Method of manufacturing a disposable electrode

• US 6,076,002 A
• Filed: 06/17/1998
• Issued: 06/13/2000
• Est. Priority Date: 12/17/1996
• Status: Expired due to Fees

• Current Assignee: Conmed Corporation (Jefferies Financial Group, Inc.)
• Original Assignee: NDM, Inc.
• Inventors: Sturtevant, Wayne Robert, Wolf, Michael Lee, Cartmell, James Vernon
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): RUDDY, DAVID M
• Application Number:
  US09/098,587
• Time in Patent Office: 727 Days
• Field of Search: 439/909, 606/32, 600/372, 600/382, 600/389, 600/386-397, 607/147, 607/152, 607/153, 29/592.1, 156/292, 156/248, 156/267, 156/268
• US Class Current: 600/372
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 2562/0217 Electrolyte containing
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/274 using snap or button fasteners
• CPC Class Codes: A61B 5/28 for electrocardiography [ECG]
• CPC Class Codes: Y10S 439/909 Medical use or attached to human body
• CPC Class Codes: Y10T 156/108 Flash, trim or excess removal
• CPC Class Codes: Y10T 156/1082 Partial cutting bonded sandwich [e.g., grooving or incising]
• CPC Class Codes: Y10T 29/49002 Electrical device making

Abstract

A biomedical electrode for an electrocardiograph or similar device is provided. The biomedical electrode includes a disposable electrode having an electrically conductive gel layer and a smooth layer film. The disposable electrode interfaces with a reusable leadwire connector having the relatively expensive metallic conductive material. The reusable leadwire adapter includes a vinyl top layer which attaches to the smooth layer film of the disposable electrode through surface attraction. The reusable leadwire adapter may include a suction cup which attaches to the disposable electrode through a partial vacuum. The reusable leadwire also includes a stud member which snaps into a standard leadwire connector.

Claims

1. A method of manufacturing a disposable electrode, comprising the steps of:

a) providing a smooth layer film having an upper side and a lower side, wherein said upper side and said lower side of said smooth layer film have an adhesive coating;

b) providing a top layer having an upper side and a lower side having an adhesive coating;

c) applying said lower side of said smooth layer film to said upper side of said top layer by means of said adhesive coating on said smooth layer film;

d) punching a hole in said smooth layer film and said top layer;

e) providing an electrically conductive gel web having an upper side and a lower side and comprising an electrically conductive gel layer and an anchoring layer formed of a porous material having sufficient porosity such that said anchoring layer is laminated on said electrically conductive gel layer; and

f) applying said upper side of said electrically conductive web to said lower side of said top layer by means of said adhesive coating on said top layer.

2. The method of manufacturing the disposable electrode of claim 1, wherein said smooth layer film comprises a polyethylene material.

3. The method of manufacturing the disposable electrode of claim 1 wherein said lower side of said top layer includes a center portion and an outer portion, said electrically conductive patch is positioned over said center portion.

4. The method of manufacturing the disposable electrode of claim 1, wherein said electrically conductive gel layer comprises a hydrogel.

5. The method of manufacturing the disposable electrode of claim 1, further comprising the step of:

g) applying a release liner to said lower side of said top layer.

6. The method of manufacturing the disposable electrode of claim 5, wherein said lower side of said top layer has a pull tab, so as to provide a grippable surface to facilitate removal of said disposable electrode from said release liner.

7. The method of manufacturing the disposable electrode of claim 5, further comprising the step of:

h) making a separation cut between successive disposable electrodes.

8. The method of manufacturing the disposable electrode of claim 1, further comprising the step of:

g) cutting said disposable electrode to a desired shape.

9. A method of manufacturing a disposable electrode, comprising the steps of:

a) providing a smooth layer film having an upper side and a lower side having an adhesive coating;

b) providing a top layer having an upper side and a lower side having an adhesive coating;

c) applying said lower side of said smooth layer film to said upper side of said top layer by means of said adhesive coating on said smooth layer film;

d) punching a hole in said smooth layer film and said top layer;

e) providing an electrically conductive gel web having an upper side and a lower side, a center portion and an outer portion, and comprising an electrically conductive gel layer and an anchoring layer formed of a porous material having sufficient porosity such that said anchoring layer is laminated on said electrically conductive gel layer;

wherein a perforated portion of said anchoring layer is positioned on said upper side and over said center portion of said electrically conductive gel web;

f) applying said upper side of said electrically conductive web to said lower side of said top layer by means of said adhesive coating on said top layer,

g) providing an electrical stabilizing strip having an adhesive coating; and

h) applying said electrical stabilizing strip to said lower side and over said center portion of said electrically conductive gel web by means of said adhesive coating on said electrical stabilizing strip.

10. The method of manufacturing the disposable electrode of is claim 9, wherein said electrical stabilizing strip is an insulator.

11. The method of manufacturing the disposable electrode of claim 10, wherein said insulator comprises a polyester material.