U.S. patent application number 10/260774 was filed with the patent office on 2003-02-06 for method of using catheters having a rapid exchange and over-the-wire operating mode.
Invention is credited to Dutta, Debashis, Nguyen, Cindy, Serina, Eugene, Welborn, Kristin E..
Application Number | 20030028143 10/260774 |
Document ID | / |
Family ID | 23851477 |
Filed Date | 2003-02-06 |
United States Patent
Application |
20030028143 |
Kind Code |
A1 |
Dutta, Debashis ; et
al. |
February 6, 2003 |
Method of using catheters having a rapid exchange and over-the-wire
operating mode
Abstract
An intravascular catheter capable of both rapid-exchange and
over-the-wire modes of operation having a relatively long proximal
shaft portion, a relatively short distal section and an
intermediate shaft section, which connects the proximal shaft
section and the distal shaft section. In one embodiment, the
intermediate shaft section includes a guide wire port and a first
guide wire lumen which extends throughout both the intermediate and
distal shaft section, and a second guide wire lumen which extends
throughout the entire catheter shaft. In another embodiment, the
intermediate shaft section includes a y-lumen junction which allows
a first guide wire lumen introduced at the intermediate shaft
section and a second guide wire lumen extending from the proximal
end of the catheter shaft throughout the proximal shaft section to
merge and communicate with a single distal guide wire lumen which
extends from the intermediate shaft section to the distal end of
the catheter shaft. In another embodiment, the catheter shaft
includes a single guide wire lumen extending from the proximal end
to the distal end wherein the guide wire lumen is defined by a
proximal section and a distal section. The proximal section guide
wire lumen includes a slit which allows a guide wire to be removed
for rapid-exchange mode of operation or retained for over-the-wire
mode of operation.
Inventors: |
Dutta, Debashis; (Santa
Clara, CA) ; Nguyen, Cindy; (San Jose, CA) ;
Serina, Eugene; (Menlo Park, CA) ; Welborn, Kristin
E.; (Santa Clara, CA) |
Correspondence
Address: |
FULWIDER PATTON LEE & UTECHT, LLP
HOWARD HUGHES CENTER
6060 CENTER DRIVE
TENTH FLOOR
LOS ANGELES
CA
90045
US
|
Family ID: |
23851477 |
Appl. No.: |
10/260774 |
Filed: |
September 30, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10260774 |
Sep 30, 2002 |
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09929407 |
Aug 14, 2001 |
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6458099 |
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09929407 |
Aug 14, 2001 |
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09466365 |
Dec 17, 1999 |
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6299595 |
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Current U.S.
Class: |
604/103.04 ;
606/194 |
Current CPC
Class: |
A61M 2025/0183 20130101;
A61M 25/104 20130101 |
Class at
Publication: |
604/103.04 ;
606/194 |
International
Class: |
A61M 029/00 |
Claims
What is claimed:
1. An intravascular catheter comprising: an elongated shaft defined
by a proximal section, an intermediate section and a distal section
wherein said proximal shaft section is attached to said distal
section at said intermediate section; a first guide wire port in
said intermediate section; a first guide wire lumen extending
therein from said first guide wire port throughout said
intermediate shaft section and said distal shaft section; a second
guide wire port at the proximal end of said proximal section; a
second guide wire lumen extending from said second guide wire port
throughout said proximal, intermediate and distal shaft sections; a
balloon attached to said distal shaft section to perform an
intravascular procedure; and an inflation lumen extending from said
proximal end of said proximal shaft section to the proximal end of
said balloon at a balloon opening and in fluid communication with
said balloon at said balloon opening.
2. The intravascular catheter of claim 1 wherein said first guide
wire port and said second guide wire port are capable of slidably
receiving a guide wire.
