Event alerting through actigraphy embedded within electrocardiographic data

• US 9,737,224 B2
• Filed: 11/16/2013
• Issued: 08/22/2017
• 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., Felix, Jason, Bishay, Jon Mikalson
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): PHAM, MINH DUC GIA
• Application Number:
  US14/082,108
• Publication Number:
  US 20150087923A1
• Time in Patent Office: 1,375 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 extended wear electrocardiography and physiological sensor 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 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 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;

the 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 upon receiving one of the IRQ signals, to embed the samples of the actigraphy event occurrences within a data stream that is recorded to an externally-powered flash memory and that comprises the samples of the electrocardiographic signals, the embedding 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 data stream; and

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

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 at least one of a positional change of the sensor and a threshold of acceleration or deceleration of the sensor.

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

5. An electrocardiography and physiological sensor monitor recorder according to claim 2, wherein the actigraphy event occurrences are 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 at least one of a positional change of the three-axis accelerometer and 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.