U.S. patent application number 10/671716 was filed with the patent office on 2004-05-20 for stent delivery system and method of use.
Invention is credited to Ricci, Donald R..
Application Number | 20040098085 10/671716 |
Document ID | / |
Family ID | 32298415 |
Filed Date | 2004-05-20 |
United States Patent
Application |
20040098085 |
Kind Code |
A1 |
Ricci, Donald R. |
May 20, 2004 |
Stent delivery system and method of use
Abstract
A balloon dilation catheter comprising: a tubular member having
a proximal end and a distal end and an inflatable balloon disposed
at the distal end of the tubular member. The tubular member
comprises a first lumen disposed in communication with an interior
of the inflatable balloon and a second lumen for receiving a
guidewire substantially along the entire length of the tubular
member. The second lumen has a first opening at the proximal end of
the tubular member and a second opening at the distal end of the
tubular member. A first slit is disposed longitudinally from the
first opening along substantially the entire length of the tubular
member to permit separation of the guidewire with respect to the
second lumen. The subject balloon dilation catheter provides
improved rapid exchange advantages of either the catheter or the
guidewire used in a catheterization technique.
Inventors: |
Ricci, Donald R.;
(Vancouver, CA) |
Correspondence
Address: |
PATENT ADMINSTRATOR
KATTEN MUCHIN ZAVIS ROSENMAN
525 WEST MONROE STREET
SUITE 1600
CHICAGO
IL
60661-3693
US
|
Family ID: |
32298415 |
Appl. No.: |
10/671716 |
Filed: |
September 29, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10671716 |
Sep 29, 2003 |
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09501981 |
Feb 11, 2000 |
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Current U.S.
Class: |
623/1.11 |
Current CPC
Class: |
A61M 39/06 20130101;
A61M 25/104 20130101; A61M 2025/107 20130101; A61M 25/0662
20130101; A61F 2/95 20130101; A61M 2025/0183 20130101; A61M
2039/062 20130101 |
Class at
Publication: |
623/001.11 |
International
Class: |
A61F 002/06 |
Claims
What is claimed is:
1. A balloon dilation catheter comprising: a tubular member having
a proximal end and a distal end; an inflatable balloon disposed at
the distal end of the tubular member; a first lumen disposed in the
tubular member and in communication with an interior of the
inflatable balloon; a second lumen disposed in the tubular member
for receiving a guidewire substantially along its entire length,
the second lumen having a first opening at the proximal end of the
tubular member and a second opening at the distal end of the
tubular member; and a first slit disposed longitudinally from the
first opening along substantially the entire length of the tubular
member to permit separation of the guidewire with respect to the
second lumen.
2. The balloon dilation catheter defined in claim 1, wherein the
first slit extends from the first opening to an area on the tubular
member which is proximal to the inflatable balloon.
3. The balloon dilation catheter defined in claim 1, wherein the
slit extends from the first opening to the second opening.
4. The balloon dilation catheter defined in claim 1, wherein the
inflatable balloon comprises a second slit in substantial alignment
with the first slit.
5. The balloon dilation catheter defined in claim 4, wherein at
least a portion of the second slit is reinforced.
6. The balloon dilation catheter defined in claim 1, further
comprising a third lumen for receiving a stiffening member.
7. The balloon dilation catheter defined in claim 6, further
comprising the stiffening member disposed in the third lumen.
8. The balloon dilation catheter defined in claim 6, wherein the
third lumen at least partially encompasses the second lumen.
9. The balloon dilation catheter defined in claim 7, wherein the
stiffening member comprises a metal wire.
10. The balloon dilation catheter defined in claim 1, wherein the
first lumen and the second lumen each comprise a passageway having
a substantially circular cross-section disposed in a substantially
solid tubular member.
11. The balloon dilation catheter defined in claim 1, further
comprising at least one radioopaque marker disposed on the tubular
member.
12. The balloon dilation catheter defined in claim 1, wherein the
tubular member is constructed from plastic material having various
density to provide a decreasing stiffness from the proximal end to
the distal end.
