U.S. patent application number 09/681182 was filed with the patent office on 2001-09-27 for catheter system with catheter and guidewire exchange.
Invention is credited to Kramer, Barry L..
Application Number | 20010025186 09/681182 |
Document ID | / |
Family ID | 24868307 |
Filed Date | 2001-09-27 |
United States Patent
Application |
20010025186 |
Kind Code |
A1 |
Kramer, Barry L. |
September 27, 2001 |
Catheter system with catheter and guidewire exchange
Abstract
An intravascular catheter system, such as a dilatation catheter
system for angioplasty procedures, which provides for the
replacement of the catheter or the guidewire during the procedure.
The intravascular catheter has a guidewire-receiving inner lumen
extending along its length. A first guidewire port is provided in
the catheter body at or near the proximal end of the catheter. A
second guidewire port is provided in the catheter body at a
location spaced distally from the first guidewire port and
proximally from a diagnostic or therapeutic tool, such as a
dilatation balloon, on a distal portion of the catheter. A third
guidewire port is provided in the distal end of the catheter. The
guidewire ports are in communication with the guidewire-receiving
inner lumen.
Inventors: |
Kramer, Barry L.; (Chicago,
IL) |
Correspondence
Address: |
MCANDREWS HELD & MALLOY, LTD
500 WEST MADISON STREET
SUITE 3400
CHICAGO
IL
60661
|
Family ID: |
24868307 |
Appl. No.: |
09/681182 |
Filed: |
February 13, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09681182 |
Feb 13, 2001 |
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08426814 |
Apr 21, 1995 |
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6273899 |
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08426814 |
Apr 21, 1995 |
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07881673 |
May 12, 1992 |
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07881673 |
May 12, 1992 |
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07713973 |
Jun 11, 1991 |
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5135535 |
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Current U.S.
Class: |
606/194 |
Current CPC
Class: |
A61M 25/104 20130101;
A61M 2025/0183 20130101; A61M 2025/107 20130101; A61M 2025/1079
20130101 |
Class at
Publication: |
606/194 |
International
Class: |
A61M 029/00 |
Claims
1. An elongated catheter for performing an intravascular procedure
within a patient's vascular system, comprising: a) an elongated
catheter body having proximal and distal ends, an exterior, and a
guidewire-receiving inner lumen extending within the catheter body
to the distal end thereof; b) means on the distal portion of the
catheter body for performing an intravascular procedure; c) a first
guidewire port in the catheter body being at or near the proximal
end of the catheter body and being in communication with the
guidewire-receiving inner lumen; d) a second guidewire port in the
catheter body being spaced proximally from the means to perform a
vascular procedure and a short distance from the distal end of the
catheter body and being in communication with the
guidewire-receiving inner lumen; e) a third guidewire port in the
distal end of the catheter body which is in communication with the
guidewire-receiving inner lumen; and f) a wall portion of the
catheter body defining at least in part the guidewire receiving
inner lumen, said wall portion being openable substantially from
said first guidewire port substantially to said second guidewire
port, and from said guidewire-receiving inner lumen to the exterior
of said catheter body, to allow a guidewire to exit laterally from
the inner lumen through the wall portion by peeling said catheter
body from said guidewire.
2. An elongated catheter for performing an intravascular procedure
within a patient's vascular system, comprising: a) proximal and
distal ends, an exterior, and a guidewire-receiving inner lumen
extending within the catheter to the distal portion; b) a tool on
the distal portion of the catheter sized and configured for
performing an intravascular procedure; c) a first guidewire port in
the catheter at or near its proximal end and communicating with the
guidewire-receiving inner lumen; d) a second guidewire port in the
catheter spaced proximally from the tool and a short distance from
the distal end of the catheter and communicating with the
guidewire-receiving inner lumen; e) a third guidewire port in the
distal end of the catheter communicating with the
guidewire-receiving inner lumen; and f) a catheter wall portion
defining at least in part the guidewire receiving inner lumen, said
wall portion being openable substantially from said first guidewire
port substantially to said second guidewire port, and from said
guidewire-receiving inner lumen to the exterior of said catheter
body, to allow a guidewire to exit laterally from the inner lumen
through the wall portion by peeling said catheter body from said
guidewire.
