Arrhythmia recorder for use with an implantable defibrillator

• US 4,223,678 A
• Filed: 05/03/1978
• Issued: 09/23/1980
• Est. Priority Date: 05/03/1978
• Status: Expired due to Term

• Current Assignee: Mirowski Family Ventures LLC
• Original Assignee: Mieczyslaw Mirowski
• Inventors: Mower, Morton M., Langer, Alois A.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US05/902,763
• Time in Patent Office: 874 Days
• Field of Search: 128/419 D, 128/2.06 A, 128/2.06 B, 128/2.06 F, 128/2.06 R, 128/2.1 A, 128/2.1 R
• US Class Current: 607/5
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/336 Magnetic recording apparatus
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

A device for recording and subsequently reproducing information, such as desired portions of an ECG signal produced by a heart prior to and during the occurrence of a disturbance in cardiac electrical activity. Two basic embodiments of the inventive recorder are contemplated. One embodiment is fully implantable and is encased with sensing and defibrillating electronics. With this embodiment, a low-power, low-capacity, continually updated recorder is continually operative, and a high-capacity stand-by recorder is actuated upon the sensing of fibrillation. An external device is used to retrieve by telemetry, the information stored in the implanted recorder. The second embodiment of the inventive recorder is an external device which has external electrodes for associating with the patient; ECG information is transmitted to the recorder unit by telemetry. Here, because power consumption is not so critical as with the implantable embodiment, a delay-type continually updated memory is continuously operative. Then, when any one of several types of arrhythmias is sensed, or when a defibrillating pulse is delivered, the data in the memory is "permanently" recorded on magnetic tape. Either embodiment may be used with an implantable defibrillator to record and subsequently reproduce information relating to the operation of the implantable defibrillator. The second embodiment also has an alarm capability to warn the patient should there be an interruption in telemetric transmission.

Claims

1. Apparatus dedicated to a single patient for monitoring the operation of an automatic defibrillator implanted in the patient, the apparatus comprising:

first detector means responsive to deliverance of defibrillating energy by said implanted defibrillator for triggering the storage of data related to said deliverance of the defibrillating energy;

storage means for durably storing said data;

external receiving means for receiving said data; and

telemetry means for transmitting said data from the patient to said external receiving means.

2. The device recited in claim 1 wherein said storage means is implanted with said defibrillator.

3. The device recited in claim 1 wherein said storage means is external to the recipient.

4. The device recited in claim 1 wherein said are disturbances in cardiac electrical activity.

5. The device recited in claim 1 wherein said data are defibrillation pulses.

6. The device recited in claim 1 wherein said data is a representation of an ECG signal.

7. The device recited in claim 1 wherein said data is a time tag.

8. The device recited in claim 1 wherein said telemetry means is external to said recipient, and includes external electrodes on said recipient for sensing the electrical activity of the heart.

9. The device recited in claim 1 wherein said telemetry means is implanted with said defibrillator.

10. The device recited in claim 1 and further comprising means for permanently recording said data transmitted to said external receiving.

11. The device according to claim 1, wherein said storage means comprises:

first storage means having a predetermined small capacity for temporarily storing and updating a small portion of said data; and

second storage means for durably storing the portion of the data occurring after the deliverance of defibrillating energy.

12. The device according to claim 11 wherein said first storage means and said second storage means comprise the same storage device.

13. The device according to claim 11 wherein said receiving device includes a tape recorder having a tape for durably storing the data stored in said first storage means and said data stored in said second storage means.

14. The device according to claim 11 wherein said first storage means includes a random access memory.

15. The device according to claim 11 wherein said first storage means includes a shift register.

16. The device according to claim 11 wherein said first storage means and said second storage means each include a random access memory.

17. The device according to claim 1 further comprising means for converting said data into a digital signal, and means for delivering said digital signal to said receiving device.

18. The device of claim 1, further comprising second detector means responsive to events characteristic of a possible fibrillation episode for triggering the storage of data related to said possible fibrillation episode, and wherein said storage means durably stores said data related to said possible fibrillation episode, said external receiving means receives said data related to said possible fibrillation episode, and said telemetry means transmits said data related to said fibrillation episode from said patient to said external receiving means.

19. The device of claim 18, further comprising means for formatting said received data related to said possible fibrillation episode and said deliverance of defibrillating energy to provide information indicative of whether or not said deliverance of defibrillating energy was made in response to the detection of fibrillation by said implanted defibrillator.

20. The device of claim 1, further comprising means for monitoring data relating to cardiac electrical activity, and wherein said first detector means, in response to said deliverance of defibrillating energy, triggers the storage of data related to said cardiac electrical activity, said external receiving means receives said data related to said cardiac electrical activity, and said telemetry means transmits said data related to said cardiac electrical activity from said patient to said external receiving means.

21. The device of claim 20, further comprising means for formatting said received data related to said cardiac electrical activity and said deliverance of defibrillating energy to provide information indicative of whether or not said deliverance of defibrillating energy was made in response to the detection of fibrillation by said implanted defibrillator.

22. The device of claim 21, further comprising second detector means responsive to events characteristic of a possible fibrillation episode for triggering the storage of said data related to said cardiac electrical activity.