13. A catheterization kit comprising: a guide catheter; a guide
wire; and a balloon dilation catheter comprising: a tubular member
having a proximal end and a distal end; an inflatable balloon
disposed at the distal end of the tubular member; a first lumen
disposed in the tubular member and in communication with an
interior of the inflatable balloon; a second lumen disposed in the
tubular member for receiving the guidewire substantially along its
entire length, the second lumen having a first opening at the
proximal end of the tubular member and a second opening at the
distal end of the tubular member; and a first slit disposed
longitudinally from the first opening along substantially the
entire length of the tubular member to permit separation of the
guidewire with respect to the second lumen.
14. The catheterization kit defined in claim 13, wherein the first
slit extends from the first opening to an area on the tubular
member which is proximal to the inflatable balloon.
15. The catheterization kit defined in claim 13, wherein the slit
extends from the first opening to the second opening.
16. The catheterization kit defined in claim 13, wherein the
inflatable balloon comprises a second slit in substantial alignment
with the first slit.
17. The catheterization kit defined in claim 16, wherein at least a
portion of the second slit is reinforced.
18. The catheterization kit defined in claim 13, wherein the
balloon dilation catheter further comprises a third lumen for
receiving a stiffening member.
19. The catheterization kit defined in claim 18, further comprising
the stiffening member disposed in the third lumen.
20. The catheterization kit defined in claim 18, wherein the third
lumen at least partially encompasses the second lumen.
21. The catheterization kit defined in claim 18, wherein the
stiffening member comprises a metal wire.
22. The catheterization kit defined in claim 13, wherein the first
lumen and the second lumen each comprise a passageway having a
substantially circular cross-section disposed in a substantially
solid tubular member.
23. The catheterization kit defined in claim 13, wherein the
balloon dilation catheter further comprises at least one
radioopaque marker disposed on the tubular member.
24. The catheterization kit defined in claim 13, wherein the
tubular member is constructed from plastic material having various
density to provide a decreasing stiffness from the proximal end to
the distal end.
25. A stent-mounted balloon catheter comprising: a tubular member
having a proximal end and a distal end; an inflatable balloon
disposed at the distal end of the tubular member; a stent mounted
on the inflatable balloon; a first lumen disposed in the tubular
member and in communication with an interior of the inflatable
balloon; a second lumen disposed in the tubular member for
receiving a guidewire substantially along its entire length, the
second lumen having a first opening at the proximal end of the
tubular member and a second opening at the distal end of the
tubular member; and a first slit disposed longitudinally from the
first opening along substantially the entire length of the tubular
member to permit separation of the guidewire with respect to the
second lumen.
26. The balloon catheter defined in claim 25, wherein the first
slit extends from the first opening to an area on the tubular
member which is proximal to the inflatable balloon.
27. The balloon catheter defined in claim 25, wherein the slit
extends from the first opening to the second opening.
28. The balloon catheter defined in claim 25, wherein the
inflatable balloon comprises a second slit in substantial alignment
with the first slit.
29. The balloon catheter defined in claim 28, wherein at least a
portion of the second slit is reinforced.
30. The balloon catheter defined in claim 25, further comprising a
third lumen for receiving a stiffening member.
31. The balloon dilation catheter defined in claim 30, further
comprising the stiffening member disposed in the third lumen.
32. The balloon catheter defined in claim 30, wherein the third
lumen at least partially encompasses the second lumen.
33. The balloon catheter defined in claim 31, wherein the
stiffening member comprises a metal wire.
34. The balloon catheter defined in claim 25, wherein the first
lumen and the second lumen each comprise a passageway having a
substantially circular cross-section disposed in a substantially
solid tubular member.
35. The balloon catheter defined in claim 25, further comprising at
least one radioopaque marker disposed on the tubular member.
