EP0127958A2
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Sensor electrode systems
Assignee: Medisense Inc
•
Filing: 1984-05-08
•
Granted: —
•
Expires: 2004-05-08
Abstract
Abstract This specification discloses sensor electrodes, and their combination with reference electrodes; the manufacture of such electrodes; apparatus utilising such electrodes; and electrical circuitry into which such electrodes can be incorporated, specifically the establishment of certain design criteria in the production of such electrodes for lay, or clinic, use. The electrodes can be used in an invasive probe (i.e. one which enters body tissue to contact a bodyfluid such as whole blood or subcutaneous tissue fluid) or as part of an external test upon a withdrawn sample (using a syringe) or upon an expressed sample (e.g. using a needle-prick device). In the specification claims, sensor means for selective detection, measurement or monitoring of a given dissolved substrate in a mixture of dissolved substrates, comprising:- (a) an area 4 of first electrode material comprising an enzyme catalytic of the said substrate and a mediator compound to transfer charge to the electrode when the enzyme is catalytically active, adjacent to but non-contiguous with; (b) an area 5 of reference electrode material; both electrodes being of small dimension, and extending as or supported on an elongate member to facilitate manipulation before or during contact with live tissue or a small withdrawn sample of body fluid.
Inventors
- 👤 Irving John Higgins
- 👤 James Michael Mccann
- 👤 Graham Davis
- 👤 Hugh Allen Oliver Hill
- 👤 Ron Zwanziger
- 👤 Bernhard Ludwig Treidl
- 👤 Nigel Norman Birket
- 👤 Elliot Verne Plotkin
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-31 11:39
CPC Classifications
A; A61; A61B; A61B5/00; A61B5/145; A61B5/1468; A61B5/1486; A61B5/14865; A61B5/68; A61B5/6846; A61B5/6847; A61B5/6848; C; C12; C12Q; C12Q1/00; C12Q1/001; C12Q1/004
Claims Analysis
Total Claims: 50
Claim 1
Independent Claim
96 words
Sensor means for selective detection, measurement or monitoring of a given dissolved substrate in a mixture of dissolved substrates, comprising:- (a) an area of first electrode material comprising an enzyme catalytic of the said substrate and a mediator compound to transfer charge to the electrode when the enzyme is catalytically active, adjacent to but non-contiguous with; (b) an area of reference electrode material; both electrodes being of small dimension, and extending as or supported on an elongate member to facilitate manipulation before or during contact with live tissue or a small withdrawn sample of body fluid.
Claim 2
Dependent Claim
96 words
Sensor means for selective detection, measurement or monitoring of a given dissolved substrate in a mixture of dissolved substrates, comprising:- (a) an area of first electrode material comprising an enzyme catalytic of the said substrate and a mediator compound to transfer charge to the electrode when the enzyme is catalytically active, adjacent to but non-contiguous with; (b) an area of reference electrode material; both electrodes being of small dimension, and extending as or supported on an elongate member to facilitate manipulation before or during contact with live tissue or a small withdrawn sample of body fluid.
Claim 3
Dependent Claim
56 words
Sensor means as claimed in claim 1 in which the area of first electrode material comprises (a) a ligand such as an antibody (b) an antiligand, such as a hapten, with specific binding properties thereto (c) the mediator, conjugated to either (a) or (b) and electrochemically active only when (a) and (b) are not specifically bound.
Claim 4
Dependent Claim
158 words
A sensor for contact with a liquid mixture of components for detecting the presence of, measuring the amount of and/or monitoring the level of one or more selected components capable of undergoing an enzyme catalysed reaction, the sensor comprising:- (a) an elongate support member, (b) on a surface thereof towards one end an expanse of a first electrode of electrically conductive material comprising at least at an outer surface thereof the combination of an enzyme and a mediator compound which transfers electrons to the first electrode when the enzyme is catalytically active, (c) on a surface of the elongate support member and also towards the said end thereof an expanse of a second, reference, electrode, and (d) separate electrical connection to each electrode for attachment to a read-out means denoting presence, amount, or monitored level of the said one or more selected components in a liquid medium into which the support member is dipped to contact both electrodes.
