Non-shortening wrapped balloon

• US 20080140173A1
• Filed: 08/07/2006
• Published: 06/12/2008
• Est. Priority Date: 08/07/2006
• Status: Abandoned Application

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: King, David R., Newcomb, Kenneth, Roeber, Peter J., Eskaros, Sherif, Towler, Jeffrey, McLaughlin, Lonzo C., Korleski, Joseph E., Streeter, John
• Application Number:
  US11/501,249
• Publication Number:
  US 20080140173A1
• 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: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• 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
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon

Abstract

A non-shortening catheter balloon having a longitudinal axis and an inflatable balloon able to be affixed to a catheter shaft is provided. The balloon has an uninflated length which remains relatively unchanged upon inflation and is formed of least two helically oriented wrapped passes of balloon materials at a balanced force angle. Methods of making this balloon are also provided.

Claims

1. A balloon catheter comprising a catheter shaft having a longitudinal axis and an inflatable balloon affixed to said shaft, said balloon having an un-inflated length which remains relatively unchanged upon inflation and comprising at least two helically wrapped passes of a first balloon material.

2. The balloon of claim 1 wherein the length change upon inflation is less than 20 percent.

3. The balloon of claim 1 wherein the length change upon inflation is less than 10 percent.

4. The balloon of claim 1 wherein the length change upon inflation is less than 5 percent.

5. The balloon of claim 1 wherein said helically wrapped passes of a first balloon material are bonded to each other through the application of heat.

6. The balloon of claim 1 wherein the first balloon material is mechanically stress relieved through annealing with heat in the inflated state.

7. The balloon of claim 1 wherein the helically wrapped passes of the first balloon material are oriented and balanced in opposite directions at an angle of less than or equal to about 55 degrees with respect to the longitudinal axis and further comprising a second balloon material oriented at an angle of greater than or equal to about 55 degrees with respect to the longitudinal axis in the inflated state.

8. The balloon of claim 7 wherein said helically wrapped passes of a first balloon material are bonded to the second balloon material through the application of heat.

9. The balloon of claim 1 wherein the helically wrapped passes are at a balanced force angle.

10. The balloon of claim 7 wherein the first balloon material is held at balanced force angle by second balloon material that is helically wrapped at an angle greater than 54 degrees.

11. The balloon of claim 7 wherein the first balloon material is held at balanced force angle by second balloon material pass that is wrapped at an angle greater than 54 degrees.

12. The balloon of claim 7 wherein the second balloon material is isotropic.

13. The balloon of claim 7 wherein the second balloon material is anisotropic.

14. The balloon catheter of claim 1 wherein the un-inflated length is changed by less than 2% upon inflation.

15. The balloon catheter of claim 1 wherein the balloon exhibits essentially radial symmetry upon inflation.

16. The balloon catheter of claim 1 wherein the balloon exhibits equal hydrostatic force on a vessel wall in clinical use.

17. The balloon catheter of claim 1 further comprising a stent with uniform deployment capability.

18. The balloon catheter of claim 1 wherein the balloon is non-compliant.

19. The balloon catheter of claim 1 wherein the balloon is semi-compliant.

20. A balloon catheter of claim 1 wherein said first balloon material or said second balloon material comprises a filler.

21. The balloon of claim 1 wherein at least one of the balloon materials comprises a porous reinforcing polymer.

22. The balloon of claim 21 wherein the porous reinforcing polymer comprises a fibrous reinforcement.

23. The balloon of claim 21 wherein the porous reinforcing polymer is a PEEK.

24. The balloon of claim 21 wherein the porous reinforcing polymer is a polyamide.

25. The balloon of claim 21 wherein the porous reinforcing polymer is a polyurethane.

26. The balloon of claim 21 wherein the porous reinforcing polymer is a polyester.

27. The balloon of claim 21 wherein the porous reinforcing polymer is a fluoropolymer.

28. The balloon of claim 21 wherein the porous reinforcing polymer is an olefin.

29. The balloon of claim 21 wherein the porous reinforcing polymer is bio-resorbable.

30. The balloon of claim 22 wherein the porous reinforcing polymer is expanded PTFE.

31. The balloon of claim 30 wherein the expanded PTFE has a matrix tensile value in one direction of greater than 690 megapascals.

32. The balloon of claim 30 wherein the expanded PTFE has a matrix tensile value in one direction of greater than 960 megapascals.

33. The balloon of claim 30 wherein the expanded PTFE has a matrix tensile value in one direction of greater than 1,200 megapascals.

34. The balloon of claim 30 wherein the maximum hoop stress of the helically wrapped layers in greater than 400 megapascals.

35. The balloon of claim 30 wherein the maximum hoop stress of the helically wrapped layers in greater than 600 megapascals.

36. The balloon of claim 1 wherein the helically wrapped passes comprise a porous reinforcing polymer and a continuous polymer layer.

37. The balloon of claim 36 wherein a layer is less than 0.0002″

thick.

38. The balloon of claim 36 wherein the continuous polymer layer is imbibed throughout the porous reinforcing polymer.

39. The balloon of claim 36 where the continuous polymer layer is comprised of a fluoropolymer.

40. The balloon of claim 36 where the continuous polymer layer is an elastomer.

41. The balloon of claim 36 wherein the continuous polymer layer is a urethane.

42. The balloon of claim 36 wherein the continuous polymer layer is a silicone.

43. The balloon of claim 36 wherein the continuous polymer layer is a styrene block copolymer.

44. The balloon of claim 36 wherein the continuous polymer layer is a fluoro-elastomer.

45. The balloon of claim 36 wherein the continuous polymer layer is bioresorbable.

46. The balloon catheter of claim 1 wherein said first balloon material or said second balloon material comprises a filler.

