Rapid exchange catheter

• US 5,472,425 A
• Filed: 04/22/1994
• Issued: 12/05/1995
• 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:
  US08/231,423
• Time in Patent Office: 592 Days
• Field of Search: 604/96-103, 604/53, 604/158, 604/160, 604/164, 606/194
• 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 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61N 2005/1003 having means for centering a radioactive source within the lumen, e.g. balloons
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

An over-the-wire rapid-exchange catheter having a guidewire channel and a rupturable membrane along one side of the guidewire channel. The catheter is exchanged by withdrawing the catheter from a guiding catheter, while stripping the operative catheter from the guidewire by tearing the guidewire through the rupturable membrane. The guidewire channel provides a sealing surface for a releasable seal on the guiding catheter, avoiding the gripping of the guidewire. A replacement catheter can be threaded onto the guidewire, and the end of the guidewire can puncture the rupturable membrane at a selected location to establish a guidewire channel at the distal end of the catheter.

Claims

1. An operative catheter, comprising:

an elongated catheter body having a distal end and a proximal end;

a branch formed on said catheter body distal from said proximal end;

an operative means mountable on said catheter body adjacent said distal end of said catheter body, for performing a diagnostic or therapeutic operation on a patient;

a communicative means extending through said catheter body from said branch on said catheter body to said operative means;

a guidewire channel formed on said catheter body, said guidewire channel having a distal entry port and a proximal exit port; and

a rupturable membrane formed in a wall of said guidewire channel, extending from said proximal end of said catheter body toward said distal end, said membrane being sufficiently thin to be parted by a guidewire at a location selected by the user.

2. An operative catheter as claimed in claim 1, wherein:

said operative means comprises an angioplasty balloon; and

said rupturable membrane extends the full length of said catheter body from said proximal end to a location beyond said balloon.

3. An operative catheter as claimed in claim 2, wherein said communicative means comprises a fluid passageway extending longitudinally through said catheter body from said branch of said catheter body to said balloon.

4. A vascular catheter system, comprising:

an elongated guiding catheter having a distal end and a proximal end;

a releasable seal mountable on said guiding catheter adjacent said proximal end of said guiding catheter;

an elongated operative catheter body having a distal end and a proximal end, said operative catheter body being insertable through said guiding catheter to an area to be treated;

a branch formed on said catheter body distal from said proximal end;

an operative means mountable on said operative catheter body adjacent said distal end of said operative catheter body, for performing a diagnostic or therapeutic operation on a patient;

a communicative means extending through said operative catheter body from said branch on said operative catheter body to said operative means;

a guidewire channel formed on said operative catheter body, said guidewire channel having a distal port and a proximal port;

a guidewire passing through said guidewire channel, with a distal end of said guidewire extending distally through said distal port and a proximal end of said guidewire extending proximally through said proximal port; and

a rupturable membrane formed in a wall of said guidewire channel, extending from said proximal end of said catheter body toward said distal end, said membrane being sufficiently thin to be parted by said guidewire at a location selected by the user.

5. A vascular catheter system as claimed in claim 4, wherein:

said operative means comprises an angioplasty balloon; and

said rupturable membrane extends the full length of said catheter body from said proximal end to a location beyond said balloon.

6. A vascular catheter system as claimed in claim 5, wherein said communicative means comprises a fluid passageway extending longitudinally through said catheter body from said branch of said catheter body to said balloon.

7. A vascular catheter system as claimed in claim 4, further comprising a reference mark placed on said operative catheter body at a longitudinal distance from said distal end of said operative catheter body, said longitudinal distance being slightly less than the length of said guiding catheter.

8. A method of removing a first over-the-wire operative catheter from a guiding catheter in a patient, and replacing it with a second operative catheter, over the same guidewire, the method comprising the steps of:

providing said first operative catheter with a rupturable membrane along one side of its guidewire channel, and an operative means mounted on a distal end of said operative catheter;

withdrawing said first operative catheter from said guiding catheter, while stripping said guidewire from said operative catheter by tearing said guidewire through said rupturable membrane from a proximal end of said operative catheter;

threading the proximal end of said guidewire through a distal end of a guidewire channel on a second operative catheter; and

inserting said second operative catheter into said guiding catheter over said guidewire.

9. A method of removing a first over-the-wire operative catheter from a guiding catheter in a patient, and replacing it with a second operative catheter, over the same guidewire, as claimed in claim 8, further comprising the steps of:

bending said operative catheter to expose said rupturable membrane on the outside of the bend; and

pushing said proximal end of said guidewire through said rupturable membrane at a selected location.

10. A method of rapid replacement of a first operative catheter with a second operative catheter, the method comprising the steps of:

providing a guiding catheter having a releasable seal;

inserting said guiding catheter through an internal passageway of a patient to a selected treatment area;

providing a first operative catheter having a guidewire channel and a rupturable membrane along a side of said guidewire channel;

providing a guidewire;

positioning said guidewire through said guidewire channel;

inserting said first operative catheter and said guidewire through said guiding catheter to a selected depth;

selectively sealingly engaging said releasable seal around said first operative catheter;

withdrawing said first operative catheter from said guiding catheter, while holding said guidewire in place by its proximal end, and while tearing said guidewire through said rupturable membrane from a proximal end of said operative catheter;

providing a second operative catheter having a guidewire channel and a rupturable membrane along a side of said guidewire channel;

threading said proximal end of said guidewire through said guidewire channel on said second operative catheter; and

inserting said second operative catheter into said guiding catheter over said guidewire.

11. A method of rapid replacement of a first operative catheter with a second operative catheter, as claimed in claim 10, further comprising the steps of:

bending said second operative catheter to expose said rupturable membrane on the outside of the bend; and

pushing said proximal end of said guidewire through said rupturable membrane at a selected location.