Claim 5
Dependent Claim
158 words
A sensor for contact with a liquid mixture of components for detecting the presence of, measuring the amount of and/or monitoring the level of one or more selected components capable of undergoing an enzyme catalysed reaction, the sensor comprising:- (a) an elongate support member, (b) on a surface thereof towards one end an expanse of a first electrode of electrically conductive material comprising at least at an outer surface thereof the combination of an enzyme and a mediator compound which transfers electrons to the first electrode when the enzyme is catalytically active, (c) on a surface of the elongate support member and also towards the said end thereof an expanse of a second, reference, electrode, and (d) separate electrical connection to each electrode for attachment to a read-out means denoting presence, amount, or monitored level of the said one or more selected components in a liquid medium into which the support member is dipped to contact both electrodes.
Claim 6
Dependent Claim
105 words
A sensor means comprising (a) a flat first electrode area of known area small enough to be completely coverable by the smear of blood produced from a non-expressed drop of blood generated from a needle-prick at a bodily extremity, (b) a reference electrode area on the same surface separate from but sufficiently close to the sensitive electrode area that the said blood smear also reaches the reference electrode to establish electrical communication and (c) separate conductive elements extending along the same surface of the elongate support member, communicating one with each electrode for connection to signal read-out means attachable to one end of the member.
Claim 7
Dependent Claim
105 words
A sensor means comprising (a) a flat first electrode area of known area small enough to be completely coverable by the smear of blood produced from a non-expressed drop of blood generated from a needle-prick at a bodily extremity, (b) a reference electrode area on the same surface separate from but sufficiently close to the sensitive electrode area that the said blood smear also reaches the reference electrode to establish electrical communication and (c) separate conductive elements extending along the same surface of the elongate support member, communicating one with each electrode for connection to signal read-out means attachable to one end of the member.
Claim 8
Dependent Claim
14 words
A sensor as claimed in claim 4 in which the first area is square.
Claim 9
Dependent Claim
18 words
A sensor as claimed in claim 4 in which the first area is less than 25 sq. mm.
Claim 10
Dependent Claim
149 words
A needle probe electrode carrier for placement through tissue into a measurement location such as a blood vessel, in the form of a generally cylindrical pointed needle having formed therein near the pointed end two flat depressions spaced apart longitudinally, each depression with a floor at right angles to the needle radius and each with a protective shoulder at each end of that floor: wherein the floor of one such depression is coated with an adherent layer comprising an enzyme and a mediator compound to transfer charge from the enzyme when it is contacted with its specific substrate and hence catalytically active; the floor of the other such depression is coated with an adherent reference electrode layer; and separate conductive elements are provided along the surface of the needle, communicating one with each electrode layer, for connection to signal readout means attachable at the outer end of the needle.
Claim 11
Dependent Claim
149 words
A needle probe electrode carrier for placement through tissue into a measurement location such as a blood vessel, in the form of a generally cylindrical pointed needle having formed therein near the pointed end two flat depressions spaced apart longitudinally, each depression with a floor at right angles to the needle radius and each with a protective shoulder at each end of that floor: wherein the floor of one such depression is coated with an adherent layer comprising an enzyme and a mediator compound to transfer charge from the enzyme when it is contacted with its specific substrate and hence catalytically active; the floor of the other such depression is coated with an adherent reference electrode layer; and separate conductive elements are provided along the surface of the needle, communicating one with each electrode layer, for connection to signal readout means attachable at the outer end of the needle.
Claim 12
Dependent Claim
80 words
A sensor for selective detection, determination or monitoring of a given dissolved substrate in a mixture of dissolved substrates, of the type in which an electrode is provided with an enzyme catalytic of said substrate and with a mediator compound to transfer charge to the electrode to provide a read-out signal against a reference electrode: wherein the reference electrode is a metallic needle surrounding, insulated from, and made of or coated with suitable reference electrode material to, the sensitive electrode.