Description
BACKGROUND OF INVENTION
[0001] This invention generally relates to a catheter system which
is suitable for intravascular procedures such as percutaneous
transluminal coronary angioplasty (PTCA) and which allows for the
exchange of guidewires and catheters during such procedures.
[0002] In classic PTCA procedures, a guiding catheter having a
preshaped distal tip is percutaneously introduced into the
cardiovascular system of a patient. The guiding catheter is
advanced until its preshaped distal tip is disposed within the
aorta adjacent the ostium of the desired coronary artery. The
guiding catheter is twisted or torqued from the proximal end to
turn the distal tip of the guiding catheter, so it can be guided
into the coronary ostium.
[0003] A dilatation catheter having a balloon on its distal end and
a guidewire slidably disposed within an inner lumen of the
dilatation catheter are introduced into and advanced through the
guiding catheter to its distal tip. The distal tip of the guidewire
is usually manually shaped (i.e. curved) by the physician or one of
the attendants before the guidewire is introduced into the guiding
catheter along with the dilatation catheter.
[0004] The guidewire is first advanced out the distal tip of the
guiding catheter, which is seated in the ostium of the patient's
coronary artery, into the patient's coronary artery. A torque is
applied to the proximal end of the guidewire, which extends out of
the patient, to guide the curved or otherwise shaped distal end of
the guidewire as the guidewire is advanced within the coronary
anatomy until the shaped distal end of the guidewire enters the
desired artery. The advancement of the guidewire within the
selected artery continues until it crosses the lesion to be
dilated.
[0005] The dilatation catheter is then advanced out of the distal
tip of the guiding catheter, over the previously advanced
guidewire, until the balloon on the distal extremity of the
dilatation catheter is properly positioned across the lesion. Once
properly positioned, the flexible, relatively inelastic balloon is
inflated to a predetermined size with radiopaque liquid at
relatively high pressures (e.g., 4-12 atmospheres) to dilate the
stenosed region of the diseased artery. The balloon is then
deflated, so the dilatation catheter can be removed from the
dilated stenosis and blood flow can then be resumed.
[0006] Further details of guiding catheters, dilatation catheters,
guidewires, and the like for angioplasty procedures can be found in
U.S. Pat. No. 4,323,071 (Simpson-Robert); U.S. Pat. No. 4,439,185
(Lundquist); U.S. Pat. No. 4,468,224 (Enzmann et al.); U.S. Pat.
No. 4,516,972 (Samson); U.S. Pat. No. 4,438,622 (Samson et al.);
U.S. Pat. No. 4,554,929 (Samson et al.); U.S. Pat. No. 4,582,185
(Samson); U.S. Pat. No. 4,616,652 (Simpson); U.S. Pat. No.
4,638,805 (Powell); U.S. Pat. No. 4,748,986 (Morrison et al.); U.S.
Pat. No. 4,898,577 (Badger et al.); and U.S. Pat. No. 4,748,982
(Horzewski et al.) which are incorporated by reference.
[0007] Recently, Advanced Cardiovascular Systems, Inc., introduced
into the marketplace an improved dilatation catheter which is
described and claimed in copending application Ser. No. 07/550,801
(Yock), filed Jul. 9, 1990 and U.S. Pat. No. 4,748,982 (Horzewski
et al.). This dilatation catheter has a short guidewire-receiving
sleeve or inner lumen extending through just the distal portion of
the catheter. The sleeve extends proximally at least 10 cm,
typically about 25 cm, from a guidewire port in the distal end of
the catheter to another guidewire port in the wall of the catheter.
A slit is provided in the catheter wall. The slit extends distally
from the second guidewire port to a location proximal to the
proximal end of the inflatable balloon. The structure of the
catheter allows for the rapid exchange of the catheter without the
need for an exchange wire or adding a guidewire extension to the
proximal end of the guidewire.
