U.S. patent application number 14/670093 was filed with the patent office on 2015-07-16 for balloon catheter having a shaft with a variable stiffness inner tubular member.
The applicant listed for this patent is ABBOTT CARDIOVASCULAR SYSTEMS INC.. Invention is credited to Lenny Barbod, Devon Brown, William S. Chin, Jessie Delgado, Quan Ritchie, John A. Simpson, Ramon Torres, Bruce Wilson.
Application Number | 20150196739 14/670093 |
Document ID | / |
Family ID | 32987961 |
Filed Date | 2015-07-16 |
United States Patent
Application |
20150196739 |
Kind Code |
A1 |
Simpson; John A. ; et
al. |
July 16, 2015 |
BALLOON CATHETER HAVING A SHAFT WITH A VARIABLE STIFFNESS INNER
TUBULAR MEMBER
Abstract
A catheter having an elongated shaft and a balloon on a distal
shaft section, the elongated shaft comprising an outer tubular
member, and an inner tubular member which has a bonded portion
along which an outer surface of the inner tubular member is bonded
to an inner surface of the outer tubular member. The inner tubular
member has a proximal portion proximal to the bonded portion, and a
distal portion distal to the bonded portion with higher axial
compression stiffness and column strength than the proximal portion
thereof. The catheter has improved trackability, axial collapse
resistance, pushability, and crossability, for improved ability to
position the balloon at a desired location in a patient's body
lumen.
Inventors: |
Simpson; John A.; (Carlsbad,
CA) ; Delgado; Jessie; (Murrieta, CA) ;
Wilson; Bruce; (Temecula, CA) ; Barbod; Lenny;
(San Diego, CA) ; Torres; Ramon; (Temecula,
CA) ; Brown; Devon; (Temecula, CA) ; Ritchie;
Quan; (Moreno Valley, CA) ; Chin; William S.;
(Moreno Valley, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ABBOTT CARDIOVASCULAR SYSTEMS INC. |
Santa Clara |
CA |
US |
|
|
Family ID: |
32987961 |
Appl. No.: |
14/670093 |
Filed: |
March 26, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13224917 |
Sep 2, 2011 |
9023174 |
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14670093 |
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11884117 |
May 3, 2010 |
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13224917 |
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10392697 |
Mar 20, 2003 |
7273485 |
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11884117 |
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Current U.S.
Class: |
604/103 |
Current CPC
Class: |
A61M 25/10 20130101;
A61M 25/0009 20130101; Y10T 156/1002 20150115; A61M 25/0054
20130101; B29C 65/02 20130101; B29C 66/5221 20130101; A61M 25/005
20130101 |
International
Class: |
A61M 25/10 20060101
A61M025/10 |
Claims
1-31. (canceled)
32. A balloon catheter having an elongated shaft with a proximal
end and a distal end and a balloon on a distal shaft section, the
elongated shaft comprising: an outer tubular member defining at
least a section of an inflation lumen in fluid communication with
an interior of the balloon, and having a proximal end and a distal
end; and an inner tubular member defining at least a section of a
guidewire lumen, extending in at least a distal section of the
outer tubular member and extending in the interior of the balloon,
the inner tubular member having a proximal end, a distal end distal
to the distal end of the outer tubular member, a length, a bonded
portion along which an outer surface of the inner tubular member is
bonded to an inner surface of the outer tubular member, a proximal
portion proximal to the bonded portion, and distal portion distal
to the bonded portion, the proximal portion of the inner tubular
member having an axial compression stiffness less than an axial
compression stiffness of the distal portion of the inner tubular
member.
33. The balloon catheter of claim 32 wherein the bonded portion has
a distal end located proximal to the balloon.
34. The balloon catheter of claim 32 wherein the bonded portion has
a proximal end located distal to a guidewire proximal port in fluid
communication with the guidewire lumen.
35. The balloon catheter of claim 32 wherein the bonded portion has
a length of about 0.1 to about 2 mm.
36. The balloon catheter of claim 32 wherein the inner tubular
member proximal end is located distal to the proximal end of the
shaft in the distal shaft section, and the bonded portion has a
length which is about 0.4% to about 8% of the length of the inner
tubular member.
37. The balloon catheter of claim 32 wherein the inner tubular
member proximal end is located at a proximal end portion of the
shaft so that the inner tubular member extends along a proximal
shaft section and the distal shaft section, and the bonded portion
has a length which is about 0.07% to about 1.5% of the length of
the inner tubular member.
