U.S. patent application number 10/428668 was filed with the patent office on 2003-10-16 for enhanced catheter with alignment means.
Invention is credited to Lieber, Glen L., Solar, Ronald J..
Application Number | 20030195546 10/428668 |
Document ID | / |
Family ID | 46203899 |
Filed Date | 2003-10-16 |
United States Patent
Application |
20030195546 |
Kind Code |
A1 |
Solar, Ronald J. ; et
al. |
October 16, 2003 |
Enhanced catheter with alignment means
Abstract
A balloon dilatation system is comprised of an elongated
flexible advancement member which terminates in a tubular tracking
member slidable over a guidewire. An inflatable balloon has
proximal and distal ends, the proximal end communicating with an
inflation channel, and the distal end attaching to the tracking
member. The balloon portion is coextensive with but not attached to
the advancement member. An alignment member aligns the advancement
member and the inflation channel. Other embodiments relate to
delivery of stents or other medical instrumentalities.
Inventors: |
Solar, Ronald J.; (San
Diego, CA) ; Lieber, Glen L.; (Poway, CA) |
Correspondence
Address: |
REED SMITH, LLP
ATTN: PATENT RECORDS DEPARTMENT
599 LEXINGTON AVENUE, 29TH FLOOR
NEW YORK
NY
10022-7650
US
|
Family ID: |
46203899 |
Appl. No.: |
10/428668 |
Filed: |
May 2, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10428668 |
May 2, 2003 |
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09629768 |
Jul 31, 2000 |
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09629768 |
Jul 31, 2000 |
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09454255 |
Dec 2, 1999 |
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6447501 |
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09454255 |
Dec 2, 1999 |
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09312529 |
May 14, 1999 |
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6394995 |
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60085636 |
May 15, 1998 |
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Current U.S.
Class: |
606/192 ;
604/103.04; 604/528 |
Current CPC
Class: |
A61M 25/0067 20130101;
A61M 2025/1061 20130101; A61M 2025/1056 20130101; A61M 2025/1093
20130101; A61M 2025/0177 20130101; A61M 2025/0183 20130101; A61M
29/02 20130101; A61M 2025/0008 20130101; A61M 2029/025 20130101;
A61M 25/104 20130101; A61M 25/0662 20130101; A61M 25/01 20130101;
A61M 25/007 20130101; A61M 25/0108 20130101; A61M 25/0105
20130101 |
Class at
Publication: |
606/192 ;
604/103.04; 604/528 |
International
Class: |
A61M 029/00 |
Claims
What is claimed is:
1. A balloon dilatation catheter system comprising: a flexible
elongated advancement member having a distal end, a tracking member
having a proximal end and a distal end, said tracking member being
adapted to slide over a guidewire and being fixedly attached to the
distal end of the advancement member, an inflation channel, and an
inflatable dilatation balloon having proximal end and distal end,
the proximal end of the balloon being in fluid communication with
the inflation channel, wherein the distal end of the balloon is
attached to the tracking member and an alignment member aligns the
advancement member and the inflation channel in the longitudinal
direction.
2. The catheter system of claim 1, wherein the tracking member
comprises two or more lumens.
3. The catheter system of claim 1, wherein the dilatation balloon
is attached to the distal end of the tracking member.
4. The catheter system of claim 1, wherein the dilatation balloon
is attached to the proximal end of the tracking member.
5. The catheter system of claim 1, wherein the tracking member has
a lubricious coating.
6. The catheter system of claim 1, wherein the tracking member is
formed integral with the dilatation balloon.
7. A balloon dilatation catheter system comprising: a flexible
elongated advancement member having a distal end, a dilatation
balloon having a proximal end and a distal end, and an inflation
channel, the proximal end of the balloon being in fluid
communication with the inflation channel, wherein the distal end of
the balloon is attached to the distal end of the advancement member
and an alignment member aligns the advancement member and the
inflation channel in the longitudinal direction.
8. The catheter system of claim 1 or 7, wherein the inflation
channel is substantially coextensive with the advancement
member.
9. The catheter system of claim 1 or 7, wherein the inflation
channel is in a spiral configuration around the advancement
member.
10. The catheter system of claim 1 or 7, wherein the advancement
member comprises a flexible wire or hypotube.
11. The catheter system of claim 1 or 7, wherein the advancement
member is rigid at its proximal end and increasingly more flexible
as it extends distally.
12. The catheter system of claim 1 or 7, wherein the inflation
channel is collapsible or noncollapsible.
