U.S. patent application number 10/330706 was filed with the patent office on 2003-05-15 for guidewire replacement device.
Invention is credited to Sirhan, Motasim Mahmoud.
Application Number | 20030093039 10/330706 |
Document ID | / |
Family ID | 25225161 |
Filed Date | 2003-05-15 |
United States Patent
Application |
20030093039 |
Kind Code |
A1 |
Sirhan, Motasim Mahmoud |
May 15, 2003 |
Guidewire replacement device
Abstract
A guidewire replacement device having an elongated catheter
shaft with an inner lumen extending within the catheter shaft, a
proximal guidewire port spaced at least 1 cm from the distal end of
the catheter which is in fluid communication with the inner lumen
and a distal guidewire port in the distal end of the catheter which
is also in fluid communication with the inner lumen. The proximal
end of an in-place guidewire is inserted through the distal
guidewire port and advanced through the inner lumen until the
proximal end of the guidewire extends through the proximal
guidewire port. The exchange device is advanced over the guidewire
until the distal end of the exchange device is seated within the
proximal guidewire port in the readily exchangeable dilatation
catheter. With the distal end of the exchange device well seated
within the proximal guidewire port of the dilatation catheter, the
in-place guidewire can be withdrawn from the patient. A replacement
guidewire is advanced through the inner lumen of the exchange
device until it exits the distal guidewire port of the exchange
device into the inner guidewire receiving lumen of the dilatation
catheter. Once the replacement guidewire is properly placed, the
exchange device can then be withdrawn from the patient.
Inventors: |
Sirhan, Motasim Mahmoud;
(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: |
25225161 |
Appl. No.: |
10/330706 |
Filed: |
December 27, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10330706 |
Dec 27, 2002 |
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09313464 |
May 17, 1999 |
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6524285 |
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09313464 |
May 17, 1999 |
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08482123 |
Jun 7, 1995 |
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5984945 |
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08482123 |
Jun 7, 1995 |
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08168571 |
Dec 16, 1993 |
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5571094 |
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08168571 |
Dec 16, 1993 |
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07818288 |
Jan 9, 1992 |
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Current U.S.
Class: |
604/284 ; 606/1;
606/194 |
Current CPC
Class: |
A61M 2025/0063 20130101;
A61M 25/0172 20130101; A61M 25/104 20130101; A61M 2025/0183
20130101 |
Class at
Publication: |
604/284 ; 606/1;
606/194 |
International
Class: |
A61M 025/00 |
Claims
What is claimed:
1. A guidewire exchange device comprising, an elongated shaft
having proximal and distal ends, and a guidewire receiving inner
lumen extending therein at least from a proximal guidewire port to
a distal guidewire port in the distal end thereof, the distal end
of the shaft being adapted to be inserted into a guidewire port in
a rapid exchange type dilatation catheter.
2. The guidewire exchange device of claim 1 wherein the proximal
guidewire port in the catheter shaft is spaced proximally at least
about 1 cm from the distal guidewire port of the catheter
shaft.
3. The guidewire exchange device of claim 1 wherein a guidewire
passageway extends between the proximal guidewire port and the
guidewire receiving inner lumen extending within the distal section
of the exchange device.
4. The guidewire exchange device of claim 3 wherein the guidewire
passageway is in-line with the guidewire receiving inner lumen
which extends within the distal section of the exchange device.
5. The guidewire exchange device of claim 1 wherein the most distal
portion of the catheter shaft is adapted to be inserted through the
proximal guidewire port of a rapid exchange type dilatation
catheter having perfusion ports between the proximal guidewire port
and the inflatable member thereof and be advanced within a
guidewire receiving inner lumen which extends between the proximal
guidewire port and the distal guidewire port in the dilatation
catheter.
6. A balloon dilatation catheter kit comprising: a) a balloon
dilatation catheter having an elongated shaft with an inflatable
balloon on the distal portion thereof and a guidewire-receiving
inner lumen which extends from a distal guidewire port in the
distal end of the dilatation catheter to a proximal guidewire port
spaced proximally from the distal guidewire port and a substantial
distance distally from the proximal end of the elongated shaft; and
b) a guidewire exchange device having an elongated shaft with an
inner lumen extending therein, a distal guidewire port in the
distal end of the exchange device and a proximal guidewire port
spaced at least 1 cm from the distal end of the exchange device,
the distal end of the guidewire exchange device being shaped and
dimensioned to enter the proximal guidewire port of the dilatation
catheter.
