Subcutaneous electrode and lead with temporary pharmacological agents

• US 20040230273A1
• Filed: 11/07/2003
• 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: Wagner, Darrell Orvin, Cates, Adam W., Heil, Ron, Lindstrom, Curtis Charles
• Granted Patent: US 7,529,592 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 1/0504 Subcutaneous electrodes
• 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

Abstract

An implantable subcutaneous device and method employ a lead and an electrode for cardiac monitoring and intervention. The device includes an implantable lead having a lead body, a subcutaneous electrode coupled to the lead body, and a pharmacological agent provided on the implantable lead and/or electrode. 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 system, comprising:

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

2. The lead system according to claim 1, wherein the temporary therapeutic treatment is localized to an area substantially surrounding a subcutaneous dissection path.

3. The lead system according to claim 1, wherein a duration of the pharmacological agent'"'"'s effectiveness is shorter than about 1 hour.

4. The lead system according to claim 1, wherein a duration of the pharmacological agent'"'"'s effectiveness is shorter than about 2 days.

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

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

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

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

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

10. An implantable system, comprising:

a can;

a lead comprising a lead body, the lead body extending from the can;

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 implantable system, the pharmacological agent providing a temporary therapeutic treatment to subcutaneous non-intrathoracic tissue.

11. The implantable system according to claim 10, wherein the temporary therapeutic treatment is localized to an area substantially surrounding a subcutaneous dissection path.

12. The implantable system according to claim 10, wherein a duration of the pharmacological agent'"'"'s effectiveness is shorter than about 1 hour.

13. The implantable system according to claim 10, wherein a duration of the pharmacological agent'"'"'s effectiveness is shorter than about 2 days.

14. The implantable system according to claim 10, wherein the pharmacological agent comprises an analgesic or an anesthetic.

15. The implantable system according to claim 10, wherein the pharmacological agent comprises an antibiotic or an antiseptic.

16. The implantable system according to claim 10, wherein the pharmacological agent comprises a steroid or an anti-inflammatory agent.

17. The implantable system according to claim 10, wherein the pharmacological agent comprises an agent that promotes hemostasis or provides vasoconstriction.

18. The implantable system according to claim 10, wherein the pharmacological agent comprises collagen or an agent that increases a rate of healing.

19. 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 electrode, the pharmacological agent providing a temporary therapeutic treatment to subcutaneous non-intrathoracic tissue.

20. The lead according to claim 19, wherein the temporary therapeutic treatment is localized to an area substantially surrounding a subcutaneous dissection path.

21. The lead according to claim 19, wherein a duration of the pharmacological agent'"'"'s effectiveness is shorter than about 1 hour.

22. The lead according to claim 19, wherein the electrode further comprises a collar, the pharmacological agent disposed at the collar.

23. The lead according to claim 19, wherein the lead further comprises a polymeric structure, the pharmacological agent infused within the polymeric structure.

24. The lead according to claim 19, wherein the electrode further comprises a porous region, the pharmacological agent at least partially filling pores of the porous region.

25. The lead according to claim 19, wherein at least a portion of the electrode comprises a coating, the coating comprising the pharmacological agent.

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

27. The lead according to claim 19, wherein the pharmacological agent comprises an analgesic or an anesthetic.

28. The lead according to claim 19, wherein the pharmacological agent comprises an antibiotic or an antiseptic.

29. The lead according to claim 19, wherein the pharmacological agent comprises a steroid or an anti-inflammatory agent.

30. The lead according to claim 19, wherein the pharmacological agent comprises an agent that promotes hemostasis or provides vasoconstriction.

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

32. An implantable lead, comprising:

a lead body;

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

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

33. The lead according to claim 32, wherein the temporary therapeutic treatments are localized to an area substantially surrounding a subcutaneous dissection path.

34. The lead according to claim 32, wherein at least one of the pharmacological agents is provided at a plurality of locations on the electrode assembly.

35. The lead according to claim 32, wherein at least two pharmacological agents are provided at a plurality of locations on the electrode assembly.

36. The lead according to claim 32, wherein a duration of at least one of the pharmacological agent'"'"'s effectiveness is shorter than about 1 hour.

37. The lead according to claim 32, wherein a duration of at least two of the pharmacological agent'"'"'s effectiveness is shorter than about 1 hour.

38. The lead according to claim 32, wherein the lead comprises a collar, at least one of the pharmacological agents disposed at the collar.

39. The lead according to claim 32, wherein the lead further comprises a polymeric structure, at least one of the plurality of pharmacological agents infused within the polymeric structure.

40. The lead according to claim 32, wherein the electrode assembly comprises a porous region, a first pharmacological agent of the plurality of pharmacological agents at least partially filling pores of the porous region.