36. The balloon catheter defined in claim 25, wherein the tubular
member is constructed from plastic material having various density
to provide a decreasing stiffness from the proximal end to the
distal end.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] In one of its aspects, the present invention relates to a
balloon dilation catheter. In another of its aspects, the present
invention relates to a catheterization method.
[0003] 2. Brief Description of the Prior Art
[0004] Balloon dilation catheters have been known for many years.
Originally, such catheters were used in interventional techniques
such as angioplasty.
[0005] In recent years, balloon dilation catheters have also been
used to facilitate endovascular prosthesis' such as stents. Stents
are generally known. Indeed, the term "stent" has been used
interchangeably with terms such as "intraluminal vascular graft"
and "expansible prosthesis". As used throughout this specification,
the term "stent" is intended to have a broad meaning and
encompasses any expandable prosthetic device for implantation in a
body passageway (e.g., a lumen or artery).
[0006] In the past dozen years, the use of stents has attracted an
increasing amount of attention due to the potential of these
devices to be used, in certain cases, as an alternative to surgery.
Generally, a stent is used to obtain and maintain the patency of
the body passageway while maintaining the integrity of the
passageway. As used in this specification, the term "body
passageway" is intended to have a broad meaning and encompasses any
duct (e.g., natural or iatrogenic) within the human body and can
include a member selected from the group comprising: blood vessels,
respiratory ducts, gastrointestinal ducts and the like.
[0007] Stent development has evolved to the point where the vast
majority of currently available stents rely on controlled plastic
deformation of the entire structure of the stent at the target body
passageway so that only sufficient force to maintain the patency of
the body passageway is applied during expansion of the stent.
[0008] Generally, in many ofthese systems, a stent, in association
with a balloon, is delivered to the target area of the body
passageway by a catheter system. Once the stent has been properly
located (for example, for intravascular implantation the target
area of the vessel can be filled with a contrast medium to
facilitate visualization during fluoroscopy), the balloon is
expanded thereby plastically deforming the entire structure of the
stent so that the latter is urged in place against the body
passageway. As indicated above, the amount of force applied is at
least that necessary to expand the stent (i.e., the applied force
exceeds the minimum force above which the stent material will
undergo plastic deformation) while maintaining the patency of the
body passageway. At this point, the balloon is deflated and
withdrawn within the catheter, and is subsequently removed.
Ideally, the stent will remain in place and maintain the target
area of the body passageway substantially free of blockage (or
narrowing).
[0009] See, for example, any of the following patents:
[0010] U.S. Pat. No. 4,323,071 (Simpson et al.),
[0011] U.S. Pat. No. 4,411,055 (Simpson et al.),
[0012] U.S. Pat. No. 4,616,648 (Simpson),
[0013] U.S. Pat. No. 4,661,094 (Simpson),
[0014] U.S. Pat. No. 4,733,665 (Palmaz),
[0015] U.S. Pat. No. 4,739,762 (Palmaz),
[0016] U.S. Pat. No. 4,800,882 (Gianturco),
[0017] U.S. Pat. No. 4,907,336 (Gianturco),
[0018] U.S. Pat. No. 5,035,706 (Gianturco et al.),
[0019] U.S. Pat. No. 5,037,392 (Hillstead),
[0020] U.S. Pat. No. 5,041,126 (Gianturco),
[0021] U.S. Pat. No. 5,092,873 (Simpson et al.),
[0022] U.S. Pat. No. 5,102,417 (Palmaz),
[0023] U.S. Pat. No. 5,147,385 (Beck et al.),
[0024] U.S. Pat. No. 5,269,793 (Simpson),
[0025] U.S. Pat. No. 5,282,824 (Gianturco),
[0026] U.S. Pat. No. 5,316,023 (Palmaz et al.),
[0027] U.S. Pat. No. 5,415,634 (Glynn et al.),
[0028] U.S. Pat. No. 5,462,529 (Simpson et al.),
[0029] U.S. Pat. No. 5,755,771 (Penn et al.),
[0030] U.S. Pat. No. 5,980,570 (Simpson),
[0031] International patent application PCT/CA97/00151 (Penn et
al.), and
[0032] International patent application PCT/CA97/00152 (Penn et
al.),
[0033] for a discussion on previous stent designs and deployment
systems.
