Drug eluting coatings for a medical lead and method therefor

• US 20070051531A1
• Filed: 09/08/2005
• Published: 03/08/2007
• Est. Priority Date: 09/08/2005
• Status: Abandoned Application

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Borgaonkar, Harshad, Heil, Ronald, Kirby, Darren, Cooke, Daniel
• Application Number:
  US11/221,588
• Publication Number:
  US 20070051531A1
• Time in Patent Office: Days
• US Class Current: 174/126.100
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0568 with drug delivery

Abstract

A medical lead including a lead body extending from a first end portion to a second end portion and a coating disposed along a portion of the lead, wherein the coating includes at least one matrix polymer layer, at least one anti-inflammatory agent and at least one anti-proliferative agent.

Claims

1. A medical lead comprising:

a lead body extending from a first end portion to a second end portion; and

a coating disposed along a portion of the lead, wherein the coating includes at least one matrix polymer layer, at least one anti-inflammatory agent and at least one anti-proliferative agent.

2. The lead of claim 1, wherein the coating is adjacent to at least one electrode.

3. The lead of claim 1, wherein the coating is about 5 to about 10 microns thick.

4. The lead of claim 1, wherein the coating is about 1 to about 50 microns thick.

5. The lead of claim 1, wherein the matrix polymer comprises polyvinylidene fluoride, room-temperature-vulcanizing silicone elastomers, silicone, ethylene vinyl alcohol (ENAL), polyethylene glycol (PEG), polycaprolactone, polylactide, polyglycolide, polyurethane or a combination thereof.

6. The lead of claim 1, wherein the polymer comprises polyvinylidene fluoride copolymer.

7. The lead of claim 1, wherein the anti-inflammatory agent comprises a steroid.

8. The lead of claim 7, wherein the steroid comprises clobetasol, dexamethasone, beclamethasone their derivatives, analogs, salts or a combination thereof.

9. The lead of claim 1, wherein the anti-proliferative agent comprises paclitaxel, rapamycin, everolimus, tacrolimus, actinomycin-D, their derivatives, analogs, salts or a combination thereof.

10. The lead of claim 1, wherein the anti-inflammatory agent comprises dexamethasone or clobetasol.

11. The lead of claim 1, wherein the anti-proliferative agent comprises paclitaxel, rapamcyin or everolimus.

12. The lead of claim 1, further comprising a primer layer on at least a portion of a surface of the lead.

13. The lead of claim 1, further comprising at least one topcoat layer selected from the group consisting of phosphorylcholine (PC), polyvinylpyrrolidone (PVP), poly(vinyl alcohol) (PVA), hyaluranic acid (HA), polyactive, or a combination thereof.

14. The lead of claim 1, further comprising hydroxyapatite (HAp).

15. The lead of claim 13, wherein the topcoat layer comprises at least one additional agent that is a therapeutic agent.

16. A medical lead comprising:

a lead body extending from a proximal end portion to a distal end portion;

an electrode disposed along the lead body; and

a coating associated with at least a portion of the electrode,

wherein the coating includes a layer of phosphorylcholine (PC), polyvinylpyrrolidone (PVP), poly(vinyl alcohol) (PVA), hyaluranic acid (HA), polyactive or a combination thereof.

17. The lead of claim 16, further comprising at least one therapeutic agent mixed in the coating.

18. The lead of claim 16, further comprising at least one therapeutic agent layered on top of or under the layer associated with the electrode.

19. The lead of claim 16, further comprising hydroxyapatite (HAp).

20. The lead of claim 19, further comprising a second layer selected from the group consisting of phosphorylcholine (PC), polyvinylpyrrolidone (PVP), poly(vinyl alcohol) (PVA), hyaluranic acid (HA), polyactive or a combination thereof.

21. The lead of claim 20, wherein at least one therapeutic agent is between the first and second layers, mixed in at least one layer, or a combination thereof.

22. The lead of claim 17, wherein the therapeutic agent comprises an anti-inflammatory agent, anti-proliferative agent, anti-arrhythmic agent, anti-migratory agent, anti-neoplastic agent, antibiotic agent, anti-restenotic agent, anti-coagulation agent, anti-clotting agent, anti-thrombogenic agent, immunosuppressive agent, steroid or a combination thereof.

23. The lead of claim 17, wherein the therapeutic agent comprises paclitaxel, clobetasole, rapamycin, everolimus, tacrolimus, actinomycin-D, dexamethasone, vitamin E, mycophenolic acid, cyclosporin, beclomethasone their derivatives, analogs, salts or a combination thereof.

24. A method comprising:

coating a portion of a medical lead with at least one matrix polymer layer, at least one anti-inflammatory agent and at least one anti-proliferative agent;

delivering the medical lead to a site of implantation; and

releasing at least one anti-inflammatory agent and at least one anti-proliferative agent from the coating so as to decrease the formation of a fibrotic capsule near an electrode of an implanted lead.