Method of processing signals characteristic of cardiac activity and an associated device

• US 5,891,169 A
• Filed: 01/29/1997
• Issued: 04/06/1999
• Est. Priority Date: 07/30/1994
• Status: Expired due to Term

• Current Assignee: Biotronik Mess-Und Therapiegeraete GmbH & Company Ingenieurbuero Berlin (Biotronik SE & Company KG)
• Original Assignee: Biotronik Mess-Und Therapiegeraete GmbH & Company Ingenieurbuero Berlin (Biotronik SE & Company KG)
• Inventors: Boheim, Gustav, Schaldach, Max, Thong, Tran, Digby, Dennis, Wyborny, Paul
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US08/776,294
• Time in Patent Office: 797 Days
• Field of Search: 607/23, 607/9, 607/4-6, 600/517, 600/518
• US Class Current: 607/4
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence

Abstract

A method for processing a signal characteristic of cardiac activity in the atrium (A) and/or ventricle (V) of a heart (H) and for evaluating this signal with a view to obtaining a control signal for a cardiac pacemaker and/or defibrillator (3) can be carried out by: receiving a time dependent signal from at least one intracardial signal sensor (1, 2) in the atrium and/or ventricle; feeding the signal picked up by each signal sensor (1, 2) to a read and evaluation circuit (6) with a threshold characteristic; comparing the signals with a detection threshold; evaluating the result of the comparison to obtain an indication as to the presence of normal sinus-type cardiac activity or fibrillations; and producing the control signal, which characterizes the comparison result. The signal from the at least one sensor (1, 2) is fed to a first input stage (8, 11) which has a first adjustable detection threshold (TS(A), TS(V) that is constant in time and to a second input stage (9, 10) which has a second adjustable detection threshold TL(A), TL(V) that can be adjusted independently of the first detection threshold but is constant in time once set. The signal from the at least one intracardial signal sensor is processed in these first and second input stages.

Claims

1. A method for processing a signal characteristic of cardiac activities in a chamber of a heart (H) to generate a control signal for at least one of a heart pacemaker and a defibrillator, the signal characteristic of cardiac activities being received from an intracardial signal sensor (1, 2) in the heart comprising the steps of:

(a) feeding the signal characteristic of cardiac activities to a first input stage (8, 11;

100A) with a first, adjustable detection threshold (TS(A), TS(V)), the first detection threshold being constant in time following an adjustment and being set to a signal amplitude for normal sinus-type cardiac activities;

(b) in the first input stage, comparing the signal characteristic of cardiac activities to the first detection threshold and generating a first stage output signal;

(c) feeding the signal characteristic of cardiac activities to a second input stage (9, 10;

100B) with a second detection threshold (TL(A), TL(V)) which is adjustable independent of the first detection threshold, the second detection threshold being constant in time following an adjustment and being set to a signal amplitude for fibrillation events

(d) in the second input stage, comparing the signal characteristic of cardiac activities to the second detection threshold and generating a second stage output signal; and

(e) evaluating the first and second stage output signals and generating the control signal.

2. A method according to claim 1, wherein the intracardial signal sensor comprises an intracardially arranged electrode (1, 2) which supplies a time-dependent course of a cardiac activity potential as the signal characteristic of cardiac activities.

3. A method according to claim 1, wherein the intracardial signal sensor comprises an intracardially arranged pressure transducer which supplies an electric signal reflecting time-dependent intracardial pressure fluctuations as the signal characteristic of cardiac activities.

4. A method according to claim 1, wherein the second input stage (9, 10;

100B) includes an amplifier with a high amplification factor, and further comprising the step of amplifying the signal characteristic of cardiac activities with the amplifier before step (d) is conducted.

5. A method according to claim 4, wherein step (d) further comprises cutting off components of the signal characteristic of cardiac activity with a magnitude larger than a predetermined limit (C_u, C_L), the predetermined limit being larger than the level for the second detection threshold (TL_U, TL_L).

6. A method according to claim 5, wherein step (d) further comprises blanking out of signal components of the signal characteristic of cardiac activities during a predetermined time interval following the appearance of a signal component with a magnitude larger than the predetermined limit.

7. A method according to claim 5, wherein step (d) further comprises digitizing the signal characteristic of cardiac activities after the signal components with a magnitude larger than the predetermined limit have been cut off.

8. A method according to claim 5, further comprising determining, during a preceding measuring cycle, the maximum or average amplitude or the signal energy of a signal component that is not cut off, and adjusting the second detection threshold (TL(A)), (TL(V)) in dependence on the maximum or average amplitude or the signal energy of the signal component that is not cut off.

9. A method according to claim 1, wherein at least one of steps (b) and (d) further comprises digitizing the signal characteristic of cardiac activities, the digitized signal being compared to the respective detection threshold.

10. A method according to claim 9, further comprising identifying noise signals fed to the second input stage (9, 10;

100B) or signals processed in the second input stage on the basis of amplitude discrimination with the aid of the digitized signals.

11. A method according to claim 1, wherein at least one of steps (b) and (d) further comprises storing at least the signal characteristic of cardiac activity or a signal processed in the respective input stage before step (e) is conducted.

12. A method according to claim 1, further comprising identifying noise signals fed to the second input stage (9, 10;

100B) or signals preprocessed in the second input stage on the basis of amplitude discrimination.

