Ambulatory cardiac monitoring system

• US 4,333,475 A
• Filed: 12/06/1979
• Issued: 06/08/1982
• Est. Priority Date: 12/06/1979
• Status: Expired due to Term

• Current Assignee: Medical Concepts, Inc.
• Original Assignee: Medical Concepts, Inc.
• Inventors: Byrne, Richard J., Moreno, John R., Shakespeare, Charles B.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US06/100,903
• Time in Patent Office: 915 Days
• Field of Search: 128/696, 128/710, 128/711, 128/901, 128/902, 128/702, 128/703, 128/704
• US Class Current: 600/524
• CPC Class Codes: A61B 5/336 Magnetic recording apparatus
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00

Abstract

An ambulatory cardiac monitoring system (10) to event record and monitor ECG signals (20) from a patient (12) for a predetermined time interval. The ambulatory cardiac monitoring system (10) includes a recorder system (18) which is carried by the patient (12). The recorder system (10) is coupled to the patient through leads (16) and electrodes (14) positionally located contiguous to the patient (12). The recorder system (18) includes an analog pre-processor (32), a first microcomputer (34) coupled in a feedback manner to analog pre-processor (32), and a cassette recorder (38). The analog pre-processor (32) has incorporated both automatic gain control and conditioning circuitry that normalizes and filters the basic ECG signal (20). The analog pre-processor (32) produces a plurality of extraction signals which are input to microcomputer (34). The microcomputer (34) continuously monitors the signal inputs from the analog pre-processor (32) as well as digitized ECG signal (20) from an analog/digital converter (36). The microcomputer (34) includes decision algorithms for classification of each heartbeat and tallies abnormal events. The memory of microcomputer (34) is used as a temporary storage area of the ECG signal (20) in order to delay the ECG signal (20) for a predetermined time interval in order that analysis of a particular signal may be obtained.

Claims

1. An ambulatory cardiac monitoring system to event record and monitor ECG signals from a patient for a predetermined time interval on a recording medium, said recording medium being removed from said patient subsequent to said predetermined time interval for insert into scanner means for producing printed outputs of said events recorded on said recording medium wherein the improvement comprises:

recorder means to be coupled to said patient during said predetermined time interval, said recorder means being electrically coupled to said patient for (1) continuously monitoring said ECG signals of said patient during said predetermined time interval, and (2) entering a record signal on said recording medium responsive to prior ECG signals monitored from said patient during said predetermined time interval, said recorder means including analog pre-processor means having means for detecting a QRS signal wave complex of said monitored ECG signal for (1) normalization, (2) filtering, and (3) gain control of said monitored ECG signals to produce a plurality of analog pre-processor output signals.

2. The ambulatory cardiac monitoring system as recited in claim 1, where said recorder means includes:

microcomputer means being connected to said analog pre-processor means in a feedback circuit for producing said record signals responsive to said prior ECG signals inserted to said analog pre-processor means during said predetermined time interval, said analog pre-processor means being coupled to said microcomputer means in a feed forward circuit.

3. The ambulatory cardiac monitoring system as recited in claim 2 where said means for detecting a QRS signal wave complex of said ECG signal input from said patient excludes a P wave complex signal and a T wave complex signal of said ECG signal for inserting predetermined portions of said QRS signal wave complex into said microcomputer means.

4. The ambulatory cardiac monitoring system as recited in claim 3 where said QRS signal wave detection means includes automatic gain control means coupled to said patient ECG signal output for maintaining an automatic gain control output signal responsive to signal amplitudes input to said automatic gain control means, said automatic gain control output signal being inserted into said microcomputer means.

5. The ambulatory cardiac monitoring system as recited in claim 4 including differentiator means coupled to said automatic gain control means for differentiating said automatic gain control output signal, said differentiator means for producing a differentiated ECG output pulse signal being inserted into said microcomputer means, said differentiated ECG output pulse signal for determining initiation and termination of predetermined sections of said ECG signal.

