MEDICAL BALLOON DEVICES AND METHODS

• US 20140172066A1
• Filed: 12/18/2013
• Published: 06/19/2014
• Est. Priority Date: 12/19/2012
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Goepfrich, James L., Hedberg, Brandon C., Trapp, Benjamin M., Haarer, Joshua C.
• Granted Patent: US 10,279,084 B2
• 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: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• 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

Abstract

A balloon or balloon cover comprising a composite material having a least one expanded fluoropolymer material and an elastomer is provided. The expanded fluoropolymer material can contain serpentine fibrils. In exemplary embodiments, the fluoropolymer is polytetrafluoroethylene. The composite material may be axially, helically, and/or circumferentially wrapped to form a balloon or balloon cover. The balloon or balloon cover exhibits a sharp increase in stiffness at a predetermined diameter. The balloon or balloon cover can be designed to have a stop point in either a radial or axial direction.

Claims

1. A medical balloon having a longitudinal axis comprising:

a composite material comprising at least one expanded fluoropolymer material and an elastomer,

wherein said expanded fluoropolymer material comprises serpentine fibrils.

2. The medical balloon of claim 1, wherein each said serpentine fibril has a width of about 1.0 micron or less.

3. The medical balloon of claim 2, wherein each said serpentine fibril has a width of 0.5 micron or less.

4. The medical balloon of claim 1, wherein said fluoropolymer is imbibed with an elastomer.

5. The medical balloon of claim 4, wherein the elastomer is selected from the group consisting of perfluoromethylvinyl ether-tetrafluoroethylene copolymers, perfluoro(alkyl vinyl ether)-tetrafluoroethylene copolymers, silicones, polyurethanes, or other high strain elastomers.

6. The medical balloon of claim 1, wherein elastic properties are present in a direction parallel to the longitudinal axis of the medical balloon.

7. The medical balloon of claim 1, wherein elastic properties are present in a radial direction of the medical balloon.

8. The medical balloon of claim 1, wherein said elastomer is present in pores of said fluoropolymer material.

9. The medical balloon of claim 1, wherein said at least one expanded fluoropolymer material comprises a plurality of pores and said elastomer is present in substantially all of said pores.

10. The medical balloon of claim 1, wherein the fluoropolymer material comprises polytetrafluoroethylene.

11. The medical balloon of claim 1, wherein the fluoropolymer material comprises a microstructure of substantially only fibrils.

12. The medical balloon of claim 1, wherein said composite material can be radially expanded up to a diameter beyond which further expansion is inhibited.

13. The medical balloon of claim 1, wherein said composite material is circumferentially wrapped to form a tubular form.

14. The medical balloon of claim 13, wherein said composite material comprises a plurality of layers, wherein a first section of the tubular form has a higher number of layers than a second section of the tubular form.

15. The medical balloon of claim 14, wherein said composite material is continuously wrapped into a tubular form.

16. The medical balloon of claim 1, wherein said balloon is not folded in its delivery conformation.

17. The medical balloon of claim 1, wherein said composite material is axially wrapped.

18. The medical balloon of claim 1, wherein said composite material is helically wrapped.

19. The medical balloon of claim 1, wherein said composite material is wrapped in at least two of the following orientations:

helically, axially, and circumferentially.

20. A medical balloon having a longitudinal axis comprising:

a balloon; and

a balloon cover comprising a composite material comprising at least one expanded fluoropolymer material and an elastomer,

wherein said expanded fluoropolymer material comprises serpentine fibrils.

21. The medical balloon of claim 20, wherein each said serpentine fibril has a width of about 1.0 micron or less.

22. The medical balloon of claim 21, wherein each said serpentine fibril has a width of 0.5 micron or less.

23. The medical balloon of claim 20, wherein said fluoropolymer is imbibed with an elastomer.

24. The medical balloon of claim 23, wherein the elastomer is selected from the group consisting of perfluoromethylvinyl ether-tetrafluoroethylene copolymers, perfluoro(alkyl vinyl ether)-tetrafluoroethylene copolymers, silicones, polyurethanes, or other high strain elastomers.

25. The medical balloon of claim 20, wherein elastic properties are present in a direction parallel to the longitudinal axis of the medical balloon.

26. The medical balloon of claim 20, wherein elastic properties are present in a radial direction of the medical balloon.

27. The medical balloon of claim 20, wherein said elastomer is present in pores of said fluoropolymer material.

28. The medical balloon of claim 20, wherein said at least one expanded fluoropolymer material comprises a plurality of pores and said elastomer is present in substantially all of said pores.

29. The medical balloon of claim 20, wherein the fluoropolymer material comprises polytetrafluoroethylene.

30. The medical balloon of claim 20, wherein the fluoropolymer material comprises a microstructure of substantially only fibrils.

31. The medical balloon of claim 20, wherein said composite material can be radially expanded up to a diameter beyond which further expansion is inhibited.

32. The medical balloon of claim 20, wherein said composite material is circumferentially wrapped to form a tubular form.

33. The medical balloon of claim 32, wherein said composite material comprises a plurality of layers, wherein a first section of the tubular form has a higher number of layers than a second section of the tubular form.

34. The medical balloon of claim 33, wherein said composite material is continuously wrapped into a tubular form.

35. The medical balloon of claim 20, wherein said balloon is not folded in its delivery conformation.

36. The medical balloon of claim 20, wherein said composite material is axially wrapped.

37. The medical balloon of claim 20, wherein said composite material is helically wrapped.

38. The medical balloon of claim 20, wherein said composite material is wrapped in at least two of the following orientations:

helically, axially, and circumferentially.

