Robust multi-layer balloon

• US 8,613,722 B2
• Filed: 09/22/2011
• Issued: 12/24/2013
• Est. Priority Date: 11/26/2008
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Lee, Jeong S., Vasquez Flores, Fortino
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US13/240,453
• Publication Number:
  US 20120065586A1
• Time in Patent Office: 824 Days
• Field of Search: 604/103.06
• US Class Current: 604/103.06
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• 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: 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 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: B29C 2049/78645 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 49/0005 characterised by the material
• CPC Class Codes: B29C 49/22 using multilayered preforms or parisons
• CPC Class Codes: B29K 2077/00 Use of PA, i.e. polyamides, e.g. polyesteramides or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2031/7542 Catheters
• CPC Class Codes: B32B 1/08 Tubular products
• CPC Class Codes: B32B 2270/00 Resin or rubber layer containing a blend of at least two different polymers
• CPC Class Codes: B32B 2307/412 Transparent
• CPC Class Codes: B32B 2307/514 Oriented
• CPC Class Codes: B32B 2307/581 Resistant to cut
• CPC Class Codes: B32B 2307/702 Amorphous
• CPC Class Codes: B32B 2307/704 : Crystalline
• CPC Class Codes: B32B 2535/00 : Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 27/08 : of synthetic resin
• CPC Class Codes: B32B 27/34 : comprising polyamides
• CPC Class Codes: B32B 7/027 : Thermal properties
• CPC Class Codes: C08L 77/00 : Compositions of polyamides obtained by reactions forming a carboxylic amide link in the main chain of polyhydrazides C08L79/06; of polyamideimides or polyamide acids C08L79/08; Compositions of derivatives of such polymers

Abstract

A multilayer balloon catheter is formed to have an inner layer and an outer layer, where the outer layer is adapted to resist shredding and premature rupture. The outer layer is formed of a material having a glass transition temperature that is lower than the transition or melting temperature of the inner layer. By forming the balloon on a mold at a temperature between the glass transition temperature of the outer layer and the glass transition or melting temperature of the inner layer, the outer layer will undergo a thermal relaxation that will alleviate some of the axial orientation of the polymer chains that develop during the formation of the multilayer balloon. This relaxation leads to a resistance to shredding when the balloon is expanded during operation.

Claims

1. A balloon catheter, comprising:

a shaft having a proximal end, a distal end, and an inflation lumen extending therein; and

a balloon on the shaft which has an interior in fluid communication with the inflation lumen, the balloon having an outer layer and an inner layer, the outer layer comprising a first material having a first transition temperature, and the inner layer comprising a second material having a second transition temperature, the second transition temperature being higher than the first transition temperature;

wherein the balloon is formed by coextruding the first material and the second material into a single piece tubular member and expanding the single piece tubular member in a balloon mold having a surface temperature between the first transition temperature and the second transition temperature.

2. The balloon catheter of claim 1 wherein the first transition temperature is a glass transition temperature.

3. The balloon catheter of claim 1 wherein the second transition temperature is a melting temperature.

4. The balloon catheter of claim 1 wherein the surface temperature of the balloon mold is between 120°

C. and 150°

C.

5. The balloon catheter of claim 1 wherein the surface temperature of the balloon mold thermally relaxes polymer chains in the outer layer from a high axial orientation to an orientation where the axial orientation is reduced.

6. The balloon catheter of claim 1 wherein the inner layer and the outer layer comprise layers of the balloon.

7. The balloon catheter of claim 1 wherein the outer layer is an amorphous polymer.

8. The balloon catheter of claim 1 wherein the inner layer is a semi-crystalline polymer.

9. The balloon catheter of claim 1 wherein the inner layer and the outer layer are both made of a polyamide.

10. The balloon catheter of claim 9 wherein the polyamide is selected from a group comprising polyamide 12, polyamide 11, polyamide 6, and polyamide 6,6 or copolyamides of polyamide 12, polyamide 11, polyamide 6, and polyamide 6,6.

11. The balloon catheter of claim 1 wherein the outer layer is comprised of a copolymer of aliphatic type with aromatic type.

12. The balloon catheter of claim 1 wherein the outer layer is comprised of a copolymer of aliphatic type with cycloaliphatic type.

13. The balloon catheter of claim 1 wherein the inner layer is comprised of a copolymer of polyamide and polytetramethylene oxide.

22. The balloon catheter of claim 1 wherein the balloon is formed with the outer layer having a first degree of axial orientation of polymer strands and the inner layer having a second degree of axial orientation of polymer strands the second degree of axial orientation being greater than the first degree of axial orientation.

14. A method for forming a multi-layer balloon catheter comprising:

providing shaft having a proximal end, a distal end, and an inflation lumen extending therein;

selecting a first material of an outer layer having a first transition temperature;

selecting a second material of an inner layer having a second transition temperature;

coextruding said first material and said second material into a single piece tubular member;

expanding the single piece tubular member in a balloon mold having a surface temperature between the first transition temperature and the second transition temperature to form a balloon with an interior; and

securing the balloon on the shaft with the interior of the balloon in fluid communication with the inflation lumen.

15. The method of claim 14 wherein the surface temperature of the balloon mold is between 120°

C. and 150°

C.

16. The method of claim 14 wherein the surface temperature of the balloon mold reorients polymer chains in the outer layer from a high axial orientation to an orientation where the axial orientation is reduced.

17. The method of claim 14 wherein the first material is an amorphous polymer having glass transition temperature.

18. The method of claim 14 wherein the second material is a semi-crystalline polyamide having melting temperature selected from a group comprising polyamide 12, polyamide 11, polyamide 6, and polyamide 6,6 or copolyamides of polyamide 12, polyamide 11, polyamide 6, and polyamide 6,6.

19. The method of claim 14 wherein the outer layer is comprised of a copolymer of aliphatic type with aromatic type.

20. The method of claim 14 wherein the outer layer is comprised of a copolymer of aliphatic type with cycloaliphatic type.

21. The method of claim 14 wherein the single piece tubular member is expanded in a series of successively larger balloon molds.

23. A balloon catheter, comprising:

a shaft having a proximal end, a distal end, and an inflation lumen extending therein; and

a balloon on the shaft which has an interior in fluid communication with the inflation lumen, the balloon having an outer layer and an inner layer, the outer layer comprising a first material having a first transition temperature, and the inner layer comprising a second material having a second transition temperature, the second transition temperature being higher than the first transition temperature;

wherein the balloon is formed by coextruding the first material and the second material into a single piece tubular member and expanding the single piece tubular member in a balloon mold having a surface temperature between the first transition temperature and the second transition temperature, further wherein the balloon is formed with the outer layer having a first degree of axial orientation of polymer strands and the inner layer having a second degree of axial orientation of polymer strands, the second degree of axial orientation being greater than the first degree of axial orientation.