Extended Wear Electrocardiography Patch With Wire Contact Surfaces

• US 20170319094A1
• Filed: 07/27/2017
• Published: 11/09/2017
• 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: Felix, Jason, Bishay, Jon Mikalson, Bardy, Gust H.
• Granted Patent: US 10,154,793 B2
• Time in Patent Office: 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

Physiological monitoring can be provided through a wearable monitor that includes a flexible extended wear electrode patch and a removable reusable monitor recorder. A pair of flexile wires is interlaced or sewn into a flexible backing, serving as electrode signal pickup and electrode circuit traces. The wearable monitor sits centrally on the patient'"'"'s chest along the sternum, which significantly improves the ability to sense cutaneously cardiac electric signals, particularly those generated by the atrium. The electrode patch is shaped to fit comfortably and conformal to the contours of the chest approximately centered on the sternal midline. To counter the dislodgment due to compressional and torsional forces, non-irritating adhesive is provided on the underside, or contact, surface of the electrode patch, but only on the distal and proximal ends. Interlacing or sewing the flexile wires into the flexile backing also provides structural support and malleability against compressional, tensile and torsional forces.

Claims

1. An extended wear electrocardiography patch with wire contact surfaces, 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 to a contact surface defined on each of the ends;

a pair of flexile wires, one of the wires forming an electrocardiographic electrode, the electrocardiographic electrode formed by a portion of the one wire that is sewn into the distal end of the elongated strip and that is configured for directly contacting the patient, the one wire continuing back along an axial path through the midsection, another one of the wires forming another electrocardiographic electrode, the electrocardiographic electrode formed by a portion of the another wire that is sewn into the proximal end of the elongated strip and that is configured for electrically contacting the patient, each of the electrodes comprising an electrically conductive area only exposed on the contact surface; and

a set of electrical contact pads comprised on the flexible backing and formed by further flexile wires, one or more of the pads of the set connected to the electrodes and configured to interface the electrodes with an electrocardiography monitor recorder.

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; and

a battery compartment formed on a bottom surface of the non-conductive receptacle operable to hold a battery for powering the electrocardiography electrocardiography monitor recorder.

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

a spring and a clasp securing the battery within the battery compartment.

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

an additional flexile wire sewn into the flexible backing securing the battery within the battery compartment.

5. An electrocardiography patch in accordance with claim 2, wherein the battery is interfaced to different one or more of the pads of the set and the different pads are configured to interface the battery to the electrocardiography monitor recorder.

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

a layer of insulation material covering at least part of a surface of the flexile wires.

7. An electrocardiography patch in accordance with claim 1, wherein the further flexile wires are over-stitched into the flexible backing.

8. An extended wear interlaced electrocardiography patch with wire contact surfaces, 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 to a contact surface defined on each of the ends;

a pair of flexile wires, one of the wires forming an electrocardiographic electrode, the electrocardiographic electrode formed by a portion of the one wire that is interlaced into the distal end of the elongated strip and that is configured for directly contacting the patient, the one wire continuing back along an axial path through the midsection, another one of the wires forming another electrocardiographic electrode, the electrocardiographic electrode formed by a portion of the another wire that is interlaced into the proximal end of the elongated strip and that is configured for electrically contacting the patient, each of the electrodes comprising an electrically conductive area only exposed on the contact surface; and

a set of electrical contact pads comprised on the flexible backing and formed by further flexile wires, one or more of the pads of the set connected to the electrodes and configured to interface the electrodes with an electrocardiography monitor recorder.

9. An electrocardiography patch in accordance with claim 8, 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; and

a battery compartment formed on a bottom surface of the non-conductive receptacle operable to hold a battery for powering the electrocardiography electrocardiography monitor recorder.

10. An electrocardiography patch in accordance with claim 9, further comprising:

a spring and a clasp securing the battery within the battery compartment.

11. An electrocardiography patch in accordance with claim 9, further comprising:

an additional flexile wire sewn into the flexible backing securing the battery within the battery compartment.

12. An electrocardiography patch in accordance with claim 9, wherein the battery is interfaced to different one or more of the pads of the set and the different pads are configured to interface the battery to the electrocardiography monitor recorder.

13. An electrocardiography patch in accordance with claim 9, further comprising:

a layer of insulation material covering at least part of a surface of the flexile wires.

14. An electrocardiography patch in accordance with claim 8, wherein the further flexile wires are over-stitched into the flexible backing.

15. An extended wear embedded electrode electrocardiography patch with wire contact surfaces, comprising:

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

a distal electrically conductive adhesive positioned on the distal end and configured for directly contacting a patient;

a proximal electrically conductive adhesive positioned on the proximal end and configured for directly contacting the patient;

a pair of flexile wires, one of the wires forming an electrocardiographic electrode by a portion of the wire embedded within the distal electrically conductive adhesive on the distal end, the one wire continuing back along an axial path through the narrow longitudinal midsection, another one of the wires forming another electrocardiographic electrode by a portion of the another wire embedded within the proximal electrically conductive adhesive, wherein the embedded portion of the one wire receives electrical potentials of the patient directly from the distal electrically conductive adhesive and the embedded portion of the another wire receives electrical potentials of the patient directly from the proximal electrically conductive adhesive; and

a set of electrical contact pads comprised on the flexible backing and formed by further flexile wires, one or more of the pads of the set connected to the electrodes and configured to interface the electrodes with an electrocardiography monitor recorder.

16. An electrocardiography patch in accordance with claim 15, 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; and

a battery compartment formed on a bottom surface of the non-conductive receptacle operable to hold a battery for powering the electrocardiography electrocardiography monitor recorder.

17. An electrocardiography patch in accordance with claim 16, further comprising:

a spring and a clasp securing the battery within the battery compartment.

18. An electrocardiography patch in accordance with claim 16, further comprising:

an additional flexile wire sewn into the flexible backing securing the battery within the battery compartment.

19. An electrocardiography patch in accordance with claim 16, wherein the battery is interfaced to different one or more of the pads of the set and the different pads are configured to interface the battery to the electrocardiography monitor recorder.

20. An electrocardiography patch in accordance with claim 15, wherein the further flexile wires are over-stitched into the flexible backing.