U.S. patent application number 15/850938 was filed with the patent office on 2018-05-24 for low profile occlusion balloon catheter.
The applicant listed for this patent is Prytime Medical Devices, Inc.. Invention is credited to Curtis J. FRANKLIN.
Application Number | 20180140806 15/850938 |
Document ID | / |
Family ID | 52629032 |
Filed Date | 2018-05-24 |
United States Patent
Application |
20180140806 |
Kind Code |
A1 |
FRANKLIN; Curtis J. |
May 24, 2018 |
LOW PROFILE OCCLUSION BALLOON CATHETER
Abstract
A low profile occlusion catheter having a guiding atraumatic tip
that prevents entry of the balloon into collateral vessels. The
occlusion catheter system is particularly well suited for use in
vascular occlusion and includes a pressure monitoring line to
monitor the degree and state of occlusion.
Inventors: |
FRANKLIN; Curtis J.;
(Lakewood, CO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Prytime Medical Devices, Inc. |
Boeme |
TX |
US |
|
|
Family ID: |
52629032 |
Appl. No.: |
15/850938 |
Filed: |
December 21, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14917286 |
Mar 8, 2016 |
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PCT/US14/54802 |
Sep 9, 2014 |
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15850938 |
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62010275 |
Jun 10, 2014 |
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61875498 |
Sep 9, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 25/1006 20130101;
A61M 25/008 20130101; A61L 2400/16 20130101; A61L 29/02 20130101;
A61L 29/04 20130101; A61L 29/06 20130101; C08L 77/12 20130101; A61M
2025/0002 20130101; A61M 2025/1079 20130101; A61L 29/18 20130101;
A61L 29/06 20130101; A61M 25/0068 20130101 |
International
Class: |
A61M 25/10 20130101
A61M025/10; A61L 29/04 20060101 A61L029/04; A61L 29/06 20060101
A61L029/06; C08L 77/12 20060101 C08L077/12; A61M 25/00 20060101
A61M025/00; A61L 29/02 20060101 A61L029/02; A61L 29/18 20060101
A61L029/18 |
Goverment Interests
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] This invention was made with government support under
Contract No. W81XWH-12-1-0558 awarded by U.S. Army Medical Research
Materiel Command. The government has certain rights in the
invention.
Claims
1-57. (canceled)
58. An occlusion catheter system for use in vascular occlusion, the
occlusion catheter system comprising: an inflation catheter member
having a proximal inflation member end, a distal inflation member
end and a first port at the distal inflation member end, the
inflation catheter having an inflation lumen extending from the
first port toward the proximal inflation member end; a proximal hub
having a fluid pathway, the proximal hub coupled to the proximal
inflation member end such that the fluid pathway communicates with
the inflation lumen; a wire having a proximal wire end and a distal
wire end, the wire defining a longitudinal axis and extending
longitudinally through the inflation lumen, the wire fixedly
coupled to the proximal hub near the proximal wire end; a distal
catheter member coupled to the distal wire end and extending along
the longitudinal axis, the inflation catheter member and the distal
catheter member positioned in a spaced-apart relationship from one
another along the longitudinal axis, thereby defining an
intermediate region of the wire, the distal catheter member
including an atraumatic tip projecting distally from the distal
catheter member; and a selectively expandable occlusion balloon
having a proximal balloon end and a distal balloon end, the
proximal balloon end attached to the distal inflation member end
and the distal balloon end attached to a proximal end of the distal
catheter member, the intermediate region of the wire covered by the
occlusion balloon.
59. The occlusion catheter system of claim 58, wherein the
atraumatic tip is formed as an extension of the distal catheter
member.
60. The occlusion catheter system of claim 58, wherein the distal
catheter member includes a distal catheter lumen extending along
the longitudinal axis, the distal catheter lumen coupled
concentrically about the distal wire end and a proximal end of the
atraumatic tip.
61. The occlusion catheter system of claim 58, wherein the
atraumatic tip includes an unconnected end and a generally circular
configuration curving proximally and then toward the longitudinal
axis, the unconnected end positioned near the longitudinal axis in
a relaxed state, the atraumatic tip configured to assume a linear
configuration co-axial with the longitudinal axis for delivery.
62. The occlusion catheter system of claim 58, wherein the
atraumatic tip includes a reinforcing member configured to offer
additional reinforcement to the atraumatic tip.
63. The occlusion catheter system of claim 58, wherein the wire is
constructed of a material selected from the group consisting of
nitinol, stainless steel, solid wire reinforced with an outer
winding.
64. The occlusion catheter system of claim 58, wherein the
atraumatic tip is constructed of a polymer material.
65. The occlusion catheter system of claim 58, wherein the proximal
wire end is fixedly coupled to the proximal hub by an adhesive.
66. The occlusion catheter system of claim 58, wherein the
atraumatic tip includes at least two planar opposing surfaces.
67. The occlusion catheter system of claim 58, wherein the
atraumatic tip includes two radiused curved opposing surfaces.
68. The occlusion catheter system of claim 58, wherein the
atraumatic tip includes an angle of curve, the angle of curve being
between two hundred seventy degrees and one thousand eighty degrees
(270.degree.-1080.degree.).
69. The occlusion catheter system of claim 58, wherein the
atraumatic tip includes a radio opaque tip marker.
70. The occlusion catheter system of claim 58, wherein the wire is
solid and is constructed of a metal material, the inflation
catheter member, the proximal hub, the distal catheter member and
the occlusion balloon being constructed of a polymeric
material.
71. An occlusion catheter system for use in vascular occlusion, the
occlusion catheter system comprising: an inflation catheter member
having a proximal inflation member end, a distal inflation member
end and a first port at the distal inflation member end, the
inflation catheter having an inflation lumen; a proximal hub having
a fluid pathway, the proximal hub coupled to the proximal inflation
member end such that the fluid pathway communicates with the
inflation lumen; a solid wire having a proximal wire end and a
distal wire end, the solid wire defining a longitudinal axis and
extending longitudinally through the inflation catheter member
within the inflation lumen, the solid wire fixedly coupled to the
proximal hub at the proximal wire end; a distal catheter member
coupled to the distal wire end and extending along the longitudinal
axis, the inflation catheter member and the distal catheter member
positioned in a spaced-apart relationship from one another along
the longitudinal axis, thereby defining an intermediate region of
the solid wire, the distal catheter member including an atraumatic
tip projecting distally from the distal catheter member, the
atraumatic tip including planar opposing surfaces; and an occlusion
balloon having a proximal balloon end, a distal balloon end and a
balloon space between the proximal balloon end and the distal
balloon end, the proximal balloon end attached to the distal
inflation member end and the distal balloon end attached to a
proximal end of the distal catheter member near the fist port, the
inflation lumen being in communication with the balloon space
through the first port, the balloon space surrounding the
intermediate region.
