U.S. patent application number 09/745828 was filed with the patent office on 2002-06-27 for multi lumen catheter shaft.
This patent application is currently assigned to Advanced Cardiovascular Systems, Inc. Invention is credited to Sanchez, Diana M., Stamberg, Barbara E..
Application Number | 20020082548 09/745828 |
Document ID | / |
Family ID | 24998407 |
Filed Date | 2002-06-27 |
United States Patent
Application |
20020082548 |
Kind Code |
A1 |
Sanchez, Diana M. ; et
al. |
June 27, 2002 |
MULTI LUMEN CATHETER SHAFT
Abstract
The invention is generally directed to an intraluminal catheter
systems including an elongated shaft having proximal and distal
shaft sections, and an inflatable member disposed on the distal
shaft section and having an interior chamber. A guidewire receiving
lumen extends along at least a portion of the proximal shaft
section and at least a portion of the distal shaft section and
extends distally to the shaft distal end. An inflation lumen
extends along at least a portion of the proximal shaft section and
at least a portion of the distal shaft section to a point proximal
to a shaft distal end and is in fluid communication with the
inflatable member interior chamber. The proximal shaft section has
multiple non-concentric lumens with at least one lumen forming at
least a portion of the guidewire receiving lumen and at least one
lumen forming at least a portion of the inflation lumen.
Inventors: |
Sanchez, Diana M.; (Santa
Clara, CA) ; Stamberg, Barbara E.; (San Jose,
CA) |
Correspondence
Address: |
Edward J. Lynch
Heller Ehrman White & McAuliffe LLP
525 University Avenue
Palo Alto
CA
94301-1900
US
|
Assignee: |
Advanced Cardiovascular Systems,
Inc
|
Family ID: |
24998407 |
Appl. No.: |
09/745828 |
Filed: |
December 21, 2000 |
Current U.S.
Class: |
604/96.01 |
Current CPC
Class: |
A61M 2025/0063 20130101;
A61M 25/0026 20130101; A61M 2025/0039 20130101; A61M 25/0021
20130101; A61M 25/005 20130101; A61M 2025/004 20130101; A61M 25/104
20130101; A61M 2025/1061 20130101; A61M 2029/025 20130101; A61M
25/0052 20130101 |
Class at
Publication: |
604/96.01 |
International
Class: |
A61M 029/00 |
Claims
What is claimed is:
1. An intravascular catheter, comprising: an elongated shaft having
proximal and distal ends; a proximal shaft section having a
plurality of tubular members forming non-concentric lumens with at
least one lumen forming at least a portion of a guidewire receiving
lumen, and at least one lumen forming at least a portion of an
inflation lumen; a distal shaft section including an outer tubular
member having a proximal extremity disposed about and securely
attached to a distal extremity of the proximal shaft section, at
least a portion of the guidewire receiving lumen extending along at
least a portion of the distal shaft section distally to the shaft
distal end, and at least a portion of the inflation lumen extending
along at least a portion of the distal shaft section to a point
proximal to the shaft distal end; and an inflatable member disposed
on the distal shaft section and having proximal and distal ends and
an interior chamber in fluid communication with the inflation
lumen.
2. The catheter of claim 1, wherein the proximal extremity of the
outer tubular member forms a seal with at least a portion of each
of the proximal shaft lumens.
3. The catheter of claim 1 wherein all of the proximal shaft lumens
except the guidewire receiving lumen are non-guidewire lumens
circumferencially disposed about the guidewire lumen.
4. The catheter of claim 1 wherein the transverse centers of the
non-guidewire receiving lumens form a triangular arrangement.
5. The catheter of claim 1, 3, or 4 wherein the proximal shaft
section includes at least three non-concentric lumens.
6. The catheter of claim 5 wherein the proximal shaft section
includes at least four non-concentric lumens.
7. The catheter of claim 3 wherein the non-guidewire receiving
lumens are inflation lumens.
8. The catheter of claim 3 wherein the non-guidewire receiving
lumens are longitudinally set apart.
9. The catheter of claim 8 wherein the guidewire receiving lumen
extends distally beyond the non-guidewire receiving lumens.
10. The catheter of claim 3 wherein the distal shaft section
includes an inner tubular member extending along at least a portion
of the outer tubular member to the shaft distal end, and forming at
least a portion of the guidewire receiving lumen in the distal
shaft section and defining with the outer tubular member at least a
portion of the inflation lumen.
