Medical devices containing segmented polyurethane biomaterials

• US 6,915,168 B1
• Filed: 05/08/1998
• Issued: 07/05/2005
• Est. Priority Date: 05/08/1997
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Hobot, Christopher M., Bonnema, Kelvin, Miller, David L., Didomenico, Edward, Benz, Michael D.
• Primary Examiner(s): Layno, Carl
• Application Number:
  US09/423,332
• Time in Patent Office: 2,615 Days
• Field of Search: 607/122, 525/46, 525/92, 528/44, 528/72
• US Class Current: 607/122
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence

Abstract

In one aspect, the present invention relates to a medical device, such as a medical electrical lead, comprising a biomaterial formed from a polymer comprising urethane groups and saturated linear polyethylene moieties wherein the saturated linear polethylene moieties have greater than 12 carbon atoms per moiety. In another aspect, the present invention relates medical devices comprising a biomaterial formed from segmented polymers or polymers having an elongation of greater than 50%. Exemplified polymers contain compounds of the formula HO—(CH₂)_n—OH wherein n is greater than 12.

Claims

1. A medical device comprising a biomaterial formed from a segmented polymer comprising urethane groups and saturated linear polyethylene moities having greater than 12 carbon atoms per moiety.

2. The medical device of claim 1 wherein the polymer comprises at least about 30 weight percent saturated linear polyethylene moieties having greater than 12 carbon atoms per moiety, based on the total weight of the polymer.

3. The medical device of claim 2 wherein the polymer comprises at least about 30 weight percent saturated linear polyethylene moieties having at least about 20 carbon atoms per moiety, based on the total weight of the polymer.

4. The medical device of claim 2 wherein the polymer is prepared from isocyanate-containing compounds and saturated linear polyethylene diols having the formula HO—

(—

CH₂—

)_n—

OH wherein n is at least about 20.

5. The medical device of claim 4 wherein n is at least about 35.

6. The medical device of claim 4 wherein n is no greater than about 45.

7. The medical device of claim 1 wherein the polymer has a molecular weight of greater than about 500.

8. The medical device of claim 1 wherein the polymer is free of sufur- or phosphorus-containing groups.

9. The medical device of claim 1 wherein the polymer comprises phase separated hard and soft segments, wherein the hard segments comprise the saturated linear polyethylene moieties having greater than 12 carbon atoms per moiety.

10. The medical device of claim 9 wherein the soft segments comprise silicone groups.

11. A medical device comprising a biomaterial formed from a segmented polymer consisting essentially of alternating urethane groups and saturated linear polyethylene moieties having greater than 12 carbon atoms per moiety.

12. A medical device comprising a biomaterial formed from a segmented polymer comprising urethane groups and saturated linear polyethylene moities having greater than 12 carbon atoms per unit, wherein the polymer has an elongation of greater than 50%.

13. A medical electrical lead comprising:

(a) an elongated insulation sheath biomaterial formed from a segmented polymer comprising urethane groups and saturated linear polyethylene moieties having greater than 12 carbon atoms per moiety;

(b) an elongated conductor, located within the elongated insulation sheath;

(c) an electrode coupled to a distal end of the elongated conductor; and

(d) an electrical connector coupled to a proximal end of the elongated conductor.

14. The medical electrical lead of claim 13 wherein the polymer comprises at least about 30 weight percent saturated linear polyethylene moieties having greater than 12 carbon atoms per moiety, based on the total weight of the polymer.

15. The medical electrical lead of claim 14 wherein the polymer comprises at least about 30 weight percent saturated linear polyethylene moieties having at least about 20 carbon atoms per moiety, based on the total weight of the polymer.

16. The medical electrical lead of claim 14 wherein the polymer is prepared from isocyanate-containing compounds and saturated linear polyethylene diols having the formula HO—

(—

CH₂—

)_n—

OH wherein n is at least about 20.

17. The medical electrical lead of claim 16 wherein n is at least about 35.

18. The medical electrical lead of claim 17 wherein n is no greater than about 45.

19. The medical electrical lead of claim 13 wherein the polymer has a molecular weight of greater than about 500.

20. The medical electrical lead of claim 13 wherein the polymer is free of sufur- or phosphorus-containing groups.

21. The medical electrical lead of claim 13 wherein the polymer comprises phase separated hard and soft segments, wherein the hard segments comprise the saturated linear polyethylene moieties having greater than 12 carbon atoms per moiety.

22. The medical electrical lead of claim 21 wherein the soft segments comprise silicone groups.

23. A medical device comprising a biomaterial formed from a segmented polymer comprising urethane groups, wherein the polymer is prepared from isocyanate-containing compounds and compounds of the formula:

HO—

(CH₂)_n—

OH

wherein n>

12.

24. The medical device of claim 23 wherein n is at least about 20.

25. The medical device of claim 24 wherein n is at least about 35.

26. The medical device of claim 24 wherein n is no greater than about 45.

27. The medical device of claim 23 wherein the polymer comprises phase separated hard and soft segments, wherein the hard segments comprise the saturated linear polyethylene moieties having greater than 12 carbon atoms per moiety.

28. The medical device of claim 27 wherein the soft segments comprise silicone groups.

29. A method of using a medical electrical lead, the method comprising:

providing a medical electrical lead comprising an elongated insulation sheath biomaterial formed from a segmented polymer comprising urethane and saturated linear polyethylene units having greater than 12 carbon atoms per moiety;

electrically connecting a first end of the medical electrical lead to implantable medical device; and

electrically stimulating or sensing a second end of the lead.