13. The catheter system of claim 1 or 7, wherein the dilatation
balloon or the inflation channel, or both, have a wire
reinforcement.
14. The catheter system of claim 1 or 7, wherein the dilatation
balloon and the inflation channel are formed integrally.
15. The catheter system of claim 1 or 7, wherein the inflation
channel is attached to the advancement member at at least one
point.
16. The catheter system of claim 1 or 7, which also comprises a
torquer attached to the proximal end of the advancement member.
17. The catheter system of claim 1 or 7, wherein the inflation
channel is not attached to the advancement member.
18. The catheter system of claim 1 or 7, wherein the balloon and/or
the inflation channel are attached to the advancement member.
19. The catheter system of claim 1 or 7, wherein the advancement
member is attached to or integral with the alignment member.
20. The catheter system of claim 19, wherein the advancement member
is attached to the inner surface of the alignment member.
21. The catheter system of claim 1 or 7, wherein the alignment
member is a hypotube.
22. A method of positioning the distal end of a dilatation system
at a desired location within a patient's body, which comprises the
step of: advancing a dilatation system of claim 1 or 7 over a
guidewire through a corporeal lumen so that the distal end of said
dilatation system is positioned at a desired location.
23. A medical delivery system comprising: a flexible elongated
advancement member having a distal end, a tracking member having a
proximal end and a distal end, said tracking member being adapted
to slide over a guidewire and being fixedly attached to the distal
end of the advancement member, and a medical instrumentality having
proximal end and distal end, the proximal end of the
instrumentality being in communication with a source, wherein the
distal end of the medical instrumentality is attached to the
tracking member and an alignment member aligns the advancement
member and any communication member connected to the medical
instrumentality.
24. The delivery system of claim 23, wherein the tracking member
comprises two or more lumens.
25. The delivery system of claim 23, wherein the medical
instrumentality is attached to the distal end of the tracking
member.
26. The delivery system of claim 23, wherein the medical
instrumentality is attached to the proximal end of the tracking
member.
27. The delivery system of claim 23, wherein the tracking member
has a lubricious coating.
28. The delivery system of claim 23, wherein the tracking member is
formed integral with the medical instrumentality.
29. A medical delivery system comprising: a flexible elongated
advancement member having a distal end, a medical instrumentality
having a proximal end and a distal end, and a communication member,
the proximal end of the medical instrumentality being in
communication with the communication member, wherein the distal end
of the medical instrumentality is attached to the distal end of the
advancement member and an alignment member aligns the advancement
member and the communication member in the longitudinal
direction.
30. The delivery system of claim 23 or 29, wherein the
communication member is substantially coextensive with the
advancement member.
31. The delivery system of claim 23 or 29, wherein the
communication member is in a spiral configuration around the
advancement member.
32. The delivery system of claim 23 or 29, wherein the advancement
member comprises a flexible wire or hypotube.
33. The delivery system of claim 23 or 29, wherein the advancement
member is rigid at its proximal end and increasingly more flexible
as it extends distally.
34. The delivery system of claim 23 or 29, wherein the medical
instrumentality and the communication member are formed
integrally.
35. The delivery system of claim 23 or 29, wherein the
communication member is attached to the advancement member at at
least one point.
36. The delivery system of claim 23 or 29, wherein the
communication member is not attached to the advancement member.
37. The delivery system of claim 23 or 29, wherein the medical
instrumentality and/or the communication member are attached to the
advancement member.
38. The delivery system of claim 23 or 29, wherein the advancement
member is attached to or integral with the alignment member.
39. The delivery system of claim 38, wherein the advancement member
is attached to the inner surface of the alignment member.
40. The delivery system of claim 23 or 29, wherein the alignment
member is a hypotube.
41. A method of positioning the distal end of a medical
instrumentality at a desired location within a patient's body,
which comprises the step of: advancing a delivery system of claim
23 or 29 over a guidewire through a corporeal lumen so that the
medical instrumentality is positioned at a desired location.
42. A stent delivery system comprising: a flexible elongated
advancement member having a proximal end and a distal end, a
tracking member having a proximal end and a distal end, said
tracking member being adapted to slide over a guidewire and being
fixedly attached to the distal end of the advancement member, an
inflation channel, and an inflatable balloon having a proximal end
and a distal end, the proximal end of the balloon being in fluid
communication with the inflation channel, wherein the distal end of
the balloon is attached to the tracking member, wherein a stent can
be arranged concentric to the balloon, and wherein an alignment
member aligns the advancement member and the inflation channel in
the longitudinal direction.