72. The occlusion system of claim 71, wherein the solid wire is
selected from the group consisting of nitinol and stainless
steel.
73. The occlusion system of claim 71, wherein the distal catheter
member is constructed of a polymeric material.
74. The occlusion system of claim 71, wherein the atraumatic tip
includes a radio opaque tip marker.
75. The occlusion system of claim 71, wherein the atraumatic tip is
constructed of a PEBAX material.
76. The occlusion system of claim 71, wherein the distal catheter
member includes a distal catheter lumen extending along the
longitudinal axis, the distal catheter lumen coupled concentrically
about the distal wire end and a proximal end of the atraumatic
tip.
77. The occlusion system of claim 71, wherein the atraumatic tip
includes a reinforcing member to reinforce the atraumatic tip.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 14/917,286, filed Mar. 8, 2016 and titled,
"Low Profile Occlusion Catheter, which is a national stage
application under 35 U.S.C. .sctn. 371 of International Patent
Application No. PCT/US2014/054802, filed Sep. 9, 2014 and titled,
"Low-Profile Balloon Occlusion Catheter," which was published under
International Publication No. WO 2015/035393 A1 and claims the
benefit of U.S. Provisional Patent Application Nos. 62/010,275,
filed on Jun. 10, 2014 and 61/875,498, filed Sep. 9, 2013, both
titled, "Low-Profile Balloon Catheter," each of the disclosures of
which are incorporated herein by reference.
BACKGROUND
[0003] The invention generally relates to percutaneously introduced
occlusion catheters, and more particularly to an occlusion catheter
having an atraumatic guiding tip formed of an elastomeric polymer.
More particularly, the present invention pertains to an occlusion
catheter in which the atraumatic guiding tip is formed of entirely
of polymer, polymer reinforced with a shape memory or superelastic
material, or entirely of a shape memory or superelastic material.
Still more particularly, the present invention pertains to an
occlusion catheter having at least one lumen suitably configured to
introduce or withdraw body fluids from a patient into which the
catheter is placed, and/or for sensing a condition within the body,
such as, for example, pressure or flow rate in the region of the
catheter. Yet still more particularly, the present invention
pertains to an occlusion catheter having a first catheter member
with a first lumen extending longitudinally through the first
catheter member and open at a distal end of the first catheter
member; a second catheter member having a second lumen extending
longitudinally through the second catheter member and open at a
distal end of the second catheter member, the second catheter
member is positioned over and in spaced apart relationship relative
to a proximal section of the first catheter member forming an
annular space between the second catheter member and the first
catheter member, the proximal section of the first catheter member
resides within the second lumen of the second catheter member and
the first catheter member extends beyond the distal end of the
second catheter member, a third catheter member having a third
lumen extending longitudinally through the third catheter member
and open at a distal end of the third catheter member; the third
catheter member is positioned over a distal section of the first
catheter member, the third catheter member having a distal section
that extends distally from a distal end of the first catheter
member such that the first lumen and the third lumen are in fluid
flow communication, whereby the second and third catheter are
spaced apart from each other along a longitudinal axis of the first
catheter member with the first catheter member extending there
between; the atraumatic guiding tip member being joined to a distal
end of the third catheter member; and an expandable member, such as
a balloon, coupled to the second catheter member and to the third
catheter member, such that the space between the second catheter
member and the third catheter member is within an area bounded by
the expandable member.
[0004] Balloon catheters generally comprise an elongated catheter
shaft with an expandable balloon on the distal end of the shaft,
and are used in a number of different medical procedures,
including, for example, angioplasty, stent placement, occlusion,
drug deliver, etc. The catheter is introduced through a
percutaneous introducer sheath and maneuvered into the patient's
blood vessels until the balloon is properly positioned within the
body, such as at the stenotic site to be dilated or at a site
requiring occlusion, drug delivery or other procedure such as stent
placement.
[0005] It is often desirable for balloon catheters to have very low
profiles in order to facilitate passage of the balloon across
severe and remote vascular obstructions. High strength materials
are commonly required in the design of balloon catheter components
to prevent shaft buckling when the balloon is inflated.
Additionally, high strength materials are required so that torque
applied to the proximal end of the catheter results in rotation of
the distal tip of the catheter. High flexibility materials are also
commonly required in the design of balloon catheter components to
maintain a low-profile and avoid trauma or perforation of the blood
vessels while the catheter is maneuvered through the patient's
tortuous vasculature.
[0006] Conventional balloon catheters, particularly those intended
for vascular occlusion, do not adequately balance the need for
proximal segment stiffness with the need for low profile, flexible
distal segment and track ability through the tortious vascular
pathway without entry into collateral vessels. Therefore, a need
exists for a low profile occlusion catheter with a high strength
and relatively stiff proximal segment and a flexible distal segment
with an atraumatic tip having a design that permits tracking along
the major vessels while preventing entry into collateral
vessels.
SUMMARY OF THE INVENTION
[0007] Described herein are systems, methods and compositions for
an occlusion catheter system comprising: a first catheter member
having a first lumen extending longitudinally through the first
catheter member and open at a distal end of the first catheter
member; a second catheter member having a second lumen extending
longitudinally through the second catheter member and open at a
distal end of the second catheter member, the second catheter
member is positioned over and in spaced apart relationship relative
to a proximal section of the first catheter member forming an
annular space between the second catheter member and the first
catheter member, the proximal section of the first catheter member
resides within the second lumen of the second catheter member and
the first catheter member extends beyond the distal end of the
second catheter member, a third catheter member having a third
lumen extending longitudinally through the third catheter member
and open at a distal end of the third catheter member; the third
catheter member is positioned over a distal section of the first
catheter member, the third catheter member having a distal section
that extends distally from a distal end of the first catheter
member such that the first lumen and the third lumen are in fluid
flow communication, whereby the second and third catheter are
spaced apart from each other along a longitudinal axis of the first
catheter member with the first catheter member extending there
between; an atraumatic tip member having a proximal section
co-axially coupled to a distal end of the third catheter member and
terminating the third lumen in the third catheter member; and an
expandable occlusion member, such as a balloon, coupled at its
proximal end to the second catheter member and at its distal end to
the third catheter member and in fluid flow communication with the
second lumen of the second catheter member, the expandable
occlusion member being positioned such that the longitudinal space
between the second catheter member and the third catheter member is
within the expandable occlusion member.
