Methods and systems involving subcutaneous electrode positioning relative to a heart

• US 20040230230A1
• Filed: 06/19/2003
• 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., Lindstrom, Curtis Charles
• Application Number:
  US10/465,520
• Publication Number:
  US 20040230230A1
• Time in Patent Office: Days
• US Class Current: 607/4
• CPC Class Codes: A61B 17/320068 using mechanical vibrations, e.g. ultrasonic A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745
• CPC Class Codes: A61B 17/3203 Fluid jet cutting instruments
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/320084 Irrigation sleeves
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/3945 Active visible markers, e.g. light emitting diodes
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• 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 1/056 Transvascular endocardial electrode systems
• 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 1/39622 : Pacing therapy

Abstract

An approach for implementing a subcutaneous medical electrode system involves positioning a number of electrode subsystems in relation to a heart so that a majority of ventricular tissue is included within a volume defined between the electrode subsystems. One of the electrode subsystems so positioned may include a can electrode located on a housing enclosing a medical device. The medical device may be configured to provide therapeutic, diagnostic, or monitoring functions, including, for example, cardiac arrhythmia therapy.

Claims

1. A medical system, comprising:

a housing;

a medical device disposed within the housing; and

subcutaneous electrode subsystems coupled to the medical device, the electrode subsystems positioned relative to a heart so that a majority of ventricular tissue is included within a volume defined between the electrode subsystems.

2. The system of claim 1, wherein the volume defined between the electrode subsystems comprises a volume defined between active portions of the electrode subsystems.

3. The system of claim 1, wherein the volume defined between the electrode subsystems comprises a volume defined between a coil electrode and a can electrode.

4. The system of claim 1, wherein the volume defined between the electrode subsystems comprises a volume defined between a first coil electrode and a second coil electrode.

5. The system of claim 1, wherein the volume defined between the electrode subsystems comprises a volume defined between a first can electrode and a second can electrode.

6. The system of claim 1, wherein the volume defined between the electrode subsystems comprises a volume associated with a cross sectional area defined by ends of the electrode subsystems.

7. The system of claim 6, wherein the ends of the electrode subsystems include a medial edge and a lateral edge of a can electrode.

8. The system of claim 6, wherein the ends of the electrode subsystems include a proximal end and a distal end of a coil electrode.

9. The system of claim 1, wherein the housing is positioned subcutaneously.

10. The system of claim 1, wherein the housing is positioned in a left pectoral region.

11. The system of claim 1, wherein the housing is positioned in a right pectoral region.

12. The system of claim 1, wherein the housing is configured to have a volume ranging from about 20 cm³ to about 100 cm³.

13. The system of claim 1, wherein the housing is configured to have a surface area ranging from about 30 cm² to about 100 cm².

14. The system of claim 1, wherein the housing is configured to have a thickness ranging from about 0.4 cm to about 2 cm.

15. The system of claim 1, wherein the medical device comprises a diagnostic device.

16. The system of claim 1, wherein the medical device comprises a therapeutic device.

17. The system of claim 1, wherein the medical device comprises a monitoring device.

18. The system of claim 1, wherein the medical device comprises a cardiac rhythm management system.

19. The system of claim 1, wherein the medical device is configured to deliver pacing stimulation to the heart.

20. The system of claim 1, wherein the medical device is configured to deliver cardioversion/defibrillation stimulation to the heart.

21. The system of claim 1, wherein one or more of the electrode subsystems are configured to sense one or more physiological signals.

22. The system of claim 21, wherein the physiological signals are cardiac system signals.

23. The system of claim 21, wherein the physiological signals are respiratory system signals.

24. The system of claim 21, wherein the physiological signals are patient activity signals.

25. The system of claim 1, wherein one or more of the electrode subsystems comprise at least one coil electrode.

26. The system of claim 1, wherein one or more of the electrode subsystems comprise at least one electrode having multiple coils.

27. The system of claim 1, wherein one or more of the electrode subsystems comprise at least one spiral coil electrode.

28. The system of claim 1, wherein one or more of the electrode subsystems comprise at least one coil electrode mounted on a non-conductive substrate.

29. The system of claim 1, wherein one or more of the electrode subsystems comprise at least one screen patch electrode.

30. The system of claim 1, wherein one or more of the electrode subsystems comprise a coil electrode having a length ranging from about 5 cm to about 12 cm.

31. The system of claim 1, wherein one or more of the electrode subsystems comprise a coil electrode having a preformed curve.

