Biomedical electrode having a disposable electrode and a reusable leadwire adapter that interfaces with a standard leadwire connector

• US 5,921,925 A
• Filed: 05/30/1997
• Issued: 07/13/1999
• Est. Priority Date: 05/30/1997
• Status: Expired due to Fees

• Current Assignee: Conmed Corporation (Jefferies Financial Group, Inc.), New Dimensions In Medicine, Inc.
• Original Assignee: NDM, Inc.
• Inventors: Sturtevant, Wayne Robert, Wolf, Michael Lee, Cartmell, James Vernon
• Primary Examiner(s): COHEN, LEE S
• Application Number:
  US08/866,847
• Time in Patent Office: 774 Days
• Field of Search: 600/391, 600/392, 600/394-397, 607/149, 607/152, 607/153, 606/32
• US Class Current: 600/391
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/257 using adhesive means, e.g. adhesive pads or tapes
• CPC Class Codes: A61B 5/266 containing electrolytes, conductive gels or pastes
• CPC Class Codes: A61B 5/274 using snap or button fasteners
• CPC Class Codes: A61B 5/28 for electrocardiography [ECG]
• CPC Class Codes: Y10T 156/1056 Perforating lamina
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing
• CPC Class Codes: Y10T 29/49222 forming array of contacts or terminals

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 reusable leadwire adapter having the relatively expensive metallic conductive material. The disposable electrode interfaces with the reusable leadwire adapter through the adhesive characteristics of the gel layer. The reusable leadwire includes a stud member which snaps into a standard leadwire connector.

Claims

1. A disposable electrode comprising:

a first layer of material having a first surface, a second surface with an adhesive coating for adhesion to the skin of a patient, and defining at least one opening; and

an electrically conductive gel layer mounted on said first surface of said first layer and covering said at least one opening such that said gel layer contacts the skin of the patient through said opening when said electrode is applied to the skin of the patient;

wherein said disposable electrode does not include a conductive terminal.

2. The disposable electrode of claim 1, further comprising a support layer disposed within said electrically conductive gel layer and coextensive therewith.

3. The disposable electrode of claim 1, further comprising an electrical stabilizing strip coupled to said electrically conductive gel layer and extending across said opening such that direct contact between said gel layer and the skin of the patient is prevented in a portion of said opening.

4. The disposable electrode of claim 3, wherein a width of said electrical stabilizing strip is less than a width of said electrically conductive gel layer and a width of said at least one opening.

5. The disposable electrode of claim 3, wherein said electrical stabilizing strip comprises an insulating material.

6. The disposable electrode of claim 5, wherein said insulating material comprises a polyester material.

7. The disposable electrode of claim 1, wherein said electrically conductive gel layer comprises a hydrogel material.

8. The disposable electrode of claim 1, wherein said first layer of material is formed of a porous material having sufficient porosity such that said electrically conductive gel layer adheres to said first layer.

9. The disposable electrode of claim 1, further comprising a release liner for protection of said disposable electrode prior to use, said release liner being secured to and covering said second surface of said first layer of material.

10. The disposable electrode of claim 9, wherein said release liner covers said first and second surfaces of said first layer of material.

11. The disposable electrode of claim 10, further comprising a pull tab coupled to said second surface of said first layer of material, so as to provide a surface which is free of said adhesive coating to facilitate removal of said electrode from said release liner.

12. The disposable electrode of claim 1, wherein said first layer of material comprises a grippable portion to facilitate handling and positioning of said electrode.

13. The disposable electrode of claim 1, wherein said adhesive coating extends substantially over the entire second surface of said first layer.

14. A biomedical electrode for use with a standard leadwire connector comprising:

a reusable leadwire adapter which is reusable and which interfaces with said standard leadwire connector; and

a disposable electrode which is discarded after each use and which interfaces with said reusable leadwire adapter and a patient, said disposable electrode comprising an electrically conductive gel layer, said reusable leadwire adapter directly engaging said electrically conductive gel layer;

wherein said reusable leadwire adapter comprises;

a mounting layer of material having a first surface, a second surface interfacing with said electrically conductive gel layer, and defining a first opening;

an electrically conductive terminal having a base portion integrally joined to a stud member, said base portion mounted to said first surface of said mounting layer over said first opening with said stud member sized to interface with said standard leadwire connector; and

an electrically conductive eyelet mounted on said second surface of said mounting layer over said first opening and electrically coupled to said conductive terminal.

15. The biomedical electrode of claim 14, wherein said conductive terminal comprises a metallic material.

16. The biomedical electrode of claim 15, wherein said metallic material comprises stainless steel.

17. The biomedical electrode of claim 14, wherein said conductive eyelet comprises at least one metallic particle.

18. The biomedical electrode of claim 17, wherein said conductive eyelet further comprises a plastic material.

19. The biomedical electrode of claim 17, wherein said at least one metallic particle comprises silver.

20. The biomedical electrode of claim 19, wherein said silver is chlorinated.

21. The biomedical electrode of claim 17, wherein said disposable electrode further comprises a first layer of material having a first surface, a second surface with an adhesive coating, and defining at least one opening, said electrically conductive gel layer being mounted on said first surface of said first layer, said electrically conductive gel layer contacting the skin of the patient through said at least one opening.

