Claims Analysis
Total Claims: 21
Claim 1
Independent Claim
314 words
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.
Claim 2
Dependent Claim
314 words
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.
Claim 3
Dependent Claim
100 words
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.
Claim 4
Dependent Claim
44 words
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).
Claim 5
Dependent Claim
38 words
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).
Claim 6
Dependent Claim
92 words
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.
Claim 7
Dependent Claim
45 words
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).
Claim 8
Dependent Claim
42 words
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.
Claim 9
Dependent Claim
14 words
Electrode according to claim 5, wherein said frangible membrane (102) comprises polypropylene film material.
Claim 10
Dependent Claim
33 words
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.
Claim 11
Dependent Claim
26 words
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.
Claim 12
Dependent Claim
25 words
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.
Claim 13
Dependent Claim
50 words
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.
Claim 14
Dependent Claim
94 words
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.
Claim 15
Dependent Claim
19 words
Electrode according to claim 13, further including breathing openings (110) extending through said flange and said adhesive means (94).
Claim 16
Independent Claim
362 words
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.
Claim 17
Independent Claim
362 words
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.
Claim 18
Dependent Claim
18 words
Method according to claim 15, wherein a surfactant (170) is retained within said first chamber portion (166, 166a).
Claim 19
Dependent Claim
29 words
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.
Claim 20
Dependent Claim
68 words
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.
Claim 21
Dependent Claim
76 words
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.