7. The kit of claim 6 wherein perfusion ports are provided in the
elongated shaft of the balloon dilatation catheter proximal and
distal to the balloon in communication with the guidewire-receiving
inner lumen.
8. The kit of claim 7 wherein the distal portion of the guidewire
exchange device is dimensioned to slide over a guidewire disposed
within the guidewire-receiving inner lumen, through the proximal
guidewire port and into the guidewire-receiving inner lumen.
9. The kit of claim 6 including a guidewire having an elongated
core and a flexible body on the distal portion thereof and adapted
to be disposed at least partially within the guidewire receiving
inner lumen of the dilatation catheter.
10. A method for exchanging a guidewire during an angioplasty
procedure wherein a readily exchangeable dilatation catheter having
a short guidewire receiving inner lumen in the distal portion
thereof extending between a distal guidewire port in the distal end
of the dilatation catheter and a proximal guidewire port spaced at
least 10 cm from the distal guidewire port, is disposed within a
patient's vasculature and wherein a first guidewire having proximal
and distal ends extends through the short guidewire receiving inner
lumen within the distal portion of dilatation catheter, the method
comprising: a) providing a guidewire exchange device comprising an
elongated shaft with a guidewire receiving inner lumen extending
therein, a distal guidewire port in the distal end of the exchange
device and a proximal guidewire port spaced at least 10 cm from the
distal end of the exchange device, both of said guidewire ports
being in fluid communication with the inner lumen of the exchange
device, and the distal end of the guidewire exchange device being
adapted to enter the proximal guidewire port of the dilatation
catheter; b) mounting the guidewire exchange device onto the
proximal end of the first guidewire; c) advancing the guidewire
exchange device over the first guidewire until the distal end of
the exchange device enters into the proximal guidewire port of the
dilatation catheter; d) withdrawing the first guidewire through the
guidewire exchange device by pulling the first guidewire from its
proximal end; and f) advancing a second guidewire through the inner
lumen of the guidewire exchange device, through the short guidewire
receiving inner lumen in distal extremity of the dilatation
catheter and out the distal end thereof.
11. A balloon dilatation catheter assembly comprising: a) a balloon
dilatation catheter having an elongated shaft with an inflatable
balloon on the distal portion thereof and a guidewire-receiving
inner lumen which extends between a distal guidewire port in the
distal end of the dilatation catheter and a proximal guidewire port
spaced at least 10 cm from the distal guidewire port; b) an
guidewire having an elongated core and a flexible body on the
distal portion thereof and being disposed at least partially within
the guidewire receiving inner lumen of the dilatation catheter; and
c) a guidewire exchange device having an elongated shaft with an
inner lumen extending therein, a distal guidewire port in the
distal end of the exchange device and a proximal guidewire port
spaced at least 10 cm from the distal end of the exchange device,
the distal end of the guidewire exchange device being dimensioned
to be seated within the proximal guidewire port of the dilatation
catheter.
12. The assembly of claim 11 wherein the elongated shaft of the
balloon dilatation catheter has perfusion ports which are located
proximal and distal to the balloon and which are in fluid
communication with the guidewire-receiving inner lumen.
13. The assembly of claim 12 wherein the guidewire exchange device
is dimensioned to slide over a guidewire disposed within the
guidewire-receiving inner lumen, through the proximal guidewire
port and the guidewire-receiving inner lumen.
14. A method for exchanging a guidewire disposed within a short
guidewire receiving inner lumen in the distal portion of an
intravascular catheter which is placed within a patient during an
intravascular procedure comprising: a) providing a guidewire
replacement device which has a proximal tubular section having
proximal and distal ends, and a distal tubular section having
proximal and distal ends, with the proximal end of the distal
tubular section being secured to the distal end of the proximal
tubular section and having a proximal guidewire port and with the
distal end of the distal tubular section having a distal guidewire
port and being adapted to be seated into a proximal guidewire port
of an intravascular catheter; b) advancing the guidewire
replacement device over the guidewire until the distal end of the
guidewire replacement device is seated within the proximal
guidewire port in the catheter through which the guidewire exits;
c) withdrawing the in-place guidewire; d) advancing a replacement
guidewire through an inner lumen extending within the guidewire
replacement device, through the proximal guidewire port in the
catheter and out the distal guidewire port in the catheter; e)
withdrawing the guidewire replacement device from the patient; f)
peeling the guidewire replacement device from the replacement
guidewire through a slit provided in the wall of the proximal
tubular section of the guidewire replacement device as it exits the
patient; and g) further withdrawing the guidewire placement device
over the replacement guidewire until the distal end of the
placement device exits the patient, manually securing the exposed
portion of the replacement guidewire distal to the distal end of
the placement device and then removing the placement device from
the replacement guidewire.