6. The ambulatory cardiac monitoring system as recited in claim 5 where said differentiator means produced differentiated ECG output pulse signal is a bi-phase signal having a positive portion and a negative pulse portion.

7. The ambulatory cardiac monitoring system as recited in claim 5 where said QRS signal wave detection means includes:

(a) first adaptive threshold detector means coupled to said differentiator means for producing (1) a high positive lobe pulse, and, (2) a low positive lobe pulse output; and

,

(b) second adaptive threshold detector means coupled to said differentiator means for producing (3) a high negative lobe pulse, and (4) a low negative lobe pulse output, said high positive lobe pulse, low positive lobe pulse, high negative lobe pulse, and low negative lobe pulse, said first and second adaptive threshold detector means being coupled to said microcomputer means for insertion of said pulses to said microcomputer means.

8. The ambulatory cardiac monitoring system as recited in claim 7 including long term negative lobe automatic gain control means coupled to said differentiator means for standardizing a negative pulse portion of said differentiated ECG output pulse signal, said standardized negative pulse for establishing a base line negative pulse portion of said differentiated ECG output pulse signal.

9. The ambulatory cardiac monitoring system as recited in claim 7 where said first and second adaptive threshold detector means includes predetermined threshold boundary level signals for elimination of a signal output responsive to said P wave complex and said T wave complex of said differentiated ECG signal.

10. The ambulatory cardiac monitoring system as recited in claim 5 including a diminished sensitivity circuit coupled to said differentiator means for adjusting said signal level of said differentiated ECG signal.

11. The ambulatory cardiac monitoring system as recited in claim 10 including a four pole Bessel filter circuit coupled to said diminished sensitivity circuit, said four pole Bessel filter having a value approximately 40.0 Hertz.

12. The ambulatory cardiac monitoring system as recited in claim 5 including frequency response control network means having an ECG signal inserted thereto and being coupled to said automatic gain control means for inputting predetermined frequency bounded signals to said automatic gain control means, said frequency response control network means having a frequency boundary approximately 0.5 Hertz to 0.05 Hertz.

13. The ambulatory cardiac monitoring system as recited in claim 12 including differential input amplifier means to be coupled on opposing ends to said patient for receiving said ECG signal and said frequency response control network means for insert of an amplified ECG signal into said frequency response control network means.

14. The ambulatory cardiac monitoring system as recited in claim 2 where said analog pre-processor means includes morphology detection means for producing a plurality of output signals response to prior ECG signal information from said patient during said predetermined time interval, said morphology detection means being feedback coupled to said microcomputer means.

15. The ambulatory cardiac monitoring system as recited in claim 14 where said morphology detection means includes:

(a) automatic gain control means coupled to said patient ECG signal output for producing an analog output signal being amplitude gain controlled as a function of signal amplitudes input thereto; and

,

(b) analog to digital conversion means connected to said automatic gain control means at an input thereof for producing a digital automatic gain controlled ECG signal for insert into said microcomputer means.

16. The ambulatory cardiac monitoring system as recited in claim 15 including microcomputer delaying means for maintaining said digital automatic gain controlled ECG signal within said microcomputer means for a predetermined time interval.

17. The ambulatory cardiac monitoring system as recited in claim 16 where said morphology detection means includes high frequency variation detection means for producing (1) a high frequency increase signal and (2) a high frequency decrease signal responsive to spectral variations between one of said ECG signals and at least one preceding ECG signal during said monitoring predetermined time interval.

18. The ambulatory cardiac monitoring system as recited in claim 17 where said high frequency variation detection means is operable within an approximate 40.0 Hertz band pass.

19. The ambulatory cardiac monitoring system as recited in claim 17 where said high frequency variation detection means includes first morphological adaptive threshold means for producing said (1) high frequency increase signal, and (2) high frequency decrease signal, said first morphological adaptive threshold means being operable on said delayed automatic gain controlled signal from said microcomputer means.

20. The ambulatory cardiac monitoring system as recited in claim 19 where said high frequency variation detection means includes delayed digital to analog converter means coupled to said microcomputer means for producing an analog delayed automatic gain controlled signal.