32. The system of claim 1, wherein one or more of the electrode subsystems comprise a coil electrode having a diameter ranging from about 3 French to about 15 French.

33. The system of claim 1, wherein at least one of the electrode subsystems is coupled to the medical device through a lead.

34. The system of claim 1, wherein at least one of the electrode subsystems comprises a first electrode located at a distal end of a lead and a second electrode located proximate the first electrode.

35. The system of claim 34, wherein the second electrode comprises a coil electrode.

36. The system of claim 34, wherein the first electrode comprises a ring electrode and the second electrode comprises a coil electrode.

37. The system of claim 34, wherein the first electrode comprises a coil electrode and the second electrode comprises a ring electrode.

38. A medical system, comprising:

a medical device disposed within a housing, the housing comprising a can electrode; and

a subcutaneous electrode subsystem coupled to the medical device, wherein the can electrode and the electrode subsystem are positioned relative to a heart so that a majority of ventricular tissue is included within a volume defined between the can electrode and the electrode subsystem.

39. The system of claim 38, wherein the housing is positioned subcutaneously.

40. The system of claim 38, wherein the housing is positioned in a right pectoral region and the electrode subsystem is positioned in relation to an inferior aspect of the heart.

41. The system of claim 38, wherein the housing is positioned in a right pectoral region and the electrode subsystem is positioned in relation to an apex of the heart.

42. The system of claim 38, wherein the housing is positioned in a left pectoral region and the electrode subsystem is positioned in relation to an inferior aspect of the heart.

43. The system of claim 38, wherein the housing is positioned in a left pectoral region and the electrode subsystem is positioned substantially parallel to a right ventricular free wall.

44. The system of claim 43, wherein one end of the electrode subsystem extends a predetermined distance beyond an apex of the heart.

45. The system of claim 44, wherein the predetermined distance is less than about 3 cm.

46. The system of claim 38, wherein the electrode subsystem comprises a coil electrode.

47. The system of claim 46, wherein the length of the coil electrode ranges from about 5 cm to about 12 cm.

48. The system of claim 38, wherein the majority of ventricular tissue is included within a volume defined by medial and lateral edges of the can electrode and proximal and distal ends of the coil.

49. A medical system, comprising:

a housing;

a medical device disposed within the housing; and

first and second subcutaneous electrode subsystems coupled to the medical device, wherein the first and the second subcutaneous electrode subsystems are positioned relative to a heart so that a majority of ventricular tissue is included within a volume defined between the first and the second electrode subsystems.

50. The system of claim 49, wherein the first electrode subsystem is positioned in relation to a superior aspect of the heart and the second electrode subsystem is positioned in relation to an inferior aspect of the heart.

51. The system of claim 49, wherein the first electrode subsystem is positioned in relation to a left ventricle and the second electrode subsystem is positioned in relation to a right ventricle.

52. The system of claim 49, wherein the first electrode subsystem is positioned substantially parallel to a left ventricular free wall.

53. The system of claim 52, wherein one end of the first electrode subsystem extends a predetermined distance beyond an apex of the heart.

54. The system of claim 53, wherein the predetermined distance is less than about 3 cm.

55. The system of claim 49, wherein the second electrode subsystem is positioned substantially parallel to a right ventricular free wall.

56. The system of claim 49, wherein one end of the second electrode subsystem extends a predetermined distance beyond an apex of the heart.

57. The system of claim 56, wherein the predetermined distance is less than about 3 cm.

58. The system of claim 49, wherein the first electrode subsystem comprises a first coil electrode and the second electrode subsystem comprises a second coil electrode.

59. The system of claim 58, wherein the majority of ventricular tissue is included within a volume defined between respective proximal and distal ends of the first coil electrode and respective proximal and distal ends of the second coil electrode.

60. An electrode system, comprising:

a first subcutaneous electrode subsystem; and

a second subcutaneous electrode subsystem positionable so that a majority of ventricular tissue is included within a volume defined between the first and the second electrode subsystems.

61. The system of claim 60, wherein the first electrode subsystem is positionable in relation to a superior aspect of the heart and the second electrode subsystem is positionable in relation to an inferior aspect of the heart.

62. The system of claim 60, wherein the first electrode subsystem is positionable in relation to a left ventricle and the second electrode subsystem is positionable in relation to a right ventricle.

63. The system of claim 60, wherein the first electrode subsystem is positionable substantially parallel to a left ventricular free wall.

64. The system of claim 60, wherein one end of the first electrode subsystem extends a predetermined distance beyond an apex of the heart.

