Hybrid transthoracic/intrathoracic cardiac stimulation devices and methods

• US 20040230229A1
• Filed: 06/13/2003
• 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: Favet, Mike, Gilliam, F. Roosevelt III, Lovett, Eric G., Haefner, Paul, Cates, Adam W., Larsen-Kelly, Kristine M.
• Application Number:
  US10/462,001
• Publication Number:
  US 20040230229A1
• Time in Patent Office: Days
• US Class Current: 607/4
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/37512 Pacemakers

Abstract

A cardiac sensing and stimulation system includes a housing within which energy delivery circuitry and detection circuitry are provided. Subcutaneous electrodes are coupled to the energy delivery and detection circuitry and arranged in a non-contacting relationship with respect to cardiac tissue, great vessels, and coronary vasculature. A lead system is coupled to the energy delivery and detection circuitry. The lead system electrodes are configured to contact cardiac tissue, great vessels, or coronary vasculature. A controller, provided in the housing, is coupled to the energy delivery and detection circuitry. The controller configures the system to operate in a first mode using at least the subcutaneous electrodes, and to operate in a second mode using at least the lead electrodes. The controller can selectively switch between the first and second modes, and selectively enable and disable components and circuitry associated with the first and second modes and combinations of these modes.

Claims

1. An implantable system, comprising:

a housing;

energy delivery circuitry provided in the housing;

detection circuitry provided in the housing;

one or more subcutaneous electrodes coupled to the energy delivery and detection circuitry and arranged in a non-contacting relationship with respect to cardiac tissue, great vessels, and coronary vasculature;

a lead system, comprising one or more lead electrodes, coupled to the energy delivery and detection circuitry, the lead electrodes configured to contact cardiac tissue, great vessels, or coronary vasculature; and

a controller provided in the housing and coupled to the energy delivery and detection circuitry, the system configurable by the controller to operate in a standard of care configuration using at least the lead electrodes, and to operate in an alternative configuration using at least the subcutaneous electrodes, each of the standard of care and alternative system configurations respectively capable of providing cardiac activity sensing and stimulation.

2. The system according to claim 1, wherein the system is configurable by the controller to operate in the standard of care configuration using only the lead electrodes.

3. The system according to claim 1, wherein the system is configurable by the controller to operate in the alternative configuration using only the subcutaneous electrodes.

4. The system according to claim 1, wherein the system is configurable by the controller to operate in the alternative configuration using at least one of the subcutaneous electrodes and at least one of the lead electrodes.

5. The system according to claim 1, wherein the housing comprises a can electrode, the system configurable by the controller to operate in the standard of care configuration or alternative configuration using the can electrode.

6. The system according to claim 1, wherein the controller configures the system to selectively operate in one of the standard of care configuration and the alternative configuration in response to a configuration signal received from a patient-external signal source.

7. The system according to claim 1, wherein the controller configures the system to operate in one of the alternative and standard of care configurations, and, in response to a predetermined condition, configures the system to switch operation to the other of the alternative and standard of care configurations or to a combination of the alternative and standard of care configurations.

8. The system according to claim 7, wherein the predetermined condition comprises unsuccessful detection of an arrhythmia.

9. The system according to claim 7, wherein the predetermined condition comprises unsuccessful treatment of an arrhythmia.

10. The system according to claim 7, wherein the predetermined condition comprises expiration of a predetermined amount of time.

11. The system according to claim 7, wherein the predetermined condition comprises occurrence of a scheduled event.

12. The system according to claim 7, wherein the predetermined condition comprises occurrence of a predetermined number of arrhythmic episodes.

13. The system according to claim 7, wherein the predetermined condition comprises occurrence of a predetermined type of arrhythmia.

14. The system according to claim 1, wherein the controller configures the system to operate concurrently in the standard of care configuration and the alternative configuration.

15. The system according to claim 1, wherein the controller configures the system to switch operation between the standard of care configuration and the alternative configuration during an arrhythmic event.

16. The system according to claim 1, wherein the controller configures the system to switch operation between the standard of care configuration and the alternative configuration to detect an arrhythmic event.

17. The system according to claim 1, wherein the controller configures the system to switch operation between the standard of care configuration and the alternative configuration to treat an arrhythmia.

18. The system according to claim 1, wherein the controller configures the system to detect an arrhythmia through use of electrodes associated with the standard of care configuration and the alternative configuration.

