Long-life biomedical application device, particularly electrode, and method of transferring electrical current

• US 4,526,176 A
• Filed: 12/22/1981
• Issued: 07/02/1985
• Est. Priority Date: 12/22/1981
• Status: Expired due to Term

• Current Assignee: Bio-Signal Partners
• Original Assignee: Frantz Medical Development Ltd. (Frantz Medical Group)
• Inventors: Bremer, Roger E., Anthony, Charles Jr., Chappel, Raymond M.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US06/333,287
• Time in Patent Office: 1,288 Days
• Field of Search: 128/639-641, 128/644, 128/798, 128/802, 128/803, 128/403, 604/20, 604/306
• US Class Current: 600/392
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 2562/0217 Electrolyte containing
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor

Abstract

To separate electrolyte (70) within a chamber (66) formed beneath a dome-like housing (24) from a signal transmission connector (34) and thus prevent corrosion of the terminal portion (38, 40) exposed to the interior of the chamber by the electrolyte, the interior of the chamber (66) is subdivided into two chambers (166, 266) by enclosing within said chamber a plastic bag (101) or stretching a membrane (102) thereacross, the subdividing means (101, 102) being ruptured upon depression of the contact terminal (34) of the housing; the electrolyte is retained solely within the chamber (266, 266a) separate from the interior portion (38, 40) of the terminal so that the corrosive influence of the electrolyte is prevented from attacking the metal of the terminal prior to use of the electrode, and during storage. Preferably, the chamber (166, 166a) to which also the terminal is exposed may retain other liquids which are inert with respect to the electrode, and which, preferably, are also separated from the electrolyte, such as a surfactant ( 170) to, additionally, permit a wider choice of, respectively, electrolytes and surfactants without unintended leakage of electrolyte through the microporous membrane (76)closing off the housing.

Claims

1. Long storage life multiple purpose biomedical electrode

for use on a subject for transferring electrical current between an external circuit and a body surface of the subject having

a generally inverted dish or cup-shaped housing (24) of a deformable material, and defining a chamber (66) therein, said housing including a roof (30), and a base (56) and being formed with an opening at the base:

a hydrophobic microporous, inducible fluid-permeable membrane (76) secured to said housing at the base, said membrane covering the opening in said housing and closing the chamber (66);

a peelable, releasable fluid-impervious protective cover film (90) overlying said membrane;

a liquid-compatible, pressure-sensitive adhesive means (94) securing said releasable cover film (90) to said base (56),

said protective film being selectively removable to expose said membrane and permit attachment of said electrode to a body surface;

electrically conductive terminal means (34) sealed to and extending through said roof of said housing and providing electrically conductive communication between the exterior of said housing of said electrode and said chamber (66);

and comprising, in accordance with the invention,

means (101,

     102) for subdividing said chamber into a first chamber portion (166, 166a) and a second chamber portion (266, 266a),

the terminal means (34) having an exposed electrically conductive portion (38,

     40) in said first chamber portion (166, 166a),

said subdividing means (101,

     102) being of frangible material subject to rupture upon deformation and displacement of a wall of the housing;

tissue-compatible electrolyte means (70) for conducting electrical current, substantially filling said second chamber portion (266, 266a), said electrolyte means being separated from said exposed electrically conductive portion (38,

     40) of the terminal means (34) prior to rupture of the subdividing means, and

wherein the first chamber portion (166, 166a) retains therein at least one material selected from the group consisting of a surfactant, a skin penetrant, a sweat-inducing agent, and an antibacterial agent.

2. Electrode according to claim 1, wherein the first chamber portion (166, 166a) retains therein a surfactant to reduce surface tension at an interface of said electrolyte means (70) and said microporous membrane (76), said surfactant and said electrolyte means mixing upon rupture of said subdividing means to facilitate passage of said electrolyte means (70) through said microporous membrane at the viscosity of the electrolyte means (70) and enhancing effective wetting of the body surface at the zone of securement of said electrode thereto after deformation of the housing (24) and upon use of the electrode upon application to a subject.

3. Electrode according to claim 1, wherein said subdividing means comprises a separate frangible plastic bag (101) located within the chamber (66) and subdividing said chamber into said two chamber portions (166, 266), the volume within said bag (101) forming said second chamber portion (266).

4. Electrode according to claim 1, wherein said subdividing means comprises a frangible separating membrane (102), impervious to the electrolyte means in the second chamber portion (266a) and subdividing said chamber (66) into said two chamber portions (166a, 266a).

5. Electrode according to claim 1, wherein the housing has a dome-shaped roof;

the subdividing means comprises a frangible separating membrane extending across the housing;

and a ring-like transformation zone (100) is provided, circumscribing said housing at a height intermediate upper and lower limits thereof, said transformation zone extending in a plane generally parallel to said fluid-permeable membrane (76) and forming a mechanical discontinuity of the wall of said housing, said dome-shaped roof of said housing being displaceable downwardly in response to pressure applied thereto to deform said housing at said transformation zone.

