Enzymatic electrode and electrode module and method of use
First Claim
1. An enzymatic sensor assembly for use in an analyzer device comprising:
- a membrane chamber having an inlet and outlet;
an enzyme bearing membrane disposed within said membrane chamber between said inlet and outlet;
a sensor disposed within said membrane chamber and located on one side of said membrane;
a membrane holder sized to carry said membrane, said holder formed to releasably mount said membrane within said membrane chamber adjacent said sensor and define on the opposite side of said membrane a fluid flow path within said membrane chamber between said inlet and outlet; and
a gasket insertable within said membrane holder to form a fluid-tight seal between said membrane holder and said membrane chamber, wherein the fluid flow path comprises a flow channel formed in said gasket.
1 Assignment
0 Petitions
Accused Products
Abstract
An improved enzymatic electrode and electrode module specifically adapted for use in a medical analyzer device is disclosed which permits rapid analysis of substances of interest contained within undiluted body fluids such as whole blood, serum and/or plasma. The enzymatic electrode is in fluid communication with an axially reciprocating probe which selectively transports either a quantity of a buffer aqueous solution or a calibrant aqueous solution presented at a wash cell or a body fluid specimen disposed within a sample cup to an active enzyme bearing membrane positioned adjacent the enzymatic electrode. The membrane comprises a composite membrane structure having a protective membrane layer adapted to prevent the passage of blood cells and other particulate or cellular substances therethrough as well as adjust the diffusion rate of the substance of interest desired to be measured into the membrane, an active enzyme layer adapted to convert the desired substance of interest to be measured into a detectable substance and a limiting membrane formed to prevent the passage of interfering low molecular weight substance therethrough. The membrane/reagent chemistry kinetics of the enzymatic electrode are specifically defined to enable a novel pseudo-rate/created peak measurement technique to be utilized which reduces measurement inaccuracies as well as signal data processing requirements. The membrane/electrode support structure and membrane/electrode solution flow path are specifically formed to permit rapid replacement of the composite membrane and aqueous solutions by non-professional personnel.
232 Citations
44 Claims
-
1. An enzymatic sensor assembly for use in an analyzer device comprising:
-
a membrane chamber having an inlet and outlet; an enzyme bearing membrane disposed within said membrane chamber between said inlet and outlet; a sensor disposed within said membrane chamber and located on one side of said membrane; a membrane holder sized to carry said membrane, said holder formed to releasably mount said membrane within said membrane chamber adjacent said sensor and define on the opposite side of said membrane a fluid flow path within said membrane chamber between said inlet and outlet; and a gasket insertable within said membrane holder to form a fluid-tight seal between said membrane holder and said membrane chamber, wherein the fluid flow path comprises a flow channel formed in said gasket. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
-
-
12. An enzymatic electrode comprising:
-
a membrane chamber; an enzyme bearing membrane disposed within said chamber; an electrode positioned to contact said membrane on one side thereof and generate a signal in response to the presence of an enzyme reaction occurring at said membrane; a probe in flow communication with said membrane chamber for transporting fluids through said membrane chamber; a wash cell formed to store in a segregated manner a first and second aqueous solution; a sample cup sized to store a quantity of a fluid specimen therein; means for selectively reciprocating said probe between said wash cell and said sample cup; means for intermittently transferring said first and second aqueous solutions and said fluid specimen through said probe and said membrane chamber when said probe is disposed in said wash cell and said sample cup;
said membrane chamber and said electrode being supported upon a carriage adapted to reciprocate with said probe during reciprocal movement of said probe between said wash cell and sample cup, said electrode comprising an electrode insert mounted to said carriage having a working electrode and a reference electrode;a printed circuit board positioned in said carriage adapted to frictionally receive a portion of said working and reference electrodes therein to form an electrical interface between said working and reference electrodes; and a counter electrode supported by said carriage, said counter electrode forming a fluid outlet for said membrane chamber and extending through said printed circuit board to be electrically interfaced to said working and reference electrode.
-
-
13. An enzymatic electrode comprising:
-
a membrane chamber; an enzyme bearing membrane disposed within said chamber; an electrode positioned to contact said membrane on one side thereof and generate a signal in response to the presence of an enzyme reaction occurring at said membrane; a probe in flow communication with said membrane chamber for transporting fluids through said membrane chamber; a wash cell formed to store in a segregated manner a first and second aqueous solution; a sample cup sized to store a quantity of a fluid specimen therein; means for selectively reciprocating said probe between said wash cell and said sample cup; means for intermittently transferring said first and second aqueous solutions and said fluid specimen through said probe and said membrane chamber when said probe is disposed in said wash cell and said sample cup;
said membrane chamber and said electrode being supported upon a carriage adapted to reciprocate with said probe during reciprocal movement of said probe between said wash cell and sample cup, said electrode comprising an electrode insert mounted to said carriage, wherein said wash cell is disposed at a vertical elevation between said sample cup and said membrane carriage. - View Dependent Claims (14, 15, 16, 17, 18, 19)
-
-
20. An enzymatic electrode comprising:
-
a membrane chamber; an enzyme bearing membrane mounted within said chamber; a membrane holder formed to carry said membrane and define a fluid flow path extending on one side of said membrane for transporting a fluid across said membrane; a sensor electrode and a reference electrode disposed on the other side of said membrane; and a counter electrode in fluid communication with said fluid flow path. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28)
-
-
29. A composite enzymatic membrane comprising:
-
a first membrane layer having a stabilized active enzyme for converting a desired substance of interest into a detectable substance; a second membrane layer disposed on one side of said first membrane layer formed to inhibit the passage therethrough of substances which interfer with the measurement of said detectable substance; and a third membrane layer disposed on the opposite side of said first membrane layer to adjust the diffusion rate of said desired substance of interest into said first membrane layer and generate a reactant utilized by said stabilized active enzyme in converting the desired substance of interest into the detectable substance. - View Dependent Claims (30, 31, 32)
-
-
33. A composite enzymatic membrane for use in a measurement sensor comprising:
-
a first membrane layer having a stabilized active enzyme for generating a measurable substance at a sensor in response to an analyte enzyme reaction; and a second membrane layer positioned on one side of said first membrane layer formed to adjust the transport rate of an analyte into said first membrane layer to linearize the signal generated by the sensor, said second membrane layer including means for generating a reactant utilized by said stabilized active enzyme in the analyte enzyme reaction. - View Dependent Claims (34, 35, 36)
-
-
37. A wash cell for an enzymatic electrode probe comprising:
-
a vessel having an aperture extending therethrough sized to permit axial reciprocation of a probe therethrough; means disposed within said vessel for axially segregating said vessel into at least two distinct chambers, each formed to maintain a first and second aqueous solution; and means disposed within said vessel and about said aperture for forming a static seal between said at least two distinct chambers and a dynamic seal between said probe and said vessel during reciprocation of said probe through said vessel, wherein said seal forming means comprises a spacer spool positioned in said aperture at the upper one of said at least two chambers having a pair of O-rings disposed on opposite ends thereof. - View Dependent Claims (38, 39, 40)
-
-
41. A composite enzymatic membrane for use in measuring glucose concentrations in a body fluid sample comprising:
-
a first membrane layer having immobilized glucose oxidase carried thereon; a second membrane layer comprising a micro-perforated polyester sheet disposed on one side of said first membrane layer defining means to prevent the passage of measurement interfering substances therethrough; and a third membrane layer disposed on the opposite side of said first membrane layer defining means for adjusting the diffusion rate of glucose into said first membrane layer. - View Dependent Claims (42, 43, 44)
-
Specification