3. An intravascular catheter comprising: an elongated shaft defined
by a proximal section, an intermediate section and a distal section
wherein said proximal shaft section is attached to said distal
section at said intermediate section; a first guide wire port in
said intermediate section; a first guide wire lumen extending
therein from said first guide wire port; a second guide wire port
at the proximal end of said proximal section; a second guide wire
lumen extending from said second guide wire port throughout said
proximal and intermediate shaft sections; a distal section guide
wire lumen extending from said intermediate shaft section to the
distal end of said distal shaft section; a lumen y-junction in said
intermediate shaft section wherein said first guide wire lumen and
said second guide wire lumen communicate in a y-junction to said
distal section guide wire lumen; a balloon attached to said distal
shaft section to perform an intravascular procedure; and an
inflation lumen extending from said proximal end of said proximal
shaft section to the proximal end of said balloon at a balloon
opening and in fluid communication with said balloon at said
balloon opening.
4. The intravascular catheter of claim 3, further comprising an
insert jacket positioned within the first guide wire lumen via the
first guide wire port whereby the operating physician can choose
either a rapid-exchange or an over-the-wire mode of operation.
5. An intravascular catheter comprising: an elongated shaft defined
by a proximal section, an intermediate section and a distal section
wherein said proximal shaft section is attached to said distal
section at said intermediate section; a first guide wire port at
the proximal end of said proximal section; a guide wire lumen
extending throughout said proximal, intermediate and distal shaft
sections defined by a proximal section located in said proximal
shaft section and a distal section located in said distal shaft
section; a guide wire lumen slit extending the length of said
proximal shaft section and which provides for a guide wire to be
peeled-away from the proximal section guide wire lumen; a strain
relief located around the circumference of said intermediate shaft
section for providing resistence from the propagation of said guide
wire lumen slit of said proximal section guide wire lumen into said
distal section guide wire lumen of said distal shaft section; an
expandable member attached to said distal shaft section to perform
an intravascular procedure; and an inflation lumen extending from
said proximal end of said proximal shaft section to the proximal
end of said expandable member at an opening in said expandable
member and in fluid communication with said balloon at said
opening.
6. The intravascular catheter of claim 5, wherein said guide wire
lumen slit has a width smaller than the diameter of a guide wire to
be used, thereby allowing the guide wire to be retained within said
proximal section guide wire lumen during the over-the-wire mode of
operation unless force is exerted to pull the guide wire out of
said proximal section guide wire lumen through said guide wire
lumen slit for the rapid-exchange mode of operation.
7. The intravascular catheter of claim 6, further comprising a
removable support mandrel embodied in said catheter shaft for
providing stiffness to said catheter shaft for easier handling of
the catheter during introduction into the vasculature.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention generally relates to intravascular
procedures, such as treating carotid arteries and percutaneous
transluminal coronary angioplasty (PTCA), and particularly to an
intravascular catheter which can be utilized in a rapid-exchange
(RX) or over-the-wire (OTW) operating mode.
[0002] In typical PTCA procedures utilizing over-the-wire mode, a
dilation catheter is advanced over a guide wire slidably disposed
within an inner lumen of the dilation catheter into a patient's
coronary artery until the balloon on the distal extremity of the
dilation catheter is properly positioned across the lesion to be
dilated. Once properly positioned across the lesion, the flexible,
relatively inelastic dilatation balloon on the catheter is inflated
to a predetermined size with radiopaque liquid at relatively high
pressures (e.g., generally 4-20 atmospheres) to dilate the stenosed
region of the diseased artery. One or more inflations of the
balloon may be required to complete the dilation of the stenosis.
After the last dilation, the balloon is deflated so that the
dilatation catheter can be removed from the dilated stenosis and so
that blood flow can resume through the dilated artery.
[0003] One significant improvement in dilatation catheters has been
the introduction of rapid-exchange type dilatation catheters. These
catheters have a short guide wire receiving sleeve or inner lumen
extending through the distal portion of the catheter which extend
from a distal guide wire port in the distal end of the catheter to
a proximal guide wire port spaced proximal to the proximal end of
the dilatation balloon. The proximal guide wire port is usually
located at least about 10 cm. and usually not more than about 50
cm. from the distal guide wire port. A slit is preferably provided
in the catheter wall which extends from the second guide wire port,
preferably to a location proximal to the proximal end of the
inflatable balloon to aid in the removal of the catheter from a
guide wire upon withdrawal of the catheter from the patient. The
structure of the catheter allows for the rapid exchange of the
catheter without the need for the use of an exchange wire or adding
a guide wire extension to the proximal end of the guide wire. The
design of this catheter has been widely praised by the medical
profession and has met with much commercial success in the market
place because of its unique design. The RX type dilation catheters
of the assignee for the present invention, Advanced Cardiovascular
Systems, Inc., have had a significant impact in the market for
rapid-exchange type dilation catheters. Such products include
dilatation catheters sold under the tradenames--The Alpha, The
Streak, and The Ellipse.