15. An intraluminal catheter adapted to exchange an in-place
guidewire with a replacement guidewire, comprising: a) an elongated
shaft having a proximal section with an inner lumen extending
therein and a distal section with an inner lumen extending therein;
b) a junction between the proximal and distal shaft sections which
includes a proximal guidewire port which is in communication with
the inner lumen of the distal shaft section and which is offset
from the inner lumen in the proximal shaft section.
16. The catheter of claim 15 wherein the distal and proximal shaft
sections are disposed at a slight angle with respect to one
another.
17. The catheter of claim 15 wherein the distal and proximal shaft
sections are separate tubular elements and the junction
therebetween includes a sleeve having a distal end secured to the
proximal end of the tubular element forming the distal shaft
section and an enlarged proximal end which is partially secured to
the distal end of the tubular element forming the proximal shaft
section and which defines the proximal guidewire port.
18. The catheter of claim 16 wherein the angle is about 5 to about
40 degrees.
19. The catheter of claim 18 wherein the angle is not more than
about 30 degrees.
Description
BACKGROUND OF THE INVENTION
[0001] This invention generally relates to intravascular
procedures, such as percutaneous transluminal coronary angioplasty
(PTCA), and particularly to the exchange of guidewires 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 and advanced therein until the
preshaped distal tip thereof is disposed within the aorta adjacent
the ostium of the desired coronary artery. The guiding catheter is
twisted or torqued from its proximal end, which extends outside of
the patient, to turn the distal tip of the guiding catheter so that
it can be guided into the coronary ostium and seated therein. A
dilatation catheter having a dilatation balloon on the distal end
thereof and a guidewire slidably disposed within an inner lumen of
the dilatation catheter are introduced into and advanced through
the proximal end of the guiding catheter to the distal tip of the
guiding catheter seated within the coronary ostium. The distal tip
of the guidewire is usually manually shaped (curved) by the
physician or one of the attendants before it is introduced into the
guiding catheter along with the dilatation catheter.
[0003] The shaped distal tip of the guidewire is first advanced out
the distal tip of the guiding catheter into the patient's coronary
artery. A torque is applied to the proximal end of the guidewire,
which extends out of the proximal end of the guiding catheter as it
is advanced within the coronary anatomy, to guide the curved or
otherwise shaped distal end of the guidewire into a branch artery
targeted for dilatation. The advancement of the guidewire within
the target artery continues until it crosses the lesion to be
dilated.
[0004] 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 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 4-12 atmospheres) to dilate the stenosed
region of the diseased artery. One or more inflations of the
balloon may be required to complete the dilatation of the stenosis.
After the last dilatation, 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.
[0005] 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.); U.S. Pat. No. 4,748,982
(Horzewski et al.); and U.S. Pat. No. 4,821,722 (Miller et al.)
which are hereby incorporated herein in their entirety by reference
thereto.
[0006] The assignee of the present invention, Advanced
Cardiovascular Systems, Inc., markets an improved dilatation
catheter under the trademark ACS RX.RTM. which is described and
claimed in U.S. Pat. No. 5,040,548 (Yock), U.S. Pat. No. 5,061,273
(Yock) and U.S. Pat. 4,748,982 (Horzewski et al.). This dilatation
catheter has a short guidewire receiving sleeve or inner lumen
extending through the distal portion of the catheter. The sleeve
extends proximally a distance of at least 10 cm and usually not
more than about 50 cm from a first guidewire port in the distal end
of the catheter to a second guidewire port in the catheter spaced
proximally from the inflatable balloon of the catheter. A slit is
preferably provided in the catheter wall which extends distally
from the second guidewire port, preferably to a location proximal
to the proximal end of the inflatable balloon to aid in the removal
of the catheter from a guidewire. 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 guidewire extension to the
proximal end of the guidewire. 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.
[0007] A substantial improvement in the rapid exchange type
dilatation catheters, such as described above, has recently been
made by McInnes et al. which is described in copending application
Ser. No. 07/476,056, filed. Feb. 7, 1990 and Ser. No. 07/541,264
filed Jun. 19, 1990, both entitled READILY EXCHANGEABLE PERFUSION
DILATATION CATHETER, which are incorporated herein by reference. In
these readily exchangeable dilatation catheters, perfusion ports
are provided in the catheter shaft proximal and distal to the
balloon which are in fluid communication with the guidewire
receiving inner lumen to allow blood to perfuse distal to the
catheter when the balloon was inflated.