[0034] Given the development of stent design, the prior art has
also focussed on delivery systems for stent deployment.
[0035] One particular delivery system is taught by U.S. Pat. No.
4,748,982 [Horzewski et al. (Horzewski)]. Horzewski teaches a
reinforced balloon dilation catheter with a slitted exchange
sleeve. Essentially, the catheter comprises a tubular member having
a first lumen and a second lumen. A dilation balloon is mounted on
the distal end of the tubular member and is in communication with
the first lumen. An opening (or notch) is disposed in the tubular
member intermediate its proximal and distal ends for receiving a
guidewire which travels through the second lumen and emanates out
of the distal end of the tubular member. A slit is disposed on the
longitudinal portion of the tubular member between the opening and
an area 0.5-1 cm proximal the dilation balloon. Thus, as
illustrated in FIG. 1 of Horzewski, the guidewire travels partly
within a lumen in the catheter (approximately 10-15 cm) and partly
along the outside of the catheter (approximately 80-90 cm ). This
approach is also known as a "monorail" delivery system. The
principal advantage of this approach is that it permits so-called
"rapid exchange" of the balloon catheter with another balloon
catheter. In design, the exchange is facilitated by the provision
of the above-mentioned slit so that the actual exchange is done
over the balloon portion only (approximately 3 cm ). The principal
disadvantages of this approach include: less than optimum
steerability of the guidewire, difficulties in moving the guidewire
with respect to the catheter, less than optimum torque control and
inability to exchange the guidewire while leaving the catheter in
place. The catheter illustrated by Horzewski has not gained
widespread commercial popularity.
[0036] Another approach for catheterization is the so-called "over
the wire" approach--this approach is discussed in many of the
above-mentioned United States patents naming John P. Simpson as an
inventor. In this approach, the catheter comprises a tubular member
having a first lumen and a second lumen. A dilation balloon is
mounted on the distal end of the tubular member and is in
communication with the first lumen. The second lumen runs through
the length of the tubular member. An opening is disposed in the
tubular member at its proximal end for receiving a guidewire which
travels through second lumen and emanates out of the distal end of
the tubular member. Thus, in the "over the wire" approach, the
guidewire is enpassed by the second lumen along the entire length
of the tubular member (approximately 90-105 cm). The principal
advantages of the this approach include: optimum steerability,
smoother movement of the guidewire with respect to the catheter
(due to the coaxial relationship thereof), optimum torque control
and the ability to exchange the guidewire while leaving the
catheter in place. The principal is disadvantage of this approach
is that exchange with another balloon catheter is relatively
cumbersome (i.e., compared to the "monorail" approach discussed
above.
[0037] Accordingly, it would be desirable to have a balloon
dilation catheter which combined the advantages of the
above-mentioned "monorail" approach and "over the wire" approach
while obviating or mitigating the disadvantages of these
approaches. It would be further advantageous if the balloon
dilation catheter were readily adaptable to be used in various
interventional techniques such as endovascular prosthesis delivery,
angioplasty and the like.
SUMMARY OF THE INVENTION
[0038] It is an object of the present invention to provide a novel
balloon dilation catheter.
[0039] It is another object of the present invention to provide a
novel catheterization method.
[0040] Accordingly, in one of its aspects, the present invention
provides a balloon dilation catheter comprising:
[0041] a tubular member having a proximal end and a distal end;
[0042] an inflatable balloon disposed at the distal end of the
tubular member;
[0043] a first lumen disposed in the tubular member and in
communication with an interior of the inflatable balloon;
[0044] a second lumen disposed in the tubular member for receiving
a guidewire substantially along its entire length, the second lumen
having a first opening at the proximal end of the tubular member
and a second opening at the distal end of the tubular member;
and
[0045] a first slit disposed longitudinally from the first opening
along substantially the entire length of the tubular member to
permit separation of the guidewire with respect to the second
lumen.
