Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-08-17
2001-01-30
Buiz, Michael (Department: 3731)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C606S108000, C606S191000
Reexamination Certificate
active
06179810
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention generally relates to catheters, and particularly intravascular catheters for use in percutaneous transluminal coronary angioplasty (PTCA) or for the delivery of stents.
In a typical PTCA procedure, a dilatation balloon catheter is advanced over a guidewire to a desired location within the patient's coronary anatomy where the balloon of the dilatation catheter is positioned within the stenosis to be dilated. The balloon is then inflated with radiopaque liquid at relatively high pressures (generally 4-16 atmospheres) to dilate the stenosed region of the diseased artery. One or more inflations may be needed to effectively dilate the stenosis. Additionally, a stent may be implanted within the artery, typically by delivery to a desired location within the artery in a contracted condition on a balloon of a catheter which is similar in many respects to a balloon angioplasty catheter and expansion to a larger diameter by inflation of the balloon.
An essential step in effectively performing a PTCA procedure is properly positioning the balloon catheter at a desired location within the coronary artery. To properly position the balloon at the stenosed region, the catheter must have good pushability and flexibility, to be readily advanceable within the tortuous anatomy of the patient's vasculature. U.S. Pat. No. 5,300,085 shows a balloon dilatation catheter having a single lumen proximal section, a coaxial lumen distal section formed by an inner tubular member coaxially disposed within an outer tubular member, and a guidewire port at a transition region spaced a substantial distance from the proximal end of the catheter and about 10-15 centimeters from the distal extremity of the catheter. The transition region is formed by bonding the proximal end of the outer tubular member of the coaxial lumen distal section around a short section of the distal end of the proximal section and the proximal end of the inner tubular member of the coaxial lumen distal section. It has been found that the catheter shown in the U.S. Pat. No. 5,300,085 patent may, on occasion, have suboptimal pushability.
What has been needed is a catheter which is highly trackable within the patient's anatomy, with improved flexibility and pushability. The catheter of the present invention provides these and other advantages.
SUMMARY OF THE INVENTION
This invention is directed to a catheter comprising an elongated shaft having a distal shaft section with a first portion having an inner lumen and an outer lumen, and a second portion having a first lumen and a second lumen separate and laterally-off set from the first lumen. The first portion of the distal shaft section is preferably disposed distal to the second portion, so that hereafter, the first portion is referred to as the distal portion of the distal shaft section, and the second portion is referred to as the proximal portion of the distal shaft section. However, the first portion may be proximal to the second portion in alternative embodiments. The proximal portion of the distal shaft section is less flexible than the distal portion of the distal shaft section, so as to provide the distal shaft section with both improved flexibility and pushability.
The proximal portion of the distal shaft section generally has a first lumen having a longitudinal axis and a separate second lumen parallel to and laterally off-set from the longitudinal axis of the first lumen. In a presently preferred embodiment, the proximal portion comprises a first tubular member secured to a second tubular member such that the longitudinal axis of the first tubular member is laterally off-set from the longitudinal axis of the second tubular member. The distal portion of the distal shaft section generally comprises an inner tubular member disposed within an outer tubular member. The proximal portion of the distal shaft section is sufficiently long so that the catheter is provided with improved pushability without disadvantageously affecting the flexibility of the catheter shaft.
In a presently preferred embodiment, the catheter is a balloon catheter generally comprising an elongated catheter shaft having a relatively stiff proximal shaft section and a relatively flexible distal shaft section, and with an inflatable dilatation member on a distal section of the catheter. In accordance with the invention, the distal shaft section has a proximal portion having an inflation lumen laterally off-set from and parallel with a guidewire lumen, and a distal portion having a guidewire lumen co-axially disposed within an inflation lumen.
The catheter may be a rapid exchange type catheter, having a guidewire receiving lumen in a distal section of the catheter shaft, such as the catheters described in U.S. Pat. Nos. 5,451,233 and 5,743,875, incorporated by reference herein in their entireties. Typically, a rapid exchange catheter has a distal guidewire port in the distal end of the catheter, a proximal guidewire port spaced a relatively short distance proximally from the distal guidewire port and a relatively long distance from the proximal end of the catheter shaft, and a relatively short guidewire receiving lumen extending therebetween.
Alternatively, the catheter may be an over-the-wire type catheter having an elongated shaft with proximal and distal ends, a guidewire port in the proximal end, a guidewire port in the distal end, and a guidewire lumen extending therein. An example of over-the-wire type catheter design which may be used is described in U.S. Pat. No. 5,480,383, incorporated by reference herein in its entirety.
The catheter of the invention is highly pushable and flexible due to the distal shaft section having a proximal portion with laterally off-set lumens and a distal portion with inner and outer lumens. The flexible and pushable distal shaft section provides a catheter with excellent trackability, and allows easy advancement over a guidewire and maneuvering within the patient's tortuous anatomy, to position the operative portion of the catheter at a desired location within the patient. These and other advantages of the invention will become more apparent from the following detailed description of the invention and the accompanying exemplary drawings.
REFERENCES:
patent: 5217482 (1993-06-01), Keith
patent: 5451233 (1995-09-01), Yock
patent: 5490837 (1996-02-01), Blaeser et al.
patent: 5743874 (1998-04-01), Fischell et al.
patent: 5792144 (1998-08-01), Fischell et al.
patent: 6036670 (2000-03-01), Wijeratne et al.
patent: 6056719 (2000-05-01), Mickley
Lee Jeong Soo
Stamberg Barbara
Wantink Kenneth Lee
Advanced Cardiovascular Systems Inc.
Buiz Michael
Heller Ehrman White & McAuliffe LLP
King Anthony S.
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