Angioplasty apparatus facilitating rapid exchanges

• US 5,061,273 A
• Filed: 07/05/1990
• Issued: 10/29/1991
• Est. Priority Date: 06/01/1989
• Status: Expired due to Term

• Current Assignee: Paul G. Yock
• Original Assignee: Paul G. Yock
• Inventors: Yock, Paul G.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US07/548,200
• Time in Patent Office: 481 Days
• Field of Search: 604/96, 604/101, 604/102, 606/192, 606/193, 606/194
• US Class Current: 606/194
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Apparatus for introduction into the vessel of a patient comprising a guiding catheter adapted to be inserted into the vessel of the patient and a device adapted to be inserted into the guiding catheter. The device includes a flexible elongate member and a sleeve carried by the flexible elongate member near the distal extremity thereof and extending from a region near the distal extremity to a region spaced from the distal extremity of the flexible elongate element. The device also includes a guide wire adapted to extend through the sleeve so that the guide wire extends rearwardly of the sleeve extending alongside of and exteriorally of the flexible elongate element into a region near the proximal extremity of the flexible elongate element.

Claims

1. An elongated dilatation catheter which is adapted to be inserted over a guidewire through a patient'"'"'s blood vessel to perform angioplasty procedures therein, comprising:

a) an elongated catheter body having an inner inflation lumen extending therethrough, a proximal portion which is adapted to extend out of the patient during angioplasty procedures and which has means to direct inflation fluid into the inner inflation lumen and a distal portion which is adapted to be disposed entirely within the patient'"'"'s vascular system during angioplasty procedures and which has a transition region with a proximal port therein opening to the exterior of the catheter and located at least 10 cm proximally from a distal port in the distal tip of the catheter body and a substantial distance distally from the proximal portion of the catheter body which extends out of the patient during an angioplasty procedure;

b) an inflatable balloon on the distal portion of the catheter body which is distal to the proximal port and which has an interior in fluid communication with the inner inflation lumen therein; and

c) an open-ended tubular member fixed with respect to the catheter body and having an inner lumen which is substantially shorter than the catheter body, which is disposed essentially in its entirety within the distal portion of the catheter body and which extends proximally within the catheter body from the distal port at the distal tip of the catheter body, through the interior of the balloon, to the proximal port in the transition region, said inner lumen of the tubular member adapted to slidably receive a guidewire therein so that a distal portion of the guidewire extends distally out of the distal port and a proximal portion thereof extends proximally out of the proximal port to the exterior of the catheter body and generally parallel and exteriorly to the catheter body over most of the length of the guidewire and out of the patient.

2. The catheter of claim 1 including an additional sleeve disposed within the tubular member which extends from the interior of the balloon to the proximal extremity of the tubular member and which has a vent tube removably disposed therein.

3. In an elongated dilatation catheter assembly for performing angioplasty procedures within a patient'"'"'s arterial system, which assembly includes a guiding catheter adapted to be positioned within a patient'"'"'s arterial system with the proximal end thereof extending out of the patient during the angioplasty procedure, a balloon dilatation catheter adapted to be positioned within an inner lumen of the guiding catheter with the proximal end thereof extending out of the proximal end of the guiding catheter during the angioplasty procedure and a guidewire adapted to be positioned within an inner lumen of the dilatation catheter during the angioplasty procedure, an improvement in the dilatation catheter of the assembly, comprising:

a) an elongated catheter body having an inflation lumen which extends therein, a proximal portion which is adapted to extend out of the proximal end of the guiding catheter during angioplasty procedures and which has means to direct inflation fluid into the inflation lumen of the catheter body, and a distal portion which is adapted to extend partially out of the distal end of the guiding catheter into the patient'"'"'s artery during angioplasty procedures and which has a distal port in the distal end thereof, a transition region in the distal portion which is adapted to remain within the inner lumen of the guiding catheter during angioplasty procedures and which has a proximal port therein disposed a substantial distance distally from the proximal portion which extends out the proximal end of the guiding catheter, and at least 10 cm proximally from the distal port;

