Balloon catheter device

• US 5,752,934 A
• Filed: 09/18/1995
• Issued: 05/19/1998
• Est. Priority Date: 09/18/1995
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Laguna, Alvaro J., Campbell, Carey V.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/532,905
• Time in Patent Office: 974 Days
• Field of Search: 604/96, 604/101, 604/264, 604/280, 606/194
• US Class Current: 604/96.01
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/12 Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
• CPC Class Codes: A61L 29/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• 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 25/10 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 25/1029 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: C08L 27/12 containing fluorine atoms
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: C08L 83/04 Polysiloxanes

Abstract

Balloon catheters having the strength and maximum inflated diameter characteristics of an angioplasty balloon and having the recovery characteristics during deflation of an elastic embolectomy balloon. The balloon catheter can be made in very small sizes and has a lubricous and chemically inert outer surface. The balloon catheter is easy to navigate through tortuous passageways, is capable of rapid inflation and deflation and has high burst strengths. Balloon covers having these same characteristics are also described for use with conventional embolectomy balloons or angioplasty balloons.

Claims

1. A balloon catheter having a balloon comprised of porous polytetrafluoroethylene and an elastomeric material, said balloon having a longitudinal axis, said porous polytetrafluoroethylene comprising a film oriented helically with respect to said longitudinal axis.

2. A balloon catheter according to claim 1 wherein said balloon following inflation to 5 atmospheres and subsequent deflation has a compaction efficiency ratio of greater than about 0.3.

3. A balloon catheter according to claim 2 wherein said balloon following inflation to 5 atmospheres and subsequent deflation has a compaction efficiency ratio of greater than about 0.7.

4. A balloon catheter according to claim 3 wherein said balloon following inflation to 5 atmospheres and subsequent deflation has a compaction efficiency ratio of greater than about 0.9.

5. A balloon catheter according to claim 1 wherein the elastomeric material is selected from the group consisting of fluoroelastomers, silicone rubbers, latex rubbers and polyurethanes.

6. A balloon catheter according to claim 1 wherein said balloon following inflation to 5 atmospheres and subsequent deflation has a compaction ratio of greater than about 0.5.

7. A balloon catheter according to claim 6 wherein said balloon following inflation to 5 atmospheres and subsequent deflation has a compaction ratio of greater than about 0.6.

8. A balloon catheter according to claim 1 wherein the balloon resists appreciable distension beyond a maximum diameter.

9. A balloon catheter according to claim 8 wherein the balloon has a burst pressure of at least about 70 psi.

10. A balloon catheter according to claim 9 wherein the balloon has a burst pressure of at least about 100 psi.

11. A balloon catheter according to claim 1 wherein the polytetrafluoroethylene is a cover that fits over the elastomeric material.

12. A balloon catheter according to claim 1 wherein the porous polytetrafluoroethylene has pores that are substantially filled with elastomeric material.

13. A balloon catheter having a balloon comprised of polytetrafluoroethylene and an inelastic material.

14. A balloon catheter according to claim 13 wherein the inelastic material is a fluoropolymer.

15. A balloon catheter according to claim 13 wherein said balloon following inflation to 5 atmospheres and subsequent deflation has a compaction ratio of greater than about 0.4.

16. A balloon catheter according to claim 15 wherein said balloon following inflation to 5 atmospheres and subsequent deflation has a compaction ratio of greater than about 0.6.

17. A balloon catheter according to claim 13 wherein the balloon resists appreciable distension beyond a maximum diameter.

18. A balloon catheter according to claim 13 wherein the polytetrafluoroethylene is a cover that fits over the inelastic material.

19. A balloon catheter according to claim 13 wherein the porous polytetrafluoroethylene has pores that are substantially filled with elastomeric material.

20. A balloon catheter according to claim 13 wherein said balloon following inflation to 5 atmospheres and subsequent deflation has a compaction efficiency ratio of greater than about 0.3.

21. A balloon catheter according to claim 20 wherein said balloon following inflation to 5 atmospheres and subsequent deflation has a compaction efficiency ratio of greater than about 0.5.

22. A balloon catheter according to claim 21 wherein said balloon following inflation to 5 atmospheres and subsequent deflation has a compaction efficiency ratio of greater than about 0.7.

23. A balloon catheter having a balloon provided with a balloon cover, said cover comprised of polytetrafluoroethylene and an elastomeric material and having a generally tubular form selected from the group consisting of continuous tubes, meshes or braids.

24. A balloon catheter having a balloon provided with a balloon cover, said cover comprised of polytetrafluoroethylene having a generally tubular form selected from the group consisting of continuous tubes, meshes or braids.

25. A catheter balloon comprising expanded polytetrafluoroethylene and elastomer;

the expanded polytetrafluoroethylene and elastomer connected to an inflation means to form the balloon;

the balloon having an initial deflated diameter and an inflated maximum diameter;

wherein the expanded polytetrafluoroethylene and the elastomer inflate together to reach the maximum diameter and the expanded polytetrafluoroethylene and the elastomer contract together when the balloon is deflated wherein the balloon recovers to substantially the initial deflated diameter.

26. A catheter balloon according to claim 25 wherein the expanded polytetrafluoroethylene and elastomer are laminated together.

27. A catheter balloon according to claim 25 wherein the elastomer is impregnated into at least a portion of void spaces in the expanded polytetrafluoroethylene.

28. A catheter balloon according to claim 27 wherein the elastomer substantially fills void spaces in the expanded polytetrafluoroethylene.

29. A catheter balloon according to claim 25 wherein the expanded polytetrafluoroethylene and elastomer are laminated together and wherein the elastomer is also impregnated into at least a portion of void spaces in the expanded polytetrafluoroethylene.

30. A catheter balloon comprising polytetrafluoroethylene and an elastomer;

inflation means connected to the balloon;

the polytetrafluoroethylene, elastomer, and inflation means combining to form the balloon which is fluid-tight with a high burst strength of at least 8 atmospheres;

wherein the balloon has an initial deflated diameter and a maximum inflated diameter; and

wherein the balloon is capable of being inflated to its maximum diameter and then deflated to substantially its initial deflated diameter.

31. A catheter balloon according to claim 30 wherein the polytetrafluoroethylene and elastomer are laminated together.

32. A catheter balloon according to claim 30 wherein the polytetrafluoroethylene is porous and contains void spaces and wherein the elastomer is impregnated into at least a portion of the void spaces in the polytetrafluoroethylene.

33. A catheter balloon according to claim 32 wherein the elastomer substantially fills void spaces in the polytetrafluoroethylene.

34. A catheter balloon according to claim 30 wherein the polytetrafluoroethylene and elastomer are laminated together and wherein the elastomer is also impregnated into at least a portion of void spaces contained in the polytetrafluoroethylene.

35. A catheter balloon comprising polytetrafluoroethylene and an elastomeric material;

wherein the balloon has an Initial deflated diameter and a maximum inflated diameter; and

wherein the balloon is capable of being inflated to its maximum diameter and then deflated to substantially its initial deflated diameter.

36. A catheter balloon comprising polytetrafluoroethylene and an elastomeric material;

wherein said polytetrafluoroethylene further comprises a helical wrapping of polytetrafluoroethylene film.

37. A catheter balloon comprising porous material and elastomeric material;

wherein the porous material include void spaces, said void spaces being sealed with elastomeric material to render the balloon liquid-tight.

38. A catheter balloon comprising polytetrafluoroethylene and elastomeric material;

said balloon being liquid-tight.