[0046] In another of its aspects, the present invention provides a
catheterization kit comprising:
[0047] a guide catheter;
[0048] a guide wire; and
[0049] a balloon dilation catheter comprising: a tubular member
having a proximal end and a distal end; an inflatable balloon
disposed at the distal end of the tubular member;
[0050] a first lumen disposed in the tubular member and in
communication with an interior of the inflatable balloon; a second
lumen disposed in the tubular member for receiving the guidewire
substantially along its entire length, the second lumen having a
first opening at the proximal end of the tubular member and a
second opening at the distal end of the tubular member; and a first
slit disposed longitudinally from the first opening along
substantially the entire length of the tubular member to permit
separation of the guidewire with respect to the second lumen.
[0051] In yet another of its aspects, the present invention
provides a stent-mounted balloon catheter comprising:
[0052] a tubular member having a proximal end and a distal end;
[0053] an inflatable balloon disposed at the distal end of the
tubular member;
[0054] a stent mounted on the inflatable balloon;
[0055] a first lumen disposed in the tubular member and in
communication with an interior of the inflatable balloon;
[0056] a second lumen disposed in the tubular member for receiving
a guidewire substantially along its entire length, the second lumen
having a first opening at the proximal end of the tubular member
and a second opening at the distal end of the tubular member;
and
[0057] a first slit disposed longitudinally from the first opening
along substantially the entire length of the tubular member to
permit separation of the guidewire with respect to the second
lumen.
[0058] Thus, the present inventors have discovered a balloon
catheter which combines the advantages of the "over the wire"
approach (i.e., optimum steerability, smoother movement of the
guidewire with respect to the catheter (due to the coaxial
relationship thereof), optimum torque control and the ability to
exchange the guidewire while leaving the catheter in place) with
the principal advantage of the "monorail" approach (i.e., rapid
exchange of the balloon catheter with another balloon catheter
while leaving the guidewire in place).
[0059] As used throughout this specification, the term "tubular
member", when used in the context of the present balloon dilation
catheter is intended to mean a portion of the catheter generally
tubular in construction and generally representing the large
majority of the overall length of the balloon dilation catheter.
Typically, the tubular member will be at least about 75%, more
preferably at least about 85%, most preferably at least about 95%,
of the overall length of the balloon dilation catheter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0060] Embodiments of the present invention will be described with
reference to the accompanying drawings wherein like numerals
designate like parts and in which:
[0061] FIG. 1 illustrates a perspective view of an embodiment of
the present balloon dilation catheter;
[0062] FIG. 2 is a sectional view along line II-II in FIG. 1;
[0063] FIG. 3 is a sectional view along line III-III in FIG. 1;
[0064] FIG. 4 illustrates an exploded view of modified proximal end
of the balloon dilation catheter illustrated in FIG. 1;
[0065] FIGS. 5-11 illustrate steps in various catheterization
techniques employing the present balloon dilation catheter;
[0066] FIG. 12 illustrates a modified balloon for use in the
present balloon dilation catheter; and
[0067] FIG. 13 illustrates a preferred embodiment of a modified
tubular member for use in the present balloon dilation
catheter.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0068] Thus, with reference to FIGS. 1-3, there is illustrated a
balloon dilation catheter 100. Balloon dilation catheter 100
comprises a proximal end 105 and a distal end 110. Distal end 110
of balloon dilation catheter 100 comprises an expandable balloon
115. Proximal end 105 of balloon dilation catheter 100 comprises an
single lumen Luer-type adaptor 120. Disposed between adaptor 120
and balloon 115 is a tubular member 125.
[0069] As will be apparent from FIG. 1, disposed in tubular member
125 is an opening 130. Also disposed in tubular member 125 is a
slit 135 which extends from opening 130 to a point in tubular
member 125 just proximal balloon 115.