11. The catheter of claim 10 wherein the guidewire receiving lumen
includes a proximal guidewire receiving lumen, and a distal
guidewire receiving lumen formed by the inner tubular member in the
distal shaft section, the proximal and the distal guidewire lumens
being in fluid communication with one another.
12. The catheter of claim 11 wherein a proximal extremity of the
inner tubular member is sealingly disposed about a distal extremity
of the proximal guidewire lumen and forming a junction
therebetween.
13. The catheter of claim 11 wherein the inner tubular member
extends proximally within the proximal guidewire receiving lumen to
the shaft proximal end.
14. The catheter of claim 10 wherein a reinforcing member extends
within at least a portion of the guidewire receiving lumen.
15. The catheter of claim 14 wherein the reinforcing member extends
within at least a portion of the guidewire receiving lumen
extending in the distal shaft section.
16. The catheter of claim 3 wherein the outer tubular member is
tapered in the distal direction.
17. The catheter of claim 16 wherein the outer tubular member taper
is in steps.
18. The catheter of claim 16 wherein the outer tubular member taper
is continuous.
19. The catheter of claim 12 wherein the junction between the inner
tubular member and the proximal guidewire lumen is in an area
within the outer tubular member having a non-tapered length.
20. An intravascular catheter, comprising: an elongated shaft
having proximal and distal ends; a proximal shaft section having at
least three non-concentric lumens with at least one lumen forming
at least a portion of a guidewire receiving lumen, and at least one
lumen forming at least a portion of an inflation lumen; a distal
shaft section including an outer tubular member having a proximal
extremity disposed about and securely attached to a distal
extremity of the proximal shaft section, at least a portion of the
guidewire receiving lumen extending along at least a portion of the
distal shaft section distally to the shaft distal end, and at least
a portion of the inflation lumen extending along at least a portion
of the distal shaft section to a point proximal to the shaft distal
end; and an inflatable member disposed on the distal shaft section
and having proximal and distal ends and an interior chamber in
fluid communication with the inflation lumen.
Description
FIELD OF INVENTION
[0001] The invention relates to the field of intravascular
catheters, and particularly to a catheter suitable for angioplasty
and/or stent deployment, and the like.
BACKGROUND OF THE INVENTION
[0002] In percutaneous transluminal coronary angioplasty (PTCA)
procedures a guiding catheter is advanced in the patient's
vasculature until the distal tip of the guiding catheter is seated
in the ostium of a desired coronary artery. A guidewire is first
advanced out of the distal end of the guiding catheter into the
patient's coronary artery until the distal end of the guidewire
crosses a lesion to be dilated. A dilatation catheter, having an
inflatable balloon on the distal portion thereof, is advanced into
the patient's coronary anatomy over the previously introduced
guidewire until the balloon of the dilatation catheter is properly
positioned across the lesion. Once properly positioned, the
dilatation balloon is inflated with inflation fluid one or more
times to a predetermined size at relatively high pressures so that
the stenosis is compressed against the arterial wall and the wall
expanded to open up the vascular passageway. Generally, the
inflated diameter of the balloon is approximately the same diameter
as the native diameter of the body lumen being dilated so as to
complete the dilatation but not overexpand the artery wall. After
the balloon is finally deflated, blood flow resumes through the
dilated artery and the dilatation catheter and the guidewire can be
removed therefrom.
[0003] In such angioplasty procedures, there may be restenosis of
the artery, i.e. reformation of the arterial blockage, which
necessitates either another angioplasty procedure, or some other
method of repairing or strengthening the dilated area. To reduce
the restenosis rate of angioplasty alone and to strengthen the
dilated area, physicians now normally implant an intravascular
prosthesis, generally called a stent, inside the artery at the site
of the lesion. Stents may also be used to repair vessels having an
intimal flap or dissection or to generally strengthen a weakened
section of a vessel or to maintain its patency. Stents are usually
delivered to a desired location within a coronary artery in a
contracted condition on a balloon of a catheter which is similar in
many respects to a balloon angioplasty catheter, and expanded
within the patient's artery to a larger diameter by expansion of
the balloon. The balloon is deflated to remove the catheter and the
stent left in place within the artery at the site of the dilated
lesion. See for example, U.S. Pat. No. 5,507,768 (Lau et aL.) and
U.S. Pat. No. 5,458,615 (Klemm et al.), which are incorporated
herein by reference. Thus, stents are used to keep open a stenosed
vessel, and strengthen the dilated area by remaining inside the
vessel. Instead of first using one catheter to dilate the body
lumen and a second catheter to deploy the stent after the
dilatation, the stent may be mounted on a balloon catheter and
deployed at the same time the balloon is inflated to dilate the
stenotic region.
