Method of detecting signal clipping in a wearable ambulatory medical device

• US 8,798,729 B2
• Filed: 10/28/2013
• Issued: 08/05/2014
• Est. Priority Date: 03/25/2011
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Inventors: Kaib, Thomas E., Volpe, Shane S., Macho, John D.
• Primary Examiner(s): Gedeon, Brian T
• Assistant Examiner(s): TEJANI, ANKIT D
• Application Number:
  US14/064,403
• Publication Number:
  US 20140051963A1
• Time in Patent Office: 281 Days
• Field of Search: None
• US Class Current: 600/509
• CPC Class Codes: A61B 2562/0204 Acoustic sensors
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/303 Patient cord assembly, e.g. cable harness
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6801 specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6805 Vests
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock
• CPC Class Codes: H03G 7/002 in untuned or low-frequency amplifiers, e.g. audio amplifiers H03G7/007, H03G7/001, H03G7/008, H03G7/02, H03G7/06 take precedence
• CPC Class Codes: H03G 7/005 using discontinuously variable devices, e.g. switch-operated

Abstract

A wearable medical device and method of detecting clipping of ECG signals is disclosed. In one embodiment, the wearable medical device comprises a plurality of ECG sensing electrodes configured to sense an ECG of a patient and an ECG acquisition circuit electrically coupled to a pair of the plurality of ECG sensing electrodes and configured to provide an amplified and conditioned analog ECG signal, a programmable attenuation/gain stage electrically coupled between a first gain stage and a second gain stage, an ADC electrically coupled to the ECG acquisition circuit to receive and digitize the amplified and conditioned analog ECG signal and provide a digitized ECG signal, and a signal conditioning to and control unit electrically coupled to the ECG acquisition circuit and the ADC to receive and monitor the digitized ECG signal and to detect clipping of the amplified and conditioned analog ECG signal based upon the digitized ECG signal.

Claims

1. A method of detecting clipping of ECG signals in a wearable medical device, the method comprising acts of:

sensing an ECG signal of a patient using ECG sensing electrodes;

amplifying the ECG signal using a first gain stage;

conditioning the amplified ECG signal from the first gain stage using a programmable attenuation/gain stage;

amplifying the conditioned ECG signal from the programmable attenuation/gain stage using a second gain stage;

receiving and digitizing the amplified and conditioned analog ECG signal to provide a digitized ECG signal;

monitoring the digitized ECG signal to detect clipping of the amplified and conditioned analog ECG signal based upon the digitized ECG signal;

determining whether the clipping of the amplified and conditioned analog ECG signal occurred before or after the programmable attenuation/gain stage; and

varying an amount of attenuation applied by the programmable attenuation/gain stage based on the digitized ECG signal responsive to determining that the clipping of the amplified and conditioned analog ECG signal occurred after the programmable attenuation/gain stage.

2. The method of claim 1, wherein the act of varying the amount includes:

determining whether a voltage level of the digitized ECG signal is above a threshold level; and

increasing the amount of attenuation applied by the programmable attenuation/gain stage.

3. The method of claim 1, wherein the act of monitoring the digitized ECG signal includes determining whether a voltage level is approaching a clipping threshold.

4. The method of claim 3, wherein the act of monitoring the digitized ECG signal further includes determining the clipping threshold based on a voltage range of an ECG of a human patient, a current gain setting and a maximum output voltage level of at least one of the first to gain stage, the programmable attenuation/gain stage and the second gain stage.

5. The method of claim 3, further comprising an act of marking the amplified and conditioned analog ECG signal as compromised in response to a determination that the voltage level is approaching the clipping threshold before the programmable attenuation/gain stage.

6. The method of claim 3, further comprising an act of attenuating the amplified and conditioned analog ECG signal in response to a determination that the voltage level is approaching the clipping threshold after the programmable attenuation/gain stage.

7. The method of claim 1, further comprising acts of attenuating the amplified and conditioned analog ECG signal in response to a determination that a voltage level is approaching a clipping threshold after the programmable attenuation/gain stage and marking the amplified and conditioned analog ECG signal as compromised in response to a determination that the voltage level is approaching the clipping threshold before the programmable attenuation/gain stage.

8. A method of detecting clipping of ECG signals in a wearable medical device, the method comprising acts of:

sensing an ECG signal of a patient using ECG sensing electrodes;

amplifying the ECG signal using a first gain stage;

conditioning the amplified ECG signal from the first gain stage using a programmable attenuation/gain stage;

amplifying the conditioned ECG signal from the programmable attenuation/gain stage using a second gain stage;

receiving and digitizing the amplified and conditioned ECG signal to provide a digitized ECG signal; and

monitoring the digitized ECG signal to determine whether a voltage level is approaching a clipping threshold based upon the digitized ECG signal, the clipping threshold being determined based on at least a voltage range of an ECG human patient, a maximum to output voltage level and a current gain setting of each of the first gain stage, the programmable attenuation/gain stage and the second gain stage.

9. The method of claim 8, wherein the clipping threshold includes a first clipping threshold indicative of clipping in the first gain stage and a second clipping threshold indicative of clipping in the second gain stage.

10. The method of claim 9, further comprising an act of identifying that the ECG signal is compromised in response to a determination that a voltage level of the ECG signal is above the first clipping threshold.

11. The method of claim 9, further comprising an act of varying an amount of attenuation applied by the programmable attenuation/gain stage based on the digitized ECG signal.

12. The method of claim 11, further comprising:

determining whether a voltage level of the conditioned ECG signal is above the second clipping threshold;

wherein the act of varying the amount of attenuation includes increasing the amount of attenuation applied by the programmable attenuation/gain stage in response to a determination that the voltage level of the conditioned ECG signal is above the second clipping threshold.

13. The method of claim 11, further comprising:

determining whether a voltage level of the conditioned ECG signal is below the second clipping threshold;

wherein the act of varying the amount of attenuation includes decreasing the amount of attenuation applied by the programmable attenuation/gain stage in response to a determination that the voltage level of the conditioned ECG signal is below the second clipping threshold.

14. The method of claim 8, further comprising an act of determining whether clipping of the amplified and conditioned ECG signal occurred before or after the programmable attenuation/gain stage.

15. The method of claim 14, further comprising an act of identifying that the amplified and conditioned ECG signal is compromised in response to a determination that the clipping of the amplified and conditioned ECG signal occurred before programmable attenuation/gain stage.

16. The method of claim 14, further comprising an act of attenuating the amplified and conditioned ECG signal in response to a determination that the clipping of the amplified and conditioned ECG signal occurred after the programmable attenuation/gain stage.

17. The method of claim 14, further comprising acts of attenuating the amplified and conditioned ECG signal in response to a determination that the clipping of the amplified and conditioned ECG signal occurred after the programmable attenuation/gain stage and identifying that the amplified and conditioned ECG signal is compromised in response to a determination that the clipping of the amplified and conditioned ECG signal occurred before the programmable attenuation/gain stage.