43. The delivery system of claim 42, wherein the tracking member
comprises two or more lumens.
44. The delivery system of claim 42, wherein the balloon is
attached to the distal end of the tracking member.
45. The delivery system of claim 42, wherein the balloon is
attached to the proximal end of the tracking member.
46. The delivery system of claim 42, wherein the tracking member
has a lubricious coating.
47. The delivery system of claim 42, wherein the tracking member is
formed integral with the balloon.
48. A stent delivery system comprising: a flexible elongated
advancement member having a proximal end and a distal end, an
inflatable balloon having a proximal end and a distal end, and an
inflation channel, the proximal end of the balloon being in fluid
communication with the inflation channel, wherein the distal end of
the balloon is attached to the distal end of the advancement
member. wherein a stent can be arranged concentric to the balloon,
and wherein an alignment member aligns the advancement member and
the inflation channel in the longitudinal direction.
49. The delivery system of claim 48, wherein the balloon is folded
to form a tracking member adapted to slide over a guidewire.
50. The delivery system of claim 42 or 48, wherein the inflation
channel is substantially coextensive with the advancement
member.
51. The delivery system of claim 42 or 48, wherein the inflation
channel is in a spiral configuration around the advancement
member.
52. The delivery system of claim 42 or 48, wherein the advancement
member comprises a flexible wire or hypotubing.
53. The delivery system of claim 42 or 48, wherein the advancement
member is rigid at its proximal end and increasingly more flexible
as it extends distally.
54. The delivery system of claim 42 or 48, wherein the inflation
channel is collapsible or noncollapsible.
55. The delivery system of claim 42 or 48, wherein the balloon or
the inflation channel, or both, have a wire reinforcement.
56. The delivery system of claim 42 or 48, wherein the balloon and
the inflation channel are formed integral.
57. The delivery system of claim 42 or 48, wherein the inflation
channel is attached to the advancement member at at least one
point.
58. The delivery system of claim 42 or 48, which also comprises a
torquer attached to the proximal end of the advancement member.
59. The delivery system of claim 42 or 48, wherein the inflation
channel is unattached to the advancement member.
60. A method of positioning a stent at a desired location within a
patient's body, which comprises the step of: advancing a delivery
system of claim 42 or 48 through a corporeal lumen so that the
distal end of said delivery system is positioned at a desired
location.
61. The method of claim 60, wherein another delivery system or
other medical device is advanced distally over the catheter of
claim 42 or 48.
62. A method of positioning a stent at a desired location within a
patient's body, which comprises the step of: advancing a delivery
system of claim 42 or 48 over a guidewire through a coporeal lumen
so that the stent is positioned at a desired location.
63. The method of claim 62, wherein in another step another medical
instrumentality is advanced distally over the guidewire and
positioned adjacent to the delivery system of claim 42 or 48.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of co-pending U.S. patent
application Ser. No. 09/629,768, filed Jul. 31, 2000, which in turn
is a continuation-in-part of U.S. patent application Ser. No.
09/454,255, filed, Dec. 2, 1999, now U.S. Pat. No. 6,447,501, which
is a continuation-in-part of U.S. patent application Serial No.
09/312,529, filed May 14, 1999, now U.S. Pat. No. 6,394,995, which
is based upon U.S. Provisional Patent Application Serial No.
60/085,636, filed May 15, 1998.
SCOPE OF THE INVENTION
[0002] This invention relates to the fields of angioplasty and
other interventional procedures. More particularly, this invention
relates to improved balloon dilatation systems where the distal end
of the inflatable dilatation balloon is attached to a tubular
tracking member or an advancement member and alignment means align
the tracking member and an inflation channel.
BACKGROUND OF THE INVENTION
[0003] Balloon dilatation catheters have been used to dilate
various types of strictures in blood vessels and other body lumens
for over twenty years. Typically, such catheters comprise a balloon
mounted on the distal end of an elongated flexible shaft and an
inflation tube or lumen extending longitudinally within the shaft
from its proximal end to the interior of the balloon. Among the
major advancements in balloon dilatation catheters have been the
development of smaller catheters that can be used in smaller and/or
more distal anatomical locations, and the development of catheters
that can be rapidly exchanged. Examples of such catheters are
described in U.S. Pat. No. 4,748,982 (Horzewski), Pat. No.
4,762,129 (Bonzel), Pat. No. 5,040,548 (Yock), Pat. No. 5,061,273
(Yock), Pat. No. 5,569,199 (Solar) and Pat. No. 5,728,067 (Enger).