Claim 13
Dependent Claim
80 words
A sensor for selective detection, determination or monitoring of a given dissolved substrate in a mixture of dissolved substrates, of the type in which an electrode is provided with an enzyme catalytic of said substrate and with a mediator compound to transfer charge to the electrode to provide a read-out signal against a reference electrode: wherein the reference electrode is a metallic needle surrounding, insulated from, and made of or coated with suitable reference electrode material to, the sensitive electrode.
Claim 14
Dependent Claim
18 words
A sensor as claimed in claim 8 in which the electrode and the needle are relatively longitudinally movable.
Claim 15
Dependent Claim
24 words
A sensor as claimed in claim 8 in which the sensitive electrode is carbon fibre carrying a coating including the said enzyme and mediator.
Claim 16
Dependent Claim
22 words
ll. A sensor as claimed in claim 8, 9 or 10 in which the reference electrode material is silver, gold, or silver/palladium.
Claim 17
Dependent Claim
76 words
A sensor for selective detection, determination or monitoring of a given dissolved substrate in a mixture of dissolved substrates, of the type in which an electrode is provided with an enzyme catalytic of said substrate and with a mediator compound to transfer charge to the electrode to provide a read-out signal against a reference electrode: wherein the sensitive electrode and the reference electrode are located on opposite faces of an elongate non-conductive support of rectangular cross-section.
Claim 18
Dependent Claim
76 words
A sensor for selective detection, determination or monitoring of a given dissolved substrate in a mixture of dissolved substrates, of the type in which an electrode is provided with an enzyme catalytic of said substrate and with a mediator compound to transfer charge to the electrode to provide a read-out signal against a reference electrode: wherein the sensitive electrode and the reference electrode are located on opposite faces of an elongate non-conductive support of rectangular cross-section.
Claim 19
Dependent Claim
21 words
A sensor as claimed in claim 12 in which the support has a square cross-section of less than 0.5 mm square.
Claim 20
Dependent Claim
17 words
14 The combination of a hollow needle and the sensor as claimed in claim 13 located therein.
Claim 21
Dependent Claim
35 words
A method of fabricating sensors as claimed in claim 13 in which the sensitive electrodes and the reference electrode are separately fabricated on separable supports and these supports are finally united to provide a sensor.
Claim 22
Dependent Claim
71 words
A two-part cell assembly each part containing a elongate recess accommodating one elongate electrode, the first electrode comprising an enzyme and charge-transferring mediator on a conductive support and the second electrode being a reference electrode: the said parts, when assembled with the recesses opposed, defining a throughflow liquid channel between the thereby located and spaced electrodes, whereby the combination is sensitive to the substrate of the enzyme passing through the channel
Claim 23
Dependent Claim
71 words
A two-part cell assembly each part containing a elongate recess accommodating one elongate electrode, the first electrode comprising an enzyme and charge-transferring mediator on a conductive support and the second electrode being a reference electrode: the said parts, when assembled with the recesses opposed, defining a throughflow liquid channel between the thereby located and spaced electrodes, whereby the combination is sensitive to the substrate of the enzyme passing through the channel
Claim 24
Dependent Claim
101 words
An assembly of circuitry and display means for use in producing a readout value as a diagnostic aid in medicine, and comprising: (a) a pen-like hollow elongate outer housing; (b) an electrically conductive socket at one end of said housing, suitable to receive the outer end of at least one detachable test member capable when contacted with a physiological test liquid of producing an electrical signal correlating with a physiological parameter to which the test member is selectively sensitive and, (c) a digital read-out window towards the other end of said housing for exhibiting a numerical value corresponding to the parameter.
Claim 25
Dependent Claim
101 words
An assembly of circuitry and display means for use in producing a readout value as a diagnostic aid in medicine, and comprising: (a) a pen-like hollow elongate outer housing; (b) an electrically conductive socket at one end of said housing, suitable to receive the outer end of at least one detachable test member capable when contacted with a physiological test liquid of producing an electrical signal correlating with a physiological parameter to which the test member is selectively sensitive and, (c) a digital read-out window towards the other end of said housing for exhibiting a numerical value corresponding to the parameter.
Claim 26
Dependent Claim
24 words
An assembly as claimed in claim 1 from 12 to 20 centimetres long and from 0.8 to 1.5 centimetres across its maximum transverse dimension.
