Cardiac signal real time monitor and method of analysis

• US 4,679,144 A
• Filed: 08/21/1984
• Issued: 07/07/1987
• Est. Priority Date: 08/21/1984
• Status: Expired due to Term

• Current Assignee: First Security Bank
• Original Assignee: QMed Inc.
• Inventors: Cohen, David J., Cox, Michael W., Frisbie, William R., Levin, Richard I.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US06/642,690
• Time in Patent Office: 1,050 Days
• Field of Search: 364/415, 364/417, 128/702, 128/703, 128/704, 128/705, 128/710, 128/696
• US Class Current: 600/516
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening

Abstract

An apparatus for monitoring EKG information includes a programmable apparatus carried by an ambulatory patient for performing continuous, real-time analyses of EKG information derived from the patient. The apparatus facilitates the determination of the existence of various conditions based on these analyses which portend cardiac complications including myocardial ischemia, and arrhythemia activity and further instructs the patient on the manner of treatment required for the detected condition.

Claims

1. A method of evaluating a curve having a rapidly changing value by determining the positive or negative quality of the slope of said curve and by determining when the value of said curve is above or below a predetermined threshold value, comprising the steps of:

determining a frequency of sampling;

determining the slope of the curve between a first sampling and a successive later sampling by substracting the value of the curve at each first sampling from the value of the curve at said later sampling;

providing four shift registers each having space for a plurality of bits and for a Flag Bit;

assigning a shift register to each of the curve values of positive slope, negative slope, above threshold and below threshold;

feeding an appropriate bit value to each shift register at each sampling;

determining a numerical value represented by said plurality of bits arrayed in each shift register;

providing a table of values correlating the status of said Flag Bit to each one of the numerical values possibly represented by said array of bits;

finding said determined numerical value in said table;

changing, as needed, the status of said Flag Bit in accordance with said determined numerical value found in said table; and

performing at each sampling said sequence of steps so that the status of said Flag Bit may be changed as needed.

18. The portable apparatus of claim 12, wherein said electrode means comprise electrodes, said electrodes each being defined by claim 1 of any one of U.S. Pat. Nos. 3,420,223 3,490,440 or 3,665,064.

2. The method for continuously monitoring every beat of the heart of a human patient subject to detect abnormal functioning of the heart and to alert the patient immediately upon the occurence of any one of a plurality of detected abnormal heart functions, comprising the steps of:

providing electrode means,

using the output signal of said electrode means to produce EKG signals,

determining, by analyzing said signals, whether or not each heart beat includes an abnormal QRS portion,

determining, by analyzing said signals, whether or not each heart beat is a VPB, and

continuously repeating each of said determining steps without interruption while actuating alarm means no later than upon conclusion of said each beat if either of said determining steps indicates an abnormal QRS portion or a VPB, which in turn indicates some abnormal heart function, and

signalling to said patient instructions for treatment of each indicated abnormal heart function as it occurs.

3. A portable computerized EKG monitir, comprising:

real-time recognition means for recognizing abnormal cardiac events in an ambulatory patient,

real-time diagnosis means for diagnosing each said recognized abnormal cardiac event, and

signalling means for communicating to the ambulatory patient a treatment for said recognized and diagnosed abnormal cardiac event.

4. A portable cardiac monitor for an ambulatory patient comprising:

computer means for performing continuous real-time analysis of EKG information derived from said patient, including first means for recognizing abnormal cardiac events, and second means for diagnosing each of said abnormal cardiac events, and

means for signalling, to the patient, a treatment corresponding to each said recognized and diagnosed abnormal cardiac event at the onset of each of said abnormal cardiac events,

whereby the patient may immediately begin self-treatment of each said recognized and diagnosed abnormal cardiac event without the need for intervention of a trained cardiac specialist.

5. Portable apparatus for continuously monitoring EKG signals generated by the heart of an ambulatory patient, comprising:

self-contained, computerized analyzing means, carried on said patient, for performing real-time analysis of said EKG signals,

said computerized analyzing means including means for diagnosing abnormal cardiac events and means for issuing instructions, to said patient, for treatment of said abnormal events.