b) a relatively short tubular member fixed with respect to the distal portion of the catheter body having an inner lumen which is adapted to slidably receive the guidewire therein and which extends through the interior of the distal portion of the catheter body between the proximal port and the distal port, with a distal portion of the guidewire extending out the distal port and a proximal portion of the guidewire extending out of the proximal port and generally parallel and exteriorly to the catheter body within the inner lumen of the guiding catheter; and

c) an inflatable balloon located on the distal portion of the catheter body distal to the proximal port having an interior which is in fluid communication with the inflation lumen in the catheter body.

4. A dilatation catheter assembly for performing an angioplasty procedure in a human patient, wherein the assembly is adapted to be disposed during the procedure within an inner lumen of an elongated guiding catheter which has a distal end inserted into an ostium of the patient'"'"'s coronary artery and a proximal end extending out of the patient, said assembly comprising:

a) a dilatation catheter which is adapted to extend out of the distal end and the proximal end of the guiding catheter during the angioplasty procedure, said dilatation catheter comprising an elongated catheter body and an inflatable balloon on the distal portion thereof, the catheter body having a first, relatively long inner lumen for directing inflation fluid from the proximal end of the catheter body to the interior of the balloon and a second inner lumen, much shorter than the first inner lumen, which is defined at least in part by a tubular member fixed with respect to the catheter body and extends through the interior of the balloon between a distal port at the distal end of the catheter body and a proximal port disposed proximally from the balloon, at least 10 cm proximally from the distal port and a substantial distance distally from the portion of the dilatation catheter which extends out of the proximal end of the guiding catheter so that the proximal port is adapted to remain within the guiding catheter during the angioplasty procedure; and

b) an elongated guidewire which is disposed within the second inner lumen of the catheter body and which has a distal portion adapted to extend out of the distal port and a proximal portion adapted to extend out of the proximal port, generally parallel and exteriorly to the portion of the catheter body disposed within the guiding catheter and out the proximal end of the guiding catheter.

5. A dilatation catheter for performing coronary angioplasty procedures which facilitates the rapid exchange thereof with another catheter without the need for exchange wires or guidewire extensions, the catheter comprising:

a) an elongated catheter shaft having proximal and distal ends and a first inner lumen extending therein;

b) an inflatable balloon disposed at the distal end of the catheter shaft having an interior in fluid communication with the first inner lumen extending within the catheter shaft; and

c) a second inner lumen which is defined at least in part by a tubular member extending through the interior of the balloon, which is adapted to slidably receive a guidewire therein, which has a first port in the distal end thereof and which has a second port spaced at least about 10 cm proximally from the distal port and spaced distally a substantial distance from the proximal end of the catheter shaft.

6. A dilatation catheter assembly for performing an angioplasty procedure within a patient'"'"'s coronary artery, comprising:

a) a guiding catheter having proximal and distal ends which is adapted to be disposed within a patient'"'"'s cardiovascular system with the distal end seated within an ostium of the patient'"'"'s coronary artery and the proximal end extending out of the patient;

b) a guidewire with proximal and distal ends which is adapted to be disposed within the guiding catheter with the distal end of the guidewire extending out the distal end of the guiding catheter into the coronary artery of the patient and the proximal end of guidewire extending out the proximal end of the guiding catheter which extends out of the patient;

c) a dilatation having an elongated catheter body with a proximal end adapted to extend out of the patient, a distal end and adapted to be advanced through a stenosis, an inflatable balloon on a distal portion of the catheter body, a first elongated inner lumen within the catheter body which is adapted to direct inflation fluid from the proximal end of the dilatation catheter to the interior of the inflatable balloon and a second much shorter inner lumen which is defined at least in part by a tubular member extending through the interior of the balloon and which is adapted to slidably receive the guidewire, the second inner lumen having a distal port located in the distal end of the catheter body and a proximal port located at least 10 cm from the distal end of the catheter body and a substantial distance from the proximal end of the catheter body.