Implantable cardiac patient monitor

• US 5,313,953 A
• Filed: 01/14/1992
• Issued: 05/24/1994
• Est. Priority Date: 01/14/1992
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: InControl, Inc. (Daikin Industries Ltd)
• Inventors: Yomtov, Barry M., Kreyenhagen, Paul E.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US07/820,580
• Time in Patent Office: 861 Days
• Field of Search: 128/419 PG, 128/696, 128/702, 128/642, 128/703-705, 128/710, 607/2, 607/32, 607/36, 607/60, 607/37, 364/413.06
• US Class Current: 600/508
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/35 by template matching
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

An implantable cardiac monitor is arranged for detecting both arrhythmias and ischemia of the human heart. The monitor includes subcutaneous electrodes for establishing electrical contact with the heart and a sense amplifier coupled to each electrode for generating an electrocardiogram of a heart beat sensed at each of the electrodes. The electrocardiograms are digitized and the digital samples thereof are stored in a memory. A microprocessor processes the digital samples of the electrocardiograms and generates characterizing data indicative of the physiology of the heart. The cardiac monitor includes telemetry to permit the cardiac data to be interrogated externally of the patient for obtaining the generated cardiac data indicative of arrhythmic and ischemic episodes.

Claims

1. A cardiac monitor for monitoring the physiology of a human heart, said monitor being fully implantable beneath the skin of a patient and comprising:

electrode means for establishing electrical contact with the heart;

sensing means coupled to said electrode means for generating an electrocardiogram of each heart beat of the heart;

arrhythmia detecting means responsive to said electrocardiograms for detecting arrhythmias of the heart and generating arrhythmia data characterizing said arrhythmias;

discriminating means responsive to said electrocardiograms for discriminating between normal sinus heart beats and abnormal heart beats;

ischemia detecting means for detecting ischemia of the heart and generating ischemia data, said ischemia detecting means being responsive to said discriminating means for detecting said ischemia for only electrocardiograms corresponding to normal sinus heart beats;

memory means coupled to said arrhythmia detecting means and said ischemia detecting means for storing said arrhythmia and ischemia data; and

telemetry means for transmitting said arrhythmia and ischemia data to a nonimplanted external receiver.

2. A cardiac monitor as defined in claim 1 wherein said electrocardiograms include ST segments and wherein said ischemia detecting means is responsive to the ST segments of said electrocardiograms corresponding only to normal sinus heart beats for detecting ischemia of the heart.

3. A cardiac monitor as defined in claim 2 wherein said ischemia detecting means is responsive to said ST segments for generating said ischemia data.

4. A cardiac monitor as defined in claim 2 further including selecting means for selecting selected ones of said electrocardiograms corresponding only to normal sinus heart beats occurring at predetermined spaced apart time intervals and wherein said ischemia detecting means detects ischemia for only said selected electrocardiograms.

5. A cardiac monitor as defined in claim 4 wherein said ischemia detecting means includes ST segment level determining means for determining if levels of said ST segments of said selected electrocardiograms are above a predetermined threshold level for detecting ischemia of the heart.

6. A cardiac monitor as defined in claim 5 further including an ischemia timer and wherein said ischemia detecting means includes incrementing means for incrementing said ischemia timer responsive to said ST segment level determining means detecting ischemia associated with one of said selected electrocardiograms.

7. A cardiac monitor as defined in claim 6 wherein said ischemia detecting means includes comparing means responsive to said timer for determining if the time kept by said timer is greater than a predetermined threshold time.

8. A cardiac monitor as defined in claim 7 wherein said ischemia detecting means includes storing means for storing in said memory means said ischemia data for each said detected ischemia.

9. A cardiac monitor as defined in claim 8 wherein said ischemia data includes the electrocardiograms of the heart beats for which ischemia is detected.

10. A cardiac monitor as defined in claim 9 wherein said ischemia detecting means includes retaining means for retaining said ischemia data in said memory means responsive to said timer reaching said threshold time.

11. A cardiac monitor as defined in claim 10 further including an event counter and wherein said ischemia detecting means includes first recording means for recording an ischemia episode in said event counter responsive to said ischemia data being retained in said memory means.

12. A cardiac monitor as defined in claim 11 wherein said ischemia detecting means include means for providing ischemia duration trend data to said memory including means for adding the duration of each said ischemia to the recording of each corresponding said ischemia episode.

