Semi-compliant catheter balloons and methods of manufacture thereof

• US 6,416,494 B1
• Filed: 06/11/1998
• Issued: 07/09/2002
• Est. Priority Date: 06/11/1998
• Status: Expired due to Fees

• Current Assignee: Infinity Extrusion & Engineering
• Original Assignee: Infinity Extrusion & Engineering
• Inventors: Wilkins, Douglas
• Primary Examiner(s): Casier, Brian L.
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/096,141
• Time in Patent Office: 1,489 Days
• Field of Search: 604/96, 604/915-919, 604/96.01, 604/103.11, 604/103.13, 428/35.2
• US Class Current: 604/96.01
• CPC Class Codes: A61L 29/041 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/049 Mixtures of macromolecular compounds
• 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: C08L 35/04 Homopolymers or copolymers of nitriles C08L35/06, C08L35/08 take precedence
• CPC Class Codes: Y10T 428/1334 Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]

Abstract

The present invention relates to catheter balloons for medical devices. In particular, the present invention provides biaxially oriented semi-compliant catheter balloons comprising acrylonitrile polymers, acrylonitrile copolymers, and acrylonitrile blends, and methods of making same. The catheter balloons provided herein exhibit relatively high tensile strength, controlled compliance, reduced tendency for pinholing, ease of coating with and of bonding to other compounds, as well as resistance to moisture.

Claims

1. A catheter balloon consisting of biaxially oriented acrylonitrile homopolymer.

2. The catheter balloon of claim 1, wherein said balloon is within its glass transition state at approximately human body temperature.

3. The catheter balloon of claim 1, wherein said acrylonitrile polymer catheter balloon has a mean wall thickness of from approximately 0.0006 inches to approximately 0.0013 inches and a tensile strength of at least approximately 15000 psi.

4. The catheter balloon of claim 3, wherein said balloon has tailored compliance from approximately 5% to approximately 15%.

5. The catheter balloon of claim 1, wherein said acrylonitrile polymer catheter balloon has a mean wall thickness of from approximately 0.0006 inches to approximately 0.0015 inches, reaches approximately quarter size at a pressure from approximately 12 atmospheres to approximately 14 atmospheres, reaches nominal size at a pressure of from approximately 4 atmospheres to approximately 6 atmospheres, and has a rated burst pressure of at least approximately 1 atmosphere greater than said pressure from approximately 12 atmospheres to approximately 14 atmospheres.

6. A single-layer catheter balloon consisting of biaxially oriented acrylonitrile copolymer, wherein said acrylonitrile copolymer comprises acrylonitrile and methyl acrylate.

7. The catheter balloon of claim 6, wherein said acrylonitrile copolymer comprises from approximately 73 to approximately 77 parts by weight of acrylonitrile and from approximately 23 to approximately 27 parts by weight of methyl acrylate.

8. The catheter balloon of claim 7, wherein said balloon has a mean wall thickness of from approximately 0.0006 inches to approximately 0.0012 inches and a tensile strength of at least approximately 15000 psi.

9. The catheter balloon of claim 8, wherein said balloon has tailored compliance of from approximately 5% to approximately 15%.

10. The catheter balloon of claim 9, wherein said balloon has intrinsic viscosity from approximately 0.8 to approximately 1.3.

11. The catheter balloon of claim 6, wherein said acrylonitrile and methyl acrylate copolymer catheter balloon has a mean wall thickness of from approximately 0.0006 inches to approximately 0.0012 inches, reaches approximately quarter size at a pressure from approximately 12 atmospheres to approximately 14 atmospheres, reaches nominal size at a pressure of from approximately 4 atmospheres to approximately 6 atmospheres, and has a rated burst pressure of at least approximately 1 atmosphere greater than said pressure from approximately 12 atmospheres to approximately 14 atmospheres.

12. A single-layer catheter balloon consisting of biaxially oriented acrylonitrile copolymer, wherein said acrylonitrile copolymer comprises from approximately 73 to approximately 77 parts by weight of acrylonitrile and from approximately 23 to approximately 27 parts by weight of methyl acrylate.

