined through a central lumen of the catheter.
14. The system of claim 8, wherein the plurality of openings is
positioned in a staggered or symmetrical pattern relative to a
horizontal line defined through a central lumen of the
catheter.
15. The system of claim 1, further comprising a receptacle to
capture and retrieve blood clots within the CSF space upon
deployment from a distal end of the catheter, the receptacle
configured for delivery through the introducer sheath and the
catheter into the CSF space.
16. The system of claim 15 wherein the receptacle comprises a
coiled microwire configured for delivery through the catheter to
capture and retrieve a blood clot within the CSF space.
17. The system of claim 15 wherein the receptacle comprises a
plurality of intertwined microwires configured for delivery through
the catheter to capture and retrieve a blood clot within the CSF
space.
18. The system of claim 15 wherein the receptacle comprises a sieve
coupled to a distal end of a micro-catheter and configured for
delivery through the catheter to capture and retrieve a blood clot
within the CSF space.
19. The system of claim 1, further comprising a positioning device
comprising a plurality of lumens and a plurality of balloons, each
balloon positioned in an individual lumen, each balloon configured
to be in a deflated state during delivery of the positioning device
through the introducer sheath and configured to transition from a
deflated state to an inflated state and back to a deflated state
during advancement into the CSF space.
20. The system of claim 1, wherein the cerebrospinal fluid space is
a space where cerebrospinal fluid flows around a ventricle of the
brain.
21. The system of claim 1, wherein the cerebrospinal fluid space is
a space where cerebrospinal fluid flows around a spinal column.
22. The system of claim 1, further comprising one or more openings
defined within an outer circumferential wall one of an inlet lumen
or an outlet lumen of the catheter to increase fluid flow through
the system.
23. The system of claim 19, wherein at least one of the one or more
openings defined within the outer circumferential wall of the inlet
lumen has a total cross-sectional surface area of less than 0.01
inches.sup.2.
24. The system of claim 19, wherein at least one of the one or more
openings defined within the outer circumferential wall of the
outlet lumen has a total cross-sectional surface area of
approximately 0.01 inches.sup.2.
25. The system of claim 1, wherein the catheter has a length of
between approximately 40 cm and approximately 120 cm.
26. The system of claim 1, wherein the catheter is configured to
bend without kinking or compromising flow within the catheter.
27. The system of claim 26, wherein the catheter is configured to
bend without kinking or compromising flow by comprising a coiled
wire having a coil pitch between approximately 0.01 inches and
approximately 0.03 inches.
28. A method of accessing and navigating a cerebrospinal fluid
(CSF) space, the method comprising introducing an introducer sheath
aligning the introducer sheath with the CSF space; deploying a
catheter having multiple lumens into the introducer sheath through
a multi-port introducer coupled to a proximal end of the introducer
sheath, the catheter having at least two transducers positioned on
or about the catheter, wherein at least one transducer is a
pressure sensor and at least one transducer is a flow sensor;
delivering the catheter through an access site in the CSF space
created by the introducer sheath; and positioning the catheter to
access and navigate the CSF space.
29. The method of claim 28, wherein the CSF space is a space where
cerebrospinal fluid flows around a ventricle of the brain.
30. The method of claim 28, wherein the CSF space is a space where
cerebrospinal fluid flows around a spinal column.
31. The method of claim 28, wherein the catheter has a length of
between approximately 40 cm and approximately 120 cm; and wherein
the catheter comprises an inlet opening and an outlet opening, the
inlet opening and the outlet opening having a spacing of between
approximately 10 cm and approximately 30 cm.
32. The method of claim 28, wherein the multiple lumens comprise a
first lumen defined by an inner wall and a second lumen defined
between the inner wall and an outer wall.
33. The method of claim 32, wherein the inner wall has an inner
diameter of approximately 0.56 mm and an outer diameter of
approximately 0.71 mm and the outer wall has an inner diameter of
approximately 1.32 mm and an outer diameter of approximately 1.689
mm.
34. The method of claim 32, wherein the catheter comprises a coiled
wire having a coil pitch selected to enable the catheter to be
deployed and positioned without kinking or compromising flow within
the catheter and to enable catheter unblocking.
35. The method of claim 34, wherein the coil pitch is between
approximately 0.01 inches and approximately 0.03 inches.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims priority to U.S. Provisional
Application No. 62/038,998, filed on Aug. 19, 2014, entitled
"Devices and Systems for Access and Navigation of Cerebrospinal
Fluid Space, the contents of which are incorporated herein by
reference in its entirety.
TECHNICAL FIELD
[0002] The present disclosure relates to systems, devices and
methods for access and navigation of the cerebrospinal fluid space
surrounding the brain and the spinal column.
BACKGROUND
[0003] Cerebrospinal fluid (CSF) is a generally clear, colorless
fluid that is produced in the ventricles, specifically the choroid
plexuses, in the brain. The choroid plexus produces approximately
500 milliliters of CSF daily in order to accommodate flushing or
recycling of CSF to remove toxins and metabolites, which happens
several times per day. From the choroid plexus, CSF flows slowly
through a channel (canal) into the spinal column, and then into the
body. CSF is found in the space between the pia mater and the
arachnoid mater, known as the subarachnoid space. CSF is also found
in and around the ventricular system in the brain, which is
continuous with the central canal of the spinal cord. In the event
of a stroke or other brain trauma, it can be desirable to remove
the CSF from one location (e.g., the cervical region of the spine,
or a brain ventricle), filter it, and return it to the CSF space at
a second location (e.g., the lumbar region of the spine). U.S. Pat.
No. 8,435,204 provides background relevant to the present
disclosure, and is hereby incorporated by reference in its entirety
for all purposes.
[0004] However, accurate delivery of medical instruments to the CSF
space can be challenging.
[0005] Against this backdrop, the present disclosure was
developed.
[0006] The information included in this Background section of the
specification, including any references cited herein and any
description or discussion thereof, is included for technical
reference purposes only and is not to be regarded subject matter by
which the scope of the invention is to be bound.
SUMMARY
[0007] Aspects of the present disclosure address the aforementioned
needs by providing systems, devices and methods for the access and
navigation of the cerebrospinal fluid space.
[0008] A system for access and navigation of a CSF space is
disclosed. In one aspect, the system includes a curved introducer
sheath having a radius of curvature configured to access and align
with the cerebrospinal fluid space and an introducer coupled to a
proximal end of the curved introducer sheath. In one embodiment,
the introducer may have a plurality of ports, which may have a
valve, such as a check valve, operably associated therewith. The
system also may include a curved catheter, which may have multiple
lumens and which may be configured to be received in the curved
introducer.
[0009] One or more sensors or transducers may be positioned on or
about the catheter. In one embodiment, at least one transducer may
be a pressure sensor and at least one transducer may be a flow
sensor, or one or more transducers may sense both and/or other
properties. Upon delivery of the catheter through the introducer
and the introducer sheath, the catheter is positioned to access and
navigate the cerebrospinal fluid space.
[0010] In some aspects, the curved catheter may include a spring
loaded tip, which may be in a pre-deployed position during delivery
through the introducer sheath and in a deployed position after
exiting the introducer sheath. In some aspects, the system may
include a strain relief and/or kink resistance feature, which may
be formed as a sleeve and disposed on the curved catheter (e.g., at
a failure point of the curved catheter). In some aspects, the
strain relief and kink resistance feature may be a coiled or a
braided wire, which may be embedded in a tube comprising medical
grade catheter material, such as silicone, nylon, polyurethane,
aromatic polyether-based thermoplastic polyurethanes, or polyether
block amide.
[0011] In some aspects, the system may include a plurality of
openings defined within an outer circumferential wall of the
catheter to increase fluid flow through the system. The plurality
of openings may have a suitable total cross-sectional surface area,
for example, at least about 0.6 mm.sup.2. The plurality of openings
may be positioned generally linearly along or parallel to a
horizontal line defined through a central lumen of the catheter.
The plurality of openings may be positioned randomly, or in a
pattern, such as a staggered or symmetrical pattern, relative to a
horizontal line defined through a central lumen of the catheter. In
some aspects, one or more openings are defined within an outer
circumferential wall one of an inlet lumen or an outlet lumen of
the catheter to increase fluid flow through the system. In some
aspects, at least one of the one or more openings defined within
the outer circumferential wall of the inlet lumen has a total
cross-sectional surface area of less than 0.01 in.sup.2. In some
aspects, at least one of the one or more openings defined within
the outer circumferential wall of the outlet lumen has a total
cross-sectional surface area of approximately 0.01 in.sup.2. In
certain implementations, the size of the lumen, material thickness
generally, and/or other configurations of the catheter may be
selected or configured to enhance the catheter's capability to
unblock an opening and/or resist blockages of an opening. For
example, in certain implementations, the inner wall of a lumen may
have an inner diameter of approximately 0.56 mm and an outer
diameter of approximately 0.71 mm, and the outer wall of the lumen
may have an inner diameter of approximately 1.32 mm and an outer
diameter of approximately 1.689 mm, however, other configurations
are possible.
[0012] In some aspects, the system may further include a receptacle
to capture and retrieve blood clots within the CSF space. In some
embodiments, the receptacle may include a coiled microwire
configured for delivery through the catheter to capture and
retrieve a blood clot within the CSF space. In some embodiments,
the receptacle comprises a plurality of intertwined microwires
configured for delivery through the catheter to capture and
retrieve a blood clot within the CSF space. In some embodiments,
the receptacle may include a sieve coupled to a distal end of a
micro-catheter and configured for delivery through the catheter to
capture and retrieve a blood clot within the CSF space.
Combinations of these and/or other structures also may be used.
[0013] In some aspects, the system may include a positioning
device. In one embodiment, a positioning device may comprise a
plurality of lumens and a plurality of balloons. Each balloon may
be positioned in an individual lumen in a deflated state during
delivery of the positioning device through the curved introducer
sheath. The balloon may transition from a deflated state to in an
inflated state and back to a deflated state during advancement of
the system into the CSF space.
[0014] In some aspects, the cerebrospinal fluid space is a space
where cerebrospinal fluid flows around in or through a ventricle of
the brain or the cerebrospinal fluid space is a space where
cerebrospinal fluid flows around in or through a spinal column.