[0008] However, one inconvenience with the above described
dilatation catheter systems adapted for rapid exchangeability has
been the inability to remove a guidewire already in place within a
patient's vasculature without losing access to the vascular
location. There has been no convenient way in which a replacement
guidewire might be advanced through the vasculature and into the
short guidewire receiving inner lumen in the distal extremity of
the dilatation catheter. The in-place guidewire may need to be
replaced with another guidewire having a different structure, e.g.
from a floppy-type design with a separate shaping ribbon to an
intermediate or standard with a core wire which extends to the
distal tip of the guidewire, or it may need to be withdrawn in
order to reshape the distal tip and then be reinserted. In both
instances the guidewire is referred to herein as the replacement
guidewire.
[0009] What has been needed and heretofore unavailable is a
intraluminal catheter system which provides for the easy and rapid
exchange of both the catheter or the guidewire used to guide the
catheter through a body lumen or both. The present invention
satisfies these and other needs.
SUMMARY OF THE INVENTION
[0010] This invention is directed to a intraluminal catheter system
which provides for the exchange of the guidewire and to the use of
this system, particularly within the coronary arteries of a human
patient during an angioplasty procedure.
[0011] The guidewire exchange device of the invention generally
comprises an elongated catheter shaft with a guidewire receiving
inner lumen extending therein to a guidewire port in the distal end
of the catheter. A proximal guidewire port is provided in the
catheter shaft spaced longitudinally at least 1 cm or more from the
distal end of the shaft which is in fluid communication with the
guidewire receiving inner lumen. The catheter shaft includes a
relatively long proximal tubular section and a relatively short
distal tubular section. The proximal guidewire port is located at
or near the transition between the proximal and distal tubular
sections of the exchange device. The distal tubular section is
preferably adapted to guide the proximal end of a guidewire out the
proximal guidewire port as the proximal end of the guidewire is
advanced through the inner lumen of the guidewire exchange device
from the distal guidewire port. In one preferred embodiment, the
transition between the proximal and distal sections are slightly
angled, e.g. about 5 to about 40 degrees, preferably about 5 to
about 30 degrees, so that the proximal end of the guidewire will
advance out the proximal guidewire port. The distal end of the
distal tubular section of the guidewire exchange device is shaped,
e.g. tapered, and dimensioned so as to be easily inserted into the
proximal guidewire port of a readily exchangeable catheter as the
exchange device is advanced over a guidewire which extends out the
proximal guidewire port of the readily exchangeable catheter.
[0012] The guidewire exchange device is adapted to be advanced over
a guidewire, which is disposed within a patient, either until the
distal tip of the exchange device is seated within the proximal
guidewire port of the readily exchangeable catheter or the distal
end of the exchange device has been advanced through the guidewire
port and well within the short guidewire receiving inner lumen
which extends within the distal portion of the readily exchangeable
catheter. Once the distal end of the guidewire exchange device is
seated within the guidewire port, the in-place guidewire can then
be withdrawn proximally from the catheter and the patient's
arterial system by pulling on the proximal end of the guidewire
which extends out of the patient. A replacement guidewire may then
be advanced through the inner lumen of the exchange device, through
the proximal guidewire port in the dilatation catheter and through
the inner lumen of the catheter until the guidewire extends out the
distal guidewire port in the dilatation catheter.
[0013] In the embodiment of the invention wherein the distal
portion of the distal tubular member of the exchange device is
adapted to be inserted into and be advanced through essentially the
entire length of the relatively short guidewire receiving inner
lumen of the readily exchangeable catheter is particularly suitable
for use with a rapid exchange type dilatation catheters having
perfusion ports, as described in the previously discussed McInnes
et al. applications incorporated herein, which allow blood to pass
through the guidewire receiving inner lumen. When using rapid
exchange type dilatation catheters with perfusion holes in the
catheter shaft, advancement of a replacement guidewire within the
guidewire receiving inner lumen sometimes results in the passage of
the guidewire out one of the perfusion holes in the catheter wall
rather than the guidewire port in the distal end of the catheter.
When the distal extremity of the guidewire exchange device of the
invention is positioned within the guidewire receiving inner lumen
of the readily exchangeable catheter, the replacement guidewire is
directed to the distal guidewire port and cannot be advanced out
one of the perfusion holes.
