Extended wear electrocardiography and respiration-monitoring patch

• US 9,545,228 B2
• Filed: 06/13/2016
• Issued: 01/17/2017
• 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., Bishay, Jon Mikalson, Felix, Jason
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US15/181,082
• Publication Number:
  US 20160296166A1
• Time in Patent Office: 218 Days
• US Class Current: 1/1
• 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 patch further includes sensors for monitoring patient'"'"'s air flow and respiratory measures contemporaneously with the ECG monitoring.

Claims

1. An extended wear electrocardiography and respiration-monitoring 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, each of the electrocardiographic electrodes adapted to be positioned axially along the midline of the sternum for capturing action potential propagation;

a non-conductive receptacle securely adhered on one end of the elongated strip opposite the contact surface and operable to removably receive an electrocardiography monitor, the non-conductive receptacle comprising electrode terminals aligned to electrically interface the pair of the circuit traces to the electrocardiography monitor;

one or more respiratory sensors configured to interface with the electrocardiography monitor when the monitor is inserted into the non-conductive receptacle; 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.

2. An extended wear electrocardiography and respiration monitoring patch according to claim 1, further comprising:

a tab extending from the flexible backing on which one or more of the respiratory sensors are comprised.

3. An extended wear electrocardiography and respiration monitoring patch according to claim 1, wherein the one or more of the respiratory sensors are located on a surface of the non-conductive receptacle that faces the flexible backing.

4. A self-contained personal air flow sensing monitor according to claim 1, wherein the one or more respiratory sensors further comprise at least one of an air flow sensor, an SpO₂ sensor, a pCO₂ sensor, and a respiratory rate sensor.

5. An extended wear electrocardiography and respiration monitoring patch according to claim 1, further comprising:

a battery compartment provided in the non-conductive receptacle and comprising a pair of battery leads electrically coupleable to a battery; and

the non-conductive receptacle further comprising power terminals aligned to electrically interface the pair of battery leads to the electrocardiography monitor.

6. An extended wear electrocardiography patch with an extension for respiration monitoring, 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, each of the electrocardiographic electrodes adapted to be positioned axially along the midline of the sternum for capturing action potential propagation;

a non-conductive receptacle securely adhered on one end of the elongated strip opposite the contact surface and operable to removably receive an electrocardiography monitor, the non-conductive receptacle comprising electrode terminals aligned to electrically interface the pair of the circuit traces to the electrocardiography monitor;

a tab extending from the flexible backing on which one or more respiratory sensors are comprised, the one or more respiratory sensors configured to interface with the electrocardiography monitor recorder when the recorder is inserted into the non-conductive receptacle; 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. An extended wear electrocardiography patch according to claim 6, wherein the respiratory sensor comprises an air flow sensor.

8. An extended wear electrocardiography patch according to claim 7, wherein the air flow sensor comprises a microphone.

9. An extended wear electrocardiography patch according to claim 7, wherein the extended tab is of a sufficient length to reach a sternal notch of the patient when the electrodes are positioned along the midline of the sternum and the air flow sensor is located on a portion of the tab located over the sternal notch when the electrodes are positioned along the midline of the sternum.

10. An extended wear electrocardiography patch according to claim 6, wherein the one or more respiratory sensors comprise a respiratory rate sensor.

11. An extended wear electrocardiography patch according to claim 6, wherein the respiratory rate sensor comprises a strain gauge comprising two arms extending beyond the tab and shaped to contact the patient'"'"'s skin when the electrodes are positioned along the midline of the sternum.

12. An extended wear electrocardiography patch according to claim 6, wherein the one or more respiratory sensors further comprise one or more of an SpO₂ sensor and a pCO₂ sensor.

13. An extended wear electrocardiography patch according to claim 6, wherein the tab comprises a continuous piece of stretchable material.

14. An extended wear electrocardiography patch according to claim 6, wherein the one or more respiratory are configured to wirelessly interface with the electrocardiography monitor when the monitor is inserted into the non-conductive receptacle.

15. An extended wear electrocardiography patch according to claim 6, wherein at least a portion of the tab is covered with an adhesive.

16. An extended wear electrocardiography patch with respiration-monitoring capabilities, 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, each of the electrocardiographic electrodes adapted to be positioned axially along the midline of the sternum for capturing action potential propagation;

a non-conductive receptacle securely adhered on one end of the elongated strip opposite the contact surface and operable to removably receive an electrocardiography monitor, the non-conductive receptacle comprising electrode terminals aligned to electrically interface the pair of the circuit traces to the electrocardiography monitor;

one or more respiratory sensors located on a surface of the non-conductive receptacle, the one or more respiratory sensors configured to interface with the electrocardiography monitor when the monitor is inserted into the non-conductive receptacle; 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.

17. An extended wear electrocardiography patch according to claim 16, wherein the surface of the non-conductive receptacle faces the flexible backing.

18. An extended wear electrocardiography patch according to claim 16, wherein the one or more respiratory sensors located on the surface comprise a microphone.

19. An extended wear electrocardiography patch according to claim 16, wherein the one or more respiratory sensors further comprise at least one of an SpO₂ sensor, a pCO₂ sensor, and a respiratory rate sensor.

20. An extended wear electrocardiography patch according to claim 16, wherein the respiratory rate sensor comprises a strain gauge comprising two arms extending beyond the flexible backing and shaped to contact the patient'"'"'s skin when the electrodes are positioned along the midline of the sternum.