[0004] Conventional balloon catheters for intravascular procedures,
such as angioplasty and stent delivery, frequently have relatively
stiff proximal shaft sections to facilitate advancement of the
catheter within the patient's body lumen and a relatively flexible
distal shaft sections to facilitate passage through tortuous
anatomy such as distal coronary and neurological arteries without
damage to the luminal wall. Typically, there is an intermediate
shaft section or junction between the relatively stiff proximal
shaft section and the relatively flexible distal shaft section
which provides a transition between the proximal shaft section and
less flexible than the distal shaft section.
[0005] A variety of shaft or junction designs have been utilized to
enhance the transition between the more stiff proximal shaft and
the more flexible distal shaft sections. However, what has been
needed is a catheter with enhanced transition and improved overall
and distal trackability, as well as improved inflation/deflation
performance. The present invention satisfies these and other
needs.
SUMMARY OF THE INVENTION
[0006] The invention is generally directed to an intraluminal
catheter system with an improved transition between a proximal
shaft portion and a more flexible distal shaft portion. The
improvement provides enhanced flexibility and kink-resistance,
thus, facilitating advancement through tortuous anatomy. The
present catheters may be used for either or both angioplasty and
stent deployment.
[0007] The catheters of the present invention includes an elongated
shaft having proximal and distal shaft sections, an inflatable
member disposed on the distal shaft section and having proximal and
distal ends and an interior chamber. A guidewire receiving lumen
extends along at least a portion of the proximal shaft section and
at least a portion of the distal shaft section and extends distally
to the shaft distal end. An inflation lumen extends along at least
a portion of the proximal shaft section and at least a portion of
the distal shaft section to a point proximal to a shaft distal end
and is in fluid communication with the inflatable member interior
chamber. The proximal shaft section has a plurality of tubular
members forming non-concentric lumens with at least one lumen
forming at least a portion of the guidewire receiving lumen and at
least one lumen forming at least a portion of the inflation
lumen.
[0008] The proximal shaft section has multiple non-concentric
lumens with at least one lumen forming at least a portion of the
guidewire receiving lumen and at least one lumen forming at least a
portion of the inflation lumen. In one embodiment, there are at
least three non-concentric lumens while in another embodiment there
are at least four such lumens. The distal shaft section includes an
outer tubular member with a proximal extremity disposed about and
securely attached to a distal extremity of the proximal In one
embodiment, the proximal extremity of the outer tubular member
forms a seal with at least a portion of each of the proximal shaft
lumens.
[0009] In a presently preferred embodiment, all of the proximal
shaft lumens except the guidewire lumen are non-guidewire receiving
lumens circumferencially disposed about the guidewire receiving
lumen. Preferably, the multiple non-concentric lumens are disposed
such that the transverse centers of the non-guidewire receiving
lumens form a triangular arrangement.
[0010] Preferably, the non-guidewire lumens are inflation lumens
usable in the delivery of all fluids, such as inflation fluids, to
and from the catheter. In a preferred embodiment, the non-guidewire
lumens are longitudinally set apart with the guidewire receiving
lumen extending distally beyond the non-guidewire lumens.
[0011] In one embodiment, the distal shaft section includes an
inner tubular member extending along at least a portion of the
outer tubular member to the shaft distal end. The inner tubular
member forms at least a portion of the guidewire receiving lumen in
the distal shaft section and defines with the outer tubular member
at least a portion of the inflation lumen.
[0012] In another embodiment, the guidewire receiving lumen
includes a proximal guidewire receiving lumen, and a distal
guidewire receiving lumen formed by the inner tubular member in the
distal shaft section, with the two guidewire lumens being in fluid
communication with one another.
[0013] In an embodiment, a proximal extremity of the inner tubular
member is sealingly disposed about a distal extremity of the
proximal guidewire lumen and forming a junction therebetween.
[0014] In another embodiment, the inner tubular member extends
proximally within the proximal guidewire receiving lumen to the
shaft proximal end.
[0015] In a presently preferred embodiment, a reinforcing member,
such as a coil, extends within at least a portion of the guidewire
receiving lumen, preferably, within at least a portion of the
guidewire receiving lumen extending in the distal shaft
section.
[0016] The outer tubular member can be tapered the distal
direction. The tapering of the outer tubular member can be
continuous or in steps.
