Non-shortening high angle wrapped balloons

• US 8,585,640 B2
• Filed: 06/28/2010
• Issued: 11/19/2013
• Est. Priority Date: 08/07/2006
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Inventors: Alpini, Alfred A., Houghton, Michael, Newcomb, Kenneth, Towler, Jeffrey
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US12/824,343
• Publication Number:
  US 20100262178A1
• Time in Patent Office: 1,240 Days
• Field of Search: 604/96.01
• US Class Current: 604/96.01
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• 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 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

The present invention provides a balloon which achieves diameters greater than 6 mm for securement to a catheter. The balloon includes an elastomeric generally hollow pressure expandable body which exhibits essentially radial symmetry and constant length when expanded under an internally applied minimum working pressure from an uninflated state.

Claims

1. A balloon having a longitudinal axis and comprising a base layer, a radial layer, and a helical layer of film, said film does not substantially change length during expansion.

2. The balloon of claim 1 wherein the balloon has an inflation ratio of equal to or greater than 400 percent upon inflation of the balloon.

3. The balloon of claim 1 formed into a non-tubular shape.

4. The balloon of claim 1 wherein the non-tubular shape is a sphere.

5. The balloon of claim 1 wherein the non-tubular shape is a barbell formation.

6. The balloon of claim 1 further comprising a plurality of each base, radial, and helical layers arranged in a configuration to create a high pressure balloon.

7. The balloon of claim 6 wherein transverse strain of the helical layer of film caused by inflation is prevented.

8. The balloon of claim 1 wherein the layers result in an overall balanced force angle upon inflation.

9. The balloon of claim 7 wherein the helical layer of film is formed at the desired final balloon diameter.

10. The balloon of claim 1 wherein the balloon further comprises sections oriented at differing angles to create semi-compliant and non-compliant sections in one balloon.

11. The balloon of claim 1 further comprising an anisotropic film.

12. The balloon of claim 1 wherein the base pass extends from the most distal point of the balloon to the most proximal point of the balloon.

13. The balloon of claim 12 wherein the most distal point is a leg of the balloon.

14. The balloon of claim 13 wherein the base layer further contiguously extends across the opposing balloon shoulder and balloon leg to cover the entire balloon.

15. The balloon of claim 12 wherein the balloon further comprises at least one leg, shoulder, and working length section and the base pass extends contiguously across the at least one leg, shoulder, and working length to tie the sections together.

16. The balloon of claim 15 wherein the base pass forms a seal between the balloon leg and the shoulder.

17. The balloon of claim 16 wherein the base pass seals the leg to a catheter.

18. The balloon of claim 1 formed in a tubular shape.

19. A method of creating a soft, high pressure, large diameter, high expansion ratio balloon with increased burst pressures, comprising:

a. layering film in essentially longitudinal and essentially helical passes around a mandrel having an outer dimension of the desired final inflated internal diameter of the catheter balloon;

b. ceasing layering of the mandrel when a final desired strength of the catheter balloon is achieved; and

c. minimizing the balloon structure diameter to create a soft, high pressure, large diameter.

20. The method of claim 19 wherein the minimizing of the balloon structure is achieved by deflating the mandrel.

21. The method of claim 19 wherein the minimizing of the balloon structure is achieved by dissolving or melting the mandrel.

22. The method of claim 19 wherein the minimizing of the balloon structure is achieved by deflating and removing the mandrel.

23. The method of claim 19 wherein the mandrel is an inflatable bladder.

24. The method of claim 23 wherein the mandrel remains as part of finished device.

25. The method of claim 24 wherein the inflatable bladder is wrapped in a continuous manner.

26. A method of creating a soft, high pressure, large diameter, high expansion ratio balloon with increased burst pressures, comprising:

a. layering film in helical layers around a mandrel having an outer dimension of the desired final inflated internal diameter of the catheter balloon;

b. ceasing layering on the mandrel when a final desired strength of the catheter balloon is achieved; and

c. minimizing the balloon structure diameter to create a soft, high pressure, large diameter, high expansion ratio balloon.

27. The method of claim 26 wherein the minimizing of the balloon structure is achieved by deflating the mandrel.

28. The method of claim 26 wherein the minimizing of the balloon structure is achieved by dissolving or melting the mandrel.

29. The method of claim 26 wherein the minimizing of the balloon structure is achieved by deflating and removing the mandrel.

30. The method of claim 26 wherein the mandrel is an inflatable bladder.

31. The method of claim 26 wherein the mandrel remains as part of finished device.

32. The method of claim 26 further comprising heating the balloon structure to set the layers in place.

33. A non-shortening catheter balloon comprising a balloon having a longitudinal axis said balloon comprising at least one radial layer;

at least one base layer; and

at least one helical layer.

34. The balloon of claim 33 wherein the at least one radial layer comprises ePTFE and a polyurethane.

35. The balloon of claim 33 wherein the at least one base layer comprises ePTFE and a polyurethane.

36. The balloon of claim 33 wherein the at least one helical layer comprises ePTFE and a polyurethane.

37. A non-shortening catheter balloon comprising a balloon having a longitudinal axis said balloon comprising at least one radial layer;

at least one base layer; and

three helical layers.

38. A non-shortening catheter balloon of claim 37 wherein the three helical layers are oriented at different angles to the longitudinal axis of the balloon.

39. The balloon of claim 37 wherein the at least one radial layer comprises ePTFE and a polyurethane.

40. The balloon of claim 37 wherein the at least one base layer comprises ePTFE and a polyurethane.

41. The balloon of claim 37 wherein the three helical layers all comprise ePTFE and a polyurethane.