Extended wear electrocardiography patch with wire interconnects

• US 10,631,748 B2
• Filed: 12/17/2018
• Issued: 04/28/2020
• 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): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US16/221,989
• Publication Number:
  US 20190117107A1
• Time in Patent Office: 498 Days
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2560/0456 Apparatus provided with a docking unit
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6833 Adhesive patches

Abstract

An extended wear electrocardiography patch with wire interconnects is provided. The patch includes a flexible backing formed of an elongated strip of stretchable material with narrow longitudinal midsection evenly tapering inward from a distal end and a proximal end, the elongated strip adherable only at a contact surface defined on each of the ends; a pair of electrocardiographic electrodes interfaced to one or more of a set of electrode pads, each of the electrodes including an electrically conductive surface only exposed on the contact surface; a battery connected to one or more of the pads of the set via at least one flexile wire interconnect, the battery secured in place via a flexile wire; and the set of electrical contact pads included on the flexible backing and formed by a set of further flexile wires, the set configured to interface the electrodes and the battery with an electrocardiography monitor recorder.

Claims

1. An extended wear electrocardiography patch with wire interconnects, comprising:

a flexible backing formed of an elongated strip of stretchable material with narrow longitudinal midsection evenly tapering inward from a distal end and a proximal end, the elongated strip adherable only at a contact surface defined on each of the ends;

a pair of electrocardiographic electrodes interfaced to one or more of a set of electrical contact pads, each of the electrodes comprising an electrically conductive surface only exposed on the contact surface;

a battery connected to one or more of the electrical contact pads of the set via at least one flexile wire interconnect, the battery secured in place via a flexile wire; and

the set of electrical contact pads comprised on the flexible backing and formed by a set of further flexile wires, the set of the further flexile wires configured to interface the electrodes and the battery with an electrocardiography monitor recorder when the electrocardiography monitor recorder is in contact with the set of the electrical contact pads, wherein the flexile wire interconnect, the flexile wire, and the further flexile wires each comprise a plurality of threads.

2. An electrocardiography patch in accordance with claim 1, further comprising:

a non-conductive receptacle securely adhered on one of the ends of the elongated strip opposite the contact surface and formed to removably receive the electrocardiography monitor recorder.

3. An electrocardiography patch in accordance with claim 2, further comprising:

a battery compartment formed on a bottom surface of the non-conductive receptacle operable to hold the battery, wherein the battery is secured via the flexile wire within the battery compartment.

4. An electrocardiography patch in accordance with claim 1, further comprising:

a physiological sensor interfaced to one of the electrical contact pads of the set via a further flexile wire interconnect.

5. An electrocardiography patch in accordance with claim 4, wherein the physiological sensor is selected from the group consisting of an SpO₂ sensor, a blood pressure sensor, a temperature sensor, respiratory rate sensor, a glucose sensor, an air flow sensor, and a volumetric pressure sensor.

6. An electrocardiography patch in accordance with claim 1, wherein at least one of the plurality of threads of the flexile wire interconnect, the flexile wire, and the further flexile wires are electrically conductive threads and at least one of the plurality of threads is electrically non-conductive threads.

7. An electrocardiography patch in accordance with claim 1, wherein all of the threads are electrically conductive threads.

8. An electrocardiography patch in accordance with claim 1, wherein an adhesive is comprised on each of the contact surfaces.

9. An electrocardiography patch in accordance with claim 1, wherein each of the electrocardiographic electrodes is comprised of an additional flexile wire and the additional flexile wires connect the electrodes to two of the electrical contact pads.

10. An extended wear electrocardiography monitor with wire interconnects, comprising:

a disposable extended wear electrocardiography patch, comprising;

a flexible backing formed of an elongated strip of stretchable material with narrow longitudinal midsection evenly tapering inward from a distal end and a proximal end, the elongated strip adherable only at a contact surface defined on each of the ends;

a pair of electrocardiographic electrodes interfaced to one or more of a set of electrical contact pads, each of the electrodes comprising an electrically conductive surface only exposed on the contact surface;

a battery connected to one or more of the electrical contact pads of the set via at least one flexile wire interconnect, the battery secured in place via a flexile wire; and

the set of electrical contact pads comprised on the flexible backing and formed by a set of further flexile wires, the set of the further flexile wires configured to interface the electrodes and the battery with an electrocardiography monitor recorder when the electrocardiography monitor recorder is in contact with the set of the electrical contact pads, wherein the flexile wire interconnect, the flexile wire, and the further flexile wires each comprise a plurality of threads; and

the electrocardiography monitor recorder, comprising;

a wearable housing;

an external interface configured to be removably connected to the set of the electrical contact pads; and

electronic circuitry provided within the wearable housing comprising;

a microcontroller operable to execute over an extended period under micro programmable control as specified in firmware;

an electrocardiographic front end circuit under the control of the microcontroller adapted to sense electrocardiographic signals through the electrocardiographic electrodes via the external interface; and

a non-volatile memory electrically interfaced with the microcontroller and operable to continuously store samples of the electrocardiographic signals throughout the extended period.

11. An extended wear electrocardiography monitor in accordance with claim 10, further comprising:

a non-conductive receptacle securely adhered on one of the ends of the elongated strip opposite the contact surface and formed to removably receive the electrocardiography monitor recorder.

12. An extended wear electrocardiography monitor in accordance with claim 11, further comprising:

a battery compartment formed on a bottom surface of the non-conductive receptacle operable to hold the battery, wherein the battery is secured via the flexile wire within the battery compartment.

13. An extended wear electrocardiography monitor in accordance with claim 10, further comprising:

a physiological sensor interfaced to one of the electrical contact pads of the set via a further flexile wire interconnect.

14. An extended wear electrocardiography monitor in accordance with claim 13, wherein the physiological sensor is selected from the group consisting of an SpO₂ sensor, a blood pressure sensor, a temperature sensor, respiratory rate sensor, a glucose sensor, an air flow sensor, and a volumetric pressure sensor.

15. An extended wear electrocardiography monitor in accordance with claim 10, wherein at least one of the plurality of threads of the flexile wire interconnect, the flexile wire, and the further flexile wires are electrically conductive threads and at least one of the plurality of threads is electrically non-conductive threads.

16. An extended wear electrocardiography monitor in accordance with claim 10, wherein all of the threads are electrically conductive threads.

17. An extended wear electrocardiography monitor in accordance with claim 10, wherein an adhesive is comprised on each of the contact surfaces.

18. An extended wear electrocardiography monitor in accordance with claim 10, wherein each of the electrocardiographic electrodes is comprised of an additional flexile wire and the additional flexile wires connect the electrodes to two of the electrical contact pads.