[0017] The catheter of the present invention provides an improved
design with superior pushability in the proximal shaft section, a
greater degree of flexibility in the distal shaft section for more
distal advancement of the catheter and an intermediate shaft
section with a smoother, more flexible transition between the
proximal and distal shaft sections.
[0018] Additionally, the catheters of the present invention provide
enhanced deflation/inflation performance as well as improved
reliability, as for example, little or no inner member collapse.
Furthermore, the present invention provides a more balanced
distribution of the inflation/deflation lumens, hence, improved
guide wire movement within the guide wire lumen.
[0019] These and other advantages of the invention will become more
apparent from the following detailed description of the invention
and the accompanying exemplary drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1 is a schematic, elevational view, partially in
section, of a catheter system embodying features of the
invention.
[0021] FIG. 2 is a transverse cross sectional view of the catheter
system of FIG. 1 taken along lines 2-2.
[0022] FIG. 3 is a transverse cross sectional view of the catheter
system of FIG. 1 taken along lines 3-3.
[0023] FIG. 4 is a transverse cross sectional view of the catheter
system of FIG. 1 taken along lines 4-4.
[0024] FIG. 5A is a transverse cross sectional view of the catheter
system of FIG. 1 taken along lines 5A-5A.
[0025] FIG. 5B is a transverse cross sectional view of another
embodiment of the catheter system of FIG. 1 taken along lines 5B-5B
showing the junction.
[0026] FIG. 6 is a transverse cross sectional view of the catheter
system of FIG. 1 taken along lines 6-6.
[0027] FIG. 7A is a is schematic, longitudinal cross sectional view
of an alternate embodiment of the catheter of FIG. 1 along a
portion of the distal shaft section.
[0028] FIG. 7B is a transverse cross sectional view of the catheter
system of FIG. 7 taken along lines 7B-7B.
[0029] FIG. 8A is a schematic, longitudinal cross sectional view of
an alternate embodiment of the catheter of FIG. 7A showing the
inner tubular member extending along substantially the entire
length of the proximal guidewire lumen.
[0030] FIG. 8B is a transverse cross sectional view of the catheter
system of FIG. 8A taken along lines 8B-8B.
[0031] FIG. 9 is a schematic, enlarged, longitudinal cross
sectional view of an alternate embodiment of the catheter of FIG. 7
along a portion of the distal shaft section showing the guidewire
lumen including a coil member.
[0032] FIG. 10 is a transverse cross sectional view of the catheter
system of FIG. 9 taken along lines 10-10.
[0033] FIG. 11 is a schematic, enlarged, longitudinal cross
sectional view of an alternate embodiment of the catheter of FIG.
10 showing the coil extending to the proximal end of the catheter
shaft.
[0034] FIG. 12 is a transverse cross sectional view of the catheter
system of FIG. 11 taken along lines 12-12.
[0035] FIG. 13 is a schematic, enlarged, longitudinal cross
sectional view of an alternate embodiment of the catheter of FIG. 7
showing a stiffening mandrel disposed along the interior of one of
the inflation lumens.
[0036] FIG. 14 is a transverse cross sectional view of the catheter
system of FIG. 13 taken along lines 14-14.
[0037] FIG. 15 is a transverse cross sectional view of an alternate
embodiment of the catheter system of FIG. 13 taken along lines
15-15 showing one of the lumens having a solid interior.
[0038] FIG. 16 is a transverse cross sectional view of an alternate
embodiment of the catheter system of FIG. 1 showing the proximal
catheter shaft having a solid wall thickness between the adjacent
non-guidewire lumens.
[0039] FIG. 17 is a transverse cross sectional view of an alternate
embodiment of the catheter system of FIG. 1 taken along lines 17-17
showing the proximal catheter shaft including three lumens.
[0040] FIG. 18 is a transverse cross sectional view of an alternate
embodiment of the catheter system of FIG. 1 taken along lines
18-18.
[0041] FIG. 19 is a schematic, enlarged, longitudinal cross
sectional view of an alternate embodiment of the catheter of FIG. 1
showing an exterior jacket disposed along at least a portion of the
catheter shaft.
[0042] FIG. 20 is a transverse cross sectional view of the catheter
system of FIG. 19 taken along lines 20-20.
[0043] FIG. 21 is a transverse cross sectional view of an alternate
embodiment of catheter system of FIG. 19 taken along lines
21-21.
[0044] FIG. 22 is a transverse cross sectional view of the multi
lumens of FIG. 1 after the lumens are first trimmed.