38. The balloon catheter of claim 32 wherein the proximal portion
of the inner tubular member has a bending stiffness less than a
bending stiffness of the distal portion of the inner tubular
member.
39. The balloon catheter of claim 32 wherein at least part of the
inner tubular member proximal portion has a first wall thickness,
and at least part of the inner tubular member distal portion has a
second wall thickness which is greater than the first wall
thickness.
40. The balloon catheter of claim 39 wherein the part of the inner
tubular member having the first wall thickness has an outer
diameter smaller than an outer diameter of the part of the inner
tubular member having the second wall thickness.
41. The balloon catheter of claim 39 wherein a wall thickness of
the inner tubular member along the bonded portion is greater than
the wall thickness of the inner tubular member proximal
portion.
42. The balloon catheter of claim 32 wherein at least part of the
inner tubular member distal portion is formed of a polymeric tube
having at least one layer with fiber reinforcement therein.
43. The balloon catheter of claim 32 wherein the inner tubular
member proximal portion comprises a first polymeric material having
a first Shore durometer hardness, and the inner tubular member
distal portion comprises a second polymeric material having a
second Shore durometer hardness which is greater than the first
Shore durometer hardness.
44. The balloon catheter of claim 32 wherein the inner tubular
member comprises a polymeric tube with a coiled reinforcing member
embedded in at least a section thereof.
45. The balloon catheter of claim 44 wherein the coiled reinforcing
member extends along an entire length of the inner tubular
member.
46. The balloon catheter of claim 44 wherein the coiled reinforcing
member extends at least in part within the proximal and distal
portions of the inner tubular member.
47. The balloon catheter of claim 32 wherein the bonded portion
extends around part of a circumference of the inner tubular member,
so that a nonbonded portion of the inner tubular member is radially
adjacent to the bonded portion.
48. The balloon catheter of claim 47 wherein the bonded portion
extends around about 10% to about 90% of the circumference of the
inner tubular member.
49. The balloon catheter of claim 32 wherein the inner tubular
member comprises a polymeric tube with a reinforcing member bonded
thereto.
50. The balloon catheter of claim 49 wherein the reinforcing member
is coiled.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a division of U.S. Ser. No. 13/224,917
filed Sep. 2, 2011, which is a division of U.S. Ser. No.
11/844,117, filed Aug. 23, 2007; now U.S. Pat. No. 8,012,300, which
is a division of U.S. Ser. No. 10/392,697 filed Mar. 20, 2003, now
U.S. Pat. No. 7,273,485.
BACKGROUND
[0002] This invention generally relates to catheters, and
particularly intravascular catheters for use in percutaneous
transluminal coronary angioplasty (PTCA) or for the delivery of
stents.
[0003] 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 over expand the artery wall. After
the balloon is finally deflated, blood resumes through the dilated
artery and the dilatation catheter and the guidewire can be removed
therefrom.
[0004] 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. For details of stents, 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.
[0005] An essential step in effectively performing a PTCA procedure
is properly positioning the balloon catheter at a desired location
within the coronary artery. To properly position the balloon at the
stenosed region, the catheter must have good pushability (i.e.,
ability to transmit force along the length of the catheter), and
good trackability and flexibility, to be readily advanceable within
the tortuous anatomy of the patient's vasculature. Conventional
balloon catheters for intravascular procedures, such as angioplasty
and stent delivery, frequently have a relatively stiff proximal
shaft section to facilitate advancement of the catheter within the
patient's body lumen and a relatively flexible distal shaft section
to facilitate passage through tortuous anatomy such as distal
coronary and neurological arteries without damage to the vessel
wall. However, one difficulty has been providing a catheter shaft
having low bending stiffness for optimum trackability, while having
sufficiently high axial stiffness (compression modulus) and column
strength (collapse point) for maximum transmission of force to the
catheter distal end. A shaft inner tubular member (extending
through the balloon interior) having inadequate column stiffness
may telescopically collapse under axial load causing balloon
bunching/buckling during advancement of the catheter, which
consequently inhibits positioning the balloon across a stenosis.
Accordingly, it would be a significant advance to provide a
catheter having an improved combination of flexibility, collapse
resistance, pushability, and crossability.
SUMMARY OF THE INVENTION
[0006] The invention is directed to a balloon catheter having an
elongated shaft and a balloon on a distal shaft section, the
elongated shaft comprising an outer tubular member, and an inner
tubular member with a bonded portion along which an outer surface
of the inner tubular member is bonded to an inner surface of the
outer tubular member. The inner tubular member has a distal portion
distal to the bonded portion with higher axial compression
stiffness and column strength than a proximal portion of the inner
tubular member. The catheter has improved trackability, axial
collapse resistance, pushability, and crossability, for improved
ability to position the balloon at a desired location in a
patient's body lumen.
