Micropotential analyzer--a Holter system with comprehensive analysis capability for very low amplitude electrocardiographic signals and method

• US 4,883,065 A
• Filed: 11/15/1988
• Issued: 11/28/1989
• Est. Priority Date: 11/15/1988
• Status: Expired due to Term

• Current Assignee: Spacelabs Healthcare LLC (OSI Systems Incorporated)
• Original Assignee: Del Mar Avionics
• Inventors: Kelen, George J.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US07/271,903
• Time in Patent Office: 378 Days
• Field of Search: 128/710, 128/711, 128/712, 128/696, 316/33 ME
• US Class Current: 600/524
• CPC Class Codes: A61B 5/337 Playback at speeds other than the recording speed
• CPC Class Codes: A61B 5/35 by template matching

Abstract

A system for detection, measurement, analysis and plotting of electrocardiographic signals with amplitudes ranging down to one microvolt (micropotentials) employing long term ambulatory (Holter) recordings. Multi-channel electrocardiograms are recorded on a Holter recorder that inscribes calibration pulses at the beginning of each tape. The tape is played back at high speed on a scanner which uses the recorded calibration pulses to automatically calibrate the signal gains for each signal channel. The played back signals are digitized at sufficient resolution and sampling rate to permit analysis of micropotentials. The digitized raw data is stored in a permanent computer file available for multiple further analyses. A template heart beat is designated and the raw data file is signal averaged to reduce random noise. The averaged beat thus produced is permanently stored, and analyzed using a variety of operator selected standard signal processing techniques to reveal and evaluate micropotential signals of clinical significance.

Claims

1. A micropotential analyzer system for long term ambulatory multi channel recording, high speed playback and analysis of electrocardiographic (ECG) signals ranging in amplitude down to one microvolt, said system including:

a multi channel magnetic tape Holter recorder;

micropotential analyzing means coupled to the recorder for allowing a user to select from an entire recording on the recorder a precise segment of raw data that is to be the subject of micropotential analysis thereby permitting analysis of multiple data segments from a single tape on the recorder and reanalysis of any raw data set by multiple processing algorithms; and

recording means coupled to said recorder for recording data on said recorder and further incorporating circuitry which records on each signal channel on said recorder a calibration signal of precisely known shape and amplitude on a portion of the recording in each such signal channel.

2. The system of claim 1, and which includes playback means for the signals recorded on said recorder and further incorporating calibration circuitry to measure the played back amplitude of the calibration signals recorded on the signal channels of said recorder and responsive to said calibration signals to adjust the overall gain of said playback means such that precisely calibrated measurements of said ECG signals recorded on said recorder can be made by said analyzing means.

3. The system defined in claim 2 and in which said playback plays back recorded ECG signals from said recorder at precisely calibrated speeds many times greater than that at which said ECG signals were recorded.

4. The system defined in claim 2, in which said analyzing means includes circuit means for performing continuous analog to digital conversion of said ECG signals generated by said playback means with sufficient precision to resolve micropotentials of 2 microvolts amplitude on multiple channels at a sampling rate equivalent to at least 500 Hz real time, suitable for evaluating signals of clinical relevance.

5. The system defined in claim 4 in which said analog to digital converting means further generates digitized data calibrated in amplitude and timing for recording in digital format on permanent media and processing by said analyzing means.

6. The system defined in claim 5, in which said analyzing mean incorporates means for generating video display signals, automatically calibrated measurement signals, annotation signals, hard copy signals, and signals for the manipulation of digitized data generated by said analog to digital conversion means under control and selection of an operator performing an analysis.

7. The system of claim 6 and which includes video display means and control means therefor having the further ability to magnify or zoom in both axes, with automatic scaling, portions of a recorded ECG signal interactively designated by said operator.

8. The system of claim 6 and calibration means therefor having the further property of being automatically applied to any portion of recorded ECG signals interactively designated by said operator.

9. The system of claim 6 and which includes manipulation means for further implementing general purpose signal processing algorithms useful in the elucidation of micropotentials, such as signal averaging for noise reduction, digital filtering of several types, rectification, scaling vector summation and root mean square amplitude calculation.

10. The system of claim 9, in which the manipulation means includes processing steps user-selectable from menus, either singly or in predefined sequential combination for performance of specific complex analyses.

11. The system of claim 6 and which includes hard copy generation means having the capability for generating a paper facsimile of any display generated by said analyzing means including results of complex multi-step analyses.

12. A computer based process for analyzing low amplitude micropotentials off Holter recorded electrocardiographic signals, comprising the steps of:

recording at least one calibration pulse(s) in at least one Holter recording medium;

Holter recording at least one orientation (view or channel) of electrophysiological data in said

Holter recording medium;

automatically calibrating a high speed recorded data scanning system with said recorded calibration pulse(s);

searching said recorded electrophysiological data with said scanning system and selecting a continuum of data for micropotential analysis;

excerpting and analog to digital converting of said data continuum with resolution suitable for micropotential analysis;

storing said digitized data continuum initially in computer memory with subsequent permanent storage in digital format;

designating a particular electrophysiological periodic wave function within said stored data continuum as a template with defined parameters to which all other periodic wave functions within said continuum may be compared;

aligning and comparing all periodic wave functions stored in said continuum with said template;

rejecting from further signal processing all said compared periodic wave functions that do not match said template within a predefined correlation;

accepting for further signal processing all said compared periodic wave functions that do correlate within acceptance limits of said template;

averaging all said accepted periodic wave functions;

storing said averaged periodic wave function in a permanent file in digital format;

subjecting said stored, averaged periodic wave functions to further operator designated signal processing for micropotential analysis by any or all of the following;

visual examination and automatic measurement of user designated signal portions;

magnification of user designated signal portions in either or both axes;

digital filtering of various types;

rectification;

vector summation;

scaling;

root mean square amplitude calculation;

paper facsimile and report generation.