Monitor recorder optimized for electrocardiography and respiratory data acquisition and processing

• US 10,265,015 B2
• Filed: 04/30/2018
• Issued: 04/23/2019
• 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: Bardy, Gust H., Bishay, Jon Mikalson, Felix, Jason
• Primary Examiner(s): Manuel, George
• Application Number:
  US15/966,882
• Publication Number:
  US 20180249950A1
• Time in Patent Office: 358 Days
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• 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 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/28 for electrocardiography [ECG]
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/335 using integrated circuit memory devices
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/6832 using adhesives A61B5/259 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 7/003 Detecting lung or respiration noise
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A monitor recorder optimized for electrocardiography and respiratory data acquisition and processing is provided. The recorder includes a sealed housing and an electronic circuitry comprised within the sealed housing, which includes an electrocardiographic front end circuit electrically interfaced to an externally-powered micro-controller and operable to sense electrocardiographic signals through electrodes provided on the patch; the micro-controller interfaced to one or more respiratory sensors, the micro-controller operable to sample the electrocardiographic signals, to sample respiratory events detected by the one or more respiratory sensors upon receiving one or more signals from the one or more respiratory sensors, to buffer each of the respiratory event samples, to compress each of the buffered respiratory event samples, to buffer each of the compressed respiratory event samples, and to write the buffered compressed respiratory event samples and the samples of the electrocardiography signals into an externally-powered flash memory; and the memory interfaced with the micro-controller.

Claims

1. A monitor recorder optimized for electrocardiography and respiratory data acquisition and processing, comprising:

a sealed housing adapted to be removably secured into a non-conductive receptacle on a disposable extended wear electrode patch; and

an electronic circuitry comprised within the sealed housing, comprising;

an electrocardiographic front end circuit electrically interfaced to an externally-powered micro-controller and operable to sense electrocardiographic signals through electrodes provided on the disposable extended wear electrode patch;

the externally-powered micro-controller operable to execute under micro programmable control and interfaced to an at least one respiratory sensor configured to sense respiratory events and to generate an interrupt signal upon sensing each of the respiratory events, the micro-controller further operable to sample the electrocardiographic signals, to sample respiratory events detected by the at least one respiratory sensor upon receiving one or more interrupt signals from the at least one respiratory sensor, to buffer each of the respiratory event samples, to compress each of the buffered respiratory event samples, to buffer each of the compressed respiratory event samples, and to write the buffered compressed respiratory event samples and the samples of the electrocardiography signals into an externally-powered flash memory; and

the externally-powered flash memory electrically interfaced with the micro-controller and operable to store samples of the electrocardiographic signals and the respiratory events.

2. A monitor recorder according to claim 1, wherein the micro-controller is further configured to store the samples of the electrocardiographic signals and the respiratory events into the flash memory until the memory is filled.

3. A monitor recorder according to claim 1, wherein the micro-controller is further configured to buffer each of the samples of the electrocardiographic signals, to compress each of the buffered samples of the electrocardiographic signals, and to buffer each of the compressed samples of the electrocardiographic signal prior to writing that sample of electrocardiographic signal into the non-volatile memory.

4. A monitor recorder according to claim 1, further comprising:

the micro-controller further operable to digitize each of the respiratory event samples prior to buffering that sample.

5. A monitor recorder according to claim 1, wherein the flash memory comprises a data record comprising at least two ECG tracks, each of the ECG tracks operable to store ECG data from an ECG data channel and the samples of the electrocardiographic signals are written into one of the ECG tracks and the respiratory event samples are written into another one of the tracks.

6. A monitor recorder according to claim 5, wherein the data record is in the SCP-ENG standard.

7. A monitor recorder according to claim 1, wherein the samples of the electrocardiographic signals are temporarily matched to the respiratory event samples.

8. A monitor recorder according to claim 1, wherein at least one respiratory sensor is selected from a group comprising an air flow sensor, an SpO₂ sensor, a pCO₂ sensor, and a respiratory rate sensor.

