Method of detecting signal clipping in a wearable ambulatory medical device

• US 9,204,813 B2
• Filed: 08/04/2014
• Issued: 12/08/2015
• 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:
  US14/451,046
• Publication Number:
  US 20150080699A1
• Time in Patent Office: 491 Days
• Field of Search: None
• US Class Current: 1/1
• 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 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 wearable medical device, comprising:

a plurality of ECG sensing electrodes configured to sense an ECG signal of a patient;

an ECG acquisition circuit, electrically coupled to a pair of the plurality of ECG sensing electrodes, including a first gain stage to amplify the ECG signal, a programmable attenuation/gain stage coupled to the first gain stage to condition the amplified ECG signal, and a second gain stage coupled to the programmable attenuation/gain stage to amplify the conditioned ECG signal;

an analog to digital converter, 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 and control unit, electrically coupled to the ECG acquisition circuit and the analog to digital converter, to monitor the digitized ECG signal, to determine whether a voltage level of the ECG signal is approaching a first threshold based on at least the digitized ECG signal, and to mark the digitized ECG signal as compromised in response to a determination that the voltage level of the ECG signal is approaching the first threshold to alert the wearable medical device that the digitized ECG signal is distorted.

2. The wearable medical device of claim 1, wherein the signal conditioning and control unit is configured to vary an amount of attenuation/gain provided by the programmable attenuation/gain stage based on the digitized ECG signal.

3. The wearable medical device of claim 2, wherein the signal conditioning and control unit is configured to determine whether a voltage level of the digitized ECG signal is above a second threshold, and to increase the amount of attenuation provided by the programmable attenuation/gain stage.

4. The wearable medical device of claim 2, wherein the signal conditioning and control unit is configured to determine whether a voltage level of the digitized ECG signal is below a second threshold, and to decrease the amount of attenuation provided by the programmable attenuation/gain stage.

5. The wearable medical device of claim 1, wherein the signal conditioning and control unit is configured to determine the first threshold based on at least one of 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 gain stage, the programmable attenuation/gain stage and the second gain stage.

6. The wearable medical device of claim 1, wherein the signal conditioning and control unit is configured to determine whether a voltage level of the conditioned ECG signal is approaching a second threshold based on at least the digitized ECG signal.

7. The wearable medical device of claim 6, wherein the signal conditioning and control unit is configured to attenuate the amplified and conditioned analog ECG signal in response to a determination that the voltage level is approaching the second threshold.

8. The wearable medical device of claim 6, wherein the signal conditioning and control unit is configured to determine the second threshold based on at least one of 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 gain stage, the programmable attenuation/gain stage and the second gain stage.

9. The wearable medical device of claim 1, wherein the signal conditioning and control unit is configured to detect high frequency noise in the ECG signal and adjusting a cutoff frequency of a filter responsive to detecting the high frequency noise.

10. The wearable medical device of claim 1, wherein the signal conditioning and control unit is configured to determine whether clipping of the amplified and conditioned ECG signal occurred before or after the programmable attenuation/gain stage.

11. The wearable medical device of claim 10, wherein the signal conditioning and control unit is configured to mark the amplified and conditioned ECG signal as compromised in response to a determination that the clipping of the amplified and conditioned ECG signal occurred before the programmable attenuation/gain stage.

12. The wearable medical device of claim 10, wherein the signal conditioning and control unit is configured to attenuate 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.

13. The wearable medical device of claim 10, wherein the signal conditioning and control unit is configured to attenuate 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 wherein the signal conditioning and control unit is configured to mark the amplified and conditioned ECG signal as compromised in response to a determination that the clipping of the amplified and conditioned ECG signal occurred before the programmable attenuation/gain stage.