23. Apparatus dedicated to a single patient for recording data pertinent to the operation of an automatic defibrillator implanted in the patient, said apparatus comprising:

means for sensing electrical activity associated with the patient'"'"'s heart as a first signal;

means for converting said first signal to a digital signal;

first memory means having a predetermined number of memory locations for storing said digital signal;

means responsive to said first signal for providing a fibrillation signal at the detection of fibrillation;

detector means responsive to the deliverance of defibrillating energy into the patient'"'"'s heart for producing a defibrillation signal;

means responsive to said fibrillation signal for disabling said first memory means, and for causing said first memory means to hold the digital signal already stored therein;

second memory means having a predetermined number of memory locations for storing said digital signal;

means responsive to said fibrillation signal for enabling said second memory means; and

means responsive to said defibrillation signal for enabling said second memory means.

24. The device according to claim 23 further comprising:

first memory address means for addressing said memory locations in said first memory means;

means responsive to said fibrillation signal for storing the address of said first memory means; and

second memory address means for addressing said memory locations in said second memory means.

25. The device according to claim 23 further comprising means for reproducing in eye-readable format the portion of the first signal stored in said first and second memory means.

26. The device of claim 23 wherein said second storage means includes a tape recorder for durably storing the output of said first storage means.

27. Apparatus dedicated to a single patient for monitoring the operation of an automatic defibrillator implanted in the patient, the apparatus comprising:

a first unit adapted to be worn by the patient, said first unit comprising,

sensing means for sensing electrical activity associated with the patient'"'"'s heart as a first signal, and

transmitting means for transmitting said sensed first signal; and

a second unit capable of easily being carried and moved, said second unit comprising,

receiving means for receiving said transmitted first signal,

detector means in circuit with said receiving means and responsive to a defibrillation attempt for triggering the storage of data related to said attempt, and

storage means for durably storing said data related to said attempt.

28. The device of claim 27 wherein said detector means is an arrhythmia detector.

29. The device according to claim 27 wherein said second unit further comprises means for retrieving from said storage means said durably stored data related to said attempt, and

means for displaying said retrieved output in eye-readable format.

30. The device according to claim 27 wherein said first unit further comprises internal timing means for providing a time tag, and means responsive to said detector means for causing said time tag to be durably stored in said storage means.

31. The device according to claim 30 wherein said internal timing means is a digital watch chip.

32. The device according to claim 27 wherein said sensing means is a set of chest electrodes.

33. The device according to claim 27 wherein said second unit further comprises:

means responsive to said received first signal for producing a detection signal when said received first signal falls below a predetermined magnitude,

audio means for producing an audible tone in response to said detection signal, and

means operatively associated with said storage means for disabling said storage in response to said detection signal.

34. The device according to claim 27 further comprising means in circuit between said receiving means and said ECG storage means for converting said received ECG signal into a digital signal.

35. The device of claim 34 wherein said storage means includes a random access memory.

36. The device of claim 34 wherein said storage means includes a shift register.

37. The device of claim 27 wherein said first unit further comprises encoding means in circuit between said sensing means and said transmitting means for encoding said sensed first signal, and said second unit further comprises decoding means in circuit with said receiver means and said storage means for decoding said received first signal.

38. The device of claim 37 wherein said encoding means is a pulse frequency modulation encoder and said decoding means is a pulse frequency modulation decoder.

39. The device of claim 37 further comprising a pulse sensor means responsive to said sensed ECG signal for providing to said encoding means a defibrillation signal produced when said pulse sensor means senses a defibrillation pulse.

40. The device of claim 37 wherein said decoding means is also in circuit between said receiver means and said detecting means.

41. The device according to claim 27 wherein said storage means includes a cassette tape recorder having a magnetic tape.

42. The device according to claim 41 wherein said second unit further comprises means for retrieving the information stored on said magnetic tape, and means for displaying said retrieved information in eye-readable format.

43. The apparatus of claim 39, wherein said second unit further comprises,

means responsive to said received first signal for producing a second signal when said received first signal falls below a predetermined magnitude, and

means for producing an audible tone in response to said second signal to alert the patient that said first signal is not being received by said second unit.

44. Apparatus dedicated to a single patient for monitoring the operation of an automatic defibrillator implanted in the patient, the apparatus comprising:

first detector means responsive to events characteristic of a possible fibrillation episode for triggering the storage of data related to said possible fibrillation episode;

second detector means responsive to deliverance of defibrillating energy by said implanted defibrillator for triggering the storage of data related to said deliverance of defibrillating energy;

storage means for durably storing the data related to said possible fibrillation episode and said deliverance of defibrillating energy;

external receiving means for receiving the data related to said possible fibrillation episode and said deliverance of defibrillating energy; and

telemetry means for transmitting the data related to said possible fibrillation episode and said deliverance of defibrillating energy from the patient to said external receiving means.

45. An implantable automatic defibrillator including treatment verification capabilities, said defibrillator comprising:

sensing means for sensing electrical activity associated with the heart of a wearer;

detector means receiving said electrical activity from said sensing means for detecting cardiac arrhythmias including fibrillation;

signal-generating means for issuing signals in response to the detection of arrhythmias by said detector means;

storage and discharge means for first storing and then automatically discharging defibrillating energy through the heart of the wearer;

charging means for charging said storage and discharge means with said defibrillating energy;

means creating an electrical link between said signal-generating means and said charging means for activating said charging means upon detection of fibrillation by said detector means;

storage means for durably storing the electrical activity sensed by said sensing means; and

means creating an electrical link between said signal-generating means and said storage means for activating said storage means upon detection of an arrhythmia by said detector means.

46. The defibrillator of claim 45, wherein said storage and discharge means and said charging means are activated simultaneously in response to a single signal produced by said signal-generating means.