REINFORCED BALLOON FOR A CATHETER

• US 20090038752A1
• Filed: 02/08/2006
• Published: 02/12/2009
• Est. Priority Date: 02/09/2005
• Status: Abandoned Application

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: Weng, Adel, Appling, William M.
• Application Number:
  US11/658,391
• Publication Number:
  US 20090038752A1
• Time in Patent Office: Days
• US Class Current: 156/276
• 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 25/10 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
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An inflatable balloon, and method of making same, for a medical catheter includes a base layer or non-compliant balloon substrate, a reinforcing layer, an adhesive. layer adhering the reinforcing layer to the non-compliant balloon substrate, and a top coat layer. The reinforcing layer is a single ply matrix of interwoven strands applied to the non-compliant balloon substrate. There are preferably three sets of strands in the single ply matrix. One set of strands extends in a longitudinal direction. Another set of strands extends circumferentially in a helical fashion with a clockwise orientation at an angle of approximately 65° with the strands that extend in the longitudinal direction. The third set of strands extends circumferentially in a helical fashion with a counter-clockwise orientation at an angle of approximately 65° with the strands that extend in the longitudinal direction. The three sets of strands are interwoven with one another by a braiding machine so as to provide a single ply of interwoven strands to achieve a uniform, reproducible reinforcing matrix.

Claims

1. An inflatable balloon for a medical catheter comprising:

a noncompliant combination of a base ply and a reinforcing ply;

said reinforcing ply comprising a first plurality of strands extending in a first direction, and a second plurality of strands extending in a second direction which is non-parallel with said first direction;

said strands of said second plurality being interwoven with the stands of said first plurality; and

said reinforcing ply being layered with said base ply to form a layered structure.

2. The inflatable balloon of claim 1 wherein said base ply of said noncompliant combination is noncompliant.

3. The inflatable balloon of claim 1 wherein said reinforcing ply of said noncompliant combination is noncompliant.

4. The inflatable balloon of claim 1 wherein said base ply and said reinforcing ply of said noncompliant combination are noncompliant.

5. The inflatable balloon of claim 1 further comprising an adhesive ply adhering said reinforcing ply with said base ply.

6. The inflatable balloon of claim 5 further comprising a top coat ply over said reinforcing ply.

7. The inflatable balloon of claim 6 wherein said base ply, said reinforcing ply, said adhesive ply and said top coat ply together form a composite laminate structure.

8. The inflatable balloon of claim 1 wherein said strands of said reinforcing ply are chosen from among high tenacity para-aramid or thermotropic liquid crystal polyester-polyacrylate.

9. The inflatable balloon of claim 1 wherein said strands of said reinforcing ply are comprised of a plurality of individual fibers.

10. The inflatable balloon of claim 1 wherein said balloon has a distal neck portion, a proximal neck portion, a body portion therebetween, a longitudinal axis, a longitudinal length defined by the distance from the distal end of the distal neck to the proximal end of the proximal neck, said longitudinal length being larger than the outside diameter of said body portion.

11. The inflatable balloon of claim 10 wherein said reinforcing ply extends over the entire area of said distal neck portion, said proximal neck portion and said body portion.

12. The inflatable balloon of claim 10 wherein said first and said second directions each form an angle of between 30°

and 70°

relative to said longitudinal axis.

13. The inflatable balloon of claim 12 wherein said first and said second directions each form an angle of between 60°

and 70°

relative to said longitudinal axis.

14. The inflatable balloon of claim 13 wherein said first and said second directions each form an angle of approximately 65°

relative to said longitudinal axis.

15. The inflatable balloon of claim 10 wherein said first direction is substantially parallel to said longitudinal axis, and wherein said second direction forms an angle of between 30°

and 70°

relative to said longitudinal axis.

16. The inflatable balloon of claim 15 wherein said second direction forms an angle of between 60°

and 70°

relative to said longitudinal axis.

17. The inflatable balloon according to claim 15 further comprising a third plurality of strands, the strands of said third plurality of strands being interwoven with the strands of said first and second plurality of strands and extending in a third direction forming an angle of between 60°

and 70°

with said longitudinal axis.

18. The inflatable balloon according to claim 16, wherein said second plurality of strands are oriented in a positive direction relative to said longitudinal axis, and wherein said third plurality of strands are oriented in a negative direction relative to said longitudinal axis.

