Subcutaneous electrode and lead with temporary pharmacological agents

• US 7,529,592 B2
• Filed: 11/07/2003
• Issued: 05/05/2009
• Est. Priority Date: 04/11/2003
• Status: Expired due to Fees

• 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
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Bertram; Eric D
• Application Number:
  US10/703,410
• Publication Number:
  US 20040230273A1
• Time in Patent Office: 2,006 Days
• Field of Search: 607/116, 607/119, 607/120
• 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, the lead body comprising a proximal end, a distal end, and a midpoint equidistant from the proximal and distal ends;

a cardiac electrode coupled to the lead body, the electrode and lead body configured for placement within a tunnel surgically formed in subcutaneous non-intrathoracic tissue;

a plurality of fixation elements disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation elements situated proximal of the midpoint such that the at least one of the fixation elements is closer to the proximal end than the distal end of the lead body, the at least one of the fixation elements configured to facilitate fixation of a proximal portion of the lead body to a proximal portion of the tunnel, and at least one other of the fixation elements situated distal of the midpoint such that the at least one other of the fixation elements is closer to the distal end than the proximal end of the lead body, the at least one other of the fixation elements configured to facilitate fixation of a distal portion of the lead body to a distal portion of the tunnel; and

a pharmacological agent provided along at least a major portion comprising at least a quarter of the lead body length, the pharmacological agent having a coverage that provides a temporary therapeutic treatment.

2. The lead system according to claim 1, wherein the lead has mechanical memory such that the lead is shape-fitable under manual force to a desired shape and generally retains the shape after implantation.

3. The lead system according to claim 2, wherein the mechanical memory of the lead is facilitated by a braid system incorporated into the lead.

4. The lead system according to claim 1, further comprising an implantable housing containing therapy circuitry coupled to the lead, wherein the lead comprises a rigid elongated structure configured to positionally stabilize the cardiac electrode with respect to the housing such that the rigid elongated structure maintains a particular spacing between the cardiac electrode and the housing.

5. The lead system according to claim 1, further comprising an implantable housing containing therapy circuitry coupled to the lead, wherein the lead and the housing form a rigid unitary structure having an arcuate shape with the cardiac electrode and another electrode near opposing ends of the unitary structure.

6. The lead system according to claim 1, further comprising a sheath located over the lead and covering the pharmacological agent, wherein retraction of the sheath relative to the lead exposes the pharmacological agent and initiates a period of pharmacological activity by the pharmacological agent as the pharmacological agent is allowed to diffuse into tissue.

7. The lead system according to claim 1, further comprising a coating containing the pharmacological agent, the coating applied along the lead and over a removable mask covering the cardiac electrode.

8. The lead system according to claim 1, further comprising:

a groove in the lead body; and

a collar seated in the groove, the collar comprising a plurality of layers, each layer having a different one of a plurality of different pharmacological agents, the plurality of different pharmacological agents including the pharmacological agent.

9. The lead system according to claim 1, further comprising:

a groove in the lead body;

a collar seated in the groove, the collar containing the pharmacological agent; and

an encapsulation layer covering the collar, the encapsulation layer comprising a non-dissolving semi-permeable membrane that regulates diffusion of the pharmacological agent.

10. The system of claim 1, wherein the plurality of fixation elements are tissue penetrating elements.

11. The system of claim 1, wherein the plurality of fixation elements are tines.

12. The system of claim 1, wherein at least one of the plurality of fixation elements comprises an expandable fixation element.

13. The system of claim 1, wherein the at least one other of the fixation elements situated distal of the midpoint is a tissue penetrating helix and the at least one of the fixation elements situated proximal to the midpoint is an expandable fixation element.

