Subcutaneous electrode and lead with phoresis based pharmacological agent delivery

• US 20040230274A1
• Filed: 12/04/2003
• Published: 11/18/2004
• Est. Priority Date: 04/11/2003
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Haefner, Paul A., Wagner, Darrell Orvin, Cates, Adam W., Heil, Ron, Lindstrom, Curtis Charles
• Granted Patent: US 7,702,399 B2
• Time in Patent Office: Days
• US Class Current: 607/120
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0568 with drug delivery
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy

Abstract

An implantable subcutaneous device includes a lead and electrode for cardiac monitoring and intervention. The device has an implantable lead including a lead body, a subcutaneous electrode supported by the lead body and a pharmacological agent impelled from the device using phoresis. The pharmacological agent provides a therapeutic treatment to subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads involves providing a lead including a lead body, a subcutaneous electrode, and a pharmacological agent and using phoresis to impel the pharmacological agent into subcutaneous non-intrathoracic tissue surrounding the lead.

Claims

1. An implantable cardiac lead, comprising:

a lead body;

an electrode supported by the lead body, the electrode configured for subcutaneous non-intrathoracic placement within a patient; and

a driving arrangement coupled to the lead, the driving arrangement configured to provide phoresis delivery of a pharmacological agent from the lead to subcutaneous tissue.

2. The lead according to claim 1, wherein the driving arrangement comprises the electrode supported by the lead body, the electrode configured for one or both of cardiac monitoring and stimulation.

3. The lead according to claim 1, wherein the driving arrangement comprises a transducer adapted to provide sonophoresis.

4. The lead according to claim 1, wherein the electrode is configured as an electrode array, and the driving arrangement comprises the electrode array.

5. The lead according to claim 1, wherein the driving arrangement comprises a conductor adapted to provide electrophoresis.

6. The lead according to claim 1, wherein the pharmacological agent provides therapeutic treatment localized to an area substantially surrounding at least a portion of a subcutaneous dissection path.

7. The lead according to claim 1, wherein the pharmacological agent is provided at a plurality of locations on the lead body.

8. The lead according to claim 1, wherein the pharmacological agent is impregnated into a membrane provided on the lead.

9. The lead according to claim 1, wherein the lead further comprises a collar, the pharmacological agent provided at the collar.

10. The lead according to claim 1, wherein the lead further comprises a polymeric structure, the pharmacological agent infused within the polymeric structure.

11. The lead according to claim 1, wherein the lead further comprises a porous region, the pharmacological agent at least partially filling pores of the porous region.

12. The lead according to claim 11, wherein the porous region comprises a doped polymer matrix.

13. The lead according to claim 1, wherein the pharmacological agent is disposed in a coating on the lead.

14. The lead according to claim 1, wherein the pharmacological agent comprises an analgesic or an anesthetic.

15. The lead according to claim 1, wherein the pharmacological agent comprises an antibiotic or an antiseptic.

16. The lead according to claim 1, wherein the pharmacological agent comprises a steroid or an anti-inflammatory agent.

17. The lead according to claim 1, wherein the pharmacological agent comprises an agent that promotes hemostasis or provides vasoconstriction.

18. An implantable system, comprising:

a lead, comprising;

a lead body; and

an electrode coupled to the lead body, the electrode configured for subcutaneous non-intrathoracic placement within a patient; and

a can coupled to the lead, the can configured to provide phoresis delivery of a pharmacological agent from at least a portion of the can to subcutaneous tissue.

19. The system according to claim 18, wherein the can is configured to provide electrophoresis.

20. The system according to claim 18, wherein the can is configured to provide sonophoresis.

21. The system according to claim 18, further comprising a driving arrangement provided on the lead and configured to provide phoresis delivery of a pharmacological agent from at least a portion of the lead to the subcutaneous tissue.

22. The system according to claim 18, wherein the lead and the can are configured to produce an electric potential between the lead and the can, the electric potential produced to provide the phoresis delivery of the pharmacological agent.

23. The system according to claim 18, wherein the pharmacological agent is impregnated into a membrane provided on the can.

24. The system according to claim 18, wherein the can comprises a reservoir fluidly coupled to a port defined on the portion of the can, the reservoir comprising one or more chambers for storing one or more pharmacological agents.

25. The system according to claim 18, wherein the can comprises a porous region, the pharmacological agent at least partially filling pores of the porous region.

26. The system according to claim 25, wherein the porous region comprises a doped polymer matrix.

27. The system according to claim 18, wherein the pharmacological agent is disposed in a coating on the can.

28. The system according to claim 27, wherein the coating covers at least 25% of a surface area of the can.

29. The system according to claim 18, wherein the pharmacological agent comprises an analgesic or an anesthetic.

30. The system according to claim 18, wherein the pharmacological agent comprises an antibiotic or an antiseptic.

31. The system according to claim 18, wherein the pharmacological agent comprises a steroid or an anti-inflammatory agent.

32. The system according to claim 18, wherein the pharmacological agent comprises an agent that promotes hemostasis or provides vasoconstriction.