[0008] The catheter design embodying the Yock and Horzewski et al.
improvements has been widely praised by members of the medical
profession and has met with much commercial success in the market
place. Nonetheless, there are some inconveniences in its use
because the catheter does not allow for the exchange or replacement
of the guidewire. For example, the shaped distal tip of the
guidewire may become deformed in use or the shape of the distal tip
or the size of the guidewire may be found to be no longer suitable
for the particular procedure within the patient's vasculature. In
this instance the physician might want to remove the guidewire and
reshape the distal tip or replace the first guidewire with another
having the desired size, stiffness or shape.
[0009] When the guidewire in a dilatation catheter system embodying
the Yock and Horzewski et al. improvements is removed, however,
access to the desired arterial location through the distal
guidewire lumen of the catheter is lost. Unfortunately, there is no
way to clinically determine before the guidewire is inserted into
the patient in an angioplasty procedure whether a guidewire or a
catheter will have to be exchanged during the procedure.
SUMMARY OF INVENTION
[0010] What has been needed and heretofore unavailable is an
intravascular catheter system which allows for the rapid exchange
of either the catheter or the guidewire during an intravascular
procedure without losing access to the desired region of the
patient's arterial system. The present invention satisfies this and
other needs.
[0011] The present invention is an elongated catheter for
performing an intravascular procedure within a patient's vascular
system. This catheter system can be used in an over-the-wire type
mode and can also allow for the exchange of either a guidewire or a
catheter mounted over a guidewire during an intraluminal procedure
without losing access to the body lumen. One example of an
interluminal procedure for which this catheter is particularly
useful is percutaneous coronary angioplasty (PTCA).
[0012] The catheter includes an elongated catheter body having
proximal and distal ends and an exterior. A guidewire-receiving
inner lumen extends within the catheter body to its distal end.
Means are provided on the distal portion of the catheter body for
performing an intravascular procedure. The means may take the form
of any known tool, such as a dilatation balloon.
[0013] A first guidewire port is provided in the catheter body at
or near the proximal end of the catheter body. The first guidewire
port is in communication with the guidewire-receiving inner
lumen.
[0014] A second guidewire port is provided in the catheter body.
The second guidewire port is spaced proximally from the tool to
perform a vascular procedure and a short distance from the distal
end of the catheter body. The second guidewire port is in
communication with the guidewire-receiving inner lumen.
[0015] A third guidewire port is provided in the distal end of the
catheter body. The third guidewire port is in communication with
the guidewire-receiving inner lumen.
[0016] A wall portion of the catheter body at least partially
defines the guidewire receiving inner lumen. The wall portion is
openable substantially from the first guidewire port substantially
to the second guidewire port, and from the guidewire-receiving
inner lumen to the exterior of the catheter body. The wall of the
catheter body opens to allow a guidewire to exit laterally from the
inner lumen through the wall portion by peeling the catheter body
from the guidewire.
[0017] In a presently preferred embodiment the catheter is a
balloon dilatation catheter adapted to perform PTCA procedures. One
of the attractive features of this catheter design is that the
catheter can be used as an over-the-wire type dilatation catheter
in a conventional fashion, yet it allows both the catheter and the
guidewire to be exchanged during the PTCA procedure. Similar
catheter designs can be used with other intraluminal catheters that
have diagnostic or therapeutic tools on the distal portion of the
catheter.
BRIEF DESCRIPTION OF DRAWINGS
[0018] FIG. 1 is an elevational view, partially in section, of a
dilatation catheter having a guidewire-receiving inner lumen that
embodies features of the invention.
[0019] FIG. 2 is a transverse, cross-sectional view of the catheter
shown in FIG. 1 taken along the lines 2-2.
[0020] FIG. 3 is a transverse, cross-sectional view of the catheter
shown in FIG. 1 taken along the lines 3-3.
[0021] FIG. 4 is a transverse, cross-sectional view of the catheter
shown is FIG. 1 taken along the lines 4-4.
[0022] FIG. 5 illustrates an alternate embodiment of the invention
in which a guidewire extends out the proximal end of an adapter
mounted on the proximal end of the catheter body.
[0023] FIG. 6 is a transverse, cross-sectional view of the catheter
shown in FIG. 5 taken along the lines 6-6.