14. An implantable system, comprising:

a can;

a lead comprising a lead body, the lead body extending from the can and comprising a proximal end, and distal end, and a midpoint between the proximal and distal ends;

a cardiac electrode coupled to the lead body, the electrode and the lead body configured for placement within a tunnel surgically formed in subcutaneous non-intrathoracic tissue;

a plurality of fixation elements disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation elements situated proximal of the midpoint such that the at least one of the fixation elements is closer to the proximal end than the distal end of the lead body, the at least one of the fixation elements configured to facilitate fixation of a proximal portion of the lead body to a proximal portion of the tunnel, and at least one other of the fixation elements situated distal of the midpoint such that the at least one other of the fixation elements is closer to the distal end than the proximal end of the lead body, the at least one other of the fixation elements configured to facilitate fixation of a distal portion of the lead body to a distal portion of the tunnel; and

a pharmacological agent provided along at least a major portion comprising at least a quarter of the lead body length, the pharmacological agent having a coverage that provides a temporary therapeutic treatment.

15. The implantable system according to claim 14, wherein the temporary therapeutic treatment is localized to an area substantially surrounding a subcutaneous dissection path.

16. The implantable system according to claim 14, wherein a duration of the pharmacological agent'"'"'s effectiveness is shorter than about 1 hour.

17. The implantable system according to claim 14, wherein a duration of the pharmacological agent'"'"'s effectiveness is shorter than about 2 days.

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

19. The implantable system according to claim 14, wherein the pharmacological agent comprises an antibiotic or an antiseptic.

20. The implantable system according to claim 14, wherein the pharmacological agent comprises a steroid or an anti-inflammatory agent.

21. The implantable system according to claim 14, wherein the pharmacological agent comprises an agent that promotes hemostasis or provides vasoconstriction.

22. The implantable system according to claim 14, wherein the pharmacological agent comprises collagen or an agent that increases a rate of healing.

23. An implantable lead, comprising:

a lead body comprising a proximal end, a distal end, and a midpoint between the proximal and distal ends;

a cardiac electrode coupled to the lead body, the electrode and lead body configured for placement within a tunnel surgically formed in subcutaneous non-intrathoracic tissue;

a plurality of fixation elements disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation elements situated proximal to the midpoint such that the at least one of the fixation elements is closer to the proximal end than the distal end of the lead body, the at least one of the fixation elements configured to facilitate fixation of a proximal portion of the lead body to a proximal portion of the tunnel, and at least one other of the fixation elements situated distal of the midpoint such that the at least one other of the fixation elements is closer to the distal end than the proximal end of the lead body, the at least one other of the fixation elements configured to facilitate fixation of a distal portion of the lead body to a distal portion of the tunnel; and

a pharmacological agent provided on at least a major portion of the lead body, including the electrically active portions of the electrode, the pharmacological agent having a coverage that provides a temporary therapeutic treatment, the electrically active portions of the electrode remaining electrically active for delivering cardiac stimulation energy through the pharmacological agent at the electrically active portions after provision of the pharmacological agent.

24. The lead according to claim 23, wherein the temporary therapeutic treatment is localized to an area substantially surrounding a subcutaneous dissection path.

25. The lead according to claim 23, wherein a duration of the pharmacological agent'"'"'s effectiveness is shorter than about 1 hour.

26. The lead according to claim 23, wherein the electrode further comprises a collar, the pharmacological agent disposed at the collar.

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

28. The lead according to claim 23, wherein the electrode further comprises a porous region, the pharmacological agent at least partially filling pores of the porous region.

29. The lead according to claim 23, wherein at least a portion of the electrode comprises a coating, the coating comprising the pharmacological agent.

30. The lead according to claim 29, wherein the coating covers at least 25% of a surface area of the electrode.

31. The lead according to claim 23, wherein the pharmacological agent comprises an analgesic or an anesthetic.

32. The lead according to claim 23, wherein the pharmacological agent comprises an antibiotic or an antiseptic.

33. The lead according to claim 23, wherein the pharmacological agent comprises a steroid or an anti-inflammatory agent.

34. The lead according to claim 23, wherein the pharmacological agent comprises an agent that promotes hemostasis or provides vasoconstriction.

35. The lead according to claim 23, wherein the pharmacological agent comprises collagen or an agent that increases a rate of healing.