[0045] FIG. 23 is a transverse cross sectional view of the multi
lumens of FIG. 22 showing the exterior surface of the guidewire
lumen after reshaping.
[0046] FIG. 24 is a transverse cross sectional view of the multi
lumens of FIG. 18 after the lumens are first trimmed.
[0047] FIG. 25 is a transverse cross sectional view of the multi
lumens of FIG. 24 showing the exterior surface of the guidewire
lumen after reshaping.
DETAILED DESCRIPTION OF THE INVENTION
[0048] FIGS. 1 through 6 illustrate an intravascular catheter 10
embodying features of the invention and generally including an
elongated catheter shaft 13 with a proximal shaft section 16, a
distal shaft section 19, and a radially expansive inflatable
balloon 22 with an interior chamber 25 on a distal portion 28 of
the distal shaft section 19. An adapter 31 is shown mounted on a
proximal end 34 of the proximal shaft section 16.
[0049] The proximal shaft section 16 includes a plurality of lumens
37 extending from the proximal end 34 of the proximal shaft section
16 to at least a proximal portion 40 of the distal shaft section
19. One of the lumens 37 is a guidewire lumen 43 extending distally
to a shaft distal end 46 for slidably receiving a guidewire 49
therein. At least one of a remaining lumens 52, which are not
guidewire lumens, forms at least part of an inflation lumen 55
extending along at least a portion of the proximal shaft section 16
to a point within the distal shaft section 19. Preferably, the
non-guidewire lumens 52, or as used herein forward, inflation
lumens, include a plurality of the inflation lumens 55, more
preferably, as many as there are lumens 37 less the guidewire lumen
43, as for example, inflation lumens 58, 61, and 64, shown in FIG.
1. It should be understood by those skilled in the art, that
inflation lumen 55 is meant to include a lumen used for both
inflation and/or deflation of the inflatable member 22, as well as,
lumens used separately for inflation, deflation, or any other fluid
delivery, to and from the shaft 13.
[0050] The distal shaft section 19 includes an outer tubular member
67 having a proximal extremity 70 disposed about and securely
attached to a distal extremity 73 of the proximal shaft section 16
at a junction 76. Preferably, in the embodiment shown in FIG. 1,
the outer tubular member 67 forms a seal 79 with at least a portion
of the exterior of the non-guidewire lumens 52, preferably, also
the guidewire lumen 43. The seal at the junction 76 can be formed
in any suitable form, such as a laser seal (FIG. 5A) or an adhesive
seal (FIG. 5B). The distal shaft section 19 further includes at
least a portion of the guidewire lumen 43. A single annular
inflation lumen 82, defined at least in part, by the outer tubular
member 67 and at least a portion of the exterior of the guidewire
lumen 43 is in fluid communication with at least one of the
inflation lumens 55 and extends to a location spaced proximal to
the distal end 46 of the catheter shaft 13.
[0051] The distal shaft section 19, optionally, along its proximal
portion 40 extending from a distal shaft section proximal end to a
proximal balloon seal 91 can be tapered in the distal direction to
a smaller transverse dimension, to include a first non-tapered
portion 94 followed by a tapering portion 97. The tapering portion
97 may be a continuous taper, or in the alternative, include
non-tapering segments. As shown in FIG. 1, the tapering portion 97
includes a tapered segment 100, with a non-tapered segment 103,
disposed distal to the tapered segment 100.
[0052] The lumens 37 at a proximal portion 106 thereof form a
distal seal 109 with the adapter 31. Additionally, the guidewire
lumen 43, extends further proximally forming a proximal seal 112
with the adapter 31.
[0053] The inflation lumens 55 are circumferentially disposed about
the guidewire lumen 43. Preferably, the center of each of the
inflation lumens 55 is 120.degree. apart from the center of an
adjacent inflation lumen 55. In a presently preferred embodiment, a
wall thickness 115 of each of the inflation lumens 55 is
substantially the same, including a wall thickness 118 between the
guidewire lumen 43 and an adjacent inflation lumen 55.
[0054] In the embodiment of FIG. 1 (e.g., FIG. 4), the outer
surface of each of the adjacent inflation lumens 55 is set apart
from an adjacent inflation lumen 55 such that the inflation lumens
55 are not in an abutting relationship with one another. However,
it should be appreciated by those skilled in the art that the
inflation lumens 55 may be of a dimension such that their exterior
walls may come into contact with one another, as for example shown
in other embodiments such as FIG. 15 below.
