System for treating a malfunctioning heart

• US 5,156,148 A
• Filed: 05/13/1991
• Issued: 10/20/1992
• Est. Priority Date: 10/06/1987
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Leonard Bloom
• Inventors: Cohen, Todd J.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): MANUEL, GEORGE C
• Application Number:
  US07/699,472
• Time in Patent Office: 526 Days
• Field of Search: 128/419 D, 128/419 B, 128/419 P, 128/419 PG
• US Class Current: 607/4
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/3918 characterised by shock pathway, e.g. by electrode configuration
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

A system for treating the malfunctioning heart of a patient includes means which derive at least one electrical signal from the patient'"'"'s heart and means which derive at least one physiologic signal from or related to the patient'"'"'s circulatory system. A central processing unit, which may be a programmable microprocessor, with a RAM and a ROM, receives and responds to the at least one electrical signal and to the at least one physiologic signal. Output means, which may include a heart assist pump, pacers, drug delivery devices and cardioverting/defibrillating apparatuses, controlled by the central processing unit provides corrective measure(s) to the patient. Adjustable or variable baselines, against which a representation of the current, short-term magnitude of the selected physiologic parameter or parameters are provided. The variable baseline(s) is (are) a representation of the selected physiologic parameter(s) determined over a long term of greater duration than the short term over which the current magnitude(s) of the parameter(s) is (are) measured.

Claims

1. In an implantable system for treating the malfunctioning heart of a patient, the combination of means for deriving at least one electrical signal from the patient'"'"'s heart, means for deriving at least one physiologic signal from or related to the patient'"'"'s circulatory system, a central processing unit for controlling delivery of selected heart-malfunction-corrective inputs to the patient, means for inputting the at least one electrical signal and the at least one physiologic signal to the central processing unit, and output means responsive to output signals form the central processing unit, including cardioverting/defibrillating means, for providing under control of the central processing unit at least one heart-malfunction-corrective input to the patient from among a plurality of the heart-malfunction-corrective inputs, whereby malfunctions of the heart may be corrected.

2. The implantable system of claim 1, wherein the output means includes antitachycardia pacing means controlled by the central processing unit.

3. The implantable system of claim 1, wherein the output means includes antibradycardia pacing means controlled by the central processing unit.

4. The implantable system of claim 1, wherein the central processing unit is programmable.

5. The implantable system of claim 1, wherein the output means includes drug delivery means controlled by the central processing unit.

6. The implantable system of claim 1, wherein the output means includes a heart-assist device controlled by the central processing unit.

7. The implantable system of claim 1, further including monitoring means and/or recording means coupled to the central processing unit for monitoring and/or recording input and output signals to and from the central processing unit.

8. The implantable system of claim 1, wherein the output means further includes drug delivery means, antitachycardia pacing means and antibradycardia pacing means controlled by the central processing unit.

9. The implantable system of claim 1, wherein the output means further include antitachycardia pacing means and antibradycardia pacing means controlled by the central processing unit.

10. The implantable system of claim 1, wherein the output means further includes antibradycardia pacing means controlled by the central processing unit.

11. The implantable system of claim 1, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying stable supraventricular tachycardia.

12. The implantable system of claim 11, which includes means for supplying therapy to the patient whereby stable supraventricular tachycardia may be overcome.

13. The implantable system of claim 1, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying unstable supraventricular tachycardia.

14. The implantable system of claim 13, which includes means for supplying therapy to the patient whereby unstable supraventricular tachycardia may be overcome.

15. The implantable system of claim 1, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying stable ventricular tachycardia.

16. The implantable system of claim 15, which includes means for supplying therapy to the patient whereby stable ventricular tachycardia may be overcome.

17. The implantable system of claim 1, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying unstable ventricular tachycardia.

18. The implantable system of claim 17, which includes means for supplying therapy to the patient whereby unstable ventricular tachycardia may be overcome.

19. The implantable system of claim 1, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsible to the at least one electrical signal for identifying rapid ventricular tachycardia and ventricular fibrillation.

20. The implantable system of claim 19, which includes means for supplying therapy to the patient whereby rapid ventricular tachycardia and ventricular fibrillation may be overcome.

21. The implantable system of claim 1, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to at least one electrical signal and to the at least one physiologic signal for identifying rapid ventricular fibrillation.

22. The implantable system of claim 21, which includes means for supplying therapy to the patient whereby rapid ventricular fibrillation may be overcome.

23. The implantable system of claim 1, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying asystole.

24. The implantable system of claim 23, which includes means for supplying therapy to the patient whereby asystole may be overcome.

25. The implantable system of claim 1, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying stable bradycardia.

26. The implantable system of claim 25, which includes means for supplying therapy to the patient whereby stable bradycardia may be overcome.

27. The implantable system of claim 1, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying unstable bradycardia.

28. The implantable system of claim 27, which includes means for supplying therapy to the patient whereby unstable bradycardia may be overcome.

29. The implantable system of claim 1, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying ischemia.

30. The implantable system of claim 29, which includes means for supplying therapy to the patient whereby ischemia may be overcome.

