US20030201178A1 - Electrochemical sensor - Google Patents
Electrochemical sensor Download PDFInfo
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- US20030201178A1 US20030201178A1 US10/419,503 US41950303A US2003201178A1 US 20030201178 A1 US20030201178 A1 US 20030201178A1 US 41950303 A US41950303 A US 41950303A US 2003201178 A1 US2003201178 A1 US 2003201178A1
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/28—Electrolytic cell components
- G01N27/30—Electrodes, e.g. test electrodes; Half-cells
- G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
- G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
- G01N27/3272—Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49002—Electrical device making
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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.
Description
- This application is a continuation of co-pending U.S. application Ser. No. 10/017,751 filed Dec. 7, 2001, which is a continuation-in-part of co-pending U.S. application Ser. No. 09/820,372, filed Mar. 23, 2001.
- The present invention generally relates to electrochemical sensors and, in particular, to molded electrochemical sensors for detection or measurement of analytes in test samples, such as fluids and dissolved solid materials, and the methods of making and using these sensors.
- Electrochemical sensors are used to determine the concentrations of various analytes in testing samples such as fluids and dissolved solid materials. For instance, electrochemical sensors have been made for measuring glucose in human blood. Such sensors have been used by diabetics and health care professionals for monitoring blood glucose levels. The sensors are usually used in conjunction with a meter, which measures light reflectance, if the strip is designed for photometric detection of a die, or which measures some electrical property, such as electrical current, if the strip is designed for detection of an electroactive compound.
- Typically, electrochemical sensors are manufactured using an electrically insulating base upon which conductive inks such as carbon and silver are printed by screen printing to form conductive electrode tracks or thin strips of metal are unrolled to form the conductive electrode tracks. The electrodes are the sensing elements of the sensor generally referred to as a transducer. The electrodes are covered with a reagent layer comprising a hydrophilic polymer in combination with an oxidoreductase or a dehydrogenase enzyme specific for the analyte. Further, mounted over a portion of the base and the electrodes is an insulating layer.
- Precision and accuracy of electrochemical measurements to a great extent rely on the reproducibility of the electrode surface area on a microscopic scale. Variations in the morphology of the electrode can result in very significant changes in the electrochemical signal readout. Screen-printing has made significant in-roads in the production of sensors for determining glucose. The wide use of screen-printing stems from the ability to mass-produce relatively inexpensive sensors. The use of metal strips unrolled from large rolls has also been employed to mass produce such sensors.
- While many advances have been made in the field of screen printing and conductive ink production, the technology still suffers from poor reproducibility of the electrode surface area, dimensional variations, thickness variations, micro-cracks, and shrinkage due to the repetitive and high temperature curing processes involved in using film printing technology. Loss of solvent during printing is another factor that leads to variations in the thickness of electrodes.
- Sensor development using printing technology requires several passes of different conductive inks demanding different screens. Slight variations in positioning the screens can lead to substantial errors in IR drop and the applied potentials. Wear and tear of these screens is another source of error. Also, sensor strip production by screen printing suffers from a high level of raw material waste. Generally, for every gram of ink used, there is a gram of ink wasted. Manufacture of such sensors also involves several lamination processes that add to the production complexity and cost of the final product.
- The present invention is an electrochemical sensor that provides for the determination of various analyte concentrations in a testing sample such as fluids and dissolved solid materials. The sensor is designed to facilitate production in large quantities using reliable and cost effective injection molding manufacturing methods. The present invention includes an injection molded plastic strip or body, at least two electrodes, an enzyme, and if desired, an electron transfer mediator. The body includes a cavity or reaction zone for receiving a fluid sample. The electrodes are at least partially embedded within the plastic body and extend into the reaction zone where they are exposed to a test sample. Also contained within the reaction zone is an enzyme capable of catalyzing a reaction involving a compound within the fluid sample.