41. The lead according to claim 40, wherein at least a portion of the electrode assembly comprises a coating, the coating comprising a second pharmacological agent of the plurality of pharmacological agents.

42. The lead according to claim 40, wherein at least a portion of the electrode assembly comprises a second pharmacological agent of the plurality of pharmacological agents, the second pharmacological agent covering at least a portion of the first pharmacological agent, thereby delaying release of at least a portion of the first pharmacological agent until after at least a majority of an effective period of the second pharmacological agent has elapsed.

43. The lead according to claim 42, wherein the second pharmacological agent comprises an analgesic or an anesthetic, and the first pharmacological agent comprises an antibiotic or an antiseptic.

44. The lead according to claim 42, wherein a duration of the second pharmacological agent'"'"'s effectiveness is shorter than about 1 hour and a duration of the first pharmacological agent'"'"'s effectiveness is longer than about 1 day.

45. The lead according to claim 42, wherein the second pharmacological agent comprises an analgesic and an antiseptic, and the first pharmacological agent comprises an antibiotic.

46. The lead according to claim 32, wherein at least a first pharmacological agent of the plurality of pharmacological agents is disposed as a coating on at least a portion of the electrode assembly.

47. The lead according to claim 46, wherein the coating covers at least 25% of a surface area of the electrode assembly.

48. The lead according to claim 46, wherein a second pharmacological agent of the plurality of pharmacological agents is disposed as a coating on at least a portion of the first pharmacological coating.

49. The lead according to claim 48, wherein the second pharmacological agent comprises an analgesic or an anesthetic, and the first pharmacological agent comprises an antibiotic or an antiseptic.

50. The lead according to claim 48, wherein a duration of the second pharmacological agent'"'"'s effectiveness is shorter than about 1 hour and a duration of the first pharmacological agent'"'"'s effectiveness is longer than about 1 day.

51. The lead according to claim 32, wherein at least one of the pharmacological agents of the plurality of pharmacological agents comprises an analgesic or an anesthetic.

52. The lead according to claim 32, wherein at least one of the pharmacological agents of the plurality of pharmacological agents comprises an antibiotic or an antiseptic.

53. The lead according to claim 32, wherein at least one of the pharmacological agents of the plurality of pharmacological agents comprises a steroid or an anti-inflammatory agent.

54. The lead according to claim 32, wherein at least one of the pharmacological agents of the plurality of pharmacological agents comprises an agent that promotes hemostasis or provides vasoconstriction.

55. A method of lead implantation, comprising:

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

delivering the pharmacological agent from the electrode to subcutaneous non-intrathoracic tissue substantially surrounding the electrode.

56. The method according to claim 55, wherein the pharmacological agent is delivered through a diffusion process.

57. The method according to claim 55, wherein delivering the pharmacological agent comprises delivering a first agent having a first activity and delivering a second agent having a second activity.

58. The method according to claim 57, wherein the first activity occurs for shorter than about 1 hour and the second activity occurs for longer than about 1 hour.

59. The method according to claim 57, wherein the first activity comprises analgesia or anesthesia and the second activity comprises antisepsis or antibiosis.

60. The method according to claim 57, wherein the first activity lasts shorter than about 1 hour and the second activity lasts more than about 1 day.

61. 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 substantially surrounding the electrode.

62. The lead according to claim 61, 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.

63. The lead according to claim 62, wherein the first pharmacological agent comprises an analgesic or an anesthetic, and the second pharmacological agent comprises an antibiotic or an antiseptic.

64. The lead according to claim 61, wherein the pharmacological agent comprises an analgesic or an anesthetic.

65. The lead according to claim 61, wherein the pharmacological agent comprises an antibiotic or an antiseptic.

66. The lead according to claim 61, wherein the pharmacological agent comprises a steroid or an anti-inflammatory agent.

67. The lead according to claim 61, wherein the pharmacological agent comprises an agent that promotes hemostasis or provides vasoconstriction.

68. An implantable system, comprising:

a can;

a lead comprising a lead body and provided with the can;

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 can, the pharmacological agent providing a temporary therapeutic treatment to subcutaneous non-intrathoracic tissue.

69. The system according to claim 68, wherein the temporary therapeutic treatment is localized to an area substantially surrounding the can.

70. The system according to claim 68, wherein a duration of the pharmacological agent'"'"'s effectiveness is shorter than about 1 hour.

71. The system according to claim 68, wherein the can comprises a porous region, the pharmacological agent at least partially filling pores of the porous region.

72. The system according to claim 68, wherein at least a portion of the can comprises a coating, the coating comprising the pharmacological agent.

73. The system according to claim 72, wherein the coating covers at least 25% of a surface area of the can.

74. The system according to claim 68, wherein the pharmacological agent comprises an analgesic or an anesthetic.

75. The system according to claim 68, wherein the pharmacological agent comprises an antibiotic or an antiseptic.

76. The system according to claim 68, wherein the pharmacological agent comprises a steroid or an anti-inflammatory agent.

