X-ray transparent monitoring electrode and method for making

• US 5,265,579 A
• Filed: 09/21/1992
• Issued: 11/30/1993
• Est. Priority Date: 09/21/1992
• Status: Expired due to Term

• Current Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Original Assignee: Ferrari R. Keith
• Inventors: Ferrari, R. Keith
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US07/947,490
• Time in Patent Office: 435 Days
• Field of Search: 128/640, 128/639, 29/825, 29/854
• US Class Current: 600/385
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 2562/17 Comprising radiolucent components
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing
• CPC Class Codes: Y10T 29/49169 Assembling electrical component directly to terminal or elongated conductor

Abstract

A biomedical monitoring electrode assembly including an X-ray translucent multi-element back electrode assembly adapted to be adhesively attached to the body of a patient, and a reference electrode adapted for positioning remote from the back electrode, preferably on the limb of a patient. An X-ray translucent lead wire assembly is attached to the back electrode assembly with two of the leads connected to the two electrodes of the back electrode assembly and another lead extending from the back electrode assembly to the remote reference electrode.

Claims

1. A monitoring electrode comprising:

at least one X-ray transparent sheet electrode member of thin flexible material having upper and lower faces and a thin silver/silver chloride coating on the lower faces, a web member of thin flexible X-ray transparent electrically insulative material having upper and lower faces, the web member having an adhesive coating on the upper face adhered to the lower face of the sheet electrode member, the web member covering only one portion of the lower face of the electrode member, a patch of skin compatible conductive adhesive on a portion of the lower face of the web member and directly contacting a second portion of the lower face of the sheet electrode member, removable carrier sheet means on a lower side of the patch of skin compatible conductive adhesive for covering the latter prior to use, an X-ray transparent electrical lead including a carbon fiber conductor sheathed in an X-ray transparent insulating material, the lead having an unsheathed portion with exposed carbon fibers at one end, X-ray transparent attaching means conductively attaching the carbon fiber conductor at said one end to the upper face of the sheet electrode member, and a cover member of X-ray transparent electrically insulative material having a pressure sensitive adhesive on a lower face thereof adhesively attaching the cover member to the upper face of the sheet electrode member and adhesively engaging the lead adjacent said one end of the lead.

2. A monitoring electrode according to claim 1 wherein said web member has a portion extending outwardly of the periphery of the sheet electrode member and adhered by the adhesive coating on the upper face thereof to the lead adjacent said one end of the lead.

3. A monitoring electrode according to claim 1 wherein said attaching means comprises an electrically conductive X-ray transparent coating on the carbon fibers and means for holding the coated fibers in contact with said upper face of the sheet electrode member.

4. A monitoring electrode according to claim 3 wherein the electrically conductive X-ray transparent coating comprises an ink impregnated with electrically conductive particles.

5. A monitoring electrode according to claim 1 wherein the lead extends from one edge of the monitoring electrode and said cover member has a notch in said one edge thereof at a location where the lead extends from the electrode.

6. A monitoring electrode according to claim 1 wherein said attaching means comprises a piece of double sided pressure sensitive tape having electrical conductivity in the plane of the tape and transverse to the plane of the tape.

7. A monitoring electrode according to claim 1 wherein said attaching means comprises a piece of tape having a conductive fiber matte and a conductive pressure sensitive adhesive coating on opposite sides of the matte, the tape having electrical conductivity in the plane of the tape and transverse to the plane of the tape, the tape being adhered to the upper face of the electrode member and to the carbon fibers at said one end of the lead.

8. A monitoring electrode comprising:

at least one X-ray transparent sheet electrode member of thin flexible material having upper and lower faces and a thin silver/silver chloride coating on one of the faces, a patch of skin compatible conductive adhesive contacting at least a portion of the lower face of the sheet electrode member, removable carrier sheet means on a lower side of the patch of conductive adhesive for covering the latter prior to use, an X-ray transparent electrical lead including a carbon fiber conductor sheathed in an X-ray transparent insulating material, the lead having an unsheathed portion with exposed carbon fibers at one end, X-ray transparent attaching means conductively attaching the carbon fiber conductor at said one end of the lead to the upper face of the sheet electrode member, and a cover member of X-ray transparent electrically insulative material having a pressure sensitive adhesive on a lower face thereof adhesively attaching the cover member to the upper face of the sheet electrode member and adhesively engaging the lead adjacent said one end of the lead, said attaching means comprising a piece of double sided pressure sensitive tape having electrical conductivity in the plane of the tape and transverse to the plane of the tape, the tape being adhered to the upper face of the electrode member and to the exposed carbon fibers at said one end of the lead.

9. A monitoring electrode according to claim 8 wherein said attaching means comprises a piece of tape having a conductive fiber matte and a conductive pressure sensitive adhesive coating on opposite sides of the matte, the tape having electrical conductivity in the plane of the tape and transverse to the plane of the tape.

10. A monitoring electrode according to claim 9 wherein one portion of the tape is directly adhered to the upper face of the electrode member and to said one end of the lead at an underside of the latter, the tape having another portion overlying and adhered to said one portion of the tape and to said lead at a side opposite said underside.