- Specifically, the device cooperates with an electronic meter capable of measuring the difference between the electrical properties of the electrically conductive electrodes within the device. The device, a sensor, includes at least two, and preferably three, spaced apart electrically conductive electrodes, a body having two ends of insulative material molded about and housing the electrodes, means for connecting the meter to the housing, means for receiving a fluid sample, and means for treating one or more electrodes with one or more chemicals to change the electrical properties of the treated electrodes upon contact with the fluid sample. One end of the housing has the means for connecting the meter and the opposite end of the housing has the means for receiving the fluid sample. The means for connecting the meter is a plug formed in the housing exposing the electrodes outside the body.
- The sensor is molded and can be a single, unitary piece or two pieces. In the two piece construction, an end cap is attached to the body. In the single piece construction, the body pivots about a hinge and connects onto itself. Protuberances formed in a portion of the body cooperate with troughs to ensure proper alignment.
- A capillary inlet is constructed at one end of the sensor to draw the fluid sample into the body upon contact with the fluid sample. The capillary inlet is molded into the end of the body and is in communications with a reaction zone. This reaction zone is a channel formed in the body about the electrodes and is adapted for reacting with the fluid drawn into the body by the capillary force. While the reaction zone may be formed above or below the electrodes, the preference has been to construct it above the electrodes. The capillary has a vent for relieving pressure.
- As noted, the electrodes are molded into the plastic. In one embodiment, the electrodes are conductive wires. In another embodiment, the electrodes are constructed from a metal plate. The electrodes may be coated with a different conductive material to enhance their performance.
- Apertures are formed in the body of the sensor to permit the holding of the electrodes during the molding process. Apertures may also be formed in the body to chemically treat one or more electrodes in the reaction zone before or after the molding process. Adding chemicals (e.g., reagents with and without enzymes) changes the electrical properties of the treated electrodes upon contact with the fluid sample. In the preferred embodiment, the enzyme is applied to the outer surface of one of the electrodes. An antibody may also be applied to another of the electrodes. An electron mediator may further be applied to the outer surface of one or more of the electrodes.
- In another embodiment in accordance with the invention, the sensor provides fill detection. Fluid drawn into the capillary inlet and the reaction zone contacts the edges of the electrodes, and upon reaching the lower end of the reaction zone, the area farthest from the capillary inlet, activates the meter. When the fluid comes in contact with the last electrode in the capillary space, it closes an open circuit in the electrochemical cell causing current to flow through the cell. The flow of current in the cell triggers the meter, signaling that the capillary chamber is filled with fluid. The vent could also be used for a visual detection of fluid fill.
- The methods of making and using the electrochemical sensor are also disclosed. The method of making the device includes the steps of positioning at least two spaced apart electrically conductive electrodes in a mold, before or after molding treating at least one of the electrodes with one or more chemicals to change the electrical properties of the treated electrode upon contact with a fluid sample, and molding a body of insulative material with two ends around the electrodes with one end having therein means for receiving a fluid sample. As before, the body is molded in two pieces, with a body and end cap for attaching to one another after the molding is completed, or in a single, unitary piece.
