Autonomic neuropathy detection and method of analysis

• US 5,299,119 A
• Filed: 12/14/1990
• Issued: 03/29/1994
• Est. Priority Date: 07/06/1989
• Status: Expired due to Term

• Current Assignee: QMed Inc.
• Original Assignee: QMed Inc.
• Inventors: Rosner, Allan, Frisbie, William R., Kraf, Teri J.
• Primary Examiner(s): Envall, Jr., Roy N.
• Assistant Examiner(s): Shingala, Gita
• Application Number:
  US07/626,710
• Time in Patent Office: 1,201 Days
• Field of Search: 364/413.06, 364/413.02, 364/413.03, 364/413.05, 128/695, 128/696, 128/701, 128/702
• US Class Current: 600/509
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4884 inducing physiological or psychological stress, e.g. applications for stress testing
• CPC Class Codes: Y10S 128/905 Feedback to patient of biological signal other than brain electric signal

Abstract

A non-invasive, programmable cardio-respiratory monitoring system for performing automated autonomic nervous system function tests by monitoring and analyzing EKG signals in relation to specific paced breathing and/or posture regimens, and immediately computing and disclosing the test results automatically upon completion of one or all of the tests. The accuracy of these tests, which are currently being performed manually and/or with multiple components, is greatly improved bt the invention'"'"'s capability to issue automated audio-visual instructions to the patient, to analyze any major peak of the QRS complex for determining heart rate variation, to discriminate between normal and abnormal EKG signals, and to edit the automated test results to enhance the validity of the test results.

Claims

1. Automated apparatus for monitoring heart beat signals generated by the heart of a patient to whom it is attached, comprising:

means for performing continuous real-time analysis of said heart beat signals derived from said patient,

means for storing one or more normative data bases for automated correlation of test result to age-matched values,

means for recognizing normal and abnormal beats,

means for diagnosing each of said abnormal beats,

means for providing audio-visual signals to the patient to instruct said patient in at least one predetermined physical regimen, whereby the patient may perform said at least one predetermined physical regimen without any additional prompting or instruction, and

means for outputting the results of said analysis.

2. The apparatus of claim 1, wherein said means for outputting results includes means adapted to cooperate with external data handling means.

3. The apparatus of claim 2, wherein said means adapted to cooperate comprises optical emitter means adapted to be coupled to an optical receiver, whereby said results can be output from said automated apparatus to said external data handling means, and said external data handling means may comprise a printer, a modem, a computer, or other external data handling means.

4. The apparatus of claim 2, wherein said means for outputting results further comprises display means, and wherein said display means is also the visual portion of said audio-visual signal providing means.

5. The apparatus of claim 1, wherein said predetermined physical regimen is a predetermined paced breathing regimen.

6. The apparatus of claim 1, wherein said predetermined physical regimen is a predetermined posture regimen.

7. A computer implemented method of performing a test of a patient'"'"'s autonomic nervous system comprising monitoring every beat of the heart of said patient to detect and correlate variations in heart functioning during a predetermined physical regimen to autonomic nervous system functioning, comprising the steps of:

attaching sensing means to the patient to sense the heart beat of said patient,

using the output signal of said sensing means to produce heart beat signals,

analyzing said heart beat signals,

determining from said analysis of said heart beat signals if each said signal is representative of one of a normal or abnormal heart beat or an artifact,

issuing continuous audio-visual instructions to the patient to guide the patient in performing said predetermined physical regimen,

storing data during the patient'"'"'s performance of said predetermined physical regimen,

performing all of the aforesaid steps in a predetermined quantity based on said heart beat signals only to thereby define a test,

correlating the results of said test with age-matched values to accurately assess the extent of automatic nervous system function, and

outputting the results of said test upon conclusion of said test.

8. The method of claim 7, wherein said predetermined physical regimen is a predetermined paced breathing regimen.

9. The method of claim 7, wherein said predetermined physical regimen is a predetermined posture regimen.

10. The method of claim 7, wherein said outputting of results step includes outputting a portion of said results.

11. The method of claim 7, and performing all of said steps continuously during the running of each said test.

12. The method of claim 7, wherein said test is performed because said patient is at least suspected of having at least one of diabetes, a predisposition to sudden death, alcohol addiction, coronary artery disease, muscular dystrophy, parkinsonism, HIV infection, Shy-Drager syndrome, impotence, sleep apnea, toxic neuropathies, and any other disease which affects the autonomic nervous system.