36. An implantable lead, comprising:

a lead body comprising a proximal end, a distal end, and a midpoint between the proximal and distal ends;

a cardiac electrode assembly coupled to the lead body, the electrode assembly and the lead body configured for placement within a tunnel surgically formed in subcutaneous non-intrathoracic tissue;

a plurality of fixation elements disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation elements situated proximal to the midpoint such that the at least one of the fixation elements is closer to the proximal end than the distal end of the lead body, the at least one of the fixation elements configured to facilitate fixation of a proximal portion of the lead body to a proximal portion of the tunnel, and at least one other of the fixation elements situated distal of the midpoint such that the at least one other of the fixation elements is closer to the distal end than the proximal end of the lead body, the at least one other of the fixation elements configured to facilitate fixation of a distal portion of the lead body to a distal portion of the tunnel; and

a plurality of pharmacological agents provided along at least a major portion of the lead, the pharmacological agents providing a plurality of temporary therapeutic treatments to the subcutaneous non-intrathoracic tissue, at least one of the pharmacological agents providing a temporary therapeutic treatment.

37. The lead according to claim 36, wherein the lead body has mechanical memory such that the lead body is shape-fitable under manual force to a desired shape and generally retains the shape after implantation.

38. The lead according to claim 37, wherein the mechanical memory of the lead body is facilitated by a braid system incorporated into the lead body.

39. The lead according to claim 36, further comprising an implantable housing containing therapy circuitry coupled to the lead body, wherein the lead body comprises a rigid elongated structure configured to positionally stabilize the cardiac electrode with respect to the housing such that the rigid elongated structure maintains a particular spacing between the cardiac electrode and the housing.

40. The lead according to claim 36, further comprising an implantable housing containing therapy circuitry coupled to the lead body, wherein the lead body and the housing form a rigid unitary structure having an arcuate shape with the cardiac electrode and another electrode on opposing ends of the unitary structure.

41. The lead according to claim 36, further comprising a sheath located over the lead body and covering the pharmacological agent, wherein retraction of the sheath relative to the lead body exposes the pharmacological agent and initiates a period of pharmacological activity by the pharmacological agent as the pharmacological agent is allowed to diffuse into tissue.

42. The lead according to claim 36, further comprising a coating containing at least one pharmacological agent of the plurality, the coating applied along the lead body and over a removable mask covering the cardiac electrode.

43. The lead according to claim 36, further comprising:

a groove in the lead body; and

a collar seated in the groove, the collar comprising a plurality of layers, each layer containing a different one of the plurality of pharmacological agents.

44. The lead according to claim 36, 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.

45. The lead according to claim 44, 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.

46. The lead according to claim 44, 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.

47. The lead according to claim 46, wherein the second pharmacological agent comprises an analgesic or an anesthetic, and the first pharmacological agent comprises an antibiotic or an antiseptic.

48. The lead according to claim 46, 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.

49. The lead according to claim 46, wherein the second pharmacological agent comprises an analgesic and an antiseptic, and the first pharmacological agent comprises an antibiotic.

50. The lead according to claim 36, 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.

51. The lead according to claim 50, wherein the coating covers at least 25% of a surface area of the electrode assembly.

52. The lead according to claim 50, 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.

53. The lead according to claim 52, 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 36, further comprising:

a groove in the lead body;

a collar seated in the groove, the collar containing at least one of the plurality of pharmacological agents; and

an encapsulation layer covering the collar, the encapsulation layer comprising a non-dissolving semi-permeable membrane that regulates diffusion of the at least one pharmacological agent from the collar.

55. The lead according to claim 36, wherein at least one of the pharmacological agents of the plurality of pharmacological agents comprises an analgesic or an anesthetic.

56. The lead according to claim 36, wherein at least one of the pharmacological agents of the plurality of pharmacological agents comprises an antibiotic or an antiseptic.

57. The lead according to claim 36, wherein at least one of the pharmacological agents of the plurality of pharmacological agents comprises a steroid or an anti-inflammatory agent.

58. The lead according to claim 36, wherein at least one of the pharmacological agents of the plurality of pharmacological agents comprises an agent that promotes hemostasis or provides vasoconstriction.