13. A cardiac monitor as defined in claim 12 wherein said ischemia detecting means includes means for determining if a recorded ischemic episode was a sustained ischemic episode.

14. A cardiac monitor as defined in claim 13 wherein said ischemia detecting means includes second recording means for recording each said sustained ischemic episode in said memory means.

15. A cardiac monitor as defined in claim 14 wherein said ischemia detecting means includes retaining means for retaining said ischemia data for each said sustained ischemic episode in said memory means for transmission by said telemetry means.

16. A cardiac monitor as defined in claim 1 further including programming means for enabling only said arrhythmia detecting means, for enabling only said ischemia detecting means, or for enabling both said arrhythmia detecting means and said ischemia detecting means.

17. A cardiac monitor as defined in claim 16 wherein said programming means include receiving means for receiving program commands from external to the patient for enabling said arrhythmia detecting means and said ischemia detecting means.

18. A cardiac monitor as defined in claim 17 further including processing means including said arrhythmia detecting means and said ischemia detecting means, wherein said memory means includes first storing means for storing a first set of operating instructions to cause said arrhythmia detecting means of said processing means to detect said arrhythmias and second storing means for storing a second set of operating instructions to cause said ischemia detecting means of said processing means to detect said ischemia, and wherein said processing means includes accessing means for obtaining from said memory means only said first set of operating instructions, only said second set of operating instructions, or both said first and second sets of operating instructions responsive to said programming commands.

19. A cardiac monitor as defined in claim 1 wherein said abnormal beats are ventricular beats.

20. A cardiac monitor as defined in claim 19 further including a total ventricular beat counter and incrementing means for incrementing said total ventricular beat counter responsive to said discriminating means detecting a ventricular beat.

21. A cardiac monitor as defined in claim 19 further including a ventricular beat string counter, incrementing means for incrementing said ventricular beat string counter in response to said discriminating means detecting a ventricular beat, and reset means for resetting said ventricular beat string counter responsive to said discriminating means detecting a normal sinus heart beat immediately following a ventricular beat.

22. A cardiac monitor as defined in claim 21 wherein a plurality of said heart beats forms a heart rhythm and wherein said cardiac monitor further includes heart rhythm classifying means for classifying a heart rhythm responsive to said discriminating means detecting a normal sinus heart beat.

23. A cardiac monitor as defined in claim 22 wherein said heart rhythm classifying means includes first means for determining if an immediately preceding heart beat was a ventricular beat responsive to said discriminating means detecting a normal sinus heart beat.

24. A cardiac monitor as defined in claim 23 wherein said heart rhythm classifying means includes second means for determining if said ventricular beat string counter is equal to one in response to said first means determining that said immediately preceding heart beat was a ventricular beat.

25. A cardiac monitor as defined in claim 24 wherein said heart rhythm classifying means includes third means for determining if said ventricular beat string counter is equal to two responsive to said second means determining that said ventricular beat string counter does not equal one, and wherein said heart rhythm classifying means includes first recording means for recording a ventricular couplet in said memory means responsive to said third means determining that said ventricular beat string counter is equal to two.

26. A cardiac monitor as defined in claim 25 wherein said heart rhythm classifying means includes fourth means for determining if said ventricular beat string counter is equal to three responsive to said third means determining that said ventricular beat string counter does not equal two, and wherein said heart rhythm classifying means includes second recording means for recording a ventricular triplet in said memory means in response to said fourth means detecting that said ventricular beat string counter is equal to three.

27. A cardiac monitor as defined in claim 26 wherein said heart rhythm classifying means includes fifth means for determining if said ventricular beat string counter is greater than a predetermined count responsive to said fourth means detecting that said ventricular beat string counter does not equal three.

28. A cardiac monitor as defined in claim 27 wherein said heart rhythm classifying means includes third recording means for recording a non-sustained ventricular tachycardia of the heart in said memory means responsive to said fifth means determining that said ventricular beat string counter is less than said predetermined count.

29. A cardiac monitor as defined in claim 27 wherein said heart rhythm classifying means includes fourth recording means for recording a ventricular tachycardia in said memory means responsive to said fifth means determining that said ventricular beat string counter is greater than said predetermined count.

30. A cardiac monitor as defined in claim 27 further including means for storing in said memory means selected ones of said electrocardiograms generated during said ventricular tachycardia.

31. A cardiac monitor as defined in claim 30 wherein said means for storing stores in said memory means at least the first and last said electrocardiograms generated during said ventricular tachycardia.

