Electrochemical sensor and method thereof
First Claim
1. An electrochemical device for cooperating with a meter to measure changes in electrochemical properties of a fluid sample as a result of chemical or enzymatic reactions, comprising:
- a unitary single piece body of molded plastic insulative material with a first end and an opposing second end;
at least two electrically conductive electrodes substantially molded into with at least a part thereof encased by the plastic, wherein the electrodes are disposed in fixed longitudinal relation in the insulative material;
means for connecting a meter to the body;
means for receiving a fluid sample;
means for detecting when a sufficient amount of fluid sample has been received selected from the group consisting of (a) an electrical indication and (b) a visual indication; and
, one or more substances deposited on at least one of the electrodes to react with the fluid sample to produce electrochemical changes correlative to the concentration of an analyte in the sample.
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Accused Products
Abstract
A sensor is provided for the determination of various concentrations of one or more components within a fluid sample. The sensor includes an injection molded body, at least two electrodes, an enzyme, and if desired, an electron transfer mediator. The body includes a reaction zone for receiving a fluid sample. The electrodes are at least partially embedded within the plastic body and extend into the reaction zone. Also contained within the reaction zone is an enzyme capable of catalyzing a reaction involving a compound within the fluid sample. Additionally, the sensor incorporates fill detection which activates a meter, attached to the sensor, for measuring the electrochemical changes occurring in the reaction zone.
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Citations
62 Claims
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1. An electrochemical device for cooperating with a meter to measure changes in electrochemical properties of a fluid sample as a result of chemical or enzymatic reactions, comprising:
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a unitary single piece body of molded plastic insulative material with a first end and an opposing second end;
at least two electrically conductive electrodes substantially molded into with at least a part thereof encased by the plastic, wherein the electrodes are disposed in fixed longitudinal relation in the insulative material;
means for connecting a meter to the body;
means for receiving a fluid sample;
means for detecting when a sufficient amount of fluid sample has been received selected from the group consisting of (a) an electrical indication and (b) a visual indication; and
,one or more substances deposited on at least one of the electrodes to react with the fluid sample to produce electrochemical changes correlative to the concentration of an analyte in the sample.
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2. An electrochemical device for cooperating with a meter to measure changes in electrochemical properties of a fluid sample as a result of chemical or enzymatic reactions, comprising:
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a body of insulative material with a first end and an opposing second end comprising an electrode housing and an end cap pivotably attached to the electrode housing at the first end of the body with both the electrode housing and the end cap being molded plastic;
at least two electrically conductive electrodes disposed in fixed longitudinal relation in the insulative material;
means for connecting a meter to the body;
means for receiving a fluid sample;
means for detecting when a sufficient amount of fluid sample has been received selected from the group consisting of (a) an electrical indication and (b) a visual indication; and
one or more substances deposited on at least one of the electrodes to react with the fluid sample to produce electrochemical changes correlative t the concentration of an analyte in the sample. - View Dependent Claims (3, 4, 5)
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6. An electrochemical device for cooperating with a meter to measure changes in electrochemical properties of a fluid sample as a result of chemical or enzymatic reactions, comprising:
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a unitary single piece body of insulative material with a first end and an opposing second end;
at least two electrically conductive electrodes disposed in fixed longitudinal relation with at least a part thereof encased by the insulative material;
a plug formed at the second end of the body for connecting a meter to the body;
means for receiving a fluid sample;
means for detecting when a sufficient amount of fluid sample has been received selected from the group consisting of(a) an electrical indication and (b) a visual indication; and
,one or more substances deposited on at least one of the electrodes to react with the fluid sample to produce electrochemical changes correlative to the concentration of an analyte in the sample.
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7. An electrochemical device for cooperating with a meter to measure changes in electrochemical properties of a fluid sample as a result of chemical or enzymatic reactions comprising:
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a unitary single piece body of insulative material with a first end and an opposing second end;
at least two electrically conductive electrodes disposed in fixed longitudinal relation with at least a part thereof encased by the insulative material;
means for connecting a meter to the body;
a capillary inlet molded into the first end for drawing the fluid sample into the body upon contact with the sample;
means for detecting when a sufficient amount of fluid sample has been received selected from the group consisting of (a) an electrical indication and (b) a visual indication; and
,one or more substances deposited on at least one of the electrodes to react with the fluid sample to produce electrochemical changes correlative to the concentration of an analyte in the sample. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14)
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15. An electrochemical device for cooperating with a meter to measure changes in electrochemical properties of a fluid sample as a result of chemical or enzymatic reactions, comprising:
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a unitary single piece body of insulative material with a first end and an opposing second end;
at least two electrically conductive wires disposed in fixed longitudinal relation with a part thereof encased by the insulative material;
means for connecting a meter to the body;
means for receiving a fluid sample;
means for detecting when a sufficient amount of fluid sample has been received selected from the group consisting of (a) an electrical indication and (b) a visual indication; and
one or more substances deposited on at least one of the conductive wires to react with the fluid sample to produce electrochemical changes correlative to the concentration of an analyte in the sample. - View Dependent Claims (16)
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17. An electrochemical device for cooperating with a meter to measure changes in electrochemical properties of a fluid sample as a insult of chemical or enzymatic reactions, comprising:
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a unitary single piece body of insulative material with a first end and an opposing second end;
at least two electrically conductive electrodes formed from a conductive plate disposed in fixed longitudinal relation with a part thereof encased by the insulative material;
means for connecting a meter to the body;
means for receiving a fluid sample;
means for detecting when a sufficient amount of fluid sample has been received selected from the group consisting of (a) an electrical indication and (b) a visual indication; and
,one or more substances deposited on at least one of the electrodes to react with the fluid sample to produce electrochemical changes correlative to the concentration of an analyte in the sample.