[0015] Methods of accessing and navigating a CSF space are
disclosed. One method includes introducing a curved introducer
sheath having a radius of curvature, aligning the introducer sheath
with the CSF space, and deploying a curved catheter having multiple
lumens into the curved introducer sheath through a multi-port
introducer coupled to a proximal end of the curved introducer
sheath. The curved catheter may have one or more transducers
positioned on or about the catheter to detect properties such as
pressure, flow, and other properties. One method includes
delivering the catheter through an access site in the CSF space
created by the curved introducer sheath and positioning the
catheter to access and navigate the CSF space. In some aspects, the
CSF space is a space where cerebrospinal fluid flows around a
ventricle of the brain. In some aspects, the CSF space is a space
where cerebrospinal fluid flows around a spinal column.
[0016] In certain implementations, the catheter may have a length
of between approximately 40 cm and approximately 120 cm and the
catheter may comprise an inlet opening and an outlet opening. The
inlet opening and the outlet opening may have a spacing of between
approximately 10 cm and approximately 30 cm. In certain
implementations, multiple lumens may comprise a first lumen defined
by an inner wall and a second lumen defined between the inner wall
and an outer wall. The inner wall may have an inner diameter of
approximately 0.56 mm and an outer diameter of approximately 0.71
mm. The outer wall may have an inner diameter of approximately 1.32
mm and an outer diameter of approximately 1.689 mm. In certain
implementations, the catheter comprises a coiled wire having a coil
pitch selected to enable the catheter to be deployed and positioned
without kinking or compromising flow within the catheter and to
enable catheter unblocking. In certain implementations, the coil
pitch may be between approximately 0.01'' and approximately
0.03''.
[0017] This Summary is provided to introduce a selection of
concepts in a simplified form that are further described below in
the Detailed Description. This Summary is not intended to identify
key features or essential features of the claimed subject matter,
nor is it intended to be used to limit the scope of the claimed
subject matter. Other features, details, utilities, and advantages
of the present invention will be apparent from the following more
particular written description of various embodiments of the
invention as further illustrated in the accompanying drawings and
defined in the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] The present disclosure, both as to its organization and
manner of operation, may be understood by reference to the
following description, taken in connection with the accompanying
drawings, in which:
[0019] FIG. 1 depicts aspects of a system for access and navigation
of the cerebrospinal fluid space in accordance with the present
disclosure;
[0020] FIGS. 2 through 4 illustrate various embodiments of an
introducer of the system of FIG. 1;
[0021] FIGS. 5 and 6 illustrate one embodiment of a catheter of the
system of FIG. 1;
[0022] FIGS. 7 through 9 illustrate some embodiments of a catheter
of the system of FIG. 1 having spring-loaded tips;
[0023] FIG. 10 illustrates an embodiment of a catheter of the
system of FIG. 1;
[0024] FIG. 11 illustrates a first, distal portion of the catheter
of FIG. 10;
[0025] FIG. 12 illustrates a second, medial portion of the catheter
of FIG. 10;
[0026] FIG. 13 illustrates an embodiment of a catheter of the
system of FIG. 1;
[0027] FIG. 14 illustrates a first, distal portion of the catheter
of FIG. 13;
[0028] FIG. 15 illustrates a second, medial portion of the catheter
of FIG. 13;
[0029] FIG. 16 illustrates an embodiment of a catheter of the
system of FIG. 1;
[0030] FIG. 17 illustrates a first, distal portion of the catheter
of FIG. 16;
[0031] FIG. 18 illustrates a second, medial portion of catheter of
FIG. 16;
[0032] FIG. 19 illustrates an embodiment of a catheter of the
system of FIG. 1;
[0033] FIG. 20 illustrates a first, distal portion of the catheter
of FIG. 19;
[0034] FIG. 21 illustrates a second, medial portion of the catheter
of FIG. 19;
[0035] FIG. 22 illustrates an embodiment of a catheter of the
system of FIG. 1;
[0036] FIG. 23 illustrates a first, distal portion of the catheter
of FIG. 22;
[0037] FIG. 24 illustrates a second, medial portion of the catheter
of FIG. 22;
[0038] FIG. 25 illustrates an embodiment of a catheter of the
system of FIG. 1;
[0039] FIG. 26 illustrates a first, distal portion of the catheter
of FIG. 25;
[0040] FIG. 27 illustrates a second, medial portion of the catheter
of FIG. 25;
[0041] FIGS. 28 through 31 illustrate several embodiments of a
blood clot removal device of the system of FIG. 1 having a coiled
microwire;
[0042] FIG. 32 illustrates an embodiment of a blood clot removal
device of the system of FIG. 1 having a plurality of intertwined
micro-wires;
[0043] FIG. 33 illustrates an embodiment of a blood clot removal
device of the system of FIG. 1 having a sieve mechanism;
[0044] FIG. 34 illustrates an embodiment of a blood clot removal
device of the system of FIG. 1 having a plurality of
microwires;
[0045] FIGS. 35 through 38 depict an embodiment of a positioning
device with one or more inflatable balloons for use with the system
of FIG. 1;
[0046] FIGS. 39 and 40 depict an embodiment of a dual lumen
catheter having proximal and distal ends with varying diameters for
use with the system of FIG. 1;
[0047] FIGS. 41 and 42 depict an embodiment of a dual lumen
catheter having a proximal end with different dimensions than a
distal end of the catheter for use with the system of FIG. 1;
[0048] FIGS. 43 and 44 depict an embodiment of a catheter
configured for use as a peripherally inserted dual lumen central
catheter having an inlet lumen and an outlet lumen and for use with
the system of FIG. 1;
[0049] FIGS. 45 through 47 depict another embodiment of a dual
lumen catheter for use with the system of FIG. 1;
[0050] FIGS. 48 through 50 depict an embodiment of a multi-lumen
catheter for use with the system of FIG. 1 having three inlet
lumens and an outlet lumen;
[0051] FIGS. 51 through 53 depict an embodiment of a multi-lumen
catheter for use with the system of FIG. 1 having two inlet lumens
and an outlet lumen;
[0052] FIGS. 54 and 55 depict another embodiment of a dual lumen
catheter for use with the system of FIG. 1;
[0053] FIGS. 56 and 57 illustrate openings of an inlet lumen and an
outlet lumen, respectively;
[0054] FIGS. 58 and 59 depict a comparison between various
embodiments of the lumens disclosed herein and known lumens;
[0055] FIG. 60 illustrates a Y-connector portion, a proximal
subassembly, and a distal subassembly of a catheter according to
certain implementations;
[0056] FIG. 61 illustrates a sectional view taken from the region
of the catheter of FIG. 60 marked with cutting plane line A-A;
[0057] FIG. 62 illustrates a sectional view taken from the region
of the catheter of FIG. 60 marked with cutting plane line B-B;
[0058] FIG. 63 illustrates an enlarged, detail view of a portion of
the Y-connector of the catheter of FIG. 60;
[0059] FIG. 64 illustrates the location of position markers on a
catheter according to certain implementations;
[0060] FIG. 65 illustrates a sectional view taken from the region
of the catheter of FIG. 64 marked with the cutting plane line
J-J;
[0061] FIG. 66 illustrates a portion of a catheter near the joining
of a proximal subassembly and a distal subassembly according to
certain implementations;
[0062] FIG. 67 illustrates a portion of a proximal subassembly
according to certain implementations;
[0063] FIG. 68 illustrates a detail view of the proximal
subassembly of FIG. 67;
[0064] FIG. 69 illustrates a sectional view taken from the region
of the proximal subassembly of FIG. 67 marked with the cutting
plane line A-A;
[0065] FIG. 70 illustrates a detail view of a portion of the
proximal subassembly of FIG. 68 taken from the view of line
D-D;
[0066] FIG. 71 illustrates a sectional view taken from the region
of the proximal subassembly of FIG. 67 marked with the cutting
plane E-E;
[0067] FIG. 72 illustrates a portion of a distal subassembly
according to certain implementations;
[0068] FIG. 73 illustrates a detailed portion of the distal
subassembly of FIG. 72;
[0069] FIG. 74 illustrates a detailed portion of the distal
subassembly of FIG. 72; and
[0070] FIG. 75 illustrates a sectional view taken from the region
of the distal subassembly of FIG. 72 marked with the cutting plane
A-A.
DETAILED DESCRIPTION
[0071] The present disclosure relates to removal, exchange and
recirculation of cerebrospinal fluid (CSF). Devices, systems and
methods disclosed herein are used to safely and efficiently
navigate the space at and around the brain and spinal cord where
the CSF flows through the body, also known as the CSF space.
Specialized devices and systems are useful and sometimes necessary
to navigate the CSF space due to the difficult points of entry and
exit and the potentially life threatening consequences if a mistake
is made. Increased safety and efficacy reduce time spent in the
surgical suite and potential complications.
[0072] Neuropheresis is the removal of blood from CSF. This and
other therapeutic techniques can be used to treat a number of
neurological diseases or conditions, such as Alzheimer's Disease,
Parkinson's Disease, Huntington's Disease, Amyotrophic Lateral
Sclerosis (ALS), Encephalitis from various causes, Meningitis from
various causes, Guillain Barre Syndrome (GBS), Multiple Sclerosis
(MS), Spinal Cord Injury, Traumatic Brain Injury, cerebral
vasospasm, stroke and other diseases or conditions as described in
previously mentioned U.S. Pat. No. 8,435,204.
[0073] The purification, conditioning, and/or compound removal
schema can be tailored to a specific disease or group of diseases
as suitable, including based on a number of features, such as size,
affinity, biochemical properties, temperature, and other features.
Purification schema may be based on diffusion, size-exclusion,
ex-vivo immunotherapy using immobilized antibodies or antibody
fragments, hydrophobic/hydrophilic, anionic/cationic, high/low
binding affinity, chelators, anti-bacterial, anti-viral,
anti-DNA/RNA/amino acid, enzymatic, and magnetic and/or
nanoparticle-based systems. The system can be adjustable to a broad
range of biologic parameters and flows.