[0024] FIG. 7 is a transverse, cross-sectional view of the catheter
shown in FIG. 5 taken along the lines 7-7.
DETAILED DESCRIPTION
[0025] While the invention will be described in connection with one
or more embodiments, it will be understood that the invention is
not limited to those embodiments. On the contrary, the invention
includes all alternatives, modifications, and equivalents as may be
included within the spirit and scope of the appended claims.
[0026] FIGS. 1-4 illustrate a dilatation catheter 10 embodying
features of the invention. The catheter 10 allows for the exchange
of a guidewire while the catheter remains in place within the
patient and which also allow for the exchange of the catheter while
the guidewire remains in place so as to avoid loss of the arterial
position. The catheter 10 generally comprises an elongated catheter
body 11 and a guidewire-receiving inner lumen 14 extending therein.
An inflation lumen 12 is adapted to direct inflation fluid from the
proximal end of the catheter body to the interior of an inflatable
balloon 13 or other diagnostic or therapeutic components on the
distal portion of the catheter body.
[0027] The catheter body 11 has a wall defining at least part of
the guidewire-receiving inner lumen 14. The body 11 has a first
guidewire port 15 near the proximal end 16 of the catheter body.
The body 11 has a second guidewire port 17 distal to the first port
and at least about 10 cm from the distal end of the catheter body.
The body 11 has a third guidewire port 18 located in the distal end
1a of the catheter body. The second guidewire port 17 is
substantially closer to the third port 18 than the first port
15.
[0028] The first guidewire port 15 is generally at or close to the
proximal end of the catheter body 11, e.g. usually not more than
about 30 cm away, and, preferably, is not more than about 10 cm
from the proximal end of the catheter body 11. The second port 17
is spaced closer to the diagnostic or therapeutic tool than it is
to the first port 15 and generally is at least about 10 cm from the
distal end of the catheter body preferably about 15 cm to about 40
cm.
[0029] An adapter 20 is provided on the proximal end 16 of the
catheter body 11 to facilitate the introduction of inflation fluid
into the inflation lumen 12 which directs the fluid to the interior
of the inflatable balloon 13 through the inflation port 22.
[0030] A first slit 23 is preferably provided in the wall of the
catheter body which defines the guidewire-receiving inner lumen 14
and extends between the first guidewire port 15 and the second
guidewire port 17. A second slit 24 is provided in the wall of the
catheter body 11 which further defines the guidewire-receiving
inner lumen and extends from the second guidewire port 17 to a
location proximal to the proximal end 25 of the balloon 13.
[0031] The catheter body 11 has a tubular extension 26 on its
distal portion that extends through the interior and out the distal
end of the balloon 13. The tubular extension 26 is adapted to
receive a guidewire 27 within the inner lumen 14. The guidewire 27
has a coil 28 on its distal end which is shown extending out the
third guidewire port 18 in the distal end 19 of the catheter body
11. The guidewire 27 has an elongated core member 29 that is shown
extending out the second guidewire port 18. The guidewire 27 is
shown in phantom in a second position disposed within the proximal
section of the inner lumen 14. The proximal portion of the
elongated core member 29 extends out the first guidewire port 15
near the proximal end 16 of the catheter body 11.
[0032] A radiopaque marker 30 is disposed about the tubular
extension 26 within the interior of the balloon 13 to facilitate
fluoroscopic observation during an intravascular procedure.
Radiopaque markers 31, 32 and 33 may also be provided on the
proximal portion of the catheter body 11 to allow the physician to
fluoroscopically determine the location of the first and second
guidewire ports and the like during the intravascular
procedures.
[0033] The catheter system of the invention can be inserted into
the patient in a conventional over-the-wire fashion with the
guidewire 27 preloaded within the inner lumen 14 and extending
proximally out the first or proximal port 15.
[0034] Alternatively, the catheter can be inserted in a manner
similar to that used to insert catheters having the improvements of
Yock and Horzewski et al. wherein the guidewire extends proximally
out the second or intermediate guidewire port 17. It sometimes is
desirable or necessary during the intravascular procedure to remove
or replace either the catheter 10 or the guidewire 27. Either may
be removed by pulling on the proximal end (that extends out of the
patient) while the catheter or guidewire which remains within the
patient is held in position in order to maintain access to the
desired intravascular location.