22. The biomedical electrode of claim 21, further comprising an electrical stabilizing strip coupled to said electrically conductive gel layer and extending across said at least one opening such that direct contact between said gel layer and the skin of the patient is prevented in a portion of said at least one opening.

23. The biomedical electrode of claim 22, wherein a width of said electrical stabilizing strip is less than a width of said electrically conductive gel layer and a width of said at least one opening.

24. The biomedical electrode of claim 21, wherein said first layer of material is a porous material having sufficient porosity such that said electrically conductive gel layer adheres to said first layer.

25. The biomedical electrode of claim 21, where said disposable electrode further comprises a support layer disposed within said electrically conductive gel layer and coextensive therewith.

26. The biomedical electrode of claim 14, wherein said mounting layer comprises a polyurethane material.

27. The biomedical electrode of claim 14, wherein said disposable electrode further comprises a first layer of material having a first surface, a second surface with an adhesive coating, and defining at least one opening, said electrically conductive gel layer being mounted on said first surface of said first layer, said electrically conductive gel layer contacting the skin of the patient through said at least one opening.

28. The biomedical electrode of claim 27, further comprising a support layer disposed within said electrically conductive gel layer and coextensive therewith.

29. The biomedical electrode of claim 27, further comprising an electrical stabilizing strip coupled to said electrically conductive gel layer and extending across said at least one opening such that direct contact between said gel layer and the skin of the patient is prevented in a portion of said at least one opening.

30. The biomedical electrode of claim 29, wherein a width of said electrical stabilizing strip is less than a width of said electrically conductive gel layer and a width of said at least one opening.

31. The biomedical electrode of claim 29, wherein said electrical stabilizing strip comprises an insulating material.

32. The biomedical electrode of claim 31, wherein said insulating material comprises a polyester material.

33. The biomedical electrode of claim 32, wherein a width of said electrical stabilizing strip is substantially equal to a width of said conductive eyelet.

34. The biomedical electrode of claim 27, wherein said electrically conductive gel layer comprises a hydrogel material.

35. The biomedical electrode of claim 27, wherein said first layer of material is a porous material having sufficient porosity such that said electrically conductive gel layer adheres to said first layer.

36. The biomedical electrode of claim 27, further comprising a release liner for protection of said disposable electrode prior to use, said release liner being secured to and covering said second surface of said first layer of material.

37. The biomedical electrode of claim 36, wherein said release liner covers said first and second surfaces of said first layer of material.

38. The biomedical electrode of claim 37, further comprising a pull tab coupled to said second surface of said first layer of material, so as to provide a surface which is free of said adhesive coating to facilitate removal of said disposable electrode from said release liner.

39. The biomedical electrode of claim 27, wherein said first layer of material comprises a grippable portion to facilitate handling and positioning of said disposable electrode.

40. The biomedical electrode of claim 27, wherein said adhesive coating extends substantially over the entire second surface of said first layer.

41. The biomedical electrode of claim 27, wherein said conductive terminal comprises a metallic material.

42. The biomedical electrode of claim 41, wherein said metallic material comprises stainless steel.

43. The biomedical electrode of claim 41, wherein said conductive eyelet comprises at least one metallic particle.

44. The biomedical electrode of claim 43, wherein said conductive eyelet further comprises a plastic material.

45. The biomedical electrode of claim 43, wherein said at least one metallic particle comprises silver.

46. The biomedical electrode of claim 45, wherein said silver is chlorinated.

47. The biomedical electrode of claim 27, wherein said mounting layer comprises a polyurethane material.

48. A biomedical electrode for use with a standard leadwire connector comprising:

a reusable leadwire adapter which is reusable and which interfaces with said standard leadwire connector; and

a disposable electrode which is discarded after each use and which interfaces with said reusable leadwire adapter and a patient, said disposable electrode comprising an electrically conductive gel layer, said reusable leadwire adapter directly engaging said electrically conductive gel layer;

wherein said reusable leadwire adapter comprises;

a mounting layer of material having a first surface, a second surface interfacing with said electrically conductive gel layer, and defining a first opening;

an electrically conductive terminal having a base portion integrally joined to a stud member, said base portion mounted to said first surface of said mounting layer over said first opening with said stud member sized to interface with said standard leadwire connector, said electrically conductive terminal comprising a metallic material; and

an electrically conductive eyelet mounted on said second surface of said mounting layer over said first opening and electrically coupled to said conductive terminal, said electrically conductive eyelet comprising at least one chlorinated silver particle; and

wherein said disposable electrode further comprises;

a first layer of material having a first surface, a second surface with an adhesive coating, and defining at least one opening, said electrically conductive gel layer being mounted on said first surface of said first layer, said electrically conductive gel layer contacting the skin of the patient through said at least one opening, said first layer of material comprising a porous material of sufficient porosity such that said electrically conductive gel layer adheres to said first layer;

an electrical stabilizing strip coupled to said electrically conductive gel layer and extending across said at least one opening such that direct contact between said gel layer and the skin of the patient is prevented in a portion of said at least one opening; and

a support layer disposed within said electrically conductive gel layer and coextensive therewith.