[0055] The catheter 10 of the present invention has a longitudinal
dimension ranging from about 135 cm to about 145 cm, preferably
from about 142 cm to about 144 cm, normally 143 cm.
[0056] The proximal shaft section 16 has a longitudinal dimension
ranging from about 90 cm to about 120 cm, preferably from about 100
cm to about 115 cm, normally 110 cm.
[0057] Distal and proximal adapter seals 109 and 112, respectively,
have a longitudinal dimension ranging from about 0.8 cm to about
1.2 cm, preferably, from about 0.9 cm to about 1.0 cm.
[0058] The seal 79 between the proximal extremity 70 of the outer
tubular member 67 and the distal extremity 73 of the proximal shaft
section 16, has a longitudinal dimension ranging from about 0.5 cm
to about 1.5 cm, preferably, from about 0.5 cm to about 0.7 cm.
[0059] In a presently preferred embodiment, the inflation lumens 55
are circular with a uniform wall thickness and having an inner
diameter ranging from about 0.008 inch to about 0.020 inch, more
preferably, from about 0.09 inch to about 0.011 inch; and an outer
diameter ranging from about 0.014 inch to about 0.026 inch, more
preferably, from about 0.015 inch to about 0.017 inch.
[0060] Preferably, the guidewire lumen 43 has an inner diameter
ranging from about 0.014 inch to about 0.022 inch, more preferably,
from about 0.016 inch to about 0.018 inch; and an outer diameter
ranging from about 0.020 inch to about 0.028 inch, more preferably,
from about 0.022 inch to about 0.024 inch.
[0061] The proximal shaft section 16 at its greatest transverse
dimension 121, has a dimension ranging from about 0.040 inch to
about 0.076 inch, preferably, from about 0.042 inch to about 0.048
inch. The inflation lumens 55, preferably, are longitudinally set
apart and terminate within the outer tubular member 67, at a point
distal to the junction 76, with the guidewire lumen 43 extending
the farthest distally. In the embodiment features of which
illustrated in FIGS. 1 and 6, the guidewire lumen 43 extends
distally to the distal end 46 of the shaft 13.
[0062] The shortest inflation lumen 58 extends within the outer
tubular member 67 in a range from about 1.5 cm to about 2.5 cm,
preferably, from about 1.0 cm to about 2.0 cm, typically, 1.5 cm.
The inflation lumens 55 are longitudinally set apart from each
other in a range from about 1.5 cm to about 3.0 cm, preferably,
from about 2.0 cm to about 2.5 cm, typically 2.0 cm.
[0063] The distal shaft section 19 has a longitudinal dimension
ranging from about 15 cm to about 50 cm, preferably from about 25
cm to about 45 cm, normally 35 cm.
[0064] The proximal portion 40 of the distal shaft section 19, has
a longitudinal dimension ranging from about 12 cm to about 50 cm,
preferably, ranging from about 22 cm to about 42 cm, typically,
about 25 cm. When tapered, the first non-tapered portion 94 has a
longitudinal dimension ranging from about 5 cm to about 50 cm,
preferably, from about 5 cm to about 15 cm, typically 5 cm; the
tapering portion 97 has a longitudinal dimension ranging from about
5.0 cm to about 45 cm, preferably, from about 7 cm to about 25 cm,
typically 7.5 to 10 cm; with the first tapered segment 100 having a
longitudinal dimension ranging from about 5 cm to about 20 cm,
preferably, from about 7.5 cm to about 10 cm, typically 7.5 cm; and
the non-tapered segment 103 having a longitudinal dimension ranging
from about 1 cm to about 25.0 cm, preferably, from about 19 cm to
about 21 cm, typically 20 cm.
[0065] The distal shaft section 19 has a first transverse outer
dimension (i.e., outer diameter) at the non-tapered portion 94
ranging from about 0.042 inch to about 0.080 inch, preferably, from
about 0.045 inch to about 0.052 inch, typically 0.050 inch, with a
tapering outer diameter along the first tapered segment 100, and
tapering to a distal outer diameter at the non-tapered segment 103
of the tapering portion 97 ranging from about 0.030 inch to about
0.050 inch, typically 0.032 inch.
[0066] The distal shaft section 19 has a first inner diameter at
the nontapered portion 94 ranging from about 0.038 inch to about
0.076 inch, preferably, from about 0.040 inch to about 0.050 inch,
typically 0.045 inch, with a tapering inner diameter along the
first tapered segment 100, and tapering to a distal inner diameter
at the non-tapered segment 103 of the tapering portion 97 ranging
from about 0.026 inch to about 0.030 inch, typically 0.028
inch.