Because these catheters have become more sophisticated and complex
in design, and despite the manufacturers's experience in
manufacturing them, these catheters are expensive to make.
Furthermore, despite these improvements, difficulties are still
encountered in advancing catheters through tortuous anatomy and
safely crossing very tight strictures and stenoses in the vascular
system and other body lumens or cavities.
[0004] Recently vascular stents have been shown to play an
important role in reducing the restenosis rates associated with
balloon angioplasty. However, stents are sometimes lost from the
delivery systems and are difficult to retrieve safely. In addition,
stents cannot completely overcome the trauma and injury that result
from balloon dilatation. Thus, there is a need for enhanced balloon
dilatation catheters.
OBJECTS OF THE INVENTION
[0005] It is an object of the invention to provide an enhanced
dilatation system that is extremely low-profile to more easily and
safely cross very tight strictures and stenoses in the vascular
system and other body lumens or cavities.
[0006] It is also an object of the invention to provide an enhanced
dilatation system that provides for an improved means for crossing
tight stenoses, as well as to navigate tortuous anatomy.
[0007] It is another object of the invention to provide an enhanced
dilatation system that has the ability to be exchanged rapidly.
[0008] It is yet another object of the invention to provide an
enhanced dilatation system that can be used to retrieve dislodged
stents.
[0009] It is a further object of the invention to provide an
enhanced dilatation system that can be manufactured inexpensively
and more reliably then currently available balloon dilatation
systems.
[0010] It is also an object of the invention to provide an enhanced
dilatation system that allows placement of an additional catheter
or instrumentality adjacent to a catheter.
[0011] It is likewise an object of the invention to provide an
enhanced dilatation system that facilitates placement of stents or
stent grafts.
[0012] It is a yet further object of the invention to provide a
balloon catheter system and a stent delivery system having a
smaller profile for crossing tight stenoses.
[0013] These and other objects of the invention will become more
apparent from the discussion below.
SUMMARY OF THE INVENTION
[0014] According to the invention, an enhanced balloon dilatation
delivery system comprises an elongated advancement member which
optionally terminates in a tubular tracking member, an inflatable
dilatation balloon having proximal and distal ends and being in
fluid communication with an inflation channel, and means for
aligning the advancement member and the inflation channel. The
proximal end of the inflatable balloon is in fluid communication
with the inflation channel, and the distal end of the inflatable
balloon is attached to the tubular tracking member or the
advancement member. During advancement of the system, the
inflatable dilatation balloon and inflation channel are somewhat
coextensive with the advancement member. The system is slidable
over a guidewire.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The above and other objects and advantages of the invention
will be apparent upon consideration of the following detailed
description, taken in conjunction with the accompanying drawings,
in which the reference characters refer to like parts throughout
and in which:
[0016] FIGS. 1 to 3 are each a schematic, lateral view of an
embodiment of the invention;
[0017] FIG. 4 is an enlarged illustration of the distal portion of
an additional embodiment of the invention;
[0018] FIG. 5 is an enlarged illustration of the proximal portion
of an alternate embodiment of the invention;
[0019] FIG. 6 is a cross-sectional view of a clamping member used
in the FIG. 5 embodiment;
[0020] FIGS. 7 and 8 are each a schematic, lateral view of an
additional embodiment of the invention;
[0021] FIG. 9 is a schematic, partly cross-sectional view of
another embodiment of the invention and FIG. 10 is a
cross-sectional view across line 10-10;
[0022] FIG. 11 is an alternate cross-sectional view of FIG. 10;
[0023] FIGS. 12, 13 and 14 are each a schematic representation of
another embodiment of the invention; and
[0024] FIG. 15 is a detail of FIG. 14.
DETAILED DESCRIPTION OF THE INVENTION
[0025] With reference to FIGS. 1 to 3, an enhanced catheter system,
designated generally as 1, has an elongated advancement member 5.
Preferably advancement member 5 is formed of a flexible wire or,
alternately, of spring hollow hypotubing. Advancement member 5
preferably has a diameter of from about 0.008" to 0.035", which
diameter could be larger or smaller depending on the application.
Advancement member 5 has sufficient column strength and flexibility
to provide for advancement of the catheter through tortuous
anatomy. Preferably, advancement member 5 is rigid at its proximal
end and becomes increasingly more flexible as it extends distally.
This may be accomplished by a number of ways known in the art,
including, but not limited to, tapering, selective heat treatment
and/or forming advancement member 5 from a composite of materials
with various properties.