13. The catheter balloon of claim 12, wherein said catheter balloon has a mean wall thickness of from approximately 0.0006 inches to approximately 0.0013 inches and a tensile strength of at least approximately 15000 psi.

14. The catheter balloon of claim 13, wherein said balloon has tailored compliance of from approximately 5% to approximately 15%.

15. The catheter balloon of claim 14, wherein said balloon has intrinsic viscosity from approximately 0.8 to approximately 1.3.

16. The catheter balloon of claim 13, wherein said catheter balloon has a mean wall thickness of from approximately 0.0006 inches to approximately 0.0013 inches, reaches approximately quarter size at a pressure from approximately 12 atmospheres to approximately 14 atmospheres, reaches nominal size at a pressure of from approximately 4 atmospheres to approximately 6 atmospheres, and has a rated burst pressure of at least approximately 1 atmosphere greater than said pressure from approximately 12 atmospheres to approximately 14 atmospheres.

17. A single-layer catheter balloon consisting of biaxially oriented acrylonitrile copolymer, wherein said acrylonitrile copolymer is thermoplastic, and wherein said acrylonitrile copolymer comprises acrylonitrile and methyl acrylate.

18. The catheter balloon of claim 17, wherein said acrylonitrile copolymer comprises from approximately 73 to approximately 77 parts by weight of acrylonitrile and from approximately 23 to approximately 27 parts by weight of methyl acrylate.

19. The catheter balloon of claim 18, wherein said balloon has a mean wall thickness of from approximately 0.0006 inches to approximately 0.0012 inches and a tensile strength of at least approximately 15000 psi.

20. The catheter balloon of claim 19, wherein said balloon has tailored compliance of from approximately 5% to approximately 15%.

21. The catheter balloon of claim 20, wherein said balloon has intrinsic viscosity from approximately 0.8 to approximately 1.3.

22. The catheter balloon of claim 17, wherein said acrylonitrile and methyl acrylate copolymer catheter balloon has a mean wall thickness of from approximately 0.0006 inches to approximately 0.0012 inches, reaches approximately quarter size at a pressure from approximately 12 atmospheres to approximately 14 atmospheres, reaches nominal size at a pressure of from approximately 4 atmospheres to approximately 6 atmospheres, and has a rated burst pressure of at least approximately 1 atmosphere greater than said pressure from approximately 12 atmospheres to approximately 14 atmospheres.

23. A single-layer catheter balloon consisting of biaxially oriented acrylonitrile copolymer, wherein said acrylonitrile copolymer is thermoplastic, and wherein said acrylonitrile copolymer comprises from approximately 73 to approximately 77 parts by weight of acrylonitrile and from approximately 23 to approximately 27 parts by weight of methyl acrylate.

24. The catheter balloon of claim 23, wherein said catheter balloon has a mean wall thickness of from approximately 0.0006 inches to approximately 0.0013 inches and a tensile strength of at least approximately 15000 psi.

25. The catheter balloon of claim 24, wherein said balloon has tailored compliance of from approximately 5% to approximately 15%.

26. The catheter balloon of claim 25, wherein said balloon has intrinsic viscosity from approximately 0.8 to approximately 1.3.

27. The catheter balloon of claim 23, wherein said catheter balloon has a mean wall thickness of from approximately 0.0006 inches to approximately 0.0013 inches, reaches approximately quarter size at a pressure from approximately 12 atmospheres to approximately 14 atmospheres, reaches nominal size at a pressure of from approximately 4 atmospheres to approximately 6 atmospheres, and has a rated burst pressure of at least approximately 1 atmosphere greater than said pressure from approximately 12 atmospheres to approximately 14 atmospheres.

28. A catheter balloon consisting of biaxially oriented acrylonitrile blend.

29. A catheter balloon consisting of biaxially oriented acrylonitrile blend, wherein said acrylonitrile blend comprises acrylonitrile and polyethylene elastomer.