[0004] However, there is one significant inconvenience with the use
of RX type dilatation catheter systems, namely, the inability to
remove a guide wire already in place within a patient's vasculature
during an angioplasty procedure without losing access to the
vascular location. There has been no convenient way in which to
withdraw an in-place guide wire and then advance a replacement
guide wire without losing access to the location of the distal end
of the RX type dilatation catheter the short guide wire receiving
inner lumen in the distal extremity of a RX type dilatation
catheter. These instances occur when there is a need to replace an
in-place guide wire with another guide wire having a different
structure, e.g., an intermediate or standard wire with a core wire
which extends to the distal tip of the guide wire. The need to
withdraw an in-place guide wire also occurs when the distal tip of
the in-place guide wire needs to be reshaped.
[0005] U.S. Pat. No. 5,807,355 (Ramzipoor et al.), which has been
assigned to the present assignee, Advanced Cardiovascular Systems,
Inc., describes an intravascular catheter with both RX and OTW
operative modes. The Ramzipoor et al. patent is incorporated herein
by reference. While this catheter provides for RX and OTW modes of
operation, which is by choice of the operating physician, only one
mode may be used at a time thus limiting the effective usefulness
of the device. Additionally, the Ramzipoor dual mode catheter does
not provide for a smooth RX guide wire exit port for used during RX
modes. During such use, the RX guide wire will deform during
passage through the expanded helical coil guide wire port. The need
still exists therefore for a catheter which allows for simultaneous
dual mode operation and which provides for a smooth exit notch. The
present invention satisfies these and other needs.
SUMMARY OF THE INVENTION
[0006] This invention is directed to an elongated intravascular
catheter which can be utilized in a rapid-exchange (RX) and/or an
over-the-wire (OTW) mode of operation to perform an intravascular
procedure, and particularly to a balloon dilatation catheter which
can be used within the coronary arteries of a human patient during
an angioplasty procedure.
[0007] The intravascular catheter of the invention generally
comprises an elongated shaft with proximal and distal ends, a port
in the distal end, a first lumen extending through the catheter
from the port in the catheter distal end to a location spaced
proximal to the proximal end of the balloon, and a second lumen
extending through the catheter from the proximal end to the port in
the distal end of the catheter. The catheter shaft has an elongated
proximal section, an intermediate section, a relatively short
distal section and a balloon or other means to perform an
intravascular procedure on the distal section.
[0008] In the RX mode, the intravascular catheter can be advanced
over an in-place guide wire within the first guide wire lumen while
holding onto the proximal extremity of the guide wire extending out
of the patient, until the distal end of the catheter is disposed
within a desired location of the patient's vascular system. The
in-place guide wire is external of the catheter proximal to the
opening in the intermediate shaft section of the catheter. In this
manner, the in-place guide wire can be removed by pulling on the
proximal extremity thereof which extends out the patient and a
replacement guide wire can be introduced into the proximal end of
the catheter shaft, advanced through the catheter shaft in the
second guide wire lumen in the OTW mode and then out the port in
the distal end of the catheter.
[0009] For coronary artery use, the opening in the intermediate
shaft section is preferably spaced longitudinally at least 30 cm
from the distal end of the catheter shaft to ensure that it remains
within a guiding catheter when the distal shaft section extends out
into the patient's coronary artery.
[0010] In one embodiment, the distal shaft section of the catheter
includes dual guide wire lumens, a first guide wire lumen entering
the RX guide wire port in the intermediate shaft section, extending
throughout the intermediate shaft section, the distal shaft section
and then out the opening in the distal end of the catheter, and a
second guide wire lumen extending throughout the entire catheter
from the proximal shaft section to the distal shaft section and
then out the port in the distal end of the catheter. The first
guide wire lumen slidably receives an RX guide wire and the second
guide wire lumen slidably receives an OTW guide wire.
