Risk monitoring

• US 6,934,577 B2
• Filed: 09/24/2001
• Issued: 08/23/2005
• Est. Priority Date: 09/26/2000
• Status: Expired due to Term

• Current Assignee: Biotronik Mess-Und Therapiegeraete GmbH & Company Ingenieurbuero Berlin (Biotronik SE & Company KG), Cortronik Mess-Und Therapiegerate GmbH
• Original Assignee: Biotronik Mess-Und Therapiegeraete GmbH & Company Ingenieurbuero Berlin (Biotronik SE & Company KG)
• Inventors: Rauchegger, Günter, Hribernigg, Martin, Hutten, Helmut
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US09/961,874
• Publication Number:
  US 20020095094A1
• Time in Patent Office: 1,429 Days
• Field of Search: 600/515
• US Class Current: 600/515
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/346 Analysis of electrocardiograms
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A risk assessment device, in particular for the risk of a severe heart functional disorder such as sudden death due to heart disease, comprising an input unit which is adapted to record or read in an electrocardiographic input signal and to output a corresponding output signal comprising a plurality of cardiac cycles and corresponding intervals, and a detection unit which is connected to the input unit and which is adapted to detect events of predetermined nature in the output signal, wherein there are provided a summing unit which is connected to the detection unit and the input unit and is adapted to add up the length of predetermined intervals connected to a detected event within the input signal and to output a corresponding sum parameter, and an evaluation unit which is adapted to evaluate the sum parameter under predetermined conditions and to output a risk parameter which is dependent on the evaluation.

Claims

1. A risk assessment device, for assessing the risk of a severe heart functional disorder, comprising:

an input unit to record, or read in, an electrocardiographic input signal and to output a corresponding processed output signal;

a detection unit, connected to the input unit, to detect events of a predetermined nature in the output signal;

a summing unit connected to the detection unit and the input unit, the summing unit adding up a length of predetermined intervals connected to a detected event within the input signal and outputting a corresponding sum parameter; and

an evaluation unit to evaluate the sum parameter under predetermined conditions and to output a risk parameter which is dependent on the evaluation.

2. The risk assessment device of claim 1 wherein the predetermined events are from a group consisting of a QRS-complex, an extrasystole, and a combination thereof.

3. The risk assessment device of claim 2, further comprising a selection unit, connected to the detection unit, to select among the detected events such events which have one or more predetermined properties.

4. The risk assessment device of claim 3, wherein the selection unit selects ventricular extrasystoles which involve a change in a morphology of a QRS-complex associated with an extrasystole in relation to QRS-complexes not linked to an extrasystole, in the output signal of the input unit.

5. The risk assessment device of claim 4, wherein the selection unit selects ventricular VES-2 extrasystoles that are followed by an interval which is increased in length by a predetermined limit value in comparison with preceding intervals not containing any extrasystoles.

6. The risk assessment device claim 5, wherein the selection unit selects, to form a reference interval, a predetermined number of intervals not containing any extrasystoles prior to and after a VES-2 extrasystole.

7. The risk assessment device of claim 6, further comprising an interval selection unit, connected to the selection unit, to select intervals that are associated with at least two VES-2 extrasystoles which occur within a predetermined period of time, to form the sum parameter.

8. The risk assessment device of claim 7, wherein the predetermined period of time is of the order of magnitude of one hour.

9. The risk assessment device of claim 8, wherein the evaluation unit forms a trend pattern by evaluating the sum parameter, in such a way that the risk parameter corresponds to a trend of the sum parameter.

10. The risk assessment device of claim 9, further comprising a second evaluation unit, connected to the evaluation unit, to take over the risk parameter as a first parameter, the second evaluation unit having at least one input for at least one further parameter, the second evaluation unit calculating a risk signal corresponding to a probability of a severe heart functional disorder based on a linear combination of at least two of the parameters, as is commonly determined by logistical regression, or by non-linear combination of at least two of the parameters.