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18. An electrochemical device for cooperating with a meter to measure changes in electrochemical properties of a fluid sample as a result of chemical or enzymatic reactions, comprising:
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a unitary single piece body of insulative material with a first end and an opposing second end;
at least two electrically conductive electrodes disposed in fixed longitudinal relation with a part thereof encased by the insulative material;
means for connecting a meter to the body;
means for receiving a fluid sample;
means for detecting when a sufficient amount of fluid sample has been received selected from the group consisting of (a) an electrical indication and (b) a visual indication; and
,one or more substances deposited on at least one of the electrodes to react with the fluid sample to produce electrochemical changes correlative to the concentration of an analyte in the sample, the substance including a coating on at least one electrode with at least one of a reagent and an enzyme.
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19. An electrochemical device for cooperating with a meter to measure changes in electrochemical properties of a fluid sample as a result of chemical or enzymatic reactions, comprising:
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a body of insulative material with a first end and an opposing second end;
at least two electrically conductive electrodes disposed in fixed longitudinal relation in the insulative material;
means for connecting a meter to the body;
means for receiving a fluid sample;
means for detecting when a sufficient amount of fluid sample has been received selected from the group consisting of (a) an electrical indication and (b) a visual indication; and
,an enzyme on an outer surface of one of the electrodes and one of an enzyme-antibody conjugate and an enzyme-analyte conjugate is on another of the electrodes. - View Dependent Claims (20)
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21. An electrochemical device for cooperating with an electronic meter capable of measuring the electrochemical properties in a fluid sample resulting from chemical or enzymatic reaction, comprising:
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a body of insulative material with a first end and a second end;
three electrically conductive electrodes spaced apart in fixed longitudinal relation to each other, housed in the body, the body including an electrode encasing unit and an end cap attached to one another with each being made of molded plastic;
a plug for connecting a meter to the body;
means for receiving a fluid sample in the body; and
,means for detecting when a sufficient amount of fluid sample has been received for analysis selected from the group consisting of (a) an electrical indication and (b) a visual indication.
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22. An electrochemical device for cooperating with an electronic meter capable of measuring the electrochemical properties in a fluid sample resulting from chemical or enzymatic reaction, comprising:
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a unitary single piece body of insulative material with a first end and a second end;
three electrically conductive electrodes spaced apart in fixed longitudinal relation to each other with a part thereof encased by the body;
a plug for connecting a meter to the body;
a capillary inlet for drawing the fluid sample into the body upon contact with the fluid sample; and
,means for detecting when a sufficient amount of fluid sample has been received for analysis selected from the group consisting of (a) an electrical indication and (b) a visual indication. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
a hinge constructed in the body permitting the pivoting and connecting of a portion of the body onto itself; - and
at least one energy director ridge formed in the body on at least one side of the hinge, such that securedly affixing the energy director ridge to the body opposite side of hinge forms a reaction zone.
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24. The electrochemical device of claim 23 further comprising one or more substances an one or more electrodes for reacting with the fluid sample to produce electrochemical changes measurable by the electrodes.
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25. The electrochemical device of claim 23 wherein the one or more substances is a coating on at least one electrode with at least one of a reagent and an enzyme.
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26. The electrochemical device of claim 23 wherein an enzyme is on the outer surface of one of the electrodes.
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27. The electrochemical device of claim 26 wherein an electron mediator is on the outer surface of one or more of the electrodes.
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28. The electrochemical device of claim 22 having
a hinge constructed in the body permitting the pivoting and connecting of a portion of the body onto itself; - and
at least one protuberance formed in the body on one side of the hinge to mate with at least one recessed surface in the body on the other side of the hinge.
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29. The electrochemical device of claim 28 further comprising one or more substances on one or more electrodes for reacting with the fluid sample to produce electrochemical changes measurable by the electrodes.
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30. The electrochemical device of claim 28 wherein the one or more substances is a coating on at least one electrode with at least one of a reagent and an enzyme.
