Drug-eluting electrode

• US 7,953,499 B2
• Filed: 09/30/2003
• Issued: 05/31/2011
• Est. Priority Date: 09/30/2003
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Wineland, Carolyn, Allex, Steve, Knapp, Christopher P.
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US10/675,920
• Publication Number:
  US 20050070985A1
• Time in Patent Office: 2,800 Days
• Field of Search: 607120-121, 607/127, 607/119, 607/122
• US Class Current: 607/120
• CPC Class Codes: A61N 1/0568 with drug delivery

Abstract

An apparatus includes an electrical lead comprising a lead body and an electrical conductor, and an electrode coupled to the electrical conductor, wherein the electrode includes a coating on at least a portion of a surface of the electrode, the coating including two or more layers, with a first layer adjacent the surface of the electrode comprising an insulative material and a second layer adjacent the first layer comprising at least one pharmacological agent.

Claims

1. An apparatus comprising:

an electrical lead comprising a lead body and an electrical conductor; and

an electrode coupled to the electrical conductor, wherein the electrode includes a coating disposed on at least a portion of a surface of the electrode, the coating including three or more layers, with a first layer comprising an insulative polymeric base material adjacent to and in contact with at least a portion of the surface of the electrode for insulating at least a portion of the electrode and increasing an impedance of the electrode, a second layer disposed over and in contact with at least a portion of the first layer, the second layer including an insulative polymer matrix material and a first pharmacological agent, and a third layer disposed over the second layer, wherein the third layer consists of a drug.

2. The apparatus of claim 1, wherein the electrode includes a helical tip.

3. The apparatus of claim 1, wherein the first pharmacological agent comprises an anti-arrhythmic agent, an angiogenic growth factor, an anti-inflammatory agent, an antiproliferative agent, or a combination thereof.

4. The apparatus of claim 3, wherein the anti-inflammatory agent is dexamethasone, clobetasol, beclomethasone, or a pharmaceutically acceptable salt thereof.

5. The apparatus of claim 1, wherein the drug is any one of an anti-arrhythmic agent, an angiogenic growth factor, an anti-inflammatory agent or an antiproliferative agent.

6. The apparatus of claim 5, wherein the anti-inflammatory agent is dexamethasone, clobetasol, beclomethasone, or a pharmaceutically acceptable salt thereof.

7. The apparatus of claim 1, wherein the polymeric base coat is ethylene vinyl alcohol.

8. The apparatus of claim 1, further comprising a fourth layer disposed over and in contact with the second layer, wherein the fourth layer includes a porous polymeric barrier having a porosity sufficient to regulate a release of the first pharmacological agent from the second layer.

9. The apparatus of claim 1, wherein the first layer is between 1 and 100 microns thick.

10. The apparatus of claim 9, wherein the amount of the at least one pharmacological agent present in the second layer is up to 60% by weight of the second layer.

11. The apparatus according to claim 1, wherein the insulative polymeric base material is selected from the group consisting of Parylene, polyurethanes, polyacrylates, polymethacrylates, polyamides, polyethers, polysiloxanes, and polyepoxy resins.

12. A system comprising:

an electrical pulse generator;

an electrical lead releasably coupled to electrical pulse generator, wherein the electrical lead includes a lead body and an electrical conductor; and

an electrode coupled to the electrical conductor, wherein an outer surface of the electrode comprises a coating disposed on a portion of an outer surface of the electrode such that the outer surface of the electrode comprises a coated region and an uncoated region, the coating including three or more discrete layers comprising a first layer including an insulative polymeric base material adjacent to and in contact with the outer surface of the electrode such that an impedance of the electrode is increased, a second layer disposed over and in contact with the first layer, the second layer including an insulative polymer matrix material and a first pharmacological agent, and a third layer disposed over the second layer, wherein the third layer consists of a drug.

13. The system of claim 12, wherein the electrode includes a helical tip.

14. The system of claim 12, wherein the first pharmacological agent comprises an antiarrhythmic agent, an angiogenic growth factor, an anti-inflammatory agent, an antiproliferative agent, or a combination thereof.