[0007] A balloon catheter of the invention generally comprises an
elongated shaft having a proximal shaft section, a distal shaft
section, an inflation lumen, and a guidewire lumen, with a balloon
on a distal shaft section. The elongated shaft is formed at least
in part by an outer tubular member defining at least a section of
the inflation lumen in fluid communication with an interior of the
balloon, and by an inner tubular member defining at least a section
of the guidewire lumen. The inner tubular member extends in at
least a distal section of the outer tubular member and in the
interior of the balloon, and in accordance with the invention has a
bonded portion bonded to the outer tubular member. The guidewire
lumen is in fluid communication with a proximal guidewire port, and
a distal guidewire port at the distal end of the shaft. In one
embodiment, the catheter is a rapid exchange type catheter having
the proximal end of the inner tubular member in the distal shaft
section located distal to the proximal end of the shaft, so that
the guidewire proximal port is in the distal shaft section spaced a
relatively short distance proximally from the guidewire distal port
and a relatively long distance distally from the proximal end of
the catheter shaft. In an alternative embodiment, the catheter is
an over-the-wire type catheter having the inner tubular member
proximal end located at a proximal end portion of the shaft so that
the inner tubular member extends along the proximal and distal
shaft sections.
[0008] The bonded portion of the inner tubular member links the
inner tubular member to the outer tubular member, preferably at or
adjacent to a stiffness transition in the inner tubular member.
Specifically, a distal portion of the inner tubular member located
distal to the bonded portion has a higher axial compression
stiffness and column strength than a proximal portion of the inner
tubular member located proximal to the bonded portion.
Additionally, in one embodiment, the proximal portion of the inner
tubular member has a lower bending stiffness than the distal
portion of the inner tubular member. Preferably, the bonded portion
is located at (i.e., radially aligned with) or longitudinally
adjacent to the proximal end of the balloon. In a presently
preferred embodiment, the bonded portion has a distal end located
proximal to the balloon and typically a relatively short distance
from the proximal end of the balloon and a relatively long distance
from the proximal end of the inner tubular member. As a result, the
length of the distal portion of the inner tubular member extending
distally from the bonded portion, through the balloon interior to
the distal end of the inner tubular member, is minimized relative
to the length of the proximal portion of the inner tubular member.
The configuration provides a maximum length to the highly flexible
proximal portion of the inner tubular member. In one embodiment,
the distal portion of the inner tubular member has a length equal
to about 1 to about 5% of the length of the entire shaft. By
linking a portion of the inner tubular member to the outer tubular
member near the proximal end of the balloon, the axial compression
stiffness of the proximal portion of the inner tubular member has
little or no influence on the amount of axial load that is carried
by the balloon. Consequently, in the catheter of the invention, the
inner tubular member proximal portion has a low bending stiffness
and a concurrently low axial stiffness, with the outer tubular
member carrying a substantial portion of the total axial force
along the shaft up to the adjoining balloon. Distal to the outer
tubular member, the distal portion of the inner tubular member is
provided with sufficient column stiffness and strength to prevent
or inhibit it from elastically shortening or telescopically
collapsing under axial load. As a result, the catheter shaft is
highly flexible, and nonetheless transfers the majority of applied
axial load to the distal end of the balloon and thereby prevents or
inhibits buckling of the balloon during advancement of the catheter
in the patient's body lumen.
[0009] The inner tubular member proximal portion typically is
constructed so as to minimize its bending stiffness, thereby being
less stiff in both bending stiffness and axial compression
stiffness than the outer tubular member. The outer tubular member
is provided with sufficient axial compression stiffness to carry a
majority of the axial load without buckling. For example, in one
embodiment, the proximal inner member carries only about 5 to about
25% of the total axial force transmitted to the distal end of the
catheter. In one embodiment, the catheter is preferably an
over-the-wire type catheter, due to the large reduction in the
axial load carried by the balloon provided by the catheter
configuration of the invention. In one embodiment, the axial load
carried by the balloon in an over-the-wire catheter of the
invention is lowered by about 40 to about 90%, compared to a
conventional catheter without the inner tubular member bonded
portion. In one embodiment, the axial load carried by the balloon
in a rapid exchange catheter of the invention is lowered by about
40 to about 80%, compared to a conventional catheter without the
inner tubular member bonded portion.