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31. The electrochemical device of claim 28 wherein an enzyme is on the outer surface of one of the electrodes.
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32. The electrochemical device of claim 31 wherein an electron mediator is on the outer surface of one or more of the electrodes.
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33. An electrochemical device for cooperating with an electronic meter capable of measuring the electrochemical properties in a fluid sample resulting from chemical or enzymatic reaction, comprising:
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a body of insulative material with a first end and a second end;
three electrically conductive electrodes spaced apart in fixed longitudinal relation to each other, housed in the body;
a plug for connecting a meter to the body;
means for receiving a fluid sample in the body; and
,a cavity forming a reaction zone in the body, the reaction zone having at least a portion of each electrode exposed therein for reacting with the fluid sample, such that sample drawn into the reaction zone contacts the exposed portion of at least one of the electrodes and activates the meter to indicate sufficient fill. - View Dependent Claims (34)
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35. An electrochemical device for cooperating with an electronic meter capable of measuring the electrochemical properties in a fluid sample resulting from chemical or enzymatic reaction, comprising:
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a unitary single piece body of insulative material with a first end and a second end;
three electrically conductive electrodes spaced apart in fixed longitudinal relation to each other with a part thereof encased by the body, the electrodes being one of isolated conductive wires and wires associated with a conductive plate;
a plug for connecting a meter to the body;
means for receiving a fluid sample in the body; and
,means for detecting when a sufficient amount of fluid sample has been received for analysis selected from the group consisting of (a) an electrical indication and (b) a visual indication.
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36. An electrochemical device for measuring the concentration of an analyte by cooperating with an electronic meter capable of measuring the electro chemical properties of a fluid sample resulting from chemical or enzymatic reaction, comprising:
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a unitary, single molded plastic body with two opposing ends;
at least two spaced apart electrically conductive electrodes with a part thereof encased by the molded body;
a plug formed at one end of the body exposing the electrodes outside the body for connecting the meter to the body;
an inlet molded into the other end of the body defining a capillary for drawing the fluid sample into the body upon contact with the fluid sample;
a reaction zone in communication with the capillary, there action zone having an interior surface and at least a portion of each electrode exposed therein for reacting with the fluid sample, such that sample drawn into the reaction zone contacts the exposed portion of at least one electrode and activates the meter to indicate sufficient fill; and
one or more substances on at least one of the interior surface of the reaction zone and at least one of the electrodes such that the one or more substances react with the fluid sample to produce electrochemical changes measurable by the meter. - View Dependent Claims (37, 38, 39, 40, 41, 42, 43)
a hinge constructed in the body permitting the pivoting and connecting of a portion of the body onto itself; - and
at least one protuberance formed in the body on one side of the hinge to mate with at least one recessed surface in the body on the other side of the hinge to form the reaction zone.
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40. The electrochemical device of claim 36 having
a hinge constructed in the body permitting the pivoting and connecting of a portion of the body onto itself; - and
at least one energy director ridge formed in the body on one side of the hinge and securedly affixable to the body on the opposite side of the hinge to form the reaction zone.
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41. The electrochemical device of claim 36 wherein the one or more substances comprises a coating having at least an enzyme.
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42. The electrochemical device of claim 41 wherein the coating includes one of an enzyme-antibody conjugate and an enzyme-analyte conjugate.
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43. The electrochemical device of claim 41 wherein the coating includes an electron mediator.
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44. A sensor comprising:
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a body having an end for cooperating with a meter and an end for receiving a fluid sample;
a plurality of electrically conductive leads with a part thereof around which a portion of the body has been molded so as to be encased by the body and having at least one lead extending into the end for receiving the fluid sample;
a cavity in the body to detect sufficiency of sample quantity; and
,an enzyme deposited on at least one of the leads. - View Dependent Claims (45, 46, 47, 48, 49, 50, 51, 52, 53, 54)
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55. A sensor comprising:
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an injection molded plastic body having a meter-attachment end and a fluid sample receiving cavity;
a plurality of electrically conductive leads with a part thereof encased by the body and with at least one lead extending from the attachment end to the fluid sample receiving cavity;
a plurality of vents communicating with the fluid sample receiving cavity for detecting the sufficiency of the amount of the fluid sample received; and
,an enzyme disposed within the fluid sample receiving cavity. - View Dependent Claims (56, 57, 58, 59, 60, 61)
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62. A sensor for analyzing a fluid sample comprising:
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an injection molded body having an attachment end and a sample receiving zone;
a plurality of electrically conductive leads with at least a part thereof encased by the body, the leads extending in substantial alignment between the two ends, at least one of the leads extending into the sample receiving zone and the body having a plurality of guides molded therein with at least one of the guides abutting against at least one of the leads;
a substance deposited within the sample receiving zone for analyzing the fluid sample; and
,a vent communicating with the sample receiving zone for determining adequate sample fill.
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Specification