Implantable ambulatory electrocardiogram monitor

• US 5,113,869 A
• Filed: 08/21/1990
• Issued: 05/19/1992
• Est. Priority Date: 08/21/1990
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Telectronics Pacing Systems, Inc (Abbott Laboratories Incorporated)
• Inventors: Hursta, William N., Steinhaus, Bruce M., Nappholz, Tibor A., Dawson, Albert K.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US07/570,379
• Time in Patent Office: 637 Days
• Field of Search: 128/696, 128/702, 128/705, 128/903
• US Class Current: 600/508
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/7207 of noise induced by motion artifacts
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

An implanted programmable ambulatory electrocardiography (AECG) patient monitoring device that senses and analyzes electrocardiographic signals from at least one subcutaneous precordial sensor chronically and frequently to detect electrocardiogram and physiological signal characteristics predictive of malignant cardiac arrhythmias. The device includes telemetric capabilities to communicate a warning signal to an external device when such arrhythmias are predicted.

Claims

1. A chronically and totally implanted heartbeat signal monitor capable of communicating with a message-receiving device, comprising:

subcutaneous sensing means, adapted to be located remote from a patient'"'"'s heart, for sensing heartbeat signals,

means responsive to sensed heartbeat signals for determining a heart abnormality, and

means responsive to said determining means for communicating with said message-receiving device to report on a heart abnormality.

2. A chronically and totally implanted heartbeat signal monitor in accordance with claim 1 wherein said communicating means initiates a communication independent of the operation of said message-receiving device.

3. A chronically and totally implanted heartbeat signal monitor in accordance with claim 2 wherein said communicating means reports a heart abnormality in the form of a diagnostic message.

4. A chronically and totally implanted heartbeat signal monitor in accordance with claim 1 wherein said sensing means is adapted for implantation at a location at which the sensed heartbeat signal is comparable to a standard body surface electrocardiogram signal.

5. A chronically and totally implanted heartbeat signal monitor in accordance with claim 1 wherein said communicating means is further operative to transmit heartbeat signal samples to said message-receiving device to allow heartbeat signal reconstruction.

6. A chronically and totally implanted heartbeat signal monitor in accordance with claim 5 wherein said communicating means transmits said heartbeat signal samples in a burst mode.

7. A chronically and totally implanted heartbeat signal monitor in accordance with claim 1 wherein said determining means applies to sensed heartbeat signals standard body surface ambulatory electrocardiography diagnostic criteria for determining heartbeat abnormalities.

8. A chronically and totally implanted heartbeat signal monitor in accordance with claim 1, wherein said monitor is capable of communicating with an external therapy applying device, and further including means for exchanging information in accordance with an established protocol with said external therapy applying device, said information exchanging means being operative to insure that said external therapy applying device applies therapy to the patient requiring it and in whom the signal monitor is implanted.

9. A chronically and totally implanted heartbeat signal monitor in accordance with claim 8 wherein said information exchanging means is operative to sense predetermined electrical signals applied directly to the patient by said external therapy applying device and in response thereto to control said device to apply its therapy.

10. A chronically and totally implanted heartbeat signal monitor in accordance with claim 1 wherein said sensing, determining and communicating means all operate continuously, independently of external control.

11. A chronically and totally implanted heartbeat signal monitor in accordance with claim 10 wherein the monitor is adapted to remain implanted in a patient for a time interval measured in years.

12. A chronically and totally implanted heartbeat signal monitor in accordance with claim 1 wherein said sensing means include electrodes adapted for implantation beneath the skin of a patient at precordial positions which are standard in body surface ambulatory electrocardiography.

13. A chronically and totally implanted heartbeat signal monitor in accordance with claim 1 wherein said sensing means includes at least two electrodes, and said determining means is further operative to measure, and said communicating means is further operative to report on, the impedance between said at least two electrodes.

14. A chronically and totally implanted heartbeat signal monitor in accordance with claim 1 wherein said communicating means further reports heart activity information along with the times at which said activity occurred to allow external analysis of the effect of drugs on the patient.