- In the accompanying drawings forming part of the specification, and in which like numerals are employed to designate like parts throughout the same,
- FIG. 1 is an enlarged top plan view of a first embodiment of an electrochemical sensor made in accordance with the teachings of the present invention;
- FIG. 2 is a sectional end view of the electrochemical sensor of FIG. 1 taken along plane2-2;
- FIG. 3 is a sectional end view of the electrochemical sensor of FIG. 1 taken along plane3-3;
- FIG. 4 is a sectional end view of the electrochemical sensor of FIG. 1 taken along plane4-4;
- FIG. 5 is a sectional end view of the electrochemical sensor of FIG. 1 taken along plane5-5;
- FIG. 6 is a sectional side view of the electrochemical sensor of FIG. 1 taken along plane6-6;
- FIG. 7 is an enlarged top plan view of a second embodiment of an electrochemical sensor made in accordance with the teachings of the present invention;
- FIG. 8 is an end elevation view of the electrochemical sensor of FIG. 7;
- FIG. 9 is a side elevation view of the electrochemical sensor of FIG. 7;
- FIG. 10 is a bottom plan view of the electrochemical sensor of FIG. 7;
- FIG. 11 is a sectional end view of the electrochemical sensor of FIG. 7 taken along plane11-11;
- FIG. 12 is a sectional end view of the electrochemical sensor of FIG. 7 taken along plane12-12;
- FIG. 13 shows an enlarged top plan view of a third embodiment of an electrochemical sensor made in accordance with the teachings of the present invention;
- FIG. 14 shows an enlarged bottom plan view of the electrochemical sensor of FIG. 13;
- FIG. 15 is a sectional side view of the electrochemical sensor of FIG. 13 taken along plane15-15;
- FIG. 16 is a sectional end view of the electrochemical sensor of FIG. 13 taken along plane16-16;
- FIG. 17 shows a top plan view of a third embodiment of an electrochemical sensor made in accordance with the teachings of the present invention;
- FIG. 18 shows an enlarged bottom view of the electrochemical sensor of FIG. 17;
- FIG. 19 shows a sectional side view of the electrochemical sensor of FIG. 17 taken along plan19-19; and,
- FIGS. 20a,b show a magnified view of the terminal end portion of the sensor of FIG. 17 having the end cap (a) extended away from the body and (b) secured to the body.
- While this invention is susceptible of embodiments in many different forms, there is shown in the drawings and will herein be described in detail preferred embodiments of the invention with the understanding the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the broad aspect of the invention to the embodiments illustrated.
- The First Embodiment
- Referring to FIGS.1-6, an electrochemical sensor in accordance with the present invention, first embodiment, is depicted. FIG. 1 shows the
sensor 10 as though it were made out of clear plastic, permitting one to look inside it. As discussed herein, the internal components and hidden external components would not normally be visible looking down on thesensor 10. This rendition would be similar to a view taken along plane x-x in FIG. 2. - The sensor or test strip of the
first embodiment 10 includes an injection moldedplastic body 12, opaque or preferably translucent, having a meter attachment end or plugend 14 and a fluidsample receiving end 16. The body has abottom surface 13, atop surface 15 and a taperedportion 20 connecting a firsttop surface 15 a to a secondtop surface 15 b, the first top surface being lower than the second top surface, and a thirdtop surface 15 c, also lower than the second top surface. Thebody 12 contains three spaced apartelectrodes plug end 14 of thebody 12 includes a pair of tapered side edges 18,19 and a wedge shapedtop portion 20. The tapered side edges 18,19 facilitate a user inserting the sensor'splug end 14 into the socket cavity of a conventional meter (not shown). Moreover, the wedgedportion 20 of the sensor serves as a stop, and frictionally holds thesensor 10 within the socket cavity of the meter. - The fluid
sample receiving end 16 of thesensor 10 includes anelectrochemical reaction zone 24 adjacent theterminal end 16 of the body. Thisreaction zone 24 is a channel formed in the thirdtop surface 15 c and about/adjacent theelectrodes body 12 for analyzing the fluid drawn into thebody 12 for a particular analyte. While the reaction zone may be formed above or below the electrodes, the preference has been to construct it above the electrodes. Anend cap 27 is welded [by ultrasonics or adhesive] over thereaction zone 24 and onto the thirdtop surface 15 c. The top of theend cap 27 aligns with the top 15,15 b of thebody 12. Theend cap 27 is preferably made of the same material as the moldedbody 12 and attached thereto by ultrasonic welding or gluing. - While the