65. The system of claim 60, wherein at least one of the electrode subsystems comprises a can electrode.

66. The system of claim 60, wherein at least one of the electrode subsystems comprises a coil electrode.

67. The system of claim 60, wherein at least one of the electrode subsystems comprises a spiral coil.

68. The system of claim 60, wherein at least one of the electrode subsystems comprises a spiral coil mounted on a non-conductive substrate.

69. The system of claim 60, wherein at least one of the electrode subsystems comprises a screen patch electrode.

70. The system of claim 60, wherein at least one of the electrode subsystems comprises a coil electrode having a length ranging between about 5 cm and about 12 cm.

71. The system of claim 60, wherein at least one of the electrode subsystems comprises a coil electrode having a preformed curve.

72. The system of claim 60, wherein at least one of the electrode subsystems comprises a coil electrode having a diameter ranging between about 3 French and about 15 French.

73. The system of claim 60, wherein at least one of the electrode subsystems comprises a first electrode located at a distal end of a lead.

74. The system of claim 73, wherein the at least one electrode subsystem further comprises a second electrode located proximate the first electrode.

75. The system of claim 74, wherein the second electrode comprises a coil electrode.

76. The system of claim 74, wherein the first electrode comprises a ring electrode and the second electrode comprises a coil electrode.

77. The system of claim 74, wherein the first electrode comprises a coil electrode and the second electrode comprises a ring electrode.

78. The system of claim 60, wherein at least one of the electrode subsystems comprises a first electrode located at a distal end of a lead, a second electrode located proximate the first electrode, and a third electrode located proximate the second electrode.

79. The system of claim 78, wherein the first electrode comprises a coil electrode.

80. The system of claim 78, wherein the first electrode comprises a coil electrode and the second and third electrodes comprise ring electrodes.

81. The system of claim 78, wherein the third electrode comprises a coil electrode.

82. The system of claim 78, wherein the third electrode comprises a coil electrode and the first and second electrodes comprise ring electrodes.

83. The system of claim 78, wherein the second electrode comprise a coil electrode.

84. The system of claim 78, wherein the second electrode comprises a coil electrode and the first and third electrodes comprise ring electrodes.

85. A method, comprising:

providing subcutaneous electrode subsystems coupled to a medical device disposed within a housing; and

positioning the electrode subsystems in relation to a heart so that a majority of ventricular tissue is included within a volume defined between the electrode subsystems.

86. The method of claim 85, further comprising sensing physiological signals using the electrode subsystems.

87. The method of claim 86, wherein sensing the physiological signals comprises sensing respiratory system signals.

88. The method of claim 86, wherein sensing the physiological signals comprises sensing cardiac system signals.

89. The method of claim 86, wherein sensing the physiological signals comprises sensing signals associated with patient activity.

90. The method of claim 86, wherein sensing the physiological signals comprises sensing transthoracic impedance signals.

91. The method of claim 86, further comprising monitoring one or more patient conditions using the sensed physiological signals.

92. The method of claim 85, further comprising sensing electrical activity of the heart using the subcutaneous electrode subsystems.

93. The method of claim 85, further comprising delivering electrical stimulation to the heart using the subcutaneous electrode subsystems.

94. The method of claim 93, wherein delivering electrical stimulation to the heart comprises delivering cardioversion/defibrillation stimulation.

95. The method of claim 93, wherein delivering electrical stimulation to the heart comprises delivering pacing stimulation.

96. The method of claim 85, wherein positioning the electrode subsystems comprises:

positioning a first electrode subsystem in relation to a superior aspect of the heart; and

positioning a second electrode subsystem in relation to an inferior aspect of the heart.

97. The method of claim 96, wherein positioning the first electrode subsystem comprises positioning the first electrode subsystem on the housing and positioning the housing subcutaneously in a pectoral region.

98. The method of claim 85, wherein positioning the electrode subsystems comprises positioning at least one electrode subsystem substantially parallel to a ventricular free wall.

99. The method of claim 85, wherein positioning the electrode subsystems comprises positioning at least one electrode subsystem parallel to a ventricular free wall and extending a predetermined distance beyond the apex of the heart.

100. The method of claim 99, wherein the predetermined distance is less than about 3 cm.

101. A medical device, comprising:

means for sensing physiological conditions;

means for detecting cardiac arrhythmia based on the sensed physiological conditions; and

means for electrically stimulating a heart to mitigate the cardiac arrhythmia, the means for electrically stimulating the heart positioned subcutaneously in relation to the heart so that a majority of ventricular tissue is included within a volume defined between the means for electrically stimulating the heart.