13. A computer implemented method of evaluating autonomic nervous system functioning comprising the steps of:

instructing a patient whose autonomic nervous system is being evaluated to perform a predetermined physical regimen,

sensing each beat of the heart of said patient,

determining by analyzing said heart beats, whether or not each said heart beat is representative of a normal or abnormal heart beat,

producing a signal corresponding to each said sensed heart beat,

calculating the time from a selected point on one signal to the corresponding point on the next succeeding signal,

correlating said predetermined physical regimen with said calculating step,

storing raw data from said steps of producing, calculating, and correlating said signals,

correlating the results of said test with age-matched values to accurately assess the extent of automatic nervous system functioning, and

providing at least one autonomic nervous system test result substantially instantaneously based on said calculating, correlating, and storing steps.

14. The method of claim 13, wherein said predetermined physical regimen is a predetermined paced breathing regimen.

15. The method of claim 13, wherein said predetermined physical regimen is a predetermined posture regimen.

16. The method of claim 13, and performing said instructing step for a plurality of times.

17. The method of claim 13, and the additional step of classifying each said sensed heart beat as normal or abnormal.

18. The method of claim 17, and the further steps of determining an autonomic nervous system test result based on said sensed normal beats only comprising:

identifying said selected point on one said sensed heart beat and the corresponding selected point on the next succeeding said sensed heart beat,

determining if said next succeeding such sensed heart beat is normal,

repeating said identifying step if said next succeeding such sensed heart beat is not normal as determined by said determining step, and

calculating the time between said corresponding selected points only if both said succeeding sensed heart beats are normal,

whereby the accuracy of said autonomic nervous system test result based on said calculating step is increased due to the inclusion of normal beats only in said calculating step.

19. The method of claim 17, and the further step of identifying each beat classified as abnormal in said last mentioned classification step as an abnormal beat originating from the heart of said patient or as an abnormal beat originating from a source other than the heart of said patient.

20. The method of claim 13, and performing said producing step to produce an EKG signal, and selecting said selected point on said succeeding signals from the group consisting of the R-wave, Q-wave, QS-wave, P-wave, T-wave or any other point on said EKG signals.

21. The method of claim 13, wherein said autonomic nervous system test result is the Standard Deviation and the further steps of:

determining the mean time of said calculating step during predetermined paced breathing regimen based on said instructing step, and

relating all of said times derived from said calculating step to said mean time to provide said Standard Deviation indicative of said autonomic nervous system function.

22. The method of claim 21, wherein the performance of said relating step is automated and substantially instantaneous.

23. The method of claim 13, wherein said autonomic nervous system test result is the Mean Circular Resultant and the further steps of:

identifying the time of onset of each cycle of breathing comprising said predetermined physical regimen,

calculating the time between the occurrence of said selected point of each said sensed heart beat relative to said time of onset of each said cycle,

converting said times produced in said calculating step to vectors comprised of X and Y components,

repeating said converting step for each said cycle,

computing a single average vector of said X and Y components for all said cycles, and

determining a Mean Circular Resultant indicative of said autonomic nervous system function.

24. The method of claim 23, wherein the performance said determining step is automated and substantially instantaneous.

25. The method of claim 13, wherein said autonomic nervous system test result is the Valsalva Index and the further steps of:

identifying the maximum time of said calculating step during said predetermined physical regimen based on said instructing step,

identifying the minimum time of said calculating step during a predetermined time following the completion of said predetermined physical regimen based on said instructing step, and

correlating said maximum and minimum times to provide said Valsalva Index indicative of said autonomic nervous system function.

26. Automated apparatus for editing a calculated test result which has been initially based on automatically selected portions of raw data derived from monitoring of heart beat signals during the performance of at least one predetermined physical regimen, comprising:

means for outputting said calculated test result,

means for storing one or more normative data bases for automated correlation of test result to age-matched values,

means for outputting automatically selected heart beat intervals selected from said raw data which were used to calculate said test result,

means for outputting said raw data,

means for inputting manually selected heart beat intervals selected from said raw data that differ from said automatically selected heart beat intervals,

means for recalculating said test result based on said manually selected heart beat intervals, and

means for outputting said recalculated test result,

whereby said calculated test result is edited.