[0074] With regard to a neuropheresis system in particular, the
disclosed system can be used to safely and quickly access the CSF
space with minimal disturbance to the CSF flow. The systems and
devices disclosed herein provide a safe a rapid flow circuit and
provide filtration by reducing the number of red blood cells in the
circuit and providing for blood clot identification and
removal.
[0075] A neuropheresis system should provide for the exchange,
removal, and/or recirculation of CSF, safely and efficiently. The
systems and devices disclosed herein may be used in a neuropheresis
system. Previously described single lumen catheter systems produce
only a local eddy, with minimal mixing and therefore recirculation
of previously processed CSF. Such single lumen systems do not
generate enough mixing to adequately draw or circulate fluid from
the CSF space. The rate of mixing, the amount of new CSF turned
over per minute, and the access provided to turning over the
cranial and spinal CSF volume multiple times using the present
invention results in a much more rapid, efficient, and feasible CSF
processing system that may provide access to up to the entire CSF
system. The system may provide for an adjustable distance between
the inflow and outflow areas, to provide enhanced ability to mix
and circulate CSF.
[0076] The systems and devices disclosed herein can be used to
access the CSF space to remove the CSF from one location (e.g., the
cervical region of the spine, or a brain ventricle), filter or
otherwise treat it, and return it to the CSF space, including at a
second location (e.g., the lumbar region of the spine), safely and
efficiently. In various aspects, the systems and devices disclosed
herein maintain the endogenous intracranial or intraspinal pressure
within a physiological range, for example, from about 5 to about 20
mm Hg or from about 0 to about 10 mm Hg or from about -5 to about
10 mm Hg or from about -5 to about 25 mm Hg. The present system
thus reduces spinal headache, for example, due to hydrocephalus
(abnormal accumulation of CSF in the ventricles of the brain). In
some aspects, the system may include sensors within the catheter or
within the flow circuit to detect clogs or blockages in the system,
thereby providing closed loop pressure control. In various aspects,
the systems and devices disclosed herein also help the system to
perform efficiently by reducing or eliminating recirculating flow
loops. The systems and devices maintain spacing between the inlet
and outlet, for example, between about 10 cm to about 40 cm. In
certain implementations, the spacing is between about 10 cm and
about 30 cm. The inlets and outlets are located in places in the
CSF space so that turning on the pump or otherwise creating
positive or negative pressure in the system will not cause or
encourage tissue being drawn into the catheter. In some aspects,
the inlets and outlets are placed near the lumbar cervical cisterns
to prevent tissue from being drawn into the catheter. In some
aspects, there may also be multiple holes along the inlet and
outlet for redundancy in case there is tissue blocking some number
of holes. In certain implementations, a particular coil pitch of a
coiled wire within the catheter may be selected in order to
facilitate catheter unblocking and/or the ability of the catheter
to resist blockage. In certain aspects, the inlet-outlet spacing
may be selected to be maximized while staying below the level of a
cervical region of a patient. In certain aspects, the inlet-outlet
spacing may be selected based on vertebral spacing. For example,
the spacing may be selected so that the inlet-outlet spacing is
between the lengths of approximately 5 vertebrae and approximately
12 vertebrae. In certain implementations, a spacing of
approximately 10 vertebrae may be selected; however, other
configurations (such as those described elsewhere in the
specification) may be utilized. When designing such spacing, it may
be assumed that a vertebra is approximately 2-3 cm in length,
however, other measurements and designs may be used. In certain
implementations, a particular size, shape, and/or other
configuration of a lumen may be selected to facilitate catheter
unblocking and/or the ability of the catheter to resist blockage.
For example, a proximal outer diameter of a lumen of between
approximately 0.060 inches and approximately 0.070 inches and a
proximal inner diameter of between approximately 0.025 inches and
0.060 inches may be selected; however, other configurations (such
as those described elsewhere in the specification) may be
utilized.
[0077] The disclosed systems and devices are used to access the CSF
space and may be used at any access point in the cervical (C1-C7),
thoracic (T1-T12), or lumbar region (L1-L5) of the vertebral
column. An access site in the cervical region may be used to access
the ventricular system in the brain. In one embodiment, the system
and device are used to access the lumbar region. In some
embodiments, the inlets and outlets are located in places in the
spine such that the drainage process will not cause tissue to be
drawn into the catheter. For example, when a patient is lying on a
table, entry may be made at a suitable angle, such as, for example,
about 90 degrees, to access the spine. A traditional catheter must
be pushed through a 90 degree bend at the L4-L6 region. The
catheters and related delivery devices disclosed herein may be
curved such that they can access and navigate this angled bend more
easily and efficiently.
[0078] For a discussion of the systems and devices that provide
access to and help to navigate the CSF space for CSF filtration,
removal and exchange, reference is now made to FIGS. 1-59.
[0079] FIG. 1 illustrates one embodiment of the disclosed system
and devices for CSF access and navigation. The CSF access and
navigation system 5 includes a curved introducer sheath 20
specifically designed to access the CSF space 15. The system 5 is
shown being introduced into the lumbar region 10 of a patient. The
introducer sheath 20 may be a single lumen, dual-lumen, or
multi-lumen device. In one embodiment, the proximal end 21 of the
introducer sheath 20 may include a multi-port introducer 25, and
each port may have a valve, such as a hemostasis valve or a one way
valve, to prevent CSF or other fluid from passing through the port.
Once the introducer 20 is inserted into the patient, a catheter 30
may be inserted into the introducer 20. The catheter 30 may be
curved, to complement the introducer 20. In some embodiments,
disposed on or within the catheter 30 are sensors 40, such as flow
and/or pressure sensors 40, and/or sensors for other properties,
such as temperature. In some aspects, the system 5 may also include
a separate catheter with a basket or other receptacle at its distal
end to capture and remove debris, such as a blood clot. In some
embodiments, the system 5 also includes a multi-lumen device having
inflatable balloons to advance the catheter 30 into the spinal
canal and the CSF space 15. In some embodiments, balloons 50 may be
co-located with or disposed about the catheter 30 and may be
anchoring balloons 50a or annular balloons 50b. The balloons 50 are
configured to stabilize the catheter during use. In some
embodiments, the balloons may be radiopaque to provide increased
visualization of the catheter 30 within the CSF space.
Curved Introducer Sheath
[0080] FIGS. 2-4 depict various aspects of the curved introducer
sheath 20 with an optional multi-port introducer 25. As can be
understood from FIG. 2, the curved introducer sheath 20 has
dimensions and orientation which align with the CSF space, which
can be difficult to navigate. In one embodiment, the sheath 20 is
made of a polyurethane jacket over a metal or metal alloy core. The
metal core may be a flexible nitinol alloy, to maintain the slight
bend during introduction and navigation, and retain that slight
bend despite repeated use. In certain embodiments, the curved
introducer sheath 20 may be configured to have a bend radius of
between approximately 2 mm and approximately 7 mm. The jacket may
be of a braided construction embedded within silicone, nylon, or
polyurethane. The use of a nitinol core enables the distal end of
the sheath 20 to be more "spring-like" and move back to its
original shape when it is delivered through a hollow tube (e.g., a
Tuohy needle). In one embodiment, the sheath 20 has a generally
hydrophilic distal section 20a to facilitate smooth placement of
the catheter into the lumbar region (e.g., L3/L4). The sheath helps
prevent tracking of blood and tissue into the spinal canal, to
reduce the incidence of blockages when the therapy begins. The
sheath 20 may further enable a 5F or 6F catheter having a length of
approximately 7 cm to approximately 11 cm to be placed above or
below the spinal cord. The distal section includes a shaft region
20b and generally curved tip 20c, which may crescent shaped or
similar to the shape of a hockey stick. The distal section 20a is
between approximately 10 cm to approximately 15 cm in length and
the tip 20c is approximately 2-4 cm in length. The angle between
the shaft region 20b and the tip 20c is approximately 120 degrees.
In certain embodiments a catheter may comprise regions or portions
having different thicknesses, diameters, materials, coils, coil
pitches, and other features and designs to facilitate a particular
bend radius and/or optimal pushability without compromising
safety.
[0081] In use, the introducer sheath 20 may be inserted through or
over a needle (not shown), such as a Tuohy needle, that has
punctured the CSF space 15, for example, the cervical or lumbar
area of the spine. The needle may be removed, leaving the
introducer sheath 20 behind. The introducer sheath 20 may be curved
to guide instruments from outside the body into the CSF space via a
multi-port introducer 25, for example.
Multi-Port Introducer
[0082] An introducer may be used at the proximal end 21 of the
introducer sheath 20. Any suitable introducer may be used, as
desired, including a single-port introducer. As shown in FIGS. 2-4,
in one embodiment, a multi-port introducer 25 may be attached or
coupled to the proximal end 21 of the introducer sheath 20, for
example by a connector 23. The connector 23 may be a Luer-Lock
fitting, such as the Luer-Lok manufactured by Becton, Dickinson and
Company. The multi-port introducer 25 includes a plurality of ports
or openings 26 and a knob 24 or other structure to help with the
steerability of the introducer. The knob may be associated with a
valve, and/or it may help indicate the orientation of the catheter
based on where the location of the end of the curved
sheath/catheter. That is, if the knob is on the same side of the
catheter as the curved tip, then when the catheter is in situ, the
user will know the orientation of the curved tip as indicated by
the knob. The multi-port introducer 25 may be made of any suitable
material, such as an injection-molded plastic. The connector 23 may
be made of nylon, polypropylene, polycarbonate or PVDF, or other
appropriate material. In one embodiment, the
introducer/sheath/peelaway sheath is configured for a 6F catheter
and has a shaft length of about 7 cm to about 11 cm and the
guidewire is about 120 cm to about 180 cm in length which equates
to the length of the catheter outside the body, which is from
approximately 80 cm to approximately 130 cm, plus approximately 40
cm to approximately 60 cm, which is approximately the length of the
catheter in the spine.
[0083] The introducer 25 may include any suitable number of ports.