6. Portable apparatus for continuous real-time monitoring of EKG signals from an ambulatory patient, comprising:

means for detecting, amplifying and digitizing said signals,

means for analyzing said digitized signals to determine the existence of abnormal heart conditions;

means for correlating information resulting from analysis of said signals with apparatus condition, and patient treatment, instructions, and

means for signalling, to said ambulatory patient, said instruments.

7. The portable apparatus of claim 6, wherein said analyzing means comprises first means for recognizing sequences of signals indicative of waveforms associated with QRS complexes and ventricular premature beats (VPB'"'"'s) and second means for recognizing sequences of signals associated with apparatus malfunction.

8. The portable apparatus of claim 7, wherein said first recognizing means comprises means for identifying a suspected QRS, or VPB, waveform associated with each heart beat and means for confirming said suspected QRS, or VPB, waveform.

9. The portable apparatus of claim 8, wherein said identifying means comprises first means for determining updatable slope values for successive digitized signals, second means for determining whether each said slope value exceeds a predetermined threshold value, third means for determining whether the sign of the slope value changes within a first predetermined time, and means for comparing the time interval between the onset of said suspected waveform and the occurrence of said slope sign change, said means for comparing being operative only if said first predetermined time is not exceeded.

10. The portable apparatus of claim 9, wherein said identifying means further comprises fourth means for determining whether said time interval is less than a second predetermined time, and means in said correlating means comprises first means for assigning a value to that sequence of signals indicative of a suspected QRS waveform if said first predetermined time is not exceeded and said time interval is less than said second predetermined time.

11. The portable apparatus of claim 10, wherein said first predetermined time is 2 seconds and said second predetermined time is 125 milliseconds.

19. The portable apparatus of claim 10, wherein said correlating means further comprises second means for assigning a value to that sequence of signals indicative of a suspected VPB wave form if the first predetermined time is not exceeded and said time interval is equal to or greater than said second predetermined time.

20. The apparatus of claim 19, wherein said first predetermined time is 2 seconds and said second predetermined time is 125 milliseconds.

12. Portable apparatus for continuous real-time monitoring of EKG signals from an ambulatory patient, comprising:

electrode means for detecting said EKG signals;

means for amplifying and digitizing the EKG signals detected by said electrode means,

means for analyzing said digitized signals and identifying abnormal events, and

means for instantaneously instructing said patient to proceed in a manner corresponding to the abnormal event identified.

13. The portable apparatus of claim 12, wherein said abnormal events include both cardiac events and events associated with operation of the monitor, and said analyzing means includes means for discriminating between said events.

14. The portable apparatus of claim 13, wherein said analyzing means further includes means for detecting the onset of QRS complex waveforms.

15. The portable apparatus of claim 14, wherein said detecting means comprises first means for calculating the slope of said digitized signals, first means for determining whether the calculated slope has exceeded a predetermined threshold valve, second means for determining whether the sign of the slope has changed within a first predetermined time, and third means for determining the interval of time occurring between the slope exceeding said predetermined threshold value and the sign of said slope changing, said third determining means being operative only if said first predetermined time is not exceeded.

16. The portable apparatus of claim 15, wherein said identifying means comprises means for comparing said time interval to a second predetermined time, and means for assigning a first value to a condition in which said time interval is less than said second predetermined time.

17. The portable apparatus of claim 16, wherein said identifying means comprises means for comparing said time interval to a second predetermined time, and means for assigning a second value to a condition in which said time interval is greater than, or equal to, said second predetermined time.

21. A method for determining cardiac conditions of an ambulatory patient using apparatus carried on the patient including electrode sensing means located in the vicinity of the patient'"'"'s heart and capable of picking up waveforms corresponding to heartbeats, signal processing means for identifying at least an EKG signal pattern characteristically including an isoelectric baseline portion, a spike portion and a generally linear portion following said spike portion at approximately the same level as said isoelectric portion, a computer means, and a display alarm means actuated by said computer means, the method comprising the steps of:

sampling a number of said waveforms picked up by said electrode means,

detecting, in said waveforms, distortions from said EKG signal pattern indicative of abnormal cardiac conditions,

distinguishing between a first distortion pattern characterized by a variation in the peak-to-peak distance between each spike of said waveforms and indicative of a ventricular premature beat, and a second distortion pattern characterized by a deviation of said linear portion from the level of said isoelectric portion in at least one of said waveforms and indicative of a myocardial ischemia condition, and

alerting said ambulatory patient of at least one of said distortion patterns.