11. A monitoring electrode assembly comprising:

a) a multi-element back electrode including;

i) X-ray transparent first and second sheet electrode members of thin flexible material each having upper and lower faces and a thin silver/silver chloride coating on one of the faces,

ii) an X-ray transparent web member of thin electrically insulative material having upper and lower faces and an adhesive coating on the upper face, the web member having a first portion adhered to the lower face of the first sheet electrode member and a second portion adhered to the lower face of the second electrode member and a central portion intermediate the first and second electrode members, the web member covering only one portion of the lower face of the first sheet electrode member and covering only one portion of the lower face of the second sheet electrode member,

iii) a first layer of skin compatible conductive adhesive on the lower face of the first portion of the web member and directly contacting a second portion of the lower face of the first sheet electrode member, a second layer of skin compatible conductive adhesive on the lower face of the second portion of the web member and directly contacting a second portion of the lower face of the second sheet electrode member;

b) X-ray transparent first and second electrical leads each including a carbon fiber conductor sheathed in an electrically insulative material, the first and second electrical leads having electrical connector means at a first end thereof for making connection to a monitoring instrument, the first and second leads each having an intermediate section overlying the central portion of the web member and adhered to the adhesive coating on the upper face of the web member, first X-ray transparent attaching means conductively attaching the carbon fiber conductor at a second end of the first lead to the upper face of the first sheet electrode member, second X-ray transparent attaching means conductively attaching the carbon fiber conductor at a second end of the second lead to the upper face of the second sheet electrode member;

c) a cover member of X-ray transparent electrically insulative material having an adhesive coating on a lower face thereof overlying and adhered to the upper faces of the first and second sheet electrode members; and

d) removable carrier sheet means on a lower side of the first and second layers of skin compatible conductive adhesive for covering the latter prior to use.

12. A monitoring electrode assembly according to claim 11 wherein said first and second X-ray transparent attaching means each include an electrically conductive coating on the carbon fibers and means for holding the coated fibers in contact with the upper face of the respective first and second electrode members.

13. A monitoring electrode according to claim 11 wherein each of said attaching means comprises a piece of tape having a conductive fiber matte and a conductive pressure sensitive adhesive coating on opposite sides of the matte, the tape having electrical conductivity in the plane of the tape and transverse to that plane.

14. A monitoring electrode assembly comprising:

a) a multi-element back electrode including;

i) an X-ray transparent cover member of thin flexible electrically insulative material having upper and lower faces, the cover member having first and second electrode zones and a central zone intermediate the first and second electrode zone;

ii) X-ray transparent first and second sheet electrode members of thin flexible material each having upper and lower faces and a thin silver/silver chloride coating on one of the faces, the first and second electrode members being adhesively attached to the cover member respectively in said first and second electrode zones;

iii) first and second layers of skin compatible conductive adhesive respectively contacting at least a portion of the lower face of the first and second sheet electrode members;

b) a reference electrode adapted for positioning remote from the back electrode, the reference electrode including;

i) a reference electrode member,

ii) a third layer of skin compatible conductive adhesive contacting a lower side of the reference electrode member;

c) X-ray transparent first, second and third electrical leads each including a carbon fiber conductor sheathed in an electrically insulative material, the first, second and third leads having electrical connector means on a first end thereof for making connection to an instrument and a first lead section extending from the connector means to the central zone of the cover member, the first, second and third leads having an intermediate section adhesively attached to the cover member, first X-ray transparent attaching means conductively attaching the carbon fiber conductor at a second end of the first lead to the first sheet electrode member, second X-ray transparent attaching means conductively attaching the carbon fiber conductor at a second end of the second lead to the second sheet electrode member, the third lead having a length substantially longer than the first and second leads to extend a substantial distance beyond the back electrode, and third means conductively attaching the carbon fiber conductor at a second end of the third lead to the reference electrode member; and

d) removable release sheet means on a lower side of each of the first, second and third layers of skin compatible conductive adhesive for covering the latter prior to use.

15. A monitoring electrode according to claim 14 wherein each of said attaching means comprises a piece of tape having a conductive fiber matte and a conductive pressure sensitive adhesive coating on opposite sides of the matte, the tape having electrical conductivity in the plane of the tape and transverse to that plane.

16. A monitoring electrode assembly comprising:

a) a multi-element back plate electrode including;

i) x-ray translucent flexible first and second sheet electrode members of thin material each having an upper face and a lower face and a thin silver/silver chloride coating on one of the faces,

ii) an x-ray transparent web member of thin flexible electrically insulative material having upper and lower faces and an adhesive coating on the upper face, the web member having a first portion adhered to the lower face of the first sheet electrode member and a second portion adhered to the lower face of the second sheet electrode member and a central portion intermediate the first and second electrode members, the web member covering only one portion of the lower face of the first sheet electrode member and covering only one portion of the lower face of the second sheet electrode member,