[0070] With particular reference to FIGS. 2 and 3, tubular member
125 comprises a first lumen 140 and a second lumen 150. First lumen
140 is designed to be in communication with an interior of balloon
115. The design of the interface between balloon 115 and first
lumen 140 is conventional--see for example Horzewski referred to
hereinabove. The construction of tubular member 125 having opening
130, slit 135, first lumen 140 and second lumen 150 is
conventional--see Horzewski referred to hereinabove.
[0071] With further reference to FIGS. 1-3, it will be apparent
that opening 130 is designed to receive a guidewire 160. Guidewire
160 passes through second lumen 150 and out of a distal opening of
tubular member 125 beyond balloon 115.
[0072] In FIG. 4, there is illustrated a modification of balloon
dilation catheter 100 illustrated in FIGS. 1-3.
[0073] Specifically, in FIG. 4, Luer-type adaptor 120a is modified
to contain a lumen 150a in communication with a slit 135a. As will
be apparent to those of skill in the art, lumen 150a is in
communication with second lumen 150 in tubular member 125. Further,
slit 135a is in communication with slit 135 in tubular member 125.
The modification of balloon dilation catheter 100 illustrated in
FIG. 4 eliminates the need for having opening 130 disposed in
tubular member 125 illustrated in FIG. 1.
[0074] With reference to FIGS. 5-9, the delivery of balloon
dilation catheter 100 will be described.
[0075] As is known in the art, catheterization is normally
performed to alleviate a lesion in an artery. This is shown
schematically in FIGS. 6-9 wherein a lesion in the form of a
blockage 15 obstructs an artery 20. In certain cases, it is
desirable to deploy a stent at the site of the lesion to maintain
the patency of artery 20 at the site of blockage 15. As shown in
FIG. 5, catheterization is performed through an incision in the
groin area of the patient.
[0076] Thus, with reference to FIGS. 6 and 7, a guide catheter 25
is initially delivered into artery 20 to a region proximal of
blockage 15. The proximal end of guide catheter 25 remains outside
the patient.
[0077] Balloon dilation catheter 100 (FIG. 1) has mounted on
balloon 115 thereof a stent 30. Further, guidewire 160 in second
lumen 150 such that it emanates from opening 130 and from distal
end 110 of balloon dilation catheter 100. Preferably, this is
achieved in a conventional manner by feeding guidewire 160 into
second lumen 150 at distal end 110 of balloon dilation catheter 100
until the proximal end of guidewire 160 emanates from opening
130.
[0078] At this point, balloon dilation catheter 100 is inserted
into guide catheter 25 and guidewire 160 is navigated through
artery 20 to a point distally of blockage 15 (FIG. 7).
[0079] Aternatively, it is possible to advance guidewire 160 to a
point distally of blockage 15, after which the distal end of second
lumen 150 of balloon dilation catheter 100 is passed onto the
proximal end of guidewire 160. If it becomes difficult to advance
guidewire 160 across blockage 15 using this technique, it is
possible to advance balloon dilation catheter over the proximal end
of guidewire 160 until that end exits opening 130 and the system
may used in the "over-the-wire" approach described herein.
[0080] In FIG. 8, there is illustrated removal of guidewire 160
while leaving balloon dilation catheter 100 in position at point
proximal to blockage 15. This is an advantageous feature of the
present balloon dilation catheter which is not possible with the
balloon dilation catheter taught in Horzewski. Thus, guidewire 160
may simply be replaced with another guidewire by removing the
original guidewire from proximal end 105 of balloon dilation
catheter 100 and simply inserting a replacement guidewire (not
shown) into the proximal end 105 of balloon dilation catheter 100
and through tubular member 125. Thereafter, the replacement
guidewire may be navigated so that it emanates from distal end 110
of balloon dilation catheter 100. The replacement guidewire is
navigated to a point distal of blockage 15.
