Method for constructing a stress-pliant physiological electrode assembly

• US 9,775,536 B2
• Filed: 08/19/2014
• Issued: 10/03/2017
• 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): TRINH, MINH N
• Application Number:
  US14/463,571
• Publication Number:
  US 20150082623A1
• Time in Patent Office: 1,141 Days
• 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 from a stretchable woven textile material, the electrode backing having a proximal electrode backing end and a distal electrode backing end, wherein the proximal electrode backing end and the distal electrode backing end each comprise a side adapted to contact skin of a patient;

providing a circuit board and affixing the circuit board only to a side of the proximal electrode backing end that is opposite to the contact side of the proximal electrode backing end, wherein the contact side of the proximal electrode backing end is adapted to contact the skin of the patient;

interlacing a flexile wire through the stretchable woven textile material, wherein one wire end of the flexile wire is positioned on the contact side of the distal electrode backing end;

forming an electrocardiographic electrode signal pickup from the flexile wire end positioned on the contact side of the distal electrode backing end; and

terminating other end of the flexile wire as an electrical connection to connect to the circuit board;

interlacing a further flexile wire other than the flexile wire through the stretchable woven textile material, wherein one wire end of the further flexile wire is positioned on the contact side of the proximal electrode backing end;

forming a further electrocardiographic electrode signal pickup from the further flexile wire end positioned on the contact side of the proximal electrode backing end; and

terminating other end of the further flexile wire as other electrical connection to connect to the circuit board.

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

interlacing the flexile wire in a spiral pattern adapted to pick up an electrode signal.

3. The method according to claim 1, wherein the flexile wire comprises a conductor core and at least one layer of an insulator surrounding the conductor core.

4. The method according to claim 3, further comprising:

removing at least a portion of the at least one layer of the insulator surrounding the one wire end of the flexile wire.

5. The method according to claim 4, wherein the removing of the at least the portion of the insulator is performed by at least one of heating, a laser, cutting, abrasion, and stripping.

6. The method according to claim 5, further comprising:

shaping the midsection of the electrode backing between the distal electrode backing and the proximal electrode backing ends into a narrow isthmus tapering inwards from both sides of the midsection.

7. The method according to claim 6, wherein the physiological monitor comprises an electrocardiography monitor.

8. The method according to claim 7, wherein the electrically conductive adhesive comprises hydrocolloid.

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

removing at least a portion of the layer of the insulator surrounding the one flexile wire end.

10. The method according to claim 7, wherein the flexile wire comprises a conductor core and at least one layer of an insulator surrounding the conductor core.

11. The method according to claim 10, wherein the removing of the at least the portion of the insulator is performed by at least one of heating, a laser, cutting, abrasion, and stripping.

12. The method according to claim 1,

wherein the flexile wire is interlaced through a midsection of the electrode backing between the distal electrode backing end and the proximal electrode backing end.

13. The method according to claim 12, wherein, the circuit board comprises a battery compartment operable to hold a battery for powering a physiological monitor, and at least one electrical pad operable to electrically couple the physiological monitor to the flexile wire and the further flexile wire, further comprising:

adhering a non-conductive receptacle securely on top of the circuit board, the non-conductive receptacle 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.

14. The method according to claim 1, further comprising:

embedding the flexile wire end positioned on the contact side of the distal electrode backing end in an electrically conductive adhesive with the electrically conductive adhesive being disposed for electrode signal pickup and affixing the one end of the flexile wire to the contact side of the distal electrode backing end.

15. The method according to claim 1, further comprising:

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

16. The method according to claim 1,

wherein a portion of the electrode backing is covered with a non-irritating adhesive dressing.

17. The method according to claim 1, wherein the flexile wire comprises at least one metal selected the group consisting of copper, aluminum, silver, or a combination thereof.

18. The method according to claim 1, wherein the flexile wire is one of a solid, stranded, and braided wire.