[0008] Also disclosed herein are systems, methods and compositions
for occlusion catheter system comprising: a first catheter member
having a first and second lumens extending along a longitudinal
axis thereof that forms a proximal section of the catheter system,
a second catheter member having a third lumen forming a distal
section of the catheter system and coupled to a distal end of the
first catheter member, an expandable occlusion balloon coupled at
its proximal end to a distal end of the first catheter member and
at its distal end to a proximal end of the second catheter member,
a first lumen of the first catheter member terminating within the
expandable occlusion balloon to communicate an inflation fluid to
an area within the expandable occlusion balloon and a second lumen
of the first catheter member being in fluid flow communication with
the third lumen of the second catheter member, an atraumatic
guiding tip coupled to a distal end of the third lumen of the
second catheter member; and a third catheter member having at least
one lumen passing longitudinally there through, the third catheter
member being disposed within each of the second lumen of the first
catheter member and the third lumen of the second catheter member
and passing there through.
[0009] The methods, systems, and apparatuses are set forth in part
in the description which follows, and in part will be apparent from
the description, or can be learned by practice of the methods,
apparatuses, and systems. The advantages of the methods,
apparatuses, and systems will be realized and attained by means of
the elements and combinations particularly pointed out in the
appended claims. It is to be understood that both the foregoing
general description and the following detailed description are
exemplary and explanatory only and are not restrictive of the
methods, apparatuses, and systems, as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] In the accompanying figures, like elements are identified by
like reference numerals among the several preferred embodiments of
the present invention.
[0011] FIG. 1 is a perspective view of an embodiment of a occlusion
catheter described herein.
[0012] FIG. 2 is an enlarged perspective view of the first port of
the inventive occlusion catheter depicted in FIG. 1.
[0013] FIG. 3 is a longitudinal cross-sectional view of FIG. 2.
[0014] FIG. 4 is a perspective view of a distal section of the
inventive occlusion catheter depicted in FIG. 1
[0015] FIG. 5 is a perspective longitudinal cross-sectional view
taken along line 5-5 of FIG. 4.
[0016] FIG. 6 is a cross-sectional view taken along line 6-6 of
FIG. 1.
[0017] FIG. 7 is a partial cross-sectional end view of a proximal
hub of the occlusion catheter of the present invention.
[0018] FIG. 8 is a transverse cross-sectional view taken along line
8-8 of FIG. 1 and line 8-8 of FIG. 6.
[0019] FIG. 9 is a perspective view of an alternative embodiment of
the inventive occlusion catheter.
[0020] FIG. 9A is a cross-sectional view taken along line 9A-9A of
FIG. 9.
[0021] FIG. 9B is a partial cross-sectional end view of FIG. 9.
[0022] FIG. 9C is a cross-sectional view taken along line 9C-9C of
FIG. 9
[0023] FIG. 9D is a cross-sectional view taken along line 9D-9D of
FIG. 9.
[0024] FIG. 10 is a perspective view of another alternative
embodiment of the inventive occlusion catheter depicting an
alternative embodiment of a guiding atraumatic tip.
[0025] FIG. 11 is an enlarged perspective view of the alternative
embodiment of the guiding alternative tip of FIG. 10.
[0026] FIG. 12 is a perspective view of another embodiment of a
occlusion catheter described herein.
[0027] FIG. 13 is an enlarged perspective view of the first port of
the inventive occlusion catheter depicted in FIG. 12.
[0028] FIG. 14 is a longitudinal cross-sectional view of FIG.
13.
[0029] FIG. 15 is a perspective view of a distal section of the
inventive occlusion catheter depicted in FIG. 12
[0030] FIG. 16 is a perspective longitudinal cross-sectional view
taken along line 16-16 of FIG. 15.
[0031] FIG. 17 is a cross-sectional view taken along line 17-17 of
FIG. 12.
[0032] FIG. 18 is a transverse cross-sectional view taken along
line 18-18 of FIG. 1 and line 18-18 of FIG. 6.
DETAILED DESCRIPTION OF THE INVENTION
[0033] The foregoing and other features and advantages of the
invention will become more apparent from the following detailed
description of exemplary embodiments, read in conjunction with the
accompanying drawings. The detailed description and drawings are
merely illustrative of the invention rather than limiting, the
scope of the invention being defined by the appended claims and
equivalents thereof.
[0034] While the invention has been described in connection with
various embodiments, it will be understood that the invention is
capable of further modifications. This application is intended to
cover any variations, uses or adaptations of the invention
following, in general, the principles of the invention, and
including such departures from the present disclosure as, within
the known and customary practice within the art to which the
invention pertains.
[0035] Furthermore, while the invention is described as an
occlusion catheter system, it will be understood that the inventive
occlusion catheter system may be used clinically for a variety of
different therapeutic or diagnostic indications involving vascular
interventions, including, for example and without limitation,
vascular occlusion, angioplasty, stent delivery, atherectomy, drug
delivery, imaging or the like. In accordance with an exemplary and
preferred embodiment, the inventive occlusion catheter system is
well suited for use as a vascular occlusion catheter, and in
particular an aortic occlusion balloon catheter. Applications
making advantageous use of embodiments of the invention may use any
suitable access site for vascular intervention. For example,
applications of the catheter system may involve access at the
femoral artery, the brachial artery, the subclavian artery, or any
other blood vessel suitable for use as an access site for
catheterization, including venous vessels.
[0036] In the following description, when reference is made to the
terms "proximal" or "proximally" it is intended to mean a portion
or component of the inventive occlusion catheter system that is
oriented away from the body into which the system is or is intended
to be placed. Conversely, when reference is made to the terms
"distal" or "distally" it is intended to mean a portion or
component of the inventive occlusion catheter system that is
oriented toward the body into which the system is or is intended to
be placed. Thus, for example, the guiding atraumatic tip described
hereinafter is located at a distal end of the occlusion catheter
system, while the proximal hub is located at a proximal end of the
occlusion catheter system.
