Apparatus for annotating physiological waveforms

• US 5,605,158 A
• Filed: 08/02/1995
• Issued: 02/25/1997
• Est. Priority Date: 08/02/1995
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Snell, Jeffery D.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US08/510,448
• Time in Patent Office: 573 Days
• Field of Search: 128/696, 128/710, 128/712
• US Class Current: 600/508
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

An apparatus for annotating physiological waveforms is provided. The apparatus comprises an implantable medical device, which may be a pacemaker or a cardioverter/defibrillator, and a programmer for use with the implantable medical device. The implantable medical device may be modeled as a finite state machine. Whenever the implantable medical device enters a new state, a state transition vector or a current state vector is transmitted to the programmer. The programmer implements a state machine model of the implantable medical device to determine the current state of the device based on the received state vectors. Because the exact state of the implantable medical device is known, the programmer can annotate the physiological waveform more completely than has previously been possible. For example, when the behavior of the implantable medical device is unclear, the programmer can place an explanatory label adjacent to the displayed physiological waveform.

Claims

1. An apparatus for monitoring a parameter indicative of a patient'"'"'s condition, comprising an implantable medical device having a plurality of operating states and an external monitoring device, wherein the implantable medical device comprises:

means for detecting at least one physiological parameter of the patient and for producing a characteristic signal in response thereto;

control means for comparing the characteristic signal to preset criteria for detecting the occurrence of a physiological event and for changing the operating state of said implantable medical device in response thereto;

means for transmitting event codes representative of the state of the implantable medical device; and

means for transmitting event codes representative of the occurrence of a physiological event;

and wherein said monitoring device comprises;

means for receiving said transmitted event codes;

means for selectively displaying annotating labels, at least some of said annotating labels functioning to represent one or more of said received event codes;

means for selectively determining annotating labels to be displayed; and

means for receiving a user input, wherein said user input selects a subset of annotating labels to be displayed.

2. An apparatus, as defined in claim 1, wherein said means for detecting a physiological parameter comprises means for detecting a cardiac waveform.

3. An apparatus, as defined in claim 2, wherein said implantable medical device further comprises means for electrically stimulating the patient'"'"'s heart.

4. An apparatus, as defined in claim 2, wherein said implantable medical device further comprises:

means for transmitting said detected cardiac waveform;

and wherein said monitoring device further comprises;

means for receiving said transmitted cardiac waveform; and

means for displaying said received cardiac waveform concurrently with said annotating labels as said cardiac waveform is received.

5. An apparatus, as defined in claim 4, further comprising:

an input interface for directing said monitoring device to freeze a display for review thereon, whereby said input interface further comprises;

means for highlighting a portion of the displayed cardiac waveform, and

means for directing said monitoring device to display additional annotating labels to further explain the operation of said implantable medical device in the vicinity of said highlighted portion of said displayed cardiac waveform.

6. An apparatus, as defined in claim 2, wherein said monitoring unit displays said annotating labels at one of three selected levels comprising:

(a) a first level in which only annotating labels which comprise traditional event markers are displayed;

(b) a second level in which said traditional event markers are supplemented with additional annotating labels; and

(c) a third level in which an annotating label corresponding to each transition in the operating state of said implantable medical device is displayed on said monitor.

7. An apparatus, as defined in claim 4, wherein said monitoring device further comprises:

means for receiving an electrocardiogram generated by an electrocardiogram measurement system; and

means for displaying said received electrocardiogram concurrently with said received cardiac waveform and said annotating labels as said electrocardiogram is received.

8. An apparatus, as defined in claim 7, wherein said monitoring device further comprises:

a memory array; and

means for synchronizing said received electrocardiogram, said received cardiac waveform, and said received event codes in said memory array.

9. An apparatus, as defined in claim 2, wherein said means for detecting said cardiac waveform comprises means for detecting the intracardiac electrogram, and wherein said implantable medical device transmits the patient'"'"'s intracardiac electrogram to said monitoring device.

10. An apparatus, as defined in claim 1, wherein said means for transmitting event codes representative of the state of the implantable medical device comprises means for transmitting current state vectors, said current state vectors representing the current state of said implanted medical device.

11. An apparatus, as defined in claim 1, wherein said monitoring device further comprises means for simulating the implantable medical device as a state machine using said received event codes and for generating current state signals that are representative of the current state of said implantable medical device.

12. An apparatus, as defined in claim 1, wherein said means for transmitting event codes representative of the state of the implantable medical device comprises means for transmitting state transition vectors, each state transition vector representing the change in state of said implantable medical device from the previous state transition vector.