[0010] A variety of suitable methods may be used to form the inner
tubular member stiffness transition between the proximal and distal
portions thereof, to provide an inner member with a relatively low
bending stiffness over the majority of its length but having
greater axial stiffness (also known as compression modulus) and
column strength (i.e., collapse point under axial load) distal to
the bonded portion. In a presently preferred embodiment, at least
part of the inner tubular member proximal portion has a first wall
thickness, and at least part of the inner tubular member distal
portion has a second wall thickness greater than the first wall
thickness. Preferably, the part of the inner tubular member having
the first wall thickness has an outer diameter smaller than an
outer diameter of the part of the inner tubular member having the
second (i.e., smaller) wall thickness, which thus increases the
size of the inflation lumen defined by the space between the
proximal portion of the inner tubular member and the inner surface
of the outer tubular member. The variable wall thickness can be
formed using a variety of processing methods during manufacture of
the inner tubular member, including decreasing (as for example by
necking) the wall thickness of the proximal portion and/or
increasing the wall thickness of the distal portion. In an
alternative embodiment, the distal portion of the inner tubular
member is provided with the higher axial stiffness. For example,
the axial stiffness of the distal portion can be increased by
providing a reinforcing member (such as braiding, or a mandrel, or
a flexible tubular splint member on an outer surface thereof), or
by adding fiber reinforcement to the shaft jacketing, or by
irradiating or heat stabilizing the polymeric material of the
distal portion to increase its stiffness. In another embodiment,
the inner tubular member distal portion is formed of a polymeric
material having a higher Shore durometer hardness than the
polymeric material of the proximal portion of the inner tubular
member. The inner tubular member typically comprises a multilayered
tubular member, so that the embodiment with a higher durometer
polymeric material in the distal portion should be understood to
refer to the durometer of at least one of the layers of the inner
tubular member. The higher durometer material forming the distal
portion may be the same type of polymeric material as the polymeric
material of the proximal portion (i.e., a polyamide), or
alternatively, a different type of polymeric material.
[0011] The bonded portion extends around part of the circumference
of the inner tubular member, so that a nonbonded portion of the
inner tubular member is radially adjacent to the bonded portion to
provide a path for the inflation fluid past the bonded portion. The
bonded portion generally extends around about 10% to about 90% of
the circumference of the inner tubular member, and most preferably
the percentage is minimized in order to maximize the fluid flow
path past the bond. The length of the bonded portion is generally
substantially less than the length of the inner tubular member,
although in one embodiment, the inner tubular member includes one
or more portions proximally spaced apart from the bonded portion,
along which the outer surface of the inner tubular member proximal
portion is bonded to the inner surface of the outer tubular
member.
[0012] In a presently preferred embodiment, the inner tubular
member comprises a polymeric tube with a coiled reinforcing member
embedded therein. Although the distal portion of the inner tubular
member typically has a higher axial compression stiffness and
column strength than the proximal portion thereof, the coiled
reinforcing member allows the inner tubular member to have a
relatively low bending stiffness and high radial collapse
resistance throughout, for excellent catheter trackability and
guidewire movement even after inflation of the balloon at
relatively high inflation pressures. The coiled reinforcing member
preferably extends at least in part within the proximal and distal
portions of the inner tubular member, and in one embodiment, the
coiled reinforcing member extends along the entire length of the
inner tubular member. In one embodiment, the coiled reinforcing
member has a uniform pitch, stiffness, and/or column strength
throughout its length. Alternatively, the coiled reinforcing member
extending along the distal portion of the inner tubular member has
a tighter coil pitch (i.e., more closely spaced coils) than along
the proximal portion of the inner tubular member, or otherwise
provided with a higher axial stiffness and column strength along
the distal portion, to produce the stiffer distal portion of the
inner tubular member. For example, a longitudinally extending wire
member bonded to the distal portion of the coiled reinforcing
member selectively stiffens the distal portion of the inner tubular
member. In one embodiment, two types or plies of wire or ribbon
form the reinforcing member, with the first type reinforcing the
entire length of the inner tubular member and the second type
located in the distal portion of the inner tubular member to
selectively stiffen the distal portion of the inner tubular member
by, for example, preventing the distal coils from moving closer
together or bunching under axial load. Similarly, a braided
reinforcing member having a variable pick count (number of braid
crossover points per unit of axial length) imparting a stiffness
transition may alternatively be used to form the inner tubular
member. The resulting catheter shaft, formed by the inner and outer
tubular members, has an improved low bending stiffness throughout
the length of the inner member, for improved trackability.