[0037] As shown in the accompanying Figures, the occlusion catheter
system 100 generally includes a catheter assembly having a first
catheter member 130 having a first lumen 230, a second catheter
member 110 having a second lumen 210, a third catheter member 120
having a third lumen 220, an expandable occlusion member 140, a
proximal hub 190 and a guiding atraumatic tip 150. The first lumen
230 of the first catheter member 130 extends longitudinally through
the first catheter member and is coupled at its proximal end to the
proximal hub 190 and at its distal end to a proximal section of the
third catheter member 120 and in fluid flow communication with the
third lumen 220 of the third catheter member 120. The second lumen
210 of the second catheter member 110 also extends longitudinally
through the second catheter member 110, and terminates in a first
port 160 distal to a proximal end of and within a space 142 defined
by the expandable occlusion balloon 140, such that the second lumen
210 is in fluid flow communication with the space 142 within the
expandable occlusion member 140 to convey a fluid to and from the
expandable occlusion member 140 from a fluid source external the
occlusion catheter system 100, coupled to the proximal hub 190 via
extension lines (not shown) and in fluid communication with the
second lumen 210. The third catheter member 120 is coupled at a
proximal end thereof to a distal end of the first catheter member
130 such that the third lumen 220 of the third catheter member 120
is in fluid flow communication with the first lumen 230 of the
first catheter member 130. The second catheter member 110 and the
third catheter member 120 are positioned in longitudinal co-axial
spaced apart relationship from one and other along a longitudinal
axis of the first catheter member 130 thereby defining an
intermediate region 115 of the first catheter member 130 within the
space 142 within the expandable occlusion balloon 140 that is not
covered by either the second catheter member 110 or the third
catheter member 120.
[0038] The expandable member, such as an expandable occlusion
balloon, 140 is attached, at its proximal end 144 to a distal end
of the second catheter member 110 and at its distal end 146 to a
proximal end of the third catheter member 120. Referring to FIGS.
2-5, a proximal radio opaque marker 158 may be affixed to the first
catheter member 130 at or near the first port 160, which is near
the attachment position of the expandable occlusion balloon at the
proximal end 144 of the expandable occlusion balloon 140. A distal
radio opaque marker 159 may be affixed to the first catheter member
130 near the attachment position of the expandable occlusion
balloon on the distal end 146 of the expandable occlusion balloon
140. The proximal and distal radio opaque markers 158, 159 may be
implemented as bands made of a radio opaque material. In one
example, the radio opaque material is a metal that is radio opaque
such as stainless steel, or an alloy, such as a platinum iridium
alloy. In another example, the proximal and distal radio opaque
markers 158, 159 may be sections of the catheters that have been
impregnated with radio opaque material such as for example
stainless steel or a suitable alloy. In another example, the
proximal and distal radio opaque markers 158, 159 may be
implemented as bands or sections of polymer, such as, for example,
polyether block amide copolymer (PEBAX, Arkema, Paris, France) that
has been mixed or doped with a radio opaque substance, such as, for
example, barium sulfate. The implementation of the proximal and
distal radio opaque markers 158, 159 on the catheter system would
aid in visualization of the balloon position within the vasculature
using fluoroscopy or x-ray.
[0039] When an expandable occlusion balloon 140 is employed, it is
inflated by introducing an inflation fluid, such as saline, from an
external source, such as a syringe, coupled to the proximal hub
190, into and through the second lumen 210, out of the first port
160 and into the space 142 within the expandable occlusion balloon
140. As is known in the art, the inflation fluid is introduced
until the expandable occlusion balloon 140 is inflated to a desired
diameter volume, pressure or visual appearance when visualized
using imaging modalities such as X-ray or fluoroscopy. Deflation of
the expandable occlusion balloon 140 is simply the reverse process
of withdrawing the inflation fluid from the space 142 of the
inflation balloon 140. In its deflated or collapsed state, the
inflation balloon 140 will be positioned either within or adjacent
to the intermediate region 115 of the first catheter member 130,
thereby providing a lower profile to the entire occlusion catheter
system 100.
[0040] The third catheter member 130 is depicted more particularly
in FIGS. 4-5. Third catheter member 120 is coupled at its proximal
end to a distal end of the first catheter member 130. A second port
170 passes through a side wall of the third catheter member and
communicates between the third lumen 220 and external the occlusion
catheter system 100. The distal end of the first catheter member
positioned within the third lumen 220 terminates proximal to the
second port 170 such that a continuous fluid flow pathway is formed
between the first lumen 230, the third lumen 220 and the second
port 170 to either introduce fluid or withdraw fluid through the
second port 170. It will also be understood by those skilled in the
art that maintaining fluid communication between the first lumen
230, the second lumen 220 and the second port 170 also permits
introduction of tethered sensors, such as flow sensing wires,
pressure sensing wires or the like into and through the first lumen
230 and the third lumen 220 to a position proximate to the second
port 170.
[0041] Finally, a guiding atraumatic tip 150 is coupled to a distal
end section of the third catheter member 120. The guiding
atraumatic tip 150 may be made of an elastic, shape memory and/or
superelastic material, such as a metal or polymer. A reinforcing
member 152 (depicted in phantom) may optionally be included either
within the guiding atraumatic tip 150 or wound about an external
surface of the guiding atraumatic tip 150 to offer additional
reinforcement to the tip 150. A proximal end of the guiding
atraumatic tip 150 is coupled to a distal end of the third lumen
220 of the third catheter member 120 and a distal end of the
guiding atraumatic tip 150 projects distally from the third
catheter member 120 and preferably has a generally circular
configuration curving proximally and then toward a central
longitudinal axis of the occlusion catheter system 100, but leaving
a unconnected end of the distal end of the guiding atraumatic tip
150 to permit the tip 150 to assume a linear configuration co-axial
with the central longitudinal axis of the occlusion catheter system
100 for delivery.
[0042] In a first embodiment of the inventive occlusion catheter
system 100 illustrated in FIGS. 1-8, the occlusion catheter system
100, when the expandable member 140 is in an unexpanded condition,
is of sufficiently small cross-segmental dimension to pass through
a 6 French (2 mm) percutaneous sheath. It will be understood by
those skilled in the art that the occlusion catheter system 100 is
not limited to a dimension sufficient to pass through a 2 mm (6
French) percutaneous sheath, but that such lower profile or smaller
is generally considered desirable to enable percutaneous
introduction of the occlusion catheter system 100 and ease of
navigation through tortuous vasculature and to a desired position
within the body for purposes of vascular occlusion. The occlusion
catheter system 100 is, therefore, not intended to be limited to
this dimensional size, but may be made of smaller or larger
dimension as desired or needed depending upon the site of required
occlusion within the body.
[0043] In one embodiment of the invention, the first catheter
member 130 is formed of stainless steel metal and is radio opaque.
In accordance with another embodiment of the invention, the first
catheter member 130 of nitinol. In accordance with yet another
embodiment of the invention the first catheter member 130 formed of
biocompatible polymers. It still yet another embodiment of the
invention the first catheter member 130 is made of a metal
reinforced polymer. The first catheter member 130 lends column
strength to the occlusion catheter system 100 and provides a
functional backbone for carrying the second catheter member 110,
the third catheter member 120 and the expandable occlusion
balloon.
