Medical leads

• US 9,220,888 B2
• Filed: 03/07/2013
• Issued: 12/29/2015
• Est. Priority Date: 04/02/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Chaffin, Kimberly A., Jolly, Matthew, Untereker, Darrel F., Buckalew, Adam J., Chen, Xiangji, Grailer, Thomas P., Alkatout, Julie
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US13/789,602
• Publication Number:
  US 20130261715A1
• Time in Patent Office: 1,027 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• 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 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: C08L 83/04 Polysiloxanes

Abstract

Medical leads, such as medical electrical leads and medical neurological leads, that include a polymeric material that includes a silicone-urethane-containing polymer having improved hydrolytic stability.

Claims

1. A medical lead comprising an elongated lead body comprising a polymeric material, wherein the polymeric material consists of a silicone-urethane polymer having hydrolytic stability greater than that of a Reference Polymer X, a Reference Polymer Y, or both Reference Polymers X and Y;

wherein the silicone-urethane polymer and at least one of Reference Polymer X and Reference Polymer Y are tested under same conditions of controlled pH, temperature, inert gas, and aqueous solution according to Method of Evaluating Hydrolytic Stability to identify the silicone-urethane polymer having hydrolytic stability greater than that of Reference polymer X, Reference Polymer Y, or both Reference Polymers X and Y;

wherein Reference Polymer X is a silicone polyurethane with a soft and hard segment weight ratio of 60/40, respectively, with the soft segment containing 80 wt-% PDMS (molecular weight approximately 1000 Da, n=10-11 repeat units) and 20 wt-% PTMO (poly(tetramethylene oxide), molecular weight approximately 1000 Da) and the hard 15 segment comprised of BDO (1,4-butanediol) and MDI (4,4′

-methylene diphenyl diisocyanate); and

wherein Reference Polymer Y is a silicone polyurethane with a soft and hard segment weight ratio of 60/40, respectively, with the soft segment containing 80 wt-% PDMS (molecular weight approximately 1000 Da, n=10-11 repeat units) and 20 wt-% PHMO (poly(hexamethylene oxide), molecular weight approximately 700 Da) and the hard segment comprised of BDO (1,4′

-butanediol) and MDI (4,4′

-methylene diphenyl diisocyanate).

2. The medical lead of claim 1 in the form of a medical electrical or neurological lead.

3. A medical electrical lead comprising:

an elongated lead body having a first lumen, extending longitudinally along said lead body; and

a conductor located within and extending longitudinally along said lumen;

wherein the lead body consists of a polymeric material, wherein the polymeric material comprises a silicone-urethane polymer having hydrolytic stability greater than that of a Reference Polymer X, a Reference Polymer Y, or both Reference Polymers X and Y;

wherein the silicone-urethane polymer and at least one of Reference Polymer X and Reference Polymer Y are tested under same conditions of controlled pH, temperature, inert gas, and aqueous solution according to Method of Evaluating Hydrolytic Stability to identify the silicone-urethane polymer having hydrolytic stability greater than that of Reference Polymer X, Reference Polymer Y, or both Reference Polymers X and Y;

wherein Reference Polymer X is a silicone polyurethane with a soft and hard segment weight ratio of 60/40, respectively, with the soft segment containing 80 wt-% PDMS (molecular weight approximately 1000 Da, n=10-11 repeat units) and 20 wt-% PTMO (poly(tetramethylene oxide), molecular weight approximately 1000 Da) and the hard 15 segment comprised of BDO (1,4-butanediol) and MDI (4,4′

-methylene diphenyl diisocyanate); and

wherein Reference Polymer Y is a silicone polyurethane with a soft and hard segment weight ratio of 60/40, respectively, with the soft segment containing 80 wt-% PDMS (molecular weight approximately 1000 Da, n=10-11 repeat units) and 20 wt-% PHMO (poly(hexamethylene oxide), molecular weight approximately 700 Da) and the hard segment comprised of BDO (1,4′

-butanediol) and MDI (4,4′

-methylene diphenyl diisocyanate).

4. The lead of claim 3 wherein the polymeric material is polymeric insulation material.

5. The lead of claim 3 wherein the silicone-urethane polymer is derived from one or more polydialkyl-, polydiaryl-, or polyalkylaryl-siloxane monomers other than a polydimethylsiloxane monomer.

6. The lead of claim 3 wherein the silicone-urethane polymer is derived from a mixture of one or more polydimethylsiloxane monomers and at least one other monomer selected from polydialkyl-, polydiaryl-, and polyalkylaryl-siloxane monomers other than a polydimethylsiloxane monomer.

7. The lead of claim 3 wherein the silicone-urethane polymer is derived from a polydimethyl siloxane diol monomer with a number average molecular weight equal to or higher than 1000 Da.