[0014] The construction of the junction between the distal and
proximal sections can be used in a variety of intraluminal and
intravascular devices including readily exchangeable dilatation
catheters such as described in the aforementioned Yock and
Horzewski et al. patents.
[0015] These and other advantages of the invention will become more
apparent from the following detailed description thereof when taken
in conjunction with the accompanying exemplary drawings.
[0016] BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 is an elevational view of the exchange device of the
invention.
[0018] FIG. 2 is an enlarged elevational view in longitudinal
section of the junction between the distal and proximal tubular
members of the exchange device taken along the lines 2-2 shown in
FIG. 1.
[0019] FIG. 3 is a transverse cross-sectional view taken along the
lines 3-3 shown in FIG. 1.
[0020] FIG. 4 is a transverse cross-sectional view taken along the
lines 4-4 shown in FIG. 1.
[0021] FIG. 5. is an elevational view of a guiding catheter and a
readily exchangeable dilatation catheter with a guidewire exchange
device having features of the invention.
[0022] FIG. 6 is an enlarged view of the section of the assembly
shown in FIG. 5 which is encircled by the ellipse 6.
[0023] FIGS. 7-14 illustrate the exchange of a guidewire utilizing
the exchange device shown in FIGS. 1-4.
[0024] FIG. 15 is an enlarged longitudinal cross-sectional view
similar to FIG. 6 of an alternate embodiment of the invention used
with a dilatation catheter which has the capability of perfusing
blood distal to the catheter upon the inflation of the balloon.
DETAILED DESCRIPTION OF THE INVENTION
[0025] Reference is made to FIGS. 1-4 which depict a guidewire
exchange device 10 embodying features of the invention. The
exchange device 10 includes a relatively long proximal tubular
section 11, a relatively short distal tubular section 12 and an
outer sleeve 13 bonded at the junction between the proximal and
distal tubular sections to the ends thereof. As shown in FIG. 2 the
larger proximal end of the outer sleeve 13 defines a proximal
guidewire port 14 communicating with the portion of the
guidewire-receiving inner lumen 15 which extends within the distal
tubular section 12 through a passageway 16. The distal tip 17 of
the exchange device 10 may be beveled or tapered as shown to
facilitate the entry thereof into the proximal guidewire port of a
readily exchangeable catheter.
[0026] The proximal tubular section 11 is relatively stiff in
comparison to the distal tubular section 12 to provide a high
degree of pushability to the catheter. As shown in FIG. 3, the
proximal tubular section is formed of hypotubing 18 and a coating
or jacket 19 of plastic material which is secured to the exterior
of the hypotubing. The hypotubing is provided with a slit 20 having
a width in excess of the maximum transverse dimension of the
replacement guidewire 21 (shown in phantom) to be used and the
jacket with a slit 22 having a much smaller spacing. This allows
the replacement guidewire 21 to be stripped from the inner lumen 23
of the proximal section 11 after it has been advanced into the
distal section 12. Preferably, a Luer adapter 24 is mounted to the
proximal end of the proximal tubular section 11 and is either
removable or is provided a slit continuous with slits 20 and 21 to
facilitate removal of the replacement guidewire 21 from the inner
lumen 25 in the proximal tubular section 11.
[0027] FIG. 4 illustrates a transverse cross-sectional view of the
proximal tubular section 12 which is a relative flexible section
formed of suitable plastic material.
[0028] FIG. 5 depicts a dilatation catheter assembly which includes
a guiding catheter 26, a readily exchangeable dilatation catheter
27, an in-place guidewire 28, a replacement guidewire 21 and the
guidewire exchange device 10. In practice, an adapter (not shown)
would be provided on the proximal end of the guiding catheter which
has a hemostatic valve large enough to accommodate the guidewire,
the dilatation catheter and the exchange device.
[0029] The area enclosed by the ellipse 6 shown in FIG. 5 is
depicted in an enlarged cross-sectional view in FIG. 6. The distal
tip of the exchange device 10 is shown seated within the proximal
guidewire port 29 of the dilatation catheter 27. A first guidewire
29 is in-place within the guidewire receiving inner lumen 30 of the
dilatation catheter 27 and extends through the inner lumen 15 of
the guidewire exchange device 10, the passageway 16 and the
proximal port 14. The sleeve 13 is preferably enlarged at its
proximal extremity and slightly angled as shown, e.g. about 5 to
about 40 degrees, preferably about 5 to about 30 degrees, so that
the guidewire passes straight through the passageway 16 and
proximal port 14 when the guidewire is advanced proximally through
the inner lumen 15 in the distal section 12. There is little or no
tendency for the guidewire to advance into the inner lumen 25. A
second or replacement guidewire 21 is shown in phantom disposed
within the inner lumen 25 within the proximal tubular section
11.
