Multilayer balloon for a catheter

Patent metadata

Field	Value
Publication number	US-9821147-B2
Application number	US-201514820664-A
Country	US
Kind code	B2
Filing date	Aug 7, 2015
Priority date	Nov 19, 2012
Publication date	Nov 21, 2017
Grant date	Nov 21, 2017

Abstract

Balloon catheter comprises an elongate catheter shaft having a proximal section, a distal section, and an inflation lumen defined therein and a multilayer balloon on the distal section of the shaft comprising a first layer made of a first polymer material having a first Shore durometer hardness, a second layer made of a second polymer material having a second Shore durometer hardness greater than the first Shore durometer hardness, wherein the second layer is an inner layer relative to the first layer, and a third layer made of a third polymer material having a third Shore durometer hardness less the first Shore durometer hardness, wherein the third layer is an inner layer relative to the second layer. Method of making a balloon catheter is also provided.

First claim

The invention claimed is:

1. A balloon catheter, comprising:
an elongate catheter shaft having a proximal section, a distal section, and an inflation lumen defined therein; and
a multilayer balloon on the distal section of the shaft comprising: a first layer made of a first polymer material having a first Shore durometer hardness;
a second layer made of a second polymer material having a second Shore durometer hardness greater than the first Shore durometer hardness, wherein the second layer is an inner layer relative to the first layer; and
a third layer made of a third polymer material having a third Shore durometer hardness less than the second Shore durometer hardness and greater than the first shore hardness, wherein the third layer is an inner layer relative to the second layer.

2. The balloon catheter of claim 1 , wherein the multilayer balloon, as blown, has a nominal working diameter.

3. The balloon catheter of claim 2 , wherein the balloon has a noncompliant limited radial expansion beyond the nominal working diameter at pressures above a nominal pressure.

4. The balloon catheter of claim 1 , wherein the multilayer balloon, as blown, has a compliance less than about 0.035 mm/atm between a nominal pressure and a rated burst pressure.

5. The balloon catheter of claim 2 , wherein the balloon has a semicomplaint radial expansion beyond the nominal working diameter at pressures above a nominal pressure.

6. The balloon catheter of claim 1 , wherein the multilayer balloon, as blown, has a balloon wall thickness less than 0.003 inch.

7. The balloon catheter of claim 1 , wherein the multilayer balloon, as blown, has a balloon wall thickness less than 0.002 inch.

8. The balloon catheter of claim 1 , wherein the multilayer balloon, as blown, has a balloon wall thickness less than 0.001 inch.

9. The balloon catheter of claim 1 , wherein the multilayer balloon, as blown, has a rated burst pressure is about 15 to about 30 atm.

10. The balloon catheter of claim 2 , wherein at least the third layer is substantially at a third layer maximum blow-up-ratio when the multilayer balloon is substantially at the nominal working diameter.

11. The balloon catheter of claim 2 , wherein at least the third layer is at a blow up ratio of at least about 90% of a third layer maximum blow-up-ratio when the multilayer balloon is substantially at the nominal working diameter.

12. The balloon catheter of claim 2 , wherein at least the third layer is at a blow up ratio of at least about 80% of a third layer maximum blow-up-ratio when the multilayer balloon is substantially at the nominal working diameter.

13. The balloon catheter of claim 1 , wherein the third layer has a blow-up-ratio between about 7.0 and about 8.0.

14. The balloon catheter of claim 1 , wherein the third layer has a blow-up-ratio between about 7.2 and about 7.8.

15. The balloon catheter of claim 2 , wherein the second layer is at a blow up ratio of at least 80% of a second layer maximum blow-up-ratio when the multilayer balloon is substantially at the nominal working diameter.

16. The balloon catheter of claim 2 , wherein the second layer is at a blow up ratio of at least 70% of a second layer maximum blow-up-ratio when the multilayer balloon is substantially at the nominal working diameter.

17. The balloon catheter of claim 2 , wherein the first layer is at a blow up ratio at least 60% of a first layer maximum blow-up-ratio when the multilayer balloon is substantially at the nominal working diameter.

18. The balloon catheter of claim 1 , further comprising an expandable stent mounted on an outer surface of the multilayer balloon.

19. The balloon catheter of claim 1 , wherein the first Shore durometer hardness is about 70D.

20. The balloon catheter of claim 1 , wherein the second Shore durometer hardness is about 72D or greater.

21. The balloon catheter of claim 1 , wherein the third Shore durometer hardness is less than about 70D.

22. The balloon catheter of claim 2 , wherein the first Shore durometer hardness is about 70D, the second Shore durometer hardness is about 72D, and the third Shore durometer hardness is about 63D.

23. The balloon catheter of claim 22 , wherein the first polymer material is a polyether block amide, the second polymer material is a polyether block amide, and the third polymer material is a polyether block amide.

24. The balloon catheter of claim 23 , wherein the balloon has a semicomplaint radial expansion beyond the nominal working diameter at pressures above a nominal pressure.

25. The balloon catheter of claim 2 , wherein the first Shore durometer hardness is about 70D, the second Shore durometer hardness is about 74D or greater, and the third Shore durometer hardness is about 63D.

26. The balloon catheter of claim 25 , wherein the first polymer material is a polyether block amide, the second polymer material is a nylon, and the third polymer material is a polyether block amide.

27. The balloon catheter of claim 26 , wherein the balloon has a noncompliant limited radial expansion beyond the nominal working diameter at pressures above a nominal pressure.

28. The balloon catheter of claim 1 , wherein the first Shore durometer hardness is between about 70D and about 72D, the second Shore durometer hardness is about 74D or greater, and the third Shore durometer hardness is between about 63D and about 70D.

29. The balloon catheter of claim 1 , wherein the third layer defines an inner surface of the balloon.

30. The balloon catheter of claim 29 , wherein the first layer defines an outer surface of the balloon.

31. The balloon catheter of claim 1 , wherein the first layer, the second layer, and the third layer are coextruded.

32. A method of making a balloon catheter comprising: providing a tube having at least a first layer, a second layer, and a third layer, wherein the first layer is made of a first polymer material having a first Shore durometer hardness; the second layer is made of a second polymer material having a second Shore durometer hardness greater than the first Shore durometer hardness, wherein the second layer is an inner layer relative to the first layer; and the third layer is made of a third polymer material having a third Shore durometer hardness less than the second Shore-durometer hardness and greater than the first Shore hardness, wherein the third layer is an inner layer relative to the second layer; radially expanding the tube in a mold to form a balloon having a nominal working diameter; providing an elongate catheter shaft having a proximal section, a distal section, and an inflation lumen defined therein; and disposing the balloon on the distal section of the shaft.

33. The method of claim 32 , wherein the tube is formed by coextruding the first layer, the second layer, and the third layer.

34. The method of claim 32 , wherein the tube is radially expanded in the mold via a single blow process.

35. The method of claim 32 , wherein the tube is radially expanded in the mold via a double blow process.

Assignees

• Abbott Cardiovascular Systems Inc

Inventors

• Lin Tung-Liang
• Lee Jeong S
• White Roseminda

Classifications

• A61M25/104

  used for angioplasty · CPC title

• A61L29/126

  having a macromolecular matrix · CPC title

• B29L2031/7543

  Balloon catheters · CPC title

• B29K2077/00

  Use of {PA, i.e.} polyamides, e.g. polyesteramides {or derivatives thereof}, as moulding material · CPC title

• A61M25/10 Primary

  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 title