Event Alerting Through Actigraphy Embedded Within Electrocardiographic Data

• US 20150087923A1
• Filed: 11/16/2013
• 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 9,737,224 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• 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 5/1117 Fall detection
• 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 5/259 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 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/335 using integrated circuit memory devices
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle

Abstract

Physiological monitoring can be provided through an actigraphy sensor imbedded into an electrocardiography monitor, which correlates movement and electrocardiographic data. 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 on the patient'"'"'s chest along the sternum. The patient can place an electrode patch anywhere within the general region of the sternum. The occurrence of actigraphy events are monitored by the monitor recorder through an actigraphy sensor. Actigraphy becomes a recordable actigraphy event occurrence when the movement of the wearable monitor and, therefore, the patient, exceeds a certain criteria threshold of acceleration or deceleration as detected by the actigraphy sensor. Certain actigraphy event occurrences as recorded by the monitor recorder are considered to be actionable, that is, of sufficient importance to warrant flagging for further consideration to a following physician.

Claims

1. An extended wear electrocardiography and physiological sensor monitor recorder, comprising:

a sealed housing adapted to be removably secured into the 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;

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;

an actigraphy sensor electrically interfaced with the micro-controller and operable to sense actigraphy event occurrences based on movement of the sealed housing using an actigraphy event occurrence criteria; and

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

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

a server computer system centrally accessible over a data communications network and comprising a processor configured to execute program code stored in a memory, comprising;

a data retrieval module configured to retrieve the samples of the electrocardiographic signals and the samples of the actigraphy event occurrences from the flash memory of the electronic circuitry;

an evaluation module configured to identify an actionable actigraphy event occurrence from the samples of the actigraphy event occurrences based on a filtering criteria;

a correlation module configured to identify those samples of the electrocardiographic signals that were sensed substantially concurrent to a time of the occurrence of the actionable actigraphy event; and

an output module configured to output the actionable event occurrence and the samples of the electrocardiographic signals that were identified.

3. An electrocardiography and physiological sensor monitor recorder according to claim 2, wherein the actigraphy event occurrence criteria comprises a threshold of acceleration or deceleration of the sealed housing.

4. An electrocardiography and physiological sensor monitor recorder according to claim 3, wherein the threshold of acceleration or deceleration of the sealed housing is expressed based on recorded g-force.

5. An electrocardiography and physiological sensor monitor recorder according to claim 2, wherein the filtering criteria is selected from the group comprising sleep, awake, hyperactivity, and falling.

6. An electrocardiography and physiological sensor monitor recorder according to claim 2, further comprising:

a three-axis accelerometer comprised in the actigraphy sensor, the actigraphy event occurrence criteria comprising a threshold of acceleration or deceleration along at least one of the axes of the three-axis accelerometer.

7. An electrocardiography and physiological sensor monitor recorder according to claim 2, further comprising:

a data retrieval module further configured to retrieve samples of physiology selected from the group comprising SpO₂, blood pressure, temperature, glucose level, air flow, and volumetric pressure.

8. An extended wear electrocardiography and physiological sensor 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, 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 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 actigraphy sensor electrically interfaced with the micro-controller and operable to sense actigraphy event occurrences based on movement of the sealed housing using an actigraphy event occurrence criteria; and

flash memory electrically interfaced with the micro-controller and operable to store samples of the electrocardiographic signals and samples of actigraphy event occurrences detected by the actigraphy sensor.

9. An extended wear electrocardiography and physiological sensor monitor according to claim 8, wherein the electrocardiographic front end circuit is optimized to sense P-wave signals in the electrocardiographic signals.

10. An extended wear electrocardiography and physiological sensor monitor according to claim 8, further comprising:

a server computer system centrally accessible over a data communications network and comprising a processor configured to execute program code stored in a memory, comprising;

a data retrieval module configured to retrieve the samples of the electrocardiographic signals and the samples of the actigraphy event occurrences from the flash memory of the electronic circuitry;

an evaluation module configured to identify an actionable actigraphy event occurrence from the samples of the actigraphy event occurrences based on a filtering criteria;

a correlation module configured to identify those samples of the electrocardiographic signals that were sensed substantially concurrent to a time of the occurrence of the actionable actigraphy event; and

an output module configured to output the actionable event occurrence and the samples of the electrocardiographic signals that were identified.

11. An extended wear electrocardiography and physiological sensor monitor according to claim 10, wherein the actigraphy event occurrence criteria comprises a threshold of acceleration or deceleration of the sealed housing.

12. An extended wear electrocardiography and physiological sensor monitor according to claim 11, wherein the threshold of acceleration or deceleration of the sealed housing is expressed based on recorded g-force.

13. An extended wear electrocardiography and physiological sensor monitor according to claim 10, wherein the filtering criteria is selected from the group comprising sleep, awake, hyperactivity, and falling.

14. An extended wear electrocardiography and physiological sensor monitor according to claim 10, further comprising:

a three-axis accelerometer comprised in the actigraphy sensor, the actigraphy event occurrence criteria comprising a threshold of acceleration or deceleration along at least one of the axes of the three-axis accelerometer.

15. An extended wear electrocardiography and physiological sensor monitor according to claim 8, 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; and

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

16. An extended wear electrocardiography and physiological sensor monitor according to claim 8, further comprising:

an expansion bus operatively interconnected to the micro-controller and electrically coupled to at least one of the electrical pads;

a physiology sensor comprised within the disposable extended wear electrode patch 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.

17. An extended wear electrocardiography and physiological sensor monitor according to claim 16, wherein the physiology sensor is selected from the group comprising an SpO₂ sensor, a blood pressure sensor, a temperature sensor, a respiratory rate sensor, a glucose sensor, an air flow sensor, and a volumetric pressure sensor.

18. An extended wear electrocardiography and physiological sensor monitor according to claim 8, further comprising:

an expansion bus operatively interconnected to the micro-controller;

a physiology sensor comprised within the reusable electrocardiography monitor and operable to sense physiology and to draw power from the battery via the pair of the electrical pads, 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 detected by the physiology sensor.

19. An extended wear electrocardiography and physiological sensor monitor according to claim 18, wherein the physiology sensor is selected from the group comprising an SpO₂ sensor, a blood pressure sensor, a temperature sensor, a respiratory rate sensor, a glucose sensor, an air flow sensor, and a volumetric pressure sensor.

20. An extended wear electrocardiography and physiological sensor monitor according to claim 8, further comprising at least one of:

a feedback output component comprised in the reusable electrocardiography monitor and electrically interfaced with the micro-controller; and

a feedback input component comprised in the reusable electrocardiography monitor and externally wearer-operable from outside the sealed housing, the feedback input further electrically interfaced with the micro-controller.