Balloons for medical devices and fabrication thereof

• US 6,110,142 A
• Filed: 03/03/1998
• Issued: 08/29/2000
• Est. Priority Date: 10/04/1988
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Pinchuk, Leonard, Trotta, Thomas, Shonk, Robert S.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US09/033,799
• Time in Patent Office: 910 Days
• Field of Search: 604/96-103, 606/191, 606/192, 606/194
• US Class Current: 604/96.01
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• 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 25/1038 Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: C08L 77/06 Polyamides derived from polyamines and polycarboxylic acids C08L77/10 takes precedence

Abstract

Dilatation balloons and catheters including same are provided. The balloons are fabricated of a biaxially orientable material such as a nylon or a polyamide material, and they have an inflated, non-distended working profile as well as a stretched inflated profile which is achieved by applying pressure through a dilatation catheter or the like that is in excess of that needed to achieve the inflated, non-distended profile and which is adequate to effect dilatation or the like up to a maximum pre-bursting pressure application. The maximum pre-bursting size of the balloon can be tailored depending upon the needs of the particular balloon within a wide range of possible maximum pre-bursting sizes.

Claims

1. A dilatation balloon, comprising:

a length of tubing of polymeric material comprising Nylon 12, which tubing had been radially expanded to a predetermined balloon diameter;

said dilatation balloon has a collapsed profile which has a diameter less than said predetermined balloon diameter, said dilatation balloon further having a non-distended, inflated working diameter at which the dilatation balloon is inflated to its said predetermined balloon diameter, and said dilatation balloon also exhibits a maximum stretched inflation diameter to which the dilatation balloon is expandable without bursting under needed dilatation conditions, said maximum stretched inflation diameter exceeds said predetermined balloon diameter by between above 5 percent and about 30 percent; and

said dilatation balloon has a calculated tensile strength of between 15,000 psi and 30,000 psi.

2. The dilatation balloon according to claim 1, wherein said maximum stretched inflation diameter of the balloon exceeds said predetermined balloon diameter by at least about 10 percentage points.

3. The dilatation balloon according to claim 1, wherein said balloon has an intrinsic viscosity of between about 0.8 and about 1.5.

4. The dilatation balloon according to claim 1, wherein said balloon is an angioplasty balloon.

5. A dilatation balloon, comprising:

a length of tubing of polymeric material comprising Nylon 12, which tubing had been radially expanded to a predetermined balloon diameter;

said dilatation balloon having a collapsed profile which has a diameter less than said predetermined balloon diameter, said dilatation balloon further having a non-distended, inflated working diameter at which the dilatation balloon is inflated to its said predetermined balloon diameter, and said dilatation balloon also exhibits a maximum stretched inflation diameter to which the dilatation balloon is expandable without bursting under needed dilatation conditions; and

said maximum stretched inflation diameter exceeds said predetermined balloon diameter by between above 5 percent and about 30 percent.

6. The dilatation balloon according to claim 5, wherein said maximum stretched inflation diameter of the balloon exceeds said predetermined balloon diameter by at least about 10 percentage points.

7. The dilatation balloon according to claim 5, wherein said balloon has an intrinsic viscosity of between about 0.8 and about 1.5.

8. The dilatation balloon according to claim 5, wherein said balloon is an angioplasty balloon.

9. A dilatation balloon, comprising:

a length of Nylon 12 tubing that had been radially expanded to a predetermined balloon diameter; and

said dilatation balloon has a collapsed profile which has a diameter less than said predetermined balloon diameter, said dilatation balloon further having a non-distended, inflated working diameter at which the dilatation balloon is inflated to its said predetermined balloon diameter, said dilatation balloon also exhibits a maximum stretched inflation diameter to which the dilatation balloon is expandable without bursting under needed dilatation conditions, and said maximum stretched inflation diameter exceeds said predetermined balloon diameter.

10. The dilatation balloon according to claim 9, wherein said maximum stretched inflation diameter of the balloon exceeds said predetermined balloon diameter by at least about 10 percentage points.