19. The system according to claim 1, wherein the controller configures the system to treat an arrhythmia through use of electrodes associated with the standard of care configuration and the alternative configuration.

20. The system according to claim 1, wherein the controller:

configures the system to operate in one of the alternative and standard of care configurations to perform a first function; and

configures the system to operate in the other of the alternative and standard of care configurations to perform a second function, wherein performance of the first function enhances performance of the second function.

21. The system according to claim 20, wherein the first function comprises a first energy delivery function to instill organization in an arrhythmia, and the second function comprises a second energy delivery function to terminate the arrhythmia.

22. The system according to claim 1, wherein:

the lead system comprises an atrial lead;

the standard of care configuration provides atrial activity sensing and atrial arrhythmia therapy delivery; and

the alternative configuration provides ventricular tachyarrhythmia backup therapy for the standard of care configuration.

23. The system according to claim 1, wherein:

the lead system comprises an atrial lead having one or more atrial electrodes; and

the controller configures the system to operate in the alternative configuration to facilitate tachyarrhythmia discrimination using the subcutaneous electrodes and the one or more atrial electrodes.

24. The system according to claim 23, wherein the controller discriminates tachyarrhythmias having a ventricular origin from tachyarrhythmias having an atrial origin.

25. The system according to claim 1, wherein:

at least two of the lead electrodes are disposed in a single heart chamber; and

the standard of care configuration provides one or both of multisite sensing and multisite stimulation with respect to the single heart chamber.

26. The system according to claim 1, wherein the lead system comprises one or more transvenous electrodes.

27. The system according to claim 1, wherein the lead system comprises one or more endocardial electrodes.

28. The system according to claim 1, wherein the lead system comprises one or more epicardial electrodes.

29. The system according to claim 1, wherein the housing defines a unitary structure, and each of the subcutaneous electrodes is respectively provided on the housing.

30. The system according to claim 1, wherein at least one of the subcutaneous electrodes is provided on a rigid or shape-alterable support structure extending outwardly from the housing.

31. An implantable system, comprising:

a housing;

energy delivery circuitry provided in the housing;

detection circuitry provided in the housing;

one or more subcutaneous electrodes coupled to the energy delivery and detection circuitry and arranged in a non-contacting relationship with respect to cardiac tissue, great vessels, and coronary vasculature;

a lead system, comprising one or more lead electrodes, coupled to the energy delivery and detection circuitry, the lead electrodes configured to contact cardiac tissue, great vessels, or coronary vasculature; and

a controller provided in the housing and coupled to the energy delivery and detection circuitry, the controller configuring the system to perform a particular function when operating in each of the first and second modes and to acquire performance data associated with performance of the particular function when operating in each of the first and second modes.

32. The system according to claim 31, wherein the particular function comprises a function associated with bradycardia and tachycardia sensing.

33. The system according to claim 31, wherein the particular function comprises a function associated with tachyarrhythmia detection.

34. The system according to claim 31, wherein the particular function comprises a first sub-function associated with rate-based tachyarrhythmia detection and a second sub-function associated with morphology-based tachyarrhythmia detection.

35. The system according to claim 31, wherein the particular function comprises a function associated with one or both of stimulus waveform generation and stimulus waveform delivery.

36. The system according to claim 31, wherein the particular function comprises a function involving a configuration of one or both of the lead system and the subcutaneous electrodes.

37. The system according to claim 31, wherein the lead system comprises one or more transvenous or endocardial electrodes.

38. The system according to claim 31, wherein the lead system comprises a can electrode of the housing.

39. The system according to claim 31, wherein the lead system comprises one or more epicardial electrodes.

40. The system according to claim 31, wherein the housing defines a unitary structure, and each of the subcutaneous electrodes is respectively provided on the housing.

41. The system according to claim 31, wherein at least one of the subcutaneous electrodes is provided on a rigid or shape-alterable support structure extending outwardly from the housing.

42. An implantable system, comprising:

a housing;

energy delivery circuitry provided in the housing;

detection circuitry provided in the housing;

one or more subcutaneous electrodes coupled to the energy delivery and detection circuitry and arranged in a non-contacting relationship with respect to cardiac tissue, great vessels, and coronary vasculature;

a lead system, comprising one or more lead electrodes, coupled to the energy delivery and detection circuitry, the lead electrodes configured to contact cardiac tissue, great vessels, or coronary vasculature; and

a controller provided in the housing and coupled to the energy delivery and detection circuitry, the controller configuring the system to operate in a first mode using at least the subcutaneous electrodes, and to operate in a second mode using at least the lead electrodes.

