Implantable cardiac patient monitor

• US 5,411,031 A
• Filed: 11/24/1993
• Issued: 05/02/1995
• Est. Priority Date: 11/24/1993
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: InControl, Inc. (Daikin Industries Ltd)
• Inventors: Yomtov, Barry M.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US08/157,605
• Time in Patent Office: 524 Days
• Field of Search: 128/706, 128/708, 128/696, 128/705, 128/702, 128/698
• US Class Current: 600/519
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61B 5/413 Monitoring transplanted tissue or organ, e.g. for possible rejection reactions after a transplant
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

A cardiac monitor which is fully implantable beneath the skin of a patient monitors heart rate variability of a human heart. The heart rate monitor includes at least one electrode which establishes electrical contact with the heart. During a heart monitoring period, time intervals between adjacent heart beats are determined for generating heart rate data. The heart rate data is stored in a memory which is accessed after the completion of the heart monitoring period for generating a heart rate variability factor. The heart rate variability factor is stored in memory for later transmission to a nonimplanted external receiver.

Claims

1. A cardiac monitor for monitoring heart rate variability 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;

timing means for timing a heart monitoring period;

sensing means coupled to said electrode means for generating an electrocardiogram of each heartbeat of the heart occurring during said heart monitoring period;

time interval determining means responsive to said electrocardiograms for determining time intervals between adjacent heartbeats;

heart rate data generating means responsive to said time intervals for generating heart rate digital data;

memory means for storing said heart rate digital data;

factor generating means responsive to said timing means and said stored heart rate digital data for generating a digital heart rate variability factor at the end of said heart monitoring period;

said memory means for storing said digital heart rate variability factor; and

telemetry means for transmitting said digital heart rate variability factor stored in said memory means to a nonimplanted external receiver.

2. A cardiac monitor as defined in claim 1 wherein said electrode means includes at least one electrode adapted to be implanted subcutaneously beneath the skin of a patient in non-touching relation to the heart.

3. A cardiac monitor as defined in claim 1 further including an R wave detector and wherein said time interval determining means is responsive to said R wave detector for determining time intervals between successive R waves.

4. A cardiac monitor as defined in claim 1 wherein said timing means times successive heart monitoring periods, and wherein said factor generating means generates a heart rate variability factor at the end of each said heart monitoring period.

5. A cardiac monitor as defined in claim 4 wherein each said heart monitoring period is between five minutes and twenty-four hours.

6. A cardiac monitor for monitoring heart rate variability 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;

timing means for timing a heart monitoring period;

sensing means coupled to said electrode means for generating an electrocardiogram of each heartbeat of the heart occurring during said heart monitoring period;

time interval determining means responsive to said electrocardiograms for determining time intervals between adjacent heartbeats;

second timing means for timing monitoring sub-periods during said heart monitoring periods;

heart rate data generating means responsive to said time intervals for generating first heart rate data and responsive to said first heart rate data for generating second heart rate data at the end of each said monitoring sub-period;

memory means for storing said first and second heart rate data;

factor generating means responsive to said stored second heart rate data for generating a digital heart rate variability factor;

said memory means for storing said heart rate variability factor; and

telemetry means for transmitting said heart rate variability factor stored in said memory means to a nonimplanted external receiver.

7. A cardiac monitor for monitoring heart rate variability 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;

timing means for timing a heart monitoring period;

sensing means coupled to said electrode means for generating an electrocardiogram of each heartbeat of the heart occurring during said heart monitoring period;

time interval determining means responsive to said electrocardiograms for determining time intervals between adjacent heartbeats;

heart rate data generating means responsive to said time intervals for generating heart rate data;

memory means for storing said heart

discriminating means for discriminating between normal sinus heart beats and ventricular heart beats;

factor generating means responsive to said stored heart rate data for generating a heart rate variability factor;

said memory means for storing said heart rate variability factor; and

telemetry means for transmitting said heart rate variability factor stored in said memory means to a nonimplanted external receiver.

8. A cardiac monitor as defined in claim 7 wherein said factor generating means includes time domain analysis means for generating a time domain heart rate variability factor and is responsive to only heart rate data associated with adjacent normal sinus heart beats for generating said time domain heart rate variability factor.

9. A cardiac monitor as defined in claim 8 further including sufficient data determining means for determining if a sufficient number of adjacent normal sinus heart beats have occurred during said heart monitoring period and wherein said factor generating means generate said time domain heart rate variability factor only if said sufficient number of adjacent normal sinus heart beats have occurred.

10. A cardiac monitor as defined in claim 9 further including clearing means for clearing said stored heart rate data from said memory means after generating said time domain heart rate variability factor or after said sufficient data determining means determines that said sufficient number of adjacent normal sinus heart beats have not occurred.