13. An apparatus, as defined in claim 12, wherein said means for transmitting event codes representative of the state of the implantable medical device further comprises means for periodically transmitting current state vectors, said current state vectors representing the current state of said implanted medical device.

14. A programmer for use with an implantable medical device having means for transmitting vectors representative of the state of the implantable medical device, the programmer comprising:

receiver means for receiving the transmitted vectors;

memory means having a plurality of memory locations;

control means for;

(a) generating a current state signal from the received vectors, such current state signal representative of the current state of the implantable medical device;

(b) storing said current state signal in a first memory location; and

(c) generating annotating labels corresponding to said current state signal;

means for displaying a selected subset of the annotating labels; and

an input interface, operably connected to said control means, for selecting the subset of annotating labels to be displayed.

15. A programmer, as defined in claim 14, wherein said control means continuously updates the displayed annotating labels such that only the most recent annotating labels are displayed.

16. A programmer, as defined in claim 15, further comprising:

an input interface operably connected to said control means, said input interface being operable to direct said control means to freeze the displayed annotating labels for review by halting the update of said displayed annotating labels, said input interface also being operable to direct said control unit to identify a portion of the displayed annotating labels, wherein said control means comprises means for displaying an alternate set of annotating labels, further wherein said input interface being operable to direct said control means to display said alternate set of annotating labels relating to such identified portion of annotating labels.

17. A programmer, as defined in claim 16, wherein said means for displaying an alternate set comprises means for displaying a superset of the prior displayed annotating labels.

18. A programmer, as defined in claim 16, wherein said means for displaying an alternate set comprises means for displaying a subset of the prior displayed annotating labels.

19. A programmer as defined in claim 14, wherein said vectors are state transition vectors representing changes in the state of the implantable medical device, and wherein said control means for generating a current state signal comprises means for generating a current state signal from state transition vectors.

20. A programmer as defined in claim 14, wherein said vectors are current state vectors representing the current state of the implantable medical device, and wherein said control means for generating a current state signal comprises means for generating a current state signal from current state vectors.

21. The programmer as defined in claim 14, wherein said vectors are current state vectors representing the current state of the implantable medical device and state transition vectors representing changes in the state of the implantable medical device, and wherein said control means for generating a current state signal comprises means for generating a current state signal from current state vectors and state transition vectors.

22. A programmer as defined in claim 14, wherein said vectors are also representative of concurrently detected events, wherein said control means further comprises:

means for generating a detected event signal from the received vectors;

means for storing said detected event signal; and

means for generating annotating labels corresponding to said detected event signal.

23. A programmer as defined in claim 14, wherein said implantable medical device also has means for detecting a physiological parameter and means for transmitting a physiological signal representative of the physiological parameter, further comprising:

means for receiving the physiological signal;

means for displaying said physiological signal; and

wherein said control means further comprises means for storing said physiological signal in a second memory location.

24. A programmer as defined in claim 14, further comprising:

means for detecting a first physiological parameter;

means for generating a first physiological signal from said detected first physiological parameter;

means for displaying said first physiological signal; and

wherein said control means further comprises means for storing said first physiological signal in a second memory location.

25. A programmer as defined in claim 24, wherein said control means continuously updates the displayed annotating labels and displayed first physiological signal such that only the most recent annotating labels and the most recent first physiological signal are displayed.

26. A programmer as defined in claim 25, further comprising:

an input interface operably connected to said control means, said input interface being operable to direct said control means to freeze the displayed annotating labels and displayed first physiological signal for review by halting the update of said displayed annotating labels and said displayed first physiological signal, said input interface also being operable to direct said control unit to identify a portion of the displayed annotating labels and a corresponding portion of said displayed first physiological signal, said input interface being operable to direct said control means to display an alternate set of annotating labels relating to such identified portion of annotating labels.

27. A programmer as defined in claim 22, wherein said implantable medical device also has means for detecting a second physiological parameter and means for transmitting a second physiological signal representative of the second physiological parameter, further comprising:

means for receiving the second physiological signal;

means for displaying said second physiological signal; and

wherein said control means further comprises means for storing said second physiological signal in a third memory location.

28. A programmer as defined in claim 27, wherein said control means continuously updates the displayed annotating labels, displayed first physiological signal, and displayed second physiological signal such that only the most recent annotating labels and the most recent physiological signals are displayed.