[0035] If the guidewire is to be removed, the catheter 10 is held
in place while the guidewire is pulled out of the proximal end of
the guiding catheter and the catheter 10. When the guidewire has
been removed from the catheter 10, a replacement guidewire may then
be inserted through the first guidewire port 15, which is outside
the patient. The guidewire is inserted into the inner lumen 14 and
advanced until the guidewire exits the third guidewire port 18 in
the distal end 19 of the catheter body 11 into the patient's
coronary artery. Once the replacement guidewire 27 is properly
positioned within the patient's artery, e.g. across a stenosis to
be dilated, the dilatation catheter 10 may then be further advanced
within the artery over the replacement guidewire. The catheter is
advanced to the desired location to perform the dilatation or other
diagnostic or therapeutic procedure in a conventional manner.
[0036] If the catheter 10 is to be removed and the guidewire 27
extends proximally out the first guidewire port 15, the guidewire
and the catheter are separated while the catheter is being removed
by peeling the catheter body 10 laterally from the guidewire while
maintaining the guidewire essentially motionless. The site of
peeling is outside the patient's body. The peeling process
continues until the guidewire extends out the second guidewire port
17. The peeling of the catheter is continued by holding the
guidewire 27 still and peeling the catheter body laterally away to
pass the guidewire 27 through the slit 24 while the catheter is
being withdrawn.
[0037] When the distal end 19 of the catheter exits the proximal
end of the guiding catheter, the guidewire may be manually gripped
distal of the distal end 19, and the catheter 10 may be removed
from the proximal end of the guidewire. If the guidewire 27 exits
the second guidewire port 17, the procedure is essentially the
same, except that there is no need to peel the catheter 10 away
from the guidewire through the slit 23 proximally of the second
guidewire port 17.
[0038] When the catheter 10 has been removed, a replacement
catheter is mounted onto the guidewire 27. This can be done by
inserting the proximal end of the guidewire 27 through the third
guidewire port 18 in the distal end 19 of the replacement catheter
and advancing the catheter 10 over the guidewire 27 disposed within
the inner lumen 14 of the catheter. The catheter 10 is advanced
until the guidewire 27 exits the second guidewire port 17. The
replacement catheter may then be inserted into the patient and
advanced in a conventional manner as described in the
previously-cited Yock application or Horzewski et al. patent which
are incorporated here by reference.
[0039] In another method the replacement catheter is mounted onto
the guidewire 27 as previously described but the replacement
catheter is advanced over the guidewire 27 until the proximal end
of the guidewire 27 exits the first guidewire port 15. In this
method the replacement catheter is advanced well within the
patient's vasculature before the proximal end of the guidewire
exits the first port. The guidewire is manually grasped and the
replacement catheter advanced further over the wire into the
patient's coronary arteries.
[0040] An alternate embodiment of the invention is illustrated in
FIGS. 5-7. This embodiment is quite similar to the embodiment shown
is FIGS. 1-4 except that the guidewire 27 extends through the
center arm of the two arm adapter 35 on the proximal end of the
catheter body 11. The corresponding parts of this embodiment are
numbered the same as the parts of the embodiments shown in FIGS.
1-4.
[0041] The first guidewire port 15 in this embodiment (not shown in
the drawings) is in the proximal end 16 of the catheter body 11 and
opens to the adapter 35. The use of this embodiment is essentially
the same as the embodiment shown in FIGS. 1-4. The adapter 35 is
modified to include a slit 44 that is continuous with the slit 23
in the catheter body 11.
[0042] The catheter body 11 can be formed by conventional
techniques, e.g. extruding, from materials already found useful in
intravascular catheters such polyethylene, polyimide, polyvinyl
chloride, polyester, or composite materials.
[0043] Some composite materials are described in U.S. Pat. No.
4,981,478 (Evard et al.) which is incorporated here by reference.