[0067] In an alternate embodiment, features of which illustrated in
FIGS. 7A and 7B, the guidewire lumen 43, is formed of at least two
lumens, proximal and distal guidewire lumens 124 and 127,
respectively; fluidically connected at a point 128 within the outer
tubular member 67 in the distal shaft section 19. The proximal
guidewire lumen 124 is formed as part of the plurality of lumens
37, with the distal guidewire lumen 127 at the distal shaft section
19, formed of an inner tubular member 130. In the embodiment
illustrated in FIG. 7, the inner tubular member 130 at a proximal
extremity 133 is sealingly disposed about a distal extremity 136 of
the proximal guidewire lumen 124, forming a seal 137. The seal 137
may be formed by adhesive or laser bond or the like, and is
preferably, located along the first non-tapered portion 94 of the
outer tubular member 67. Preferably, the seal 137 has a
longitudinal dimension ranging from about 0.7 cm to about 0.3 cm,
preferably from about 0.4 cm to about 0.5 cm, typically, 0.5
cm.
[0068] When the guidewire lumen 43 includes a proximal guidewire
lumen 124 and an inner tubular member 130, a distal end 138 of the
proximal guidewire lumen 124 is longitudinally set apart from a
distal end 139 of the longest inflation lumen 64 in a range from
about 0.5 cm to about 1.5 cm, preferably, from about 0.8 cm to
about 1.2 cm, typically 1.0 cm.
[0069] In an alternate embodiment, shown in FIGS. 8A and 8B, the
inner tubular member 130 may extend along substantially the entire
length of the proximal guidewire lumen 124. The inner tubular
member 130 has a longitudinal dimension ranging from about 142 cm
to about 152 cm, preferably, from about 149 cm to about 151 cm,
typically about 150 cm; an outer diameter ranging from about 0.018
inch to about 0.028 inch, preferably, from about 0.018 inch to
about 0.025 inch, typically about 0.018 inch; and an inner diameter
ranging from about 0.014 inch to about 0.022 inch, preferably, from
about 0.016 inch to about 0.018 inch, typically about 0.016 inch to
0.0165 inch.
[0070] Now referring to FIGS. 9 and 10, in yet another embodiment,
a reinforcing member such as a coil member 142 is inserted into a
portion of the guidewire lumen 43, such as a distal portion 145 of
the proximal guidewire lumen 124 of FIG. 7. The coil member 142,
preferably, extends proximally from the distal end 138 of the
proximal guidewire lumen 124 to a point, preferably, distal to the
seal 79 formed between the outer tubular member 67 and the distal
extremity 73 of the proximal shaft section 16. In yet another
embodiment, features of which are illustrated in FIGS. 11 and 12,
the coil member 142 extends proximally to a proximal end 145 of the
of the guidewire lumen 43.
[0071] The coil member 142, preferably, has a longitudinal
dimension ranging from about 40 cm to about 120 cm, preferably,
ranging from about 100 cm to about 115 cm, typically, 110 cm.
Preferably, the coil has a pitch between the adjacent turns of
typically 0.012 inch.
[0072] In yet another embodiment features of which are illustrated
in FIGS. 13 and 14, a stiffening mandrel 150, metallic or
polymeric, may be disposed along the interior of one of the
inflation lumens 55. Preferably, the stiffening mandrel is loosely
fitted within the host inflation lumen.
[0073] In an alternate embodiment, features of which are shown in
FIG. 15, one of the non-guide wire lumens 52' is a solid
member.
[0074] Now referring to FIG. 16, the proximal shaft section 16' has
an outer surface 153 with a solid wall thickness 156 between the
adjacent inflation lumens 55' (i.e., no gap).
[0075] In yet another embodiment, features of which are illustrated
in FIGS. 17-18, the proximal shaft section 16" includes three
lumens 37", one of which is a guidewire lumen 43" and the others
are non-guidewire lumens 52", including at least one inflation
lumen 55". The non-guidewire lumens 52" are disposed about the
guidewire lumen 43, each in a different transverse plane.
Preferably, the non-guidewire lumens 52" are circumferentially
disposed about the guidewire lumen 43" providing a substantially
balanced distribution of weight on the transverse dimension of the
proximal shaft section 16". The non-guidewire lumens 52",
preferably as shown in FIG. 18, are 30.degree. off a longitudinal
axis 159" of the proximal shaft section 16", with the guidewire
lumen 43" having a longitudinal axis 162" extending substantially
parallel to the longitudinal axis 159" of the proximal shaft
section 16". At least a portion of a thickness 115" for each of the
inflation lumens 37" is shared with the thickness of the other two
lumens.
