Rapid exchange catheter

• US 5,336,184 A
• Filed: 07/15/1993
• Issued: 08/09/1994
• Est. Priority Date: 07/15/1993
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Dr. Paul Teirstein
• Inventors: Teirstein, Paul S.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Wilkens, Frank
• Application Number:
  US08/092,332
• Time in Patent Office: 390 Days
• Field of Search: 128/656-658, 604/96-103, 606/192-194
• US Class Current: 604/103.04
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• 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 25/104 used for angioplasty
• CPC Class Codes: A61N 2005/1003 having means for centering a radioactive source within the lumen, e.g. balloons

Abstract

A novel over the wire-rapid exchange catheter is provided comprising a novel proximal end, which works in conjunction with the distal end of a traditional rapid exchange catheter, having a particular arrangement as shown in FIG. 1 which serves to enhance the users ability to properly operate and maneuver the guidewire/catheter, and thus to more effectively carry out the catherization procedure.

Additionally, an OTW-RE catheter is provided with a means for rapidly removing the guidewire from the proximal end of the catheter, at the appropriate time during the procedure, while preserving the integrity of the device.

Claims

1. An improved over the wire rapid exchange catheter having a generally elongated catheter body with a proximal end and a distal end, a first guidewire port at said distal end where the guidewire enters said catheter body, and a second guidewire port spaced proximally from said distal end where the guidewire exits said catheter body, the improvement comprising:

a reference marker affixed to said catheter body near said proximal end;

an elongated guidewire channel formed on said catheter body near said proximal end;

a third guidewire port formed in said proximal guidewire channel where the guidewire enters said proximal guidewire channel distal to said reference marker; and

a fourth guidewire port formed in said proximal guidewire channel where the guidewire exits said proximal guidewire channel at the extreme proximal end of said elongated catheter body.

2. An over the wire-rapid exchange catheter according to claim 1, wherein the distal end of the catheter is a balloon or other therapeutic or diagnostic means.

3. An over the wire-rapid exchange catheter according to claim 1, wherein the distal end of the catheter is a balloon means, having a guidewire port at the distal end of the balloon.

4. An over the wire-rapid exchange catheter according to claim 1, having an overall length of 145 cm, wherein the distal end of the catheter is a balloon or other therapeutic or diagnostic means and the catheter is provided with a minimum of four distinct guidewire ports, said four ports being a guidewire entry port at the distal end of the catheter, a guidewire exit port located within 50 cm of the distal end of the catheter, a guidewire re-entry port located between 32-57 cm from the proximal end of the catheter, and a guidewire exit port at the extreme proximal end of the catheter body.

5. An over the wire-rapid exchange catheter according to claim 1 having a proximal end, wherein the elongated catheter body and proximal guidewire channel are formed in such a manner as to create a generally rounded or oval cross section.

6. An over the wire-rapid exchange catheter according to claim 1 having a proximal end, wherein the elongated catheter body is indented to form a portion of the proximal guidewire channel.

7. An over the wire-rapid exchange catheter according to claim 1 having a proximal end, wherein the proximal guidewire channel is formed within the elongated catheter body.

8. An over the wire-rapid exchange catheter according to claim 1, wherein the distal end is a balloon or other therapeutic or diagnostic means, and wherein the guidewire re-entry port is located at a distance of from about 32 to 57 cm from the proximal end of the catheter.

9. An over the wire-rapid exchange catheter according to claim 1, wherein the distal end is a balloon or other therapeutic or diagnostic means wherein the guidewire re-entry port is located about 51-57 cm from the proximal end of the catheter.

10. An over the wire-rapid exchange catheter according to claim 1, wherein the guidewire channel incorporated into the proximal end thereof is provided with a rupturable membrane which forms at least a portion of the outer wall of said guidewire channel.

11. An over the wire-rapid exchange catheter according to claim 1, wherein the proximal guidewire channel is incorporated into the outer wall of the elongated catheter body in order to form a generally rounded cross section shape, wherein the outer wall of the said guidewire channel is provided with a rupturable membrane which forms at least a portion of the said outer wall and runs the length of the said guidewire channel.

12. A method of using an OTW-RE catheter, comprising the steps of:

providing a guide catheter inserted into a patient to a selected location, said guide catheter having a selectively sealable "O" ring for sealing a proximal end of said guide catheter;

providing an OTW-RE catheter having a balloon or other therapeutic or diagnostic distal end, having a distal end of a guidewire threaded through a distal portion of the body of said OTW-RE catheter, having said guidewire exiting said distal portion of said catheter body, having an intermediate portion of said guidewire passing alongside said catheter body from said distal portion to a guidewire entrance port on a guidewire channel formed on a proximal portion of said catheter body where said guidewire re-enters said catheter body, and having a proximal end of said guidewire exiting said proximal guidewire channel;

providing a reference marker on said catheter body at a selected location to demonstrate appropriate length of insertion of said catheter body into the patient;

providing a torque device attached to said proximal end of said guidewire;

advancing said OTW-RE catheter through said guide catheter until said reference marker on said OTW-RE catheter is reached;

tightening said "O" ring around said reference marker;

advancing said guidewire to a selected treatment location with the simultaneous injection of contrast dye;

advancing said OTW-RE catheter as required to support said guidewire in regions of tortuosity;

dilating by inflating said balloon or effecting another therapeutic or diagnostic means;

subsequently withdrawing said OTW-RE catheter so that said guidewire entrance port is exposed;

tightening said "O" ring to prevent further movement of said OTW-RE catheter;

flexing said catheter body so that said guidewire separates slightly from said catheter body;

removing said torque device from said guidewire;

pulling on said guidewire until it is removed from said proximal guidewire channel; and

exchanging said OTW-RE catheter in the conventional rapid exchange manner.

13. A method of using an OTW-RE catheter according to claim 12, further comprising the step of providing a rupturable membrane in an outer wall of said proximal guidewire channel, wherein the step of pulling on said guidewire removes said guidewire from said proximal guidewire channel by severing said rupturable membrane which forms a portion of said outer wall of said guidewire channel.