Pre-stretched catheter balloon

• US 5,868,705 A
• Filed: 03/06/1997
• Issued: 02/09/1999
• Est. Priority Date: 05/20/1996
• Status: Expired due to Term

• Current Assignee: Mirage IP LLC (IP Edge LLC)
• Original Assignee: Percusurge Inc. (Medtronic Plc)
• Inventors: Ha, Hung V., Muni, Ketan P., Lam, Sivette, Zadno-Azizi, Gholan-Reza, Bagaoisan, Celso J.
• Primary Examiner(s): Bockelman, Mark
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/812,140
• Time in Patent Office: 705 Days
• Field of Search: 604/96, 604/97, 604/98, 604/101, 606/191-194, 264/530, 264/532, 264/573, 264/523, 264/540
• US Class Current: 604/103.11
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61L 29/00 Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters shape or structure of catheters A61M25/00
• CPC Class Codes: A61M 2025/0018 having a plug, e.g. an inflatable plug for closing catheter lumens
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0075 : Valve means
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61M 25/09033 : with fixed mandrils, e.g. mandrils fixed to tip; Tensionable wires
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 25/10184 : Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/1027 : Making of balloon catheters
• CPC Class Codes: A61M 25/104 : used for angioplasty
• 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 prestretched during the balloon manufacture process.

Claims

1. A compliant catheter balloon formed in part by longitudinly stretching an extruded styrene-ethylene-butylene-styrene (SEBS) tube at a forming temperature between about 0°

and 90°

C. such that the tube increases in length by at least 200%, wherein the stretching of the tube reduces the longitudinal expansion of the balloon by at least about 20% upon inflation compared to a balloon formed from an unstretched tube of identical composition.

2. The balloon of claim 1, wherein the tube increases in length by at least 400%.

3. The balloon of claim 1, further comprising stretching the tube at a rate of less than 30 cm/min.

4. The balloon of claim 2, wherein the longitudinal expansion of the balloon formed in part by stretching the extruded tube is at least 20% less than a balloon formed from an unstretched tube of identical composition.

5. A method of making a compliant inflatable catheter balloon with reduced longitudinal expansion comprising the steps of:

providing an extruded SEBS tube having a first length and a first inner diameter;

stretching the extruded SEBS tube longitudinally at a forming temperature between about 0° and

90°

C. so that the tube forms a second inner diameter smaller than the first diameter, and a second length greater than the first length.

6. The method of claim 5, further comprising cutting the stretched SEBS tube within two hours of the stretching step.

7. The method of claim 5, wherein the second length is at least 200% greater than the first length.

8. The method of claim 7, wherein the stretched second length is at least 400% greater than the first length.

9. The method of claim 8, wherein the stretched second length is at least 600% greater than the first length.

10. The method of claim 5, wherein the second diameter is 10% smaller than the first diameter.

11. The method of claim 10, wherein the second diameter is 40% smaller than the first diameter.

12. The method of claim 5, wherein the longitudinal stretching occurs at a rate of about 10 cm/min.

13. The method of claim 5, wherein the stretching takes place at a temperature of between about 25°

and 30°

C.

14. The method of claim 5, wherein the extruded SEBS tube has a first wall thickness prior to the stretching step, and a second wall thickness after the stretching step, and the first wall thickness is greater than the second wall thickness.

15. The method of claim 14, wherein the first wall thickness is at least 10% greater than the second wall thickness.

16. The method of claim 15, wherein the first wall thickness is at least 30% greater than the second wall thickness.

17. A longitudinally pre-stretched SEBS compliant catheter balloon.

18. A method of making a compliant inflatable catheter balloon with reduced longitudinal expansion comprising the steps of:

extruding a styrene-ethylene-butylene-styrene (SEBS) resin to form a tube having a first length and a first inner diameter;

stretching the extruded tube longitudinally so that the tube forms a second inner diameter smaller than the first diameter, and a second length greater than the first length, wherein the stretching of the tube reduces the longitudinal expansion of the balloon by at least about 20% upon inflation compared to a balloon formed from an unstretched tube of identical composition.

19. The method of claim 18, wherein the extruded tube is longitudinally stretched at a forming temperature between about 0°

and 90°

C.