Claim 27
Dependent Claim
19 words
An assembly as claimed in claim 1 in further combination with an invasive needle probe as the test member.
Claim 28
Dependent Claim
25 words
An assembly as claimed in claim 1 in further combination with a flat strip electrode as an external non-invasive test member for a blood droplet.
Claim 29
Dependent Claim
166 words
The operative combination of (I) an assembly of circuitry and display means for use in producing a readout value of blood glucose level as a diagnostic acid in treatment or control of diabetes, comprising: (a) a pen-like hollow elongate housing; (b) an electrically conductive socket one end of said housing suitable to receive a detachable strip electrode carrier, and (c) a digital readout window towards the other end of said housing connected to said socket for exhibiting a numerical value corresponding to the said glucose level and (II) a strip test electrode carrier held at one end in said socket, carrying (a) a flat electrode of area not greater than 25 sq. mm and comprising a glucose catalytic enzyme and a metallocene mediator whereby it is sensitive to blood glucose levels, (b) a reference electrode area non-contiguous with but closely adjacent to the said sensitive electrode area and (c) separate conductive elements extending along the strip communicating one with each electrode for connection to the socket.
Claim 30
Dependent Claim
166 words
The operative combination of (I) an assembly of circuitry and display means for use in producing a readout value of blood glucose level as a diagnostic acid in treatment or control of diabetes, comprising: (a) a pen-like hollow elongate housing; (b) an electrically conductive socket one end of said housing suitable to receive a detachable strip electrode carrier, and (c) a digital readout window towards the other end of said housing connected to said socket for exhibiting a numerical value corresponding to the said glucose level and (II) a strip test electrode carrier held at one end in said socket, carrying (a) a flat electrode of area not greater than 25 sq. mm and comprising a glucose catalytic enzyme and a metallocene mediator whereby it is sensitive to blood glucose levels, (b) a reference electrode area non-contiguous with but closely adjacent to the said sensitive electrode area and (c) separate conductive elements extending along the strip communicating one with each electrode for connection to the socket.
Claim 31
Dependent Claim
208 words
Analytical equipment for detecting the presence of, measuring the amount of and/or monitoring the level of one or more selected components of a liquid mixture, comprising: a cell the parts of which on assembly jointly define a low-volume liquid chamber, at least one of the said cell parts being provided with liquid inlet and outlet ports communicating with the said defined chamber when the parts are assembled; a selectively operable pump for causing the liquid mixture to flow into the inlet means and out of the outlet means either continuously or intermittently; a first electrode in the form of a thin expanse of conductive material and comprising at least at an external surface thereof the combination of an enzyme and a mediator compound which transfers electrons to the electrode when the enzyme is catalytically active. a second, reference, electrode also in the form of a thin expanse of conductive material; each said electrode presenting an operative surface within said defined low-volume liquid chamber; a potentiostat for poising a predetermined voltage difference between the electrodes; means for detecting or measuring current flow between the electrodes when a liquid sample is introduced into the chamber; and signal storage and/or readout means operatively connected to the means for measuring current flow.
Claim 32
Dependent Claim
208 words
Analytical equipment for detecting the presence of, measuring the amount of and/or monitoring the level of one or more selected components of a liquid mixture, comprising: a cell the parts of which on assembly jointly define a low-volume liquid chamber, at least one of the said cell parts being provided with liquid inlet and outlet ports communicating with the said defined chamber when the parts are assembled; a selectively operable pump for causing the liquid mixture to flow into the inlet means and out of the outlet means either continuously or intermittently; a first electrode in the form of a thin expanse of conductive material and comprising at least at an external surface thereof the combination of an enzyme and a mediator compound which transfers electrons to the electrode when the enzyme is catalytically active. a second, reference, electrode also in the form of a thin expanse of conductive material; each said electrode presenting an operative surface within said defined low-volume liquid chamber; a potentiostat for poising a predetermined voltage difference between the electrodes; means for detecting or measuring current flow between the electrodes when a liquid sample is introduced into the chamber; and signal storage and/or readout means operatively connected to the means for measuring current flow.