6. Electrode according to claim 5, further including an ultrasonically produced ring seal (82) securing said microporous membrane (76) to the housing (24);

and an ultrasonically produced attachment weld securing said frangible membrane (102) to the housing in the region of said ring-like transformation zone (100).

7. Electrode according to claim 5, wherein said frangible membrane (102) comprises a material sealable to the housing, and secured to the housing in the region of said ring-like transformation zone (100), and break or score lines (103) are formed on the membrane.

8. Electrode according to claim 5, wherein said frangible membrane (102) comprises polypropylene film material.

9. Electrode according to claim 5, wherein said frangible membrane (102) comprises a polypropylene film material and a filler of the material of the group consisting of glass, fiber, mica, talc and mineral filler.

10. Electrode according to claim 1, wherein said terminal means (34) includes silver, and wherein silver chloride is located in at least one of said chamber portions.

11. Electrode according to claim 1, wherein the housing includes a vaulted, dome-shaped structure and the subdividing means comprises a membrane (102) extending across the structure.

12. Electrode according to claim 1, further including rupturing or penetrating projections (138) on the electrically conductive terminal means (34) extending and projecting inwardly in the direction towards said subdividing means (101, 102) to facilitate rupture of the subdividing means upon deformation of said housing consequent to application of pressure thereto.

13. Electrode according to claim 1, further including a laterally extending annular flange (28) extending outwardly from the base of the housing, said protective film extending over said flange, and said pressure sensitive adhesive means (94) being releasably secured over said flange and said membrane, and forming a unitary element,

to permit stripping off of said pressure sensitive adhesive means to adhesively attach the electrode to the surface of the subject with the flange holding the electrode in place, and the microporous membrane (76) being exposed and in contact with the surface of the subject.

14. Electrode according to claim 13, further including breathing openings (110) extending through said flange and said adhesive means (94).

15. A method of transferring electrical current flow between an electrically conductive terminal (34) and a body surface of a subject, said method including

providing a biomedical electrode having

an assembly of

a generally cup-shaped housing (24) of a flexible material including a vaulted, downwardly open dish or cup-like structure, with

an electrically conductive terminal (34) being sealed in and extending through said housing;

a microporous membrane (76) sealed to and extending across said housing at a base thereof,

said membrane closing off said downwardly open structure and defining therein a chamber (66);

subdividing mean (101,

     102) subdividing said chamber (66) into a first chamber portion (166, 166a) and a second chamber portion (266, 266a), said subdividing means being of frangible plastic material subject to rupture, the terminal extending into the first chamber portion (166, 166a);

wherein the second chamber portion (266, 266a) is substantially filled by a tissue-compatible electrolyte means (70) the subdividing means (101,

     102) separating the electrolyte means (70) and the terminal (34), and

wherein the first chamber portion (166, 166a) retains therein at least one material selected from the group consisting of a surfactant, a skin penetrant, a sweat-inducing agent and an antibacterial agent,

and comprising the steps of

firmly pressing said electrode assembly into positive contact with the body surface and securing said membrane in contact with the body surface;

deforming the walls of said housing to physically transform the shape of the housing to assume a different profile with a resulting change of configuration,

said step of deforming the walls of said housing including rupturing or breaking the subdividing means to release the electrolyte means from said second chamber portion (266, 266a) into said chamber (66) and to establish thereby mechanical contact, and electrically conductive connection between said electrolyte means and the terminal (34), after rupture, and to mix said at least one of the materials in the first chamber portion and the electrolyte means upon rupture or breakage of said subdividing means

and to provide for pressure upon said electrolyte means and urge the electrolyte means through said microporous membrane (76) to establish effective minimal resistance direct electrical contact between the body surface and the terminal.

16. Method according to claim 15, wherein

a surfactant (170) is retained within said first chamber portion (166, 166a).

17. Method according to claim 15, wherein the housing has a vaulted, dome-shaped roof;

and the step of deforming the housing comprises pressing down on the roof of the housing.

18. Methods according to claim 15, wherein the step of deformation of the housing (24) is carried out with sufficient force to cause pressure on the electrolyte means to seek out and penetrate skin pores, hair follicles, and in combination with the substances in the chamber assist the electrolyte means to penetrate sebum, oil and dead skin to achieve optimum electrical conduction with minimal or no prior skin abrasion.

19. Method according to claim 15, wherein the step of deformation of the housing is carried out over an extended time period to induce a continued pressure over the expected period of use, which together with the control over evaporation of the electrolyte means assures more uniform performance over the period of use with much less susceptability to drying out compared to pre-gelled sponge electrodes and thereby assuring more uniformity of signals and less need for replacement.