19. A reinforced balloon on a catheter, the balloon having a longitudinal axis, comprising:

a noncompliant combination of a substrate, and a reinforcing layer of interwoven strands adhered to said substrate, said interwoven strands including first, second and third sets of strands, said first set of strands being a set of longitudinal strands oriented in a direction substantially parallel to said longitudinal axis, said second set of strands being a set of strands oriented in a positive direction relative to said longitudinal axis, said third set of strands being a set of strands oriented in a negative direction relative to said longitudinal axis, wherein individual strands of each of said first, second and third sets of strands are interwoven with strands of each of the other sets of strands.

20. The reinforced balloon of claim 19 wherein each strand of said second set is oriented at a clockwise angle of approximately between +30 and +70 degrees to said set of longitudinal strands and each strand of said third set is oriented at a counter-clockwise angle of approximately between −

30 and −

70 degrees to said set of longitudinal strands.

21. The reinforced balloon of claim 20 wherein said angle of said strands is approximately between 60 and 70 degrees.

22. The reinforced balloon of claim 21 wherein said angle of said strands is approximately 65 degrees.

23. The reinforced balloon of claim 19 wherein at least some of said strands are composed of multiple fiber elements.

24. The reinforced balloon of claim 19 wherein said substrate is non-compliant.

25. The reinforced balloon of claim 19 wherein each of said sets of strands comprises multiple strands.

26. The reinforced balloon of claim 19 further comprising a top coat layer covering said reinforcing layer.

39. The method of claim 26 wherein said base ply and said reinforcing ply of said combination are noncompliant.

27. A method of making an inflatable balloon for a medical catheter comprising:

applying a reinforcing ply having a first plurality of strands extending in a first direction, and a second plurality of strands extending in a second direction which is non-parallel with said first direction to a base ply forming a combination of base ply and reinforcing ply;

wherein said strands of said second plurality being interwoven with the stands of said first plurality, and said reinforcing ply being layered with said base ply to form a laminate structure.

28. The method of claim 27 further comprising applying an adhesive to said base ply prior to applying said reinforcing ply.

29. The method of claim 27 further comprising applying a top coat ply over said reinforcing ply after applying said reinforcing ply.

30. The method of claim 29 further comprising curing said base ply, said reinforcing ply, said adhesive ply and said top coat ply into said laminate structure.

31. The method of claim 27 wherein said balloon has a distal neck portion, a proximal neck portion, a body portion therebetween, a longitudinal axis, a longitudinal length defined by the distance from the distal end of the distal neck to the proximal end of the proximal neck, said longitudinal length being larger than the outside diameter of said body portion.

32. The method of claim 31 wherein said reinforcing ply is applied over the entire area of said distal neck portion, said proximal neck portion and said body portion.

33. The method of claim 27 wherein said reinforcing ply comprises a third plurality of strands, the strands of said third plurality of strands being interwoven with the strands of said first and second plurality of strands and extending in a third direction forming an angle of between 60°

and 70°

with said longitudinal axis.

34. The method of claim 27 wherein said second plurality of strands of said reinforcing ply are oriented in a positive direction relative to said longitudinal axis, and wherein said third plurality of strands of said reinforcing ply are oriented in a negative direction relative to said longitudinal axis.

35. The method of claim 27 wherein said strands of said reinforcing ply are comprised of a plurality of individual fibers.

36. The method of claim 27 wherein said strands of said reinforcing ply are chosen from among high tenacity para-aramid or thermotropic liquid crystal polyester-polyacrylate.

37. The method of claim 27 wherein said base ply of said combination is noncompliant.

38. The method of claim 27 wherein said reinforcing ply of said combination is noncompliant.

40. A method of making an inflatable balloon for a medical catheter comprising:

applying a reinforcing ply to a base ply forming a layered combination of base ply and reinforcing ply, said reinforcing ply having a first plurality of strands extending in a first direction, and a second plurality of strands extending in a second direction which is non-parallel with said first direction, said strands of said second plurality being interwoven with the stands of said first plurality,

applying a top coat ply over said reinforcing ply after said reinforcing ply is applied to said base ply; and

curing said layered combination of base ply and reinforcing ply with said top coat ply thereby forming a laminate structure.

41. The method of claim 40 further comprising applying an adhesive ply to said base ply prior to applying said reinforcing ply.

42. The method of claim 40 wherein said curing is carried out by inserting said layered combination of base ply and reinforcing ply with said top coat into a heated curing mold, the walls of which are compressed into contact with said top coat to form said laminate structure.

43. The method of claim 40 wherein said curing is carried out by inserting said layered combination of base ply and reinforcing ply with said top coat into an air baking chamber, inflating said layered combination of base ply and reinforcing ply so that the pressure within said layered combination exceeds the pressure within said air baking chamber, and heating the air within said chamber thereby forming said laminate structure.