39. A medical balloon having a longitudinal axis comprising,

a balloon and

a balloon cover comprising a composite material comprising at least one expanded fluoropolymer material and an elastomer,

wherein said balloon cover is circumferentially wrapped at a first diameter,

wherein said composite material can be radially expanded up to a second, nominal diameter beyond which further expansion is inhibited, and

wherein said second, nominal diameter is at least 3 times greater than the first diameter.

40. The medical balloon of claim 39, wherein said second, nominal diameter is at least 4 times greater than the first diameter.

41. The medical balloon of claim 39, wherein said second, nominal diameter is at least 6 times greater than the first diameter.

42. The medical balloon of claim 39, wherein said second, nominal diameter at least 8 times greater than the first diameter.

43. The medical balloon of claim 39, wherein said second, nominal diameter is at least 10 times greater than the first diameter.

44. The medical balloon of claim 39, wherein said expanded fluoropolymer material comprises serpentine fibrils.

45. The medical balloon of claim 44, wherein each said serpentine fibril has a width of about 1.0 micron or less.

46. The medical balloon of claim 45, wherein each said serpentine fibril has a width of 0.5 micron or less.

47. The medical balloon of claim 39, wherein the elastomer is selected from the group consisting of perfluoromethylvinyl ether-tetrafluoroethylene copolymers, perfluoro(alkyl vinyl ether)-tetrafluoroethylene copolymers, silicones, polyurethanes, or other high strain elastomers.

48. The medical balloon of claim 39, wherein elastic properties are present in a direction parallel to the longitudinal axis of the medical balloon.

49. The medical balloon of claim 39, wherein elastic properties are present in a radial direction of the medical balloon.

50. The medical balloon of claim 39, wherein said at least one expanded fluoropolymer material comprises a plurality of pores and said elastomer is present in at least of portion of said pores.

51. The medical balloon of claim 39, wherein said at least one expanded fluoropolymer material comprises a plurality of pores and said elastomer is present in substantially all of said pores.

52. The medical balloon of claim 39, wherein the fluoropolymer material comprises polytetrafluoroethylene.

53. The medical balloon of claim 39, wherein the fluoropolymer material comprises a microstructure of substantially only fibrils.

54. The medical balloon of claim 39, wherein the fluoropolymer material comprises a plurality of serpentine fibrils.

55. The medical balloon of claim 39, wherein the expanded fluoropolymer material comprises a microstructure of substantially only serpentine fibrils.

56. The medical balloon of claim 39, wherein said composite material can be radially expanded up to a diameter beyond which further expansion is inhibited.

57. The medical balloon of claim 39, wherein said composite material is circumferentially wrapped to form a tubular form at a first diameter.

58. The balloon of claim 57 wherein said composite material comprises a plurality of layers, wherein a first section of the tubular form has a higher number of layers than a second section of the tubular form.

59. The medical balloon of claim 39, wherein said balloon is not folded in its delivery conformation.

60. A method of manufacturing a medical balloon device comprising:

wrapping a composite material approximately circumferentially to form a tubular member having a diameter that is approximately equal to the delivery diameter,

positioning the tubular member about a balloon; and

attaching the tubular member at its proximal and distal end to a catheter,

wherein said composite material comprises at least one expanded fluoropolymer material and an elastomer, and

wherein said expanded fluoropolymer material comprises serpentine fibrils.

61. A medical balloon delivery system having a longitudinal axis comprising:

a balloon;

a balloon cover having a length and comprising a composite material comprising at least one expanded fluoropolymer material and an elastomer, the balloon cover having a first section and a second section, wherein the stiffness of the first section is greater than the stiffness of the second section; and

an endoprosthetic device having a length and collocated with at least a portion of the balloon cover, the endoprosthetic device having a first section and a second section, wherein the stiffness of the first section is greater than the stiffness of the second section;

wherein said first section of the balloon cover is collocated with the second section of the endoprosthetic device and the second section of the balloon cover is collated with the first section of the endoprosthetic device.

62. The medical balloon delivery system of claim 61, wherein the balloon cover comprises a plurality of wrapped layers of the composite material, wherein the first section of the balloon cover has a higher number of layers than the second section of the balloon cover.

63. The medical balloon delivery system of claim 61, wherein the balloon cover comprises a thickness, wherein the first section of the balloon cover is thicker than the second section of the balloon cover.

64. A medical balloon having a longitudinal axis comprising:

a balloon comprising a continuously wrapped composite material comprising at least one expanded fluoropolymer material and an elastomer,

wherein said balloon cover comprises delivery conformation and an inflated conformation, wherein the delivery conformation is a substantially tubular form and the inflated conformation comprises a shape, the shape comprising a proximal tapered conical section and a distal tapered conical section and a working length there between, and

wherein the continuously wrapped composite material consists essentially of substantially constant, opposing angles.

65. The medical balloon having a longitudinal axis of claim 64, the shape further comprising a proximal waist and a distal waist respectively located at the ends of the balloon.

66. A method of making a balloon device comprising

helically wrapping a film with a first tension to form a first section of a tubular form having a proximal end and a distal end;

helically wrapping the film with a second tension to form a second section of the tubular form, wherein the first tension is less than the second tension; and

securing the tubular form at the proximal end and the distal end to a catheter, wherein upon inflation of the tubular form the first section will distend more than the second section.

67. A method of making a balloon device comprising

shaping a film into a non-rectangular sheet and circumferentially wrapping the non-rectangular sheet into a tubular form;

and

securing the tubular form to a catheter.

68. The method of making of claim 67, wherein the catheter comprises a balloon and the tubular form is collocated with the balloon to form a balloon cover.

69. The method of making of claim 67, wherein the tubular form is in fluid communication with a lumen of the catheter.

70. The method of making of claim 67, wherein the tubular form comprises wrapped layers of the film and wherein a first section of the tubular form has more wrapped layers than a second section of the tubular form.