21. The ambulatory cardiac monitoring system as recited in claim 20 where said high frequency variation detection means includes high frequency band pass filter means for filtering a frequency band pass approximating 40.0 Hertz of said analog delayed automatic gain controlled signal.

22. The ambulatory cardiac monitoring system as recited in claim 21 including first full wave rectifier means for rectifying said filtered signal from said high frequency band pass filter means, said first full wave rectifier means being coupled to said high frequency band pass filter means.

23. The ambulatory cardiac monitoring system as recited in claim 22 including a first gated integrator circuit coupled on opposing ends to said first full wave rectifier means for signal input therefrom and to said first morphological adaptive threshold detector means, said first gated integrator circuit being coupled to said microcomputer means for receiving an actuating signal during a predetermined time interval.

24. The ambulatory cardiac monitoring system as recited in claim 14 where said morphological detection means includes:

(a) automatic gain control means coupled to said patient ECG signal output for producing an analog output signal being substantially amplitude independent as a function of signal amplitudes input thereto; and

,

(b) low frequency variation detection means for producing (1) a low frequency increase signal and (2) a low frequency decrease signal responsive to spectral variations above and below a predetermined set of signal threshold signal levels.

25. The ambulatory cardiac monitoring system as recited in claim 24 where said low frequency variation detection means is operable in an approximate frequency range between 2.0 to 30.0 Hertz band pass.

26. The ambulatory cardiac monitoring system as recited in claim 25 where said low frequency variation detection means includes second morphological adaptive threshold detector means being actuated during a predetermined time interval for producing said (1) low frequency increase signal, and, (2) low frequency decrease signal, said second morphological adaptive threshold means being operable on said automatic gain controlled signal from said automatic gain control means.

27. The ambulatory cardiac monitoring system as recited in claim 26 where said low frequency variation detection means includes low frequency band pass filter means coupled to said automatic gain control means for filtering a frequency band pass approximating 2.0 to 30.0 Hertz of said automatic gain control signal.

28. The ambulatory cardiac monitoring system as recited in claim 27 including second full wave rectifier means for rectifying said filtered signal from said low frequency band pass filter means, said second full wave rectifier means being coupled to said low frequency band pass filter means.

29. The ambulatory cardiac monitoring system as recited in claim 28 including a second gated integrator circuit coupled on opposing ends thereof to said second full wave rectifier means for signal input therefrom and to said second morphological adaptive threshold detector means, said second gated integrator circuit being coupled to said microcomputer means for receiving an actuating signal during a predetermined time interval.

30. The ambulatory cardiac monitoring system as recited in claim 14 where said morphology detection means includes:

(a) automatic gain control means coupled to said patient signal output for producing an analog output signal being substantially amplitude gain controlled as a function of signal amplitudes input thereto; and

,

(b) analog to digital conversion means coupled to said automatic gain control means at an input thereof for producing a digital automatic gain controlled ECG signal for insert into said micro-computer means.

31. The ambulatory cardiac monitoring system as recited in claim 30 including microcomputer delaying means for storing said digital automatic gain controlled ECG signal within a memory means within said microcomputer means for a predetermined time interval.

32. The ambulatory cardiac monitoring system as recited in claim 31 where said morphology detection means includes QRS wave complex variation detection means for producing (1) a positive peak differential decrease signal and (2) a negative peak differential decrease signal responsive to a differentiated delayed automatic gain controlled signal from said micro-computer means.

33. The ambulatory cardiac monitoring system as recited in claim 32 where said QRS wave complex variation detection means includes:

(a) third morphological adaptive threshold means being actuated during a predetermined time interval for producing said positive peak differential signal; and

,

(b) fourth morphological adaptive threshold means being actuated during said predetermined time interval for producing said negative peak differential signal, said positive peak differential signal and said negative peak differential signal being inserted into said microcomputer means.