[0011] In another embodiment of the invention, a y-section inner
member having a slidable insert jacket provides a first (RX) guide
wire lumen and a second (OTW) guide wire lumen of the proximal
shaft section to communicate, forming a notch junction in the
intermediate shaft section, wherein a single lumen, the distal
section guide wire lumen, is formed which extends throughout the
distal shaft section of the catheter and then out the port in the
distal end of the catheter. The slidable insert jacket allows the
physician to dictate the mode of operation. For the RX mode, the
slidable insert jacket is pushed forward blocking off the second
guide wire lumen at the notch junction and allowing the first guide
wire lumen to be in fluid communication with the distal section
guide wire lumen of the distal shaft section. For the OTW mode, the
slidable insert jacket is slightly pulled back thus allowing the
second guide wire lumen to be in fluid communication with the
distal section guide wire lumen of the distal shaft section.
Therefore, by a simple pull or push of the slidable insert jacket,
the physician may choose either RX or OTW modes of operation.
[0012] In yet another embodiment, the proximal shaft section of the
catheter comprises a lumen having a "peel-away" slit. The peel-away
proximal shaft section serves both OTW and RX modes of operation.
The guide wire lumen of the proximal shaft section has a slit which
allows for the guide wire to be "peeled-away" and removed from the
guide wire lumen, wherein the slit width is slightly smaller than
the guide wire diameter thereby allowing the guide wire to remain
within the lumen during the OTW mode of operation. The guide wire
lumen slit, because of the deformable character of the material
used, allows for the guide wire to be "peeled-away" or pulled out
of the guide wire lumen via the guide wire lumen slit, thus
allowing the RX mode of operation. The guide wire lumen slit runs
throughout the proximal shaft section and ends in a location
proximal to the distal shaft section at the intermediate shaft
section. The intermediate shaft section is reinforced with a
peel-away strain relief which ensures that the guide wire lumen
slit will not propagate distally into the distal shaft section of
the catheter.
[0013] Other features and advantages of the present invention will
become apparent from the following detailed description, taken in
conjunction with the accompanying drawings, which illustrate, by
way of example, the principles of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is an elevational view, partially in section, of one
embodiment of the invention.
[0015] FIG. 2 is a transverse cross-sectional view of the
embodiment shown in FIG. 1 taken along lines 2-2.
[0016] FIG. 3 is a transverse cross-sectional view of the
embodiment shown in FIG. 1 taken along lines 3-3.
[0017] FIG. 4 is an elevational view, partially in section, of
another embodiment of the invention.
[0018] FIG. 5 is a transverse cross-sectional view of the
embodiment shown in FIG. 4 taken along lines 5-5.
[0019] FIG. 6 is a transverse cross-sectional view of the
embodiment shown in FIG. 4 taken along lines 6-6.
[0020] FIG. 7 is a transverse cross-sectional view of the
embodiment shown in FIG. 4 taken along lines 7-7.
[0021] FIG. 8 is an elevational view, partially in section, of the
embodiment shown in FIG. 4, configured for use in over-the-wire
mode in which the insert sleeve is slightly pulled back.
[0022] FIG. 9 is an elevational view, partially in section, of
another embodiment of the invention.
[0023] FIG. 10 is a transverse cross-sectional view of the
embodiment shown in FIG. 9 taken along lines 10-10 depicting the
peel-away slit of the proximal shaft section.