32. A cardiac monitor as defined in claim 24 further including a bigeminy string counter for counting each cycle of consecutively alternating normal sinus heart beats and ventricular beats, and wherein said heart rhythm classifying means includes incrementing means for incrementing said bigeminy string counter responsive to said second means determining that said ventricular beat string counter is equal to one prior to said reset means resetting said ventricular beat string counter.

33. A cardiac monitor as defined in claim 32 further including a bigeminy event counter and wherein said heart rhythm classifying means includes second incrementing means for determining if said bigeminy string counter is greater than one and incrementing said bigeminy event counter upon determining that said bigeminy string counter is greater than one.

34. A cardiac monitor as defined in claim 33 further including heart rate determining means for determining if an immediately preceding ventricular beat was premature responsive to said bigeminy event counter being equal to zero.

35. A cardiac monitor as defined in claim 34 further including fifth recording means for recording a premature ventricular contraction in said memory means responsive to said heart rate determining means determining that said immediately preceding ventricular beat was premature.

36. A cardiac monitor as defined in claim 34 further including sixth recording means for recording a ventricular ectopic beat is said memory means responsive to said heart rate determining means determining that said immediately preceding ventricular beat was not premature.

37. A cardiac monitor as defined in claim 33 wherein said heart rhythm classifying means includes fifth recording means for determining if said bigeminy event counter is greater than zero responsive to said discriminating means detecting first and second consecutive normal sinus heart beats for recording a bigeminy rhythm in said memory means.

38. A cardiac monitor as defined in claim 37 wherein said heart rhythm classifying means includes sustained bigeminy rhythm determining means for determining if there has been a sustained bigeminy rhythm of the heart responsive to a recorded bigeminy rhythm in said memory means.

39. A cardiac monitor as defined in claim 38 wherein said sustained bigeminy rhythm determining means is responsive to said bigeminy string counter containing a count greater than a predetermined number of counts for determining if there has been a sustained bigeminy rhythm of the heart.

40. A cardiac monitor as defined in claim 39 wherein said heart rhythm classifying means includes sixth recording means for recording a sustained bigeminy rhythm and the corresponding bigeminy string counter count in said memory means responsive to said sustained bigeminy rhythm determining means determining that there has been a sustained bigeminy rhythm of the heart.

41. A cardiac monitor as defined in claim 40 further including means responsive to the first incrementing of said bigeminy string counter for storing the generated electrocardiograms in said memory means.

42. A cardiac monitor as defined in claim 41 further including means for maintaining said stored electrocardiograms in said memory responsive to said sustained bigeminy rhythm determining means determining a sustained bigeminy rhythm of the heart.

43. A cardiac monitor as defined in claim 42 further including clearing means for clearing said bigeminy string counter and said bigeminy event counter responsive to said sixth recording means recording said sustained bigeminy rhythm and said bigeminy string counter count in said memory means.

44. A cardiac monitor as defined in claim 37 further including heart rate determining means for determining if said detected second normal sinus heart beat was premature responsive to said bigeminy event counter being zero.

45. A cardiac monitor as defined in claim 44 further including a premature atrial contraction event counter and sixth recording means for recording a premature atrial contraction in said premature atrial contraction event counter responsive to said heart rate determining means determining that said detected second normal sinus heart beat was premature.

46. A cardiac monitor as defined in claim 44 further including high sinus rate determining means for determining the presence of a high sinus rate of the heart responsive to said heart rate determining means determining that said detected second normal sinus heart beat was not premature.

47. A cardiac monitor as defined in claim 46 further including irregular heart rate determining means for determining if there has been an irregular heart rate of the heart responsive to said high sinus rate determining means determining the presence of a high sinus rate of the heart.

48. A cardiac monitor as defined in claim 47 further including sustained irregular heart rate determining means for determining if there has been a sustained irregular heart rate of the heart responsive to said irregular heart rate determining means determining an irregular heart rate of the heart.

49. A cardiac monitor as defined in claim 48 further including sixth recording means for recording a sustained irregular rhythm in said memory means responsive to said sustained irregular heart rate determining means determining that there has been a sustained irregular heart rate of the heart.

50. A cardiac monitor as defined in claim 48 further including sixth recording means for recording an irregular heart rate in said memory means responsive to said sustained irregular heart rate determining means determining the absence of a sustained irregular heart rate of the heart.