[0013] In a method of making a balloon catheter embodying features
of the invention, an elongated shaft having a proximal end, a
distal end, an inflation lumen, and a guidewire lumen is assembled
by placing an inner tubular member within at least a distal section
of an outer tubular member, so that the inner tubular member
defines the guidewire lumen and the outer tubular member defines
the inflation lumen, the inner tubular member having a proximal
portion with an axial compression stiffness and bending stiffness
less than an axial compression stiffness and bending stiffness of a
distal portion of the inner tubular member. A portion of the inner
tubular member is then bonded to the outer tubular member at or
adjacent a junction between the proximal and distal portions of the
inner tubular member, to form a bonded portion along which an outer
surface of the inner tubular member is bonded to an inner surface
of the outer tubular member. A balloon is bonded to the distal
shaft section so that the balloon has an interior in fluid
communication with the inflation lumen, to form the balloon
catheter.
[0014] The inner tubular member having a stiffness transition can
be formed using a variety of suitable methods. For example, in one
embodiment, forming the inner tubular member comprises necking a
proximal part of a polymeric tube to reduce a wall thickness and an
outer diameter thereof without reducing an inner diameter thereof,
to thereby reduce the axial compression stiffness of the proximal
part of the polymeric tube, and embedding a coiled reinforcing
member in the polymeric tube. In another embodiment, forming the
inner tubular member comprises increasing the wall thickness of a
distal section of a polymeric tubular member having a coiled
reinforcing member embedded therein, by a method selected from the
group consisting of heat shrinking an outer polymeric layer onto
the distal section of the coil reinforced polymeric tubular member,
melt bonding an outer polymeric layer onto the distal section of
the coil reinforced polymeric tubular member, or dip coating the
distal section of the coiled reinforced polymeric tubular member.
In another embodiment, forming the inner tubular member comprises
joining the distal end of a first tube to a proximal end of a
second tube to form a polymeric tubular member, and fusing the
polymeric tubular member to a coiled reinforcing member, and the
second tube is formed of a polymeric material having a higher Shore
durometer hardness or has a wall thickness greater than a wall
thickness of the first tube. In another embodiment, forming the
inner tubular member comprises fusing a polymeric tube to a braided
reinforcing member, the braided reinforcing member having a distal
part with a pick count which is higher than a pick count of a
proximal part of the braided reinforcing member. In another
embodiment, forming the inner tubular member comprises applying an
adhesive or melt bondable polymer to a portion of a mandrel, and
applying a coil on the mandrel with a distal part of the coil on
the adhesive or melt bondable polymer, and fusing a polymeric layer
on the coil, to form the coil reinforced polymeric tubular member.
In another embodiment, forming the inner tubular member comprises
joining the distal end of a coil reinforced polymeric tubular
member to the proximal end of a polymer tube having a greater axial
stiffness and column strength than the coil reinforced polymeric
tubular member. In another embodiment, forming the inner tubular
member comprises irradiating or heat stabilizing a distal part of a
polymeric tube to increase the stiffness of the distal part of the
polymeric tube.
[0015] The balloon catheter of the invention has improved
pushability and trackability, due to the low bending stiffness
inner tubular member having a bonded portion bonded to the outer
tubular member and excellent force transmission through the balloon
interior to the distal tip. The shaft configuration prevents or
inhibits the balloon from buckling or bunching during advancement
in the patient's blood vessel, despite the low bending stiffness of
the inner tubular member and resulting excellent trackability.
Thus, the catheter shaft of the invention accommodates typically
competing considerations in the design of catheters, to facilitate
positioning the balloon at a desired location in the patient's
blood vessel. 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
[0016] FIG. 1 is an elevational view, partially in section, of a
rapid exchange type balloon catheter which embodies features of the
invention.
[0017] FIG. 2-3 are transverse cross sections of the catheter shown
in FIG. 1, taken along lines 2-2 and 3-3, respectively.
[0018] FIG. 4 is an enlarged, longitudinal cross sectional view of
the catheter shown in FIG. 1, taken within circle 4.
[0019] FIG. 5 is a transverse cross section of the catheter shown
in FIG. 4, taken along line 5-5.