In one embodiment, the introducer 25 includes four ports 26. In
other embodiments, the introducer 25 includes one port, two ports,
three ports, five ports, six ports or more. Each port 26 includes a
valve 27 or other structure to prevent backflow or fluid from
leaking from the CSF space and out through the port 26. In one
embodiment, the valve 27 is a check valve, a one-way valve, or
non-return valve. The valve 27 may be adapted such that a catheter
or other device may be introduced through the valve 27 without
allowing fluid within the lumen of introducer sheath 20 to escape,
and, conversely, without allowing foreign substances to enter the
lumen of introducer sheath 20. In certain implementations, the
ports 26 and valves 27 may be used to sample fluid at multiple time
points and/or for checking flow/pressure.
[0084] The multi-port introducer 25 may be a manifold or entry
point for catheters, endoscopes, guidewires, flush tubes, and/or
other medical instruments, and the sheath 20 may include a lumen
for passing any of these. Each port may have the same or similar
diameter or may have different diameters. In one embodiment, as
shown in FIG. 3, a four port introducer 25 includes two small
diameter ports 26a, 26b and two larger diameter ports 26c, 26d. The
two smaller diameter ports 26a, 26b may have a diameter of
approximately 0.3 mm to approximately 1 mm and are configured to
receive a medical instrument 28, such as a pressure transducer
and/or flow transducer or sensors or other smaller diameter
instrument. The two larger diameter ports 26c, 26d may have a
diameter of approximately 1 mm to approximately 3 mm and are
configured to receive a medical instrument 28, such as a flow
catheter or other larger diameter instrument. In certain
implementations, the introducer 25 may have a radiused or otherwise
tapered design configured to maintain a good seal with the catheter
to prevent or substantially resist accumulation of debris as well
as fluid leakage back from the catheter.
[0085] In use, the surgeon can attach the multi-port introducer
device 25 to the proximal end 21 of the introducer sheath 20 or the
device 25 may already be attached prior to use. The surgeon can
then use the various ports 26 to insert and/or remove different
medical instruments 28, such as guidewires, cauterizers,
micro-manipulators, sensors, etc. through the introducer sheath 20
and into a catheter in the CSF space for a procedure.
Advantageously, the instruments 28 are aligned with the CSF space
in the spinal column after introduction through the introducer
sheath 20.
Catheter
[0086] As indicated in FIGS. 5-27, and with reference to FIG. 1,
the system 5 may further include a curved catheter 30. In some
embodiments, the catheter 30 may include a shielded coating for
MRI-safety and to provide little to no reduction in image quality
with specific scans such as gradient echo scans or fast spin scans.
In some embodiments, the catheter 30 is a 5F catheter. In some
embodiments, the catheter 30 is a 6F catheter with an approximately
7-10 cm introducer. In some embodiments, as shown in FIGS. 5 and 6,
the tip 31 of catheter 30 may be spring-loaded, such that the
catheter 30 maintains a generally linear form during delivery
through the introducer 20 but transitions into a curved shape as it
exits the introducer sheath 20 or needle. In one embodiment, the
tip 31 is a curved atraumatic spring-loaded tip. The spring 32 may
be made of a shape memory material, such as nitinol, or metal, such
as stainless steel, or a metal alloy. In other embodiments, coil,
braid, mesh, or other materials can be used in addition to or in
lieu of a spring. The spring loaded tip 31 has a curved shape with
a curve or bend of less than or equal to about 90 degrees. As
explained above with respect to the curved introducer sheath, the
curve or bend in the catheter tip facilitates a smooth transition
from the outside of the body in the L5 region through to the spinal
canal. In addition, it helps to avoid nerve roots in this region
and help align the distal tip for its movement up to the cervical
region. The curve or angle provides access to the CSF space on a
patient that is likely lying perpendicularly, but the catheter and
wire make a bend to traverse the canal smoothly and with reduced or
minimal kinking, pinching, and/or strain near the point of entry.
Sharp bends of 90 degrees or less can reduce flow of CSF through
the catheter and facilitate clotting via the formation of stagnant
flow and local eddy currents, which can block holes and result in
therapy failure. In certain embodiments, the bend radius may be
between approximately 0 mm and approximately 10 mm. In certain
implementations, this bend radius may enable optimal CSF flow
through a luminal device in the spinal canal. In some embodiments,
the bend radius may be between approximately 3 mm and approximately
7 mm. In certain embodiments, the catheter may comprise a coiled
wire having a coil pitch selected to provide particular rigidity
for navigation and for unblocking the catheter For example, in
certain implementations, the coil pitch may be between
approximately 0.01 inches and approximately 0.03 inches. In some
embodiments, the catheter 30 is a lumbar catheter and is configured
for delivery in a lumbar region of the spinal column. In some
embodiments, the catheter 30 is a cervical catheter and is
configured for delivery in a cervical region of the spinal column.
While certain embodiments of the introducer, introducer sheath,
catheter and other components of the present invention may be
described as having a curve, bend radius, or a radius of curvature,
it is to be understood that some or all of the components of the
present invention may be provided straight, i.e., with no
curve.
[0087] In use, once the introducer sheath 20 is in place in the
patient, a catheter 30 (or other instruments) can be introduced
through the introducer into the CSF space.
[0088] Advantageously, the catheter 30 is aligned with the CSF
space in the spinal column after introduction through the
introducer sheath 20. In some embodiments, the catheter is
navigated up to the cervical region in the C-2 area, or higher into
the ventricles, to facilitate the drainage of fluids.
[0089] As illustrated in FIGS. 7-27, the catheter 30 may include
structures that assist in the access to and/or navigation of the
CSF space, and that facilitate the efficacy of the neuropheresis.
Some of these structures include, but are not limited to,
temperature, pressure, flow, and/or other sensors or transducers 40
(see, e.g., FIG. 1); structures to provide strain relief and/or
kink resistance to the catheter (see, e.g., FIGS. 7-9, among
others); visualization features (see, e.g., FIGS. 10-27);
structures to increase flow profile (see, e.g., FIGS. 10-27);
structures to unblock and/or catch blood clots, to reduce filter
clogging (see, e.g., FIGS. 28-33); structures to help position or
advance the catheter within the CSF space (see, e.g., FIGS. 1 and
11); and structures to allow multiple instruments to be introduced
into the CSF space simultaneously (see, e.g., FIGS. 39 through
52).
Sensors
[0090] As can be understood from FIG. 1, in some embodiments,
transducers 40, such as sensors or microsensors 40, are positioned
on or about the catheter 30 or other instrument or may be embedded
within the catheter wall. The transducers 40 may include pressure
sensors, flow sensors, temperature sensors and/or sensors designed
to measure other parameters such as viscosity, turbidity, or the
like associated with normal, disease, and/or injury states of the
CSF space. The transducers 40 may be positioned along the length L
of the catheter or at or near a distal end 33 of the catheter 30.
The transducers 40 may be positioned at locations that correspond
to specific lumbar or cervical regions of the spine and measure
flow and pressure at those locations. The pressure and flow sensors
may also be used for kink or clog detection, as described
below.
Strain Relief and Kink Resistance
[0091] As indicated in FIGS. 7-9 and with reference to FIGS. 10-27,
the catheter 30 may include a strain relief and kink resistance
feature 60. The feature 60 may be a sleeve configured to be
positioned over or about the catheter 30 at a desired location and
may be "locked" in position (e.g., passive fixation) for a period
of time, such as between about 30 minutes and about 120 minutes.
For example, such a feature 60 may be provided at a fracture point
61 of the body of the catheter 30 for strain relief and to allow
flex or deformation of the catheter (see FIG. 9). As shown in FIG.
7, in one embodiment, the feature 60 is a coiled wire 62, which may
be embedded in a flexible tube 63, such as a silicone or polyether
block amide (e.g., as sold under the trade name PEBAX) tube 63.
[0092] In certain implementations, the coiled wire 62 may comprise
an approximately 0.003'' round wire. In certain implementations,
the coiled wire 62 may be configured with a coil pitch of between
approximately 0.01'' and approximately 0.03'', however other
configurations are also possible. This arrangement may enable the
catheter to make a bend into a spinal canal and retain its position
without kinking or compromising flow and flow under suction. In
some implementations, the pitch may change over the length of the
catheter 30. For example, a distal section may have a coil pitch of
between approximately 0.06'' and approximately 0.07'', while a
proximal portion may have a coil pitch of between approximately
0.01'' and approximately 0.03''. In some implementations, the coil
pitch may be between approximately 0.027'' and approximately
0.037'' in the proximal section. The coil pitch may be selected to
enable the size of inlet or other holes in the catheter to fit
within the coil spacing. The coil pitch may also be selected to
enable a kink-resistant design while maintaining pushability.
[0093] In another embodiment, as shown in FIG. 8, the feature 60
may be a braided wire 64 embedded in a tube 63. In various
embodiments, the feature 60 is between approximately 3 inches and
approximately 10 inches in length. In some embodiments, the feature
60 is approximately 3 inches, approximately 4 inches, approximately
5 inches, approximately 6 inches, approximately 7 inches,
approximately 8 inches, approximately 9 inches, approximately 10
inches in length, or any other desired dimension.
[0094] As can be seen in FIG. 10 and others, a position marker 100,
such as a green polyether block amide (e.g., PEBAX) position marker
100, may be integral with the catheter, or it may be positioned
about or around the catheter. The position marker 100 is provided
to indicate a transition point of the catheter at a point where it
is entering/exiting the body. Such an indicator may be useful if
imaging technology (e.g., MRI) is not used and the indicator can
provide a guide. The position marker 100 also provides additional
strength and kink resistance.
Visualization Features
[0095] In some embodiments, as shown in FIGS. 10-27, the catheter
30 may include a visualization feature 70 for diagnostic imaging
purposes. The visualization feature 70 may be a marker band 70 that
will help to confirm the location of the inlet and outlet at, for
example, the cisterns in the spine, rather than placing the
catheter near nerve tissue, soft pia mater, or other tissue that
can be drawn into the catheter, thereby reducing flow.
