Multilayer catheter balloon

• US 6,132,824 A
• Filed: 08/06/1997
• Issued: 10/17/2000
• Est. Priority Date: 09/25/1989
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Schneider Electric SE
• Inventors: Hamlin, Robert N.
• Primary Examiner(s): DYE, RENA
• Application Number:
  US08/907,170
• Time in Patent Office: 1,168 Days
• Field of Search: 428/35.2, 428/36.9, 428/36.91, 606/192, 604/96
• US Class Current: 428/35.2
• CPC Class Codes: A61L 29/041 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/126 having a macromolecular matrix
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• 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 25/1034 Joining of shaft and balloon
• CPC Class Codes: B29C 49/04 Extrusion blow-moulding
• CPC Class Codes: B29C 49/22 using multilayered preforms or parisons
• CPC Class Codes: B29K 2023/06 PE, i.e. polyethylene
• CPC Class Codes: B29K 2023/083 EVA, i.e. ethylene vinyl acetate copolymer
• CPC Class Codes: B29K 2067/00 Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2031/7542 Catheters
• CPC Class Codes: C08L 23/00 Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 67/02 Polyesters derived from dicarboxylic acids and dihydroxy compounds C08L67/06 takes precedence
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: Y10T 428/1334 Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
• CPC Class Codes: Y10T 428/139 Open-ended, self-supporting conduit, cylinder, or tube-type article
• CPC Class Codes: Y10T 428/1393 : Multilayer [continuous layer]
• CPC Class Codes: Y10T 428/1397 : Single layer [continuous layer]

Abstract

A method of producing laminated inflatable, substantially inextensible expander members having composite properties enhancing their use on intravascular catheters, such as angioplasty catheters is described. Diverse polymeric compounds of differing properties are coextruded to create a multilayer parison. The parison is subsequently drawn and expanded in a blow molding operation to yield an expander member exhibiting enhanced properties including lubricity, burst-strength, limited radial expansion, bondability, and rupture characteristics.

Claims

1. An expandable catheter balloon comprising:

(a) a first layer comprising a first biaxially oriented polymer; and

(b) a second layer adhered to the first layer and comprising a second biaxially oriented polymer other than the first biaxially oriented polymer;

the balloon being sized and configured for coronary transluminal application and having a burst pressure in excess of 7 atmospheres.

2. The balloon of claim 1 wherein the second layer consists essentially of biaxially oriented polyolefin.

3. The balloon of claim 2 wherein the second layer consists essentially of biaxially oriented polyethylene.

4. The balloon of claim 1 wherein the first layer is an outermost layer of the balloon.

5. The balloon of claim 1 wherein the second layer is an innermost layer of the balloon.

6. The balloon of claim 1 further comprising a lubricious coating on an outermost layer of the balloon.

7. The balloon of claim 1 wherein the first biaxially oriented polymer is more crystalline than the second biaxially oriented polymer.

8. The balloon of claim 7 wherein the second layer consists essentially of biaxially oriented polyester.

9. The balloon of claim 1 further comprising a third polymeric layer adhered to one of the first or second layers.

10. An expandable catheter balloon comprising:

(a) a first layer comprising biaxially oriented polyester; and

(b) a second layer adhered to the first layer and comprising biaxially oriented polymer other than the biaxially oriented polyester of the first layer;

the balloon being sized and configured for coronary transluminal application and having a burst pressure in excess of 7 atmospheres.

11. The balloon of claim 10 wherein the first layer consists essentially of biaxially oriented polyethylene terephthalate co-polyester or homopolyester.

12. The balloon of claim 11 wherein the first layer consists essentially of biaxially oriented polyethylene terephthalate homopolyester.

13. The balloon of claim 11 wherein the first layer consists essentially of biaxially oriented polyethylene terephthalate co-polyester.

14. The balloon of claim 10 wherein the second layer consists essentially of biaxially oriented polyolefin.

15. The balloon of claim 14 wherein the second layer consists essentially of biaxially oriented polyethylene.

16. The balloon of claim 10 wherein the first layer is an outermost layer of the balloon.

17. The balloon of claim 10 wherein the second layer is an innermost layer of the balloon.

18. The balloon of claim 10 further comprising a lubricious coating on an outermost layer of the balloon.

19. The balloon of claim 10 wherein the biaxially oriented polyester of the first layer is more crystalline than the biaxially oriented polymer of the second layer.

20. The balloon of claim 19 wherein the second layer consists essentially of biaxially oriented polyester other than the biaxially oriented polyester of the first layer.

21. The balloon of claim 10 further comprising a third polymeric layer adhered to one of the first or second layers.

22. An expandable angioplasty catheter balloon comprising:

(a) a first layer consisting essentially of biaxially oriented polyester; and

(b) a second layer adhered to the first layer and consisting essentially of biaxially oriented polyolefin;

the balloon being sized and configured for coronary transluminal angioplasty and having a burst pressure in excess of 7 atmospheres.

23. The balloon of claim 22 wherein the second layer consists essentially of biaxially oriented polyethylene.

24. The balloon of claim 22 wherein the first layer consists essentially of biaxially oriented polyethylene terephthalate.

25. The balloon of claim 24 wherein the second layer consists essentially of biaxially oriented polyethylene.