Biomedical electrode and method for its manufacture

• US 6,415,170 B1
• Filed: 05/03/1999
• Issued: 07/02/2002
• Est. Priority Date: 12/09/1996
• Status: Expired due to Fees

• Current Assignee: 3M Innovative Properties Company (3M Company)
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Wright, Derek, Wiedenhaupt, Paul, Loutis, Nikolaus
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): RUDDY, DAVID M
• Application Number:
  US09/214,878
• Time in Patent Office: 1,156 Days
• Field of Search: 607/152, 295/921, 156/267, 600/372-392
• US Class Current: 600/391
• 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: A61N 1/046 Specially adapted for shock therapy, e.g. defibrillation
• CPC Class Codes: A61N 1/048 Electrodes characterised by a specific connection between lead and electrode
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence

Abstract

A biomedical electrode comprises a connector stud (1) anchored in a patch of adhesive-coated backing material (7) which is used to secure the electrode to the skin of a patient. The connector stud (1), which is located in a pierced opening in the backing material (7), has a head portion (2) to which an electrical lead of an electromedical monitoring/diagnostic system can be attached, and an electrode plate (3) which, when the biomedical electrode is in use, is placed in electrical communication with the skin of the patient. A strip of ionically-conductive adhesive (9) extends across the backing material and over the electrode plate (3) and a strip of scrim material (17) is located adjacent the adhesive coating on the backing material, underneath the adhesive strip (9). The two strips (9, 17) are displaced, relative to the electrode plate (3), towards a tab (13) which is used for removing the electrode from the skin of the patient.

Claims

1. A biomedical electrode comprising:

(a) a backing material coated on a first side with a pressure-sensitive adhesive and having a non-adhesive margin to facilitate the handling of the electrode;

(b) a connector stud located in the backing material, the stud having an electrode plate located on the first side of the backing material for electrical connection to the skin of a patient and, on a second side of the backing material, a head portion to which an electrical connector can be attached;

(c) a strip of ionically-conductive adhesive extending, generally parallel to the non-adhesive margin, across the adhesive-coated first side of the backing material from edge to edge and over the electrode plate of the stud; and

(d) a parallel strip of scrim material located at the interface of the ionically-conductive and pressure-sensitive adhesive, the strip of scrim material being displaced, relative to the electrode plate of the stud, towards the non-adhesive margin of the backing material, and the edges of both strips nearest to the non-adhesive margin being positioned to one side of the electrode plate.

2. biomedical electrode as claimed in claim 1, in which the edges of the strips of scrim material and ionically-conductive material nearest to the non-adhesive margin of the backing material are substantially contiguous.

3. A method of manufacturing a biomedical electrode, comprising:

providing a connector stud comprising an electrode plate for electrical connection to the skin of a patient and a head portion;

inserting the connector stud into a pierced opening in a backing material, to locate the stud in the backing material with the electrode plate and the head portion on opposite sides of the material; and

providing a strip of scrim material located to one side of the center of the electrode plate of the stud on a first side of the backing material.

4. A method as claimed in claim 3, including the step of holding the pierced opening in an open condition while the stud is being inserted.

5. A method of manufacturing a biomedical electrode, comprising:

forming an opening in a backing material;

inserting a tubular member through the opening from one side of the backing material;

providing a connector stud comprising an electrode plate for electrical connection to the skin of a patient, and a head portion;

locating the stud, head portion first, in the end of the tubular member from the other side of the backing material; and

providing a strip of scrim material located to one side of the center of the electrode plate of the stud on a first side of the backing material.

6. A method as claimed in claim 5, in which the opening is a punched opening.

7. A biomedical electrode comprising:

a backing material coated on a first side with a pressure-sensitive adhesive and having a non-adhesive margin to facilitate the handling of the electrode;

a connector stud located in the backing material, the stud having an electrode plate located on the first side of the backing material for electrical connection to the skin of a patient and, on a second side of the backing material, a head portion to which an electrical connector can be attached;

a strip of ionically-conductive adhesive extending, generally parallel to the non-adhesive margin, across the adhesive-coated first side of the backing material and over the electrode plate of the stud, wherein the strip of ionically-conductive material is displaced, relative to the electrode plate of the stud, towards the non-adhesive margin of the backing material; and

a parallel strip of scrim material located at the interface of the ionically-conductive and pressure-sensitive adhesive, the strip of scrim material being displaced, relative to the electrode plate of the stud, towards the non-adhesive margin of the backing material, and the edges of both strips nearest to the non-adhesive margin being positioned to one side of the electrode plate.

8. A biomedical electrode as claimed in claim 7, in which the edges of the strips of scrim material and ionically-conductive material nearest to the non-adhesive margin of the backing material are substantially contiguous.

9. A biomedical electrode as claimed in claim 7, in which the strip of scrim material is located to one side of the center of the electrode plate of the stud.