51. A cardiac monitor as defined in claim 1 wherein said memory means includes means for storing a template representing a normal sinus heart beat and wherein said discriminating means includes comparing means for comparing each said electrocardiogram to said template to discriminate between said normal sinus heart beats and said abnormal heart beats.

52. A cardiac monitor as defined in claim 51 wherein said template includes a QRS portion, and wherein said electrocardiograms include a QRS portion, and wherein said comparing means compares the QRS portions of said electrocardiograms to said QRS portion of said template.

53. A cardiac monitor as defined in claim 51 further including means for revising said template stored in said memory means at spaced apart time intervals in response to said electrocardiograms generated over a last said time interval.

54. A cardiac monitor as defined in claim 1 further including heart rate determining means responsive to said electrocardiograms for determining the heart rate of the heart for each said heart beat.

55. A cardiac monitor as defined in claim 54 further including average heart rate determining means for determining an average heart rate based upon a last given number of heart rates determined by said heart rate determining means.

56. A cardiac monitor for monitoring the physiology of a human heart, said monitor being fully implantable beneath the skin of a patient and comprising:

electrode means for establishing electrical contact with the heart;

sensing means coupled to said electrode means for sensing each heart beat of the heart;

data generating means coupled to said sensing means for generating electrocardiogram data for each heart beat sensed by said sensing means;

processing means for processing said electrocardiogram data for each heart beat to generate characterizing data indicative of the physiology of the heart;

memory means coupled to said data generating means and to said processing means for storing said electrocardiogram data for each heart beat and said characterizing data,

said processing means further including accessing means for obtaining said electrocardiogram data from said memory means; and

timing means responsive to said sensing means sensing each heart beat for timing a time period, said time period being of sufficient length to permit said electrocardiogram data for each heart beat to be stored in said memory means,

said processing means being responsive to said timing means completing the timing of said time period before obtaining said electrocardiogram data from said memory means and processing said electrocardiogram data for a corresponding heart beat to assure that said electrocardiogram data for each heart beat is stored in said memory means prior to said processing means processing said electrocardiogram data for each said heart beat.

57. A cardiac monitor as defined in claim 56 further including direct memory access means coupling said memory means to said data generating means and to said processing means for providing said memory means with said generated electrocardiogram data.

58. A cardiac monitor as defined in claim 56 further including means coupled to said sensing means and to said processing means for detecting non-spontaneous heart beats of the heart and for causing said processing means to process only said electrocardiogram data corresponding to spontaneous heart beats of the heart.

59. A cardiac monitor as defined in claim 56 wherein said processing means includes arrhythmia detecting means for detecting arrhythmias of the heart and wherein said characterizing data includes arrhythmia data.

60. A cardiac monitor as defined in claim 59 wherein said processing means includes ischemia detecting means for detecting ischemia of the heart and wherein said characterizing data includes ischemia data.

63. A cardiac monitor as defined in claim 56 further including telemetry means for transmitting said characterizing data to a nonimplanted external receiver.

64. A cardiac monitor for monitoring the physiology of a human heart, said monitor being fully implantable beneath the skin of a patient and comprising:

electrode means including a plurality of electrodes for establishing electrical contact with the heart to detect heart beats of the heart;

sensing means coupled to said plurality of electrodes for generating a corresponding plurality of electrocardiograms of each heart beat of the heart;

processing means including arrhythmia detecting means responsive to a first plurality of said plurality of electrocardiograms for detecting arrhythmias of the heart and generating arrhythmia data characterizing said arrhythmias and ischemia detecting means responsive to a second plurality of said plurality of electrocardiograms for detecting ischemia of the heart and generating ischemia data characterizing said ischemia, said second plurality of electrocardiograms being greater than said first plurality of electrocardiograms;

memory means coupled to said processing means for storing said arrhythmia and ischemia data; and

telemetry means for transmitting said arrhythmia and ischemia data to a nonimplanted external receiver.

65. A cardiac monitor as defined in claim 64 wherein said plurality of electrodes comprise first, second, and third electrodes, wherein said corresponding plurality of electrocardiograms comprise first, second, and third electrocardiograms, wherein said first plurality of said plurality of electrocardiograms consist of said first and second electrocardiograms and wherein said second plurality of said electrocardiograms include said first, second, and third electrocardiograms.

66. A cardiac monitor as defined in claim 64 wherein said processing means further includes discriminating means responsive to said first and second electrocardiograms for discriminating between normal sinus heart beats and ventricular beats and wherein said ischemia detecting means is responsive to said discriminating means for detecting said ischemia and generating said ischemia data for only normal sinus heart beats.