[0044] The outer diameter of the first catheter member 130 is
smaller than the inner diameter of the second lumen 210 of the
second catheter member 110 thereby forming an annular space 212
between the outer surface of the first catheter member 130 and the
inner surface of the second catheter member 110 210 (FIGS.
7-8).
[0045] In one embodiment of the invention, the distal end of the
second catheter member 110 may have a tapering or narrowing
diameter of the outside surface and/or the second lumen 210
diameter. Preferably, there is a minimal amount of narrowing on the
second catheter member 110 and the proximal lumen 210 to allow the
annular space 212 to remain sufficiently large down the length of
the second catheter member 110 to permit adequate flow of the
inflation fluid through the annular space 212.
[0046] Turning now to FIGS. 4-5, the distal portion of the
occlusion catheter system 100 is illustrated. The first lumen 230
of the first catheter member 130 may be used as a pressure
monitoring line, such as by using a fluid column therein to sense
pressures through the second port 170; alternatively, the first
lumen 230 may be used to introduce or withdraw fluids, such as
drugs, contrast media or blood through the second port 170.
Referring to FIG. 5, the outer surface of the first catheter member
130 is coupled to at least a portion of the inner surface of the
distal lumen 220, such that there is no annular space between the
outer surface of the first catheter member 130 and the inner
surface of the second lumen 220. In one embodiment, the portion of
the inner surface of the distal lumen 220 may be the length of the
second lumen 220. Referring now to FIG. 4, the third catheter
member 120 may include a plurality of segments of distally
decreasing durometer polymer to provide a step-down transition to
the guiding atraumatic tip 150. The number of step down durometer
segments may be between 1 and 6 and may step down in decreasing
fashion by regular or irregular increments, such, for example 75 D,
63 D, 55 D, 40 D, etc. Alternatively, the third catheter member 120
may be made of a single durometer polymer, but having distally
tapering wall thicknesses to impart a flexibility gradient to the
third catheter member 120. The plurality of segments of decreasing
durometer plastic may be abutted and be bonded together or may be
manufactured from a single extrusion including decreasing durometer
strengths. Still further, the third catheter member 120 may be
fabricated in such a manner as to have varying hardness of the
polymer material along the longitudinal length of the third
catheter member 120 in combination with varying wall thickness
along its longitudinal length. For example, as the wall thickness
along the longitudinal length lessens, the hardness of the polymer
material may also decrease. Alternatively, as the wall thickness
along the longitudinal length of the third catheter member lessens,
the hardness of the polymer material may be selected to increase.
Thus, there may be a linear relationship or an inverse relationship
between wall thickness of the third catheter member and the
hardness of the polymer forming the third catheter member.
[0047] As depicted in FIGS. 4-5, the guiding atraumatic tip 150 is
shown in its unstrained and undeformed state as it would assume
when in the body. The guiding atraumatic tip 150 is used to
minimize trauma to or perforation of the vasculature as the
occlusion catheter system 100 is advanced through the patient's
tortuous anatomy. The size, shape and material of the distal
section of the tip 150 are such that it will not pass into
collateral vessels during delivery. The guiding atraumatic tip 150
has a constrained state when passing through an introducer sheath
in which the distal section of the tip 150 is substantially linear
and co-axial with the longitudinal axis of the occlusion catheter
system 100, and a relaxed state, as depicted, which is assumed upon
exiting the introducer sheath and entering a blood vessel. As also
described with reference to an alternative embodiment of the
guiding atraumatic tip 450 described with reference to FIGS. 10-11,
below, in its unstrained and undeformed state, the guiding
atraumatic tip 150 consists generally of a polymeric cylindrical or
tubular member that has a distal section that has been formed, such
as by molding, into a curved section that forms an incomplete
circle that project proximally toward the proximal end of the
occlusion catheter system 100. The distal section has a distally
extending section that first projects distally and a curved section
continuous with the distally extending section that curves away
from the central longitudinal axis of the occlusion catheter system
100, then proximally toward the occlusion member and subtends an
incomplete generally circular arc toward the central longitudinal
axis of the occlusion catheter system 100. The angle of the curve
may be between 270 degrees to 1080 degrees, desirably the curve is
between about 300 degrees and 350 degrees such that a gap is
provided between a terminal end of the distal section and a more
proximal portion of the distal section. It will also be understood
that the distally extending section and curved section may be
formed as a generally in plane circular shape or may be formed as
an out-of-plane generally helical shape, where a terminal end of
the curved section is laterally displaced from the central
longitudinal axis of the occlusion catheter system 100.
[0048] The guiding atraumatic tip 150 may be formed of elastomeric,
shape memory or superelastic material, including metals and
polymer. The guiding atraumatic tip 150 may optionally also have a
reinforcing elastic, shape memory or superelastic core 152 which
aids in transition between the unstressed state and the stressed
state of the guiding atraumatic tip 150. In accordance with an
exemplary embodiment of the tip 150, the largest outer diameter of
the guiding atraumatic tip 150 may be between 1-7 mm, preferably
between 2-6 mm and most preferably between 4-6 mm.
[0049] The guiding atraumatic tip 150 is joined to the third
catheter member 120 by engaging a proximal section of the
atraumatic tip 150 within the third lumen 220 of the third catheter
member 120 and creating a bond between the two elements, such as by
thermal welding, thermal reflow, adhesive or other biocompatible
methods of joining catheter components as is generally known to
those skilled in the field to which this invention pertains.
[0050] Turning now to FIGS. 6-8, a proximal portion of the
occlusion catheter system 100 and the proximal hub 190 are
illustrated. The second catheter member 110 is coupled to the
proximal hub 190 and the distal end of the first catheter member
130 may be operably coupled to the proximal hub 190 at a proximal
bonding site using an adhesive 180 to bond an inner wall surface of
the proximal hub 190 to an outer wall surface of the first catheter
member 130. As illustrated, the proximal hub 190 has two fluid
pathways 192 and 194. A first fluid pathway 192 communicates with
the first lumen 230 of the first catheter member and a second fluid
pathway 194 communicates with the second lumen 210 of the second
catheter member 120. It will be understood that the proximal hub
190 may be configured to have more than two fluid pathways, with
each fluid pathway communicating with a different lumen in the
occlusion catheter system 100. The first fluid pathway 192 of the
proximal hub 190 may be connected to an external pressure sensor,
which would transduce pressure from a fluid column within the first
lumen 230 and through the second port 170 (FIG. 5).
