Subcutaneous lead with temporary pharmacological agents

• US 20040230272A1
• Filed: 11/07/2003
• Published: 11/18/2004
• Est. Priority Date: 04/11/2003
• Status: Abandoned Application

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Wagner, Darrell Orvin, Cates, Adam W., Heil, Ron, Lindstrom, Curtis Charles
• Application Number:
  US10/703,409
• Publication Number:
  US 20040230272A1
• 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 1/36542 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
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

An implantable subcutaneous device and method employ a lead and/or electrode for cardiac monitoring and intervention. The device includes an implantable lead having a lead body, a subcutaneous electrode supported by the lead body, and a pharmacological agent provided on the implantable lead body and/or an inactive can portion. The pharmacological agent provides a temporary 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 delivering the pharmacological agent to subcutaneous non-intrathoracic tissue surrounding the lead.

Claims

1. An implantable lead, comprising:

a lead body;

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

a pharmacological agent provided on the lead body, the pharmacological agent providing a temporary therapeutic treatment to subcutaneous non-intrathoracic tissue.

2. The lead according to claim 1, wherein the pharmacological agent'"'"'s effectiveness is shorter than about one hour.

3. The lead according to claim 1, wherein the pharmacological agent'"'"'s effectiveness is shorter than about one day.

4. The lead according to claim 1, wherein the pharmacological agent'"'"'s effectiveness is shorter than about two weeks.

5. The lead according to claim 1, wherein the temporary therapeutic treatment is localized to an area substantially surrounding at least a portion of a subcutaneous dissection path.

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

7. The lead according to claim 1, wherein the pharmacological agent comprises a membrane provided on the lead.

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 comprises a collar, the pharmacological agent provided at the collar.

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

11. The lead according to claim 1, wherein the lead 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 13, wherein the coating covers at least 25% of a surface area of the lead.

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

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

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

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

19. The lead according to claim 1, wherein the pharmacological agent comprises collagen or an agent that increases a rate of healing.

20. An implantable system, comprising:

a can comprising an inactive area that is not electrically coupled to tissue substantially surrounding at least a portion of the inactive area;

a lead body;

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

a pharmacological agent provided on at least a portion of the inactive area of the can, the pharmacological agent providing a temporary therapeutic treatment to subcutaneous non-intrathoracic tissue.

21. The system according to claim 20, wherein the pharmacological agent'"'"'s effectiveness is shorter than about one hour.

22. The system according to claim 20, wherein the pharmacological agent'"'"'s effectiveness is shorter than about one day.

23. The system according to claim 20, wherein the pharmacological agent'"'"'s effectiveness is shorter than about two weeks.

24. The system according to claim 20, the can further comprising an insulating coating insulating a portion or all of the inactive area of the can from surrounding tissue, wherein the insulating coating comprises the pharmacological agent.

25. The system according to claim 20, wherein the pharmacological agent comprises a membrane provided on the can.

26. The system according to claim 20, wherein the pharmacological agent is impregnated into a membrane provided on the can.

27. The system according to claim 20, wherein the can comprises a porous region, the pharmacological agent at least partially filling pores of the porous region.

28. The system according to claim 27, wherein the porous region comprises a doped polymer matrix.

29. The system according to claim 20, wherein the pharmacological agent is disposed in a coating on the can.

30. The system according to claim 29, wherein the coating covers at least 25% of the inactive area of the can.

31. The system according to claim 20, wherein the pharmacological agent comprises an analgesic or an anesthetic.

32. The system according to claim 20, wherein the pharmacological agent comprises an antibiotic or an antiseptic.

33. The system according to claim 20, wherein the pharmacological agent comprises a steroid or an anti-inflammatory agent.

34. The system according to claim 20, wherein the pharmacological agent comprises an agent that promotes hemostasis or provides vasoconstriction.

35. The system according to claim 20, wherein the pharmacological agent comprises collagen or an agent that increases a rate of healing.

36. The system according to claim 20, comprising a plurality of pharmacological agents provided on at least a portion of the inactive area of the can, the pharmacological agents providing temporary therapeutic treatments to subcutaneous non-intrathoracic tissue.

37. An implantable lead, comprising:

a lead body;

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

a plurality of pharmacological agents provided on the lead body, the pharmacological agents providing a plurality of temporary therapeutic treatments to subcutaneous non-intrathoracic tissue.

