Extended Wear Electrocardiography Patch Using Interlaced Wire Electrodes

• US 20150087951A1
• Filed: 08/19/2014
• Published: 03/26/2015
• 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 9,717,432 B2
• Time in Patent Office: Days
• US Class Current: 600/382
• 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 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 using interlaced wire electrodes, 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 pair of flexile wires;

a pair of electrodes, one such electrode comprising one of the flexile wires interlaced into the distal end of the elongated strip and continuing back along an axial path through the midsection, another such electrode comprising the other of the flexile wires interlaced into the proximal end of the elongated strip, each of the electrodes further comprising an electrically conductive area only exposed on the contact surface;

a circuit board affixed on the proximal end of the elongated strip, comprising a battery compartment operable to hold a battery for powering an electrocardiography monitor, and an electrical pad operable to electrically couple the electrocardiography monitor with the pair of the electrodes; and

a non-conductive receptacle securely adhered on the one end of the elongated strip opposite the contact surface and formed to removably receive the electrocardiography monitor, the non-conductive receptacle comprising electrode terminals aligned to electrically interface the pair of the flexile wires to the electrocardiography monitor.

2. An electrode patch according to claim 1, further comprising:

one of the electrocardiographic electrodes being disposed for being adhered to the region overlying the lower sternum on a patient'"'"'s chest; and

an other of the electrocardiographic electrodes being disposed for being adhered to the region near the manubrium or upper sternum upwards on the patient'"'"'s chest oriented centrally (in the midline) along the sternum from the one electrocardiographic electrode.

3. An electrode patch according to claim 1, further comprising:

an upper part of the elongated strip defined on one end of the flexible backing and sized to be affixed to the bottom surface of the non-conductive receptacle, one of the electrocardiographic electrodes being affixed to and conductively exposed on the contact surface of the upper part; and

a lower part of the elongated strip defined on another end of the flexible backing;

another of the electrocardiographic electrodes being affixed to and conductively exposed on the contact surface of the lower part,

wherein the lower part of the elongated strip is provided for being adhered to the region overlying the lower sternum on a patient'"'"'s chest with the narrow longitudinal midsection oriented centrally (in the midline) along the sternum and the upper part of the elongated strip oriented upwards towards the manubrium.

4. An electrode patch according to claim 1, further comprising:

a non-irritating adhesive dressing at least partially coated on each end of the elongated strip on the contact surface.

5. An electrode patch according to claim 1, further comprising:

at least one pattern of interlaced flexile wires on the ends of the elongated strip selected from the group of a circle, a square, a triangle, and an arbitrary shape.

6. An electrode patch according to claim 1, further comprising:

a plurality of holes arranged at regularly spaced intervals along an axial path defined between the circuit board and the distal end of the flexible backing, through which one of the flexible wires is threaded.

7. An electrode patch according to claim 1, further comprising:

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

8. An electrode patch according to claim 1, wherein the flexile wires comprise at least one of copper, aluminum, silver, and other metals.

9. An electrode patch according to claim 1, wherein a core of the flexile wires comprises at least one of solid, stranded, and braided form.

10. An electrode patch according to claim 1, further comprising:

the 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.

11. An extended wear electrocardiography patch using non-metal electrodes, 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 pair of flexile wires;

a pair of electrodes, one such electrode comprising one of the flexile wires positioned on the distal end of the elongated strip on the contact surface and continuing back along an axial path through the narrow longitudinal midsection, another such electrode comprising the other of the flexile wires positioned on the proximal end of the elongated strip on the contact surface, each of the electrodes being imbedded in an electrically conductive adhesive;

a circuit board affixed on the proximal end of the elongated strip, comprising a battery compartment operable to hold a battery for powering an electrocardiography monitor, and an electrical pad operable to electrically couple the electrocardiography monitor with the pair of the electrodes; and

a non-conductive receptacle securely adhered on the one end of the elongated strip opposite the contact surface and formed to removably receive the electrocardiography monitor, the non-conductive receptacle comprising electrode terminals aligned to electrically interface the pair of the flexile wires to the electrocardiography monitor.

12. An electrode patch according to claim 11, further comprising:

one of the electrocardiographic electrodes being disposed for being adhered to the region overlying the lower sternum on a patient'"'"'s chest; and

an other of the electrocardiographic electrodes being disposed for being adhered to the region near the manubrium upwards on the patient'"'"'s chest oriented centrally (in the midline) along the sternum from the one electrocardiographic electrode.

13. An electrode patch according to claim 11, further comprising:

an upper part of the elongated strip defined on one end of the flexible backing and sized to be affixed to the bottom surface of the non-conductive receptacle, one of the electrocardiographic electrodes being affixed to and conductively exposed on the contact surface of the upper part; and

a lower part of the elongated strip defined on another end of the flexible backing;

another of the electrocardiographic electrodes being affixed to and conductively exposed on the contact surface of the lower part,

wherein the lower part of the elongated strip is provided for being adhered to the region overlying the lower sternum on a patient'"'"'s chest with the narrow longitudinal midsection oriented centrally (in the midline) along the sternum and the upper part of the elongated strip oriented upwards towards the manubrium.

14. An electrode patch according to claim 11, further comprising:

a non-irritating adhesive dressing at least partially coated on each end of the elongated strip on the contact surface.

15. An electrode patch according to claim 14, further comprising:

a contoured surface comprised on the non-irritating adhesive dressing on at least one end of the elongated strip.

16. An electrode patch according to claim 11, further comprising:

at least one pattern of interlaced flexile wires on the ends of the elongated strip selected from the group of a circle, a square, a triangle, and an arbitrary shape.

17. An electrode patch according to claim 11, further comprising:

a plurality of holes arranged at regularly spaced intervals along an axial path defined between the circuit board and the distal end of the flexible backing, through which one of the flexible wires is threaded.

18. An electrode patch according to claim 11, further comprising:

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

19. An electrode patch according to claim 11, further comprising:

a moisture-resistant seal formed on the non-conductive receptacle circumferentially about the electrode terminals and adapted to substantially protect the electrocardiography monitor against moisture intrusion.

20. An electrode patch according to claim 11, further comprising:

the 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.