11. A cardiac monitor as defined in claim 9 wherein said sufficient number of adjacent normal sinus heart beats is equal to or greater than fifty percent of said heart beats being adjacent normal sinus heart beats.

12. A cardiac monitor as defined in claim 7 further including interpolating means responsive to said discriminating means for interpolating heart beat time intervals associated with ventricular heart beats.

13. A cardiac monitor as defined in claim 12 further including second memory means for storing all said time intervals and wherein said telemetry means transmits all said time intervals stored in said second memory means to an external receiver to permit frequency domain processing of all said time intervals.

14. A cardiac monitor as defined in claim 13 wherein said telemetry means is responsive to a command originating from external to the skin of a patient for transmitting all said time intervals stored in said memory means.

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

timing means for timing successive heart monitoring periods;

electrode means for establishing electrical contact with the heart;

R wave detecting means coupled to said electrode means for detecting R waves of the heart, during each said heart monitoring period;

interval determining means responsive to said R wave detecting means for determining the time intervals between adjacent R waves;

data generating means responsive to said time intervals for generating heart rate digital data;

memory means for storing said heart rate digital data;

factor generating means responsive to the completion of each said heart monitoring period timed by said timing means and said stored heart rate digital data for generating a digital heart rate variability factor for each said heart monitoring period;

said memory means for storing said digital heart rate variability factors; and

telemetry means for transmitting said digital heart rate variability factors stored in said memory means to a nonimplanted external receiver.

16. A cardiac monitor as defined in claim 15 wherein said electrode means includes at least one electrode adapted to be implanted subcutaneously beneath the skin of a patient in non-touching relation to the heart.

17. A cardiac monitor as defined in claim 15 wherein said heart monitoring periods have a duration between five minutes and twenty-four hours.

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

timing means for timing successive heart monitoring periods;

electrode means for establishing electrical contact with the heart;

R wave detecting means coupled to said electrode means for detecting R waves of the heart, during each said heart monitoring period;

interval determining means responsive to said R wave detecting means for determining the time intervals between adjacent R waves;

second timing means for timing monitoring sub-periods during said heart monitoring periods;

generating means responsive to said time intervals for generating first heart rate data and responsive to said first heart rate data for generating second heart rate data at the end of each said monitoring sub-period;

memory means for storing said first and second heart rate data;

factor generating means responsive to the completion of each said heart monitoring period and said second stored heart rate data for Generating a heart rate variability factor for each said heart monitoring period;

said memory means for storing said heart rate variability factors; and

telemetry means for transmitting said heart rate variability factors stored in said memory means to a nonimplanted external receiver.

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

timing means for timing successive heart monitoring periods;

electrode means for establishing electrical contact with the heart;

R wave detecting means coupled to said electrode means for detecting R waves of the heart, during each said heart monitoring period;

interval determining means responsive to said R wave detecting means for determining the time intervals between adjacent R waves;

data generating means responsive to said time intervals for generating heart rate data;

memory means for storing said heart rate data;

discriminating means for discriminating between normal sinus heart beats and ventricular heart beats;

factor generating means responsive to the completion of each said heart monitoring period and said stored heart rate data for generating a heart rate variability factor for each said heart monitoring period;

said memory means for storing said heart rate variability factors; and

telemetry means for transmitting said heart rate variability factors stored in said memory means to a nonimplanted external receiver.

20. A cardiac monitor as defined in claim 19 wherein said factor generating means includes time domain analysis means for generating a time domain heart rate variability factor and is responsive to only heart rate data associated with adjacent normal sinus heart beats for generating said time domain heart rate variability factor.

21. A cardiac monitor as defined in claim 20 further including sufficient data determining means for determining if a sufficient number of adjacent normal sinus heart beats have occurred during each said monitoring period and wherein said factor generating means generate said time domain heart rate variability factor only if said sufficient number of adjacent normal sinus heart beats have occurred.

22. A cardiac monitor as defined in claim 21 further including clearing means for clearing said stored heart rate data from said memory means after generating said time domain heart rate variability factor or after said sufficient data determining means determines that said sufficient number of adjacent normal sinus heart beats have not occurred.

23. A cardiac monitor as defined in claim 21 wherein said sufficient number of adjacent normal sinus heart beats is equal to or greater than fifty percent of said heart beats being adjacent normal sinus heart beats.

24. A cardiac monitor as defined in claim 19 further including interpolating means responsive to said discriminating means for interpolating heart beat time intervals associated with ventricular heart beats.

25. A cardiac monitor as defined in claim 24 further including second memory means for storing all said time intervals and wherein said telemetry means transmits all said time intervals stored in said second memory means to an external receiver to permit frequency domain processing of all said time intervals.

26. A cardiac monitor as defined in claim 25 wherein said telemetry means is responsive to a command originating from external to the skin of a patient for transmitting all said time intervals stored in said memory means.