67. A cardiac monitor as defined in claim 65 wherein said first, second, and third electrodes are subcutaneous electrodes.

68. A cardiac monitor as defined in claim 65 wherein said plurality of electrodes include a fourth electrode, wherein said plurality of electrocardiograms include a fourth electrocardiogram, and wherein said second plurality of electrocardiograms include said fourth electrocardiogram.

69. A cardiac monitor for monitoring the physiology of the human heart, said monitor being fully implantable beneath the skin of a patient and comprising:

a hermetically sealed enclosure, said enclosure defining a cavity having an opened perimeter, and a header sealingly engaging said perimeter;

first and second electrical conductors covering first and second respective discrete portions of said enclosure for forming first and second sensing electrodes respectively for sensing activity of the heart;

a third electrical conductor covering a third discrete portion of said enclosure for forming a reference electrode; and

circuit means within said enclosure and coupled to said electrodes for monitoring the activity of the heart sensed by said sensing electrodes.

70. A cardiac monitor as defined in claim 69 wherein said third electrical conductor is equally spaced from said first and second conductors.

71. A cardiac monitor for monitoring the physiology of the human heart, said monitor being fully implantable beneath the skin of a patient and comprising:

a hermetically sealed enclosure, said enclosure defining a cavity having an opened perimeter, and a header sealingly engaging said perimeter;

first and second electrical conductors covering first and second respective discrete portions of said enclosure for forming first and second sensing electrodes respectively for sensing activity of the heart;

a third electrical conductor covering a third discrete portion of said enclosure for forming a reference electrode; and

circuit means within said enclosure and coupled to said electrodes for monitoring the activity of the heart sensed by said sensing electrodes,

said header being formed from electrically insulating material and each said first and second electrical conductors comprising an electrically conductive coating covering said discrete portions of said header.

72. A cardiac monitor as defined in claim 71 wherein said header comprises a first header, and wherein said enclosure includes a second header formed from electrically insulating material, said second header being opposite, said first header.

73. A cardiac monitor as defined in claim 72 wherein said circuit means generates data indicative of the monitored activity of the heart, wherein said monitor further includes telemetry means for transmitting said data to a non-implanted external receiver, and wherein said telemetry means is disposed in said second header.

74. A device which monitors activity of the human heart, said device being fully implantable beneath the skin of a patient and comprising:

a hermetically sealed enclosure, said enclosure including a perimeter, and an electrically insulating header sealingly engaging said perimeter;

at least one electrode for sensing activity of the heart;

circuit means within said enclosure and coupled to said at least one electrode for monitoring the activity of the heart sensed by said at least one electrode and for generating data indicative of the monitored activity of the heart; and

telemetry means disposed within said header for transmitting said data to a non-implanted external receiver.

61. A cardiac monitor as defined in claim 77 wherein said processing means includes discriminating means responsive to said electrocardiogram data for discriminating between normal sinus heart beats and ventricular beats of the heart.

62. A cardiac monitor as defined in claim 61 wherein said ischemia detecting means is responsive to said discriminating means for detecting said ischemia for only normal sinus heart beats.

75. A device as defined in claim 74 wherein said perimeter comprises a bottom perimeter of said enclosure.

76. A device as defined in claim 74 wherein said telemetry means comprises an antenna.

77. A device as defined in claim 76 wherein said antenna is an antenna coil.

79. A cardiac monitor as defined in claim 74 further including direct memory access means coupling said memory means to said data generating means for providing said memory means with said generated electrocardiogram data.

78. A cardiac monitor for monitoring the physiology of a human heart, said monitor being fully implantable beneath the skin of a patient and comprising:

electrode means for establishing electrical contact with the heart;

sensing means coupled to said electrode means for sensing each heart beat of the heart;

data generating means coupled to said sensing means for generating electrocardiogram data for each heart beat sensed by said sensing means;

processing means for processing said electrocardiogram data for each heart beat to generate characterizing data indicative of the physiology of the heart; and

memory means coupled to said data generating means and to said processing means for storing said generated electrocardiogram data for each heart beat and said characterizing data,

said processing means including accessing means for obtaining said electrocardiogram data for each said heart beat from said memory means for processing said electrocardiogram data for each said heart beat.

80. A cardiac monitor as defined in claim 78 further including telemetry means for transmitting said characterizing data to a nonimplanted receiver.