Electrocardiography and respiratory monitor

• US 10,602,977 B2
• Filed: 04/19/2019
• Issued: 03/31/2020
• 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:
  US16/389,863
• Publication Number:
  US 20190239799A1
• Time in Patent Office: 347 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. An electrocardiography and respiratory monitoring patch, comprising:

a flexible backing;

a pair of electrocardiographic electrodes respectively affixed to and conductively exposed on a contact surface of each end of the flexible backing to sense electrocardiographic data;

a circuit comprising a pair of circuit traces, each circuit trace originating within one of the ends of the flexible backing and coupled to one of the electrocardiographic electrodes;

a non-conductive receptacle adhered on one end of the flexible backing opposite the contact surface and comprising a battery and a plurality of electrical pads, wherein a pair of the electrical pads is coupled with the pair of circuit traces; and

at least one respiratory sensor comprising a strain gauge and positioned on a surface of the non-conductive receptacle facing the flexible backing, wherein the respiratory sensor is electrically connected to the battery and senses respiratory data and at least a part of the strain gauge extends beyond the non-conductive receptacle and the flexible backing to contact a patient'"'"'s skin.

2. An electrocardiography and respiratory monitoring patch according to claim 1, wherein the strain gauge that extends beyond the non-conductive receptacle and the flexible backing comprises arms that contact skin of a patient on which the flexible backing is adhered.

3. An electrocardiography and respiratory monitoring patch according to claim 1, wherein the strain gauge detects expansion and contraction of a patient'"'"'s chest on which the flexible backing is adhered.

4. An electrocardiography and respiratory monitoring patch according to claim 1, wherein the respiratory sensor comprises a transthoracic impedance sensor.

5. An electrocardiography and respiratory monitoring patch according to claim 1, wherein the respiratory sensor transmits the respiratory data over a wireless transceiver or via wires.

6. An electrocardiography and respiratory monitoring patch according to claim 1, further comprising:

a further respiratory sensor positioned on the surface of the non-conductive receptacle facing the flexible backing adjacent to the respiratory sensor.

7. An electrocardiography and respiratory monitoring patch according to claim 1, wherein at least one respiratory event is identified from the respiratory data.

8. An electrocardiography and respiratory monitoring patch according to claim 7, wherein the electrocardiographic data occurring concurrent to the respiratory event is utilized to identify a type of the respiratory event.

9. An electrocardiography and respiratory monitoring patch according to claim 1, further comprising:

a microphone positioned on the flexible backing to detect sounds of breathing.

10. An electrocardiography and respiration monitor, comprising:

a flexible backing;

a pair of electrocardiographic electrodes respectively affixed to and conductively exposed on a contact surface of each end of the flexible backing to sense electrocardiographic data;

a circuit comprising a pair of circuit traces, each circuit trace originating within one of the ends of the flexible backing and coupled to one of the electrocardiographic electrodes;

a non-conductive receptacle adhered on one end of the flexible backing opposite the contact surface and comprising a battery and a plurality of electrical pads, wherein a pair of the electrical pads is coupled with the pair of circuit traces; and

at least one respiratory sensor comprising a strain gauge and positioned on a surface of the non-conductive receptacle facing the flexible backing, wherein the respiratory sensor is electrically connected to the battery and senses respiratory data and at least a part of the strain gauge extends beyond the non-conductive receptacle and the flexible backing to contact a patient'"'"'s skin; and

an electrocardiography monitor recorder, comprising;

a sealed housing shaped to be removably attached to the electrocardiography patch;

an externally-powered micro-controller; and

an electrocardiographic front end circuit interfaced to the micro-controller and operable to sense the electrocardiographic data.

11. An electrocardiography and respiratory monitor according to claim 10, wherein the strain gauge that extends beyond the non-conductive receptacle and the flexible backing comprises arms that contact skin of a patient on which the flexible backing is adhered.

12. An electrocardiography and respiratory monitor according to claim 10, wherein the strain gauge detects expansion and contraction of a patient'"'"'s chest on which the flexible backing is adhered.

13. An electrocardiography and respiratory monitor according to claim 10, wherein the respiratory sensor comprises a transthoracic impedance sensor.

14. An electrocardiography and respiratory monitor according to claim 10, wherein the respiratory sensor transmits the respiratory data over a wireless transceiver or via wires.

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

a further respiratory sensor positioned on the surface of the non-conductive receptacle facing the flexible backing adjacent to the respiratory sensor.

16. An electrocardiography and respiratory monitor according to claim 10, wherein at least one respiratory event is identified from the respiratory data.

17. An electrocardiography and respiratory monitor according to claim 16, wherein the electrocardiographic data occurring concurrent to the respiratory event is utilized to identify a type of the respiratory event.

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

a microphone positioned on the flexible backing to detect sounds of breathing.