Ambulatory electrocardiography monitor recorder optimized for internal signal processing

• US 9,955,888 B2
• Filed: 04/10/2017
• Issued: 05/01/2018
• 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, Bishay, Jon Mikalson, Bardy, Gust H.
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US15/483,142
• Publication Number:
  US 20170209064A1
• Time in Patent Office: 386 Days
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/332 Portable devices specially adapted therefor
• CPC Class Codes: A61B 5/335 using integrated circuit memory devices
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61B 5/725 using specific filters therefor, e.g. Kalman or adaptive filters A61B5/316 take precedence

Abstract

Physiological monitoring can be provided through a lightweight wearable monitor that includes two components, a flexible extended wear electrode patch and a reusable monitor recorder that removably snaps into a receptacle on the electrode patch. The wearable monitor sits centrally (in the midline) on the patient'"'"'s chest along the sternum oriented top-to-bottom. The placement of the wearable monitor in a location at the sternal midline, with its unique narrow “hourglass”-like shape, significantly improves the ability of the wearable monitor to cutaneously sense cardiac electrical potential signals, particularly the P-wave and, to a lesser extent, the QRS interval signals indicating ventricular activity in the ECG waveforms. Additionally, the monitor recorder includes an ECG sensing circuit that measures raw cutaneous electrical signals and performs signal processing prior to outputting the processed signals for sampling and storage.

Claims

1. An ambulatory electrocardiography monitor recorder optimized for internal signal processing, comprising:

a wearable housing adapted to be coupled to a pair of electrocardiographic electrodes that are fitted for dermal placement along a sternal midline; and

an electronic circuitry provided within the wearable housing and comprising;

an electrocardiographic front end circuit under the control of a low power microcontroller and configured to output electrocardiographic signals representative of cardiac activation wave front amplitudes, comprising;

a signal lead operable to sense cardiac electrical potentials dermally through one of the electrocardiographic electrodes;

a reference lead operable to sense the cardiac electrical potentials dermally through the other of the electrocardiographic electrodes;

an AC coupling capacitor, a termination resistor, and a filter capacitor through which at least a portion of the electrocardiographic signal pass prior to reaching an operational amplifier;

the operational amplifier that amplifies a current of the sensed electrocardiographic potentials;

a high pass filter that is applied to the electrocardiographic potentials whose current was amplified by the operational amplifier;

a further operational amplifier that amplifies voltage of the electrocardiographic potentials filtered by the high pass filter; and

an anti-aliasing filter applied to the electrocardiographic potentials with the amplified voltage prior to the output of the electrocardiographic potentials as the electrocardiographic signals;

the low power microcontroller operable to execute over an extended period under modular micro program control as specified in firmware and further operable to acquire samples of the output electrocardiographic signals; and

a non-volatile memory electrically interfaced with the low power microcontroller and operable to continuously store the samples of the electrocardiographic signals throughout the extended period.

2. An electrocardiography monitor recorder in accordance with claim 1, wherein the electrocardiographic signals are output by the electrocardiographic front end circuit as an analog signal and the microcontroller acquires the samples by sampling the analog signal, each of the samples comprising a disruption in the analog signal.

3. An electrocardiography monitor recorder in accordance with claim 2, further comprising:

a hold capacitor comprised in the microcontroller and that is charged to supply the analog signal provided by the electrocardiographic front end circuit for the acquisition by the microcontroller.

4. An electrocardiography monitor recorder in accordance with claim 1, wherein a low pass filter is applied to the electrocardiographic signals filtered by the high pass filter while the voltage of the electrocardiographic signals is amplified by the further operational amplifier.

5. An electrocardiography monitor recorder in accordance with claim 1, further comprising:

a further coupling capacitor that implements at least in part the high pass filter.

6. An electrocardiography monitor recorder in accordance with claim 5, wherein the further coupling capacitor is a further AC coupling capacitor.

7. An electrocardiography monitor recorder in accordance with claim 1, further comprising:

a resistor and a further capacitor that implement the anti-aliasing filter.

8. An electrocardiography monitor recorder in accordance with claim 1, further comprising:

a reference generator comprised in the electrocardiographic front end circuit and configured to inject a driven reference containing power supply noise and system noise to the reference lead.