59. A method of lead implantation, comprising:

delivering into subcutaneous non-intrathoracic chest tissue along the rib cage, a cardiac lead comprising a lead body, a proximal end, a distal end, a midpoint between the proximal and distal ends, a proximal portion, a distal portion, a cardiac electrode, a plurality of fixation elements disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation elements situated proximal to the midpoint such that the at least one of the fixation elements is closer to the proximal end than the distal end of the lead and at least one other of the fixation elements situated distal of the midpoint such that the at least one other of the fixation elements is closer to the distal end than the proximal end of the lead, the cardiac lead having a pharmacological agent along at least a major portion of the lead body;

fixing the proximal portion of the lead body to a proximal portion of the tunnel using the at least one of the fixation elements situated proximal to the midpoint and fixing the distal portion of the lead body to a distal portion of the tunnel using the at least one other of the fixation elements situated distal of the midpoint; and

delivering the pharmacological agent from the lead body to subcutaneous non-intrathoracic chest tissue substantially surrounding the lead body, the pharmacological agent providing a temporary therapeutic treatment.

60. The method according to claim 59, wherein the plurality of fixation elements, including the at least one of the fixation elements and the at least one other of the fixation elements, comprise a plurality of tines.

61. The method according to claim 59, wherein delivering the pharmacological agent comprises delivering a first agent having a first activity and delivering a second agent having a second activity.

62. The method according to claim 61, wherein the first activity occurs for shorter than about 1 hour and the second activity occurs for longer than about 1 hour.

63. The method according to claim 61, wherein the first activity comprises analgesia or anesthesia and the second activity comprises antisepsis or antibiosis.

64. The method according to claim 61, wherein the first activity lasts shorter than about 1 hour and the second activity lasts more than about 1 day.

65. An implantable lead, comprising:

a lead body comprising a proximal end, a distal end, and a midpoint equidistant from the proximal and distal ends;

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

a plurality of fixation elements disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation elements situated proximal to the midpoint such that the at least one of the fixation elements is closer to the proximal end than the distal end of the lead body and at least one other of the fixation elements situated distal of the midpoint such that the at least one other of the fixation elements is closer to the distal end than the proximal end of the lead body; and

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

66. The lead according to claim 65, wherein the lead body has mechanical memory such that the lead body is shape-fitable under manual force to a desired shape and generally retains the shape after implantation.

67. The lead according to claim 65, further comprising an implantable housing containing therapy circuitry coupled to the lead body, wherein the lead body comprises a rigid elongated structure configured to positionally stabilize the cardiac electrode with respect to the housing such that the rigid elongated structure maintains a particular spacing between the cardiac electrode and the housing.

68. The lead according to claim 65, further comprising an implantable housing containing therapy circuitry coupled to the lead body, wherein the lead body and the housing form a rigid unitary structure having an arcuate shape with the cardiac electrode and another electrode near opposing ends of the unitary structure.

69. The lead according to claim 65, further comprising a sheath located over the lead body and covering the pharmacological agent, wherein retraction of the sheath relative to the lead body exposes the pharmacological agent and initiates a period of pharmacological activity by the pharmacological agent as the pharmacological agent is allowed to diffuse into tissue.

70. The lead according to claim 65, further comprising a coating containing the pharmacological agent, the coating applied along the lead body and over a removable mask covering the cardiac electrode.

71. The lead according to claim 65, further comprising:

a groove in the lead body;

a collar seated in the groove, the collar containing the pharmacological agent; and

an encapsulation layer covering the collar, the encapsulation layer comprising a non-dissolving semi-permeable membrane that regulates diffusion of the pharmacological agent.

