Lead electrode incorporating extracellular matrix

• US 20060136027A1
• Filed: 12/20/2004
• Published: 06/22/2006
• Est. Priority Date: 12/20/2004
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Westlund, Randy, Ross, Jeffrey
• Granted Patent: US 7,981,065 B2
• Time in Patent Office: Days
• US Class Current: 607/123
• CPC Class Codes: A61N 1/0575 with drug delivery
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/059 Anchoring means

Abstract

Implantable devices containing extracellular matrix and methods of using the devices are provided.

Claims

1. A lead comprising:

a lead body including one or more electrodes disposed therealong, at least one of the one or more electrodes or the lead body including isolated extracellular matrix (ECM) associated therewith.

2. The lead of claim 1, wherein the isolated ECM further comprises one or more cytokines.

3. The lead of claim 2, wherein one cytokine is SCF, IGF, HGF or G-CSF.

4. The lead of claim 1, wherein the isolated ECM is applied to at least a portion of a surface of at least one electrode.

5. The lead of claim 4, wherein the isolated ECM is applied to the one or more electrodes as a gel.

6. The lead of claim 5, wherein the gel is lyophilized after application.

7. The lead of claim 4, wherein the isolated ECM is applied to the one or more electrodes in particulate form.

8. The lead of claim 4, wherein the isolated ECM is applied to the one or more electrodes as a sheet.

9. The lead of claim 1, wherein the isolated ECM is affixed to a surface of the one or more electrodes.

10. The lead of claim 1, wherein the isolated ECM inhibits fibrotic capsule formation and/or enhances excitable tissue formation around the lead after implantation of the lead.

11. The lead of claim 1, wherein the isolated ECM is applied to at least a portion of a surface of the lead body.

12. A method comprising applying isolated ECM to at least a portion of an electrode in an amount effective to inhibit fibrotic capsule formation and/or enhance excitable tissue formation around a lead comprising the electrode after implantation of the lead.

13. The method of claim 12, wherein the isolated ECM is applied to the surface of the electrode.

14. The method of claim 13, wherein applying the isolated ECM includes affixing the isolated ECM to the electrode.

15. The method of claim 12, wherein donor cells and/or one or more cytokines are contacted with the isolated ECM after applying the isolated ECM to the electrode.

16. The method of claim 15, wherein one cytokine is G-CSF, SCF, HGF or IGF.

17. The method of claim 12, wherein donor cells and/or one or more cytokines are contacted with the isolated ECM prior to applying the isolated ECM to the electrode.

18. The method of claim 17, wherein one cytokine is G-CSF, SCF, HGF or IGF.

19. The method of claim 12, wherein the isolated ECM is applied as a sheet, gel or in particulate form.

20. The method of claim 12, wherein the ECM is isolated from small intestine submucosa or urinary bladder submucosa.

26. The method of claim 12, 21 or 22 wherein the isolated ECM is xenogeneic.

21. A method, comprising:

introducing to a mammal a lead comprising one or more electrodes including an amount of isolated ECM effective to inhibit fibrotic capsule formation associated with lead implantation.

23. The method of claim 21 or 22 wherein the ECM is isolated from small intestine submucosa or urinary bladder submucosa.

24. The method of claim 21 or 22 wherein the isolated ECM further comprises cells and/or one or more cytokines.

25. The method of claim 24, wherein one cytokine is G-CSF, SCF, HGF or IGF.

36. The method of claim 21 or 22, further comprising administering an immunosuppressant.

37. The method of claim 21 or 22, further comprising administering donor cells and an immunosuppressant.

22. A method, comprising:

introducing to a mammal a lead comprising one or more electrodes including an amount of isolated ECM effective to enhance electrically excitable cells at a site of implantation of the lead.

27. A cardiac rhythm management (CRM) system, comprising:

a lead having one or more electrodes including isolated ECM, the one or more electrodes disposed along the lead; and

an implantable medical device including an energy source and electronic circuitry adapted to deliver electrical stimulation pulses to the one or more electrodes.

28. The CRM system of claim 27, wherein the electronic circuitry comprises a pacing circuit configured to deliver pacing pulses to the one or more electrodes and/or a sensing circuit to sense one or more cardiac signals through one or more electrodes.

29. The CRM system of claim 27, further comprising at least one reference electrode incorporated onto the implantable medical device.

30. The CRM system of claim 29, wherein the implantable medical device comprises:

a metal housing including at least portions of the electronic circuitry therein, at least a portion of the housing forming the at least one reference electrode.

31. The CRM system of claim 27, wherein the isolated ECM further comprises cells and/or one or more cytokines.

32. The CRM system of claim 27, wherein the ECM is isolated from small intestine submucosa or urinary bladder submucosa.

33. A method for treating a myocardial region including at least portions of an injured area, comprising:

delivering pacing pulses to the myocardial region of a mammal through one or more electrodes of a plurality of pacing electrodes, wherein the one or more electrodes include isolated ECM when introduced to the mammal with the plurality of pacing electrodes.

34. The method of claim 33, wherein delivering the pacing pulses comprises delivering the pacing pulses to approximately uniformly reduce workload and stress on the myocardial region.

35. The method of claim 33, further comprising administering one or more cytokines to the mammal.