Increased Flow Profile
[0096] CSF flow through the spinal column is considered a generally
low flow system, as compared to a higher flow system such as the
cardiac system. As can be understood from FIGS. 10-27, to increase
the CSF or other fluid flow profile through the system 5, the
catheter 30 optionally may include a plurality of openings 80
(which may or may not have a defined pattern) along certain
portions of the catheter 30. The openings 80 may be elongated
openings defined within the outer circumferential wall 30a of the
catheter 30 and may be of oval, elliptical, other, or undefined
shape. In some embodiments, the plurality of openings 80 has a
total cross sectional surface area of approximately 0.6 mm.sup.2 or
greater, or approximately 1.5 mm.sup.2. In general, the ratio of
the cross sectional area of the openings 80 to the cross sectional
area of an internal lumen of the catheter 30 is from 1:1 to 3:1. In
one embodiment, the plurality of openings 80 has a total cross
sectional surface area of approximately 0.8 mm.sup.2. The openings
80 (which may be vents, slots, slits, or other) in the catheter 30
provide an increased flow profile for the system 5.
[0097] As shown in FIGS. 11 and 12, and with reference to FIG. 10,
in one embodiment, a first portion 85 of catheter 30 may optionally
include a plurality of openings 80 positioned generally linearly
along or generally parallel to or along a horizontal line through a
lumen of the catheter 30. The distal end 86 of the first portion 85
may optional includes a round or rounded tip, or a soft distal
portion, to prevent puncture or lessen damage to any nearby tissue
or other anatomical feature during delivery of the device. The
length L.sub.F of the first portion 85 is approximately 2 cm. A
second portion 90 of catheter 30 includes a plurality of openings
80, which may be positioned in a random, staggered, symmetrical, or
other pattern (or non-pattern) relative to a horizontal line
defined through a lumen of the catheter 30. The second portion 90
also optionally may include a spring or coil 95, which may be
provided for reinforcement of the inner and outer lumens. The
function of the spring 95 is to lessen the likelihood of collapse
of the section, from suction or from the weight of tissue on the
catheter or otherwise. The coil or spring 95 may be made of
platinum, stainless steel, or other suitable materials depending on
whether imaging is desired. Any suitable number of springs or coils
may be used. The length L.sub.S of the second portion 90 is
approximately 3 cm. The distance D.sub.1 between a distal end 86 of
the first portion 85 and a distal end 91 of the second portion 90
is approximately 30 cm. The distance D.sub.2 between a distal end
86 of the first portion 85 and a proximal end 92 of the second
portion 90 is approximately 33 cm. In some embodiments, the
distance D.sub.2 between a distal end 86 of the first portion 85
and a proximal end 92 of the second portion 90 is between
approximately 33 cm and approximately 38 cm. The total length
L.sub.1 of the catheter 30 is approximately 68 cm. The distance
D.sub.3 between the proximal end 92 of the second portion 90 and a
distal end 93 of the position marker 100 is approximately 6 cm.
[0098] As shown in FIGS. 14 and 15, and with reference to FIG. 13,
in one embodiment, a first portion 85 of catheter 30 may optionally
include a plurality of openings 80 positioned generally linearly
along or generally parallel to or along a horizontal line through a
lumen of the catheter 30. The distal end 86 of the first portion 85
may include a round or rounded tip or a soft distal end portion to
prevent puncture or lessen damage to any nearby tissue or other
anatomical feature during delivery of the device. The length
L.sub.F of the first portion 85 is approximately 2 cm. A second
portion 90 of catheter 30 includes a plurality of openings 80,
which may be positioned in a random, staggered, symmetrical, or
other pattern relative to the horizontal line through a lumen of
the catheter 30. The length L.sub.s of the second portion 90 is
approximately 3 cm. The distance D.sub.1 between a distal end 86 of
the first portion 85 and a distal end 91 of the second portion 90
is approximately 20 cm. The distance D.sub.2 between a distal end
86 of the first portion 85 and a proximal end 92 of the second
portion 90 is approximately 23 cm. The total length L.sub.1 of the
catheter 30 is approximately 58 cm. The distance D.sub.3 between
the proximal end 92 of the second portion 90 and a distal end 93 of
the position marker 100 is approximately 6 cm.
[0099] As shown in FIGS. 17 and 18, and with reference to FIG. 16,
in one embodiment, a first portion 85 of catheter 30 may optionally
include a plurality of openings 80 positioned generally linearly
along or generally parallel to a horizontal line through a lumen of
the catheter 30. The distal end 86 of the first portion 85 may
include a round or rounded tip or a soft distal end portion to
prevent puncture or lessen damage to any nearby tissue or other
anatomical feature during delivery of the device. The first portion
85 also may include springs or coils 95a, 95b separated by a marker
band 70. The springs or coils 95 resist reinforcement of the inner
and outer lumens. The separation of the springs 95a, 95b resists
collapse of the section from suction or from the weight of tissue
on the catheter. The coils or springs 95 may be made of platinum or
stainless steel depending on whether imaging is desired. Any
suitable number of springs or coils may be used, with or without
one or more marker bands. The length L.sub.F1 of the first portion
85 between the distal end 86 and the marker band 70a is
approximately 2 cm. The length L.sub.F2 of the first portion 85
between the marker band 70a and marker band 70b is approximately 2
cm. A second portion 90 of catheter 30 may include a plurality of
openings 80 positioned in a random, staggered, symmetrical, or
other pattern relative to a horizontal line through a lumen of the
catheter 30. The second portion 90 also may include a spring 95c.
The separation of the springs 95a, 95b and 95c resists collapse of
the section from suction or from the weight of tissue on the
catheter. The length L.sub.S of the second portion 90 is
approximately 3 cm. The distance D.sub.1 between a distal end 86 of
the first portion 85 and a distal end 91 of the second portion 90
is approximately 30 cm. The distance D.sub.2 between a distal end
86 of the first portion 85 and a proximal end 92 of the second
portion 90 is approximately 33 cm. In some embodiments, the
distance D.sub.2 between a distal end 86 of the first portion 85
and a proximal end 92 of the second portion 90 is between
approximately 33 cm and approximately 38 cm. The total length
L.sub.1 of the catheter 30 is approximately 68 cm. The distance
D.sub.3 between the proximal end 92 of the second portion 90 and a
distal end 93 of the position marker 100 is approximately 6 cm.
[0100] As shown in FIGS. 20 and 21, and with reference to FIG. 19,
in one embodiment, a first portion 85 of catheter 30 includes a
plurality of openings 80 positioned generally linearly along or
generally parallel to a horizontal line through a central lumen of
the catheter 30. The distal end 86 of the first portion 85 may
include a round or rounded tip or soft distal end portion to
prevent puncture or lessen damage to any nearby tissue or other
anatomical feature during delivery of the device. The first portion
85 also may include springs 95a, 95b separated by a marker band 70.
The springs or coils 95 resist reinforcement of the inner and outer
lumens. The coils or springs 95 may be made of platinum, stainless
steel, or other suitable materials depending on whether imaging is
desired. The separation of the springs 95a, 95b resists collapse of
the section from suction or from the weight of tissue on the
catheter. The coils or springs 95 may be made of platinum,
stainless steel, or other suitable materials depending on whether
imaging is desired. Any suitable number of springs or coils may be
used. The length L.sub.F1 of the first portion 85 between the
distal end 86 and the marker band 70a is approximately 2 cm. The
length L.sub.F2 of the first portion 85 between the marker band 70a
and marker band 70b is approximately 2 cm. A second portion 90 of
catheter 30 may include a plurality of openings 80 positioned in a
random, staggered, symmetrical or other pattern relative to a
horizontal line through a lumen of the catheter 30. The second
portion 90 also includes a spring 95c. The separation of the
springs 95a, 95b and 95c resists collapse of the section from
suction or from the weight of tissue on the catheter. The length
L.sub.S of the second portion 90 is approximately 3 cm. The
distance D.sub.1 between a distal end 86 of the first portion 85
and a distal end 91 of the second portion 90 is approximately 20
cm. The distance D.sub.2 between a distal end 86 of the first
portion 85 and a proximal end 92 of the second portion 90 is
approximately 23 cm. The total length L.sub.1 of the catheter 30 is
approximately 58 cm. The distance D.sub.3 between the proximal end
92 of the second portion 90 and a distal end 93 of the position
marker 100 is approximately 6 cm.
[0101] As shown in FIGS. 23 and 24, and with reference to FIG. 22,
in one embodiment, a first portion 85 of catheter 30 includes a
plurality of openings 80 positioned in a random, staggered,
symmetrical or other pattern relative to a horizontal line through
a lumen of the catheter 30. The distal end 86 of the first portion
85 may include a round or rounded tip or a soft distal end portion
to prevent puncture or lessen damage to any nearby tissue or other
anatomical feature during delivery of the device. The first portion
85 may also include a spring 95d. The spring or coil 95 resists
reinforcement of the inner and outer lumens. The coil or spring 95
may be made of platinum, stainless steel, or other suitable
materials depending on whether imaging is desired. Any suitable
number of springs or coils may be use. The length L.sub.F of the
first portion 85 is approximately 2.1 cm. A second portion 90 of
catheter 30 may include a plurality of openings 80 positioned in a
random, staggered, symmetrical or other pattern relative to a
horizontal line defined through a lumen of the catheter 30. The
second portion 90 also includes a spring 95e. The separation of the
springs 95d and 95e resists collapse of the section from suction or
from the weight of tissue on the catheter. The length L.sub.S of
the second portion 90 is approximately 3 cm. The distance D.sub.1
between a distal end 86 of the first portion 85 and a distal end 91
of the second portion 90 is approximately 30 cm. The distance
D.sub.2 between a distal end 86 of the first portion 85 and a
proximal end 92 of the second portion 90 is approximately 33 cm. In
some embodiments, the distance D.sub.2 between a distal end 86 of
the first portion 85 and a proximal end 92 of the second portion 90
is between approximately 33 cm and approximately 38 cm. The total
length L.sub.1 of the catheter 30 is approximately 68 cm. The
distance D.sub.3 between the proximal end 92 of the second portion
90 and a distal end 93 of the position marker 100 is approximately
6 cm.