72. An implantable system, comprising:

a can;

a lead comprising a lead body, a proximal end, a proximal portion, a distal end a midpoint equidistant from the proximal end and the distal end, and a distal portion, provided with the can;

a cardiac electrode coupled to the lead body, the electrode and lead body configured for subcutaneous non-intrathoracic placement within a tunnel surgically formed within subcutaneous non-intrathoracic tissue of a patient;

a plurality of fixation elements disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation elements situated proximal to the midpoint such that the at least one of the fixation elements is closer to the proximal end than the distal end of the lead body, the at least one of the fixation elements configured to facilitate fixation of the proximal portion of the lead body to a proximal portion of the tunnel, and at least one other of the fixation elements situated distal of the midpoint such that the at least one other of the fixation elements is closer to the distal end than the proximal end of the lead body, the at least one other of the fixation elements configured to facilitate fixation of the distal portion of the lead body to a distal portion of the tunnel; and

a pharmacological agent provided on the can, a major portion of the lead body, and the electrically active portions of the electrode, the pharmacological agent providing a temporary therapeutic treatment to subcutaneous non-intrathoracic tissue adjacent the can, lead body, and electrode, respectively, the electrically active portions of at least the electrode remaining electrically active for delivering cardiac stimulation energy through the pharmacological agent after provision of the pharmacological agent.

73. The system according to claim 72, wherein the lead comprises a rigid elongated structure configured to positionally stabilize the cardiac electrode with respect to the can such that the rigid elongated structure maintains a particular spacing between the cardiac electrode and the can.

74. The system according to claim 72, further comprising a sheath located over the lead and covering the pharmacological agent on the lead, wherein retraction of the sheath relative to the lead exposes the pharmacological agent on the lead and initiates a period of pharmacological activity by the pharmacological agent as the pharmacological agent is allowed to diffuse into tissue.

75. The system according to claim 72, wherein the lead and the can form a rigid unitary structure having an arcuate shape with the cardiac electrode and another electrode near opposing ends of the rigid unitary structure.

76. The system according to claim 72, wherein the lead has mechanical memory such that the lead is shape-fitable under manual force to a desired shape and retains the shape after implantation.

77. The system according to claim 76, wherein the mechanical memory of the lead is facilitated by a braid system incorporated into the lead.

78. The system according to claim 72, further comprising a coating containing the pharmacological agent, the coating applied along the lead and over a removable mask covering the cardiac electrode.

79. The system according to claim 72, further comprising:

a groove in the lead body; and

a collar seated in the groove, the collar comprising a plurality of layers, each layer having a different one of a plurality of different pharmacological agents, the plurality of different pharmacological agents including the pharmacological agent.

80. The system according to claim 72, further comprising:

a groove in the lead body;

a collar seated in the groove, the collar containing the pharmacological agent; and

an encapsulation layer covering the collar, the encapsulation layer comprising a non-dissolving semi-permeable membrane that regulates diffusion of the pharmacological agent from the collar.

81. The system according to claim 72, wherein the plurality of fixation elements comprises a plurality of tines.

82. The system according to claim 72, wherein the pharmacological agent comprises collagen or an agent that increases a rate of healing.

83. An implantable lead configured for placement within a tunnel surgically formed in subcutaneous non-intrathoracic tissue, comprising:

a lead body comprising a proximal end, a distal end, and a midpoint between the proximal and distal ends;

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

a plurality of fixation elements disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation elements situated proximal to the midpoint such that the at least one of the fixation elements is closer to the proximal end than the distal end of the lead body, the at least one of the fixation elements configured to facilitate fixation of a proximal portion of the lead body to a proximal portion of the tunnel, and at least one other of the fixation elements situated distal of the midpoint such that the at least one other of the fixation elements is closer to the distal end than the proximal end of the lead body, the at least one other of the fixation elements configured to facilitate fixation of a distal portion of the lead body to a distal portion of the tunnel; 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 electrically active portions of the electrode, and the electrically active portions of the electrode remain electrically active for delivering cardiac stimulation energy through the first pharmacological agent after provision of the first pharmacological agent.

84. The lead according to claim 83, wherein at least one of the plurality of pharmacological agents is provided at a plurality of locations on the lead body.

85. The lead according to claim 83, wherein at least two of the plurality of pharmacological agents are provided at a plurality of locations on the lead body.

86. The lead according to claim 83, 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.

87. The lead according to claim 83, 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.

88. The lead according to claim 83, wherein the lead comprises a collar, at least one of the pharmacological agents disposed at the collar.

