Extended wear ambulatory electrocardiography and physiological sensor monitor

• US 10,478,083 B2
• Filed: 08/14/2017
• Issued: 11/19/2019
• 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: Felix, Jason, Bishay, Jon Mikalson, Bardy, Gust H.
• Primary Examiner(s): Stoklosa, Joseph A
• Assistant Examiner(s): Antiskay, Brian M
• Application Number:
  US15/676,896
• Publication Number:
  US 20170340215A1
• Time in Patent Office: 827 Days
• Field of Search: 600372, 600382, 600384, 600386, 600388, 600390-393, 600508-509
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• 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 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• 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 5/0816 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 5/091 Measuring volume of inspired or expired gases, e.g. to determine lung capacity
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• 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 5/14542 for measuring blood gases A61B5/14551 takes precedence
• 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
• CPC Class Codes: A61B 5/35 : by template matching
• CPC Class Codes: A61B 5/4809 : Sleep detection, i.e. determining whether a subject is asleep or not
• CPC Class Codes: A61B 5/6801 : specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6823 : Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/7455 : characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: G01N 27/307 : Disposable laminated or multilayered electrodes G01N27/3272 takes precedence

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.

Claims

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

a sealed housing having a rounded isosceles trapezoid shape with substantially straight edge on a proximal end that is longer than a substantially straight edge on a distal end and configured to be removably secured into a receptacle on an electrode patch that comprises a battery electrically interfaced to a pair of electrical pads on the receptacle;

a set of electrical contacts that protrude from a bottom surface of the proximal end of the sealed housing and correspond with further electrical pads on the receptacle;

a patient feedback button located on the proximal end of the sealed housing on a surface opposite the electrical contacts on the bottom surface; and

electronic circuitry comprised within the sealed housing, comprising;

an electrographic front end circuit operable to sense electrocardiographic signals through electrocardiographic electrodes provided on the electrode patch;

a micro-controller electrically interfaced to the electrocardiographic front end circuit and operable to execute under micro-programmable control to sample the electrocardiographic signals sensed by the electrocardiographic front end circuit, to stage each electrocardiographic signal sample in a buffer, to compress each of the staged electrocardiographic signal samples, to further buffer each of the compressed electrocardiographic signal samples, and to write the buffered electrocardiographic signal samples to memory; and

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

2. An electrocardiography and physiological sensor monitor recorder according to claim 1, wherein the micro-controller executes a power up sequence during which the battery on the electrode patch is checked, a state of the flash memory is confirmed, and operation of the micro-controller is confirmed.

3. An electrocardiography and physiological sensor monitor recorder according to claim 1, wherein the sealed housing is removed from the electrode patch and removably secured into a further receptacle on a further electrode patch.

4. An electrocardiography and physiological sensor monitor recorder according to claim 1, the 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;

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

a flexible circuit affixed on each end of the elongated strip and comprising a pair of circuit traces electrically coupled to the pair of the electrocardiographic electrodes and a different pair of the electrical pads.

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

an expansion port operatively interconnected to the micro-controller;

a physiology sensor comprised within the electrode patch and operable to sense physiology and to draw power from the battery via battery leads, the physiology sensor electrically interfaced with the micro-controller over the expansion port; and

;

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

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

an expansion port operatively interconnected to the micro-controller;

a physiology sensor comprised within the sealed housing and operable to sense physiology and to draw power from the battery, the physiology sensor electrically interfaced with the micro-controller over the expansion port; and

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

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

an electrode patch, comprising;

a flexible backing formed of an elongated strip;

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

a receptacle adhered to an outward-facing side of the elongated strip opposite the contact surface and comprising a plurality of electrical pads;

a battery electrically interfaced to a pair of the electrical pads on the receptacle; and

a flexible circuit affixed on each end of the elongated strip and comprising a pair of circuit traces electrically coupled to the pair of electrocardiographic electrodes and another pair of the electrical pads; and

an electrocardiography monitor having a sealed housing formed as a rounded isosceles trapezoid shape with a substantially straight edge on a proximal end that is longer than a substantially straight edge on a distal end and configured to be removably secured into the receptacle on the electrode patch and comprising;

a set of electrical contacts that protrude from a bottom surface on the proximal end of the sealed housing and correspond with further electrical pads on the receptacle;

a patient feedback button located on the proximal end of the sealed housing on a surface opposite the electrical contacts on the bottom surface; and

electronic circuitry comprised within the sealed housing, comprising;

a micro-controller operable to execute under micro-programmable control;

an electrographic front end circuit electrically interfaced to the micro-controller and operable to sense electrocardiographic signals through the electrocardiographic electrodes provided on the electrode patch;

a micro-controller electrically interfaced to the electrocardiographic front end circuit and operable to execute under micro-programmable control to sample the electrocardiographic signals sensed by the electrocardiographic front end circuit, to stage each electrocardiographic signal sample in a buffer, to compress each of the staged electrocardiographic signal samples, to further buffer each of the compressed electrocardiographic signal samples, and to write the buffered electrocardiographic signal samples to memory; and

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

10. An electrocardiography and physiological sensor monitor according to claim 9, wherein the micro-controller executes a power up sequence during which the battery on the electrode patch is checked, a state of the flash memory is confirmed, and operation of the micro-controller is confirmed.

11. An electrocardiography and physiological sensor monitor according to claim 9, wherein the sealed housing is removed from the electrode patch and removably secured into a further receptacle on a further electrode patch.

12. An electrocardiography and physiological sensor monitor according to claim 9, the electrode patch further comprising:

a cryptographic circuit to authenticate the electrode patch for use with the electrocardiography monitor.

13. An electrocardiography and physiological sensor monitor according to claim 9, further comprising:

an expansion port 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 battery leads, the physiology sensor electrically interfaced with the micro-controller over the expansion port; and

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

14. An electrocardiography and physiological sensor monitor according to claim 13, 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.

15. An electrocardiography and physiological sensor monitor according to claim 9, further comprising:

an expansion port operatively interconnected to the micro-controller;

a physiology sensor comprised within the electrocardiography monitor and operable to sense physiology and to draw power from a battery via a pair of the electrical pads, the physiology sensor electrically interfaced with the micro-controller over the expansion port; and

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

16. An electrocardiography and physiological sensor monitor according to claim 15, 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.