10. A biomedical electrode as claimed in claim 9, in which the strip of scrim material is located to one side of the electrode plate of the stud.

11. A biomedical electrode as claimed in claim 7, in which the strip of scrim material extends between the pressure-sensitive adhesive and the electrode plate of the stud.

12. A biomedical electrode as claimed in claim 11, in which the width of the strip of ionically-conductive adhesive is such that the adhesive covers the electrode plate of the stud but does not extend substantially beyond the electrode plate at the edge remote from the non-adhesive margin of the backing material.

13. A biomedical electrode as claimed in claim 12, in which the strips of adhesive and scrim material are substantially co-extensive.

14. A biomedical electrode as claimed in claim 13, in which the backing material is substantially rectangular in shape and has the non-adhesive margin along one side, the strips of scrim material and ionically-conductive adhesive extending across the backing material substantially parallel to the non-adhesive margin.

15. A biomedical electrode as claimed in claim 14, in which the scrim material is laminated to the pressure-sensitive adhesive on the backing material.

16. A biomedical electrode as claimed in claim 15, in which the ionically-conductive adhesive is in the form of a pre-cured strip which is laminated to the scrim and backing materials and to the electrode plate.

17. A biomedical electrode as claimed in claim 16, in which the connector stud is a one-piece stud and is located in a pierced hole in the backing material.

18. A biomedical electrode as claimed in claim 17, in which the adhesive-carrying side of the electrode is covered by a removable liner.

19. A biomedical electrode comprising:

a backing material coated on a first side with a pressure-sensitive adhesive and having a non-adhesive margin to facilitate the handling of the electrode;

a connector stud located in the backing material, the stud having an electrode plate located on the first side of the backing material for electrical connection to the skin of a patient and, on a second side of the backing material, a head portion to which an electrical connector can be attached;

a strip of ionically-conductive -adhesive-extending, generally parallel to the non-adhesive margin, across the adhesive-coated first side of the backing material and over the electrode plate of the stud; and

a parallel strip of scrim material located at the interface of the ionically-conductive and pressure-sensitive adhesive, wherein the strip of scrim material is displaced, relative to the electrode plate of the stud, towards the non-adhesive margin of the backing material, wherein the edges of both strips nearest to the non-adhesive margin are positioned to one side of the electrode plate, and further wherein the strip of scrim material is located to one side of the center of the electrode plate of the stud.

20. A biomedical electrode as claimed in claim 19, in which the edges of the strips of scrim material and ionically-conductive material nearest to the non-adhesive margin of the backing material are substantially contiguous.

21. A biomedical electrode as claimed in claim 19, in which the strip of scrim material is located to one side of the electrode plate of the stud.

22. A biomedical electrode comprising:

a backing material coated on a first side with a pressure-sensitive adhesive and having a non-adhesive margin to facilitate the handling of the electrode;

a connector stud located in the backing material, the stud having an electrode plate located on the first side of the backing material for electrical connection to the skin of a patient and, on a second side of the backing material, a head portion to which an electrical connector can be attached;

a strip of ionically-conductive adhesive extending, generally parallel to the non-adhesive margin, across the adhesive-coated first side of the backing material and over the electrode plate of the stud; and

a parallel strip of scrim material located at the interface of the ionically-conductive and pressure-sensitive adhesive, wherein the strip of scrim material is displaced, relative to the electrode plate of the stud, towards the non-adhesive margin of the backing material, wherein the edges of both strips nearest to the non-adhesive margin being positioned to one side of the electrode plate, and further wherein the strip of scrim material extends between the pressure-sensitive adhesive and the electrode plate of the stud.

23. A biomedical electrode as claimed in claim 22, in which the width of the strip of ionically-conductive adhesive is such that the adhesive covers the electrode plate of the stud but does not extend substantially beyond the electrode plate at the edge remote from the non-adhesive margin of the backing material.

24. A biomedical electrode as claimed in claim 23, in which the strips of adhesive and scrim material are substantially co-extensive.

25. A biomedical electrode as claimed in claim 24, in which the backing material is substantially rectangular in shape and has the non-adhesive margin along one side, the strips of scrim material and ionically-conductive adhesive extending across the backing material substantially parallel to the non-adhesive margin.

26. A biomedical electrode as claimed in claim 25, in which the scrim material is laminated to the pressure-sensitive adhesive on the backing material.

27. A biomedical electrode as claimed in claim 26, in which the ionically-conductive adhesive is in the form of a pre-cured strip which is laminated to the scrim and backing materials and to the electrode plate.

28. A biomedical electrode as claimed in claim 27, in which the connector stud is a one-piece stud and is located in a pierced hole in the backing material.

29. A biomedical electrode as claimed in claim 28, in which the adhesive-carrying side of the electrode is covered by a removable liner.