Medical balloon

• US 6,946,092 B1
• Filed: 10/02/2002
• Issued: 09/20/2005
• Est. Priority Date: 09/10/2001
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Bertolino, William, Campbell, Andrew J., Barry, Ralph Jr., Andonian, Shahen, Chay, Nil, Carrion, Geraldo
• Primary Examiner(s): McDowell, Suzanne E.
• Application Number:
  US10/263,225
• Time in Patent Office: 1,084 Days
• Field of Search: 264/512, 264/515, 264/532, 264/535, 264/540, 264/570, 264/573
• US Class Current: 264/512
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• 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 25/104 used for angioplasty
• CPC Class Codes: B29C 2049/4825 for cooling moulds or mould parts B29C2049/5889 takes precedence
• CPC Class Codes: B29C 2049/7831 characterised by pressure values or ranges
• CPC Class Codes: B29C 2049/7879 Stretching, e.g. stretch rod
• CPC Class Codes: B29C 48/09 Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
• CPC Class Codes: B29C 48/10 flexible, e.g. blown foils
• CPC Class Codes: B29C 48/18 the components being layers
• CPC Class Codes: B29C 49/087 Means for providing controlled or limited stretch ratio
• CPC Class Codes: B29C 49/14 Clamps
• CPC Class Codes: B29C 49/22 using multilayered preforms or parisons
• CPC Class Codes: B29C 49/42362 Electric drive means, e.g. servomotors
• CPC Class Codes: B29C 49/4823 with incorporated heating or cooling means
• CPC Class Codes: B29C 55/22 of tubes B29C61/08 takes precedence
• CPC Class Codes: B29K 2021/00 Use of unspecified rubbers as moulding material
• CPC Class Codes: B29K 2067/00 Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2077/00 Use of PA, i.e. polyamides, e.g. polyesteramides or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2079/08 PI, i.e. polyimides or derivatives thereof
• CPC Class Codes: B29L 2009/00 Layered products
• CPC Class Codes: B29L 2022/022 : Balloons
• CPC Class Codes: B29L 2031/7542 : Catheters
• CPC Class Codes: Y10T 428/1359 : Three or more layers [continuous layer]

Abstract

Low polymer stress balloons are made by expanding a tube radially while allowing the ends of the tube to move axially in response to the radial expansion.

Claims

1. A method of making a medical balloon, comprising:

providing a polymer tube suitable for being formed into the medical balloon, the tube having two ends;

drawing the tube axially; and

expanding the tube radially while allowing the ends of the tube to move axially in response to said radial expansion.

2. The method of claim 1, wherein the tube is below a glass transition temperature of a material of the tube during drawing.

3. The method of claim 2, wherein the tube is below about 100°

C. during drawing.

4. The method of claim 1, wherein the tube is internally pressurized during drawing.

5. The method of claim 1, wherein expanding the tube comprises heating the tube.

6. The method of claim 5, wherein the tube is heated to a temperature about equal to or greater than a glass transition temperature of a material of the tube.

7. The method of claim 1, wherein the tube is expanded to an expanded diameter about 5 to 9 times larger than an unexpanded diameter of the tube.

8. The method of claim 1, wherein expanding the tube comprises simultaneously heating and pressurizing the tube.

9. The method of claim 1, wherein expanding the tube comprises:

positioning the tube into a mold; and

simultaneously heating and pressurizing the tube.

10. The method of claim 1, wherein expanding the tube comprises contacting the tube with a liquid.

11. The method of claim 10, wherein the liquid comprises water.

12. The method of claim 1, wherein the ends of the tube are allowed to move axially a distance between about 5 and about 30 percent of an original length of the tube.

13. The method of claim 1, wherein the tube is formed of a polymer having regions of different hardnesses.

14. The method of claim 1, wherein the tube comprises a block copolymer including hard segments and soft segments.

15. The method of claim 14, wherein the block copolymer comprises a material selected from a group consisting of a polyether-ester elastomer, a polyester elastomer, and a polyether block amide.

16. The method of claim 14, wherein the block copolymer comprises a polyether-ester elastomer.

17. The method of claim 1, wherein the tube comprises a material selected from a group consisting of a polyester and a polyamide.

18. The method of claim 1, wherein the tube is a multilayer tube.

19. The method of claim 1, wherein the tube is a coextruded tube having layers of different hardnesses.

20. The method of claim 1, further comprising characterizing the balloon by birefringence.

21. The method of claim 1, further comprising attaching the balloon to a catheter to form a balloon catheter device.

22. The method of claim 1, further comprising sterilizing the balloon by heating between about 32°

C. and about 60°

C.

23. The method of claim 1, wherein expanding the tube radially comprises allowing the ends of the tube to move inwardly in response to said radial expansion.

35. The method of claim 1, further comprising positioning a stent on the balloon.

24. A method of making a medical balloon, comprising:

providing a polymer tube suitable for being formed into the medical balloon, the tube having two ends; and

expanding the tube radially while allowing the ends of the tube to move axially in response to said radial expansion.

25. The method of claim 24, further comprising axially orienting a material of the tube.

26. The method of claim 25, wherein axially orienting the material comprises axially drawing the tube.

27. The method of claim 26, wherein axially orienting the material further comprises internally pressurizing the tube.

28. The method of claim 24, wherein expanding the tube comprises contacting the tube with a liquid.

29. The method of claim 28, wherein the liquid comprises water.

30. The method of claim 24, wherein expanding the tube comprises:

heating the tube to a temperature about equal to or greater than a glass transition temperature of a material of the tube; and

introducing a gas into the tube.

31. The method of claim 24, wherein expanding the tube further comprises placing the tube into a mold.

32. The method of claim 24, wherein the tube comprises a block copolymer.

33. The method of claim 24, further comprising characterizing the balloon by birefringence.

34. The method of claim 24, further comprising attaching the balloon to a catheter to form a balloon catheter device.

36. The method of claim 24, further comprising positioning a stent on the balloon.