34. The ambulatory cardiac monitoring means as recited in claim 33 where said QRS wave complex variation detection means includes delayed digital to analog converter means for producing an analog delayed automatic gain controlled signal.

35. The ambulatory cardiac monitoring means as recited in claim 34 where said QRS wave complex variation detection means includes second differentiator means for differentiating said analog delayed automatic gain controlled signal from said digital to analog converter means.

36. The ambulatory cardiac monitoring system as recited in claim 35 where said QRS wave complex variation detection means includes first gated peak detector circuit coupled on opposing ends thereof to said second differentiator means and said third morphological adaptive threshold detector means for charging to a predetermined voltage signal level of a particular QRS wave complex signal, said first gated peak detector circuit for discharging said voltage signal level to said third morphological adaptive threshold detector means responsive to a signal from said microcomputer means.

37. The ambulatory cardiac monitoring system as recited in claim 35 where said QRS wave complex variation detection means includes inverter means coupled to said second differentiator means for inverting said differentiated delayed automatic gain controlled signal emitted from said second differentiator means.

38. The ambulatory cardiac monitoring system as recited in claim 37 where said QRS wave complex variation detection means includes second gated peak detector circuit coupled on opposing ends to said inverter means and said fourth morphological adaptive threshold detector means for input of a signal thereto responsive to a signal introduced from said micro-computer means.

39. The ambulatory cardiac monitoring system as recited in claim 2 where said analog pre-processor means includes base line artifact detector means for sensing (1) an excursion of a base line signal external of predetermined boundary signal level, and (2) a rate of change of said base line signal external a predetermined boundary rate of change, said base line artifact detector means being coupled to said micro-computer means for insertion thereto of a base line signal.

40. The ambulatory cardiac monitoring system as recited in claim 39 where said base line artifact detector means includes automatic gain control means coupled to said patient ECG signal output for maintaining an automatic gain control output signal responsive to signal amplitude input to said automatic gain control means, said automatic gain control output signals providing a base line signal level for said patient ECG signal.

41. The ambulatory cardiac monitoring system as recited in claim 40 where said base line artifact detector means includes base line filter means coupled to said automatic gain control means for substantial removal of (1) a T wave signal component, (2) a QRS wave complex signal component, and (3) a P wave signal component of said ECG signal, said base line filter means outputting said base line signal.

42. The ambulatory cardiac monitoring system as recited in claim 41 where said base line filter means is a 2.0 Hertz low pass Bessel filter circuit.

43. The ambulatory cardiac monitoring system as recited in claim 41 where said base line artifact detector means includes:

(a) base line positive threshold detector means coupled to said base line filter means for outputting a signal when said base line signal exceeds a predetermined positive threshold level; and

,

(b) base line negative threshold detector means coupled to said base line filter means for outputting a signal when said base line signal exceeds a predetermined negative threshold level.

44. The ambulatory cardiac monitoring system as recited in claim 41 where said base line artifact detector means includes base line differentiator means coupled to said base line filter means for outputting a differentiated base line signal for producing enhanced base line signal variations.

45. The ambulatory cardiac monitoring system as recited in claim 44 including base line rectification means coupled to said base line differentiator means for providing full wave rectification of said differentiated base line signal.

46. The ambulatory cardiac monitoring system as recited in claim 45 including:

(a) baseline absolute low threshold detector means; and

,

(b) baseline absolute high threshold detector means coupled in parallel relation with said baseline absolute low threshold detector means to said baseline rectification means, each of said baseline low and high threshold detector means for outputting a baseline detect signal when said rectified differentiated baseline signal exceeds a predetermined low and high valve respectively.

47. The ambulatory cardiac monitoring system as recited in claim 46 where said base line artifact detector means includes dual rate integrator means coupled to said base line absolute low threshold detector means and said base line absolute high threshold detector means for producing an integrated output signal.

48. The ambulatory cardiac monitoring system as recited in claim 47 including integrated base line detector means coupled to said dual rate integrator means and said microcomputer means for outputting a signal to said microcomputer means responsive to said integrated output signal exceeding a predetermined signal level.