cap 27 is shown as a separate piece, it can also be constructed as part of thebody 12 and hingeably connected to the body such that it can be pivoted onto the thirdtop surface 15 c and attached [e.g., see The Second Embodiment]. In this manner, the entire sensor can be made at one time and as one molded, unitary piece. - A
capillary opening 28 is formed in theterminal end 16 of thesensor 10 when thecap 27 is welded (or folded) to thebody 12. This capillary opening leads to thereaction zone 24. Preferably, thesensor 10 is a capillary fill device, that is, thereaction zone 24 is small enough to draw a fluid sample into the zone when the capillary opening orinlet 28 is placed in contact with the fluid being tested, such as a drop of blood. Accordingly, if one wants to test his/her blood, s/he touches theterminal end 16 to the blood and the blood is drawn into thesensor 10 andreaction zone 24 through thecapillary opening 28. This is much easier than placing the sample (such as blood) on the sensor and on a target zone as in the prior art. To effectuate the capillary effect with thecapillary opening 28 to thereaction zone 24, avent 29 is constructed into thecap 27. This vent is in communication with thereaction zone 24. Thisvent 29 releases air pressure as thereaction zone 24 draws and fills with fluid. For additional discussion regarding capillary filling, see U.S. Pat. Nos. 4,254,083; 4,413,407; 4,473,457; 5,798,031; 5,120,420; and 5,575,895, the disclosures of which are hereby incorporated by reference. - Mostly encased within the injection molded
body 12 are a plurality of electrically conductive leads orelectrodes body 12 is molded about theseleads body 12 and run from theplug end 14 to thereaction zone 24, just before theterminal end 16. The leads' 30,31,32 ends 26 are positioned just before theterminal end 16 of the sensor. - The conductive leads30,31,32 consist of an electrically conductive material like metal or metal alloy such as platinum, palladium, gold, silver, nickel, nickel-chrome, stainless steel, copper or the like. Moreover, each lead preferably consists of a single wire, or in an alternative preferred embodiment (See The Second Embodiment), a stamped metal member plated with gold or the like. In the first embodiment, the outer leads 30 and 32 are equally spaced from the
inner lead 31 with the spacing of the leads at the fluidsample receiving end 16 of thebody 12 being closer together than at themeter attachment end 14. -
Segments 33 of theleads plug end 14 of thebody 12 to providecontact surface areas contact surface areas top portion 20 of thebody 12 to theplug end 14 of thebody 12 on or partially embedded into the firsttop surface 15 a. Specifically, thebody 12 may be molded such that thesegments 33 of theleads top surface 15 a) and held by thebody 12 opposite thecontact surface areas - The portion of the
leads sensor plug end 14 and the fluidsample receiving end 16 are embedded within the plastic injection moldedbody 12. Accordingly, thebody 12 is constructed of an electrically insulating injection moldable plastic. - Certain structural support components are molded within the
body 12 of thesensor 10 to hold and maintain theleads body 12 for proper mounting of theleads top surface 15 andbottom surface 13 of thebody 12 for permitting the ingress and egress of fingers into the mold during the molding process (to be discussed below). In particular, afirst aperture 46 is molded into the secondtop surface 15 b and asecond aperture 48 andthird aperture 50 are formed into thebottom surface 13 of thebody 12. Once the molding is completed, each of theseapertures leads - Within the
reaction zone 24, onelead 30 serves as a primary workingelectrode 52, asecond lead 31 acts as a reference orcounter electrode 53, and thethird lead 32 serves as an auxiliary, secondary or second workingelectrode 54. Desirably, the conductive leads 30,31,32 (orelectrodes sensor 10. Theelectrodes sensor 10 by molded plastic to ensure a signal carried by the leads arises only from that portion exposed to the test sample in theelectrochemical reaction zone 24. - In the embodiment, an