38. The lead according to claim 37, wherein the effectiveness of at least one of the pharmacological agents of the plurality of pharmacological agents is shorter than about one hour.

39. The lead according to claim 37, wherein the effectiveness of a first pharmacological agent of the plurality of pharmacological agents is shorter than about one hour and the effectiveness of a second pharmacological agent of the plurality of pharmacological agents is greater than about one hour and shorter than about two weeks.

40. The lead according to claim 37, wherein the effectiveness of at least two of the pharmacological agents of the plurality of pharmacological agents is shorter than about one hour.

41. The lead according to claim 37, wherein the effectiveness of at least two of the pharmacological agents of the plurality of pharmacological agents is greater than about one hour and shorter than about two weeks.

42. The lead according to claim 37, wherein the temporary therapeutic treatments are localized to an area substantially surrounding at least a portion of a subcutaneous dissection path.

43. The lead according to claim 37, wherein at least one of the pharmacological agents of the plurality of pharmacological agents is provided at a plurality of locations on the lead body.

44. The lead according to claim 37, wherein at least two pharmacological agents of the plurality of pharmacological agents are provided at a plurality of locations on the lead body.

45. The lead according to claim 37, wherein at least one of the pharmacological agents of the plurality of pharmacological agents is impregnated into a membrane provided on the lead.

46. The lead according to claim 37, wherein at least one of the pharmacological agents of the plurality of pharmacological agents comprises a membrane provided on the lead.

47. The lead according to claim 37, wherein the lead comprises a collar, wherein at least one of the pharmacological agents of the plurality of pharmacological agents is provided at the collar.

48. The lead according to claim 37, wherein the lead comprises a polymeric structure, at least one of the pharmacological agents of the plurality of pharmacological agents infused within the polymeric structure.

49. The lead according to claim 37, wherein the lead comprises a porous region, a first pharmacological agent of the plurality of pharmacological agents at least partially filling the pores of the porous region.

50. The lead according to claim 49, wherein the porous region comprises a doped polymer matrix.

51. The lead according to claim 50, wherein a second pharmacological agent of the plurality of pharmacological agents coats a portion of the lead.

52. The lead according to claim 51, wherein the second pharmacological agent covers at least a portion of the porous region, thereby delaying release of at least a portion of the first pharmacological agent until after a majority of an effectiveness period of the second pharmacological agent has elapsed.

53. The lead according to claim 51, wherein the second pharmacological agent comprises an analgesic or an anesthetic, and the first pharmacological agent comprises an antibiotic or an antiseptic.

54. The lead according to claim 51, wherein an effectiveness of the second pharmacological agent is shorter than about one day and an effectiveness of the first pharmacological agent is greater than about one day.

55. The lead according to claim 51, wherein the second pharmacological agent comprises an analgesic and an antiseptic, and the first pharmacological agent comprises an antibiotic.

56. The lead according to claim 37, wherein at least a first pharmacological agent of the plurality of pharmacological agents is provided in a coating on the lead.

57. The lead according to claim 56, wherein the coating covers at least 25% of a surface area of the lead.

58. The lead according to claim 56, wherein a second pharmacological agent of the plurality of pharmacological agents coats at least a portion of the first pharmacological coating.

59. The lead according to claim 58, wherein the second pharmacological agent comprises an analgesic or an anesthetic, and the first pharmacological agent comprises an antibiotic or an antiseptic.

60. The lead according to claim 58, wherein an effectiveness of the second pharmacological agent is shorter than about one day and an effectiveness of the first pharmacological agent is greater than about one day.

61. The lead according to claim 37, wherein at least one of the pharmacological agents of the plurality of pharmacological agents comprises an analgesic or an anesthetic.

62. The lead according to claim 37, wherein at least one of the pharmacological agents of the plurality of pharmacological agents comprises an antibiotic or an antiseptic.

63. The lead according to claim 37, wherein at least one of the pharmacological agents of the plurality of pharmacological agents comprises a steroid or an anti-inflammatory agent.

64. The lead according to claim 37, wherein at least one of the pharmacological agents of the plurality of pharmacological agents comprises an agent that promotes hemostasis or provides vasoconstriction.

65. The lead according to claim 37, wherein at least one of the pharmacological agents of the plurality of pharmacological agents comprises collagen or an agent that increases a rate of healing.