31. The implantable system of claim 1, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying early infarction.

32. The implantable system of claim 31, which includes means for supplying therapy to the patient whereby early infarction may be overcome.

33. The implantable system of claim 1, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying heart failure alone.

34. The implantable system of claim 33, which includes means for supplying therapy to the patient whereby heart failure alone may be overcome.

35. The implantable system of claim 1, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying stable supraventricular tachycardia, unstable supraventricular tachycardia, stable ventricular tachycardia, unstable ventricular tachycardia, stable atrial fibrillation, unstable atrial fibrillation, ventricular fibrillation, asystole, stable bradycardia, unstable bradycardia, ischemia, early infarction and heart failure alone.

36. The implantable system of claim 1, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying stable supraventricular tachycardia, unstable supraventricular tachycardia, stable ventricular tachycardia, unstable ventricular tachycardia, stable atrial fibrillation, unstable atrial fibrillation, ventricular fibrillation, asystole, stable bradycardia, and unstable bradycardia.

37. The implantable system of claim 1, including means coupled to said means for deriving at least one physiologic signal and responsive thereto for determining a change in a given physiologic parameter of at least a predetermined magnitude from a baseline for the parameter as represented by the physiologic signal.

38. The implantable system according to claim 1, including means coupled to said means for deriving at least one physiologic signal and responsive thereto over a period of given duration for establishing a varying baseline for a given physiologic parameter as represented by the physiologic signal, and means coupled to said means for deriving at least one physiologic signal and responsive thereto for determining current level of the parameter as represented by the physiologic signal over a period of predetermined duration which is shorter than the period of given duration.

39. The implantable system according to claim 1, including means for adjustably setting a baseline for a given physiologic parameter as represented by the physiologic signal.

73. The implantable system of claim 22, which includes means for supplying therapy to the patient whereby stable ventricular tachycardia may be overcome.

40. In a system for treating the malfunctioning heart of a patient, a combination of means for deriving at least one electrical signal from the patient'"'"'s heart, means for deriving at least one physiologic signal from or related to the patient'"'"'s circulatory system, means responsive to the physiologic signal for determining a change in a physiologic parameter of at least a predetermined magnitude from a baseline for the parameter, a central processing unit, means for inputting the at least one electrical signal and the at least one physiologic signal to the central processing unit, and output means coupled to the central processing unit and responsive to output signals therefor, including cardioverting/defibrillating means, for providing under control of the central processing unit at least one heart-malfunction-corrective input to the patient from among a plurality of the heart-malfunction-corrective inputs, whereby malfunctions of the heart may be corrected.

41. The system of claim 40, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying stable supraventricular tachycardia.

42. The system of claim 41, which includes means for supplying therapy to the patient whereby stable supraventricular tachycardia may be overcome.

43. The system of claim 40, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying unstable supraventricular tachycardia.

44. The system of claim 43, which includes means for supplying therapy to the patient whereby unstable supraventricular tachycardia may be overcome.

45. The system of claim 40, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying stable ventricular tachycardia.

46. The system of claim 45, which includes means for supplying therapy to the patient whereby stable ventricular tachycardia may be overcome.

47. The system of claim 40, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying unstable ventricular tachycardia.

48. The system of claim 47, which includes means for supplying therapy to the patient whereby unstable ventricular tachycardia may be overcome.

49. The system of claim 40, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsible to the at least one electrical signal for identifying rapid ventricular tachycardia and ventricular fibrillation.

50. The system of claim 49, which includes means for supplying therapy to the patient whereby rapid ventricular tachycardia and ventricular fibrillation may be overcome.

51. The system of claim 40, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to at least one electrical signal and to the at least one physiologic signal for identifying rapid ventricular fibrillation.

52. The system of claim 51, which includes means for supplying therapy to the patient whereby rapid ventricular fibrillation may be overcome.

53. The system of claim 40, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying asystole.

54. The system of claim 53, which includes means for supplying therapy to the patient whereby asystole may be overcome.

55. The system of claim 40, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying stable bradycardia.

56. The system of claim 55, which includes means for supplying therapy to the patient whereby stable bradycardia may be overcome.

57. The system of claim 40, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying unstable bradycardia.

58. The system of claim 57, which includes means for supplying therapy to the patient whereby unstable bradycardia may be overcome.

59. The system of claim 40, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying ischemia.

60. The system of claim 59, which includes means for supplying therapy to the patient whereby ischemia may be overcome.

61. The system of claim 40, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying early infarction.

62. The system of claim 61, which includes means for supplying therapy to the patient whereby early infarction may be overcome.

63. The system of claim 40, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying heart failure alone.

64. The system of claim 63, which includes means for supplying therapy to the patient whereby heart failure alone may be overcome.

65. The combination according to claim 40, including means responsive to the physiologic signal over a period of given duration for establishing a varying baseline for the parameter, and means responsive to the physiologic signal for determining current level of the parameter over a period of predetermined duration which is shorter than said period of given duration.

66. The combination according to claim 40, including means for adjustably setting the baseline for the physiologic parameter.