[0024] FIG. 11 is a transverse cross-sectional view of the
embodiment shown in FIG. 9 taken along lines 11-11.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0025] The present invention provides for treatment of diseased
vessels and arteries by giving the physician the option to utilize
either an OTW or RX mode operation using the same catheter. In
keeping with the invention, reference is made to FIGS. 1-3 which
depict one embodiment of the current dual guide wire lumen catheter
invention. In particular, the catheter 10 includes an elongated
catheter shaft 12 with a relatively long proximal shaft section 14,
an intermediate shaft section 16, and a relatively short distal
shaft section 18. The catheter shaft 12 has a first guide wire
lumen 20 which begins at the RX guide wire port 26 located near the
distal end of the intermediate shaft section 16 and extends
throughout the distal shaft section 18 and then out the distal end
guide wire port 34 in the distal end of the catheter 10. The
catheter also includes a second guide wire lumen 22 which extends
throughout the catheter shaft 12 from the proximal end (not shown)
of the proximal shaft section 14 to the distal end of the distal
shaft section 18 and then out the distal end guide wire port 34. An
inflation lumen 24 extends throughout the catheter shaft 12 from
the proximal end of the proximal shaft section 14 to balloon
opening 32 located at one end of the distal shaft section 18. A
guide wire port 34 is provided in the distal end of the distal
shaft section 18 which is in fluid communication with the first
guide wire lumen 20 and the second guide wire lumen 22. Both the
first guide wire lumen 20 and the second guide wire lumen 22 are
capable of slidably receiving a guide wire. The distal shaft
section 18 is further provided with a dilatation balloon 28 which
has an interior 30 in fluid communication with the inflation lumen
24 through balloon opening 32.
[0026] As seen in FIG. 1, the proximal shaft section 14 and the
distal shaft section 18 are interconnected at the intermediate
shaft section 16. The proximal shaft section 14 is coupled to the
distal shaft section by any means of adhesion, including laser
bonding or fusion, glueing or melting. The communication between
the proximal shaft section 14 and the distal shaft section 18 is
provided by RX guide wire port 26. Additionally, the distal shaft
section is in fluid communication with a dilatation balloon 28, the
proximal end of the balloon is in communication with the distal
shaft section via the balloon opening 32 and the distal end 31 of
the balloon is attached to the distal end of the distal shaft
section 18.
[0027] FIG. 2 depicts a cross-sectional view of the intermediate
shaft section 16 of FIG. 1 taken along lines 2-2 wherein the
intermediate shaft section encompasses the first guide wire lumen
20 and the proximal shaft section 14, which encompasses the second
guide wire lumen 22 and the inflation lumen 24. FIG. 3 illustrates
a cross-sectional view of the distal shaft section 18 which
encompasses the first guide wire lumen 20, the second guide wire
lumen 22 and the inflation lumen 24.
[0028] FIGS. 4 through 8 depict a preferred embodiment of the
current invention. In particular, FIG. 4 depicts a notch junction
catheter having an elongated catheter shaft 52 with a relatively
long proximal shaft section 54, an intermediate shaft section 56,
and a relatively short distal section 58. The catheter shaft 52 has
a first guide wire lumen 60 which begins at the RX guide wire port
66, located near the proximal end of the intermediate shaft section
56, and which extends throughout the intermediate shaft section 56.
The first guide wire lumen communicates with the distal section
lumen 68 at the lumen y-junction 72. A second guide wire lumen 62,
which begins at the proximal end of the proximal shaft section 54,
extends throughout the proximal shaft section 54 and the
intermediate shaft section 56 and communicates with the distal
section lumen 68 at the lumen y-junction 72. A distal section lumen
is in fluid communication with the first guide wire lumen 60 and
the second guide wire lumen 62 at the lumen y-junction 72. The
distal section lumen 68 extends from the lumen y-junction 72
throughout the distal shaft section 58 to the distal end of the
catheter shaft 52.
[0029] As seen in FIG. 4, insert jacket 70 is used to determine the
mode of operation, either the RX or OTW models. During use, insert
jacket 70 is inserted into the RX guide wire port. For the RX mode
of operation, the insert jacket is pushed distally into the first
guide wire lumen until there is closed communication with the
distal section guide wire lumen 68, thus allowing a guide wire to
be slidably received by the distal section guide wire lumen 68
through the insert jacket 70 placed within the first guide wire
lumen 60. As depicted in FIG. 8, for the OTW mode of operation, the
insert jacket is pulled proximally or placed slightly proximal to
the distal section guide wire lumen 68 within the first guide wire
lumen 60, thereby allowing the second guide wire lumen 62 to be in
fluid communication with the distal section guide wire lumen 68.