enzyme 56 is applied to the outer surface of the primary workingelectrode 52 and, if desired, an electron transfer mediator. The enzyme can consist of, for instance, flavo-proteins, pqq-enzymes, haem-containing enzymes, oxidoreductase, or the like. For additional discussion regarding mediators, see U.S. Pat. Nos. 4,545,382 and 4,224,125, the disclosures of which are hereby incorporated by reference. In an alternative embodiment, anantibody 57 can be applied to the outer surface of the secondary workingelectrode 54. As such, thereaction zone 24 can contain antibodies, enzyme-antibody conjugates, enzyme-analyte conjugates, and the like. It should be noted that anenzyme 56 can also be applied to the second workingelectrode 54 and an antibody can be applied to the outer surface of the primary workingelectrode 52. - As will be appreciated by those having skill in the art, the
enzyme 56 is specific for the test to be performed by thesensor 10. For instance, the workingelectrode 52, or secondary workingelectrode 54, or both, can be coated with anenzyme 56 such as glucose oxidase or glucose dehydrogenase formulated to react at different levels or intensities for the measurement of glucose in a human blood sample. Thus, as an individual's body glucose concentration increases, theenzyme 56 will make more products. The glucose sensor is used with a meter to measure the electrochemical signal, such as electrical current, arising from oxidation or reduction of the enzymatic turnover product(s). The magnitude of the signal is directly proportional to the glucose concentration or any other compound for which a specific enzyme has been coated on the electrodes. - In an embodiment, the
enzyme 56 can be applied to the entire exposed surface area of the primary electrode 52 (or secondary electrode 54). Alternatively, the entire exposed area of the electrode may not need to be covered with the enzyme as long as a well defined area of the electrode is covered with the enzyme. - In a further embodiment and as shown in the prior art, an
enzyme 57 can be applied to all theelectrodes reaction zone 24 and measures can be taken by a meter. - In the preferred embodiment, one of the working electrodes (52 or 54) is selectively coated with the
enzyme 57 carrying a reagent with the enzyme and the other working electrode (54 or 52) is coated with a reagent lacking the respective enzyme. As such, with a meter, one can simultaneously acquire an electrochemical signal from each working electrode and correct for any “background noise” arising from a sample matrix. Thus, the potential or current between the reference and the electrode without the enzyme can be compared with the potential or current between the reference and the electrode with the enzyme. The measuring and comparing of the potential and current differences are well known to those skilled in the art. - As indicated above, the
sensor 10 is used in conjunction with a meter capable of measuring an electrical property of the fluid sample after the addition of the fluid sample into thereaction zone 24. The electrical property being measured may be, for example, electrical current, electrical potential, electrical charge, or impedance. An example of measuring changes in electrical potential to perform an analytical test is illustrated by U.S. Pat. No. 5,413,690, the disclosure of which is hereby incorporated by reference. - An example of measuring electrical current to perform an analytical test is illustrated by U.S. Pat. Nos. 5,288,636 and 5,508,171, the disclosures of which are hereby incorporated by reference.
- The
plug end 14 of thesensor 10 can be inserted and connected to a meter, which includes a power source (a battery). Improvements in such meters and a sensor system are found in U.S. Pat. Nos. 4,999,632; 5,243,516; 5,366,609; 5,352,351; 5,405,511; and 5,438,271, the disclosures of which are hereby incorporated by reference. - Many analyte-containing fluids can be analyzed by the electrochemical sensor of the present invention. For example, analytes in human and animal body fluids, such as whole blood, blood serum and plasma, urine and cerebrospinal fluid may all be measured. Also, analytes found in fermentation products, food and agricultural products, and in environmental substances, which potentially contain environmental contaminants, may be measured.
- The Molding Process of the First Embodiment
- In the past, while recognized for its strength and durability, plastic injection molding of sensors has been difficult and thus avoided. One reason is the reluctance to mold around the conductive wires or plates. The industry choice has been to make such sensors like sandwiches, having a top and bottom piece with the insides (conductive elements) being formed on one of the pieces or placed between the pieces. The sandwich-like sensor is then assembled together and sealed closed, such as with an adhesive.