9. An electrocardiography monitor recorder in accordance with claim 1, further comprising:

an analog-to-digital converter operable to convert the electrocardiographic signals into digital representations of the cardiac activation wave front amplitudes;

at least one low pass filter comprised in the firmware; and

at least one further high pass filter comprised in the firmware,

wherein the cardiac activation wave front amplitudes are passed through the at least one low pass filter and the at least one high pass filter following conversion into the digital representations.

10. An ambulatory electrocardiography monitor optimized for internal signal processing, comprising:

a disposable extended wear electrode patch, comprising;

a flexible backing comprising stretchable material defined as an elongated strip with a narrow longitudinal midsection, each end of the flexible backing comprising an adhesive contact surface adapted to serve as a crimp relief;

a pair of electrocardiographic electrodes comprised on the contact surface of each end of the flexible backing, each electrocardiographic electrode conductively exposed for dermal adhesion and adapted to be positioned axially along a midline of a sternum for capturing action potential propagation, one of the electrocardiographic electrodes comprising a protection circuit;

a non-conductive receptacle affixed to a non-contacting surface of the flexible backing and comprising an electro mechanical docking interface; and

a pair of flexible circuit traces affixed at each end of the flexible backing with each circuit trace connecting one of the electrocardiographic electrodes to the docking interface; and

an ambulatory electrocardiography monitor recorder, comprising;

a wearable housing adapted to securely fit into the receptacle; and

electronic circuitry provided within the wearable housing and comprising;

an electrocardiographic front end circuit under the control of a low power microcontroller and configured to output electrocardiographic signals representative of cardiac activation wave front amplitudes, comprising;

a signal lead operable to sense cardiac electrical potentials dermally through one of the electrocardiographic electrodes;

a reference lead operable to sense the cardiac electrical potentials dermally through the other of the electrocardiographic electrodes;

an AC coupling capacitor, a termination resistor, and a filter capacitor through which at least a portion of the electrocardiographic signal pass prior to reaching an operational amplifier;

the operational amplifier that amplifies a current of the sensed electrocardiographic potentials;

a high pass filter that is applied to the electrocardiographic potentials whose current was amplified by the operational amplifier;

a further operational amplifier that amplifies voltage of the electrocardiographic potentials filtered by the high pass filter; and

an anti-aliasing filter applied to the electrocardiographic potentials with the amplified voltage prior to the output of the electrocardiographic potentials as the electrocardiographic signals;

the low power microcontroller operable to execute over an extended period under modular micro program control as specified in firmware and further operable to acquire samples of the output electrocardiographic signals; and

a non-volatile memory electrically interfaced with the low power microcontroller and operable to continuously store the samples of the electrocardiographic signals throughout the extended period.

11. An electrocardiography monitor in accordance with claim 10, wherein the electrocardiographic signals are output as an analog signal by the electrocardiographic front end circuit and the microcontroller acquires the samples by sampling the analog signal, each of the samples comprising a disruption in the analog signal.

12. An electrocardiography monitor in accordance with claim 11, further comprising:

a hold capacitor comprised in the microcontroller and that is charged to supply the analog signal provided by the electrocardiographic front end circuit for the acquisition by the microcontroller.

13. An electrocardiography monitor in accordance with claim 10, wherein a low pass filter is applied to the electrocardiographic signals filtered by the high pass filter while the voltage of the electrocardiographic signals is amplified by the further operational amplifier.

14. An electrocardiography monitor in accordance with claim 10, further comprising:

a further coupling capacitor that implements at least in part the high-pass high pass filter.

15. An electrocardiography monitor in accordance with claim 14, wherein the further coupling capacitor is a further AC coupling capacitor.

16. An electrocardiography monitor in accordance with claim 10, further comprising:

a resistor and a further capacitor that implement the anti-aliasing filter.

17. An electrocardiography monitor in accordance with claim 10, further comprising:

a reference generator comprised in the electrocardiographic front end circuit and configured to inject a driven reference containing power supply noise and system noise to the reference lead.

18. An electrocardiography monitor in accordance with claim 10, further comprising:

an analog-to-digital converter operable to convert the electrocardiographic signals into digital representations of the cardiac activation wave front amplitudes;

at least one low pass filter comprised in the firmware; and

at least one further high pass filter comprised in the firmware,

wherein the cardiac activation wave front amplitudes are passed through the at least one low pass filter and the at least one high pass filter following conversion into the digital representations.