[0020] FIG. 6 is an elevational view, partially in section, of an
over-the-wire type balloon catheter which embodies features of the
invention
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0021] FIG. 1 illustrates rapid exchange type balloon catheter 10
embodying features of the invention. Catheter 10 generally
comprises an elongated catheter shaft 11 having a proximal end, a
distal end, a proximal shaft section 12 and a distal shaft section
13 at the distal end of the proximal shaft section, and an
inflatable balloon 14 on the distal shaft section. The shaft 11 has
an inflation lumen 21, and a guidewire receiving lumen 22. The
proximal shaft section 12 comprises a proximal tubular member
defining a proximal portion of the inflation lumen 21. The distal
shaft section 13 comprises an outer tubular member 19 defining a
distal portion of the inflation lumen 21, and an inner tubular
member 20 defining the guidewire lumen 22 in fluid communication
with a guidewire distal port 24 at the distal end of the catheter
and a guidewire proximal port 25 at the proximal end of the inner
tubular member 20, configured to slidably receive guidewire 23
therein. Balloon 14 has a proximal end sealingly secured to the
distal end of outer tubular member 19 and a distal end sealingly
secured to the distal end of inner tubular member 20, so that its
interior 15 is in fluid communication with inflation lumen 21. An
adapter 17 at the proximal end of the catheter provides access to
the inflation lumen 21. FIG. 1 illustrates the balloon 14 in a low
profile configuration, prior to inflation, for introduction and
advancement within the patient's body lumen 18, with a stent 16
mounted on the working length of the balloon 14. In use, the distal
end of catheter 10 is advanced to a desired region of the patient's
body lumen 18 in a conventional manner either over previously
positioned guidewire 23, or with guidewire 23 already in the
catheter 10. The balloon 14 is inflated to expand the stent 16, and
the balloon deflated, and the catheter 10 removed from or
repositioned within the body lumen 18, leaving stent 16 implanted
in the body lumen 18. Although illustrated as a stent delivery
catheter in the embodiment of FIG. 1, the balloon catheter 10 of
the invention may be configured to perform a variety of medical
procedures including dilating a stenosis. Similarly, rapid exchange
type catheter 10 of the embodiment of FIG. 1 may comprise a variety
of suitable rapid exchange catheter shaft configurations as are
conventionally known. FIGS. 2 and 3 illustrate transverse cross
sectional views of the catheter of FIG. 1, taken along lines 2-2
and 3-3, respectively.
[0022] The inner tubular member 20 has a bonded portion 30 along
which the outer surface of the inner tubular member is bonded to
the inner surface of the outer tubular member 19, as best shown in
FIG. 4, illustrating an enlarged longitudinal cross section of the
catheter of FIG. 1, taken within circle 4. The bonded portion is
proximally adjacent to the proximal end of the balloon 14, with a
distal end proximal to the balloon 14. The bonded portion 30 is
typically spaced proximally apart from the proximal end of the
balloon a sufficient distance, so that forming the bonding portion
30 does not damage the balloon 14 secured to the outer tubular
member 19. For example, in one embodiment, the distal end of the
bonded portion is within about 0.5 to 2 cm from the proximal end of
the balloon. However, the bonded portion 30 can have a variety of
suitable locations. For example, the bonded portion 30 can
alternatively extend at least in part underneath the balloon
proximal skirt section (i.e., radially aligned therewith), with the
distal end of the bonded portion located distal to the proximal end
of the balloon, provided the balloon 14 is not damaged by the
bonding process.
[0023] Preferably, the bonded portion 30 length is about 0.1 to
about 2 cm, which in the rapid exchange catheter of FIG. 1 is about
0.4% to about 8% of the length of the inner tubular member 20 (the
inner tubular member 20 having a length of about 20 to about 30
cm). The bonded portion 30 extends partially around the
circumference of inner tubular member 20, as best shown in FIG. 5
illustrating a transverse cross section of FIG. 4, taken along line
5-5. In the illustrated embodiment, the bonded portion extends
around about 30% to about 40% of the inner tubular member
circumference.
