Implantable lead with dissolvable coating for improved fixation and extraction

• US 7,218,971 B2
• Filed: 06/24/2003
• Issued: 05/15/2007
• Est. Priority Date: 03/29/1999
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Westlund, Randy, Heil, Ronald W. Jr., Heil, John E.
• Primary Examiner(s): Getzow; Scott M.
• Application Number:
  US10/608,850
• Publication Number:
  US 20040215306A1
• Time in Patent Office: 1,421 Days
• Field of Search: 607/120, 607/121, 607/116
• US Class Current: 607/121
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0568 with drug delivery

Abstract

A cardiac rhythm management system provides an endocardial cardiac rhythm management lead with an at least partially dissolvable coating at least partially on insulating portions of the lead body at or near its distal end. Upon dissolution, the coating promotes tissue ingrowth to secure the lead in place within fragile vascular structures or elsewhere. Dissolution of one such coating releases a therapeutic agent, such as a steroid that modifies the fibrotic scar tissue content of tissue ingrowth, such that the resulting bond between the tissue and the lead is weak, so that the lead can be easily extracted if desired. One such lead includes an insulating elongate body carrying at least. The lead also includes an at least partially dissolvable coating on an insulating portion of the peripheral distal lead surface. The coating provides one or more of a rough surface, a porous surface, or a swollen surface after being exposed to an aqueous substance.

Claims

1. An apparatus comprising:

an implantable device including a substantially cylindrical insulating exterior peripheral surface of an elongate intravascular lead body having a proximal end and a distal end and the peripheral surface; and

an at least partially dissolvable coating at least partially on a portion of the peripheral surface of the device body, the coating initially providing a slippery lubricating surface after being exposed to an aqueous substance, and then later providing at least one of a rough surface and a porous surface after being exposed to the aqueous substance, the at least one of the rough and the porous surface allowing tissue ingrowth.

2. The apparatus of claim 1, the lead including at least one elongate electrical conductor in the insulating body.

3. The apparatus of claim 2, in which a distal portion of the lead is sized and shaped to be inserted into at least one of a coronary sinus and a great cardiac vein.

4. The apparatus of claim 1, in which coating includes a therapeutic agent and a non-therapeutic agent, and in which the therapeutic agent has a different release rate than the non-therapeutic agent.

5. The apparatus of claim 4, in which the non-therapeutic agent includes mannitol.

6. The apparatus of claim 4, in which the non-therapeutic agent includes glycerol.

7. The apparatus of claim 1, in which the coating includes a first therapeutic agent and a second therapeutic agent that is different from the first therapeutic agent.

8. The apparatus of claim 7, in which the first therapeutic agent has a different release rate than the second-therapeutic agent.

9. The apparatus of claim 1, in which the coating includes particles disposed in a water-vapor permeable medium.

10. An apparatus comprising:

an implantable device including a substantially cylindrical insulating exterior peripheral surface of an elongate intravascular lead body having a proximal end and a distal end and the peripheral surface that is sized and shaped to be inserted into at least one of a coronary sinus and a great cardiac vein; and

an at least partially dissolvable coating at least partially on a portion of the peripheral surface of the device body, the coating providing at least one of a rough surface and a porous surface after being exposed to the aqueous substance, the at least one of the rough and the porous surface allowing tissue ingrowth.

11. The apparatus of claim 10, in which the implantable device includes a lead, the lead including:

an insulating elongate body having a proximal end and a distal end and the peripheral surface; and

at least one elongate electrical conductor in the insulating body.

12. The apparatus of claim 10, in which coating includes a therapeutic agent and a non-therapeutic agent, and in which the therapeutic agent has a different release rate than the non-therapeutic agent.

13. The apparatus of claim 12, in which the non-therapeutic agent includes mannitol.

14. The apparatus of claim 12, in which the non-therapeutic agent includes glycerol.

15. The apparatus of claim 10, in which the coating includes a first therapeutic agent and a second therapeutic agent that is different from the first therapeutic agent.

