Polyisobutylene-based polyurethanes

• US 8,962,785 B2
• Filed: 11/20/2012
• Issued: 02/24/2015
• Est. Priority Date: 01/12/2009
• Status: Active Grant

• Current Assignee: University Of Massachusetts
• Original Assignee: University Of Massachusetts
• Inventors: Faust, Rudolf, Ojha, Umaprasana
• Primary Examiner(s): Gulakowski, Randy
• Assistant Examiner(s): WASHVILLE, JEFFREY D
• Application Number:
  US13/681,811
• Publication Number:
  US 20130079487A1
• Time in Patent Office: 826 Days
• US Class Current: 528/75
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 29/049 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/085 Macromolecular materials
• 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: A61L 31/10 Macromolecular materials
• CPC Class Codes: C08G 18/32 Polyhydroxy compounds; Polyamines; Hydroxyamines
• CPC Class Codes: C08G 18/3206 aliphatic
• CPC Class Codes: C08G 18/4063 Mixtures of compounds of group C08G18/62 with other macromolecular compounds
• CPC Class Codes: C08G 18/44 Polycarbonates
• CPC Class Codes: C08G 18/4854 Polyethers containing oxyalkylene groups having four carbon atoms in the alkylene group
• CPC Class Codes: C08G 18/6204 Polymers of olefins unsaturated polymers of conjugated dienes C08G18/69
• CPC Class Codes: C08G 18/6511 compounds of group C08G18/3203
• CPC Class Codes: C08G 18/7671 containing only one alkylene bisphenyl group
• CPC Class Codes: C08L 75/04 Polyurethanes

Abstract

An elastomeric polymer, comprising (1) a hard segment in the amount of 10% to 60% by weight of the elastomeric polymer, wherein the hard segment includes a urethane, urea or urethaneurea; and (2) a soft segment in the amount of 40% to 90% by weight of the elastomeric polymer. The soft segment comprises (a) at least 2% by weight of the soft segment of at least one polyether macrodiol, and/or at least one polycarbonate macrodiol; and (b) at least 2% by weight of the soft segment of at least one polyisobutylene macrodiol and/or diamine.

Claims

1. An implantable lead comprising:

an elastomeric polymer, the elastomeric polymer of the implantable lead comprising;

a hard segment in the amount of 10% to 60% by weight of the elastomeric polymer, wherein the hard segment includes a urethane, urea or urethaneurea; and

a soft segment in the amount of 40% to 90% by weight of the elastomeric polymer, wherein the soft segment comprises at least about 70% by weight of the soft segment of at least one polyisobutylene macrodiol and/or diamine, and wherein the elastomeric polymer has a tensile strength of at least 18 MPa, an elongation at break of at least 150%, and a tear strength of at least 300 pounds per linear inch.

2. The implantable lead of claim 1, wherein the hard segment is in the amount of 20% to 60% by weight of the elastomeric polymer, and wherein the elastomeric polymer has a tensile strength of 18 MPa to 40 MPa.

3. The implantable lead of claim 2, wherein the elastomeric polymer has an elongation at break of 150% to 740%.

4. The implantable lead of claim 1, wherein the soft segment comprises at least about 80% by weight of the soft segment of at least one polyisobutylene macrodiol and/or diamine.

5. The implantable lead of claim 4, wherein the elastomeric polymer has a tensile strength of 18 MPa to 29 MPa.

6. The implantable lead of claim 5, wherein the elastomeric polymer has an elongation at break of 150% to 680%.

7. The implantable lead of claim 1, wherein the soft segment comprises at least about 90% by weight of the soft segment of at least one polyisobutylene macrodiol and/or diamine.

8. The implantable lead of claim 7, wherein the elastomeric polymer has a tensile strength of 18 MPa to 20 MPa.

9. The implantable lead of claim 8, wherein the elastomeric polymer has an elongation at break of 150% to 400%.

10. The implantable lead of claim 1, wherein the hard segment is in the amount of 35% to 60% by weight of the elastomeric polymer and wherein the elastomeric polymer has a tensile strength of 18 MPa to 40 MPa.

11. The implantable lead of claim 10, wherein the elastomeric polymer has an elongation at break of 150% to 400%.

12. The implantable lead of claim 1, wherein the soft segment further comprises at least one polyether macrodiol.

13. The implantable lead of claim 1, wherein the number average molecular weight of the elastomeric polymer is at least 40 kilodaltons.

14. The implantable lead of claim 1, wherein the number average molecular weight of the elastomeric polymer is at least 50 kilodaltons.

15. A method of forming an implantable medical lead, the method comprising:

preparing an elastomeric polymer for the implantable medical lead by;

forming a mixture that includes at least one polyisobutylene macrodiol and/or diamine and at least one chain extender; and

reacting the mixture with a diisocyanate to yield an elastomeric polymer, wherein the elastomeric polymer includes;

a hard segment in the amount of 10% to 60% by weight of the elastomeric polymer, wherein the hard segment includes a urethane, urea or urethaneurea; and

a soft segment in the amount of 40% to 90% by weight of the elastomeric polymer, wherein the soft segment comprises at least about 70% by weight of the soft segment of at least one polyisobutylene macrodiol and/or diamine, wherein the elastomeric polymer has a tensile strength of at least 18 MPa, an elongation at break of at least 150%, and a tear strength of at least 300 pounds per linear inch; and

extruding, injecting or compression molding the elastomeric polymer to form the implantable medical lead.

16. The method of claim 15, wherein the hard segment is in the amount of 20% to 60% by weight of the elastomeric polymer and wherein the elastomeric polymer has a tensile strength of 18 MPa to 40 MPa.

17. The method of claim 15, wherein the hard segment is in the amount of 35% to 60% by weight of the elastomeric polymer and wherein the elastomeric polymer has a tensile strength of 18 MPa to 40 MPa.

18. The method of claim 15, wherein the soft segment comprises at least about 80% by weight of the soft segment of at least one polyisobutylene macrodiol and/or diamine, and wherein the elastomeric polymer has a tensile strength of 18 MPa to 29 MPa.

19. The method of claim 15, wherein the soft segment comprises at least about 90% by weight of the soft segment of at least one polyisobutylene macrodiol and/or diamine, and wherein the elastomeric polymer has a tensile strength of 18 MPa to 20 MPa.

20. The method of claim 19, wherein the elastomeric polymer has an elongation at break of 150% to 400%.