PTCA catheter

• US 5,002,559 A
• Filed: 11/30/1989
• Issued: 03/26/1991
• Est. Priority Date: 11/30/1989
• Status: Expired due to Fees

• Current Assignee: NU Med Main Street Hopkinton NY 12940
• Original Assignee: Numed LLC
• Inventors: Tower, Allen J.
• Primary Examiner(s): Millin, Vincent
• Assistant Examiner(s): BAHR, JENNIFER DOYLE
• Application Number:
  US07/443,387
• Time in Patent Office: 481 Days
• Field of Search: 604/164, 604/96, 606/194, 128/772
• US Class Current: 606/194
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A PTCA catheter is provided in which the extreme distal end is reduced to a diameter of 3 thousandths of an inch and enclosed in a coiled spring which is welded to the guidewire of the catheter at its tip and at a thicker 8 thousandths diameter portion of the guidewire to increase the strength of the tip and reduce breakage when inserted in a coronary artery. A dual lumen catheter body is provided at the proximal end for capturing and actuating the guidewire and for inflating the balloon at the distal end.

Claims

1. A PTCA catheter that includes an elongated, hollow catheter body having a distal end and a proximal end;

a guidewire with a main diameter smaller than the internal diameter of said body;

said guidewire being positioned in said catheter body and having its distal end tapering in multiple steps from said main diameter to a very small diameter flexible tip;

said tip portion extending outwardly of said catheter body for at least two tapered steps;

a flexible coiled spring positioned about said guidewire tip and extending over at least two tapered guidewire steps;

at least one end of said coiled spring being welded to said guidewire;

a plastic sheath secured about said spring and the adjacent portion of said guidewire at the proximal end of said spring;

a thin walled balloon secured at one end about the distal end of said catheter body and at the other end about said plastic sheath covering said spring; and

control means operatively connected to said guidewire at the proximal end thereof for causing the distal tip of said coiled spring to twist and bend to steer the PTCA catheter to the desired artery, and for inflating said balloon.

2. A device as described in claim 1 wherein said guidewire tapers at its distal end in two steps from the main diameter to the tip diameter.

3. A device as described in claim 2 wherein said main diameter of the guidewire is in the range of 14-16 thousandths of an inch and tapers to 8 thousandths of an inch in diameter and then to 3 thousandths of an inch diameter at the distal tip.

4. A device as described in claim 3 wherein said distal 3 thousandths of an inch diameter tip of the guidewire is flattened at its tip to a width of approximately 6 thousandths by 5/ten thousandths of an inch thickness.

5. A device as described in claim 4 wherein said spring is welded at one end to the flattened tip of said guidewire and at other end of said spring to the guidewire at the 8 thousandths of an inch diameter portion.

6. A device as described in claim 1 wherein said flexible coiled spring is welded to the guidewire at both ends of said spring.

7. A device as described in claim 1 wherein the distal end of said coiled spring extends approximately 2 centimeters beyond the distal end of the balloon of said PTCA catheter.

8. A device as described in claim 7 wherein the plastic sheath extends over said coiled spring from the proximal end of said spring to the distal end of said balloon.

9. A device as described in claim 1 wherein the internal diameter of said catheter body is greater than 20 thousandths of an inch;

the outside diameter of said guidewire is between 14-16 thousandths of an inch;

the tip of said guidewire tapers from 14-16 thousandths of an inch to a step of 8 thousandths of an inch and then to a tip of 3 thousandths of an inch in diameter; and

said coiled spring has an internal diameter of 8 thousandths of an inch and outside diameter of 12 thousandths of an inch.

10. A device as described in claim 1 wherein said plastic sheath is secured about said guidewire by adhesive means and heat shrink means to form a dual sealed bond of plastic to wire.

11. A device as described in claim 10 wherein said plastic sheath is secured about the 8 thousandths step of the tip of said guidewire for a distance of approximately 2 millimeters.

12. A device as described in claim 11 wherein said thin walled balloon is secured at its proximal end to the distal end of said catheter body and at its distal end to said sheath for a length of approximately 5 millimeters.

14. A device as described in claim 1 wherein said control means comprises:

a dual lumen catheter body joined to the proximal end of said elongated catheter body with one lumen receiving the proximal end of said guidewire and the other lumen being in fluid communication with the interior of said catheter body;

said guidewire receiving lumen being interlocked with the proximal end of said guidewire whereby twisting of said dual lumen catheter body will cause the distal tip of said coiled spring to twist without twisting said balloon

13. A device as described in cl-aim 1 wherein said balloon is adhesively and thermally sealed to the distal end of said plastic sheath approximately 2 centimeters from the distal end of said coiled spring member.

15. The method of manufacturing a PTCA catheter that includes the steps of:

forming first and second reduced diameter sections adjacent each other in the distal end of a guidewire;

inserting said 1st and 2nd reduced sections into a coiled spring member;

welding said coiled spring to said guidewire at each end thereof;

enclosing said spring in a plastic sheath;

sealing said sheath about said guidewire at the proximal end of said spring;

inserting said guidewire into a catheter body having proximal and distal ends with said reduced diameter sections extending from the distal end of said catheter body;

forming a thin walled tubular balloon about the distal end of said catheter body and at least one of said reduced diameter sections of said spring and sheath covered guidewire;

sealing one end of said tubular balloon about the distal end of said catheter body;

sealing the other end of said tubular balloon to the sheath enclosing said spring at a point spaced from the distal end of said spring;

joining manipulating means to the proximal end of said catheter body; and

securing the proximal end of said guidewire to said manipulating means.