29. A programmer as defined in claim 28, further comprising:

an input interface operably connected to said control means, said input interface being operable to direct said control means to freeze the displayed annotating labels and displayed physiological signals for review by halting the update of said displayed annotating labels and said displayed physiological signals, said input interface also being operable to direct said control unit to identify a portion of the displayed annotating labels and a corresponding portion of said displayed physiological signals, said input interface being operable to direct said control means to display an alternate subset of annotating labels relating to such identified portion of annotating labels.

30. A programmer as defined in claim 27, further comprising means for synchronizing said current state signal, said first physiological signal and said second physiological signal.

31. A programmer as defined in claim 14, wherein said control means generates said current state signal by simulating said implantable medical device as a state machine using said vectors.

32. A programmer as defined in claim 14, wherein the subsets of annotating labels comprise:

(a) a subset consisting of traditional event markers;

(b) a subset consisting of traditional event markers supplemented with additional annotating labels; and

(c) a subset comprising labels corresponding to each transition in the state of the implanted medical device.

33. A method, utilizing a programmer, for controlling the display of annotating labels relating to the operation of an implantable medical device, comprising the steps of:

receiving state vectors representing the current state of the implantable medical device;

generating a current state signal representative of the current state of the implantable medical device using the received state vectors;

storing in a memory means having a plurality of memory locations the current state signal in a first memory location;

generating annotating labels corresponding to the current state signal;

receiving a user input for selecting a subset of annotating labels to be displayed;

selecting a set of annotating labels to be displayed; and

displaying said selected annotating labels.

34. The method defined in claim 33, wherein the step of displaying said selected annotating labels further comprises continuously updating the displayed annotating labels such that only the most recent annotating labels are displayed.

35. The method defined in claim 34, further comprising the steps of:

halting the updating of the displayed annotating labels;

identifying a portion of the displayed annotating labels; and

displaying an alternate set of annotating labels relating to such identified portion of annotating labels.

36. The method defined in claim 35, wherein said alternate set is a superset of the prior displayed labels.

37. The method defined in claim 35, wherein said alternate set is a subset of the prior displayed annotating labels.

38. The method defined in claim 33, wherein said vectors are state transition vectors representing changes in the state of the implantable medical device.

39. The method defined in claim 33, wherein said vectors are current state vectors representing the current state of the implantable medical device.

40. The method defined in claim 33, wherein said vectors are current state vectors representing the current state of the implantable medical device and state transition vectors representing changes in the state of the implantable medical device.

41. The method defined in claim 33, wherein said vectors are also representative of concurrently detected events, further comprising the steps of:

generating a detected event signal from the received vectors;

storing the detected event signal; and

generating annotating labels corresponding to said detected event signal.

42. The method defined in claim 33, wherein said implantable medical device also has means for detecting a physiological parameter and means for transmitting a physiological signal representative of the physiological parameter, further comprising the steps of:

receiving the physiological signal;

displaying the physiological signal; and

storing the physiological signal in a second memory location.

43. The method defined in claim 33, further comprising the steps of:

detecting a first physiological parameter;

generating a first physiological signal from said detected first physiological parameter;

displaying said first physiological signal; and

storing said first physiological signal in a second memory location.

44. The method defined in claim 43, further comprising the steps of:

updating the displayed annotating labels such that only the most recent annotating labels are displayed; and

updating the displayed first physiological signal such that only the most recent first physiological signal is displayed.

45. The method defined in claim 44, further comprising the steps of:

halting the updating of the displayed annotating labels;

halting the updating of the displayed first physiological signal;

identifying a portion of the displayed annotating labels; and

displaying an alternate subset of annotating labels relating to such identified portion of annotating labels.

46. The method defined in claim 43, wherein said implantable medical device also has means for detecting a second physiological parameter and means for transmitting a second physiological signal representative of the second physiological parameter, further comprising the steps of:

receiving the second physiological signal;

displaying the second physiological signal; and

storing the second physiological signal in a third memory location.

47. The method defined in claim 46, further comprising the steps of:

updating the displayed annotating labels such that only the most recent annotating labels are displayed;

updating the displayed first physiological signal such that only the most recent first physiological signal is displayed; and

updating the displayed second physiological signal such that only the most recent second physiological signal is displayed.

48. The method defined in claim 47, further comprising the steps of:

halting the updating of the displayed annotating labels;

halting the updating of the displayed first physiological signal;

halting the updating of the displayed second physiological signal;

identifying a portion of the displayed annotating labels; and

displaying an alternate subset of annotating labels relating to such identified portion of annotating labels.

49. The method defined in claim 43, further comprising the step of synchronizing the current state signal and the first physiological signal.

