Method for providing dynamic gain over electrocardiographic data with the aid of a digital computer

• US 9,345,414 B1
• Filed: 01/15/2016
• Issued: 05/24/2016
• Est. Priority Date: 09/25/2013
• Status: Active Grant

• Current Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Original Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Inventors: Felix, Jason, Bardy, Gust H., Bishay, Jon Mikalson, Dreisbach, Ezra M.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US14/997,416
• Time in Patent Office: 130 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0456 Apparatus provided with a docking unit
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/333 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/339 Displays specially adapted therefor
• CPC Class Codes: A61B 5/35 by template matching
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period

Abstract

In one embodiment, ECG data collected during the long-term monitoring are compressed through a two-step compression algorithm executed by an electrocardiography monitor. Minimum amplitude signals may become indistinguishable from noise if overly inclusive encoding is employed in which voltage ranges are set too wide. The resulting ECG signal will appear “choppy” and uneven with an abrupt slope. The encoding used in the first stage of compression can be dynamically rescaled on-the-fly when the granularity of the encoding is too coarse. In a further embodiment, offloaded ECG signals are automatically gained as appropriate on a recording-by-recording basis to preserve the amplitude relationship between the signals. Raw decompressed ECG signals are filtered for noise content and any gaps in the signals are bridged. The signal is then gained based on a statistical evaluation of peak-to-peak voltage (or other indicator) to land as many ECG waveforms within a desired range of display.

Claims

1. A method for providing dynamic gain over electrocardiographic data with the aid of a digital computer, comprising the steps of:

continuously sensing and recording cutaneous action potentials with an ambulatory monitor recorder and representing each of the action potentials as a compression code in a sequence stored into the monitor recorder'"'"'s memory;

electronically interfacing the monitor recorder with an external download station and offloading the sequence of compression codes from the memory;

decompressing the sequence of compression codes on the download station into a time series that comprises a digital representation of a raw electrocardiography signal;

identifying cardiac waveforms within the time series on the download station and measuring peak-to-peak voltages in the cardiac waveforms that fall within a preferred voltage range inside of a temporal window in the time series;

statistically representing a correlation between the peak-to-peak voltages on the download station and determining a signal gain that places the correlation between the peak-to-peak voltages within the preferred range; and

gaining the cardiac waveforms on the download station by the signal gain.

2. A method in accordance with claim 1, further comprising the step of:

defining the correlation between the peak-to-peak voltages within the preferred range as one of average voltage, maximum observed voltage, minimum observed voltage, and mean voltage.

3. A method in accordance with claim 1, further comprising the step of:

selecting the signal gain such that the correlation between the peak-to-peak voltages is substantially centered within the preferred range.

4. A method in accordance with claim 1, further comprising the steps of:

identifying and marking noise in the digital representation of the raw electrocardiography signal; and

ignoring those portions of the raw electrocardiography signal that have been marked as noise when measuring the peak-to-peak voltages in the cardiac waveforms.

5. A method in accordance with claim 4, further comprising the step of:

applying a filter in the identification of the noise selected from the group comprising a high pass filter, a low pass filter, an amplitude change filter, and a zero-crossings filter.

6. A method in accordance with claim 5, further comprising the step of:

triggering the high pass filter when at least eight seconds of substantially sub-0.2 mV peak-to-peak voltages are detected.

7. A method in accordance with claim 5, further comprising the steps of:

triggering the low pass filter when supra-20 mV peak-to-peak voltages are detected; and

marking a span of substantially 60 seconds as noise, 30 seconds preceding and 30 seconds following the triggering of the low pass filter.

8. A method in accordance with claim 5, further comprising the steps of:

triggering the amplitude change filter when peak-to-peak voltage strengths of adjoining segments of substantially three seconds change by at least 300% in strength; and

marking a span of substantially 30 seconds as noise, starting from the triggering of the amplitude change filter.

9. A method in accordance with claim 5, further comprising the steps of:

triggering the zero-crossings filter when the voltage of the raw electrocardiography signal crosses zero more than ten times in one second; and

marking a span of substantially 15 seconds as noise, starting from the triggering of the zero-crossings filter.

10. A method in accordance with claim 4, further comprising the step of:

bridging segments of the raw electrocardiography signal that have been marked as noise before measuring the peak-to-peak voltages in the cardiac waveforms.

11. A method for optimizing cardiac signal detail capture during ambulatory monitoring using a monitor recorder, comprising the steps of:

defining a temporal window and a peak-to-peak voltage threshold;

sensing a series of electrocardiography values with a monitor recorder;

defining a plurality of bins, each of the bins comprising an upper electrocardiography threshold, a lower electrocardiography threshold, and a code;

processing the series of the electrocardiography values in successively-occurring temporal windows, for each temporal window comprising the steps of;

calculating a peak-to-peak voltage of the electrocardiography values in the temporal window;

adjusting the upper electrocardiography threshold and the lower electrocardiography threshold of each of the plurality of bins when the peak-to-peak voltage is less than the peak-to-peak voltage threshold; and

encoding each of the electrocardiography values from the series with the code for the bin comprised with an upper electrocardiography threshold and a lower electrocardiography threshold between which the electrocardiography value falls; and

writing each of the codes into a sequence in a non-volatile memory of the monitor recorder.

12. A method in accordance with claim 11, further comprising at least one of the steps of:

defining the temporal window as substantially in the range of four to six seconds; and

defining the peak-to-peak voltage threshold as substantially 1.0 mV.

13. A method in accordance with claim 11, further comprising the step of:

adjusting the upper electrocardiography threshold and the lower electrocardiography threshold of each of the plurality of bins when the peak-to-peak voltage is greater than the upper electrocardiography threshold.

14. A method in accordance with claim 11, further comprising the step of:

decreasing the upper electrocardiography threshold and the lower electrocardiography threshold of those of the plurality of bins close to the electrocardiography value that was less than the peak-to-peak voltage threshold.

15. A method in accordance with claim 11, further comprising the step of encoding the sequence into a single number between 0 and 1.

16. A method in accordance with claim 15, further comprising encoding the sequence by the steps of:

setting a range of 0 to 1 for an initial code from the sequence of the represented codes; and

processing each of the codes remaining in the sequence, comprising the steps of;

obtaining an estimation of probabilities of next codes;

dividing the range into sub-ranges, each sub-range representing a fraction of the range proportional to the probabilities of the next codes;

obtaining a next code;

selecting the sub-range corresponding to the next code;

representing the next code by the selected sub-range; and

continuing the steps of the process using the selected sub-range in place of the range.

17. A method in accordance with claim 16, wherein the probabilities of the next codes are obtained through a sample electrocardiography data or the sequence of the represented codes.

18. A method in accordance with claim 16, further comprising the step of adjusting the probabilities during at least one of recursive range divisions.

19. A method in accordance with claim 11, wherein the value derived from the identified bin may be based on one of the lower threshold electrocardiography value, the upper threshold electrocardiography value, a modification of the lower electrocardiography value with a constant number or a variable number, and a modification of the upper threshold electrocardiography value with a constant number or variable number.

20. A method in accordance with claim 11, further comprising the steps of:

setting a serial accumulator to a pre-determined value;

processing each of the electrocardiography values from the series of the electrocardiography values, comprising the steps of;

selecting the electrocardiography value next remaining to be processed;

taking a difference of the selected electrocardiography value and the serial accumulator;

identifying the bin in the plurality of the bins corresponding to the difference;

representing the selected electrocardiography value by the code for the identified bin;

adjusting the serial accumulator by a value derived from the identified bin.