43. The system according to claim 42, wherein the controller configures the system to operate in the second mode using only the lead electrodes.

44. The system according to claim 42, wherein the controller configures the system to operate in the second mode using the lead electrodes and the subcutaneous electrodes.

45. The system according to claim 42, wherein, in the first mode, the subcutaneous electrodes sense conditions necessitating cardiac stimulation therapy and deliver cardiac stimulation therapy in response to the sensed conditions.

46. The system according to claim 42, wherein, in the second mode, the lead electrodes sense conditions necessitating cardiac stimulation therapy and deliver cardiac stimulation therapy in response to the sensed conditions.

47. The system according to claim 42, wherein, in the second mode, the lead electrodes sense conditions necessitating cardiac stimulation therapy and the subcutaneous electrodes deliver cardiac stimulation therapy in response to the sensed conditions.

48. The system according to claim 42, wherein, in the second mode, the subcutaneous electrodes sense conditions necessitating cardiac stimulation therapy and the lead electrodes deliver cardiac stimulation therapy in response to the sensed conditions.

49. The system according to claim 42, wherein the first and second modes comprise cardioversion/defibrillation modes.

50. The system according to claim 42, wherein the first and second modes comprise pacing modes.

51. The system according to claim 42, wherein one of the first and second modes comprises a pacing mode, and the other of the first and second modes comprises a cardioversion/defibrillation mode.

52. The system according to claim 42, wherein the controller comprises memory for storing information associated with each of the first and second modes.

53. The system according to claim 42, wherein the controller comprises memory for storing system performance information acquired when operating in each of the first and second modes.

54. The system according to claim 53, wherein the controller is coupled to communication circuitry for communicating with a patient-external processing system, the processing system receiving the system performance information acquired for each of the first and second modes in real-time or in a batch mode.

55. The system according to claim 53, wherein the patient-external processing system produces comparison data using the system performance information, the comparison data comprising data indicative of system performance when operating in one of the first and second modes relative to the other of the first and second modes.

56. The system according to claim 42, wherein the controller is coupled to communication circuitry for communicating with a patient-external processing system, the processing system communicating with the controller to selectively operate the system in the first mode or the second mode.

57. The system according to claim 42, wherein the controller configures the system to operate in one of the first and second modes as a primary mode of operation, and to operate in the other of the first and second modes as a redundant mode of operation, the controller configuring the system to operate in the redundant mode in response to detection of a sensing or energy delivery deficiency while operating in the primary mode.

58. The system according to claim 42, wherein at least one of the subcutaneous electrodes defines a can electrode of the housing, and at least one other subcutaneous electrode is electrically and physically coupled to the housing via a second lead.

59. The system according to claim 42, wherein the lead system comprises one or more transvenous electrodes.

60. The system according to claim 42, wherein the lead system comprises one or more endocardial electrodes.

61. The system according to claim 42, wherein the lead system comprises one or more epicardial electrodes.

62. The system according to claim 42, wherein the housing defines a unitary structure, and each of the subcutaneous electrodes is respectively provided on the housing.

63. The system according to claim 42, wherein at least one of the subcutaneous electrodes is provided on a rigid or shape-alterable support structure extending outwardly from the housing.

64. The system according to claim 42, wherein the controller:

configures the system to operate in one of the first and second modes to perform a first function; and

configures the system to operate in the other of the first and second modes to perform a second function, wherein performance of the first function enhances performance of the second function.

65. The system according to claim 64, wherein the first function comprises a first energy delivery function to instill organization in an arrhythmia, and the second function comprises a second energy delivery function to terminate the arrhythmia.

66. The system according to claim 42, wherein:

the lead system comprises an atrial lead;

the second mode provides atrial activity sensing and atrial arrhythmia therapy delivery; and

the first mode provides backup ventricular tachyarrhythmia therapy support for the second mode.

67. The system according to claim 42, wherein:

the lead system comprises an atrial lead having one or more atrial electrodes; and

the controller configures the system to operate in the first mode to facilitate tachyarrhythmia discrimination using the subcutaneous electrodes and the one or more atrial electrodes.