27. The apparatus of claim 26, wherein said means for outputting said test result further includes means adapted to cooperate with external data handling means.

28. The apparatus of claim 26, wherein said means adapted to cooperate comprising optical emitter means coupled to an optical receiver, whereby said test results can be output from said apparatus to said external data handling means, and said external data handling means may comprise a printer, a modem, or a computer.

29. The apparatus of claim 26, wherein said automated apparatus is self-contained and portable.

30. The apparatus of claim 26, wherein said predetermined physical regimen is a predetermined paced breathing regimen.

31. The apparatus of claim 26, wherein said predetermined physical regimen is a predetermined posture regimen.

32. An automated apparatus for evaluating the function of a patient'"'"'s autonomic nervous system comprising:

means for storing one or more normative data bases for automated correlation of test result to age-matched values,

means for sensing signals,

means for determining if said sensed signals are representative of a heart beat or an artifact,

means for classifying said signals representative of a heart beat as normal or abnormal,

means for performing continuous real-time analysis of said signals derived from said patient,

means for providing audio-visual signals to said patient to instruct said patient in at least one predetermined physical regimen,

means for correlating said signals with said at least one predetermined physical regimen,

means for automatically calculating test results based on said correlating step for evaluating said function of the autonomic nervous system of said patient,

means for outputting said test results,

means for outputting said signals,

means for interfacing said outputting of said test result with external data handling means,

means for editing said test result,

means for inputting portions of said signals for automatic recalculation of said test result, and

display means forming part of all of said means for providing audio-visual signals, all of said means for outputting, said means for inputting, and said means for editing.

33. The apparatus of claim 32, wherein said predetermined physical regimen is a predetermined paced breathing regimen.

34. The apparatus of claim 32, wherein said predetermined physical regimen is a predetermined posture regimen.

35. A computer implemented method of evaluating autonomic nervous system functioning comprising the steps of:

instructing a patient whose autonomic nervous system is being evaluated to perform a predetermined posture regimen,

sensing each beat of the heart of said patient,

determining by analyzing said heart beats, whether or not each said heart beat is representative of a normal or abnormal heart beat,

producing a signal corresponding to each said sensed heart beat,

calculating the time from a selected point on one signal to the corresponding point on the next succeeding signal,

correlating said predetermined posture regimen with said calculating step,

storing raw data from said steps of producing, calculating, and correlating said signals,

correlating the results of said test with age-matched values to accurately assess the extent of autonomic nervous system functioning, and

providing at least one autonomic nervous system test result substantially instantaneously based on said calculating, correlating, and storing steps.

36. The method of claim 35, wherein said predetermined posture regimen comprises standing and lying down maneuvers.

37. The method of claim 35, wherein said predetermined posture regimen is 10 seconds of standing, then 60 seconds of lying, followed by 60 seconds of standing.

38. The method of claim 36, wherein said standing maneuver is performed for at least 30 beats of the heart.

39. The method of claim 35, wherein said autonomic nervous system test result is the Posture Index and the further steps of:

identifying the maximum time of said calculating step,

identifying the minimum time of said calculating step,

correlating said maximum and minimum times using an established formula to produce said Posture Index indicative of said autonomic nervous system function.

40. The method of claim 39, wherein said last mentioned correlating step is performed automatically and substantially instantaneously.

41. A computer implemented method of editing at least one autonomic nervous system test result which has been previously calculated from automatically selected heart beat intervals of recorded raw data, comprising the steps of:

providing an output means,

outputting at least a portion of said automatically selected heart beat intervals,

outputting at least a portion of said recorded raw data,

identifying said portion of recorded raw data that differs from said automatically selected heart beat intervals for recalculating said test result,

providing input means,

inputting said portion of recorded data identified in identifying step,

recalculating said test result based on said data input in said inputting step,

correlating the results of said tests with age-matched values to accurately assess the extent of autonomic nervous system functioning, and

outputting said recalculated test result,

whereby the accuracy of said test result is increased due to the said method of editing by an operator.

42. The method of claim 41, wherein said recalculating step is performed automatically and substantially instantaneously.

43. The method of claim 41, and repeating of said steps of identifying, providing, inputting, recalculating and outputting until said test result is acceptable to said operator.