16. The apparatus of claim 15, in which the first therapeutic agent has a different release rate than the second-therapeutic agent.

17. The apparatus of claim 10, in which the coating includes particles disposed in a water-vapor permeable medium.

18. An apparatus comprising:

an implantable device including an insulating exterior peripheral surface of an elongate intravascular lead body having a proximal end and a distal end and the peripheral surface; and

an at least partially dissolvable coating at least partially on a portion of the peripheral surface of the device body, the coating including a therapeutic agent disposed in a medium that is permeable by water vapor.

19. The apparatus of claim 18, in which the coating provides at least one of a rough surface and a porous surface after being exposed to the aqueous substance, the at least one of the rough and the porous surface allowing adhesive but breakable tissue ingrowth.

20. The apparatus of claim 19, in which the coating initially provides a slippery lubricating surface after being exposed to an aqueous substance, and then later provides the at least one of the rough surface and the porous surface after being exposed to the aqueous substance.

21. The apparatus of claim 18, in which the implantable device includes a lead, the lead including:

an insulating elongate body having a proximal end and a distal end and the peripheral surface; and

at least one elongate electrical conductor in the insulating body.

22. The apparatus of claim 21, in which a distal portion of the lead is sized and shaped to be inserted into at least one of a coronary sinus and a great cardiac vein.

23. The apparatus of claim 18, in which coating includes a therapeutic agent and a non-therapeutic agent, and in which the therapeutic agent has a different release rate than the non-therapeutic agent.

24. The apparatus of claim 23, in which the non-therapeutic agent includes mannitol.

25. The apparatus of claim 23, in which the non-therapeutic agent includes glycerol.

26. The apparatus of claim 18, in which the coating includes a first therapeutic agent and a second therapeutic agent that is different from the first therapeutic agent.

27. The apparatus of claim 26, in which the first therapeutic agent has a different release rate than the second-therapeutic agent.

28. An apparatus comprising:

an implantable device including a substantially cylindrical insulating exterior peripheral surface of an elongate intravascular lead body having a proximal end and a distal end and the peripheral surface; and

an at least partially dissolvable coating at least partially on a portion of the peripheral surface of the device body, the coating providing at least one of a rough surface and a porous surface after being exposed to the aqueous substance, the coating including two therapeutic agents with different release rates.

29. The apparatus of claim 28, in which the implantable device includes a lead, the lead including:

an insulating elongate body having a proximal end and a distal end and the peripheral surface; and

at least one elongate electrical conductor in the insulating body.

30. The apparatus of claim 28, in which the two therapeutic agents include at least one of dexamethasone acetate and dexamethasone sodium phosphate.

31. The apparatus of claim 28, in which the coating further includes at least one of mannitol and glycerol.

32. An apparatus comprising:

an implantable device including a substantially cylindrical insulating exterior peripheral surface of an elongate intravascular lead body having a proximal end and a distal end and the peripheral surface; and

an at least partially dissolvable coating at least partially on a portion of the peripheral surface of the device body, the coating providing at least one of a rough surface and a porous surface after being exposed to the aqueous substance, the coating including at least one therapeutic agent and at least one lubricating agent.

33. The apparatus of claim 32, in which the implantable device includes a lead, the lead including:

an insulating elongate body having a proximal end and a distal end and the peripheral surface; and

at least one elongate electrical conductor in the insulating body.

34. The apparatus of claim 32, in which the at least one therapeutic agent includes dexamethasone.

35. The apparatus of claim 32, in which the at least one therapeutic agent includes dexamethasone sodium phosphate.

36. The apparatus of claim 32, in which the at least one lubricating agent includes mannitol.

37. The apparatus of claim 32, in which the at least one of the rough surface and the porous surface allows enough tissue ingrowth to affix an intravascular lead, and the tissue ingrowth is modified by the at least one therapeutic agent to allow the intravascular lead to be easily intravascularly extracted by breaking the tissue ingrowth.