BALLOON CATHETER DEVICE

• US 20080312730A1
• Filed: 06/25/2008
• Published: 12/18/2008
• Est. Priority Date: 09/18/1995
• Status: Abandoned Application

• 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., Spencer, Mark S.
• Application Number:
  US12/146,194
• Publication Number:
  US 20080312730A1
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61L 29/041 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• 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 25/0014 Connecting a tube to a hub
• 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: A61M 25/1034 Joining of shaft and balloon
• 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
• CPC Class Codes: Y10T 428/1334 Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
• CPC Class Codes: Y10T 428/1359 Three or more layers [continuous layer]

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 lubricious 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, comprising:

a catheter shaft having a longitudinal axis with a proximal end and a distal end, said catheter shaft having an inflation lumen extending within at least a portion of a distal shaft section; and

a balloon comprising a material having a microstructure of interconnected fibrils, said balloon having a longitudinal axis, said material oriented helically with respect to the balloon'"'"'s longitudinal axis, wherein the balloon is mounted on the distal section of the catheter shaft with an interior chamber in fluid communication with the inflation lumen;

said balloon further comprising an elastomeric material.

2. The balloon catheter according to claim 1, in which the balloon has substantially uniform radial expansion.

3. The balloon catheter according to claim 2, in which the balloon has an initial deflated diameter and a maximum inflated diameter, and the balloon is capable of being inflated to its maximum diameter and then deflated to substantially its initial deflated diameter.

4. The balloon catheter according to claim 1, in which the material having a microstructure of interconnected fibrils comprises expanded polytetrafluoroethylene.

5. The balloon catheter according to claim 1, in which the elastomeric material comprises latex.

6. The balloon catheter according to claim 1, in which the elastomeric material comprises silicone.

7. The balloon catheter according to claim 1, in which the elastomeric material comprises polyurethane.

8. The balloon catheter according to claim 4, in which the elastomeric material comprises latex.

9. The balloon catheter according to claim 4, in which the elastomeric material comprises silicone.

10. The balloon catheter according to claim 4, in which the elastomeric material comprises polyurethane.

11. The balloon catheter according to claim 1, further comprising a stent disposed about and mounted onto the balloon.

12. The balloon catheter according to claim 2, further comprising a stent disposed about and mounted onto the balloon.

13. The balloon catheter according to claim 3, further comprising a stent disposed about and mounted onto the balloon.

14. The balloon catheter according to claim 4, further comprising a stent disposed about and mounted onto the balloon.

15. The balloon catheter according to claim 5, further comprising a stent disposed about and mounted onto the balloon.

16. The balloon catheter according to claim 6, further comprising a stent disposed about and mounted onto the balloon.

17. The balloon catheter according to claim 7, further comprising a stent disposed about and mounted onto the balloon.

18. The balloon catheter according to claim 8, further comprising a stent disposed about and mounted onto the balloon.

19. The balloon catheter according to claim 9, further comprising a stent disposed about and mounted onto the balloon.

20. The balloon catheter according to claim 10, further comprising a stent disposed about and mounted onto the balloon.

21. A balloon catheter, comprising:

a catheter shaft having a longitudinal axis with a proximal end and a distal end, said catheter shaft having an inflation lumen present at least at a portion of a distal shaft section; and

a balloon comprising a porous material having a microstructure of interconnected fibrils, said porous material having a plurality of void spaces which are impregnated with an elastomeric material,

said balloon being mounted on the distal section of said catheter shaft and having an interior chamber in fluid communication with said inflation lumen.

22. The balloon catheter according to claim 21, in which said material having a microstructure of interconnected fibrils comprises polytetrafluoroethylene.

23. The balloon catheter according to claim 21, in which said material having a microstructure of interconnected fibrils comprises expanded polytetrafluoroethylene.

24. The balloon catheter according to claim 21, in which said elastomeric material comprises a latex.

25. The balloon catheter according to claim 21, in which said elastomeric material comprises a silicone.

26. The balloon catheter according to claim 21, in which said elastomeric material comprises a polyurethane.

27. The balloon catheter according to claim 21, in which said elastomeric material comprises a silicone adhesive mixture.

28. The balloon catheter according to claim 21, in which said elastomeric material comprises an adhesive.

29. The balloon catheter according to claim 28, having a number of said plurality of said void spaces substantially filled by said adhesive.

30. The balloon catheter according to claim 28, in which said adhesive comprises a fluoroelastomer.

31. The balloon catheter according to claim 28, in which said adhesive comprises a polyurethane.

32. The balloon catheter according to claim 21, in which said balloon comprises a PTFE film and an elastomeric silicone laminated together.

33. The balloon catheter according to claim 21, in which said material having a microstructure of interconnected fibrils comprises a PTFE.

34. The balloon catheter according to claim 21, in which said material having a microstructure of interconnected fibrils comprises an expanded PTFE.

35. The balloon catheter according to claim 21, in which the balloon has a length and the elastomer content of the porous material is not the same along the length.

36. The balloon catheter according to claim 21, in which the balloon is a composite balloon.

37. The balloon catheter according to claim 36, in which said composite balloon comprises a silicone and a PTFE.

38. The balloon catheter according to claim 21, in which the balloon further comprises a length and has a differing elastomeric content impregnating said porous material along at least a portion of said length.

39. The balloon catheter according to claim 21, in which said balloon further comprises a drug.

40. The balloon catheter according to claim 21, in which said balloon is liquid-tight.

41. The balloon catheter according to claim 21, in which said balloon further comprises a compaction efficiency in a range of 0.10 to 0.89.

42. The balloon catheter according to claim 21, in which said balloon further comprises a compaction efficiency in a range of 0.15 to 0.89.

43. The balloon catheter according to claim 21, in which said balloon further comprises a compaction efficiency in a range of 0.21 to 0.89.

44. The balloon catheter according to claim 21, in which said balloon further comprises a compaction efficiency in a range of 0.68 to 0.89.

45. The balloon catheter according to claim 21, further comprising a balloon cover covering at least a part of said balloon.

46. The balloon catheter according to claim 21, in which said balloon has substantially uniform radial expansion.

47. The balloon catheter according to claim 21, in which said balloon has an initial deflated diameter and a maximum inflated diameter, and in which the balloon is capable of being inflated to its maximum diameter and then deflated to substantially its initial deflated diameter.

48. The balloon catheter according to claim 21, in which said balloon has a radial compliance of at least about 0.06 millimeters/atmospheres at an inflation pressure in a range of about 8 atmospheres to about 15 atmospheres.

49. The balloon catheter according to claim 21, in which a number of said plurality of void spaces are impregnated with said elastomeric material and substantially seal said porous material.

50. The balloon catheter according to claim 21, further comprising a stent disposed about and mounted onto the balloon.