11. The risk assessment device of claim 3, wherein the selection unit selects ventricular VES-2 extrasystoles in which a QRS-complex is premature at least by a predetermined limit value, when compared to QRS-complexes of preceding intervals containing no extrasystoles.

12. The risk assessment device of claim 11, wherein the selection unit selects ventricular VES-2 extrasystoles that are followed by an interval which is increased in length by a predetermined limit value in comparison with preceding intervals not containing any extrasystoles.

13. The risk assessment device of claim 12, wherein the selection unit selects, to form a reference interval, a predetermined number of intervals not containing any extrasystoles prior to and after a VES-2 extrasystole.

14. The risk assessment device of claim 13, further comprising an interval selection unit, connected to the selection unit, to select intervals that are associated with at least two VES-2 extrasystoles which occur within a predetermined period of time, to form the sum parameter.

15. The risk assessment device of claim 14, wherein the predetermined period of time is of the order of magnitude of one hour.

16. The risk assessment device of claim 15, wherein the evaluation unit forms a trend pattern by evaluating the sum parameter, in such a way that the risk parameter corresponds to a trend of the sum parameter.

17. The risk assessment device of claim 16, further comprising a second evaluation unit, connected to the evaluation unit, to take over the risk parameter as a first parameter, the second evaluation unit having at least one input for at least one further parameter, the second evaluation unit calculating a risk signal corresponding to a probability of a severe heart functional disorder based on a linear combination of at least two of the parameters, as is commonly determined by logistical regression, or by non-linear combination of at least two of the parameters.

18. The risk assessment device of claim 1, further comprising a selection unit, connected to the detection unit, to select among the detected events such events which have one or more predetermined properties.

19. The risk assessment device of claim 18, wherein the selection unit selects ventricular extrasystoles which involve a change in a morphology of a QRS-complex associated with an extrasystole in relation to QRS-complexes not linked to an extrasystole, in the output signal of the input unit.

20. The risk assessment device of claim 19, wherein the selection unit selects ventricular VES-2 extrasystoles that are followed by an interval which is increased in length by a predetermined limit value in comparison with preceding intervals not containing any extrasystoles.

21. The risk assessment device of claim 20, wherein the selection unit selects, to form a reference interval, a predetermined number of intervals not containing any extrasystoles prior to and after a VES-2 extrasystole.

22. The risk assessment device of claim 21, further comprising an interval selection unit, connected to the selection unit, to select intervals that are associated with at least two VES-2 extrasystoles which occur within a predetermined period of time, to form the sum parameter.

23. The risk assessment device of claim 22, wherein the predetermined period of time is of the order of magnitude of one hour.

24. The risk assessment device of claim 23, wherein the evaluation unit forms a trend pattern by evaluating the sum parameter, in such a way that the risk parameter corresponds to a trend of the sum parameter.

25. The risk assessment device of claim 24, further comprising a second evaluation unit, connected to the evaluation unit, to take over the risk parameter as a first parameter, the second evaluation unit having at least one input for at least one further parameter, the second evaluation unit calculating a risk signal corresponding to a probability of a severe heart functional disorder based on a linear combination of at least two of the parameters, as is commonly determined by logistical regression, or by non-linear combination of at least two of the parameters.

26. The risk assessment device of claim 18, wherein the selection unit selects ventricular VES-2 extrasystoles in which a QRS-complex is premature at least by a predetermined limit value, when compared to QRS-complexes of preceding intervals containing no extrasystoles.

27. The risk assessment device of claim 26, wherein the selection unit selects ventricular VES-2 extrasystoles that are followed by an interval which is increased in length by a predetermined limit value in comparison with preceding intervals not containing any extrasystoles.

28. The risk assessment device of claim 27, wherein the selection unit selects, to form a reference interval, a predetermined number of intervals not containing any extrasystoles prior to and after a VES-2 extrasystole.

29. The risk assessment device of claim 28, further comprising an interval selection unit, connected to the selection unit, to select intervals that are associated with at least two VES-2 extrasystoles which occur within a predetermined period of time, to form the sum parameter.