13. A method according to claim 1, wherein step (e) comprises finding a time average with respect to a sequence of second stage output signals via a predetermined number of second stage output signals or a predetermined time cycle for determining an average rate for the second stage output signals, a signal characterizing whether fibrillations are present or absent being output depending on the average rate.

14. A method according to claim 13, wherein step (d) comprises determining peak signal values or an average signal value or signal energy of any components of the signal characteristic of cardiac activities that are located above the second detection threshold, and wherein step (e) further comprises outputting a signal characterizing whether fibrillations are present or absent as a function of the average rate and the peak signal values, the average signal value or the signal energy.

15. A method according to claim 1, wherein step (e) comprises determining a time average with respect to a sequence of first stage output signals over a predetermined number of first stage output signals or a predetermined time cycle for determining an average rate for the first stage output signals, determining a time window from the average rate, and outputting a signal characterizing a type of actual cardiac activity in dependence on whether any components of the signal characteristic of cardiac activity are located above the first detection threshold as well as above the second detection threshold during the time window.

16. A device for processing a signal characteristic of cardiac activities in a chamber of a heart to generate a control signal for at least one of a pacemaker and a defibrillator the signal characteristic of cardiac activities being received from an intracardial signal sensor (1, 2), said device comprising:

a first input stage (8,

     11) which receives the signal characteristic of cardiac activities, the first input stage having a first detection threshold (TS(A)), TS(V)) that is adjustable but constant in time following an adjustment, the first detection threshold being set to a signal amplitude for normal sinus-type cardiac activities, the first input stage including a comparator unit (8, 4, 11,4) with a first detection output signal (8a, 11a); and

a second input stage (9,

     10) which receives the signal characteristic of cardiac activities, the second input stage having a second detection threshold (TL(A)), TL(V)) that can be adjusted independent of the first one but that is constant in time following an adjustment, the second detection threshold being set to a signal amplitude for fibrillation events, the second input stage including a comparator unit (9.4, 10.4) with a second detection output signal (9a, 10a).

17. A device according to claim 16, further comprising evaluation unit means (12 to 16) for receiving the first and second detection output signals and generating the control signal in response thereto.

18. A device according to claim 17 in combination with an automatic defibrillator which has a control input (5a) to receive the control signal and which selectively generates a defibrillation pulse if fibrillations occur.

19. A device according to claim 17 in combination with a pacemaker having a control input (4a) to receive the control signal and selectively generating a stimulation pulse if bradycardia appears.

20. A device according to claim 16, wherein the intracardial signal sensor comprises an intracardially arranged electrode (1, 2) which supplies a time-dependent course of a cardiac activity potential as the signal characteristic of cardiac activities.

21. A device according to claim 16, wherein the intracardial signal sensor comprises an intracardially arranged pressure transducer which supplies an electric signal reflecting intracardial, time-dependent pressure fluctuations as the signal characteristic of cardiac activities.

22. A device according to claim 16, wherein the second input stage (9, 10;

100B) further comprises a wide-band amplifier (9.2, 10.2;

     104) with a high amplification factor.

23. A device according to claim 22, wherein the second input stage (9, 10;

100B) further comprises a level limiter circuit (9.1, 10.1;

     104) for cutting off components of the signal characteristic of cardiac activity with a magnitude larger than a predetermined limit (C_U, C_L), the predetermined limit being larger than the second detection threshold.

24. A device according to claim 23, wherein the second input stage (9, 10;

100B) further comprises a blanking circuit (9.1, 10.1;

     104) for blanking components of the signal characteristic of cardiac activities during a predetermined time interval, following an appearance of a component of the signal characteristic of cardiac activities with a magnitude larger than the predetermined limit.

25. A device according to claim 23, wherein the second input stage further comprises an A/D converter (107) having an input which is connected to an output for the level limiter circuit (104).

26. A device according to claim 23, further comprising means (12 to 16;

103,

     109) for amplitude discrimination and means (16;

     103) for adjusting the second detection threshold in dependence on an evaluation of the maximum or an average amplitude for a total component of the signal characteristic of cardiac activities that is not cut off during a preceding measuring cycle.

27. A device according to claim 26, wherein the second input stage further comprises an A/D converter, the means for amplitude discrimination (103, 109) being connected in series after the A/D converter (107).

28. A device according to claim 16, wherein the second input stage (100B) further comprises an A/D converter (107) for digitizing the signal characteristic of cardiac activities or signals already preprocessed, and wherein the comparator unit of the second input stage is a digital comparator (103, 109).

29. A device according to claim 28, wherein the device further comprises an evaluation unit (103) which receives the first and second detection output signals and generates the control signal in response thereto, and wherein the second input stage further comprises a signal memory (110) having a data input which is connected to an output of the A/D converter (107), the memory additionally having a data output which is connected to the evaluation unit (103).

30. A device according to claim 16, wherein the device further comprises timing means (103) for determining evaluation time intervals, and wherein each of the first and second input stages (100A, 100B) further comprises a rate determination circuit (102, 104), cooperating with the timing means, for determining an average rate for components of the signal characteristic of cardiac activities that are located above the respective detection threshold.

31. A device according to claim 16, wherein the device further comprises a microprocessor (16;

103) which receives the first and second detection output signals.