77. The system according to claim 68, wherein the pharmacological agent comprises an agent that promotes hemostasis or provides vasoconstriction.

78. The system according to claim 68, wherein the pharmacological agent comprises collagen or an agent that increases a rate of healing.

79. An implantable lead, comprising:

a lead body;

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; and

an electrode coupled to the lead body, the electrode configured for subcutaneous non-intrathoracic placement within a patient, wherein a first pharmacological agent is provided on at least a portion of the electrode.

80. The lead according to claim 79, wherein at least one of the plurality of pharmacological agents is provided at a plurality of locations on the lead body.

81. The lead according to claim 79, wherein at least two of the plurality of pharmacological agents are provided at a plurality of locations on the lead body.

82. The lead according to claim 79, wherein a duration of effectiveness of at least one of the plurality of pharmacological agents or the first pharmacological agent is shorter than about 1 hour.

83. The lead according to claim 79, wherein a duration of effectiveness of at least two of the plurality of pharmacological agents or the first pharmacological agent is shorter than about 1 hour.

84. The lead according to claim 79, wherein the lead comprises a collar, at least one of the pharmacological agents disposed at the collar.

85. The lead according to claim 79, wherein the lead further comprises a polymeric structure, at least one of the plurality of pharmacological agents infused within the polymeric structure.

86. The lead according to claim 79, wherein a second pharmacological agent of the plurality of pharmacological agents is disposed as a coating on at least a portion of the lead.

87. The lead according to claim 86, wherein the second pharmacological agent covers at least a portion of a porous region of the lead body, thereby delaying release of at least a portion of one of the plurality of pharmacological agents until after commencement of an effective period of the second pharmacological agent.

88. The lead according to claim 87, wherein the second pharmacological agent comprises an analgesic or an anesthetic, and the first pharmacological agent comprises an antibiotic or an antiseptic.

89. The lead according to claim 86, wherein a duration of the second pharmacological agent'"'"'s effectiveness is shorter than about 1 hour and a duration of the first pharmacological agent'"'"'s effectiveness is longer than about 1 day.

90. The lead according to claim 86, wherein the second pharmacological agent comprises an analgesic and an antiseptic, and the first pharmacological agent comprises an antibiotic.

91. The lead according to claim 79, wherein at least one of the plurality of pharmacological agents or the first pharmacological agent comprises an analgesic or an anesthetic.

92. The lead according to claim 79, wherein at least one of the plurality of pharmacological agents or the first pharmacological agent comprises an antibiotic or an antiseptic.

93. The lead according to claim 79, wherein at least one of the plurality of pharmacological agents or the first pharmacological agent comprises a steroid or an anti-inflammatory agent.

94. The lead according to claim 79, wherein at least one of the plurality of pharmacological agents or the first pharmacological agent comprises an agent that promotes hemostasis or provides vasoconstriction.

95. An implantable system, comprising:

a can;

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

a first pharmacological agent provided on the lead, the first pharmacological agent providing a temporary therapeutic treatment to subcutaneous non-intrathoracic tissue; and

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

96. The system according to claim 95, wherein the temporary therapeutic treatment is localized to subcutaneous non-intrathoracic tissue.

97. The system according to claim 95, wherein a duration of effectiveness of one or both of the first and second pharmacological agents is shorter than about 1 hour.

98. The system according to claim 95, wherein the lead comprises a porous region, the first pharmacological agent at least partially filling the pores of the porous region.

99. The system according to claim 95, wherein at least a portion of the lead comprises a coating, the coating comprising the first pharmacological agent.

100. The system according to claim 99, wherein the coating covers at least 25% of a surface area of the lead.

101. The system according to claim 95, wherein one or both of the first and second pharmacological agents comprises an analgesic or an anesthetic.

102. The system according to claim 95, wherein one or both of the first and second pharmacological agents comprises an antibiotic or an antiseptic.

103. The system according to claim 95, wherein one or both of the first and second pharmacological agents comprises a steroid or an anti-inflammatory agent.

104. The system according to claim 95, wherein one or both of the first and second pharmacological agents comprises an agent that promotes hemostasis or provides vasoconstriction.

105. The system according to claim 95, wherein one or both of the first and second pharmacological agents comprises collagen or an agent that increases a rate of healing.

106. The system according to claim 95, wherein a duration of effectiveness of the first pharmacological agent is about equal to a duration of effectiveness of the second pharmacological agent.

107. The system according to claim 95, wherein a duration of effectiveness of the first pharmacological agent is longer than about 1 day and a duration of effectiveness of the second pharmacological agent is shorter than about 2 hours.