[0024] In one embodiment, the bonded portion 30 is formed by
heating and applying a radially inward force to press a portion of
the outer tubular member 19 down onto the underlying inner tubular
member 20 using a crescent shaped mandrel to preserve the inflation
lumen. As a result, the outer diameter of the distal shaft 13 is
decreased along the bonded portion 30. The inflation lumen 21 and
guidewire lumen 22 are in a side-by-side relation along the length
of the bonded portion 30. In the embodiment of FIG. 1, proximal to
the bonded portion 30, the outer and inner tubular members 19, 20
are separate as best illustrated in FIG. 2, although they may be
intermittently bonded in like manner at other more proximal
locations. A continuous bond line is not recommended however
because of the accompanying increase in bending stiffness. The bond
between the outer and inner tubular members 19, 20 along the bonded
portion 30 is preferably a fusion bond, although the bond may
alternatively or additionally be an adhesive bond. For example, the
outer and inner tubular members 19, 20 are heated along the length
of the desired bonded portion, typically with a mandrels in the
lumens 21, 22 and heat shrink tubing (not shown) positioned around
the outer tubular member 19, to soften and melt bond the tubular
members together. The tubular members 19, 20 are preferably heated
using a laser and the heat directed only along the part of the
circumference of the outer tubular member to be bonded to the inner
tubular member to reduce heat spread during formation of bonded
portion 30. However, a variety of suitable heating methods may be
used including using a hot air heating nozzle and heating the
entire circumference of the outer tubular member.
[0025] In the embodiment illustrated in FIG. 4, the bonded portion
30 is formed by directly bonding the outer and inner tubular
members 19, 20 together. However, in an alternative embodiment, a
tube (not shown) may be provided in the inflation lumen 21 which
has an outer surface bonded to both the outer surface of the inner
tubular member and to the inner surface of the outer tubular
member, to thereby bond the outer and inner tubular members
together to form bonded portion 30 (i.e., the tube is only on one
side of the inner tubular member), and the inner tubular member may
therefore be coaxial with the outer tubular member.
[0026] The inner tubular member 20 has a proximal portion proximal
to the bonded portion 30, and a distal portion distal to the bonded
portion 30. The distal portion of the inner tubular member 20 has a
higher axial compressive stiffness and column strength than the
proximal portion of the inner tubular member 20. In the embodiment
of FIG. 4, the distal portion of the inner tubular member 20 has a
larger wall thickness and a larger outer diameter than the proximal
portion of the inner tubular member 20, although a variety of
suitable methods may be used to provide the inner tubular member
stiffness transition. The reduced outer diameter of the proximal
portion of the inner tubular member 20 increases the size of the
inflation lumen 21 extending therealong, for more rapid
inflation/deflation. Additionally, the smaller wall thickness of
the proximal portion of the inner tubular member 20 provides the
proximal portion of the inner tubular member 20 with a lower
bending stiffness than the distal portion thereof.
[0027] In the embodiment of FIG. 4, the wall thickness of the inner
tubular member 20 along the bonded portion 30 is greater than the
wall thickness of the inner tubular member proximal portion.
Specifically, the proximal end of the bonded portion 30 is radially
aligned with the proximal end of the part of the inner tubular
member having the larger wall thickness than the proximal portion
of the inner tubular member. The stiffness transition provided by
the change in wall thickness of the inner member preferably takes
place over a relatively short length, to provide maximum benefit of
the lower bending stiffness of the proximal inner member. In the
embodiment of FIG. 4, the outer diameter of the inner tubular
member tapers proximally to the smaller outer diameter of the
proximal portion along a length of about 1 mm.
[0028] The inner tubular member preferably comprises a polymeric
tube 31 with a coiled reinforcing member 32 embedded therein. In
the embodiment of FIG. 4, the coiled reinforcing member 32 is a
coiled flat ribbon, spiraling along the length of the inner tubular
member with uniformly spaced-apart coils. However, a variety of
suitable reinforcing members may be used as are conventionally
known, including a coiled round wire. The coiled reinforcing member
extends at least in part within the proximal and distal portions of
the inner tubular member 20, and preferably extends along
substantially the entire length of the inner tubular member 20 to
prevent radial collapse under extreme balloon inflation pressures.
Although the polymeric tube 31 is shown as a single layered member
for ease of illustration, it should be understood that the
polymeric tube 31 is typically a multilayered polymeric member, as
for example with an inner lubricious polymeric layer, and an outer
polymeric layer coextruded or heat shrunk around the inner
polymeric layer, with the coiled member 32 embedded in one or both
layers. Typically, the extruded single or multilayered polymeric
tube is necked to reduce the inner and outer diameter thereof. In a
presently preferred embodiment, the reduced wall thickness proximal
portion of the inner tubular member 20 is then formed by necking
the proximal part of the extruded tube to reduce a wall thickness
and an outer diameter thereof without reducing an inner diameter
thereof. Alternatively, an outer layer of polymeric material may be
provided on the outer surface of the inner tubular member distal to
the proximal portion of the inner tubular member, as for example by
heat shrinking a polymeric tube down onto the distal portion of the
inner tubular member, to increase the wall thickness and axial
compression stiffness of the inner tubular member distal portion
relative to the proximal portion thereof.