[0081] Balloon dilation catheter 100 is then navigated over the
replacement guidewire such that stent 30 is in proper position with
respect to blockage 15 (FIG. 8). Once the guidewire and balloon
dilation catheter 100 are in the correct position, fluid is
injected into first lumen 150 thereby expanding balloon 115 and
stent 30 mounted thereon. Deployment of a stent in this manner is
conventional and within the purview of a person skilled in the
art.
[0082] In FIGS. 10 and 11, there is illustrated rapid exchange of
balloon dilation catheter 100 while leaving guidewire 160 in place.
In this case, for clarity, stent 30 is not shown on balloon 115.
One of the features of the present balloon dilation catheter which
distinguishes it from that in Horzewski is that guidewire 160
emanates from a proximal portion of balloon dilation catheter 100
which is always outside the body of the patient. This provides the
practitioner with the "over-the-wire" approach described above.
Thus, either opening 130 is located outside the body at all times
during use of catheter 100 illustrated in FIG. 1 or it is
necessarily emanating from the proximal end of balloon dilation
catheter 100 if the modified embodiment in FIG. 4 is utilized.
[0083] When it is desired to exchange balloon dilation catheter
100, the balloon dilation catheter is withdrawn from artery 20
while leaving guidewire 160 in place. As balloon dilation catheter
100 is withdrawn from the body of the patient, it may be readily
separated from guidewire 160 via slit 135 along virtually the
entire length of tubular member 125--this is one of the principal
advantages of the present balloon dilation catheter which, to the
knowledge of the present inventors, has not been achieved with a
prior balloon dilation catheter. Once distal end 110 of balloon
dilation catheter 100 is withdrawn from the body, balloon 115 may
be exchanged from guidewire 160 in a conventional manner.
[0084] A replacement balloon dilation catheter may then be fed over
guidewire 100 and navigated into artery 20 in the area of blockage
15.
[0085] With reference to FIG. 12, there is illustrated yet a
further alternate embodiment to the present balloon dilation
catheter. In this case, a slit 135b is provided in balloon 115b
such that slit 135 is in communication with slit 135b on balloon
115b. This modification of balloon catheter 100 is particularly
advantageous when the catheter is being used in an angioplasty
application (i.e., without a stent mounted on balloon 115) as a
pre-dilation balloon catheter allowing for enhanced rapid exchange
features by facilitating withdrawal of guidewire 160 in a rapid
exchange manner along virtually the entire length of tubular member
125 and balloon 115b via the combination of slits 135 and 135b.
This feature is generally advantageous since it facilitates
withdrawal of the balloon dilation catheter from the patient.
[0086] With reference to FIG. 13, there is illustrate a preferred
modification to tubular member 125 of balloon catheter 100.
Specifically, a third lumen 180 is provided along substantially the
entire length of tubular member 125. Disposed within third lumen
180 is a stiffening member 185 which serves to improve the
"torqueability" of balloon dilation catheter. Unlike, the approach
in Horzewski described above wherein a single lumen does double
duty for receiving: (i) a stiffening member along most of the
length of the catheter and (ii) the guidewire along a minor portion
of its length, the approach shown in FIG. 13 is a significant
improvement over Horzewski since it maximizes both the distance
over which rapid exchange may be effected and the distance over
which stiffening may be conferred to the tubular member.
[0087] While this invention has been described with reference to
illustrative embodiments, this description is not intended to be
construed in a limiting sense. For example, while the illustrated
embodiments depict use of the present balloon dilation catheter in
delivery of a stent, those of skill in the art will immediately
appreciate that the present balloon dilation catheter may be used
in percutaneous transluminal coronary angioplasty techniques.
Various modifications of the illustrative embodiments, as well as
other embodiments of the invention, will be apparent to persons
skilled in the art upon reference to this description. It is
therefore contemplated that the appended claims will cover any such
modifications or embodiments.
[0088] All publications, patents and patent applications referred
to herein are incorporated by reference in their entirety to the
same extent as if each individual publication, patent or patent
application was specifically and individually indicated to be
incorporated by reference in its entirety.
* * * * *