Inflatable shaped balloons

• US 20080097374A1
• Filed: 08/07/2006
• Published: 04/24/2008
• 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: Korleski, Joseph E., Towler, Jeffrey
• Application Number:
  US11/500,837
• Publication Number:
  US 20080097374A1
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• 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 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• 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

An inflatable device with at least two helically wrapped passes forming a tube and an inflation means connected to said tube is provided. The tube is configured and joined in at least one area forming a low profile continuous inflatable device with multiple cross-sectional segmented areas.

Claims

1. An inflatable device comprising at least two helically wrapped passes forming a non-configured tube which is configured and joined into an inflatable form, wherein one of the at least two helically wrapped passes is oriented at an angle of less than or equal to about 55 degrees, and one of the at least two helically wrapped passes is oriented at an angle of greater than or equal to about 55 degrees.

2. The inflatable device of claim 1 wherein the helically wrapped passes comprise a porous reinforcing layer and a continuous polymer layer.

3. The inflatable device of claim 1 further comprising an outer configuration layer which fixes the non-configured tube into an inflatable form.

4. The inflatable device of claim 1 wherein the at least two helically wrapped passes are anisotropic and the outer configuration layer is anisotropic.

5. The inflatable device of claim 1 wherein the helical wrap layers are anisotropic and the outer configuration layer is isotropic.

6. An inflatable device comprising at least two helically wrapped passes and at least one configuration layer forming a tube and an inflation means connected to said tube, wherein the tube is configured and joined in at least one area forming an inflatable device with multiple cross-sectional segmented areas.

7. The inflatable device of claim 6 wherein one of the one of the two helically wrapped passes is oriented at an angle of less than or equal to about 55 degrees, and one of the at least two helically wrapped passes is oriented at an angle of greater than or equal to about 55 degrees.

8. The inflatable device of claim 6 further comprising a non-distensible region.

9. The inflatable device of claim 8 wherein the two passes and the non-distensible region are continuously wrapped.

10. The inflatable device of claim 6 wherein the tube is configured into a folded multi-lobed shape around a center axis.

11. The inflatable device of claim 9 wherein the non-distensible regions are located at the foldover points of the tube.

12. The inflatable device of claim 6 wherein the tube is configured into a spiral wound flat disc shape.

13. The inflatable device of claim 6 wherein the tube is configured into a coiled shape around a center axis.

14. The inflatable device of claim 6 further comprising an open region.

15. The inflatable device of claim 6 further comprising an outer configuration layer.

16. The inflatable device of claim 6 configured in the form of a multi-lobed balloon suitable for bifurcation.

17. The inflatable device of claim 6 configured in the form of a multi-lobed balloon suitable for trifurcation.

18. The inflatable device of claim 6 configured in the form of a sequential multi-lobed balloon wherein the lobes are interconnected via a single, common inflation lumen.

19. The inflatable device of claim 6 wherein the inflatable device has an un-inflated length which remains relatively unchanged upon inflation.

20. The inflatable device of claim 6 wherein the at the least two helically wrapped inner layers comprise a fibrous reinforcement.

21. The inflatable device of claim 6 wherein the at least two helically wrapped inner layers are comprised of a porous reinforcing polymer.

22. The inflatable device of claim 6 wherein the at least two helically wrapped layers are comprised of a porous reinforcing polymer and a continuous phase of polymer.

23. The inflatable device of claim 21 wherein the porous reinforcing polymer is an olefin.

24. The inflatable device of claim 21 wherein the porous reinforcing polymer comprises an anisotropic polymer.

25. The inflatable device of claim 21 wherein the porous reinforcing polymer comprises PEEK.

26. The inflatable device of claim 21 wherein the porous reinforcing polymer comprises a polyamide.

27. The inflatable device of claim 21 wherein the porous reinforcing polymer is a polyurethane.

28. The inflatable device of claim 21 wherein the porous reinforcing polymer is a polyester.

29. The inflatable device of claim 21 wherein the porous reinforcing polymer comprises a fluoropolymer.

30. The inflatable device of claim 29 wherein the fluoropolymer 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 is greater than 400 megapascals.

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

36. The inflatable device of claim 22 wherein the continuous phase of a polymer is a fluoropolymer.

37. The inflatable device of claim 22 wherein the continuous phase of a polymer is an elastomer.

38. The inflatable device of claim 22 wherein the continuous phase of a polymer is a urethane.

39. The inflatable device of claim 22 wherein the continuous phase of a polymer is a silicone.

40. The inflatable device of claim 22 wherein the continuous phase of a polymer is a fluoro-elastomer.

41. The inflatable device of claim 19 wherein the continuous phase of a polymer is bioresorbable.

42. A deployment mechanism for a planar item comprising the inflatable device of claim 8 attached to a planar item in a manner such that the planar item may be folded and compressed prior to inflation so that upon inflation, the balloon inflates and restores the sheet-like item to its original planar form.

43. The balloon of claim 6 further comprising a treatment element.

44. The balloon of claim 43 wherein the treatment element is radioactive.

45. A method of making an inflatable shaped balloon comprising the steps of:

helically wrapping at least two layers of composite film around a tube;

applying heat to the helically wrapped layers, bonding the helically wrapped layers together;

attaching the bonded helically wrapped layer to an inflation means;

inflating the helically wrapped layers and configuring the balloon into a shape; and

fixing the configured balloon in said shape.

46. The method of claim 45 wherein said shape is a folded multi-lobed shape around a center axis.

47. The method of claim 45 wherein the said shape is a spiral wound shape.

49. The method of claim 45 wherein the composite film comprises a porous reinforcing polymer and a continuous polymer layer.

50. The method of claim 49 wherein the porous reinforcing polymer is ePTFE.

48. The method of 45 wherein the said shape is a coiled shape around a center axis.

51. A method of controlling the flow through a vessel comprising the steps of

positioning the shaped balloon in a desired location in a vessel;

and

inflating the balloon to a desired pressure thereby reducing the open area and reducing the flow through the vessel.

52. The method of claim 51 wherein the vessel is a blood vessel.

53. The method of claim 51 wherein the flow is blood flow.

54. A method of controlling the flow through a vessel comprising the steps of

positioning the hollow-centered balloon in a desired location in a vessel;

and

inflating the balloon to a desired pressure thereby increasing the diameter of the vessel and increasing the open area and increasing flow through the vessel.

55. The method of claim 54 wherein the vessel is a blood vessel.

56. The method of claim 54 wherein the flow is blood flow.