[0051] Turning now to FIGS. 9 and 9A-9D, an alternative embodiment
of the occlusion catheter system 300 is illustrated. Like the
occlusion catheter system 100, occlusion catheter system 300
generally includes a catheter assembly including a first catheter
member 310 having at least two lumens 210, 330 passing
longitudinally through the first catheter member 310, a second
catheter member 320 having a single lumen 230 passing
longitudinally through the second catheter member 320 and an
expandable occlusion member 140. Expandable occlusion member 140
may be an inflatable balloon or may be another expandable member
capable of occluding a vessel. The first catheter member 310 is
coupled at its proximal end to a proximal hub 190 (not shown) and
at a distal end thereof to a proximal end of the expandable
occlusion member 140. The second catheter member 320 is coupled at
its distal end to a proximal end of the first catheter member 310
such that one of the first lumen 210 or the second lumen 330 is in
fluid flow communication with the second catheter member 320. The
other of the first lumen 210 or the second lumen 230 terminates at
the distal end of the first catheter member 310. For purposes of
illustration only and for clarity in the following description, it
will be assumed that second lumen 330 terminates at the distal end
of the first catheter member 310 and has a distal port opening 160,
it will also be assumed that the first lumen 210 is in fluid flow
communication with the second catheter member 320. As with the
first embodiment of the occlusion catheter system 100 described
above, the second embodiment of the occlusion catheter system 300,
when the occlusion member 140 is in an contracted state, it is of a
sufficiently small cross-sectional diameter to pass through a 6
French (2 mm) percutaneous sheath. It will be understood by those
skilled in the art that the occlusion catheter system 300 is not
limited to a dimension sufficient to pass through a 2 mm (6 French)
percutaneous sheath, but that such lower profile or smaller is
generally considered desirable to enable percutaneous insertion and
removal and passage through tortuous vasculature and to a desired
position within the body for purposes of vascular occlusion. The
occlusion catheter system 300 is, therefore, not intended to be
limited to this dimensional size, but may be made of smaller or
larger dimension as desired or needed.
[0052] Referring now to FIG. 9A, the first catheter member 310
includes first lumen 330 and a second lumen 210. The second
catheter member 320 includes a first lumen 220. The first catheter
member 310 terminates at its distal end within the space defined
under the balloon 140, where it is both coupled to the second
catheter member 320 and terminates with an open port 160 in fluid
communication with lumen 330, permitting fluid to be delivered to
and from the balloon 140 for inflation and/or deflation. In
accordance with an alternative embodiment, the distal end of the
first catheter member 310 may, optionally, be tapered, such as by
narrowing the wall thickness of the catheter member 310 or by
crimping the first catheter member 310 to a smaller diameter,
thereby compressing and reducing the open area of the first lumen
330 and the second lumen 210. If the first catheter member 310 is
crimped to a tapered diameter, it is preferable that the extent of
the crimping does not compress the open area of the first lumen 330
and the second lumen 210 in a manner that significantly reduces
fluid flow there through of fluid flow pressures therein,
particularly with the second lumen 330 when it is used for the
inflation fluid for the inflation balloon 140.
[0053] The third catheter member 130 is positioned within one of
the first lumen 210 or the second lumen 330 of the first catheter
member 310. As depicted in the figures this arrangement is
illustrated with the third catheter member 130 being positioned
within the first lumen 210 of the first catheter member 310 and
also within the first lumen 220 of the second catheter member 320.
The outer diameter of the third catheter member 130 is less than
the inner diameter of the first lumen 210 of the first catheter
member 310 as well as smaller than the inner diameter of the first
lumen 210 of the second catheter member 320, such that an annular
space 212 is formed there between as depicted in FIG. 9C. In the
more distal region of the first catheter member 310, within the
region of the distal taper discussed above, the annular space 212
is compressed and either closes or is substantially closed to fluid
flow, thereby effectively sealing the distal end of the first lumen
210 near the transition to the proximal attachment point of the
expandable occlusion balloon 140, as depicted in FIG. 9A.
[0054] The third catheter member 130 passes longitudinally into the
first lumen 230 of the second catheter member 320 and has a first
lumen 230 passing longitudinally through the third catheter member
130. As with the first catheter member 130 of the first alternative
embodiment described above, the first lumen 230 of the third
catheter member 130 permits monitoring of conditions within the
body, such as arterial pressure monitoring by hydrostatic pressure
within a fluid column within the first lumen 230, or allows for the
introduction of tethered sensors, such as flow sensing wires,
pressure sensing wires or the like to the distal end of the
occlusion catheter system 300. First lumen 230 may also be used to
deliver drugs, contrast media, or permit the introduction or
withdrawal of fluids to and from the body.
[0055] As with the alternative embodiment discussed above with
reference to FIGS. 1-8, the embodiment depicted in FIGS. 9-9D may,
optionally, include the second catheter member 320 being
constructed of plural segments having distally increasing
flexibility, such as by making the segments of distally decreasing
durometer polymer or fashioning the second catheter member 320 to
have a distally tapering wall thickness. The second catheter member
320 may be formed of discrete segments abutted and coupled together
to form an elongated second catheter member 320 with either
distally decreasing durometers or distally tapering wall
thicknesses. Alternatively, the second catheter member 320 may be
made by extrusion or molding polymers of distally decreasing
Durometer, distally tapering wall thicknesses or combinations
thereof.
[0056] As with the alternative embodiment of the occlusion catheter
system 100, the second catheter member 320 includes an open port
170 that is in fluid flow communication with the first lumen 230 of
the third catheter member. Similarly, as with the occlusion
catheter system 100, occlusion catheter system 300 includes a
guiding atraumatic tip (not shown in FIGS. 9-9D) as described above
with reference to guiding atraumatic tip 150, which is joined to a
distal end of the second catheter member 320.
