Implantable lead with dissolvable coating for improved fixation and extraction

• US 6,584,363 B2
• Filed: 07/16/2001
• Issued: 06/24/2003
• 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:
  US09/906,571
• Publication Number:
  US 20020045926A1
• Time in Patent Office: 708 Days
• Field of Search: 607/1-156
• US Class Current: 607/126
• 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. A device including:

a device body at least partially covered by a 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 an aqueous substance.

2. The device of claim 1, in which the coating provides a substantially smooth surface before being exposed to the aqueous substance.

3. The device of claim 2, in which the coating includes a plurality of substantially soluble particles dispersed in a substantially insoluble medium.

4. The device of claim 3, in which the soluble particles include a therapeutic agent.

5. The device of claim 4, in which the therapeutic agent includes at least one of a drug, a steroid, a corticosteroid, an antibiotic, and an antirejection agent.

6. The device of claim 4, in which the therapeutic agent includes one of dexamethasone acetate and dexamethasone sodium phosphate.

7. The device of claim 3, in which the insoluble medium includes a biocompatible medical adhesive.

8. The device of claim 7, in which the medical adhesive includes silicone.

9. The device of claim 1, which the coating includes a therapeutic agent that promotes friable tissue associated with the portion of the peripheral surface of the device body for easier device removal.

10. The device of claim 1, in which the device body is an elongate body including a proximal and a distal end.

11. The device of claim 10, further including at least one elongate electrical conductor, having a proximal end and a distal end, the conductor carried within the elongate body and extending longitudinally along substantially the entire length between the proximal and distal ends of the elongate body, and in which the peripheral surface of the elongate body includes an insulating portion.

12. The device of claim 11, in which the coating includes a plurality of substantially soluble particles dispersed in a substantially insoluble medium, the insoluble medium adhered to the insulating portion of the elongate body.

13. The device of claim 11, further including at least one electrode located at or near the distal end of the elongate body, the electrode being coupled to the distal end of the conductor.

14. The device of claim 13, in which the coating also covers at least part of the at least one electrode.

15. The device of claim 11, in which the at least partially dissolvable coating is on the insulating portion of the peripheral surface at or near the distal end of the elongated body.

16. A device including:

a flexible elongate body having a proximal and a distal end and a peripheral surface; and

a partially dissolvable coating at least partially on a portion of the peripheral surface of the elongate body, the coating providing at least one of a rough surface, a porous surface, and a swollen surface after being exposed to an aqueous substance, the coating including a plurality of substantially soluble particles dispersed in a substantially insoluble silicone adhesive that is bonded to the elongate body, and in which the substantially soluble particles are selected from the group consisting of dexamethasone, dexamethasone acetate and dexamethasone sodium phosphate.

17. The device of claim 16, in which the coating includes up to 40% substantially soluble particles dispersed in the adhesive.

18. The device of claim 16, in which the coating includes up to 35% substantially soluble particles dispersed in the adhesive.

19. The device of claim 16, in which the coating includes up to 30% substantially soluble particles dispersed in the adhesive.

20. The device of claim 17, further including a plurality of electrodes located at or near the distal end of the elongate body, each electrode being coupled to the distal end of at least one of the conductors.

21. The device of claim 20, in which the coating also covers at least part of at least one of the electrodes.

22. The device of claim 16, further including a plurality of elongate electrical conductors, each conductor having a proximal end and a distal end, each conductor carried within the elongate body and extending longitudinally along substantially the entire length between the proximal and distal ends of the elongate body, of which the peripheral surface includes an insulating portion.

23. A device including:

a flexible elongate body having a proximal and a distal end and a peripheral surface; and

an at least partially-dissolvable means for coating a portion of the peripheral surface at or near the distal end of the elongate body, providing at least one of a rough surface, a porous surface, and a swollen surface, after being exposed to an aqueous substance, for fixation of tissue thereto.

24. The device of claim 23, further including a plurality of elongate electrical conductors, each conductor having a proximal end and a distal end, each conductor carried within the elongate body and extending longitudinally along substantially the entire length between the proximal and distal ends of the elongate body, of which the peripheral surface includes an insulating portion.

25. The device of claim 24, further including a plurality of electrodes located at or near the distal end of the elongate body, each electrode being coupled to the distal end of at least one of the conductors.

26. The device of claim 25, in which the means for coating includes a means for coating at least part of at least one of the electrodes.

27. A method including:

implanting an implantable medical device;

exposing the an implantable medical device to an aqueous substance; and

partially dissolving a coating at least partially on a portion of the implantable medical device to provide at least one of a rough surface, a porous surface, and a swollen surface, thereby promoting tissue ingrowth.

28. The method of claim 27, in which partially dissolving the coating includes releasing a therapeutic agent.

29. The method of claim 28, in which releasing the therapeutic agent includes releasing at least one of a drug, a steroid, a corticosteroid, an antibiotic, and an antirejection agent.

30. The method of claim 28, in which releasing the therapeutic agent includes releasing at least one of dexamethasone, dexamethasone acetate, and dexamethasone sodium phosphate.

31. The method of claim 27, in which dissolving the coating includes releasing a therapeutic agent that promotes friable tissue associated with the portion of the implantable medical device for easier device removal.

32. The method of claim 27, in which the implanting the implantable medical device includes disposing a cardiac rhythm management lead.

33. The method of claim 27, in which disposing the lead includes translumenally disposing the lead in at least one of a right atrium and a right ventricle of the heart.

34. The method of claim 27, in which disposing the lead includes translumenally disposing the lead in at least one of a coronary sinus and a great cardiac vein of the heart.