This fluid communication between the second guide wire lumen 62 and
the distal section guide wire lumen 68 allows for a guide wire to
extend throughout the catheter shaft 52 in the OTW mode of
operation.
[0030] For further clarification, FIGS. 5-7 depict cross-sectional
views taken at various locations along the catheter shaft 52. FIG.
5 depicts a cross-sectional view of the proximal shaft section 54
of FIG. 4 taken along lines 5-5 wherein the proximal shaft section
54 encompasses the second guide wire lumen 62 and the inflation
lumen 64. The insert jacket 70 is located externally of the
proximal guide wire lumen. FIG. 6 depicts a cross-sectional view of
the intermediate shaft section 56 of FIG. 4 taken along lines 6-6
wherein the intermediate shaft section 56 encompasses the first
guide wire lumen 60 which further encompasses the insert jacket 70
and the proximal shaft section 54, which encompasses the second
guide wire lumen 62 and the inflation lumen 64. FIG. 7 depicts a
cross-sectional view of the distal shaft section 58 of FIG. 4 taken
along lines 7-7 wherein the distal shaft section 58 encompasses the
distal section guide lumen 68 and the inflation lumen 64.
[0031] FIGS. 9-11 illustrate yet another embodiment of the
invention. In particular, FIG. 9 depicts the peel-away catheter
having an elongated catheter shaft 82 with a relatively long
proximal shaft section 84, an intermediate shaft section 86, and a
relatively short distal section 88. The catheter shaft 82 has a
guide wire lumen comprised of the proximal section guide wire lumen
90 and distal section guide wire lumen 92, an inflation lumen 98, a
balloon 100 located in the distal shaft section 88, and an optional
support mandrel 110 providing support for the catheter shaft 82.
The proximal shaft section comprises an inflation lumen 98, a
proximal section guide wire lumen 90 and a guide wire lumen slit
94. The guide wire lumen slit 94 is aligned parallel to and along
the length of the proximal shaft section 84 and provides the
peel-away mechanism of the proximal shaft section 84. The guide
wire lumen slit 94 is smaller in width than the diameter of the
typical guide wire, therefore during use, the guide wire is
retained within the proximal section guide wire lumen unless force
is exerted by the physician to pull the guide wire out of the guide
wire lumen slit 94 and peel it away from the catheter.
[0032] The intermediate shaft section 86 includes the proximal
section guide wire lumen 90 wherein the proximal section guide wire
lumen 90 comes into fluid contact with the distal section guide
wire lumen 92, the inflation lumen 98, and the peel-away strain
relief 96. The peel-away strain relief 96 is positioned on the
outside circumference of the intermediate shaft section 86 and
provides resistance from the propagation of the guide wire lumen
slit 94 of the proximal shaft section 84 into the distal shaft
section 88. The peel-away strain relief may be constructed of the
same material as the catheter shaft.
[0033] The distal shaft section 88 includes the inflation lumen 98,
the balloon 100 and the distal section guide wire lumen 92. The
distal section guide wire lumen 92 is in continuous contact and in
fluid communication with the proximal section guide wire lumen 90
at the intermediate shaft section 86 as described above. The
balloon is located at the distal end of the distal shaft section
and is defined by a proximal end, distal end, and an interior. The
proximal end of the balloon 100 is in fluid communication with the
inflation lumen 98 via the balloon opening 104, the distal end of
the balloon defines the end of the catheter shaft and ends at the
distal end guide wire port 112. The proximal end of the balloon 100
is permanently connected to the distal shaft section 88 at a
location slightly proximal to the end of the catheter shaft 82.
