Method For Constructing A Stress-Pliant Physiological Electrode Assembly

• US 20150082623A1
• 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 9,775,536 B2
• Time in Patent Office: Days
• US Class Current: 29/825
• CPC Class Codes: A61B 2562/0209 Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 2562/227 Sensors with electrical connectors
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/263 characterised by the electrode materials
• CPC Class Codes: A61B 5/273 Connection of cords, cables or leads to electrodes
• CPC Class Codes: A61B 5/28 for electrocardiography [ECG]
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

A method for constructing a stress-pliant physiological electrode assembly is provided. An electrode backing is formed from a stretchable woven textile material compatible to contact the skin on at least one surface. A pair of flexile wires is provided to serve as electrode circuit trace and electrode signal pickup. At least one of the flexile wires is sewn into the textile material which provides a stress-pliant malleability. Each of the flexile wires has an electrically-contacting area functioning for electric signal pickup. The electrically-contacting area may be sewn into the woven textile or affixed to the woven textile via conductive adhesives. The stress-pliant physiological electrode assembly is applicable for a wide array of physiological monitors, including ECG monitors, and especially is suitable for long-term wear. The method disclosed is both environmentally friendly and low-cost.

Claims

1. A method for constructing a stress-pliant physiological electrode assembly, comprising:

forming an electrode backing comprising of stretchable woven textile material compatible to contact the skin on at least one surface;

obtaining a length of flexile wire with a cross-sectional girth greater than the interstices formed between individual threads comprised in the stretchable woven textile material;

defining an electrical contact area on the at least one surface area and providing an electrically-contacting end of the flexile wire substantially within the electrical contact area; and

interlacing the flexile wire through the stretchable woven textile material from the electrical contact area to a surface of the stretchable woven textile material opposite to the electrical contact area and oriented in a manner operable to receive an electrical connection.

2. A method according to claim 1, further comprising:

interlacing the electrically-contacting end of the flexile wire through substantially the electrical contact area, with the electrically-contacting end being disposed for electrode signal pickup.

3. A method according to claim 2, further comprising:

interlacing the flexile wire via a pattern that facilitates the electrical signal pickup.

4. A method according to claim 2, wherein the flexile wire comprises a conductor core and at least one layer of insulator surrounding the conductor core.

5. A method according to claim 4, further comprising:

removing at least a portion of the layer of the insulator surrounding the electrically-contacting end of the flexile wire substantially within the electrical contact area, to be performed before, during, or after the process of interlacing the electrically-contacting end of the flexile wire through substantially the electrical contact area.

6. A method according to claim 5, wherein the removal of the insulator is performed by at least one of the processes of heating, laser, cutting, abrasion, and stripping.

7. A method according to claim 1, further comprising:

defining on the electrode backing a distal end, a proximal end, and a midsection between the two ends, wherein the flexile wire is interlaced substantially through the midsection; and

the electrical contact area is within the distal end;

providing a further flexile wire;

defining a further electrical contact area on the distal end and providing a further electrically-contacting end of the further flexile wire substantially within the further electrical contact area; and

interlacing the further flexile wire through the stretchable woven textile material from the further electrical contact area to the surface of the stretchable woven textile material opposite to the electrical contact area and oriented in a manner operable to receive an electrical connection.

8. A method according to claim 7, further comprising:

processing the midsection into a narrow isthmus tapering inwards from both sides of the midsection, to provide for the distal end electrode being disposed for being adhered to the region overlying the Xiphoid process on a patient'"'"'s chest, and to further provide for the proximal electrode 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.

9. A method according to claim 8, further comprising:

affixing a circuit board onto the surface of the stretchable woven textile material opposite to the electrical contact area, comprising a battery compartment operable to hold a battery for powering an physiological monitor, and an electrical pad operable to electrically couple the physiological monitor to the flexile wire and the further flexile wire; and

adhering a non-conductive receptacle securely on top of the circuit board and formed to removably receive the physiological monitor, the non-conductive receptacle comprising electrode terminals aligned to electrically interface the flexile wire and the further flexile wire to the physiological monitor.

10. A method according to claim 9, wherein the physiological monitor comprises an electrocardiography monitor.

11. A method according to claim 1, further comprising:

affixing an electrically conductive adhesive at least partially onto the electrically-contacting end of the flexile wire substantially within the electrical contact area, with the electrically conductive adhesive being disposed for electrode signal pickup and affixing the electrically-contacting end to the electrical contact area.

12. A method according to claim 11, wherein the electrically conductive adhesive comprises hydrocolloid.

13. A method according to claim 11, wherein the flexile wire comprises a conductor core and at least one layer of insulator surrounding the conductor core.

14. A method according to claim 13, further comprising:

removing at least a portion of the layer of the insulator surrounding the electrically-contacting end of the flexile wire substantially within the electrical contact area, to be performed before or during the process of affixing the electrically conductive adhesive at least partially onto the electrically-contacting end of the flexile wire.

15. A method according to claim 14, wherein the removal of the insulator is performed by at least one of the processes of heating, laser, cutting, abrasion, and stripping.

16. A method according to claim 1, further comprising:

covering the interlaced flexile conductive wire with at least one layer of an insulation material.

17. A method according to claim 1, further comprising:

adhering at least partially to the at least one surface of the electrode backing a non-irritating adhesive dressing.

18. A method according to claim 1, wherein the pair of the flexile conductive wires comprises at least one of the group of copper, aluminum, silver, and silver compounds.

19. A method according to claim 1, wherein interlacing the flexile wire is performed through stitching, sewing, or printing.

20. A method according to claim 1, wherein the flexile wire is chosen from a group of solid, stranded, and braided wires.