22. A method according to claim 21, wherein said detecting step includes analyzing at least one of the slope, amplitude, the area, inflection points and sequences of said waveforms for determining whether said waveforms approximate said EKG pattern.

23. The method according to claim 22, wherein said detecting step further includes the step of comparing the slope of said waveforms with a predetermined threshold value for a given period of time.

24. The method according to claim 22, wherein said inflection points are within the range of from 3 to 5 for approximating said EKG signal pattern.

25. The method according to claim 22, wherein said sequence of said waveforms is detected for a given time period of between 125 milliseconds and 2 seconds.

26. The method according to claim 22, wherein said inflection points are within the range of from 3 to 7 for a ventricular premature beat waveform.

27. The method according to claim 21, wherein an average time for successive peaks in said waveforms is computed, and further comprising the step of comparing said average time with a time between a current waveform peak and an immediately preceding waveform peak.

28. The method according to claim 21, wherein a compensatory time interval is computed for the succession of a normal waveform beat and a ventricular premature waveform beat for establishing a reference compensatory pause, and further comprising the step of comparing the time interval between a current succession of waveforms with said reference compensatory pause for determining the presence of an actual compensatory pause, and hence the presence of said ventricular premature waveform beat.

29. The method according to claim 21, including the further step of storing and updating the duration of said linear portions in said waveforms sampled in said sampling step.

30. A method for detecting the significance of slope conditions for a series of complex waveforms in which a computer means and a plurality of shift registers are used for analyzing said waveforms, comprising the steps of:

calculating a current slope value as the difference between the amplitudes of two successive values in the waveform;

assigning to a first group of shift registers from said plurality of shift registers a value corresponding to the sign value of said current slope value;

comparing the quantitative value of said current slope value with a predetermined threshold value;

assigning to a second group of shift registers from said plurality of shift registers a value corresponding to said quantitative comparison;

assigning a bit from each of said first group of shift registers for said sign value of each said current slope value;

assigning a bit from each of said second group of shift registers for the output of said step of comparing; and

updating one of the peripheral bits of each of said registers as a Flag Bit after each sampling period for indicating a trend, or the absence of a trend, in said registers.

31. The method of claim 30, wherein said predetermined slope values comprise a negative slope value, a positive slope value, an active slope value and a quiescent slope value.

32. The method of claim 30, wherein for said current slope value corresponding to a negative value, bits of one register of said first group of registers are shifted to the left and the rightmost bit therein is set to zero, and bits of another register of said first group of registers are shifted to the left and the rightmost bit therein is set to one.

33. The method of claim 30, wherein for said current slope value corresponding to a positive value, bits of one register of said first group of registers is shifted to the left and the rightmost bit therein is set to one, and bits of another register of said first group of registers is shifted to the left and the rightmost bit therein is set to zero.

34. The method of claim 30, wherein for said quantitative value corresponding to a value less than said threshold value, bits of one register of said second group of registers is shifted to the left and the rightmost bit therein is set to zero, and bits of another register of said second group of registers is shifted to the left and the rightmost bit therein is set to one.

35. The method of claim 30, wherein for said quantitative value corresponding to a value equal to or greater than said threshold value, bits of one register of said second group of registers is shifted to the left and the rightmost bit therein is set to one, and bits of another register of said second group of registers is shifted to the left and the rightmost bit therein is set to zero.

36. The method of claim 30, wherein said predetermined threshold value corresponds to 0.02 millivolt change in each 256th part of a second during the sampling period.

37. The method of claim 32, wherein the status of said Flag Bit is determined as a function of the number of ones in each of said shift register bits arrayed in each shift register.

38. The method of claim 33, wherein the status of said Flag Bit is determined as a function of the number of ones in each of said shift register bits arrayed in each shift register.

39. The method of claim 34, wherein the status of said Flag Bit is determined as a function of the number of ones in each of said shift register bits arrayed in each shift register.

40. The method of claim 35, wherein the status of said Flag Bit is determined as a function of the number of ones in each of said shift register bits arrayed in each shift register.