50. The method defined in claim 46, further comprising the step of synchronizing the current state signal, the first physiological signal, and the second physiological signal.

51. The method defined in claim 42, further comprising the step of synchronizing the current state signal and the physiological signal.

52. The method defined in claim 33, wherein said step for generating a current state signal comprises generating a current state signal by simulating the implantable medical device as a state machine using said vectors.

53. The method defined in claim 33, wherein said implantable medical device is also a cardiac monitoring device.

54. The method defined in claim 33, wherein said implantable medical device is also a cardiac stimulating device.

55. The method defined in claim 46, wherein said implantable medical device is also a cardiac monitoring device, said first physiological signal is an electrocardiogram signal, and said second signal is an intracardiac electrogram signal.

56. The method defined in claim 33, where the subsets of annotating labels that can be selected comprise at least:

(a) a subset consisting of traditional event markers;

(b) a subset consisting of traditional event markers supplemented with additional annotating labels; and

(c) a subset comprising labels corresponding to each transition in the state of the implanted medical device.

57. An apparatus for monitoring a parameter indicative of a patient'"'"'s condition, comprising an implantable medical device having a plurality of operating states and an external monitoring device, wherein the implantable medical device comprises:

means for detecting at least one physiological parameter of the patient and for producing a characteristic signal in response thereto;

control means for comparing the characteristic signal to preset criteria for detecting the occurrence of a physiological event and for changing the operating state of said implantable medical device in response thereto;

means for transmitting event codes representative of the state of the implantable medical device; and

means for transmitting event codes representative of the occurrence of a physiological event;

and wherein said monitoring device comprises;

means for receiving said transmitted event codes;

means for selectively displaying annotating labels, at least some of said annotating labels functioning to represent one or more of said received event codes;

means for selectively determining annotating labels to be displayed; and

means for simulating the implantable medical device as a state machine using said received event codes and for generating current state signals that are representative of the current state of said implantable medical device.

58. An apparatus, as defined in claim 57, wherein said means for detecting a physiological parameter comprises means for detecting a cardiac waveform.

59. An apparatus, as defined in claim 58, wherein said implantable medical device further comprises means for electrically stimulating the patient'"'"'s heart.

60. An apparatus, as defined in claim 58, wherein said implantable medical device further comprises:

means for transmitting said detected cardiac waveform;

and wherein said monitoring device further comprises;

means for receiving said transmitted cardiac waveform; and

means for displaying said received cardiac waveform concurrently with said annotating labels as said cardiac waveform is received.

61. An apparatus, as defined in claim 60, further comprising:

an input interface for directing said monitoring device to freeze a display for review thereon, whereby said input interface further comprises;

means for highlighting a portion of the displayed cardiac waveform, and

means for directing said monitoring device to display additional annotating labels to further explain the operation of said implantable medical device in the vicinity of said highlighted portion of said displayed cardiac waveform.

62. An apparatus, as defined in claim 60, wherein said monitoring device further comprises:

means for receiving an electrocardiogram generated by an electrocardiogram measurement system; and

means for displaying said received electrocardiogram concurrently with said received cardiac waveform and said annotating labels as said electrocardiogram is received.

63. An apparatus, as defined in claim 58, wherein said means for detecting said cardiac waveform comprises means for detecting the intracardiac electrogram, and wherein said implantable medical device transmits the patient'"'"'s intracardiac electrogram to said monitoring device.

64. An apparatus, as defined in claim 57, wherein said means for transmitting event codes representative of the state of the implantable medical device comprises means for transmitting current state vectors, said current state vectors representing the current state of said implanted medical device.

65. An apparatus, as defined in claim 57, wherein said means for transmitting event codes representative of the state of the implantable medical device comprises means for transmitting state transition vectors, each state transition vector representing the change in state of said implantable medical device from the previous state transition vector.

66. An apparatus, as defined in claim 65, wherein said means for transmitting event codes representative of the state of the implantable medical device further comprises means for periodically transmitting current state vectors, said current state vectors representing the current state of said implanted medical device.

67. A programmer for use with an implantable medical device having means for transmitting vectors representative of the state of the implantable medical device, the programmer comprising:

receiver means for receiving the transmitted vectors;

memory means having a plurality of memory locations;

control means for;

(a) generating a current state signal from the received vectors by simulating said implantable medical device as a state machine using said vectors, such current state signal representative of the current state of the implantable medical device;

(b) storing said current state signal in a first memory location; and

(c) generating annotating labels corresponding to said current state signal; and

means for displaying a selected subset of the annotating labels.