15. A chronically and totally implanted heartbeat signal monitor in accordance with claim 1 further including means responsive to externally generated and transmitted signals for accepting downloaded signal acquisition and analysis programs to allow tailoring of the monitor to the needs of a particular patient.

16. A chronically and totally implanted heartbeat signal monitor in accordance with claim 1 wherein said determining means is operative to distinguish between normal cardiac rhythms and arrhythmias by setting an arrhythmia rate threshold at a higher level when the patient is exercising.

17. A chronically and totally implanted heartbeat signal monitor in accordance with claim 1 whose life is extended by the omission of a pacing capability.

18. A chronically and totally implanted heartbeat signal monitor in accordance with claim 1 wherein said determining means adjusts the bandwidth which characterizes the processing of the sensed heartbeat signals in accordance with the particular part of a cardiac cycle which is in progress.

19. A chronically and totally implanted heartbeat signal monitor in accordance with claim 1 wherein said sensing means includes electrodes adapted to be positioned for optimizing ST-segment analysis.

20. A chronically and totally implanted heartbeat signal monitor in accordance with claim 1 wherein said communicating means further alerts the patient to commence self-treatment.

21. A chronically and totally implanted heartbeat signal monitor capable of communicating with a message-receiving device, comprising:

subcutaneous sensing means for sensing heartbeat signals remote from a patient'"'"'s heart, said sensing means including electrodes adapted for implantation beneath the skin of a patient at precordial positions which are standard in body surface ambulatory electrocardiography,

means responsive to sensed heartbeat signals for deriving cardiac information therefrom, and

means responsive to said deriving means for communicating with said message-receiving device to report on the derived cardiac information.

22. A method for monitoring heartbeat signals comprising the steps of:

chronically and totally implanting a heartbeat signal monitor having an electronic device and at least one sensing lead, said sensing lead having an electrode thereon, and said electronic device being capable of deriving cardiac information from signals appearing at said electrode and telemetering such information to an external device, and

implanting said at least one sensing lead subcutaneously with said electrode being positioned beneath the skin of the patient, remote from the patient'"'"'s heart, at a precordial position which is standard in ambulatory electrocardiography.

23. A method for monitoring heartbeat signals by a heartbeat monitoring device comprising the steps of:

sensing heartbeat signals from at least one electrode, positioned beneath the skin of the patient and remote from the patient'"'"'s heart, at a precordial position which is standard in ambulatory electrocardiography,

analyzing sensed heartbeat signals to detect a morphology and timing indicative of a heart abnormality,

upon the detection of a heart abnormality, initiating communication with a non-implanted message-receiving device independent of the operation of said message-receiving device,

identifying the non-implanted message-receiving device adapted to communicate with the heartbeat monitoring device, and

transmitting diagnostic messages to said message-receiving device upon successful device identification.

24. A method for monitoring heartbeat signals in accordance with claim 23 wherein the step of transmitting diagnostic messages is performed in a burst mode.

25. A method for monitoring heartbeat signals in accordance with claim 23 further including the steps of:

exchanging information in accordance with an established protocol with an external therapy applying device, said information exchanging step being operative to insure that said external therapy applying device applies therapy to the patient requiring it and in whom the signal monitor is implanted.

26. A method for monitoring heartbeat signals in accordance with claim 25 wherein said information exchanging step includes the sub-steps of sensing predetermined electrical signals applied directly to the patient by said external therapy applying device and in response thereto controlling said device to apply its therapy.

27. A method for monitoring heartbeat signals in accordance with claim 23 further including the steps of:

sensing the impedance between at least two implanted electrodes, and

analyzing the sensed impedance together with the sensed heartbeat signal to detect a morphology and timing indicative of a heart abnormality.

28. A method for monitoring heartbeat signals in accordance with claim 23 wherein said diagnostic message transmitting step alerts the patient to commence self-treatment.