[0026] Advancement member 5 terminates at its distal end 6 in an
elongated tubular tracking member 7. Tracking member 7 has a
tubular configuration and is adapted to slide over a standard
guidewire 9 to allow system 1 to advance easily to a desired
location within a patient's body. Tracking member 7 has an open
proximal end 11 and an open distal end 8, and is preferably formed
of a flexible polymeric tube, a spring coil, or a combination
thereof. Tracking member 7 is preferably about 10 to 50 cm long and
has an inner diameter that is sized to accommodate guidewire 9,
most preferably approximately from about 0.012" to 0.040".
Optionally tracking member 7 has an inner, outer, or inner and
outer coating with a lubricious material to aid in its movement
over the guidewire. Lubricious materials for this purpose are
well-known in the art.
[0027] Advancement member 5 and tracking member 7 are attached by
any suitable means known in the art, such as by fusion or a
non-toxic adhesive. Alternatively, advancement member 5 and
tracking member 7 may be integrally formed during manufacture.
[0028] System 1 also has an inflatable balloon 10 having a proximal
end 12 and distal end 14. Distal end 14 of balloon 10 is attached
to tracking member 7 by any suitable means known in the art, such
as by fusion, adhesive bonding or integral formation, and moves
therewith. Distal end 14 of balloon 10 may be attached to distal
end 8 of tracking member 7, as shown in FIG. 1, or preferably,
distal end 14 of balloon 10 is attached to the proximal end 11 of
tracking member 7, as shown in FIG. 3. Balloon 10 is formed of a
very thin-walled, preferably less than 0.001" thick, polymeric
material. Balloon 10 may be formed of any one of a variety of
suitable materials known in the art. Optionally balloon 10 may be
suitable for dilatation and/or deployment of a stent.
[0029] Proximal end 12 of balloon 10 communicates with an elongated
inflation channel 15 that extends proximally through a corporeal
lumen. Inflation means 15 is formed preferably of a polymeric
tubular film that will allow inflation channel 15 to collapse to a
smaller profile when not being used for inflation of balloon 10.
The wall thickness of inflation channel 15 should preferably be
less than 0.001". When inflated, inflation channel 15 will have a
diameter of approximately 0.010" or more, depending upon the
application. Alternatively, inflation channel 15 may be fabricated
out of a non-collapsible tubing material as would be familiar to
one skilled in this art. As shown in FIG. 3, inflation channel 15
may have position markers 13 on its proximal portion. Position
markers 13, which may be applied by ink or other suitable means
known in the art, correspond to similar markers on advancement
member 5. Such markers provide visual confirmation of concurrent
movement of inflation channel 15 and advancement member 5 during
advancement and withdrawal of system 1.
[0030] Inflation channel 15 has a hub 16 at its opposite, proximal
end. Hub 16 is a standard LUER.RTM. lock connector that allows
connection of inflation means 15 to standard balloon inflator
devices or syringes (not shown). By this means, balloon 10 is in
fluid communication with an inflator.
[0031] As noted above, distal end 14 of inflatable balloon 10 is
attached to tubular tracking member 7. In this way, as tubular
tracking member 7 travels through the body along the path of
guidewire 9, inflatable balloon 10 is pulled along with tracking
member 7 to the desired site. However, although balloon 10 lies
coextensively with advancement member 5 (FIGS. 2 and 3) and/or
tracking member 7 (FIG. 1), it is unattached to advancement member
5. In this most preferred embodiment of least attachment, pushing
on advancement member 5 causes balloon 10 to be easily pulled
through the anatomy and tight strictures and stenoses. Since the
balloon is not being pushed through a stenosis, there is no
tendency for the balloon to compress longitudinally and increase in
profile and bulk. Such an occurrence, which may be found in prior
art catheters where the balloon is attached proximally and distally
to the catheter shaft, can impede advancement and crossing, as well
as result in vascular trauma and clinical complications. Since
there is no bulky catheter structure within the interior of the
balloon (as is found in prior art catheters), the very thin balloon
material can easily fold and conform as required to cross a
stenosis with minimal friction and trauma as it is pulled across by
the tracking member.
[0032] As shown in FIG. 3 a wire 2 can optionally extend at least
partially within the inflation channel 15 to the distal end 14 of
balloon 10. Wire 2 may provide support to the inflation channel 15
and balloon 10 which may be required in some applications. The
support wire may be permanently mounted, or alternatively, it may
be removable and used as needed. Also, as shown in FIG. 3, the
dilatation system may have radiopaque markers 17 to allow the
system's position to be monitored, and the proximal ends of the
advancement member 5 and/or inflation channel 15 may have one or
more visual markers 13 to indicate the lengths inserted. The
radiopaque markers may be comprised of conventional radiopaque
materials such as gold or platinum, and the visual markers may be
comprised of physiological acceptable inks or coatings, preferably
in bright or fluorescent colors.