[0102] As shown in FIGS. 26 and 27, and with reference to FIG. 25,
in one embodiment, a first portion 85 of catheter 30 includes a
plurality of openings 80 positioned in a random, staggered,
symmetrical or other pattern relative to a horizontal line through
a lumen of the catheter 30. The distal end 86 of the first portion
85 includes a round or rounded tip or soft distal end portion to
prevent puncture or lessen damage to any nearby tissue or other
anatomical feature during delivery of the device. The first portion
85 may include a spring 95. The spring or coil 95 resists
reinforcement of the inner and outer lumens. The coil or spring 95
may be made of platinum or stainless steel depending on whether
imaging is desired. Any suitable number of springs or coils may be
use. The length L.sub.F of the first portion 85 is approximately
2.1 cm. A second portion 90 of catheter 30 may include a plurality
of openings 80 positioned in a random, staggered, symmetrical or
other pattern relative to the horizontal line through a lumen of
the catheter 30. The length L.sub.S of the second portion 90 is
approximately 3 cm. The distance D.sub.1 between a distal end 86 of
the first portion 85 and a distal end 91 of the second portion 90
is approximately 20 cm. The distance D.sub.2 between a distal end
86 of the first portion 85 and a proximal end 92 of the second
portion 90 is approximately 23 cm. The total length L.sub.1 of the
catheter 30 is approximately 58 cm. The distance D.sub.3 between
the proximal end 92 of the second portion 90 and a distal end 93 of
the position marker 100 is approximately 6 cm.
Blood Clot Removal
[0103] In some embodiments, the system 5 or catheter 30 may be used
with other devices to help increase the efficiency and safety of
the neuropheresis system. For example, blood clots can reduce or
stop fluid flow in the vasculature and can cause similar problems
in the CSF space. As such, their removal is desirable and can be
accomplished with aspects of the systems and devices disclosed
herein. In some embodiments, a chemical agent, such as saline,
tissue plasminogen activator (tPA), or urokinase, may be introduced
into the CSF space through the catheter 30 to unblock clots. To
retrieve those clots, the system 5 may further include a basket,
coiled wire, or other receptacle 105 to hold or remove pieces of
the clot to reduce or prevent clogging of a filter.
[0104] As shown in FIGS. 28 through 31, the receptacle 105 may be a
coiled microwire 110 that may be inserted into the catheter 30 and
advanced to the blood clot C. A balloon 108 may be positioned over
the catheter 30 to either push tissue away from the openings in the
catheter and enable flow to occur more easily, or to actually
perform the function of isolation while suction (via pump) and/or
mechanical manipulation with the micro-wires is applied. The coiled
microwire 110 engages blood clot C by intertwining with pieces of
clot C (see FIGS. 29 and 30). The microwire 110 with clot C
intertwined may be withdrawn through the catheter 30, thereby
removing the clot C from the CSF space (FIG. 31).
[0105] As indicated in FIG. 32, in another embodiment, the
receptacle 105 may include a plurality of intertwined microwires
115 that may be inserted into the catheter 30 and advanced to the
blood clot C. The multiple microwires 115 engage blood clot C by
intertwining with pieces of clot C. The microwires 115 with clot C
intertwined therein may be withdrawn through the catheter 30,
thereby removing the clot C from the CSF space.
[0106] As illustrated in FIG. 33, in another embodiment, the
receptacle 105 may be a sieve mechanism 120 that may be attached to
a microcatheter 125 that may be inserted into the catheter 30 and
advanced to the blood clot C. A balloon 108 may be positioned over
the catheter 30 as described above. The sieve mechanism 120 may
include openings that are large enough to pass blood cells but
small enough for the debris (clot C) to be captured by the sieve
mechanism 120. As the mechanism 120 is withdrawn through the
catheter 30, clot C is removed from the CSF space.
[0107] As shown in FIG. 34, in another embodiment, the receptacle
105 may include a plurality of microwires 115, which may have
pressure sensors 126 positioned on, in, or about the catheter 30.
The pressure sensors 126 help detect problems in the overall flow
circuit, and highlight when there is a blockage. A balloon (not
shown) may be positioned over the catheter 30 as described above
and the balloon may further be used to deploy flexible pressure
sensors 127. In other embodiments, the flexible pressure sensors
127 may be printed on a substrate (e.g., silicone) and deployed at
or near the blood clot C.
Balloons
[0108] As can be understood from FIGS. 35-38, in some embodiments,
the system 5 or catheter 30 may be used with other devices to help
increase the efficiency and safety of the neuropheresis system. For
example, and as shown in FIGS. 35 and 36, in one embodiment, a
positioning device 130 with multiple inflatable/deflatable balloons
135, each of which may have its own lumen and/or port 130a, can be
inserted through the introducer sheath 20 (not shown) and directly
into the spinal canal. The balloons 135 may be co-located with or
disposed about the positioning device 130. In one embodiment, the
balloon 135 has a length between approximately 0.5 cm and
approximately 2.0 cm and a height between approximately 0.25 cm and
approximately 0.6 cm. In some embodiments, the balloons 135 may be
radiopaque to provide increased visualization of the catheter 30 or
positioning device 130 within the CSF space.
[0109] As depicted in FIGS. 37 and 38, the positioning device's
first (distal-most 135a) and second (next to first 135b) balloons
may be inflated to push tissue structures back; the second balloon
135b can then be deflated, so that the catheter 30 can be advanced
into the space that was occupied by tissue and nerves, before it
was pushed back by the second balloon 135b. The first balloon 135a
is deflated, and the deflated balloons are advanced further into
the CSF space 15, where they are reinflated. This process is
repeated until the catheter 30 is in the desired position in the
spinal column, at which point the positioning device 130 can be
withdrawn.
Multiple Lumens and Other Features of the Catheter
[0110] In some embodiments, the system 5 includes a multi-lumen
(e.g. more than one lumen) catheter 30. A multi-lumen catheter can
provide stability under a vacuum. The lumens themselves can provide
redundancy such that, if one gets clogged, other lumens may be
utilized. The lumens enable real-time sampling and spinal pressure
measurement, thus enabling action to be taken if pressure is too
high or too low which indicates blockage and/or overdrainage. In
some embodiments, the diameter of the distal end is smaller (e.g.,
4 French (4F)) than the diameter of the proximal end in order to
maintain flow despite the lack of space in the cervical region of
the spine. In some embodiments, the diameter of the proximal end is
greater than the diameter of the distal end to enable rapid
drainage of large amounts of blood-filled CSF quickly. The
catheters are constructed to maintain patency despite anatomical
challenges, such as being squeezed by tissue in the dura or being
subject to a large suction force from the pump on the walls of the
catheter. In some embodiments, the catheter includes a cross
sectional area of approximately 0.8 mm.sup.2 to enhance flow and a
round distal section to facilitate cervical placement via a
guidewire. In some embodiments, the separation between the inlet
and outlet is between approximately 33 cm and approximately 38 cm
to reduce likelihood of local recirculating loops and enhance rapid
clearing of a large amount, up to and including substantially all,
of the entire volume of CSF.
[0111] In some embodiments, the inlet and outlet of the catheter
are switched. For example, in a subarachnoid hemorrhage (SAH),
there is often a bolus of bloody CSF at the base of the brain,
which can leak into the spine over time. When the therapy is
deployed and fluid is being moved at the rate of about 120/240
ml/hr (or any other desired rate), it may be helpful from time to
time to switch the inlet and outlet of catheter (particularly if a
short catheter is being used) to prevent local recirculation of
fluid and enhance unfiltered CSF being drawn into the filter. Other
therapeutic uses of switching the inlet and outlet includes use in
a method of preventing stagnating flow, dislodging clots, and/or
opening up blockages, which may be due to thick blood or suction
effects on the inlet. In one embodiment, two microcatheters may be
used within a central lumen to change the position of inlet and
outlet. In other embodiments, an outer sheath with cut-outs or
openings may be used to change the position of the inlet and
outlet. Such a feature may also make clot-removal from within the
catheter easier without having to extract the catheter and place it
again.
[0112] In some embodiments, the catheter having a tubular body may
include a plurality of openings over at least a portion of the
tubular body. A sheath configured to cover certain openings on the
tubular body may be used such that the catheter remains in place
while the sheath is rotated to open or close the openings in the
tubular body to increase or decrease flow as needed.
[0113] FIGS. 39 through 57 illustrate various embodiments of a
catheter 30 that may be used with the present systems. FIGS. 39
through 42 illustrate embodiments of a catheter 30 having proximal
and distal ends with varying diameters. More specifically, FIG. 39
and FIG. 40 illustrate one embodiment of a 5F catheter 30 having a
proximal end 200 with different dimensions than a distal end 250 of
the catheter. As shown in FIG. 39, the proximal end 200 of the
catheter 30 includes an outer lumen 205 and an inner lumen 210. The
outer lumen 205 is defined by an inner wall 205a, and outer wall
205b and a middle wall 205c. Other embodiments may include greater
or fewer walls. The outer wall 205b may be a 55D polyether block
amide (e.g., a polyether block amide sold under name PEBAX) 5F
approximately 0.003'' wall jacket. The outer wall 205b may have a
diameter D.sub.1 of about 0.065'' or about 0.17 cm. The middle wall
205c may be about an approximately 0.001''.times.0.003'' braid. The
inner wall 205a may be a PTFE etching approximately 0.058''
ID.times.0.0015'' wall liner having a diameter D.sub.2 of about
0.058'' or about 0.15 cm. The inner lumen 210 is defined by an
inner wall 210b and an outer wall 210a. The outer wall 210a may be
a 55D polyether block amide 3F approximately 0.003'' wall having a
diameter D.sub.3 of about 0.038'' or about 0.10 cm. The inner wall
210b, may have a diameter D.sub.4 of about 0.033'' or about 0.08
cm. As shown in FIG. 40, the distal end 250 of the catheter 30
includes an outer lumen 260 defined by an outer wall 260a, an inner
wall 260b, and a middle wall 260c. Other embodiments may include
greater or fewer walls. The outer wall 260a may be a 55D polyether
block amide 4F approximately 0.005'' wall jacket having a diameter
D.sub.1 of about 0.054 in or about 0.14 cm. The middle wall 260c
may be an approximately 0.001''.times.0.003'' braid. The inner wall
260b may be a PTFE etched approximately 0.042''.times.0.0015'' wall
liner having a diameter D.sub.2 of about 0.041'' or about 0.10
cm.
