High pressure catheter balloon

• US 6,336,936 B2
• Filed: 06/13/2001
• Issued: 01/08/2002
• Est. Priority Date: 12/21/1999
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Ghanta, Venu, Simhambhatla, Murthy V., Tomas, Timoteo
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): HO, UYEN T
• Application Number:
  US09/880,983
• Publication Number:
  US 20010027329A1
• Time in Patent Office: 209 Days
• Field of Search: 623/1-1-, 623/1, 606/194, 606/192, 604/96.1, 604/103.06, 604/103.13, 604/103.11, 604/103.12
• US Class Current: 623/1.11
• 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 25/1029 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: B29C 2049/7831 characterised by pressure values or ranges
• CPC Class Codes: B29C 2049/7862 characterised by temperature values or ranges
• CPC Class Codes: B29C 2949/08 Preforms made of several individual parts, e.g. by welding or gluing parts together
• CPC Class Codes: B29C 49/18 using several blowing steps B29C49/16 takes precedence
• CPC Class Codes: B29C 49/6472 in several stages
• CPC Class Codes: B29K 2105/258 Tubular
• CPC Class Codes: B29L 2022/022 Balloons
• CPC Class Codes: B29L 2031/7542 Catheters
• CPC Class Codes: C08L 67/02 Polyesters derived from dicarboxylic acids and dihydroxy compounds C08L67/06 takes precedence

Abstract

A balloon formed of a single layer of polybutylene terephthalate and polytetramethylene ether glycol terephthalate copolymer in a substantially unblended form. The copolymer has a flexural modulus of greater than about 150,000 psi. The presently preferred copolymer is Hytrel® 8238 by DuPont. The balloon of the invention would be substantially unblended, defined as greater than about 60% by weight to about 100% by weight of the copolymer. The balloon is formed in a series of molds. The balloon of the invention exhibits high rupture pressure and low compliance coupled with good lesion cross and recross ability.

Claims

1. An inflatable single layered balloon for a medical device, formed of 100% polybutylene terephthalate/polytetramethylene ether glycol terephthalate copolymer, the copolymer having a flexural modulus of greater than about 150,000 psi.

2. The single layered balloon as in claim 1 wherein the copolymer is a randomized block copolymer.

3. The single layered balloon as in claim 1 wherein the copolymer has a hardness, shore D scale, of greater than about 72.

4. The single layered balloon as in claim 1 wherein the copolymer has a hardness, shore D scale, of about 72 to about 82.

5. The single layered balloon as in claim 1 wherein the copolymer has a hardness, shore D scale, of about 82.

6. The single layered balloon as in claim 1 wherein the copolymer has a flexural modulus of about 150,000 psi to about 300,000 psi.

7. The single layered balloon as in claim 1 wherein the copolymer has a flexural modulus of about 175,000 psi.

8. The single layered balloon as in claim 1 wherein the balloon has a compliance of less than about 0.045 millimeters per atmosphere within an inflation pressure range of 135 psi to 270 psi.

9. The single layered balloon as in claim 1 wherein the balloon has a compliance of less than about 0.02 millimeters per atmosphere within an inflation pressure range of 135 psi to 270 psi.

10. The balloon as in claim 1 wherein the balloon has a wall strength of at least about 10,000 psi to about 30,000 psi.

11. The balloon as in claim 1 wherein the balloon has a wall strength of at least about 25,000 psi to about 30,000 psi.

12. The balloon as in claim 1 wherein the balloon has a double wall thickness of no greater than about 0.0025 inches.

13. The balloon as in claim 1 wherein the balloon has a double wall thickness of no greater than about 0.0009 inches.

14. The balloon as in claim 1 wherein the balloon has an average rupture pressure of at least about 270 psi.

15. The balloon as in claim 1 wherein the balloon has an average rupture pressure of at least about 345 psi.

16. An intraluminal balloon catheter, comprising:

a) an elongated shaft having a proximal end, a distal end, an inflation lumen extending within at least a portion of a distal shaft section to a location spaced proximally from the distal end; and

b) a single layered balloon for a medical device, formed of 100% polybutylene terephthalate/polytetramethylene ether glycol terephthalate copolymer, the copolymer having a flexural modulus of greater than about 150,000 psi.

17. The intraluminal catheter of claim 16 further including a stent mounted on the balloon.

18. A method for implanting a stent within a patient, comprising

a) advancing within the patient'"'"'s vasculature a catheter having a balloon on a distal shaft section, the balloon being formed of 100% polybutylene terephthalate/polytetramethylene ether glycol terephthalate copolymer having a flexural modulus of about 150,000 psi to about 300,000 psi;

b) positioning the catheter so that at least a length of the balloon is across a non-dilated region within the patient'"'"'s vasculature; and

c) expanding the balloon to simultaneously dilate the undilated lesion and implant the stent.