30. The catheter balloon of claim 29, wherein said acrylonitrile blend comprises approximately 70 parts by weight of acrylonitrile and approximately 30 parts by weight of polyethylene elastomer.

31. The catheter balloon of claim 29, wherein said catheter balloon has a mean wall thickness of from approximately 0.00065 inches to approximately 0.0015 inches and a tensile strength of at least approximately 15000 psi.

32. The catheter balloon of claim 29, wherein said balloon has tailored compliance from approximately 5% to approximately 15%.

33. The catheter balloon of claim 29, wherein said balloon has intrinsic viscosity from approximately 0.8 to approximately 1.3.

34. The catheter balloon of claim 29, wherein said acrylonitrile and polyethylene elastomer blend catheter balloon has a mean wall thickness of from approximately 0.0006 inches to approximately 0.0012 inches, reaches approximately quarter size at a pressure from approximately 12 atmospheres to approximately 14 atmospheres, reaches nominal size at a pressure of from approximately 4 atmospheres to approximately 6 atmospheres, and has a rated burst pressure of at least approximately 1 atmosphere greater than said pressure from approximately 12 atmospheres to approximately 14 atmospheres.

35. A catheter balloon comprising biaxially oriented acrylonitrile blend, wherein said acrylonitrile blend comprises acrylonitrile and a block copolymer comprising crystalline polybutylene terephthalate and amorphous long chain glycols.

36. The catheter balloon of claim 35, wherein said acrylonitrile blend comprises approximately 70 parts by weight of acrylonitrile and approximately 30 parts by weight of said block copolymer.

37. The catheter balloon of claim 35, wherein said catheter balloon has a mean wall thickness of from approximately 0.0006 inches to approximately 0.0013 inches and a tensile strength of at least approximately 15000 psi.

38. The catheter balloon of claim 35, wherein said balloon has tailored compliance from approximately 5% to approximately 15%.

39. The catheter balloon of claim 35, wherein said balloon has intrinsic viscosity from approximately 0.8 to approximately 1.3.

40. The catheter balloon of claim 35, wherein said balloon has a mean wall thickness of from approximately 0.0006 inches to approximately 0.0013 inches, reaches approximately quarter size at a pressure from approximately 12 atmospheres to approximately 14 atmospheres, reaches nominal size at a pressure of from approximately 4 atmospheres to approximately 6 atmospheres, and has a rated burst pressure of at least approximately 1 atmosphere greater than said pressure from approximately 12 atmospheres to approximately 14 atmospheres.

41. A catheter balloon consisting of biaxially oriented acrylonitrile blend, wherein said acrylonitrile blend comprises acrylonitrile and polyether block amide.

42. The catheter balloon of claim 41, wherein said acrylonitrile blend comprises approximately 60 parts by weight of acrylonitrile and approximately 40 parts by weight of polyether block amide.

43. The catheter balloon of claim 41, wherein said acrylonitrile and polyether block amide blend catheter balloon has a mean wall thickness of from approximately 0.0006 inches to approximately 0.0013 inches and a tensile strength of at least approximately 15000 psi.

44. The catheter balloon of claim 41, wherein said balloon has tailored compliance from approximately 5% to approximately 15%.

45. The catheter balloon of claim 41, wherein said balloon has intrinsic viscosity from approximately 0.8 to and approximately 1.3.

46. The catheter balloon of claim 41, wherein said acrylonitrile and polyether block amide blend catheter balloon has intrinsic viscosity from approximately 0.8 to and approximately 1.3, a mean wall thickness of from approximately 0.0006 inches to approximately 0.0013 inches, reaches approximately quarter size at a pressure from approximately 12 atmospheres to approximately 14 atmospheres, reaches nominal size at a pressure of from approximately 4 atmospheres to approximately 6 atmospheres, and has a rated burst pressure of at least approximately 1 atmosphere greater than said pressure from approximately 12 atmospheres to approximately 14 atmospheres.

47. A single-layer catheter balloon comprising biaxially oriented acrylonitrile copolymer, wherein said acrylonitrile copolymer comprises acrylonitrile and methyl acrylate.