[0034] For further clarification, FIGS. 10 and 11 depict
cross-sectional views taken at various locations along the catheter
shaft 82. FIG. 10 depicts a cross-sectional view of the proximal
shaft section 84 of FIG. 9 taken along lines 10-10 wherein the
proximal shaft section 54 encompasses the proximal section guide
wire lumen 90 and the inflation lumen 98. The guide wire lumen slit
94 allows for an opening in the proximal section guide wire lumen
90, however, because the guide wire lumen slit 94 typically is
closed or at least defines a very narrow gap that is smaller than
the diameter of the typical guide wire to be used with this
catheter, the guide wire is retained within the proximal section
guide wire lumen 90 unless force is exerted by the operating
physician to pull the guide wire out of the guide wire lumen slit
94. FIG. 11 depicts a cross-sectional view of the distal shaft
section 88 of FIG. 9 taken along lines 11-11 wherein the distal
shaft section 88 encompasses the distal section guide wire lumen 92
and the inflation lumen 98. Both FIGS. 10 and 11 illustrate the
optional support mandrel which adds stiffness to the catheter shaft
which allows for easier handling of the catheter during
introduction into the patient's vasculature.
[0035] From FIG. 9 it is seen that for the RX mode of operation,
the guide wire is inserted in the proximal end of the proximal
shaft section 84 and into the proximal section guide wire lumen 90.
The guide wire traverses the length of the proximal section guide
wire lumen 90 into the distal section guide wire lumen 92 and out
the distal end guide wire port 112. After the catheter is in place
in the patient's vasculature, the guide wire lumen slit 94 in the
proximal shaft section guide wire lumen 90 allows for the guide
wire to be quickly removed by pulling it out of the guide wire
lumen slit. Furthermore, as seen from FIG. 9, for the OTW mode of
operation, the guide wire is inserted in the proximal end of the
proximal shaft section 84 into the proximal section guide wire
lumen 90. The guide wire traverses the length of the proximal
section guide wire lumen 90 into the distal section guide wire
lumen 92 and out the distal end guide wire port 112. After the
catheter is in place in the patient's vasculature, the guide wire
remains in the proximal section guide wire lumen 90 and may be
removed by pulling it out of the catheter shaft by the operating
physician, at the proximal end of the proximal shaft section
84.
[0036] The use of the catheters of the invention for the most part
follow the procedures described in U.S. Pat. No. 5,135,535
(Kramer), assigned to the present assignee (Advanced Cardiovascular
Systems, Inc.). The Kramer patent is incorporated herein by
reference.
[0037] The catheter shaft of the invention can be formed by
conventional techniques well known in the art, e.g., extruding from
a variety of polymer materials already found useful in
intravascular catheters such as polyethylene, polyimide, polyamide,
PVC, polyester (e.g., Hytrel) and high strength polymers such as
polyetheretherketone (PEEK). The various components of the catheter
can be joined by conventional adhesives, such as acrylonitrile
based adhesives, heat shrinking, fusion bonding and the like.
[0038] The traverse dimensions of the catheter shaft and the guide
wire lumens are for the most part determined by the transverse
dimensions of the guide wire to be used in the catheter. Typically,
the guide wire is about 0.008 to about 0.035 inch (0.2-0.9 mm) in
diameter. The guide wire lumen is configured to slidably receive
the guide wire, i.e., it should be about 0.001 to about 0.005 inch
(0.025-0.13 mm) larger than the guide wire diameter. The catheter
shaft is sufficiently long to extend from outside the proximal end
of the guiding catheter, which likewise extends out of the patient
during the procedure, to a vascular location where the procedure is
to be performed. Typically, the catheter is about 135 cm in length.
In the peel-away catheter embodiment, the guide wire lumen slit 94
should have a width smaller than that of the guide wire diameter in
order to retain the guide wire within the proximal section guide
wire lumen 90 for the OTW mode of operation. Additionally the slit
width should be sufficiently wide enough to allow deformation when
force is applied by the operating physician in order to pull the
guide wire out of the proximal section guide wire lumen via the
guide wire lumen slit for the RX mode of operation.
[0039] While the invention is described herein in terms of a
dilatation catheter, those skilled in the art will recognize that
it is applicable to a variety of intravascular catheters.
Additionally, while several particular forms of the invention have
been illustrated and described, it will be apparent that to those
skilled in the art that various modifications can be make without
departing from the spirit and scope of the invention. Although
individual features of embodiments of the invention may be shown in
some of the drawings and not in others, those skilled in the art
will recognize that individual features of one embodiment of the
invention can be combined with any or all the features of another
embodiment.
* * * * *