Balloon catheter

• US 20010001113A1
• Filed: 12/08/2000
• Published: 05/10/2001
• Est. Priority Date: 04/21/1998
• Status: Abandoned Application

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Lim, Florencia, Long, Chi Le, Bei, NianJiong
• Application Number:
  US09/733,120
• Publication Number:
  US 20010001113A1
• Time in Patent Office: Days
• US Class Current: 604/96.01
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61L 29/049 Mixtures of macromolecular compounds
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• 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: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: B29C 48/00 Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor extrusion blow-moulding B29C49/04
• 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 48/21 the layers being joined at their surfaces
• CPC Class Codes: B29C 55/24 radial
• CPC Class Codes: B29K 2075/00 Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2022/022 Balloons
• CPC Class Codes: B29L 2031/7542 Catheters

Abstract

An intravascular catheter system for properly implanting a stent in a body lumen generally comprising a catheter having an elongated shaft with an inflatable balloon formed of compliant material and a stent mounted on the working length of the balloon. The balloon material is compliant within the working range of the balloon to provide substantial radial expansion. The wingless radially expansive balloon expands in a uniform manner, thereby producing uniform expansion and implantation of the stent. Another embodiment is directed to a balloon catheter, having a semi-compliant balloon or a noncompliant balloon formed at least in part of a block copolymer.

Claims

1. A balloon catheter, comprising

a) an elongated shaft having a proximal end, a distal end, and at least one lumen therein;

and

b) a radially noncompliant balloon formed at least in part of a polycarbonate polyurethane block copolymer having a compliance of less than about 0.025 mm/atm in the working pressure range of the balloon, the polycarbonate polyurethane block copolymer comprising the product of the reaction of poly(1,6-hexyl 1,2-ethylcarbonate) diol and 4,4′

-methylene bisphyenyl diisocyanate (MDI) and a chain extender.

2. The balloon catheter of

claim 1

wherein the balloon compliance is about 0.012 to about 0.016 mm/atm in an inflation pressure range of about 7 to about 22 atm.

3. The balloon catheter of

claim 1

wherein the polycarbonate polyurethane block copolymer has a tensile elongation at break of at least 250%.

4. The balloon catheter of

claim 1

wherein the polycarbonate polyurethane block copolymer has a tensile elongation at break of about 255% to about 320%.

5. The balloon catheter of

claim 1

wherein the balloon is axially noncompliant.

6. The balloon catheter of

claim 1

wherein the chain extender comprises 1,4-butanediol.

7. The balloon catheter of

claim 1

wherein the polyurethane block copolymer has a flexural modulus of at least about 300,000 psi.

8. The balloon catheter of

claim 1

wherein the balloon comprises an expanded extruded polymeric tube comprising the polyurethane block copolymer.

9. The balloon catheter of

claim 1

wherein the balloon rupture pressure is greater than about 18 atm.

10. A method of making a radially and axially noncompliant balloon for a catheter, comprising

a) extruding a tubular product formed at least in part of a block copolymer, having a first outer diameter and a first inner diameter;

b) annealing the tubular product at not less than about 50°

C.

c) heating the tubular product at a first elevated temperature, and radially expanding the tubular product to a second outer diameter;

d) heating the expanded tubular product at a second elevated temperature not less than the first elevated temperature; and

e) cooling the expanded tubular product to form the noncompliant balloon.

11. The method of

claim 10

wherein the extruded tubular product is annealed for about 16 to about 24 hours.

12. The method of

claim 10

wherein the extruded tubular product is annealed at about 55°

C.

13. The method of

claim 12

wherein the extruded tubular product is annealed for about 16 hours.