[0033] The embodiment of the invention shown in FIG. 7 has an
inflatable balloon 22 and a flexible, torqueable, advancement
member 23. The distal portion 24 of balloon 22 is fixedly attached
to the distal end 25 of advancement member 23. Advancement member
distal end 25 may optionally have a flexible spring tip 26.
[0034] The proximal portion 27 of balloon 22 is in fluid
communication with an inflation channel or means 28 having a hub 29
for connection to an inflation source (not shown). Inflation
channel 28 preferably is attached to or wound about advancement
member 23 in spiral fashion, in such a way to lower the profile of
the system but to not interfere with the fluid communication.
[0035] A torquer or rotator member 30 may optionally grip the
proximal portion of advancement member 23 and inflation channel 28,
to allow radial positioning of advancement member 23. In this
embodiment it is preferred that the inflation means spirally wrap
around the advancement member. Turning the proximal end of the
advancement member with torquer 30 will allow distal end 25 of the
advancement member 23 to be positioned at a desired radial location
relative to balloon 22 within a corporeal lumen. A torquer 30 could
also be used with the embodiments shown in FIGS. 1 and 2, where the
tracking means and advancement means would be radially
positioned.
[0036] In FIG. 9, an enhanced balloon dilatation system, designated
generally as 80, has an elongated advancement member 82. Preferably
advancement member 82 is formed of a flexible wire or, alternately,
of spring hollow hypotubing, and has the characteristics described
above.
[0037] Advancement member 82 terminates at its distal end 84 in a
tubular tracking member 86. Tracking member 86 has a tubular
configuration and is adapted to slide over a standard guidewire 88
to allow system 80 to advance easily to a desired location within a
patient's body. Tracking member 86 has an open proximal end 90 and
an open distal end 92, and is preferably formed of a flexible
polymeric tube, a spring coil, or a combination thereof. Tracking
member 86 is preferably about 3 to 30 cm long and has an inner
diameter that is sized to accommodate guidewire 88, most preferably
approximately from about 0.012" to 0.040". Optionally tracking
member 86 has an inner, outer, or inner and outer coating with a
lubricious material to aid in its movement over the guidewire.
[0038] Advancement member 82 and tracking member 86 are attached by
any suitable means known in the art, such as by fusion or a
non-toxic adhesive, or, alternatively, have been integrally formed
during manufacture.
[0039] System 80 also has an inflatable balloon 94 having a
proximal end 96 and distal end 98. Distal end 98 of balloon 94 is
attached to advancement member 82 or tracking member 86 by any
suitable means known in the art, such as by fusion, adhesive
bonding or integral formation, and moves therewith. Distal end 98
of balloon 94 may be attached to advancement member 82, as shown in
FIG. 9, or optionally distal end 98 of balloon 94 can be attached
to the proximal end 90 of tracking member 86, as similar to the
arrangement shown in FIG. 3. Balloon 94 is formed of a very
thin-walled, preferably less than 0.001" thick, polymeric material,
of any one of a variety of suitable materials known in the art.
[0040] Proximal end 96 of balloon 94 communicates with an elongated
inflation channel 100 that extends proximally through a corporeal
lumen. Inflation channel 100 is formed preferably of a polymeric
tubular film that will allow inflation channel 100 to collapse to a
smaller profile when not being used for inflation of balloon 94.
When inflated, inflation channel 100 will have a diameter of
approximately 0.010" or more, depending on the application.
Alternatively, inflation channel 100 may be fabricated out of a
non-collapsible tubing material as would be familiar to one skilled
in this art.
[0041] Inflation channel 100 has a hub 101 at its opposite,
proximal end. Hub 101 is a standard LUER.RTM. lock connector that
allows connection of inflation channel 100 to standard balloon
inflator devices or syringes (not shown). By this means, balloon 94
is in fluid communication with an inflator.
[0042] An alignment member or sheath 102 extends longitudinally,
whereby it encompasses at least inflation channel 100. Alignment
member 102 preferably is attached to or integral with advancement
member 82, and preferably advancement member 82 also is encompassed
by alignment member 102. Alignment member 102 can be comprised of
any suitable flexible or substantially flexible medically
acceptable material, such as a polymer or metal. In a preferred
embodiment alignment sheath comprises a stainless steel hypotube
and advancement member 82 is bonded to its inner or outer
surface.