35. A method comprising:

covering at least a portion of an implantable medical device with an insulating peripheral surface; and

coating at least a portion of the insulating peripheral surface with an at least partially dissolvable coating, the coating providing at least one of a rough surface, a porous surface, and a swollen surface after being exposed to an aqueous substance.

36. The method of claim 35, in which coating includes applying a medium carrying soluble elements.

37. The method of claim 36, in which coating further includes applying biocompatible silicone adhesive carrying a steroid.

38. The method of claim 36, in which coating further includes applying biocompatible silicone adhesive including at least one of dexamethasone, dexamethasone acetate, and dexamethasone sodium phosphate.

39. The method of claim 36, in which coating includes applying biocompatible silicone adhesive including up to 40% of at least one of dexamethasone, dexamethasone acetate, and dexamethasone sodium phosphate.

40. The method of claim 36, in which coating includes applying biocompatible silicone adhesive including up to 35% of at least one of dexamethasone, dexamethasone acetate, and dexamethasone sodium phosphate.

41. The method of claim 36, in which coating includes applying biocompatible silicone adhesive including up to 30% of at least one of dexamethasone, dexamethasone acetate, and dexamethasone sodium phosphate.

42. The method of claim 36, in which coating includes applying biocompatible silicone adhesive including between 30% and 40% of at least one of dexamethasone, dexamethasone acetate, and dexamethasone sodium phosphate.

43. The method of claim 35, further including forming at least an electrode coupled to the implantable medical device.

44. The method of claim 43, further including coating a portion of the electrode with the at least partially dissolvable coating.

45. The method of claim 35, in which coating at least a portion of the insulating peripheral surface includes providing a therapeutic agent that, upon at least partial dissolution of the coating, provides friable tissue associated with the insulating peripheral surface of the implantable medical device for easier device removal.

46. A device including:

a device body at least partially covered by a 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 a rough surface after being exposed to an aqueous substance.

47. A device including:

a device body at least partially covered by a 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 a porous surface after being exposed to an aqueous substance.

48. A device including:

a flexible elongate body having a proximal and a distal end and a peripheral surface; and

a partially dissolvable coating at least partially on a portion of the peripheral surface of the elongate body, the coating providing a rough surface after being exposed to an aqueous substance, the coating including a plurality of substantially soluble particles dispersed in a substantially insoluble silicone adhesive that is bonded to the elongate body, and in which the substantially soluble particles are selected from the group consisting of dexamethasone, dexamethasone acetate and dexamethasone sodium phosphate.

49. A device including:

a flexible elongate body having a proximal and a distal end and a peripheral surface; and

a partially dissolvable coating at least partially on a portion of the peripheral surface of the elongate body, the coating providing a porous surface after being exposed to an aqueous substance, the coating including a plurality of substantially soluble particles dispersed in a substantially insoluble silicone adhesive that is bonded to the elongate body, and in which the substantially soluble particles are selected from the group consisting of dexamethasone, dexamethasone acetate and dexamethasone sodium phosphate.

50. A device including:

a flexible elongate body having a proximal and a distal end and a peripheral surface; and

a partially dissolvable coating at least partially on a portion of the peripheral surface of the elongate body, the coating providing a swollen surface after being exposed to an aqueous substance, the coating including a plurality of substantially soluble particles dispersed in a substantially insoluble silicone adhesive that is bonded to the elongate body, and in which the substantially soluble particles are selected from the group consisting of dexamethasone, dexamethasone acetate and dexamethasone sodium phosphate.

51. A device including:

a flexible elongate body having a proximal and a distal end and a peripheral surface; and

an at least partially-dissolvable means for coating a portion of the peripheral surface at or near the distal end of the elongate body, providing a rough surface after being exposed to an aqueous substance, for fixation of tissue thereto.

52. A device including:

a flexible elongate body having a proximal and a distal end and a peripheral surface; and

an at least partially-dissolvable means for coating a portion of the peripheral surface at or near the distal end of the elongate body, providing a porous surface after being exposed to an aqueous substance, for fixation of tissue thereto.

53. A device including:

a flexible elongate body having a proximal and a distal end and a peripheral surface; and

an at least partially-dissolvable means for coating a portion of the peripheral surface at or near the distal end of the elongate body, providing a swollen surface, after being exposed to an aqueous substance, for fixation of tissue thereto.

54. A method including:

implanting an implantable medical device;

exposing the an implantable medical device to an aqueous substance; and

partially dissolving a coating at least partially on a portion of the implantable medical device to provide a rough surface, thereby promoting tissue ingrowth.

55. A method including:

implanting an implantable medical device;

exposing the an implantable medical device to an aqueous substance; and

partially dissolving a coating at least partially on a portion of the implantable medical device to provide a porous surface, thereby promoting tissue ingrowth.

56. A method including:

implanting an implantable medical device;

exposing the an implantable medical device to an aqueous substance; and

partially dissolving a coating at least partially on a portion of the implantable medical device to provide a swollen surface, thereby promoting tissue ingrowth.

57. A method comprising:

covering at least a portion of an implantable medical device with an insulating peripheral surface; and

coating at least a portion of the insulating peripheral surface with an at least partially dissolvable coating, the coating providing a rough surface after being exposed to an aqueous substance.

58. A method comprising:

covering at least a portion of an implantable medical device with an insulating peripheral surface; and

coating at least a portion of the insulating peripheral surface with an at least partially dissolvable coating, the coating providing at least one of a porous surface after being exposed to an aqueous substance.

59. A method comprising:

covering at least a portion of an implantable medical device with an insulating peripheral surface; and

coating at least a portion of the insulating peripheral surface with an at least partially dissolvable coating, the coating providing a swollen surface after being exposed to an aqueous substance.