Self-Contained Personal Air Flow Sensing Monitor

• US 20150087922A1
• Filed: 11/15/2013
• Published: 03/26/2015
• 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., Felix, Jason, Bishey, Jon Mikalson
• Granted Patent: US 9,364,155 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• 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

Physiological monitoring can be provided through a wearable monitor that includes two components, a flexible extended wear electrode patch and a removable reusable monitor recorder. 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 (or immediately to either side of the sternum) benefits extended wear by removing the requirement that ECG electrodes be continually placed in the same spots on the skin throughout the monitoring period. Instead, the patient can place an electrode patch anywhere within the general region of the sternum. Power is provided through a battery provided on the electrode patch, which avoids having to open the monitor recorder'"'"'s housing for battery replacement. The monitor further includes sensors for monitoring patient'"'"'s air flow and respiratory measures contemporaneously with the ECG monitoring.

Claims

1. A self-contained personal air flow sensing 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 externally-powered micro-controller operable to execute under micro programmable control and electrically interfaced to one or more respiratory sensors comprising an air flow sensor and at least one of an SpO₂ sensor, a pCO₂ sensor, and a respiratory rate sensor, the one or more respiratory sensors comprised within at least one of the disposable extended wear electrode patch and the sealed housing;

an electrocardiographic front end circuit electrically interfaced to the micro-controller and operable to sense electrocardiographic signals through electrocardiographic electrodes provided on the disposable extended wear electrode patch, each of the electrocardiographic electrodes adapted to be positioned axially along the midline of the sternum for capturing action potential propagation; and

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

2. A self-contained personal air flow sensing monitor recorder according to claim 1, further comprising:

a server computer system centrally accessible over a data communications network and operable to receive physiological data comprising the respiratory events and the samples of the electrocardiographic signals and to execute programming code stored in a memory, comprising;

an identification module to identify non-air flow physiological data comprising the samples of the electrocardiographic signals and the respiratory events detected by one of the SpO₂ sensor, the pCO₂ sensor, and the respiratory rate sensor collected approximately concurrently to air flow events; and

an output module to output the air flow events and the identified non-air flow data.

3. A self-contained personal air flow sensing monitor recorder according to claim 2, further comprising at least one of:

a processing module to process non-air flow events and to detect the non-air flow events; and

a type module to determine a type of one of the air flow events based on the physiological data,

wherein the output module outputs at least one of the non-air flow events and the type of the air flow event.

4. A self-contained personal air flow sensing monitor recorder according to claim 3, further comprising:

a respiratory efforts module to determine whether respiratory efforts are associated with the air flow event based on the physiological data; and

a condition module to determine that the air flow event is indicative of one of an obstructive sleep apnea condition and a central sleep condition based on whether the respiratory efforts are associated with the air flow event,

wherein the physiological data further comprises at least one of an actigraphy sensor data and respiratory rate events.

5. A self-contained personal air flow sensing monitor recorder according to claim 1, further comprising:

a pair of electrical contacts external to the sealed housing and electrically connected to at least one of the micro-controller and the flash memory;

a battery provided on the disposable extended wear electrode patch; and

a pair of electrical pads external to the disposable extended wear electrode patch and disposed to operatively couple with the pair of the electrical contacts, the electrical pads further electrically interfaced via battery leads to the battery.

6. A self-contained personal air flow sensing monitor recorder according to claim 1, the disposable extended wear electrode patch further 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 tab extending from the flexible backing on which at least one of the respiratory event sensors is comprised;

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

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 as a strain relief and comprising a pair of circuit traces electrically coupled to the pair of the electrocardiographic electrodes and a pair of the electrical pads, at least one of the circuit traces adapted to extend along the narrow longitudinal midsection to serve as the strain relief.

7. A self-contained personal air flow sensing 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 electrocardiographic 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 as a strain relief and comprising a pair of circuit traces electrically coupled to the pair of the electrocardiographic electrodes and a pair of the electrical pads, at least one of the circuit traces adapted to extend along the narrow longitudinal midsection to serve as the strain relief; and

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

a micro-controller operable to execute under micro programmable control and electrically interfaced to an electrocardiographic front end circuit that is operable to sense electrocardiographic signals through the electrocardiographic electrodes via the pair of the electrical pads;

an air flow sensor operable to sense air flow events, the air flow sensor electrically interfaced with the micro-controller over an expansion bus operatively interconnected to the micro-controller; and

a flash memory electrically interfaced with the micro-controller and operable to store samples of the electrocardiographic signals and the air flow events.

8. A self-contained personal air flow sensing monitor according to claim 7, further comprising:

a battery comprised on the disposable extended wear electrode patch and electrically interfaced via battery leads to a pair of the electrical pads; and

at least one of;

the micro-controller operable to draw power from the battery via the pair of the electrical pads;

the flash memory operable to draw power from the battery via the pair of the electrical pads; and

the air flow sensor operable to draw power from the battery via the pair of the electrical pads.

