Inflatable toroidal-shaped balloons

• US 8,460,240 B2
• Filed: 08/07/2006
• Issued: 06/11/2013
• Est. Priority Date: 08/07/2006
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Towler, Jeffrey
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): GILBERT, ANDREW M
• Application Number:
  US11/501,148
• Publication Number:
  US 20080086083A1
• Time in Patent Office: 2,500 Days
• Field of Search: 604/96.01, 604/97.01, 604/101.01, 604/101.02, 604/103, 604/103.05, 604/103.07, 604/103.08, 604/103.09
• US Class Current: 604/103.07
• CPC Class Codes: A61L 29/126 having a macromolecular matrix
• CPC Class Codes: A61L 29/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• 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 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An inflatable toroidal-shaped balloon for medical use is provided with a central opening traversing the balloon in an inflated state. The balloon is useful to achieve larger outer diameters than conventional balloons.

Claims

1. An inflatable balloon for medical use comprising at least two helically wrapped layers formed into a wrapped balloon with a sealed region at least partially radially surrounded by an inflatable region, and an inflation means;

wherein the sealed region is formed from the wrapped layers, extends along a length in a radial dimension, does not inflate, and is adjacent to an opening traversing an open region passing through the balloon in an inflated state.

2. The balloon of claim 1 wherein the inflatable region conforms to seal vessels or span a void within a tissue.

3. The balloon of claim 1 wherein the balloon is bioresorbable.

4. The balloon of claim 1 further comprising a bioresorbable media used to reach an inflated state.

5. The balloon of claim 1 wherein the balloon inflates to a toroidal shape.

6. The balloon of claim 5 wherein the inflatable balloon comprises an outer diameter that is greater than 1.5 times a diameter of the inflatable region.

7. The balloon of claim 5 wherein the inflatable balloon comprises an outer diameter that is greater than 2.0 times a diameter of the inflatable region.

8. The balloon of claim 5 wherein the inflatable region comprises an outer diameter that is greater than 3.0 times a diameter of the inflatable region.

9. The balloon of claim 5 wherein the inflatable region conforms to seal wound openings.

10. The balloon of claim 5 wherein at least one of the helically wrapped layers are oriented at an angle less than or equal to about 55 degrees.

11. The balloon of claim 1 wherein the helically wrapped layers are anisotropic.

12. The balloon of claim 5 further comprising a sleeve with an open channel.

13. The balloon of claim 12 wherein the open region closes upon inflation.

14. The balloon of claim 1 wherein the balloon is a catheter balloon for opening obstructions in vessels and permits through flow of blood.

15. The balloon of claim 1 wherein the balloon exhibits concentric deflation.

16. The balloon of claim 1 wherein the balloon is detachable from the inflation means.

17. The balloon of claim 1 wherein the balloon is comprised of a self-sealing material.

18. The balloon of claim 1 wherein at least one of the helically wrapped layers comprises a porous reinforcing polymer.

19. The balloon of claim 18 wherein the porous reinforcing polymer comprises a fibrous reinforcement.

20. The balloon of claim 18 wherein the porous reinforcing polymer is a PEEK.

21. The balloon of claim 18 wherein the porous reinforcing polymer is a polyamide.

22. The balloon of claim 18 wherein the porous reinforcing polymer is a polyurethane.

23. The balloon of claim 18 wherein the porous reinforcing polymer is a polyester.

24. The balloon of claim 18 wherein the porous reinforcing polymer is a fluoropolymer.

25. The balloon of claim 18 wherein the porous reinforcing polymer is an olefin.

26. The balloon of claim 18 wherein the porous reinforcing polymer is bioresorbable.

27. The balloon of claim 18 wherein the porous reinforcing polymer is expanded PTFE.

28. The balloon of claim 27 wherein the expanded PTFE has a matrix tensile value in one direction of greater than 690 megapascals.

29. The balloon of claim 27 wherein the expanded PTFE has a matrix tensile value in one direction of greater than 960 megapascals.

30. The balloon of claim 27 wherein the expanded PTFE has a matrix tensile value in one direction of greater than 1,200 megapascals.

31. The balloon of claim 27 wherein the maximum hoop stress of the helically wrapped layers is greater than 400 megapascals.

32. The balloon of claim 27 wherein the maximum hoop stress of the helically wrapped layers is greater than 600 megapascals.

33. The balloon of claim 18 wherein the wrapped layers comprise a porous reinforcing polymer and a continuous polymer layer.

34. The balloon of claim 33 wherein the continuous polymer layer is imbibed throughout the porous reinforcing polymer.

35. The balloon of claim 33 wherein the continuous polymer layer forms a surface coating layer on at least one side of the porous reinforcing polymer.

36. The balloon of claim 33 where the continuous polymer layer is comprised of a fluoropolymer.

37. The balloon of claim 33 where the continuous polymer layer is an elastomer.

38. The balloon of claim 33 wherein the continuous polymer layer is a urethane.

39. The balloon of claim 33 wherein the continuous polymer layer is a silicone.

40. The balloon of claim 33 wherein the continuous polymer layer is a fluoro-elastomer.

41. The balloon of claim 33 wherein the continuous polymer layer is bioresorbable.

42. An inflatable balloon for medical use comprising at least two helically wrapped layers formed into at least two wrapped balloons each with a sealed region and at least partially radially surrounded by an inflatable region, a treatment element and an inflation means;

wherein the sealed region is formed from the wrapped layers, extends along a length in a radial dimension, does not inflate, and is adjacent to an open region passing through the balloon in an inflated state.

43. The balloon of claim 42, wherein treatment element is radioactive.

44. The balloon of claim 42, wherein treatment element is a therapeutic agent.

45. A method of controlling the flow through a vessel comprising the steps of positioning a toroidal-shaped balloon in a desired location in a vessel, wherein said toroidal-shaped balloon comprises at least two helically wrapped layers formed into the toroidal-shaped balloon with a sealed region formed from the wrapped layers and at an inner diameter of the balloon and extending along a length in a radial dimension, wherein the sealed region does not inflate and is at least partially radially surrounded by an inflatable region;

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

46. The method of claim 45 wherein the vessel is a blood vessel.

47. The method of claim 45 wherein the flow is blood flow.

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

positioning a toroidal-shaped balloon in a desired location in a vessel, wherein said toroidal-shaped balloon comprises at least two helically wrapped layers formed into the toroidal-shaped balloon with a sealed region formed from the wrapped layers and at an inner diameter of the balloon and extending along a length in a radial dimension, wherein the sealed region does not inflate and is at least partially radially surrounded by an inflatable region; and

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

49. The method of claim 48 wherein the vessel is a blood vessel.

50. The method of claim 48 wherein the flow is blood flow.