[0043] The distal end 104 of alignment member 102 is open, and the
proximal end 106 of alignment member 102 is optionally attached to
hub 101, optionally with an opening for the proximal portion 108 of
advancement member 82.
[0044] In the cross-sectional view along line 10-10 in FIG. 9 that
is represented by FIG. 10, advancement member 82 and inflation
channel 100 are positioned within alignment member 102. However, in
an alternative embodiment reflected in FIG. 11, advancement member
82 is attached to the outer surface 110 of alignment member
102.
[0045] In a preferred embodiment the advancement member has a
proximal portion and a distal portion. The proximal portion has at
least one lumen having open ends. Inflation channel 100 is
positioned within one of said lumens and the proximal portion of
the advancement member functions as the alignment member. The
distal portion of the advancement member extends distally from the
distal end of the proximal portion of the advancement member.
[0046] In a preferred embodiment of the invention a stent or stent
graft may be delivered. An example of this preferred embodiment is
shown in FIG. 12. In this embodiment, an inflatable balloon 40 is
folded and formed into a tubular shape, and a stent or stent graft
42 is mounted onto the balloon by various methods known in the art
such as, for example, crimping, interference fit, or encapsulation.
See, for example, U.S. Pat. Nos. 4,800,882 and 5,836,965. In this
embodiment, the distal end 44 of balloon 40 is attached to
advancement means 46 adjacent to the distal end of advancement
means 46, and the balloon/stent assembly 40/42 acts as a tracking
member. The proximal end 48 of balloon 40 is in fluid communication
with hub 50 through flexible conduit 52.
[0047] Alternatively, the embodiment illustrated in FIG. 1 may be
used to deliver a stent or stent graft. With the distal end 14 of
balloon 10 attached to the distal end 8 of the tracking member 7,
the balloon is folded around tracking member 7, and the stent/stent
graft 54 is mounted onto the folded balloon (FIGS. 1 and 13).
Tracking member 7 is advanced over guidewire 9.
[0048] In the embodiment shown in FIGS. 14 and 15, the distal end
62 of an inflatable balloon 64 is attached to the proximal end 66
of a tracking member 68. Balloon 64 is folded and formed into a
tubular shape, and a stent or stent graft 70 is mounted onto the
balloon by various methods known in the art. Optionally, a sheath
can be extended over the stent (various designs and methods are
known in the art).
[0049] To summarize use of the embodiments of the present invention
described above, a guidewire is first laid in place within a
corporeal lumen through any of the means well-known in the art.
With use of an advancement member, a tracking member or folded
balloon is advanced into the corporeal lumen over the guidewire. As
the advancement member or folded balloon is advanced into the
corporeal lumen, an inflatable balloon is pulled along with it by
virtue of the attachment of its distal end to the tracking member
or the advancement member. Once the inflatable balloon is in a
desired position within the corporeal lumen, the balloon is
inflated via the inflation means and hub.
[0050] It is contemplated that the tracking member can be varied to
provide alternative embodiments of the catheter system of the
invention. For example, the length of the tracking member may
either be made longer or shorter. In the embodiment of the
invention shown in FIG. 2, the tracking means has been shortened to
a loop 18. Alternatively, it is contemplated that the tracking
member may extend as an elongated tubular member the full length of
system, from a proximal position outside the body lumen all the way
to its distal end, to allow fluid administration of the treatment
site. Also, the distal end of the advancement member could extend
distally of the tracking member. Moreover, in one embodiment of the
invention the inflatable balloon may be detachable.
[0051] In addition, it is contemplated that the tracking member may
be single-lumen, so that it accommodates only a guidewire, or it
may be multi-lumen, so that it can perform other functions as well.
For example, the multi-lumen tracking member 19 shown in FIG. 4
contains lumen 3 for advancing over guidewire 9 and lumen 20, which
provides a convenient means for attachment to advancement member 5.
Advancement member 5 may be hollow to provide an alternative means
for fluid administration to the treatment site. Lumen 20 may be
open at the distal end 4 of tracking member 19, and tracking member
19 may alternatively have side holes 21 which provide communication
from lumen 20 to the exterior of tracking member 19. Tracking
member 19 may also be enlarged and/or lengthened to facilitate
perfusion during balloon inflation.
[0052] It is further contemplated that, in some applications, it
may be deemed desirable to provide one or more additional
attachment points between the inflation channel and the advancement
member at various locations along the advancement member's length.
