Electrocardiography And Respiratory Monitor Recorder

• US 20170119305A1
• Filed: 01/13/2017
• Published: 05/04/2017
• 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
• Granted Patent: US 9,955,911 B2
• Time in Patent Office: 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

An electrocardiography and respiratory monitor recorder is provided. The recorder includes 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. The electronic circuitry 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 operable to execute electrically interfaced to one or more respiratory sensors provided on at least one of the patch and the sealed housing, the micro-controller further operable to sample the electrocardiographic signals and 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; and an externally-powered flash memory electrically interfaced with the micro-controller and operable to store samples of the electrocardiographic signals and the respiratory events.

Claims

1. An electrocardiography and respiratory monitor recorder, 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, each of the electrodes adapted to be positioned axially along the midline of the sternum for capturing action potential propagation;

the micro-controller operable to execute under micro programmable control and electrically interfaced to one or more respiratory sensors provided on at least one of the disposable extended wear electrode patch and the sealed housing, the micro-controller further operable to sample the electrocardiographic signals and 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; and

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

2. An electrocardiography and respiratory monitor recorder according to claim 1, further comprising:

at least one of the respiration sensors operable to sense a respiration abnormality, to compare the abnormaility to a threshold, to detect one of the respiration events upon sensing the abnormality satisfying the threshold, and to provide one of the signals to the micro-processor upon detecting the event.

3. An electrocardiography and respiratory monitor recorder according to claim 2, wherein the respiration abnormality comprises an interruption of air flow of a patient and the threshold is a temporal threshold.

4. An electrocardiography and respiratory monitor recorder according to claim 3, wherein the temporal threshold is 10 seconds.

5. An electrocardiography and respiratory monitor recorder according to claim 2, wherein the respiration abnormality comprises hyperpnea and the threshold comprises a breathing frequency.

6. An electrocardiography and respiratory monitor recorder according to claim 2, wherein the at least one sensor comprises a a microphone.

7. An electrocardiography and respiratiory monitor recorder according to claim 1, further comprising:

the micro-controller further operable 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 into the flash memory.

8. An electrocardiography and respiration monitor recorder according to claim 7, further comprising:

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

9. An electrocardiography and respiratory monitor, comprising:

a 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

a 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 an externally-powered micro-controller and operable to sense electrocardiographic signals through the electrodes provided on the disposable extended wear electrode patch;

the micro-controller operable to execute under micro programmable control and electrically interfaced to the one or more respiratory sensors over an expansion bus electrically coupled to the at least one electrical pad, the micro-controller further operable to sample the electrocardiographic signals and 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; and

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

10. An electrocardiography and respiratory monitor according to claim 9, further comprising:

at least one of the respiration sensors operable to sense a respiration telemetry, to compare the telemetry to a threshold, to detect one of the respiration events upon sensing the telemetry satisfying the threshold, and to provide one of the signals to the micro-processor upon detecting the event.

11. An electrocardiography and respiration monitor recorder according to claim 10, wherein the at least one sensor comprises an airflow sensor, the telemetry comprises a presence of patient breathing, and the threshold comprises one of a duration of an absence of the breathing and a frequency of the breathing.

12. An electrocardiography and respiration monitor recorder according to claim 10, wherein the at least one sensor comprises a respiratory rate sensor, the telemetry comprises one of a respirate rate and an amplitude of movement of a patient'"'"'s chest, and the threshold comprises one of a threshold respiration rate and a threshold chest movement amplitude.

13. An electrocardiography and respiration monitor recorder according to claim 12, wherein the respiratory rate sensor comprises a strain gauge comprising two arms shaped to contact the patient'"'"'s skin when the electrodes are positioned along the midline of the sternum.

14. An electrocardiography and respiration monitor recorder according to claim 10, wherein the at least one sensor comprises an SpO₂ sensor, the telemetry comprises a patient'"'"'s blood oxygen level, and the threshold comprises a threshold blood oxygen level.

15. An electrocardiography and respiration monitor recorder according to claim 10, wherein the at least one sensor comprises an pCO₂ sensor, the telemetry comprises a patient'"'"'s blood carbon dioxide level and the threshold comprises a threshold blood carbon dioxide level.

16. An electrocardiography and respiraty monitor according to claim 9, further comprising:

the micro-controller further operable 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 into the flash memory.

17. An electrocardiography and respiration monitor recorder according to claim 16, further comprising:

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

18. An electrocardiography and respiration monitor recorder according to claim 9, further comprising:

a tab extending from the flexible backing on which one or more of the respiratory sensors are comprised.

19. An electrocardiography and respiration monitor recorder according to claim 18, wherein the extended tab is of a sufficient length to reach a sternal notch of a patient when the electrodes are positioned along the midline of the sternum of the patient and one of the respiratory sensor comprises the air flow sensor that located on a portion of the tab located over the sternal notch when the electrodes are positioned along the midline of the sternum.

20. An extended wear electrocardiography and respiration monitoring patch according to claim 9, wherein the one or more of the respiratory sensors are located on a surface of the non-conductive receptacle that faces the flexible backing.