[0030] The exchange of an in-place guidewire 28 with a replacement
guidewire 21 is illustrated in the sequence of FIGS. 7-14. As shown
in FIG. 7, the in-place guidewire is disposed within the short
guidewire receiving inner lumen 30 (not shown) in the distal
section of the readily exchangeable dilatation catheter 27. Both
the in-place guidewire 28 and the dilatation catheter 27 are
disposed within a guiding catheter 26, as shown in FIG. 5 with the
distal end of the dilatation catheter extending out the distal end
of the guiding catheter. As discussed in the Background of the
Invention, the distal end of the guiding catheter 26 is seated
within the ostium of the patient's coronary artery during the
angioplasty procedure so as to guide the guidewires and dilatation
catheters into the patient's coronary anatomy.
[0031] The proximal end of the in-place guidewire is inserted, i.e.
back-loaded, into the distal port of the guidewire exchange device
10 and through the inner lumen 15 and passageway 16 until the
proximal end exits the proximal port 14 at the junction between the
proximal and distal tubular sections 11 and 12. The proximal end of
the guidewire may then be manually grasped and the exchange device
10 advanced, as shown in FIG. 8, over the in-place guidewire 28
until the distal tip of the exchange device is seated within the
proximal guidewire port 29 in the readily exchangeable dilatation
27, as shown in FIG. 9. At this point the in-place guidewire 28 may
be withdrawn from the dilatation catheter 27 and the patient as
shown by the arrow in FIG. 10. The distal end of a replacement
guidewire 21 is advanced through the adapter 24 as shown in FIG. 11
and the inner lumens 15 and 25 of the exchange device 10 and out
the tapered distal end 17 thereof which is seated within the
guidewire port 29 of the easily exchangeable dilatation catheter
27. As shown in FIG. 5 the replacement guidewire 21 may be
positioned within the inner lumen 25 before the in-place guidewire
28 is removed. The advancement of the replacement guidewire 21
continues until the distal tip thereof extends out the distal end
of the dilatation catheter 27 into the patient's coronary artery.
The exchange device may then be removed from the patient. As the
guidewire exchange device is withdrawn from the patient, it is
stripped from the replacement guidewire 21 through slits 20 and 21
in the proximal section 11 as shown in FIG. 14. When the guidewire
exchange device is withdrawn completely from the patient so that
the replacement guidewire 21 extends out the proximal port 14 and
bare guidewire 21 is visible extending out the distal end 17 of the
exchange device, the exposed guidewire distal to the distal end 17
can be manually grasped to hold the guidewire in position while the
exchange device is removed therefrom.
[0032] The readily exchangeable dilatation catheter 27 can be
exchanged for another readily exchangeable dilatation catheter over
either the in-place guidewire 28 or the replacement guidewire
21.
[0033] The procedure for a readily exchangeable dilatation catheter
with perfusion ports proximal and distal to the inflatable member
or balloon on the distal portion of the catheter is essentially the
same as illustrated in FIGS. 7-14 except that the distal section 12
of the guidewire exchange device 10 extends well into the inner
lumen 30 as shown in FIG. 15 to ensure that the guidewire does not
divert out one of the perfusion ports 31 when the guidewire is
advanced through the inner lumen 30.
[0034] The overall length of the guidewire exchange device is
typically about 85 to about 130 cm. The transverse dimensions are
for the most part controlled by the maximum transverse dimension of
the guidewires to be used but they generally range from about 0.03
to about 0.05 inch (0.76-1.3) in outer diameter. The length of the
distal section can ranged from about 1 to about 40 cm, but
preferably ranges from about 7 to about 20 cm. The hypotubing of
the proximal section 11 can be formed of stainless steel or a
superelastic NiTi alloy and the jacket can be a low density
polyethylene. The distal section 12 and the sleeve 13 may be formed
of a high density polyethylene. The guiding catheter, the
dilatation catheter and the guidewires can be of conventional
construction and materials.
[0035] While the invention has been described herein in terms of a
catheter device which facilitates guidewire replacement in a
readily exchangeable dilatation catheter, improved catheter
construction can be employed in dilatation catheters such a readily
exchangeable dilatation catheters. Those skilled in the art will
recognize that other modifications and improvements can be made to
the invention without departing from the scope thereof.
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