33. A method of lead implantation, comprising:

delivering a lead into subcutaneous non-intrathoracic tissue of a patient, the lead comprising a lead body, an electrode, and a pharmacological agent on the lead; and

impelling, using phoresis, the pharmacological agent from at least a portion of the lead to the subcutaneous non-intrathoracic tissue.

34. The method according to claim 33, wherein impelling the pharmacological agent comprises generating an electric field for impelling the pharmacological agent using electrophoresis.

35. The method according to claim 33, wherein impelling the pharmacological agent comprises generating ultrasonic waves for impelling the pharmacological agent ultrasonically.

36. The method according to claim 33, wherein impelling the pharmacological agent using phoresis comprises impelling a plurality of pharmacological agents.

37. The method according to claim 33, wherein impelling the pharmacological agent comprises impelling a first pharmacological agent using electrophoresis and impelling a second pharmacological agent using sonophoresis.

38. The method according to claim 33, further comprising

delivering a can into subcutaneous non-intrathoracic tissue of the patient, the can comprising an electrode or an electrically conductive region, and a pharmacological agent;

and

impelling, using phoresis, the pharmacological agent from at least a portion of the can to the subcutaneous non-intrathoracic tissue.

39. The method according to claim 38, wherein impelling the pharmacological agent from the can comprises generating an electric field for impelling the pharmacological agent from the can using electrophoresis.

40. The method according to claim 38, wherein impelling the pharmacological agent comprises generating ultrasonic waves for impelling the pharmacological agent ultrasonically from the can.

41. The method according to claim 38, wherein impelling the pharmacological agent from the can using phoresis comprises impelling a plurality of pharmacological agents from the can.

42. The method according to claim 38, wherein impelling the pharmacological agent from the can comprises impelling a first pharmacological agent using electrophoresis and impelling a second pharmacological agent using sonophoresis.

43. The method according to claim 33, further comprising:

providing a removable sheath having a lumen;

advancing the lead through the lumen to an implant location; and

removing the sheath from the lead with the lead remaining at the implant location.

44. The method according to claim 33, wherein the pharmacological agent comprises an analgesic or an anesthetic.

45. The method according to claim 33, wherein the pharmacological agent comprises an antibiotic or an antiseptic.

46. The method according to claim 33, wherein the pharmacological agent comprises a steroid or an anti-inflammatory agent.

47. The method according to claim 33, wherein the pharmacological agent comprises an agent that promotes hemostasis or provides vasoconstriction.

48. An implantable cardiac lead, comprising:

a lead body;

an electrode coupled to the lead body, the electrode configured for subcutaneous non-intrathoracic placement in a patient; and

means, coupled to the implantable lead, for impelling a pharmacological agent using phoresis into subcutaneous non-intrathoracic tissue.

49. The lead according to claim 48, wherein the impelling means comprises means for impelling the pharmacological agent using electrophoresis.

50. The lead according to claim 48, wherein the impelling means comprises means for impelling the pharmacological agent using sonophoresis.

51. The lead according to claim 48, wherein the pharmacological agent comprises an analgesic or an anesthetic.

52. The lead according to claim 48, wherein the pharmacological agent comprises an antibiotic or an antiseptic.

53. The lead according to claim 48, wherein the pharmacological agent comprises a steroid or an anti-inflammatory agent.

54. The lead according to claim 48, wherein the pharmacological agent comprises an agent that promotes hemostasis or provides vasoconstriction.

55. A system, comprising:

an implantable medical device, comprising;

a can that houses circuitry configured to provide one or both of cardiac monitoring and cardiac stimulation; and

a lead coupled to the can, the lead comprising a lead body and an electrode coupled to the lead body, the electrode configured for subcutaneous non-intrathoracic placement within a patient; and

a driver apparatus detachably coupled to the implantable medical device, the driver apparatus configured to facilitate phoresis delivery of a pharmacological agent from one or both of the can and the lead.

56. The system according to claim 55, wherein the driver apparatus facilitates electrophoresis delivery of the pharmacological agent.

57. The system according to claim 55, wherein the driver apparatus facilitates sonophoresis delivery of the pharmacological agent.

58. The system according to claim 55, wherein the lead and the can are configured to produce an electric potential between the lead and the can to provide the phoresis delivery of the pharmacological agent.

59. The system according to claim 55, wherein the driver is configured to provide a phoresis power signal to the implantable medical device.

60. The system according to claim 59, wherein the phoresis power signal is a DC voltage.

61. The system according to claim 59, wherein the phoresis power signal is an AC signal alternating at an ultrasonic frequency.

62. The system according to claim 59, wherein the phoresis power signal is a DC bias voltage with an AC signal alternating at an ultrasonic frequency.

63. The system according to claim 55, wherein the pharmacological agent comprises an analgesic or an anesthetic.

64. The system according to claim 55, wherein the pharmacological agent comprises an antibiotic or an antiseptic.

65. The system according to claim 55, wherein the pharmacological agent comprises a steroid or an anti-inflammatory agent.

66. The system according to claim 55, wherein the pharmacological agent comprises an agent that promotes hemostasis or provides vasoconstriction.