iii) a first layer of skin compatible conductive adhesive on the lower face of the first portion of the web member and directly contacting a second portion of the lower face of the first sheet electrode member and a second layer of skin compatible conductive adhesive on the lower face of the second portion of the web member and directly contacting a second portion of the lower face of the second sheet electrode member;

b) a reference electrode adapted for positioning remote from the back electrode and including;

i) a reference electrode member;

ii) a third layer of skin compatible conductive adhesive on a lower side of the reference electrode member for connecting the reference electrode member to the skin of a patient;

c) x-ray transparent first and second and third electrical leads each including a carbon fiber conductor sheathed in an electrically insulative material, the first, second and third electrical leads having electrical connectors at a first end thereof and an intermediate section adhesively attached to the web member, first x-ray transparent attaching means conductively attaching the carbon fiber conductor at a second end of the first lead to the upper face of the first sheet electrode member, second x-ray transparent attaching means conductively attaching the carbon fiber conductor at a second end of the second lead to the upper face of the second sheet electrode member, the third lead having a length substantially longer than the first and second leads to extend a substantial distance from the back electrode, and means conductively attaching the carbon fiber conductor at a second end of the third lead to the reference electrode member;

d) an x-ray transparent cover member of electrically insulative material having an adhesive coating on a lower face thereof overlying and adhered to the upper faces of the first and second sheet electrode members and to said intermediate sections of the first, second and third leads, and

e) removable carrier sheet means on a lower side of each of the first, second and third layers of skin compatible conductive adhesive for covering the latter prior to use.

17. A monitoring electrode assembly according to claim 16 wherein the back plate electrode has a pair of opposing long side edges and a pair of opposing short side edges, the central portion of the web member being substantially mid-way between the short side edges, the first, second and third leads extending from the central portion of the web member at one long side edge of the back plate electrode to the electrical connectors and the third lead extending from the central portion of the web member at the other long edge of the back plate electrode to the reference electrode.

18. A monitoring electrode assembly according to claim 17 including notches in the edges of the cover member at locations where the leads extend from the back plate electrode.

19. A monitoring electrode assembly according to claim 16 wherein said intermediate portions of said first, second and third leads are adhesively attached to the web member at said central portion.

20. A monitoring electrode assembly according to claim 16 wherein said first and second sheet electrode members are imperforate sheets of carbon filled polymer and each of said attaching means comprises an electrically conductive X-ray transparent coating on the carbon fibers.

21. A monitoring electrode assembly according to claim 16 wherein said first and second electrode members are fine mesh screens.

22. A monitoring electrode assembly according to claim 16 wherein the reference electrode comprises a X-ray transparent third sheet electrode member of thin flexible material having upper and lower faces, a second web member of thin flexible X-ray transparent electrically insulative material having upper and lower faces, the second web member having an adhesive coating on the upper face adhered to the lower face of the third sheet electrode member and covering only one portion of the lower face of the third sheet electrode member, and said third layer of skin compatible conductive adhesive on the lower face of the second web member directly contacting a second portion of the lower face of the third sheet electrode member.

23. A monitoring electrode according to claim 16 wherein each of said attaching means comprises a piece of tape having a conductive matte and a conductive pressure sensitive adhesive coating on opposite sides of the matte, the tape having electrical conductivity in the plane of the tape and transverse to the plane of the tape.

24. The method of forming an X-ray transparent monitoring electrode comprising:

a) providing an X-ray transparent sheet electrode member of thin flexible material having upper and lower faces with a skin compatible adhesive contacting at least a portion of the lower face,

b) providing an X-ray transparent electrical lead having a carbon fiber conductor sheathed in an X-ray transparent insulating material and with the sheath removed from one end of the lead; and

c) adhesively attaching the carbon fiber conductor at said one end of the lead to the upper face of the electrode member with a piece of double sided pressure sensitive tape having a conductive graphite fiber matte and a conductive pressure sensitive adhesive on opposite sides of the matte providing conductivity in the plane of the tape and transverse to the plane of the tape.

25. The method of claim 24 including applying the tape so that one portion of the tape is directly adhered to the upper face of the electrode member and is adhered to said one end of the lead at an underside of the latter and another portion of the tape is adhered to said one portion of the tape and to said lead at a side opposite said underside.

26. An X-ray transparent monitoring electrode comprising, an X-ray transparent sheet electrode member of thin flexible material having upper and lower faces, a skin compatible conductive adhesive contacting at least a portion of the lower face of the sheet electrode member, an X-ray transparent electrical lead having a carbon fiber conductor sheathed in an X-ray transparent insulating material, the lead having an unsheathed portion with exposed carbon fiber conductors at one end, and a piece of double sided pressure sensitive tape having a conductive graphite fiber matte and a conductive pressure sensitive adhesive on opposite sides of the matte providing electrical conductivity in the plane of the tape and transverse to the plane of the tape, the tape being adhered to the upper face of the electrode member and to the exposed carbon fibers at said one end of the lead.

27. A monitoring electrode according to claim 26 wherein one portion of the tape is directly adhered to the upper face of the electrode member and to said one end of the lead at an underside of the latter, the tape having another portion overlying and adhered to said one portion of the tape and to said lead at a side opposite said underside.