68. The system according to claim 67, wherein the controller discriminates tachyarrhythmias having a ventricular origin from tachyarrhythmias having an atrial origin.

69. The system according to claim 42, wherein:

at least two of the lead electrodes are disposed in a single heart chamber; and

the second mode provides one or both of multisite sensing and multisite stimulation with respect to the single heart chamber.

70. The system according to claim 42, wherein:

at least one of the lead electrodes is disposed in each of a plurality of heart chambers; and

the second mode provides one or both of multi-chamber sensing and multi-chamber stimulation with respect to the plurality of heart chambers.

71. The system according to claim 70, wherein the system is configurable to provide resynchronization therapy.

72. The system according to claim 42, wherein the controller configures one of the first and second modes as a standard of care mode, and the other of the first and second modes as a monitoring mode for monitoring operation of the system in the standard of care mode.

73. The system according to claim 42, wherein the controller configures the first mode as a monitor-only mode, and the second mode as a treatment mode.

74. A cardiac sensing and stimulation method, comprising:

in a first mode, transthoracicly sensing cardiac activity and, in response to cardiac conditions necessitating therapy sensed while operating in the first mode, delivering cardiac stimulation therapy transthoracicly or intrathoracicly;

in a second mode, intrathoracicly sensing cardiac activity and, in response to cardiac conditions necessitating therapy sensed while operating in the second mode, intrathoracicly or transthoracicly delivering cardiac stimulation therapy; and

selectively enabling and disabling the first and second modes for independent or cooperative operation.

75. The method according to claim 74, wherein:

in the first mode, sensing cardiac activity transthoracicly or intrathoracicly, and, in response to cardiac conditions necessitating therapy sensed while operating in the first mode, delivering cardiac stimulation therapy transthoracicly; and

in the second mode, sensing cardiac activity intrathoracicly or transthoracicly and, in response to cardiac conditions necessitating therapy sensed while operating in the second mode, intrathoracicly delivering cardiac stimulation therapy.

76. The method according to claim 74, wherein one of the first and second modes is a standard of care mode, and the other of the first and second modes is a monitoring mode.

77. The method according to claim 74, wherein the first mode is a monitor-only mode, and the second mode is a treatment mode.

78. The method according to claim 74, wherein selectively enabling and disabling the first and second modes comprises enabling the first and second modes for concurrent operation.

79. The method according to claim 74, wherein selectively enabling and disabling the first and second modes comprises selectively enabling and disabling the first and second modes for sequential operation.

80. The method according to claim 74, wherein selectively enabling and disabling the first and second modes comprises selectively enabling and disabling the first and second modes for tiered operation during an arrhythmic event.

81. The method according to claim 74, wherein the first and second modes comprise cardioversion/defibrillation modes.

82. The method according to claim 74, wherein the first and second modes comprise pacing modes.

83. The method according to claim 74, wherein one of the first and second modes comprises a pacing mode, and the other of the first and second modes comprises cardioversion/defibrillation mode.

84. The method according to claim 74, further comprising selectively enabling and disabling the first and second modes from a patient-external location.

85. The method according to claim 74, further comprising storing information associated with each of the first and second modes.

86. The method according to claim 74, further comprising storing performance information acquired when operating in each of the first and second modes.

87. The method according to claim 86, further comprising transmitting the performance information to a patient-external location in real-time or in a batch mode.

88. The method according to claim 86, further comprising producing comparison data using the performance information, the comparison data comprising data indicative of performance when operating in one of the first and second modes relative to the other of the first and second modes.

89. The method according to claim 74, further comprising operating in one of the first and second modes as a primary mode of operation, and operating in the other of the first and second modes as a redundant mode of operation in response to a deficiency detected while operating in the primary mode.

90. The method according to claim 74, wherein one of the first and second modes defines a standard of care mode, and the other of the first and second modes defines a test mode.

91. The method according to claim 74, further comprising:

performing a first function while operating in one of the first and second modes; and

performing a second function while operating in the other of the first and second modes, wherein performance of the first function enhances performance of the second function.

92. The method according to claim 91, wherein the first function comprises a first energy delivery function to instill organization in an arrhythmia, and the second function comprises a second energy delivery function to terminate the arrhythmia.

93. The method according to claim 74, further comprising:

sensing atrial activity; and

delivering one or both of bradycardia pacing and antitachycardia pacing.