Claim 33
Dependent Claim
37 words
A measuring device for use with an electron-transfer electrode, comprising means for comparing an electrical output of the electrode with an electronic reference and means for providing a signal related to the electrical output of the electrode.
Claim 34
Dependent Claim
37 words
A measuring device for use with an electron-transfer electrode, comprising means for comparing an electrical output of the electrode with an electronic reference and means for providing a signal related to the electrical output of the electrode.
Claim 35
Dependent Claim
33 words
A measuring device as claimed in claim 23 in which the electron-transfer electrode is poised at a fixed potential against a reference electrode, and the current flowing in the electron-transfer electrode is measured.
Claim 36
Dependent Claim
26 words
A sensor as claimed in any one of claims 1, 2, 3, 4,7, 12, 16 and 22 in which the reference electrode is an Ag/AgCl electrode.
Claim 37
Dependent Claim
26 words
A sensor as claimed in any one of claims 1, 2, 3, 4, 7,8, 10, 12,16, and 22 in which the enzyme is a glucose enzyme.
Claim 38
Dependent Claim
27 words
A sensor as claimed in any one of claims 1, 2, 3, 4, 7, 8, 10, 12, 16 and 22 in which the mediator is a ferrocene.
Claim 39
Dependent Claim
26 words
A sensor as claimed in any one of claims 1, 2, 3, 4, 7, 8,10, 12, 16 and 22 in which the mediator is 1,1 -dimethylferrocene.
Claim 40
Dependent Claim
64 words
A sensor as claimed in any one claims 3, 4, 7, 8, 10, 12, 16 and 22 in which the first electrode material comprises (a) a ligand such as an antibody (b) an antiligand, such as a hapten, with specific binding properties thereto (c) the mediator, conjugated to either (a) or (b) and electrochemically active only when (a) and (b) are not specifically bound.
Claim 41
Dependent Claim
57 words
A suspension in a liquid medium of carbon together with at least one of (a) an enzyme and (b) a mediator compound capable of transferring charge to the aid carbon from the enzyme when the enzyme is catalytically active, the said suspension being formed as a printable and conductive ink for use in the fabrication of electrodes.
Claim 42
Dependent Claim
57 words
A suspension in a liquid medium of carbon together with at least one of (a) an enzyme and (b) a mediator compound capable of transferring charge to the aid carbon from the enzyme when the enzyme is catalytically active, the said suspension being formed as a printable and conductive ink for use in the fabrication of electrodes.
Claim 43
Dependent Claim
17 words
A suspension as claimed in claim 30 in which both the enzyme and the mediator are present.
Claim 44
Dependent Claim
19 words
A suspension as claimed in claim 30 in which the enzyme is glucose oxidase and the mediator is ferrocene.
Claim 45
Dependent Claim
14 words
A suspension as claimed in claim 30, 31 or 32 comprising a mediator/hapten conjugate.
Claim 46
Dependent Claim
14 words
A suspension as claimed inclaim 30, 31 or 32 which comprises a theophylline/ferrocene conjugate.
Claim 47
Dependent Claim
29 words
An electrode dip or contact solution suitable for a noble metal electrode and comprising a sulphur-containing ferrocene derivative whereby the ferrocene compound is linked directly to the noble metal.
Claim 48
Dependent Claim
29 words
An electrode dip or contact solution suitable for a noble metal electrode and comprising a sulphur-containing ferrocene derivative whereby the ferrocene compound is linked directly to the noble metal.
Claim 49
Dependent Claim
31 words
An electrode dip or contact solution for a gold electrode comprising a sulphur-linked ferrocene derivative with a thiol group linked directly or by an interposed alkylene chain to a ferrocene ring.
Claim 50
Dependent Claim
31 words
An electrode dip or contact solution for a gold electrode comprising a sulphur-linked ferrocene derivative with a thiol group linked directly or by an interposed alkylene chain to a ferrocene ring.
References Cited (Backward Citations)
No citation records indexed.
USPTO Annuity & Maintenance Windows
Maintenance schedule is calculated for granted US utility patents.