30. The risk assessment device of claim 29, wherein the predetermined period of time is of the order of magnitude of one hour.

31. The risk assessment device of claim 30, wherein the evaluation unit forms a trend pattern by evaluating the sum parameter, in such a way that the risk parameter corresponds to a trend of the sum parameter.

32. The risk assessment device of claim 31, further comprising a second evaluation unit, connected to the evaluation unit, to take over the risk parameter as a first parameter, the second evaluation unit having at least one input for at least one further parameter, the second evaluation unit calculating a risk signal corresponding to a probability of a severe heart functional disorder based on a linear combination of at least two of the parameters, as is commonly determined by logistical regression, or by non-linear combination of at least two of the parameters.

33. The risk assessment device of claim 1, wherein the evaluation unit forms a trend pattern by evaluating the sum parameter, in such a way that the risk parameter corresponds to a trend of the sum parameter.

34. The risk assessment device of claim 33, further comprising a second evaluation unit, connected to the evaluation unit, to take over the risk parameter as a first parameter, the second evaluation unit having at least one input for at least one further parameter, the second evaluation unit calculating a risk signal corresponding to a probability of a severe heart functional disorder based on a linear combination of at least two of the parameters, as is commonly determined by logistical regression, or by non-linear combination of at least two of the parameters.

35. The risk assessment device of claim 1, further comprising a second evaluation unit, connected to the evaluation unit, to take over the risk parameter as a first parameter, the second evaluation unit having at least one input for at least one further parameter, the second evaluation unit calculating a risk signal corresponding to a probability of a severe heart functional disorder based on a linear combination of at least two of the parameters, as is commonly determined by logistical regression, or by non-linear combination of at least two of the parameters.

36. A risk assessment device, for assessing the risk of a severe heart functional disorder, comprising

an input unit to record, or read in, an electrocardiographic input signal and to output a corresponding processed output signal;

a detection unit, connected to the input unit, to detect events of a predetermined nature in the output signal, the predetermined events being from a group consisting of a QRS-complex, an extrasystole, and a combination thereof;

a selection unit, connected to the detection unit, to select among the detected events such events which have one or more predetermined properties, wherein the selection unit selects ventricular extrasystoles which involve a change in a morphology of a QRS-complex associated with an extrasystole in relation to QRS-complexes not linked to an extrasystole, in the output signal of the input unit, and

wherein the selection unit further selects ventricular VES-2 extrasystoles in which the QRS-complex is premature at least by a predetermined limit value, when compared to the QRS-complexes of preceding intervals containing no extrasystoles, and

wherein the selection unit further selects ventricular VES-2 extrasystoles that are followed by an interval which is increased in length by a predetermined limit value in comparison with preceding intervals not containing any extrasystoles, and

wherein the selection unit further selects, for formation of a reference interval, a predetermined number of intervals not containing any extrasystoles prior to and after a VES-2 extrasystole;

a summing unit connected to the detection unit and the input unit, the summing unit adding up a length of predetermined intervals connected to a detected event within the input signal and outputting a corresponding sum parameter;

an evaluation unit to evaluate the sum parameter under predetermined conditions and to output a risk parameter which is dependent on the evaluation, the evaluation unit forming a trend pattern by evaluating the sum parameter, in such a way that the risk parameter corresponds to a trend of the sum parameter;

an interval selection unit, connected to the selection unit, to select intervals that are associated with at least two VES-2 extrasystoles which occur within a predetermined period of time, to form the sum parameter, wherein the predetermined period of time is of the order of magnitude of one hour; and

a second evaluation unit, connected to the evaluation unit, to take over the risk parameter as a first parameter and to calculate a risk signal, the second evaluation unit having at least one input for at least one further parameter, the second evaluation unit calculating the risk signal corresponding to a probability of a severe heart functional disorder based on a linear combination of the parameters, as is commonly determined by logistical regression, or by non-linear combination of the parameters.