8. The lead of claim 3 wherein the silicone-urethane polymer is derived from a polydimethyl siloxane diol monomer of the formula:

9. The lead of claim 8 wherein n is from 15 to 1500 and m is from 5 to 18.

10. The lead of claim 9 wherein n is from 20 to 1500 and m is 10 to 18.

11. The lead of claim 3 wherein the silicone-urethane polymer is derived from a polydimethyl siloxane diol monomer of the formula:

12. The lead of claim 3 wherein the silicone-urethane polymer is derived from a PDMS diol with hydrophobic end groups/blocks.

13. The lead of claim 12 wherein the PDMS diol with hydrophobic end groups is derived from a hydride-terminated siloxane and an unsaturated alcohol selected from the group of 9-decen-1-ol, 10-undecen-1-ol, oleyl alcohol, and combinations thereof.

14. The lead of claim 3 wherein the silicone-urethane polymer is derived from a hydrophobic co-soft segment and/or chain extender.

15. The lead of claim 3 wherein the silicone-urethane polymer is crosslinked.

16. The lead of claim 3 wherein the conductor is a coiled conductor.

17. A medical, neurological lead for use in electrical signaling and/or drug delivery comprising:

an elongated body with a distal portion, a central portion and a proximal portion;

wherein the body includes delivery means extending to said distal portion; and

wherein the elongated body consists of a polymeric material, wherein the polymeric material comprises a silicone-urethane polymer having hydrolytic stability greater than that of a Reference Polymer X, a Reference Polymer Y, or both Reference Polymers X and Y;

wherein the silicone-urethane polymer and at least one of Reference Polymer X and Reference Polymer Y are tested under same conditions of controlled pH, temperature, inert gas, and aqueous solution according to Method of Evaluating Hydrolytic Stability to identify the silicone-urethane polymer having hydrolytic stability greater than that of Reference Polymer X, Reference Polymer Y, or both Reference Polymers X and Y;

wherein Reference Polymer X is a silicone polyurethane with a soft and hard segment weight ratio of 60/40, respectively, with the soft segment containing 80 wt-% PDMS (molecular weight approximately 1000 Da, n=10-11 repeat units) and 20 wt-% PTMO (poly(tetramethylene oxide), molecular weight approximately 1000 Da) and the hard 15 segment comprised of BDO (1,4-butanediol) and MDI (4,4′

-methylene diphenyl diisocyanate); and

wherein Reference Polymer Y is a silicone polyurethane with a soft and hard segment weight ratio of 60/40, respectively, with the soft segment containing 80 wt-% PDMS (molecular weight approximately 1000 Da, n=10-11 repeat units) and 20 wt-% PHMO (poly(hexamethylene oxide), molecular weight approximately 700 Da) and the hard segment comprised of BDO (1,4′

-butanediol) and MDI (4,4′

-methylene diphenyl diisocyanate).

18. The lead of claim 17 wherein the delivery means comprises electrical signal delivery means.

19. The lead of claim 18 wherein the electrical signal delivery means is an implantable lead having at least one electrode.

20. The lead of claim 17 wherein the delivery means comprises drug delivery means.

21. The lead of claim 20 wherein the drug delivery means comprises a catheter.

22. The lead of claim 17 wherein the polymeric material is polymeric insulation material.

23. The lead of claim 17 wherein the silicone-urethane polymer is derived from one or more polydialkyl-, polydiaryl-, or polyalkylaryl-siloxane monomers other than a polydimethylsiloxane monomer.

24. The lead of claim 17 wherein the silicone-urethane polymer is derived from a mixture of one or more polydimethylsiloxane monomers and at least one other monomer selected from polydialkyl-, polydiaryl-, and polyalkylaryl-siloxane monomers other than a polydimethylsiloxane monomer.

25. The lead of claim 17 wherein the silicone-urethane polymer is derived from a polydimethyl siloxane diol monomer with a number average molecular weight equal to or higher than 1000 Da.

26. The lead of claim 17 wherein the silicone-urethane polymer is derived from a polydimethyl siloxane diol monomer of the formula:

27. The lead of claim 26 wherein n is from 15 to 1500 and m is from 5 to 18.

28. The lead of claim 27 wherein n is from 20 to 1500 and m is 10 to 18.

29. The lead of claim 17 wherein the silicone-urethane polymer is derived from a polydimethyl siloxane diol monomer of the formula:

30. The lead of claim 17 wherein the silicone-urethane polymer is derived from a PDMS diol with hydrophobic end groups/blocks.

31. The lead of claim 30 wherein the PDMS diol with hydrophobic end groups is derived from a hydride-terminated siloxane and an unsaturated alcohol selected from the group of 9-decen-1-ol, 10-undecen-1-ol, oleyl alcohol, and combinations thereof.

32. The lead of claim 17 wherein the silicone-urethane polymer is derived from a hydrophobic co-soft segment and/or chain extender.

33. The lead claim 17 wherein the silicone-urethane polymer is crosslinked.