[0029] The axial compression stiffness and column stiffness of the
distal portion of the inner tubular member 20 are about the same as
those of the entire length of an inner tubular member in a
conventional catheter. However, the bending stiffness of the
proximal portion of the inner tubular member 20 is as low as can be
practically attained in order to minimize the catheter's overall
bending stiffness there.
[0030] In one embodiment (not shown), the inner tubular member
includes one or more portions proximally spaced apart from the
bonded portion, along which the outer surface of the inner tubular
member proximal portion is bonded to the inner surface of the outer
tubular member. In one embodiment, the inner tubular member has a
plurality of these portions bonded to the outer tubular member
which are intermittently spaced apart from one another with
portions of the inner tubular member therebetween which are not
bonded to the outer tubular member.
[0031] In the embodiment of FIG. 1, the catheter 10 is a rapid
exchange catheter. In an alternative embodiment, the catheter is an
over-the-wire catheter, so that the guidewire proximal port is at
the proximal end of the catheter shaft. FIG. 6 illustrates an
over-the-wire type balloon catheter 40 embodying features of the
invention, generally comprising a shaft 41 having a proximal shaft
section 42 and a distal shaft section 43, and a balloon 44 on the
distal shaft section. The elongated shaft comprises an outer
tubular member 45 defining an inflation lumen 46, and an inner
tubular member 47 defining a guidewire lumen 48 configured to
slidably receive a guidewire 23 therein. Inner tubular member 47,
extending within the proximal and distal shaft sections 42, 43,
extends distally beyond the distal end of the outer tubular member
45 and through the interior of the balloon 44. The guidewire lumen
48 is in fluid communication with a guidewire distal port 49 at the
distal end of the shaft 41, and with a guidewire proximal port (not
shown) at a proximal end of the shaft 41. An adapter 50 at the
proximal end of catheter shaft 41 is configured to provide access
to guidewire lumen 48, and to direct inflation fluid into inflation
lumen 46 through arm 51. In accordance with the invention, inner
tubular member 47 has a stiffness transition and a bonded portion
60, as discussed above in relation to the embodiment of FIG. 1. In
the embodiment of FIG. 6, the bonded portion 60 having a length of
about 0.1 to about 2 cm, is about 0.07% to about 1.5% of the length
of the inner tubular member (the inner tubular member having a
length of about 135 to about 145 cm).
[0032] Although illustrated as one-piece tubular members, it should
be understood that the tubular members forming the catheter shaft
11, 41 may be formed of multiple tubular members or multilayered
tubular members. For example, the outer tubular member 19, 45 may
comprise multiple tubular members joined end to end, providing
increasing flexibility distally along the length of the
catheter.
[0033] To the extent not previously discussed herein, the various
catheter components may be formed and joined by conventional
materials and methods. For example, the tubular members forming the
catheter shaft 11, 41 can be formed by conventional techniques,
such as by extruding and necking materials found useful in
intravascular catheters such as polyethylene, polyvinyl chloride,
polyesters, polyamide, polyimides, polyurethanes, polyether block
amides, and composite materials.
[0034] The length of the balloon catheter 10, 40 is generally about
137 to about 145 centimeters, and typically about 143 centimeters
for PTCA. The outer tubular member 19, 45 proximal section has an
OD of about 0.036 to about 0.043 inch (0.91-1.1 mm), and an inner
diameter (ID) of about 0.032 to about 0.036 inch (0.81-0.91 mm),
and the outer tubular member 19, 45 distal section has an outer
diameter (OD) of about 0.028 to about 0.036 inch (0.70-0.91 mm),
and an inner diameter (ID) of about 0.024 to about 0.035 inch
(0.60-0.89 mm). The inner tubular member 20, 47 has an OD of about
0.017 to about 0.026 inch (0.43-0.66 mm), and an ID of about 0.015
to about 0.019 inch (0.38-0.48 mm) depending on the diameter of the
guidewire to be used with the catheter. The balloon 14, 44 has a
length of about 8 mm to about 40 mm, and an inflated working
diameter of about 1.5 mm to about 5 mm.
[0035] While the present invention has been described herein in
terms of certain preferred embodiments, those skilled in the art
will recognize that modifications and improvements may be made
without departing from the scope of the invention. Moreover, while
individual features of one embodiment of the invention may be
discussed or shown in the drawings of the one embodiment and not in
other embodiments, it should be apparent that individual features
of one embodiment may be combined with one or more features of
another embodiment or features from a plurality of embodiments.
* * * * *