Balloon catheter and method of manufacture

• US 6,554,795 B2
• Filed: 02/19/1998
• Issued: 04/29/2003
• Est. Priority Date: 03/06/1997
• Status: Expired due to Fees

• Current Assignee: Mirage IP LLC (IP Edge LLC)
• Original Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Inventors: Ha, Hung V., Muni, Ketan P., Lam, Sivette, Patel, Mukund R., Bagaoisan, Celso J., Zadno-Azizi, Gholam-Reza
• Primary Examiner(s): Casler; Brian L.
• Assistant Examiner(s): MAYNARD, JENNIFER J
• Application Number:
  US09/026,225
• Publication Number:
  US 20020010420A1
• Time in Patent Office: 1,895 Days
• Field of Search: 604/96,97,98,101,96.01,97.01,98.01,99.01,103,103.6,103.11,103.12,103.13 606/191-194,198 264/532,530,573,523,540 600/201,204,207
• US Class Current: 604/103.11
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: B29C 55/04 uniaxial, e.g. oblique

Abstract

Disclosed herein is a compliant catheter balloon with an improved elastic response and reduced longitudinal expansion, and a method of forming the same. The balloon comprises a SEBS block copolymer, which is longitudinally pre-stretched during the balloon manufacture process. In order to control the working length of a balloon on a catheter, at least one adhesive stop is provided on the catheter which prevents adhesive from wicking into the working length of the balloon. Preferably, a pair of thermoset tubings with an outer diameter size close to the size of the inner diameter of the balloon are inserted on the distal portion of the catheter. After the proper placement of the balloon, the adhesive is applied at the balloon'"'"'s proximal and distal ends. As the adhesive wicks to the balloon, the thermoset tubings will eventually stop the adhesive to prevent further wicking of adhesive into the balloon'"'"'s working length. In another aspect of the present invention, there is provided a method of manufacturing a balloon catheter to improve centering of the balloon on the catheter. After a balloon tubing is stretched, the stretched tubing is clamped to a fixture and stabilized at about 100° C. for 15 minutes. This stabilization step ensures that a balloon mounted on a catheter will inflate in a uniform manner.

Claims

1. An occlusion device, comprising:

an elongate catheter body having a distal end portion; and

a longitudinally pre-stretched occlusion balloon mounted along the distal end portion of the catheter body, the balloon being compliant and having a collapsed profile so dimensioned for advancement through a blood vessel having an inner diameter of about 4 mm or less, the balloon having a substantially constant outer diameter before inflation and exhibiting a longitudinal expansion during inflation that is at least about 20% less than that of a balloon with identical dimensions and composition that has not been longitudinally pre-stretched when each of the balloons is inflated under identical conditions.

2. The occlusion device of claim 1, wherein the longitudinal expansion of the longitudinally pre-stretched balloon is about 20% to 50% less during inflation than that of the balloon with identical dimensions and composition that has not been longitudinally pre-stretched when each of the balloons is inflated under identical conditions.

3. The occlusion device of claim 1, wherein the balloon has a working length in the range of about 2 to 8 mm.

4. The occlusion device of claim 1, wherein the longitudinally pre-stretched balloon has an inner diameter that is about 0.002 to 0.003 inches larger than an outer diameter of the catheter.

5. The occlusion device of claim 1, wherein the balloon is made of a styenic block copolymer.

6. An inflatable balloon catheter, comprising:

an elongate tubular catheter body having proximal and distal ends;

an inflation lumen extending through the catheter body from the proximal end to the distal end; and

a compliant longitudinally pre-stretched non-molded balloon mounted on the distal end of the catheter body, the balloon being made of a styrenic block copolymer material and having a substantially constant outer diameter before inflation with a collapsed profile so dimensioned for advancement through a blood vessel having an inner diameter of about 4 mm or less, the balloon having an interior volume in fluid communication with the inflation lumen to provide for inflation of the balloon, the balloon exhibiting a reduced longitudinal expansion of at least about 20% upon inflation compared to an unstretched balloon of identical dimensions and composition that has not been longitudinally pre-stretched when each of the balloons is inflated under identical conditions.

7. The inflatable balloon catheter of claim 6, further comprising an inflation port on the catheter body, the inflation port in fluid communication with the inflation lumen in the catheter body for inflating the balloon.

8. The inflatable balloon catheter of claim 6, wherein the balloon is made of a styrene-ethylene-butylene-styrene (SEBS) material.

9. The inflatable balloon catheter of claim 6, wherein the longitudinal expansion of the longitudinally pre-stretched balloon is about 20% to 50% less during inflation than that of the balloon with identical dimensions and composition that has not been longitudinally pre-stretched when each of the balloons is inflated under identical conditions.