[0114] FIG. 41 and FIG. 42 illustrate one embodiment of a 6F
catheter 30 having a proximal end 300 with different dimensions
than a distal end 350 of the catheter. As shown in FIG. 41, the
proximal end 300 of the catheter 30 includes an outer lumen 305 and
an inner lumen 310. The outer lumen 305 is defined by an inner wall
305a, an outer wall 305b, and a middle wall 305c. Other embodiments
may include greater or fewer walls. The middle wall 305c may be an
approximately 0.001''.times.0.003'' braid. The outer wall 305b may
be a 55D polyether block amide 6F approximately 0.003'' wall
jacket. Any other suitable material and dimensions also may be
used. The outer wall 305b may have a diameter D.sub.1 of about
0.078'' or about 0.20 cm. The inner wall 305a may be a PTFE etching
approximately 0.068'' ID.times.0.0015'' wall liner having a
diameter D.sub.2 of approximately 0.068'' or approximately 0.17 cm.
The inner lumen 310 is defined by an inner wall 310b and an outer
wall 310a. The outer wall 310a may be a 55D polyether block amide
3F approximately 0.003'' wall having a diameter D.sub.3 of about
0.038'' or about 0.10 cm. The inner wall 310b may have a diameter
D.sub.4 of about 0.033'' or about 0.08 cm. As shown in FIG. 42, the
distal end 350 of the catheter 30 includes an outer lumen 360
defined by an outer wall 360a, an inner wall 360b, and a middle
wall 360c. Other embodiments may include greater or fewer walls.
The outer wall 360a may be a 55D polyether block amide 4F
approximately 0.005'' wall jacket having a diameter D.sub.1 of
about 0.054'' or about 0.14 cm. The middle wall 360c may be an
approximately 0.001''.times.0.003'' braid. The inner wall 360b may
be a PTFE etched approximately 0.042''.times.0.0015'' wall liner
having a diameter D.sub.2 of about 0.041'' or about 0.10 cm. Any
other suitable material and dimensions also may be used.
[0115] FIGS. 43 through 57 depict other embodiments of the catheter
30 having multiple lumens. FIGS. 43 and 44 depict a catheter 30
configured for use as a peripherally inserted central catheter
(PICC) having an inlet lumen 400a and an outlet lumen 400b. The
inlet lumen 400a has a surface area of about 0.00084 in.sup.2 and a
diameter D.sub.1 of about 0.022 in. The outlet lumen 400b has a
surface area of 0.00084 in.sup.2 and a diameter D.sub.2 of about
0.022 in. The inlet and outlet lumens are defined by an outer wall
405 and a middle wall 410. The thickness T.sub.o of the outer wall
405 is about 0.010''. The thickness T.sub.M of the middle wall 410
is about 0.004''. Any other suitable material and dimensions also
may be used.
[0116] FIGS. 45 through 47 depict a dual lumen catheter 30 having
an inlet lumen 415a and an outlet lumen 415b. The inlet lumen 415a
has a surface area of about 0.00115 in.sup.2 and a diameter D.sub.1
of about 0.023''. The outlet lumen 415b has a surface area of about
0.000314 in..sup.2 and a diameter D.sub.2 of about 0.020 in. The
inlet and outlet lumens are defined by an outer wall 420 and a
middle wall 425. The thickness T.sub.o of the outer wall 420 is
about 0.008''. The thickness T.sub.M of the middle wall 425 is
about 0.004''. The radius of curvature R.sub.1 of the inlet lumen
415a is about 0.005''. The radius R.sub.2 of the outlet lumen is
about 0.014''. The diameter D.sub.C of the catheter 30 is about
0.065''. Any other suitable material and dimensions also may be
used.
[0117] FIGS. 48 through 50 depict a multi-lumen catheter 30 having
three inlet lumens 430a and an outlet lumen 430b. Other embodiments
may include a greater number of inlet or outlet lumens. The inlet
lumens 430a have a total surface area of about 0.00144 in.sup.2 and
each has a diameter D.sub.1 of about 0.012 in. The outlet lumen
430b has a surface area of about 0.00031 in.sup.2 and a diameter
D.sub.2 of about 0.020 in. The inlet and outlet lumens are defined
by an outer wall 435 and a middle wall 440. The thickness T.sub.o
of the outer wall 435 is about 0.006''. The thickness T.sub.M of
the middle wall 440 is about 0.004''. The radius R.sub.1 of the
inlet lumen 430a is about 0.013''. The radius R.sub.2 of the outlet
lumen 430b is about 0.027''. The diameter D.sub.C of the catheter
30 is about 0.065''. Any other suitable material and dimensions
also may be used.
[0118] FIGS. 51 through 53 depict a multi-lumen catheter 30 having
two inlet lumens 445a and an outlet lumen 445b. Other embodiments
may include a greater number of inlet or outlet lumens or the inlet
and outlet lumens may be positioned differently relative to each
other. The inlet lumens 445a have a total surface area of about
0.0013 in.sup.2 and each has a diameter D.sub.1 of about 0.022''.
The outlet lumen 445b has a surface area of about 0.00065''
in.sup.2 and a diameter D.sub.2 of about 0.022''. The inlet and
outlet lumens are defined by an outer wall 450 and a middle wall
455. The thickness T.sub.o of the outer wall 450 is about 0.006''.
The thickness T.sub.M of the middle wall 455 is about 0.004''. The
radius R.sub.1 of the inlet lumen 445a is about 0.027''. The radius
R.sub.2 of the outlet lumen 445b is about 0.027''. The diameter
D.sub.C of the catheter 30 is about 0.065''. Any other suitable
material and dimensions also may be used.
[0119] FIGS. 54 through 57 depict a dual lumen catheter 30 having
an inlet lumen 460a and an outlet lumen 460b. The inlet lumen 460a
has a surface area of about 0.00151 in.sup.2 and a diameter D.sub.1
of about 0.044''. The outlet lumen 460b has a surface area of about
0.00038 in.sup.2 and a diameter D.sub.2 of about 0.022''. The inlet
and outlet lumens are defined by an outer wall 465 and a middle
wall 470. The thickness T.sub.o of the outer wall 465 is about
0.0065''. The thickness T.sub.M of the middle or inner wall 470 is
about 0.003''. The diameter D.sub.C of the catheter 30 is about
0.065''. As shown in FIGS. 56 and 57, and discussed in more detail
above, the inlet lumen 460a and outlet lumen 460b may optionally
include one or more openings 80 along certain portions of the
catheter to increase the CSF or other fluid flow through the system
5. FIGS. 56 and 57 illustrate one opening 80 in each of the inlet
and outlet lumens for clarity but it is understood that each lumen
may include one or more openings 80. The openings 80 may be
elongated openings defined within the outer circumferential wall
462a of the inlet lumen 460a and/or in the outer circumferential
wall 462b of the outlet lumen 460b. The openings 80 may be of oval,
elliptical, other, or undefined shape. In some embodiments, the one
or more openings 80 defined in the outer circumferential wall 462a
of the inlet lumen 460a has a total cross sectional surface area of
approximately 0.00126 in.sup.2 and the size of each individual
opening 80 is approximately 0.022''.times.0.062''. The one or more
openings 80 defined in the outer circumferential wall 462b of the
outlet lumen 460b has a total cross sectional surface area of
approximately 0.000314 in.sup.2 and the diameter of each individual
opening 80 is approximately 0.020 in. Any other suitable material
and dimensions also may be used.
[0120] FIGS. 58 and 59 are surface area comparison charts. FIG. 58
shows a comparison of the distal/outlet lumens of the catheters of
the present disclosure in comparison to the surface area of the
distal/outlet lumens of known catheters. FIG. 59 shows a comparison
of the proximal/inlet lumens of the catheters of the present
disclosure in comparison to the surface area of the proximal/inlet
lumens of known catheters.
[0121] FIGS. 60-66, 67-71, and 72-75 illustrate overall views,
proximal subassembly views, and distal subassembly views,
respectively, of an embodiment of a catheter 500 according to
certain implementations. FIG. 60 illustrates a Y-connector portion
502, a proximal subassembly 540, and a distal subassembly 560. The
Y-connector portion 502 may include connectors 504, 506, features
508, 510, 512, position marker 514, and other components. The
connectors 504, 506 may take various forms. For example, as
illustrated, the connectors 504, 506 are female and male Luer-lock
connectors, respectively. The features 508, 510, 512 may be strain
relief and kink resistance features, for example, as described
above with reference to strain relief and kink resistance feature
60. The feature 508 may be configured to allow flex or deformation
of the catheter 500 at portions near a central meeting point of the
Y-connector 502. The features 510, 512 may be configured to allow
flex or deformation of the catheter 500 near the connectors 504,
506. In certain implementations, the features 510, 512 may be color
coded to indicate to which lumen of a multi-lumen catheter, the
connectors 504, 506, correspond. In certain embodiments, the
features 508, 510, 512 may take the form of approximately 1/8''
polyolefin heat shrink tubing. The position marker 514 may be a
position marker as described above with reference to position
marker 100.
[0122] The length L.sub.1 of the catheter 500 may be approximately
1,300 mm with a working length L.sub.2 of approximately 1,150 mm.
The working length L.sub.2 may be defined based on various use and
design considerations. As illustrated, the working length L.sub.2
is the distance from the distal end of the distal subassembly 560
to the distal end of the feature 508. The distance D.sub.1 from the
distal end of the feature 508 to the proximal end of the connector
506 may be approximately 150 mm. The feature 508 may have a length
L.sub.3 of approximately 35 mm and the features 510, 512 may have a
length L.sub.4 of approximately 7 mm. In certain implementations,
the catheter 500 may have a length L.sub.1 of between approximately
400 mm and approximately 1200 cm, with the working length L.sub.2
and other measurements changed accordingly.
[0123] FIG. 61 illustrates a sectional view taken from the region
of the catheter 500 marked with cutting plane line A-A. This view
illustrates a lumen 516A defined by a wall 516B. The
characteristics and properties of the lumen 516A and wall 516B may
be similar to the other walls and lumens described herein. As
illustrated, the wall 516B has an inner diameter D.sub.2 of
approximately 0.54 mm and an outer diameter D.sub.3 of
approximately 1.14 mm.
