Dilatation balloon fabricated from low molecular weight polymers

• US 5,264,260 A
• Filed: 06/20/1991
• Issued: 11/23/1993
• Est. Priority Date: 06/20/1991
• Status: Expired due to Term

• Current Assignee: Vention Medical Advanced Components, Inc. (Nordson Corporation)
• Original Assignee: Mark A. Saab
• Inventors: Saab, Mark A.
• Primary Examiner(s): Robinson, Ellis P.
• Assistant Examiner(s): DYE, RENA
• Application Number:
  US07/717,933
• Time in Patent Office: 887 Days
• Field of Search: 604/96, 604/281, 604/280, 606/192, 606/194, 428/36.92, 428/34.3, 428/35.2, 428/480, 428/910, 428/35.5, 264/528, 264/529, 264/532
• US Class Current: 428/35.5
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/14 Materials characterised by their function or physical properties , e.g. lubricating compositions
• 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 25/1027 Making of balloon catheters
• CPC Class Codes: C08L 67/02 Polyesters derived from dicarboxylic acids and dihydroxy compounds C08L67/06 takes precedence
• CPC Class Codes: Y10S 428/91 Product with molecular orientation
• CPC Class Codes: Y10T 428/1334 Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
• CPC Class Codes: Y10T 428/1345 Single layer [continuous layer]
• CPC Class Codes: Y10T 428/1397 Single layer [continuous layer]
• CPC Class Codes: Y10T 428/31786 Of polyester [e.g., alkyd, etc.]

Abstract

A low molecular weight, flexible, biaxially oriented, dilatation catheter balloon comprising oriented polyethylene terephthalate, and having a calculated radial tensile strength of greater than about 25,000 psi.

Claims

1. A thin-walled, flexible, dilation catheter balloon having an intrinsic viscosity less than or equal to 0.6 dl/gram and a calculated radial tensile strength greater than about 25,000 psi, and consisting essentially of oriented polyethylene terephthalate.

2. A balloon as set forth in claim 1, wherein said polyethylene terephthalate is a copolymer.

3. A balloon as set forth in claim 1, wherein said polyethylene terephthalate is biaxially oriented.

4. A flexible, oriented, dilation catheter balloon having an intrinsic viscosity of not more than about 0.6 dl/gram and a calculated radial tensile strength greater than about 25,000 psi, and consisting essentially of oriented polyethylene terephthalate.

5. A balloon as set forth in claim 4, wherein said polyethylene terephthalate is a copolymer.

6. A balloon as set forth in claim 4, wherein said polyethylene terephthalate is biaxially oriented.

7. A balloon as set forth in claim 4, wherein the calculated radial tensile strength is greater than about 35,000 psi.

8. A flexible, oriented, dilatation catheter balloon having an intrinsic viscosity of less than about 0.6 dl/gram and a calculated radial tensile strength greater than about 25,000 psi, and consisting essentially of oriented polyethylene terephthalate.

9. A balloon as set forth in claim 8, wherein said polyethylene terephthalate is a copolymer.

10. A balloon as set forth in claim 8, wherein said polyethylene terephthalate is biaxially oriented.

11. A balloon as set forth in claim 8, wherein the calculated radial tensile strength is greater than about 35,000 psi.

12. Medical apparatus for use as or in combination with a balloon dilatation catheter, said apparatus comprising a very thin-walled, flexible, high strength balloon having an intrinsic viscosity equal to or less than about 0.6 dl/gram and a calculated radial tensile strength greater than or equal to 25,000 psi, and consisting essentially oriented polyethylene terephthalate.

13. Medical apparatus according to claim 12 wherein said polyethylene terephthalate is biaxially oriented.

14. Medical apparatus according to claim 12 wherein said balloon has a wall thickness equal to or less than about 0.0003 inches.

15. Medical apparatus according to claim 12 further wherein said balloon has a radial tensile strength equal to or greater than about 35,000 psi.

16. Medical apparatus according to claim 12 wherein said polyethylene terephthalate is a copolymer.

17. Medical apparatus for use as or in combination with a balloon dilatation catheter made by the method of axially drawing and radially expanding a tubular section of low molecular weight polyethylene terephthalate so as to expand and orient the polymer in two directions to form a balloon having an intrinsic viscosity equal to or less than about 0.6 dl/gram and a calculated radial tensile strength greater than or equal to 25,000 psi.

18. Medical apparatus according to claim 17 wherein said tubular section consists essentially of polyethylene terephthalate having an intrinsic viscosity of about 0.6 dl/gram or below.

19. Medical apparatus according to claim 17 wherein said tubular section is stretched axially and, before, during or after the axial stretching, is expanded radially by introduction of a pressurized fluid internally into said tubular section.

20. Medical apparatus according to claim 17 wherein said balloon has a wall thickness equal to or less than about 0.0003 inches.

21. Medical apparatus according to claim 17 wherein said balloon has a radial tensile strength equal to or greater than about 35,000 psi.

22. Medical apparatus according to claim 17 wherein said polyethylene terephthalate is a copolymer.