11. The dilatation balloon according to claim 9, wherein said balloon has an intrinsic viscosity of between about 0.8 and about 1.5.

12. The dilatation balloon according to claim 9, wherein said balloon is an angioplasty balloon.

13. A dilatation balloon, comprising a length of Nylon 12 tubing that had been radially expanded to a predetermined balloon diameter.

14. The dilatation balloon according to claim 13, wherein said balloon is an angioplasty balloon.

15. A dilatation catheter, comprising:

a catheter body;

a dilatation balloon member positioned along the length of said catheter body;

said balloon member being constructed of a tubing of polymeric material comprising Nylon 12, which tubing had been radially expanded to provide a predetermined balloon diameter;

said balloon member has a collapsed profile at which the outer diameter of the balloon member approximates the outer diameter of said catheter body, said balloon member further having a non-distended working diameter to which the balloon is inflated to its said predetermined balloon diameter without significant stretching thereof, and said balloon member also exhibits an expanded maximum inflated diameter to which the balloon member is stretched without bursting during dilatation, said maximum inflated diameter being in excess of said predetermined balloon diameter by between above 5 percent and about 30 percent; and

said dilatation balloon member has a calculated tensile strength of between about 15,000 psi and about 30,000 psi.

16. The dilatation catheter according to claim 15, wherein said maximum stretched inflation diameter of the balloon exceeds said predetermined balloon diameter by at least about 10 percentage points.

17. The dilatation catheter according to claim 15, wherein said balloon member material has an intrinsic viscosity of between about 0.8 and about 1.5.

18. The dilatation catheter according to claim 15, wherein said balloon is an angioplasty balloon.

19. A dilatation catheter, comprising:

a catheter body;

a dilatation balloon member positioned along the length of said catheter body;

said balloon member being constructed of a tubing of polymeric material comprising Nylon 12, which tubing had been radially expanded to provide a predetermined balloon diameter; and

said balloon member has a collapsed profile at which the outer diameter of the balloon member approximates the outer diameter of said catheter body, said balloon member further having a non-distended working diameter to which the balloon is inflated to its said predetermined balloon diameter without significant stretching thereof, and said balloon member also exhibits an expanded maximum inflated diameter to which the balloon member is stretched without bursting during dilatation, said maximum inflated diameter being in excess of said predetermined balloon diameter by between above 5 percent and about 30 percent.

20. The dilatation catheter according to claim 19, wherein said maximum stretched inflation diameter of the balloon exceeds said predetermined balloon diameter by at least about 10 percentage points.

21. The dilatation catheter according to claim 19, wherein said balloon member material has an intrinsic viscosity of between about 0.8 and about 1.5.

22. The dilatation catheter according to claim 19, wherein said balloon is an angioplasty balloon.

23. A dilatation catheter, comprising:

catheter body;

a dilatation balloon member positioned along the length of said catheter body;

said balloon member being constructed of a Nylon 12 tubing that had been radially expanded to provide a predetermined balloon diameter; and

said balloon member has a collapsed profile at which the outer diameter of the balloon member approximates the outer diameter of said catheter body, said balloon member further having a non-distended working diameter to which the balloon is inflated to its said predetermined balloon diameter without significant stretching thereof, and said balloon member also exhibits an expanded maximum inflated diameter to which the balloon member is stretched without bursting during dilatation, said maximum inflated diameter being in excess of said predetermined balloon diameter.

24. The dilatation catheter according to claim 23, wherein said maximum stretched inflation diameter of the balloon exceeds said predetermined balloon diameter by at least about 10 percentage points.

25. The dilatation catheter according to claim 23, wherein said balloon member material has an intrinsic viscosity of between about 0.8 and about 1.5.

26. The dilatation catheter according to claim 23, wherein said balloon is an angioplasty balloon.

27. A dilatation catheter, comprising a catheter body;

and a dilatation balloon member positioned along the length of said catheter body, said balloon member being constructed of Nylon 12 tubing that had been radially expanded to provide a predetermined balloon diameter.

28. The dilatation catheter according to claim 27, wherein said balloon is an angioplasty balloon.