Extended wear electrocardiography patch using interlaced wire electrodes

• US 9,717,432 B2
• Filed: 08/19/2014
• Issued: 08/01/2017
• 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.
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US14/463,585
• Publication Number:
  US 20150087951A1
• Time in Patent Office: 1,078 Days
• Field of Search: 600382, 600391-393, 600509
• 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 interlaced 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 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 a 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 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 one or more electrical pads operable to electrically couple the electrocardiography monitor with the pair of the electrodes; and

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.

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

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

an other of the electrocardiographic electrodes being disposed for being adhered to a 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 a 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 the 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 consisting of a circle, a square, and a triangle.

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 the one of the flexile 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 a metal selected from the group consisting of copper, aluminum, silver, and a combination thereof.

9. An electrode patch according to claim 1, wherein a form of a core of the flexile wires is selected from the group consisting of a solid, stranded, braided form, and a combination thereof.

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 the 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 ambulatory electrocardiography interlaced electrode monitor, comprising:

a disposable extended wear electrode patch, comprising;

a flexible backing comprising stretchable material defined as an elongated strip with a narrow longitudinal midsection, each end of the flexible backing comprising an adhesive contact surface adapted to serve as a crimp relief;

a pair of flexile wires, one of the wires forming an electrocardiographic electrode configured for directly contacting a patient, the electrocardiographic electrode formed by a portion of the one wire interlaced in a spiral pattern into a distal one of the ends of the elongated strip, the one wire interlaced along an axial path through the narrow longitudinal midsection to serve as a strain relief, another one of the wires forming another electrocardiographic electrode configured for directly contacting the patient, the another electrocardiographic electrode formed by a portion of the another wire interlaced in a further spiral pattern into a proximal one of the ends of the elongated strip, each electrocardiographic electrode conductively exposed for dermal adhesion and adapted to be positioned axially along a midline of a sternum of the patient;

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

wherein the ambulatory electrocardiography interlaced electrode monitor further comprises the ambulatory electrocardiography monitor recorder, the ambulatory electrocardiography monitor recorder, comprising;

a wearable housing adapted to securely fit into the non-conductive receptacle; and

electronic circuitry provided within the wearable housing and comprising an external interface configured to be removably connected to the electrocardiographic electrodes via the non-conductive receptacle, further 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; and

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

12. An ambulatory electrocardiography interlaced electrode monitor according to claim 11, further comprising:

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

an other of the electrocardiographic electrodes being disposed for being adhered to a 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.

13. An ambulatory electrocardiography interlaced electrode monitor 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 a 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 a region overlying the lower sternum on the 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 ambulatory electrocardiography interlaced electrode monitor 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 ambulatory electrocardiography interlaced electrode monitor according to claim 11, wherein the spiral pattern and the further spiral pattern are the same.

16. An ambulatory electrocardiography interlaced electrode monitor according to claim 11, further comprising:

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

17. An ambulatory electrocardiography interlaced electrode monitor according to claim 11, further comprising:

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

18. An ambulatory electrocardiography interlaced electrode monitor according to claim 11, wherein the flexile wires comprise a metal selected from the group consisting of copper, aluminum, silver, and a combination thereof.

19. An ambulatory electrocardiography interlaced electrode monitor according to claim 11, wherein a form of a core of the flexile wires is selected from the group consisting of a solid, stranded, braided form, and a combination thereof.

20. An extended wear interlaced electrode 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 to a contact surface defined on each of the ends;

a pair of flexile wires, one of the wires forming an electrocardiographic electrode configured for directly contacting a patient, the electrocardiographic electrode formed by a portion of the one wire interlaced in a spiral pattern into the distal end of the elongated strip, 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 interlaced in a further spiral pattern 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 one or more electrical pads operable to electrically couple the electrocardiography monitor with the pair of the electrodes; and

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.