Electrocardiography and actigraphy monitoring system

• US 10,413,205 B2
• Filed: 08/18/2017
• Issued: 09/17/2019
• 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., Felix, Jason, Bishay, Jon MIkalson
• Primary Examiner(s): Fairchild, Mallika D
• Assistant Examiner(s): Pham, Minh Duc G
• Application Number:
  US15/681,064
• Publication Number:
  US 20170367609A1
• Time in Patent Office: 760 Days
• Field of Search: 600301
• 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 electrocardiography and actigraphy monitoring system, comprising:

a monitor recorder, comprising;

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

electronic circuitry comprised within the sealed housing, comprising;

an externally-powered flash memory electrically interfaced with an externally-powered micro-controller and comprising a data record comprising at least two electrocardiogram (ECG) tracks, each of the ECG tracks operable to store ECG data from an ECG data channel;

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

an actigraphy sensor electrically interfaced with the micro-controller and operable to sense one or more actigraphy event occurrences based on movement of the sensor using an actigraphy event occurrence criteria and to send an interrupt request (IRQ) signal to the micro-controller upon sensing each of the actigraphy event occurrences; and

an externally-powered micro-controller operable to execute under micro-programmable control, the micro-controller further operable to sample the electrocardiographic signals and to sample one of the actigraphy event occurrences sensed by the actigraphy sensor upon receiving one of the IRQ signals, to embed samples of the electrocardiographic signals within one of the ECG tracks for storage into the data record in the memory and to embed the samples of the actigraphy event occurrences into another one of the ECG tracks for storage into the data record in the memory, the embedding of the samples of the actigraphy event occurences comprising buffering each of the actigraphy event occurrences samples, compressing each of the buffered actigraphy event occurrences samples, buffering each of the compressed actigraphy event occurrences samples, and writing the buffered compressed actigraphy event occurrences samples into the another one of ECG tracks.

2. A system according to claim 1, wherein the format of the data record is Standard communications.

3. A system according to claim 1, further comprising:

the 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;

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

the 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.

4. A system according to claim 3, further comprising:

a battery comprised on the disposable extended wear electrode patch and electrically interfaced 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.

5. A system according to claim 4, 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, 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.

6. A system according to claim 5, 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.

7. A system according to claim 4, 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.

8. A system according to claim 7, 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.

9. A system 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.

10. A system according to claim 9, wherein the filtering criteria is selected from the group comprising sleep, awake, hyperactivity, and falling.

11. A system according to claim 9, further comprising:

a patient management program executed by the server computer system configured to store the samples of the electrocardiographic signals and the samples of the actigraphy event occurrences into a secure database using a data communications network; and

the secure database interconnected to the data communications network and operable to maintain the samples of the electrocardiographic signals on behalf of the server computer system.

12. A system, according to claim 11, further comprising:

a subscription module configured to implemented a subscription service that controls authorization of a duration of an operation of the monitor recorder and parameters of the operation.

13. A system according to claim 1, further comprising

a download station comprising:

a non-conductive receptacle adapted to removably receive the monitor recorder; and

a download station controller operable to retrieve the samples of the electrocardiographic signals and the samples of the actigraphy event occurrences from the flash memory; and

a computer system operatively coupled to the download station controller and centrally accessible over a data communications network and operable to maintain the samples of the electrocardiographic signals and the samples of the actigraphy event occurrences upon retrieval.

14. A system to claim 1, further comprising

a download station configured to wirelessly interface with the monitor recorder and to wirelessly retrieve the samples of the electrocardiographic signals and the samples of the actigraphy event occurrences from the flash memory.

15. A system according to claim 1, further comprising:

an analog-to-digital converter comprised within the micro-controller and configured to digitize the samples of the actigraphy event occurrences.

16. A system to claim 1, 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.

17. An extended wear electrocardiography and physiological sensor monitor according to claim 1, wherein the electrocardiographic front end circuit is optimized to sense P-wave signals in the electrocardiographic signals.

18. A system according to claim 1, wherein the actigraphy event occurrence criteria comprise at least one of a threshold of acceleration or deceleration of the sealed housing.

19. A system according to claim 18, wherein acceleration or deceleration of the sealed housing is expressed based on recorded g−

the threshold force.