47. The balloon catheter of claim 46 wherein the filler is radio opaque.

48. The balloon catheter of claim 46 wherein the filler provides therapeutic value.

49. The balloon catheter of claim 1 wherein the balloon contains an integral non-distending wrapped seal region.

50. The balloon catheter of claim 49 wherein the integral non-distending wrapped seal region is located between at least two passes of balloon material.

51. The balloon catheter of claim 49 wherein the integral non-distending wrapped seal region is located on the outer surface of a balloon material.

52. The balloon catheter of claim 1 further comprising a reinforced catheter shaft under the balloon to push out balloon after deflation which prevents distended material from folding over the seals.

53. The balloon catheter of claim 1 further comprising a stent wherein the first balloon material pass and a second balloon material pass flows into interstices of a stent to provide stent embedment when used as a stent delivery system.

54. The balloon catheter of claim 53 wherein the stent is embedded without the use of heat.

55. The balloon catheter of claim 54 wherein the stent is embedded without balloon inflation.

56. The balloon catheter of claim 1 wherein the first balloon material and the second balloon material are comprised of the same materials.

57. The balloon catheter of claim 1 wherein the first balloon material and the second balloon material are comprised of different materials.

58. The balloon catheter of claim 56 wherein the first balloon material pass and the second balloon material pass are less than 2 micrometers thick.

77. The balloon of claim 1 wherein the at least two helically wrapped passes of the first balloon material are balanced in opposite directions of one another relative to the longitudinal axis of the balloon.

59. A method of creating a non-shortening balloon with increased burst pressures, said balloon comprising:

a) wrapping a mandrel with at least one first balloon material to form a balloon preform;

b) exposing the first balloon material to heat;

c) removing the mandrel;

d) exposing the balloon preform to internal pressure at a reflow temperature;

e) inflating the balloon preform into a balloon as it is continued to be exposed to said internal pressure at an increased temperature; and

f) removing heat and internal pressure.

60. The method of claim 59 wherein the wire core of step (a) is wrapped with film at a low angle of between 3 and 54 degrees.

61. The method of claim 59 further comprising step (f)(1) inflating the non-shortening balloon and wrapping with a second balloon material pass at a high angle of between 54 and 90 degrees.

62. The method of claim 59 further comprising step (f)(2) passing heat to bond said second balloon pass to the inflated balloon.

63. The method of claim 59 wherein the heat and pressure are added and the balloon is inflated into a mold.

64. The method of claim 59 wherein the heat and pressure are added and the balloon is inflated without a mold.

65. The method of claim 59 wherein the second balloon material is cigarette wrapped.

66. The method of claim 59 wherein the second balloon material is helically wrapped.

67. A method of creating a non-shortening catheter balloon with increased burst pressures, comprising:

a) wrapping a wire core with a plurality of first balloon material layer at a low angle;

b) further wrapping with a plurality of first balloon material at a low angle in the opposite direction of a) relative to the longitudinal balloon axis;

c) exposing the plurality of first balloon material layers to heat to bond them together creating a preform;

d) removing the wire core;

e) placing the balloon preform in a mold and exposing the balloon preform to internal pressure;

f) inflating the balloon preform as it is continued to be exposed to said internal pressure creating a balloon;

g) removing the balloon from the mold;

h) wrapping the inflated balloon with second balloon material layers oriented at an angle between 54 and 90 degrees; and

i) bonding the first and second balloon material.

68. The method of claim 67 wherein the second balloon material is isotropic.

69. The method of claim 67 wherein the second balloon material is anisotropic.

70. The method of claim 67 where heat is used to bond said second balloon material to first balloon material.

78. The method of claim 67 wherein the first balloon material is anisotropic

71. A balloon catheter comprising a catheter shaft having a longitudinal axis and an inflatable balloon affixed to said shaft, said balloon having an un-inflated length which remains relatively unchanged upon inflation and comprising at least two helically wrapped passes of a first balloon material which are wrapped in opposing directions each with a wrap angle of less than 15 degrees with respect to the longitudinal axis.

72. The balloon catheter of claim 71 wherein the helically wrapped passes are at a balanced force angle in the inflated state.

73. The balloon catheter of claim 72 wherein the helically wrapped passes are exposed to heat and inflation pressure to reach the inflated state.

74. A catheter balloon comprising a balloon having two ends with a longitudinal axis running therebetween, and a catheter shaft comprising a reinforced inner member located adjacent to the longitudinal axis of the balloon and between the shaft and the balloon wherein the reinforced inner member is modulated to compensate for pressure changes in the balloon and prevent foreshortening of the catheter balloon upon inflation.

75. A balloon catheter comprising a balloon having two ends with a longitudinal axis running therebetween, and catheter shaft comprising an expandable pleated shaft section located adjacent to the longitudinal axis of the balloon wherein the expandable pleated shaft section is formed to compensate for pressure changes in the balloon and prevent foreshortening of the catheter balloon upon inflation.

76. A balloon catheter comprising a balloon having two ends with a longitudinal axis running therebetween, and a catheter shaft comprising an outer seal dimension having both convex portions and concave portions which provide an increased surface area and increased seal strength when attached to the balloon ends.