15. The system of claim 14, wherein the anti-inflammatory agent is dexamethasone, clobetasol, beclomethasone, or a pharmaceutically acceptable salt thereof.

16. The system of claim 14, wherein the anti-inflammatory agent is dexamethasone.

17. The system of claim 12, wherein the drug is any one of an anti-arrhythmic agent, an angiogenic growth factor, an anti-inflammatory agent or an anti-proliferative agent.

18. The system of claim 17, wherein the anti-inflammatory agent is dexamethasone, clobetasol, beclomethasone, or a pharmaceutically acceptable salt thereof.

19. The system of claim 12, wherein the polymeric base coat is ethylene vinyl alcohol.

20. The system of claim 12, further comprising a fourth layer disposed between the second layer and the third layer in contact with the second layer, wherein the fourth layer comprises a porous polymeric barrier having a porosity sufficient to regulate a release of the first pharmacological agent from the second layer.

21. The system of claim 12, wherein the first layer is between 1 and 100 microns thick.

22. The system of claim 21, wherein the amount of the first pharmacological agent present in the second layer is up to 60% by weight of the second layer.

23. An apparatus comprising:

an electrical lead comprising a lead body and an electrical conductor; and

an electrode coupled to the electrical conductor, wherein the electrode includes a coating disposed on a portion of a surface of the electrode, the coating including three or more layers, with an inner layer including a first pharmacological agent dispersed within an insulative polymer matrix for increasing an impedance of the electrode and regulated, chronic release of the first pharmacological agent, an outer layer consisting of a drug such that the drug of the outer layer is exposed to tissue upon implant of the electrode, and a middle layer disposed between the inner layer and the outer layer, wherein the middle layer includes a porous polymer barrier and is adjacent to and in contact with the inner layer and not adjacent to the surface of the electrode.

24. The apparatus of claim 23, wherein the electrode includes a helix.

25. The apparatus of claim 23, further including a fourth layer directly adjacent a surface of the electrode comprising a polymer primer layer, with the inner layer adjacent the polymer primer layer.

26. The apparatus of claim 23, wherein the first pharmaceutical agent in the polymer matrix includes an anti-inflammatory drug.

27. The apparatus of claim 23, wherein the first pharmacological agent in the polymer matrix includes an anti-proliferative drug.

28. The apparatus of claim 23, wherein the amount of the first pharmacological agent present in the inner layer is up to 60% by weight of the inner layer.

29. A method comprising:

coating a portion of a surface of an electrode with a first layer, wherein the first layer comprises an insulative polymeric base coat for insulating a portion of the electrode and increasing impedance of the electrode;

coating the first layer of the electrode with a second layer, wherein the second layer comprises an insulative polymer and at least a first pharmacological agent, and at least partially coats the first layer and not the surface of the electrode; and

coating the second layer with a third layer, wherein the third layer consists of a drug.

30. The method of claim 29, wherein the drug is any one of an anti-arrhythmic agent, an angiogenic growth factor, an anti-inflammatory agent or an antiproliferative agent.

31. The method of claim 30, wherein the anti-inflammatory agent is dexamethasone, clobetasol, beclomethasone, or a pharmaceutically acceptable salt thereof.

32. The method of claim 29, wherein the polymeric base coat is ethylene vinyl alcohol.

33. The method of claim 29, further comprising a fourth layer positioned between the second and third layer, wherein the fourth layer comprises a porous polymeric barrier.

34. The method of claim 33, wherein the second layer comprises a matrix including a polymer and at least one pharmacological agent and the fourth layer regulates the release of the pharmacological agent from the matrix.

35. The method of claim 29, further comprising the step of contacting an exterior surface of the electrode with a composition comprising the insulative polymer and the first pharmacological agent to form the second layer.

36. The method of claim 35, wherein the contacting includes spraying.

37. The method of claim 29, wherein the first layer is between 1 and 100 microns thick.

38. The method of claim 37, wherein the amount of the first pharmacological agent present in the second layer is up to 60% by weight of the second layer.