67. The system according to claim 40, which is adapted to be implanted in a patient.

68. The implantable system of claim 67, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying stable supraventricular tachycardia.

69. The implantable system of claim 68, which includes means for supplying therapy to the patient whereby stable supraventricular tachycardia may be overcome.

70. The implantable system of claim 67, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying unstable supraventricular tachycardia.

71. The implantable system of claim 70, which includes means for supplying therapy to the patient whereby unstable supraventricular tachycardia may be overcome.

72. The implantable system of claim 67, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying stable ventricular tachycardia.

74. The implantable system of claim 67, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying unstable ventricular tachycardia.

75. The implantable system of claim 74, which includes means for supplying therapy to the patient whereby unstable ventricular tachycardia may be overcome.

76. The implantable system of claim 67, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsible to the at least one electrical signal for identifying rapid ventricular tachycardia and ventricular fibrillation.

77. The implantable system of claim 76, which includes means for supplying therapy to the patient whereby rapid ventricular tachycardia and ventricular fibrillation may be overcome.

78. The implantable system of claim 67, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to at least one electrical signal and to the at least one physiologic signal for identifying rapid ventricular fibrillation.

79. The implantable system of claim 78, which includes means for supplying therapy to the patient whereby rapid ventricular fibrillation may be overcome.

80. The implantable system of claim 67, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying asystole.

81. The implantable system of claim 80, which includes means for supplying therapy to the patient whereby asystole may be overcome.

82. The implantable system of claim 67, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying stable bradycardia.

83. The implantable system of claim 82, which includes means for supplying therapy to the patient whereby stable bradycardia may be overcome.

84. The implantable system of claim 67, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying unstable bradycardia.

85. The implantable system of claim 84, which includes means for supplying therapy to the patient whereby unstable bradycardia may be overcome.

86. The implantable system of claim 67, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying ischemia.

87. The implantable system of claim 86, which includes means for supplying therapy to the patient whereby ischemia may be overcome.

88. The implantable system of claim 67, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying early infarction.

89. The implantable system of claim 88, which includes means for supplying therapy to the patient whereby early infarction may be overcome.

90. The implantable system of claim 67, including means for monitoring heart rhythm to develop the at least one electrical signal, and means responsive to the at least one electrical signal and to the at least one physiologic signal for identifying heart failure alone.

91. The implantable system of claim 90, which includes means for supplying therapy to the patient whereby heart failure alone may be overcome.

92. The combination according to claim 67, including means responsive to the physiologic signal over a period of given duration for establishing a varying baseline for the parameter, and means responsive to the physiologic signal for determining current level of the parameter over a period of predetermined duration which is shorter than said period of given duration.

93. The combination according to claim 67, including means for adjustably setting the baseline for the physiologic parameter.

94. Apparatus for treating a malfunctioning heart of a patient by supplying cardioverting/defibrillating energy to the patient to overcome or avoid hemodynamic comprise and avoid consequent death of the patient who may be exhibiting sudden death syndrome, comprising computerized means having at least a first input and a second input, and at least one output, means for obtaining an electrical signal from the patient'"'"'s heart and for feeding that electrical signal to the first input of the computerized means, means for monitoring at least one selected parameter of the patient'"'"'s circulatory system to develop a physiologic signal representation thereof, means for feeding the physiologic signal to the second input, means within the computer means for establishing a baseline for the selected parameter of the patient to develop a baseline signal representation thereof, comparison means within said computerized means for comparing the baseline signal on a short term basis with the physiological signal, cardioverting/defibrillating means for delivering cardioverting/defibrillating energy to the patient, and means coupled to and responsive to the output from the computerized means for triggering the cardioverting/defibrillating means to thereby provide cardioverting/defibrillating energy to the patient'"'"'s heart to avoid or overcome hemodynamic comprise of the patient.

95. The apparatus of claim 94, wherein the computerized means comprises a programmable microprocessor.

96. The apparatus of claim 94, wherein the means for monitoring at least one selected parameter comprises means for monitoring pressure in the patient'"'"'s circulatory system.

97. The apparatus of claim 94, wherein the means for monitoring at least one selected parameter comprises means for monitoring pressure in the right atrium of the patient'"'"'s heart.

98. The apparatus of claim 94, wherein the selected parameter is oxygen saturation in mixed venous blood.

99. The apparatus of claim 94, wherein the selected parameter is potassium ion level in the patient'"'"'s blood.

100. The apparatus of claim 94, wherein the selected parameter is lactic acid in the patient'"'"'s blood.

101. The apparatus of claim 94, wherein the means for establishing a baseline comprises means for establishing a long-term variable baseline of the selected parameter.

102. The apparatus of claim 94, wherein the apparatus is an implantable apparatus which is adapted to be implanted in its entirety into the patient.

103. The apparatus of claim 94, wherein the apparatus is adapted to be at least partially external to the patient.

104. The apparatus of claim 94, further including antibradycardia pacing means, antitachycardia pacing means and drug delivery devices, and means for selectively energizing the antibradycardia pacing means, the antitachycardia pacing means and the drug delivery devices.