66. The lead according to claim 37, wherein a first pharmacological agent of the plurality of pharmacological agents provides a first dosage of the first pharmacological agent, and a second pharmacological agent of the plurality of pharmacological agents provides a second dosage of the first pharmacological agent.

67. An implantable lead system, comprising:

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

a delivery apparatus comprising a sheath configured to introduce the lead to a desired subcutaneous non-intrathoracic location within the patient; and

a pharmacological agent provided on the sheath.

68. The lead system according to claim 67, wherein the pharmacological agent'"'"'s effectiveness is shorter than about one hour.

69. The lead system according to claim 67, wherein the pharmacological agent'"'"'s effectiveness is shorter than about one day.

70. The lead system according to claim 67, wherein the pharmacological agent'"'"'s effectiveness is shorter than about two weeks.

71. The lead system according to claim 67, wherein the pharmacological agent is provided at a plurality of locations on the sheath.

72. The lead system according to claim 67, wherein the sheath comprises a polymeric structure, the pharmacological agent infused within the polymeric structure.

73. The lead system according to claim 67, wherein the sheath comprises a porous region, the pharmacological agent at least partially filling the pores of the porous region.

74. The lead system according to claim 73, wherein the porous region comprises a doped polymer matrix.

75. The lead system according to claim 67, wherein the pharmacological agent is provided in a coating on the sheath.

76. The lead system according to claim 75, wherein the coating covers at least 25% of a surface area of the sheath.

77. The lead system according to claim 67, wherein the pharmacological agent comprises an analgesic or an anesthetic.

78. The lead system according to claim 67, wherein the pharmacological agent comprises an antibiotic or an antiseptic.

79. The lead system according to claim 67, wherein the pharmacological agent comprises a steroid or an anti-inflammatory agent.

80. The lead system according to claim 67, wherein the pharmacological agent comprises an agent that promotes hemostasis or provides vasoconstriction.

81. The lead system according to claim 67, further comprising a pharmacological agent provided on the lead body, the pharmacological agent providing a temporary therapeutic treatment to subcutaneous non-intrathoracic tissue.

82. A method of lead implantation, comprising:

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

delivering the pharmacological agent from the lead to subcutaneous non-intrathoracic tissue substantially surrounding at least a portion of the lead.

83. The method according to claim 82, wherein the pharmacological agent'"'"'s effectiveness is shorter than about one hour.

84. The method according to claim 82, wherein the pharmacological agent'"'"'s effectiveness is shorter than about one day.

85. The method according to claim 82, wherein the pharmacological agent'"'"'s effectiveness is shorter than about two weeks.

86. The method according to claim 82, wherein the pharmacological agent is delivered through a diffusion process.

87. The method according to claim 82, wherein delivering the pharmacological agent comprises delivering a first agent having a first activity and delivering a second agent having a second activity.

88. The method according to claim 82, wherein delivering the pharmacological agent comprises delivering a first agent at a first dosage and delivering the first agent at a second dosage.

89. The method according to claim 88, wherein the first activity occurs for shorter than about one hour and the second activity occurs for longer than about one hour.

90. The method according to claim 88, wherein the first activity comprises analgesia or anesthesia and the second activity comprises antisepsis or antibiosis.

91. The method according to claim 88, wherein the first activity lasts shorter than about one day and the second activity lasts longer than about one day.

92. The method according to claim 82, further comprising:

providing a removable sheath having a lumen;

advancing the lead through the lumen; and

retracting the sheath away from the lead.

93. An implantable 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 for delivering a pharmacological agent to subcutaneous non-intrathoracic tissue.

94. The lead according to claim 93, wherein the delivering means comprises a first means for delivering a first pharmacological agent having a first effectiveness time period and a second means for delivering a second pharmacological agent having a second effectiveness time period.

95. The lead according to claim 94, wherein the first pharmacological agent comprises an analgesic or an anesthetic, and the second pharmacological agent comprises an antibiotic or an antiseptic.

96. The lead according to claim 93, wherein the pharmacological agent comprises an analgesic or an anesthetic.

97. The lead according to claim 93, wherein the pharmacological agent comprises an antibiotic or an antiseptic.

98. The lead according to claim 93, wherein the pharmacological agent comprises a steroid or an anti-inflammatory agent.

99. The lead according to claim 93, wherein the pharmacological agent comprises an agent that promotes hemostasis or provides vasoconstriction.

100. The lead according to claim 93, wherein the pharmacological agent comprises collagen or an agent that increases a rate of healing.