Polyisobutylene urethane, urea and urethane/urea copolymers and medical leads containing the same

• US 8,676,344 B2
• Filed: 01/18/2013
• Issued: 03/18/2014
• Est. Priority Date: 09/02/2009
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Desai, Shrojalkmar, Boden, Mark W., DeRoche, Stephen E., Foster, Arthur J., Reddy, G. Shantanu
• Primary Examiner(s): Seidleck, James J
• Assistant Examiner(s): Salamon, Peter A
• Application Number:
  US13/744,832
• Publication Number:
  US 20130131767A1
• Time in Patent Office: 424 Days
• Field of Search: 607/116, 428/500, 428/523
• US Class Current: 607/116
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: C08G 18/4854 Polyethers containing oxyalkylene groups having four carbon atoms in the alkylene group
• CPC Class Codes: C08G 18/698 Mixtures with compounds of group C08G18/40
• CPC Class Codes: C08L 75/02 Polyureas
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor
• CPC Class Codes: Y10T 428/31855 Of addition polymer from unsaturated monomers
• CPC Class Codes: Y10T 428/31938 Polymer of monoethylenically unsaturated hydrocarbon

Abstract

The present invention provides medical devices that contain polyisobutylene urethane copolymers, polyisobutylene urea copolymers and polyisobutylene urethane/urea copolymers. More particularly, the present invention provides medical leads that contain such copolymer.

Claims

1. An implantable medical lead comprising:

an elongated polymeric component disposed over at least one electrical conductor, wherein the elongated polymeric component comprises a polyisobutylene-based urethane copolymer having a weight ratio of soft segments to hard segments ranging from 90;

10 to 50;

50, and wherein the elongated polymeric component further comprises;

a main lead portion ranging from about 5 cm to about 125 cm in length and having a Shore hardness ranging from about 75A to about 100A; and

a distal tip portion positioned distal to the main lead portion, the distal tip portion ranging from about 1 cm to about 12 cm in length and having a lower Shore hardness than the main lead body ranging from about 30A to 80A.

2. The implantable medical lead of claim 1, wherein the weight ratio of the soft segments to the hard segments ranges from 80:

20 to 60;

40.

3. The implantable medical lead of claim 1, wherein the soft segments comprise polyisobutylene and the hard segments comprise a diisocyanate residue.

4. The implantable medical lead of claim 3, wherein the soft segments further comprise residue of a polyether diol.

5. The implantable medical lead of claim 3, wherein the soft segments further comprise residue of a polytetramethylene oxide diol.

6. The implantable medical lead of claim 1, wherein the elongated polymeric component comprises an inner lumen and an inner surface of the inner lumen comprises the polyisobutylene-based urethane copolymer.

7. The implantable medical lead of claim 1, wherein the elongated polymeric component comprises a proximal portion that is positioned proximal to the main lead portion, the proximal portion ranging from about 10 to about 15 cm in length and having a Shore hardness ranging from about 80A to about 98A.

8. The implantable medical lead of claim 7, wherein the proximal portion has a Shore hardness ranging from about 80A to about 90A.

9. The implantable medical lead of claim 7, wherein the elongated polymeric component further comprises an additional portion positioned between the proximal portion and the main lead portion, the additional portion ranging from about 7.5 to about 12 cm in length and having a Shore hardness ranging from about 70A to 85A.

10. A method of manufacturing an implantable medical lead comprising:

forming a tubular main lead body portion from a polyisobutylene-based urethane copolymer comprising soft segments and hard segments and having a weight of soft segments to hard segments ranging from 90;

10 to 50;

50, the main lead body portion ranging from about 5 cm to about 125 cm in length and having a Shore hardness ranging from about 75A to about 100A;

forming a distal tip portion positioned distal to the main lead body portion, the distal tip portion ranging from about 1 cm to about 12 cm in length and having a lower Shore hardness that the main lead body portion ranging from about 30A to about 80A;

associating at least the tubular main lead body portion with a conductor and an electrode connected to the conductor.

11. The method claim 10, wherein the weight ratio of the soft segment to the hard segment ranges from 80:

20 to 60;

40.

12. The method of claim 10, wherein the soft segments comprise polyisobutylene and the hard segments comprise a diisocyanate residue.

13. The method of claim 12, wherein the soft segments further comprise residue of a polyether diol.

14. The method of claim 12, wherein the soft segments further comprise residue of a polytetramethylene oxide diol.

15. The method of claim 10, wherein the distal tip is formed from a copolymer comprising a polyisobutylene segment.

16. The method of claim 10, wherein forming the tubular main lead body portion comprises extruding or injection molding the copolymer to form the tubular main lead body portion.

17. The method of claim 10, and further comprising forming a tubular proximal lead body portion from a polyisobutylene-based urethane copolymer, the tubular proximal lead body portion having a Shore hardness ranging from about 80A to about 90A and positioned proximal to the tubular main lead body portion.

18. The method of claim 17, and further comprising forming an additional lead body portion from a polyisobutylene-based urethane copolymer, the additional lead body portion having a Shore hardness ranging from about 70A to 85A and positioned between the proximal lead body portion and the main lead body portion.

19. The method of claim 10, wherein forming the tubular main lead body portion comprises forming a first portion and a second portion that is coaxial with the first portion, wherein at least one of the first and second portions is formed from the polyisobutylene-based urethane copolymer.

20. The method of claim 19, wherein forming at least one of the first and second portions of the main lead body portion comprises extruding the polyisobutylene-based urethane copolymer.