68. A programmer as defined in claim 67, wherein said vectors are state transition vectors representing changes in the state of the implantable medical device, and wherein said control means for generating a current state signal comprises means for generating a current state signal from state transition vectors.

69. A programmer as defined in claim 67, wherein said vectors are current state vectors representing the current state of the implantable medical device, and wherein said control means for generating a current state signal comprises means for generating a current state signal from current state vectors.

70. The programmer as defined in claim 67, wherein said vectors are current state vectors representing the current state of the implantable medical device and state transition vectors representing changes in the state of the implantable medical device, and wherein said control means for generating a current state signal comprises means for generating a current state signal from current state vectors and state transition vectors.

71. A programmer as defined in claim 67, wherein said vectors are also representative of concurrently detected events, wherein said control means further comprises:

means for generating a detected event signal from the received vectors;

means for storing said detected event signal; and

means for generating annotating labels corresponding to said detected event signal.

72. A programmer as defined in claim 67, wherein said implantable medical device also has means for detecting a physiological parameter and means for transmitting a physiological signal representative of the physiological parameter, further comprising:

means for receiving the physiological signal;

means for displaying said physiological signal; and

wherein said control means further comprises means for storing said physiological signal in a second memory location.

73. A method, utilizing a programmer, for controlling the display of annotating labels relating to the operation of an implantable medical device, comprising the steps of:

receiving state vectors representing the current state of the implantable medical device;

generating a current state signal representative of the current state of the implantable medical device using the received state vectors by simulating the implantable medical device as a state machine using said vectors;

storing in a memory means having a plurality of memory locations the current state signal in a first memory location;

generating annotating labels corresponding to the current state signal;

selecting a set of annotating labels to be displayed; and

displaying said selected annotating labels.

74. The method defined in claim 73, wherein said vectors are state transition vectors representing changes in the state of the implantable medical device.

75. The method defined in claim 73, wherein said vectors are current state vectors representing the current state of the implantable medical device.

76. The method defined in claim 73, wherein said vectors are current state vectors representing the current state of the implantable medical device and state transition vectors representing changes in the state of the implantable medical device.

77. The method defined in claim 73, wherein said vectors are also representative of concurrently detected events, further comprising the steps of:

generating a detected event signal from the received vectors;

storing the detected event signal; and

generating annotating labels corresponding to said detected event signal.

78. The method defined in claim 73, wherein said implantable medical device is also a cardiac monitoring device.

79. The method defined in claim 73, wherein said implantable medical device is also a cardiac stimulating device.

80. An apparatus for monitoring a parameter indicative of a patient'"'"'s condition, comprising an implantable medical device having a plurality of operating states and an external monitoring device, wherein the implantable medical device comprises:

means for detecting at least one physiological parameter of the patient and for producing a characteristic signal in response thereto, wherein said means for detecting comprises means for detecting a cardiac waveform;

control means for comparing the characteristic signal to preset criteria for detecting the occurrence of a physiological event and for changing the operating state of said implantable medical device in response thereto;

means for transmitting event codes representative of the state of the implantable medical device; and

means for transmitting event codes representative of the occurrence of a physiological event;

and wherein said monitoring device comprises;

means for receiving said transmitted event codes;

means for selectively displaying annotating labels, at least some of said annotating labels functioning to represent one or more of said received event codes;

means for selectively determining annotating labels to be displayed; and

wherein said monitoring unit displays said annotating labels at one of three selected levels comprising;

(a) a first level in which only annotating labels which comprise traditional event markers are displayed;

(b) a second level in which said traditional event markers are supplemented with additional annotating labels; and

(c) a third level in which an annotating label corresponding to each transition in the operating state of said implantable medical device is displayed on said monitor.

81. A method, utilizing a programmer, for controlling the display of annotating labels relating to the operation of an implantable medical device, comprising the steps of:

receiving state vectors representing the current state of the implantable medical device;

generating a current state signal representative of the current state of the implantable medical device using the received state vectors;

storing in a memory means having a plurality of memory locations the current state signal in a first memory location;

generating annotating labels corresponding to the current state signal;

selecting a set of annotating labels to be displayed;

displaying said selected annotating labels by continuously updating the displayed annotating labels such that only the most recent annotating labels are displayed;

halting the updating of the displayed annotating labels;

identifying a portion of the displayed annotating labels; and

displaying an alternate set of annotating labels relating to such identified portion of annotating labels.

82. The method defined in claim 81, wherein said alternate set is a superset of the prior displayed labels.

83. The method defined in claim 81, wherein said alternate set is a subset of the prior displayed annotating labels.