Coated sleeve for wrapping dilatation catheter balloons

• US 5,425,710 A
• Filed: 10/26/1993
• Issued: 06/20/1995
• Est. Priority Date: 10/26/1993
• Status: Expired due to Fees

• Current Assignee: Dianne M.F. Plunkett
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Khair, Alexander K., Anderson, Darryl A.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): VANOVER, PERRY
• Application Number:
  US08/142,779
• Time in Patent Office: 602 Days
• Field of Search: 604/96, 604/95, 604/51, 604/52, 604/99, 604/104, 606/191, 606/194, 128/662.06, 128/772, 128/DIG. 21
• US Class Current: 604/103.05
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A hollow, cylindrical protector for a dilatation catheter balloon. The disclosed protector is made from silicone tubing having a coating on at least an inner surface thereof for enhancing the lubricity of the protector and thus facilitating easy installation of the protector over a dilatation catheter'"'"'s balloon. In this way, the risk of damage to the balloon resulting from protector installation is reduced. In the disclosed embodiment, the inner surface of a silicone balloon protector is coated via vacuum deposition or the like with parylene. The parylene-coated protector is then slid over a deflated and wrapped dilatation catheter balloon. The catheter is then subjected to elevated temperatures for the purposes of heat-setting. The elevated temperatures cause the silicone protector to be reduced in diameter, further reducing the balloon'"'"'s profile. Also, the compression and heating causes the balloon material to heat-set, increasing the reliability of symmetrical deflation and re-wrap of the balloon.

Claims

1. A removable balloon protector for a dilatation catheter, which is removed prior to catheter insertion, comprising:

a hollow, cylindrical tube made of silicon, having inner and outer surfaces; and

a parylene coating on at least said inner surface of said tube increasing the lubricity of said inner surface.

2. A balloon protector in accordance with claim 1, wherein said parylene is vacuum deposited.

3. A method of preparing a dilatation balloon catheter having an inflatable balloon at a distal end thereof, comprising the steps of:

wrapping said balloon such that said balloon defines a substantially circular cross-section of a first diameter;

coating, with parylene, at least an inner surface of a hollow cylindrical silicone protector having a second diameter larger than said first diameter;

sliding said protector over said wrapped balloon;

exposing said balloon and protector to elevated temperatures, such that said protector shrinks to have a third diameter, smaller than said first diameter.

4. A method in accordance with claim 3, wherein said step of coating comprises vacuum depositing parylene on at least an inner surface of said protector.

5. A catheter system comprising:

a catheter having a proximal end and a distal end;

a balloon affixed to the distal end; and

a removable balloon protector comprising a hollow, cylindrical tube made of silicone, having inner and outer surfaces, a parylene coating on at least said inner surface of said tube, said coating increasing the lubricity of said inner surface, said balloon disposed within said tube.

6. A catheter system according to claim 5, wherein said parylene is vacuum deposited.