89. The lead according to claim 83, wherein the lead further comprises a polymeric structure, at least one of the plurality of pharmacological agents infused within the polymeric structure.

90. The lead according to claim 83, wherein a second pharmacological agent of the plurality of pharmacological agents is disposed as a coating on at least a portion of the lead.

91. The lead according to claim 90, 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.

92. The lead according to claim 91, wherein the second pharmacological agent comprises an analgesic or an anesthetic, and the first pharmacological agent comprises an antibiotic or an antiseptic.

93. The lead according to claim 90, 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.

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

95. The lead according to claim 83, wherein at least one of the plurality of pharmacological agents or the first pharmacological agent comprises an analgesic or an anesthetic.

96. The lead according to claim 83, wherein at least one of the plurality of pharmacological agents or the first pharmacological agent comprises an antibiotic or an antiseptic.

97. The lead according to claim 83, wherein at least one of the plurality of pharmacological agents or the first pharmacological agent comprises a steroid or an anti-inflammatory agent.

98. The lead according to claim 83, wherein at least one of the plurality of pharmacological agents or the first pharmacological agent comprises an agent that promotes hemostasis or provides vasoconstriction.

99. An implantable system, comprising:

a can;

a lead provided with the can, the lead including a lead body, a proximal end, a proximal portion, a distal end, a distal portion, a midpoint equidistant from the distal and proximal ends, and an electrode, coupled to the lead body, the lead body and electrode configured for placement within a tunnel surgically formed in subcutaneous non-intrathoracic tissue;

a plurality of fixation tines disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation tines situated proximal to the midpoint such that the at least one of the fixation tines is closer to the proximal end than the distal end of the lead body, the at least one of the fixation tines configured to facilitate fixation of the proximal portion of the lead body to a proximal portion of the tunnel, and at least one other of the fixation tines situated distal of the midpoint such that the at least one other of the fixation tines is closer to the distal end than the proximal end of the lead body, the at least one other of the fixation tines configured to facilitate fixation of the distal portion of the lead body to a distal portion of the tunnel;

a first pharmacological agent provided on at least the proximal portion of the lead, the first pharmacological agent providing a temporary therapeutic treatment; and

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

100. The system according to claim 99, wherein the lead has mechanical memory such that the lead is shape-fitable under manual force to a desired shape and generally retains the shape after implantation.

101. The system according to claim 100, wherein the mechanical memory of the lead is facilitated by a braid system incorporated into the lead.

102. The system according to claim 99, wherein the lead comprises a rigid elongated structure configured to positionally stabilize the cardiac electrode with respect to the can such that the rigid elongated structure maintains a particular spacing between the cardiac electrode and the can.

103. The system according to claim 99, wherein the lead and the can form a rigid unitary structure having an arcuate shape with the cardiac electrode and at least one other electrode near opposing ends of the unitary structure.

104. The system according to claim 103, further comprising a sheath located over the lead and covering the first pharmacological agent, wherein retraction of the sheath relative to the lead exposes the first pharmacological agent and initiates a period of pharmacological activity by the first pharmacological agent as the first pharmacological agent is allowed to diffuse into tissue.

105. The system according to claim 99, further comprising a coating containing the first pharmacological agent, the coating applied along the lead and over a removable mask covering the cardiac electrode.

106. The system according to claim 99, further comprising:

a groove in the lead body;

a collar seated in the groove, the collar containing the first pharmacological agent; and

an encapsulation layer covering the collar, the encapsulation layer comprising a non-dissolving semi-permeable membrane that regulates diffusion of the pharmacological agent.

107. The system according to claim 99, wherein one or both of the first and second pharmacological agents comprises a steroid or an anti-inflammatory agent.

108. The system according to claim 99, wherein one or both of the first and second pharmacological agents comprises an agent that promotes hemostasis or provides vasoconstriction.

109. The system according to claim 99, wherein one or both of the first and second pharmacological agents comprises collagen or an agent that increases a rate of healing.

110. The system according to claim 99, wherein a duration of effectiveness of the first pharmacological agent is about equal to a duration of effectiveness of the second pharmacological agent.

111. The system according to claim 99, 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.