Non-shortening high angle wrapped balloons

• US 7,785,290 B2
• Filed: 08/07/2006
• Issued: 08/31/2010
• Est. Priority Date: 08/07/2006
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated (W.L. Gore and Associates)
• Inventors: Houghton, Michael, Newcomb, Kenneth, Towler, Jeffrey, Alpini, Alfred A.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US11/501,190
• Publication Number:
  US 20080097301A1
• Time in Patent Office: 1,485 Days
• Field of Search: 604/96.01, 604/523, 604/103.06, 428/35.7
• US Class Current: 604/103.06
• 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 high pressure, large diameter, high expansion ratio balloon having a longitudinal axis and comprising a composite film wound into a wrapped balloon having a base pass, a radial pass, and a helical pass, said composite film forming a predefined maximum expanded diameter and which does not change length during expansion.

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

3. The balloon of claim 1 wrapped in a non-tubular shape.

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

5. The balloon of claim 1 wherein a plurality of each base, radial, and helical pass are wrapped in a configuration to create a high pressure balloon.

6. The balloon of claim 1 wherein said at least two passes are wrapped at the final balloon diameter and then deflated.

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

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

9. The balloon of claim 7 wherein the composite film is wrapped at the desired final balloon diameter.

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

34. The balloon of claim 1 comprising an anisotropic composite film.

35. 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.

36. The balloon of claim 35 wherein the most distal point is a leg of the balloon.

37. The balloon of claim 35 wherein the balloon comprises at least one leg, shoulder, and working length section and the base pass is wrapped contiguously across the at least one leg, shoulder, and working length to tie the sections together.

38. The balloon of claim 36 wherein the base layer further contiguously extends to wrap the opposing balloon shoulder and balloon leg to cover the entire balloon.

39. The balloon of claim 37 wherein the base pass forms a seal between the balloon leg and the shoulder.

40. The balloon of claim 39 wherein the base pass seals the leg to a catheter.

41. The balloon of claim 1 wrapped in a tubular shape.

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

a. wrapping composite 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 wrapping of the mandrel when a final desired strength of the catheter balloon is achieved with the film thickness to form a balloon structure; and

c. minimizing the balloon structure diameter to create a soft, high pressure, large diameter, greater than 400 percent expansion ratio balloon.

11. The method of claim 10 wherein the minimization of the balloon structure is achieved by deflating the mandrel.

12. The method of claim 10 wherein the minimization of the balloon structure is achieved by dissolving or melting the mandrel.

13. The method of claim 10 wherein the minimization of the balloon structure is achieved by deflating and removing the mandrel.

14. The method of claim 10 wherein the mandrel is an inflatable bladder.

15. The method of claim 14 wherein the mandrel remains as part of finished device.

16. The method of claim 15 wherein bladder is wrapped in a continuous manner.

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

a. wrapping film in essentially force resultant 54 degree helical layers around a mandrel having an outer dimension of the desired final inflated internal diameter of the catheter balloon;

b. ceasing wrapping 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, high expansion ratio balloon.

18. The method of claim 17 wherein the minimization of the balloon structure is achieved by deflating the mandrel.

19. The method of claim 17 wherein the minimization of the balloon structure is achieved by dissolving or melting the mandrel.

20. The method of claim 17 wherein the minimization of the balloon structure is achieved by deflating and removing the mandrel.

21. The method of claim 17 wherein the mandrel is an inflatable bladder.

22. The method of claim 17 wherein the mandrel remains as part of finished device.

23. The method of claim 17 further comprising heating the balloon structure to set the layers in place.

24. A non-shortening wrapped catheter balloon having a longitudinal axis and comprising a composite film wound into a wrapped balloon having at least one radial wrap layer;

at least one base wrap layer; and

at least one helical wrap layer.

27. The balloon of claim 24 wherein the radial wrap layer comprises ePTFE and a polyurethane.

28. The balloon of claim 24 wherein the base wrap layer comprises ePTFE and a polyurethane.

29. The balloon of claim 24 wherein the at least one helical wrap layer comprises ePTFE and a polyurethane.

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

at least one base wrap layer; and

three helical layers.

26. A non-shortening wrapped catheter balloon of claim 25 wherein the three helical wrap layers are oriented at different angles to the longitudinal axis of the balloon.

30. The balloon of claim 25 wherein the radial wrap layer comprises ePTFE and a polyurethane.

31. The balloon of claim 25 wherein the base wrap layer comprises ePTFE and a polyurethane.

32. The balloon of claim 25 wherein the three helical wrap layers all comprise ePTFE and a polyurethane.