9. A monitor recorder according to claim 1, wherein the signals are provided by the at least one respiratory sensor after detecting a respiratory abnormality.

10. A monitor recorder according to claim 9, wherein the respiratory abnormality comprises at least one of an interruption of air flow of the patient and a hyperpnea.

11. A monitor optimized for electrocardiography and respiratory data acquisition and processing, comprising:

at least one respiratory sensor provided on at least one of a disposable extended wear electrode patch and a reusable electrocardiography monitor recorder, the at least one respiratory sensor configured to sense respiraratory events and to provide an interrupt signal to an externally-powered microcontroller upon sensing each of the respiratory events;

disposable extended wear electrode patch comprising;

a flexible backing formed of an elongated strip of stretchable material with a narrow longitudinal midsection and, on each end, a contact surface at least partially coated with an adhesive dressing provided as a crimp relief;

a pair of electrodes conductively exposed on the contact surface of each end of the elongated strip;

a non-conductive receptacle adhered to an outward-facing surface of the elongated strip and comprising a plurality of electrical pads; and

a flexible circuit affixed on each end of the elongated strip and comprising a pair of circuit traces electrically coupled to the pair of the electrodes and a pair of the electrical pads, at least one of the circuit traces adapted to extend along the narrow longitudinal midsection; and

one or more respiratory sensors electrically coupled to at least one of the electrical pads; and

the reusable electrocardiography monitor recorder having a sealed housing adapted to be removably secured into the non-conductive receptacle and comprising;

an electronic circuitry comprised within the sealed housing, comprising;

an electrocardiographic front end circuit electrically interfaced to the externally-powered micro-controller and operable to sense electrocardiographic signals through electrodes provided on the disposable extended wear electrode patch;

the externally-powered micro-controller operable to execute under micro programmable control and interfaced to the at least one respiratory sensor, the micro-controller further operable to sample the electrocardiographic signals, to sample respiratory events detected by the at least one respiratory sensors sensor upon receiving one or more signals from the at least one respiratory sensor, to buffer each of the respiratory event samples, to compress each of the buffered respiratory event samples, to buffer each of the compressed respiratory event samples, and to write the buffered compressed respiratory event samples and the samples of the electrocardiography signals into an externally-powered flash memory; and

the externally-powered flash memory electrically interfaced with the micro-controller and operable to store samples of the electrocardiographic signals and the respiratory events.

12. A monitor according to claim 11, wherein the micro-controller is further configured to store the samples of the electrocardiographic signals and the respiratory events into the flash memory until the memory is filled.

13. A monitor according to claim 11, wherein the micro-controller is further configured to buffer each of the samples of the electrocardiographic signals, to compress each of the buffered samples of the electrocardiographic signals, and to buffer each of the compressed samples of the electrocardiographic signal prior to writing that sample of electrocardiographic signal into the non-volatile memory.

14. A monitor according to claim 11, further comprising:

the micro-controller further operable to digitize each of the respiratory event samples prior to buffering that sample.

15. A monitor according to claim 11, wherein the flash memory comprises a data record comprising at least two ECG tracks, each of the ECG tracks operable to store ECG data from an ECG data channel and the samples of the electrocardiographic signals are written into one of the ECG tracks and the respiratory event samples are written into another one of the tracks.

16. A monitor according to claim 15, wherein the data record is in the SCP-ENG standard.

17. A monitor according to claim 11, wherein the samples of the electrocardiographic signals are temporarily matched to the respiratory event samples.

18. A monitor according to claim 11, wherein the at least one respiratory sensor is selected from a group comprising an air flow sensor, an SpO₂ sensor, a pCO₂ sensor, and a respiratory rate sensor.

19. A monitor according to claim 11, wherein the signals are provided by the at least one respiratory sensor after detecting a respiratory abnormality.

20. A monitor according to claim 19, wherein the respiratory abnormality comprises at least one of an interruption of air flow of the patient and a hyperpnea.