[0124] FIG. 62 illustrates a sectional view taken from the region
of the catheter 500 marked with cutting plane line B-B. This view
illustrates a lumen 518A defined by an inner wall 518B and a lumen
520A defined by the space between the inner wall 518B and an outer
wall 520B. The characteristics and properties of the lumens 518A,
520A and the walls 518B, 520B may be similar to the other walls and
lumens described herein. The inner wall 518B may have an inner
diameter D.sub.4 of approximately 0.56 mm and an outer diameter
D.sub.5 of approximately 0.71 mm. The outer wall 520B may have an
inner diameter of approximately 1.32 mm and an outer diameter of
approximately 1.689 mm.
[0125] FIG. 63 illustrates an enlarged, detail view of a portion of
the Y-connector 502 according to certain implementations, including
tubes 522, first branch 524, and second branch 526. The tubes 522
may be hypotubes or other lengths of tubing. The tubes 522 may have
a length L.sub.5 of approximately 10 mm. In certain
implementations, the first branch 524 may place the connector 504
in fluid connection with the lumen 520A and the second branch 526
may place the connector 506 in fluid connection with the lumen
518A.
[0126] FIG. 64 illustrates the location of two position markers 514
on the catheter 500. The distal end of the first position marker
514 is located a distance D.sub.9 of approximately 450 mm away from
the distal end of the catheter 500. The distal end of the second
position marker 514 is located a distance D.sub.8 of approximately
550 mm away from the distal end of the catheter 500. The length
L.sub.4 of the position markers 514 is approximately 10 mm. In
certain implementations, the bands and/or position markers (such as
position markers 514) may comprise PET heat shrink tubing.
[0127] FIG. 65 illustrates a sectional view taken from the region
of the catheter 500 marked with the cutting plane line J-J. This
view illustrates an embodiment wherein an outer portion of the
position marker 514 is substantially adjacent to an inner portion
of the wall 520B. Accordingly, in this portion of this embodiment,
the lumen 520A is defined by the outer portion of the wall 518B and
the inner portion of the position marker 514. As illustrated, the
outer wall 520B has an outer diameter D.sub.10 of approximately
1.75 mm.
[0128] FIG. 66 illustrates a portion of the catheter 500 near the
joining of the proximal subassembly 540 and the distal subassembly
560, including bands 528A, 528B, 530, openings 532, and a radiused
tip 534. The distal portion of the band 530A may be located a
distance D.sub.11 of approximately 300 mm away from the distal
portion of the band 528A. The distal end of the band 528A may be
located a distance D.sub.12 of approximately 2 mm away from the
distal end of the radiused tip 530. The radiused tip may have a
radius R.sub.1 of approximately 0.28 mm.
[0129] FIG. 67 illustrates a portion of the proximal subassembly
540. As illustrated, the distance D.sub.1 from the distal end of
the proximal subassembly 540 to the proximal end of the proximal
subassembly 540 is approximately 893 mm. The distance D.sub.2 from
a distal end of a marker band 544B to a distal end of a band 530A
is approximately 248 mm. A distance D.sub.4 from a proximal end of
the proximal subassembly 540 to the distal end of a band 530B is
approximately 845 mm. A distance D.sub.3 from a distal end of the
marker band 544A to a distal end of the band 530A is approximately
148 mm. The marker bands 544A, 544B may have a length L.sub.1 of
approximately 10 mm. A portion of the proximal subassembly 540 may
comprise coiled wire 542A having a coil pitch of approximately
0.018''. A portion of the proximal subassembly 540 may comprise
coiled wire 542B having a coil pitch of approximately 0.095''. In
certain implementations, the wires 542A, 542B may comprise
approximately 0.003'' round wire spool of 304V spring temper
material.
[0130] In certain implementations, the proximal subassembly 540 of
the catheter 500 may have an outer diameter of between
approximately 0.06'' and approximately 0.07''. This configuration
may maximize the size of the catheter between layers of tissue to
enable a desired level of drainage and/or suction without collapse.
The thickness of the proximal subassembly 540 and other sections of
the catheter 500 may be a function of a design of one or more
layers of coil and sheath. The thickness may affect the stiffness
and pushability of the catheter 500 and kink-resistance. In certain
implementations, the diameter of an inner lumen of the catheter 500
(such as the diameter of a lumen of the proximal subassembly 540)
may be chosen to provide optimum drainage and/or suction given the
constraints of particular anatomy or procedures. For example, the
minimum diameter of a proximal inner lumen may be chosen to be
between approximately 0.025'' and approximately 0.060''.
[0131] FIG. 68 illustrates a detail view of the proximal
subassembly 540 of FIG. 67. As illustrated, a portion of the
proximal subassembly 540 defines a plurality of openings 532A. The
openings 532A may be in fluid connection with a lumen of the
catheter 500. The openings 532A may be spaced with 2 coil pitch
spacing of the wire 542A. The distance D.sub.6 between the distal
end of the band 530B and the distal end of the band 530A is
approximately 45 mm. A distance D.sub.5 from the distal end of the
band 530A to the distal end of the proximal subassembly 540 may be
approximately 3 mm. In certain implementations, the bands 530A,
530B may comprise a PT/10% IR band having an inner diameter of
approximately 0.061'' and an outer diameter of approximately
0.064''.
[0132] FIG. 69 illustrates a sectional view taken from the region
of the proximal subassembly 540 marked with the cutting plane line
A-A, including a liner 546 and tubing 548. The liner 546 and the
tubing 548 may be arranged such that the tubing 548 is within the
liner 546. In certain implementations, the liner 456 may comprise
approximately 0.001'' WT PTFE liner. The tubing 548 may comprise
approximately 0.004'' WT polyether block amide tubing. The outer
diameter D.sub.7 of the combination tubing 548 and liner 546 may be
approximately 1.69 mm. The inner diameter D.sub.8 of the same may
be approximately 1.32 mm.
[0133] FIG. 70 illustrates a detail view of a portion of the
proximal subassembly 540 taken from the view of line D-D and
illustrating one of the openings 532A. The illustrated opening 532A
has dimensions of approximately 1.57 mm by approximately 0.56
mm.
[0134] FIG. 71 illustrates a sectional view taken from the region
of the proximal subassembly 540 marked with the cutting plane E-E.
As illustrated the outer diameter D.sub.9 this portion, inclusive
of marker band 544 is approximately 1.75 mm.
[0135] FIG. 72 illustrates a portion of the distal subassembly 560.
The length L.sub.1 of the distal subassembly 560 may be
approximately 302 mm. The distance D.sub.1 from the proximal end of
the distal subassembly 560 to the distal end of a band 528B is
approximately 270 mm. A portion of the distal subassembly 560 may
comprise a coiled wire 462B may have a coil pitch of approximately
0.032''. This and other portions of the catheter 500 may comprise
approximately 0.003'' WT nylon 12 tubing having an inner diameter
of approximately 0.022'' and approximately 0.007'' WT PEBAX tubing
having an inner diameter of approximately 0.04''.
[0136] FIG. 73 illustrates a detailed portion of the distal
subassembly 560, including the band 528A, a plurality of openings
532B, the band 528B, a wire 462A, and the wire 462B. In certain
implementations, the wires 462A, 462B may be different portions of
the same wire or may be separate sections of wire. As illustrated,
the wire 462A and 462B may be separated by band 528B. The wire 462A
may have a coil pitch of approximately 0.065''. The wires 462A,
462B may comprise approximately 0.003'' round wire spool 304V
spring temper material. The openings 532B may be spaced with 2 coil
pitch spacing and arranged on a top and a bottom portion of the
catheter 500 and made a fluid connection with an inner lumen of the
catheter 500. A distance D.sub.2 between the distal end of the band
528B and the distal end of the band 528A may be approximately 30
mm. The wire 462A may be disposed within this region. The bands
528A, 528B may have an inner diameter of approximately 0.032'' and
an outer diameter of approximately 0.034''. The bands 528A, 528B
may comprise a material of PT/10% IR.
[0137] FIG. 74 illustrates a detailed portion of the distal
subassembly 560, including the radiused tip 530, the band 528A, and
the wire 462A. The distance from the distal end of the band 528A
and the distal end of the radiused tip 530 is approximately 2 mm.
The radiused tip may have a radius R.sub.1 of approximately 0.28
mm.
[0138] FIG. 75 illustrates a sectional view taken from the region
of the distal subassembly 560 marked with the cutting plane A-A. As
illustrated, this section of the distal subassembly 560 has an
outer diameter of approximately 1.14 mm and an inner diameter of
approximately 0.53 mm.
[0139] All directional references (e.g., proximal, distal, upper,
lower, upward, downward, left, right, lateral, front, back, top,
bottom, above, below, vertical, horizontal, clockwise, and
counterclockwise) are only used for identification purposes to aid
the reader's understanding of the present invention, and do not
create limitations, particularly as to the position, orientation,
or use of the invention. Connection references (e.g., attached,
coupled, connected, and joined) are to be construed broadly and may
include intermediate members between a collection of elements and
relative movement between elements unless otherwise indicated. As
such, connection references do not necessarily infer that two
elements are directly connected and in fixed relation to each
other. It should be noted that delivery sheath and delivery
catheter may be used interchangeably for purposes of this
description. The exemplary drawings are for purposes of
illustration only and the dimensions, positions, order and relative
sizes reflected in the drawings attached hereto may vary.
[0140] The above specification, examples and data provide a
complete description of the structure and use of exemplary
embodiments of the invention as claimed below. Although various
embodiments of the invention as claimed have been described above
with a certain degree of particularity, or with reference to one or
more individual embodiments, those skilled in the art could make
numerous alterations to the disclosed embodiments without departing
from the spirit or scope of this invention. Other embodiments are
therefore contemplated. It is intended that all matter contained in
the above description and shown in the accompanying drawings shall
be interpreted as illustrative only of particular embodiments and
not limiting. Changes in detail or structure may be made without
departing from the basic elements of the invention as defined in
the following claims.
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