[0057] With reference to FIGS. 10 and 11, there is depicted an
alternative embodiment of the guiding atraumatic tip 450. It will
be understood that guiding atraumatic tip 450 may be employed with
any of the foregoing embodiments of the inventive occlusion
catheter system 100 or of the inventive occlusion catheter system
300. Guiding atraumatic tip 450 consists generally of a polymeric
cylindrical or tubular member 452 that has a distal section 454
thereof that has been formed, such as by molding or extrusion, into
a generally flattened shape having at least two generally planar
opposing surfaces 455, 457. Depending upon the formation process,
two generally radiused curved opposing surfaces 458, 459 may also
be formed during the formation process. The distal section 454 has
a distally extending section 453 that projects distally and a
curved section 456 continuous with the distally extending section
that curves away from the central longitudinal axis of the
occlusion catheter system 100, 300 then proximally toward the
occlusion balloon and subtends a generally circular arc toward the
central longitudinal axis of the occlusion catheter system 100,
300. The angle of the curve may be between 270 degrees to 1080
degrees, desirably the curve is between about 300 degrees and 350
degrees such that a gap is provided between the terminal end of the
generally cylindrical flattened distal section 454 and the more
proximal surface of the distal section 454. It will also be
understood that the distally extending section 453 and curved
section 456 may be formed as a generally in plane circular shape or
may be formed as an out-of-plane generally helical shape, where a
terminal end of the curved section 456 is laterally displaced from
the central longitudinal axis of the occlusion catheter system 100
or occlusion catheter system 300. In this manner, the generally
flattened distal section 454 is characterized by a generally
circular, proximally oriented bend that operates in a manner
similar to the guiding atraumatic tip 150 or guiding atraumatic tip
350, but is made of a polymer material without the need for a
reinforcing member 152 as described above.
[0058] A tapered transition section 451 may, optionally, be
provided between the polymeric cylindrical or tubular member 452
and the generally flattened distal section 454. Guiding atraumatic
tip 450 may be integral with the third catheter member 120 of
occlusion catheter system 100 or the second catheter member 320 of
occlusion catheter system 300. Alternatively, guiding atraumatic
tip 450 may be fabricated as a discrete member and joined to the
third catheter member 120 of occlusion catheter system 100 or the
second catheter member 320 of occlusion catheter system 300.
[0059] The guiding atraumatic tip 450 may be made of PEBAX having a
durometer of 40, or a similar polymer, such polyurethane, that
matches the catheter shaft and balloon to make bonding easier and
more secure. As discussed above, the longitudinal flexibility of
guiding atraumatic tip 450 may be manipulated by varying the
thickness, the hardness or both properties of the curved distal
section of the guiding atraumatic tip 450. Thus the curved distal
section 456 may have a hardness of 40 D (Shore Durometer), while
the proximal section of the guiding atraumatic tip 450 may have a
higher hardness, such as 72 D (Shore Durometer). As discussed
above, the guiding atraumatic tip 450 may be either cylindrical or
tubular, or have a solid cylindrical section and a tubular section.
The curve of the guiding atraumatic tip 450 may be made by any of a
wide number of processes, including, for example, injection
molding, round extrusion, flattening and post-processing into the
curved distal section 456, a flat extrusion bonded to a round
extrusion, or an extrusion that is pressed into a hot die having a
shape of the desired curved distal section 450.
[0060] The atraumatic tip 450 may include a radio opaque tip marker
460. The radio opaque tip marker 460 may be implemented as a band
surrounding the tip 450 or as a two-dimensional planar material on
one or both of the planar opposing surfaces 455. Alternatively, the
radio opaque tip marker 460 may be located at the most distal point
of the atraumatic tip 450 indicated at 460' in FIG. 11. The band or
the planar material may be composed of any suitable radio opaque
material, such as for example, stainless steel or a suitable alloy
such as platinum iridium. In another example embodiment, the tip
450 may be made of a plastic or polymer, such as for example, PEBAX
that is impregnated or doped with a radio opaque material. In
another example embodiment, the plastic or polymer composition
forming the tip 450 may be mixed with a radio opaque compound such
as, for example, barium sulfate sufficient to permit visualization
of the tip 450 using X-ray or fluoroscopy.
[0061] In an alternative embodiment described herein with reference
to FIGS. 12-18, a occlusion catheter system 500 generally includes
a catheter assembly having a solid wire 530, an inflation catheter
member 510 having an inflation lumen 610, a distal catheter member
520, an expandable occlusion balloon 540, a proximal hub 590 and a
guiding atraumatic tip 550. The solid wire 530 extends
longitudinally through the inflation catheter member 510, and is
coupled at its proximal end to the proximal hub 590 and at its
distal end to a proximal section of the distal catheter member 520.
The inflation lumen 610 of the inflation catheter member 510 also
extends longitudinally through the inflation catheter member 510,
and terminates in a first port 560 distal to a proximal end of and
within a space 542 defined by the expandable occlusion balloon 540,
such that the inflation lumen 610 is in fluid flow communication
with the space 542 within the expandable occlusion balloon 540 to
convey an inflation fluid to and from the expandable occlusion
balloon 540 from a source external the occlusion catheter system
500. The distal catheter member 520 is coupled at a proximal end
thereof to a distal end of the solid wire 530. The inflation
catheter member 510 and the distal catheter member 520 are
positioned in longitudinal co-axial spaced apart relationship from
one and other along a longitudinal axis of the solid wire 530
thereby defining an intermediate region of the solid wire 530
within the space 542 within the expandable occlusion balloon 540
that is not covered by either the inflation catheter member 510 or
the distal catheter member 520.
[0062] In general, the alternative embodiment described herein with
reference to FIGS. 12-18 includes a wire 530 instead of a tube with
a lumen. The wire 530 may be implemented as a solid flexible wire
made of any suitable material that may be formed into a wire-like
component, or may be a solid wire reinforced with an outer wire
winding or windings. Examples of materials that may be used for the
solid flexible wire include nitinol and stainless steel. The wire
530 implementation without a lumen eliminates the fluid
communication with a third lumen having sensors thereby removing
the elements used to implement the sensing function in the catheter
system 100 described above with reference to FIGS. 1-8. The wire
530 does, however, allow for the achieving a lower profile for the
catheter system.
[0063] Referring to FIGS. 12-18, the expandable occlusion balloon
540 is attached, at its proximal end 544 to a distal end of the
inflation catheter member 510 and at its distal end 546 to a
proximal end of the distal catheter member 520. In operation,
expandable occlusion balloon 540 is inflated by introducing an
inflation fluid, such as saline, from an external source, such as a
syringe, coupled to the proximal hub 590, into and through the
inflation lumen 610, out of the first port 560 and into the space
542 within the expandable occlusion balloon 540. Inflation and
deflation of the expandable occlusion balloon 540 in FIGS. 1-8 is
performed as described above with reference to FIGS. 1-8.