9. A self-contained personal air flow sensing monitor according to claim 8, further comprising:

a physiology sensor comprised within one of the disposable extended wear electrode patch and the reusable electrocardiography monitor and operable to sense physiology and to draw power from the battery via the battery leads, the physiology sensor electrically interfaced with the micro-controller over the expansion bus; and

the flash memory further operable through the expansion bus to store samples of the physiology sensed by the physiology sensor.

10. An self-contained personal air flow sensing monitor according to claim 9, wherein the physiology sensor is selected from the group comprising an SpO₂ sensor, a pCO₂ sensor, a blood pressure sensor, a temperature sensor, a respiratory rate sensor, a glucose sensor, an air flow sensor, and a volumetric pressure sensor.

11. An self-contained personal air flow sensing monitor according to claim 9, wherein the expansion bus is electrically coupled to at least one of the electrical pads.

12. A self-contained personal air flow sensing monitor according to claim 7, further comprising:

a server computer system centrally accessible over a data communications network and operable to receive physiological data comprising the air flow events and samples of the electrocardiographic signals and to execute programming code stored in a memory, comprising;

an identification module to identify non-air flow physiological data comprising the samples of the electrocardiographic signals collected approximately concurrently to the air flow events; and

an output module to output the air flow events and the identified non-air flow data.

13. A self-contained personal air flow sensing monitor according to claim 12, further comprising at least one of:

a processing module to process non-air flow events and to detect the non-air flow events; and

a type module to determine a type of one of the air flow events based on the physiological data,

wherein the output module outputs at least one of the non-air flow events and the type of the air flow event.

14. A self-contained personal air flow sensing monitor according to claim 13, further comprising:

a respiratory efforts module to determine whether respiratory efforts are associated with an air flow event based on the physiological data; and

a condition module to determine that the air flow event is indicative of one of an obstructive sleep apnea condition and a central sleep condition based on whether the respiratory efforts are associated with the air flow event,

wherein the physiological data further comprises at least one of an actigraphy sensor data and respiratory rate data.

15. A self-contained personal monitor with a disposable air flow sensing component, 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 electrocardiographic electrodes conductively exposed on the contact surface of each end of the elongated strip, respectively;

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 as a strain relief and comprising a pair of circuit traces electrically coupled to the pair of the electrocardiographic electrodes and a pair of the electrical pads, at least one of the circuit traces adapted to extend along the narrow longitudinal midsection to serve as the strain relief; and

respiratory sensors comprising an air flow sensor and a respiratory rate sensor electrically coupled to at least one of the electrical pads and operable to sense air flow events;

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

a micro-controller operable to execute under micro programmable control and electrically interfaced to an electrocardiographic front end circuit that is operable to sense electrocardiographic signals through the electrocardiographic electrodes via the pair of the electrical pads, the micro-controller further electrically interfaced to respiratory event sensors over an expansion bus electrically coupled to the at least one electrical pad;

a flash memory electrically interfaced with the micro-controller and operable to store samples of the electrocardiographic signals and the respiratory events comprising air flow events and respiratory rate events.

16. A self-contained personal monitor with a disposable air flow sensing component according to claim 15, further comprising:

a server computer system centrally accessible over a data communications network and operable to receive physiological data comprising the air flow events and samples of the electrocardiographic signals and to execute programming code stored in a memory, comprising;

an identification module to identify non-air flow physiological data comprising ECG data and the respiratory rate events collected approximately concurrently to the air flow events; and

an output module to output the air flow events and the identified non-air flow data.

17. A self-contained personal monitor with a disposable air flow sensing component according to claim 16, further comprising at least one of:

a processing module to process non-air flow event and to detect the non-air flow events; and

a type module to determine a type of one of the air flow events based on the physiological data,

wherein the output module outputs at least one of the non-air flow events and the type of the air flow event.

18. A self-contained personal monitor with a disposable air flow sensing component according to claim 17, further comprising:

a respiratory efforts module to determine whether respiratory efforts are associated with an air flow event based on the physiological data; and

a condition module to determine that the air flow event is indicative of one of an obstructive sleep apnea condition and a central sleep condition based on whether the respiratory efforts are associated with the air flow event.

19. A self-contained personal monitor with a disposable air flow sensing component according to claim 15, further comprising:

an elongated tab extending off the flexible backing and on which at least one of the air flow sensor and the respiratory rate sensor are comprised.

20. A self-contained personal monitor with a disposable air flow sensing component according to claim 19, further comprising:

a physiology sensor comprised within one of the disposable extended wear electrode patch and the reusable electrocardiography monitor and operable to sense physiology, the physiology sensor electrically interfaced with the micro-controller over the expansion bus; and

the flash memory further operable through the expansion bus to store samples of the physiology sensed by the physiology sensor.