A preferred method of attachment employs a removable clamping
member 22 as shown in FIGS. 5 and 6. Clamping member 22 holds
inflation channel 15 stationary with respect to advancement member
5 during withdrawal of catheter system 1. Clamping member 22 is
preferably removed or loosened during catheter system advancement
to optimize the pulling forces on the balloon. It is contemplated
that in some instances more than one clamp 22 might be used.
[0053] Further, it is envisioned that the inflatable balloon and
the inflation channel may be formed from the same material or they
may be formed independently and subsequently attached by suitable
known means. In addition, the distal extension of the balloon may
be molded or otherwise formed to the shape of the tracking
member.
[0054] In yet another alternative preferred embodiment of the
invention, the advancement member and the tracking member may be
formed in multiple segments each having varying mechanical
properties which will allow for the customization of the catheter
to a particular need.
[0055] The catheter systems of the present invention provides the
user with a number of significant advantages not otherwise
obtainable with currently available catheters. For example, they
are less bulky than other available catheter systems and thus the
balloon is able to move against resistance more easily, which
allows less traumatic crossing of restrictions. Also, pushing on
the advancement member has the effect of pulling the balloon along
through the stenosis, and avoids the problem of bunching or
gathering which occurs with other catheters. With a thin film
balloon and inflation channel there is no dead space or volume that
needs to be evacuated prior to use; therefore, little or no
preparation is required. The smaller profile of the catheter system
of the invention allows the inflatable balloon to be passed through
stents easily. Partial inflation of the inflatable balloon can grab
a previously inserted stent and facilitate retrieval of the stent.
The smaller profile also permits passage through displaced stent
struts.
[0056] Separating the inflatable balloon from a catheter shaft
allows greater design flexibility to allow one to provide catheter
systems with improved handling characteristics, and the fewer bonds
between the balloon and the advancement shaft results in greater
reliability. The simplicity of construction of the system of the
present invention results in lower manufacturing costs. For
example, fewer bonding operations are required, and expensive
balloon folding processes can be avoided. Inflating the balloon
against the advancement member or tracking member provides a
focused force to enable the user to crack hard lesions at low
pressure before the balloon is fully inflated. Doing so would allow
vessel stretching to occur at a lower strain rate, which would
minimize the trauma associated with balloon dilatation. With a
guidewire in place, the balloon can be inflated additionally
against the guidewire, thus providing an additional area of focused
force.
[0057] A further advantage of the present invention is that the
design allows additional catheters or devices to be placed over the
guidewire adjacent to the inflatable balloon, and to be exchanged
without first removing the catheter system. In addition, the
advancement member may also act as an additional guidewire. For
example, while balloon catheter 1 is in place within a vascular
lesion, a second dilatation system or catheter may be advanced over
the advancement member and its balloon positioned along side the
first balloon (to increase the effective diameter of the
dilatation) or adjacent to the first balloon (to increase the
effective length of the dilatation). An imaging catheter such as an
intravascular ultrasound catheter may be placed next to the first
balloon to access the progress of the treatment without removing
the balloon. A drug delivery catheter may be utilized in this
manner, and the balloon of system 1 may be inflated at low pressure
to provide vascular occlusion to improve the efficacy of the drug
delivery. Likewise, various other catheters and devices may be
suitably employed.
[0058] Although the discussion above has been concerned with
inflatable balloon systems and/or catheters, other types of
catheters or systems may embody the present invention as
schematically illustrated in FIG. 8. In FIG. 8, advancement member
5 terminates in a tubular tracking member 7, which tracks over
guidewire 9. Distal end 32 of instrumentality 31 is attached to
tracking member 7. Proximal end 33 of instrumentality 31 is
unattached to either advancement member 5 or tracking member 7.
Instrumentality 31 may be a laser, infusion tube, suction device,
atherectomy means, other stent expansion means or another
therapeutic or diagnostic apparatus. As required, a connecting
member 34 may be attached to instrumentality 31. Connecting member
34 may be an electrical conducting wire, optical fiber, tube, or
the like.
[0059] It will thus be seen that the objects set forth above, among
those made apparent from the preceding description, are efficiently
attained, and since certain changes may be made in the
constructions set forth without departing from the spirit and scope
of the invention, it is intended that all matter contained in the
above description and shown in the accompanying drawings shall be
interpreted as illustrative and not in a limiting sense.
[0060] It is also to be understood that the following claims are
intended to cover all of the generic and specific features of the
invention herein described and all statements of the scope of the
invention, which, as a matter of language, might be said to fall
therebetween.
* * * * *