[0076] Optionally, as shown in FIGS. 19 and 20, at least a portion
of the proximal and distal shaft sections, 16 and 19, respectively,
may include an exterior jacket 170.
[0077] The proximal shaft section 16 may be formed of Nylon 12;
polyether block amides available under the trade name Pebax from
Atochem; polyurethanes; polyester block copolymers (containing one
or more of the following glycols) comprising hard segments of
polyethylene-terephthalate or polybutylene-terephthalate, and soft
segments of polyether such as polyethylene glycol, polypropylene
glycol or polytetramethylene glycol ethers, such as those available
under the trade name Hytrel from DuPont; polyesters available from
Dutch State Mines under the trade name Arnitel; or blends
thereof.
[0078] The outer tubular member 67 may be formed of a polymeric
material, including nylons; polyether block amides such as Pebax;
polyurethanes; polyester block copolymers (containing one or more
of the following glycols) comprising hard segments of
polyethylene-terephthalate or polybutylene-terephthalate, and soft
segments of polyether such as polyethylene glycol, polypropylene
glycol or polytetramethylene glycol ethers, such as those available
under the trade name Hytrel; polyesters under the trade name
Arnitel; or blends thereof. The outer tubular member 67 is
preferably formed at least in part of Nylon 12.
[0079] The inner tubular member 130 may be formed from a lubricious
material such as high density polyethylene, polyimide, PEEK, or a
braided combination thereof, and preferably, is of a tri-layer
tubular construction including high density polyethylene as an
inner layer, a copolymer of ethylene and acrylic acid such as
Primacor from Dow Chemical Co. as a middle layer, and a nylon as
the outer layer.
[0080] The coil member 142 and the stiffening mandrel 150 may,
independently, be formed of a metallic material, and are
preferably, formed of 304 v stainless steel, NiTi alloy, MP35N,
Elgiloy and the like. Non-metallic materials may also be used such
as braided polyimide, and high strength polymers such as
polyetheretherketone (PEEK), polyetherketone, and polyketone.
[0081] The exterior jacket 170 may be formed of any nylon,
polyether block amides such as Pebax, copolymers of ethylene and
acrylic acid such as Primacor from Dow Chemical Co., and
polyolefins such as Plexar from Equistar Chemical Co., or any
combination thereof. The exterior polymeric jacket 170 is
preferably formed at least in part of nylon. Preferably, the jacket
170, as shown in FIG. 21, has a two layered structure, an outer
layer 171 being relatively lubricious to facilitate advancement of
the catheter through the lumen of a guiding catheter, other lumens
and ports, and an inner layer 172 being of high strength to
withstand the pressures of the inflation fluid.
[0082] The balloon 22 may be formed of suitable compliant,
non-compliant, or hybrid compliant material, including
thermoplastic and thermosetting polymers depending upon the end
use, e.g. dilatation, stent delivery etc. The presently preferred
balloon polymeric material is a relatively compliant polyether
block amide such as Pebax 70 sold by Elf Atochem. Other materials
include Nylon 11 and 12 and Pebax 72. Compliant polymeric
materials, i.e. compliant within the working expansion of the
balloon, which provide a wingless balloon and which have
substantially elastic recoil during deflation are also suitable for
stent delivery work. Other desirable polymeric materials for
balloon manufacture include polyurethanes such as TECOTHANE.
[0083] By way of forming the multi-lumen proximal shaft section 16
of the present invention, a multi-lumen shaft is first extruded.
The various lumens 37 are then trimmed, preferably at an angle,
longitudinally by first inserting a mandrel into the other lumens
which may be adversely affected during the trimming process. The
exterior surface of the guidewire lumen 180 is then reshaped (e.g.
using heat) to smooth the exterior surface 183 as seen in FIGS. 22
and 23. The catheter shaft assembly, is then constructed according
to conventional techniques. Similarly, FIGS. 24 and 25, show a
similar process for the alternate catheter of FIG. 18.
[0084] It will be apparent from the foregoing that, while
particular forms of the invention have been illustrated and
described, various modifications can be made without departing from
the spirit and scope of the invention. Moreover, those skilled in
the art will recognize that features shown in one embodiment may be
utilized in other embodiments.
* * * * *