[0064] Referring to FIGS. 15 and 16, the third catheter member 520
is fixedly coupled at its proximal end concentrically about a
distal end of the solid wire 530. In the example shown in FIG. 16,
the distal catheter member 520 has a lumen 620 extending
longitudinally through the distal catheter member and coupled
concentrically about a proximal end of the atraumatic tip 550. The
guiding atraumatic tip 150 may be made of an elastic, shape memory
and/or superelastic material, such as a metal or polymer. A
reinforcing member 552 (depicted in phantom) may optionally be
included either within the guiding atraumatic tip 550 or wound
about an external surface of the guiding atraumatic tip 550 to
offer additional reinforcement to the tip 550. A distal end of the
guiding atraumatic tip 550 projects distally from the distal
catheter member 520 and preferably has a generally circular
configuration curving proximally and then toward a central
longitudinal axis of the occlusion catheter system 500, but leaving
a unconnected end of the distal end of the guiding atraumatic tip
550 to permit the tip 550 to assume a linear configuration co-axial
with the central longitudinal axis of the occlusion catheter system
500 for delivery.
[0065] As noted above in the description of the first embodiment of
the inventive occlusion catheter system 100 illustrated in FIGS.
1-8, the occlusion catheter system 100, when the expandable
occlusion member 140 is in an unexpanded state, it is of
sufficiently small cross-segmental dimension to pass through a 6
French (2 mm) percutaneous sheath. It will be understood by those
skilled in the art that example implementations of the occlusion
catheter system 500 described herein with reference to FIGS. 12-18
may have an even smaller cross-sectional dimension due to the use
of a solid wire 530 instead of a catheter with a lumen. The
diameter of the solid wire 530 is smaller than the inner diameter
of the inflation lumen 610 of the inflation catheter member 510
thereby forming an annular space 612 between the outer surface of
the solid wire 530 and the inner surface of the inflation catheter
member 510. The dimensions of the inner diameter of the inflation
lumen 610 and the diameter of the solid wire 530 may be specified
in example implementations to provide optimal inflation fluid flow
as well as a reduced profile that may further ease deployment.
[0066] Turning now to FIGS. 14-16, the distal portion of the
occlusion catheter system 500 is illustrated. As shown in FIG. 16,
the outer surface of the solid wire 530 is coupled to at least a
portion of the inner surface of the second lumen 620, such that
there is no annular space between the outer surface of the solid
wire 530 and the inner surface of the second lumen 620. Referring
now to FIG. 15, the distal catheter member 520 may include a
plurality of segments of distally decreasing durometer polymer to
provide a step-down transition to the guiding atraumatic tip 150.
The number of step down durometer segments may be between 1 and 6
and may step down in decreasing fashion by regular or irregular
increments, such, for example 75 D, 63 D, 55 D, 40 D, etc.
Alternatively, the distal catheter member 520 may be made of a
single durometer polymer, but having distally tapering wall
thicknesses to impart a flexibility gradient to the third catheter
member 520. The plurality of segments of decreasing durometer
plastic may be abutted and be bonded together or may be
manufactured from a single extrusion including decreasing durometer
strengths, wall thicknesses, or combinations thereof.
[0067] In an alternative embodiment, the wire 530 extends
completely into the space shown for the second lumen 620 such that
the distal catheter member 520 completely covers the distal end of
the wire 530. The atraumatic tip 550 may also be formed as an
extension of the second catheter body 520 rather than as a separate
member joined to the second catheter body 520.
[0068] Turning now to FIG. 17, the proximal portion of the
occlusion catheter system 500 is illustrated. The inflation
catheter member 510 is coupled to the proximal hub 590 and the
distal end of the solid wire 530 is fixedly coupled to the proximal
hub 590 at a proximal bonding site using an adhesive 580 to bond an
inner wall surface of the proximal hub 590 to an outer wall surface
of the solid wire 530. The amount of adhesive 580 used should be
sufficient to fixedly couple the solid wire 530 to the proximal hub
590. As shown in FIG. 17, the adhesive 580 may fill the entire
portion 592 of the proximal hub 590 that holds the solid wire 530.
Since the solid wire 530 has no lumen, no fluid pathway is needed
in the portion 592 that holds the solid wire 530. As illustrated,
the proximal hub 190 has a single fluid pathway 694. The fluid
pathway--694 communicates with the inflation lumen 610 of the
inflation catheter member 520. It will be understood that the
proximal hub 590 may be configured to have more than the single
fluid pathway 694, with each fluid pathway communicating with a
different one of any additional lumens in the occlusion catheter
system 500.
[0069] It will be understood that when reference is made to
coupling two or more component pieces of the occlusion catheter
system, that conventional catheter material bonding modalities are
intended to be encompassed and employed. For example, a wide
variety of biocompatible adhesives useful in catheter manufacture
are known, similarly, thermobonding techniques used in catheter
manufacture are also known. Thus, for example, where it is
described that the guiding atraumatic tip is coupled to the third
catheter member or to the distal catheter member, it is
contemplated that such coupling may be made using thermobonding,
biocompatible adhesives or other methods of fixedly bonding two
components in medical devices.
[0070] It will also be understood by those skilled in the art that
it is well known to manufacture catheters of a variety of medical
grade, biocompatible polymers, such as, for example and without
limitation, silicone, nylon, polyurethane, PETE, latex,
thermoplastic elastomers, polyether block amides (PEBAX, Arkema,
Paris, France). Alternatively, it is known to manufacture catheters
of metals, such as nitinol or stainless steel. Similarly, it is
known to manufacture catheters of metal-reinforced polymer, such
as, for example and without limitation, stainless steel braiding
over polyurethane, stainless steel helical windings over silicone
or nitinol reinforced polymer. Thus, any or all of the first
catheter member, the second catheter member, the inflation catheter
member, the distal catheter member, or the third catheter member in
any of the foregoing embodiments may be fabricated of biocompatible
polymers, biocompatible metals or metal-reinforced polymers, as is
known in the art.
[0071] It will also be understood by those skilled in the art that
while the implementation of radio opaque markers are described in
the context of embodiments described with reference to FIGS. 1-8,
it may be desirable to include radio opaque marker bands positioned
at the proximal and distal ends of the balloon in implementations
of embodiments described above with reference to FIGS. 9-11, and
embodiments described above with reference to FIGS. 12-18. It is
also desirable to include length markers on the outer catheter
shaft to indicate to the physician the insertion depth of the
occlusion catheter system 100, the occlusion catheter system 300,
or the occlusion catheter system 500. The length markers may be
printed or laser etched onto the outside of the catheter shaft.
[0072] It will also be understood by those skilled in the art that
it is well known to coat the catheters and balloons with a variety
of coatings, including without limitation, antibacterial,
antimicrobial, lubricants, anticoagulant and/or antifouling
coatings. Thus, any or all of the first catheter members, the solid
wire, the inflation catheter member, the second catheter member,
the distal catheter member, the third catheter member, the
expandable occlusion balloon or the guiding atraumatic tip may
further include one or more coatings as is known in the art.
* * * * *