94. The method according to claim 74, further comprising:

intrathoracicly sensing atrial activity; and

discriminating tachyarrhythmias using sensed ventricular activity and the sensed atrial activity.

95. The method according to claim 94, further comprising discriminating tachyarrhythmias having a ventricular origin from tachyarrhythmias having an atrial origin.

96. The method according to claim 74, wherein the second mode provides one or both of multisite sensing and multisite stimulation with respect to a single heart chamber.

97. The method according to claim 74, further comprising:

intrathoracicly sensing atrial activity and, in response to conditions necessitating atrial therapy, delivering atrial stimulation therapy intrathoracicly or transthoracicly; and

providing transthoracic ventricular tachyarrhythmia backup therapy in response to conditions necessitating ventricular therapy sensed while delivering atrial stimulation therapy.

98. A cardiac sensing and stimulation method, comprising:

in a first mode, transthoracicly sensing cardiac activity and, in response to cardiac conditions necessitating therapy sensed while operating in the first mode, delivering cardiac stimulation therapy transthoracicly or intrathoracicly;

in a second mode, intrathoracicly sensing cardiac activity and, in response to cardiac conditions necessitating therapy sensed while operating in the second mode, intrathoracicly or transthoracicly delivering cardiac stimulation therapy;

performing a particular function when operating in each of the first and second modes; and

acquiring performance data associated with performance of the particular function when operating in each of the first and second modes.

99. The method according to claim 98, wherein the particular function comprises a function associated with bradycardia and tachycardia sensing.

100. The method according to claim 98, wherein the particular function comprises a function associated with bradyarrhythmia or tachyarrhythmia detection.

101. The method according to claim 98, wherein the particular function comprises a first sub-function associated with rate-based tachyarrhythmia detection and a second sub-function associated with morphology-based tachyarrhythmia detection.

102. The method according to claim 98, wherein the particular function comprises a function associated with stimulus waveform generation or stimulus waveform delivery.

103. The method according to claim 98, wherein the particular function comprises a function involving a configuration of one or both of the lead system and the subcutaneous electrodes.

104. The method according to claim 98, further comprising storing performance information associated with performance of the particular function when operating in each of the first and second modes.

105. The method according to claim 104, further comprising transmitting the performance information to a patient-external location in real-time or in a batch mode.

106. The method according to claim 104, further comprising producing comparison data using the performance information, the comparison data comprising data indicative of performance when operating in one of the first and second modes relative to the other of the first and second modes.

107. A cardiac sensing and stimulation system, comprising:

means for transthoracicly sensing cardiac activity in a first mode;

means for delivering cardiac stimulation therapy transthoracicly or intrathoracicly in response to cardiac conditions necessitating therapy sensed while operating in the first mode;

means for intrathoracicly sensing cardiac activity in a second mode;

means for intrathoracicly or transthoracicly delivering cardiac stimulation therapy in response to cardiac conditions necessitating therapy sensed while operating in the second mode; and

means for selectively enabling and disabling the first and second modes.

108. The system according to claim 107, further comprising:

means for sensing cardiac activity transthoracicly or intrathoracicly in the first mode;

means for delivering cardiac stimulation therapy transthoracicly in response to cardiac conditions necessitating therapy sensed while operating in the first mode;

means for sensing cardiac activity intrathoracicly or transthoracicly in the second mode; and

means for intrathoracicly delivering cardiac stimulation therapy in response to cardiac conditions necessitating therapy sensed while operating in the second mode.

109. The system according to claim 107, further comprising:

means for performing a first function while operating in one of the first and second modes; and

means for performing a second function while operating in the other of the first and second modes, wherein performance of the first function enhances performance of the second function.

110. A cardiac sensing and stimulation system, comprising:

means for transthoracicly sensing cardiac activity in a first mode;

means for delivering cardiac stimulation therapy transthoracicly or intrathoracicly in response to cardiac conditions necessitating therapy sensed while operating in the first mode;

means for intrathoracicly sensing cardiac activity in a second mode;

means for intrathoracicly or transthoracicly delivering cardiac stimulation therapy in response to cardiac conditions necessitating therapy sensed while operating in the second mode;

means for performing a particular function when operating in each of the first and second modes; and

means for acquiring performance data associated with performance of the particular function when operating in each of the first and second modes.

111. The method according to claim 110, further comprising:

means for storing performance information associated with performance of the particular function when operating in each of the first and second modes; and

means for transmitting the performance information to a patient-external location.