The various components of the catheter can be joined by suitable
adhesive such as the acrylonitrile-based adhesive sold as
Loctite.TM. 405. Heat shrinking may also be employed where
appropriate. A venting means (i.e. a vent) may be provided to
remove air from the interior of the balloon before the catheter is
inserted into the patient such as described in U.S. Pat. No.
4,638,805 (Powell) and U.S. Pat. No. 4,821,722 (Samson et al.)
which are incorporated here by reference.
[0044] The size of the catheter body 11 and the guidewire-receiving
inner lumen 14 to a large extent are determined by the size of the
guidewires 27 to be employed and the size of the artery or other
body lumen through which the catheter must pass. Generally, the
diameter of the inner lumen is sufficient to accommodate the
guidewire and to allow it to be slidably disposed therein. The
diameters of guidewires for coronary use can vary. They may be from
about 0.008 to about 0.035 inch (0.2-0.89 mm) in diameter. The
inner diameter of the guidewire-receiving inner lumen 14 of the
catheter 10 should be about 0.001 to about 0.005 inch (0.025-0.127
mm) larger than the diameter of the guidewire.
[0045] The catheter body 11 is sufficiently long to extend from
outside the proximal end of a guiding catheter, which likewise
extends out of the patient, to a stenosis to be treated within the
patient's vascular system (or other desired location therein). The
length of the catheter may be from about 100 to about 150 cm when a
Seldinger approach through the femoral artery is employed to
introduce the catheter 10 into the patient's vasculature. The wall
forming the catheter must be of sufficient thickness and strength
that it can be pushed over the guidewire 27 to the desired location
within the patient's blood vessel. If desired the proximal portion
of the dilatation catheter 10 can be provided with a stiffener to
facilitate the advancement of the catheter within the patient's
vasculature.
[0046] The catheter system of the invention also allows for the
exchange of an in-place guidewire during an intraluminal procedure
while holding the catheter in place to maintain access to the
intraluminal position. To replace an in-place guidewire, it is
removed from the guidewire-receiving inner lumen of the catheter
and the patient by pulling on its proximal end that extends out of
the patient.
[0047] When the in-place guidewire is removed from the inner lumen
of the in-place catheter, the replacement guidewire is inserted
into the guidewire-receiving inner lumen of the in-place catheter
through the proximal guidewire port. The replacement catheter is
advanced through the guidewire-receiving inner lumen and out the
third port in its distal end to the desired location within the
patient's body lumen. If the in-place guidewire extends out the
second guidewire port, it may be desirable to have the replacement
guidewire inserted into the proximal portion of the
guidewire-receiving inner lumen through the first or proximal
guidewire port before the in-place guidewire is removed from the
distal portion of the inner lumen. If that is done, there is little
chance of losing access to the site of treatment by the accidental
movement of the in-place catheter. The replacement guidewire is
advanced through the in-place catheter and properly positioned in a
desired location therein, e.g. across a stenosis in a patient's
artery which is to be dilated. The catheter may then be advanced
over the replacement guidewire to the desired location to perform
the desired diagnostic or therapeutic treatment therein.
[0048] The intravascular catheter of the invention also allows for
the removal and reinsertion of a guidewire, for example, when the
physician wishes to change the shape of the distal end of a
guidewire during a procedure. In this operative modality, the
in-place guidewire can be withdrawn in essentially the manner
described above and its distal tip can be reshaped. Then the
guidewire can be reintroduced into the in-place catheter in
essentially the same manner as described above.
[0049] The intravascular catheter system of the invention allows
for a wide variety of intravascular procedures that were heretofore
impossible to perform with a single catheter system. These and
other advantages are described in the following detailed
description when taken in conjunction with the accompanying
exemplary drawings.
[0050] While the invention has been described herein in terms of
certain presently preferred embodiments directed to balloon
dilatation catheters for use in coronary angioplasty procedures,
those skilled in the art will recognize that the catheter of the
invention may be used in a variety of body lumens. For example, the
invention can be utilized in a wide variety of diagnostic and
therapeutic intravascular catheters. Additionally, the catheter
body may be of concentric construction rather than the dual lumen
construction shown herein. Other modifications and improvements may
be made to the invention without departing from the scope of the
claims.
* * * * *