- The present invention molds the sensors with the conductive elements inside the mold during the molding process. The advantages are many. In addition to making a stronger more durable sensor, such a process reduces labor involvement and steps and produces a more consistent product.
- While
multiple sensors 10 can be produced with one mold, the making of a single sensor will be discussed. The mold has the shape of thebody 12. Theconductive wires apertures - Once the plastic has formed and hardened, the fingers are pulled from and exit the mold through the openings (
apertures sensor 12 is next ejected from the mold. - The reagents are next applied to the electrodes after the molding process is finished. First, after molding is finished, the cap is treated with a surfactant that facilitates pulling or drawing the fluid (e.g., test blood) into the capillary gap at the end of the sensor. Then, the reagents (including the enzyme) are applied to the electrodes.
- The
end cap 27 is thereafter connected to themain body 12 and any undesirable openings in the sensor can be sealed closed by the same plastic used for the mold. In the alternative, the chemicals can be applied to the wires after the end cap is married to the body. Any extraneous wire(s) projecting from the sensor can be cut and removed. Then, any desired writings on the sensor (e.g., manufacturing codes, product name, etc.) can then be applied to the sensor by conventional means. - The Second Embodiment Referring to FIGS.7-12, an electrochemical sensor in accordance with the present invention, second embodiment, is depicted. In these figures, components similar to those in the first embodiment. (10) will be identified with the same reference numbers, but in the 100 series. Specifically, FIG. 7 shows the
sensor 110 as though it were made out of clear plastic, permitting one to look inside it. As noted previously, the internal components and hidden external components would not normally be visible looking down on thesensor 110. The sensor of thesecond embodiment 110 includes a moldedplastic body 112 having a meter attachment end or plugend 114 and a fluidsample receiving end 116. The body has abottom surface 113 and atop surface 115. Anend cap 127 is integral to thebody 112 and molded with the body. Ahinge 227 permits the pivoting of the end cap onto the main body as will be explained. Specifically, thetop surface 115 of thesensor 110 has threetop surfaces l 15 c. The firsttop surface 115 a runs most of the length of the body and terminates at aledge 215; the secondtop surface 115 b is positioned below or is lower than the first 115 a ; and, the thirdtop surface 115 c is separated from the other twotop surfaces hinge 227. During construction of thesensor 110, theend cap 127 is rotated about the hinge such that the thirdtop surface 115 c abuts the secondtop surface 115 b, face-to-face, and rests adjacent theledge 215 of thetop surface 115 a. Thebottom surface 13 a of thecap 127 thus becomes the top surface adjacent the firsttop surface 115 a. See FIG. 8. A pair of taperedprotuberances 125 formed in theend cap 127 and a pair of taperedtroughs 122 formed in themain body 112 align and mate when the cap is folded into place. This facilitates and ensures correct alignment of the hinged parts. - The
body 112 contains three spaced apartelectrodes plug end 114 of thebody 112 includes a pair of tapered side edges 118,119 to facilitate a user inserting the sensor'splug end 114 into the socket cavity of a conventional meter (not shown). - The fluid
sample receiving end 116 of thesensor 110 includes anelectrochemical reaction zone 124 adjacent theterminal end 116 of the body. Thisreaction zone 124 is a channel formed in the secondtop surface 115 b and about/adjacent theelectrodes body 112 for reacting with the fluid drawn into thebody 112. While this reaction zone may be formed above or below the electrodes, the preference has been to construct it above the electrodes. Aridge 327 is formed on the top surface (thirdtop surface 115 c) of the end cap. This ridge prevents any fluid from leaving thereaction zone 124 or debris from entering the reaction zone once theend cap 127 is welded [by ultrasonics or adhesive] onto the secondtop surface 115 b. When the end cap is folded, it is welded into position along the side surfaces of thepiece 110. Thus, the ridge can be collapsed during welding and not affect the performance of the sensor. An optional channel 327 a may be constructed in the thirdtop surface 115 c to increase the height of thereaction zone 124. - A
capillary opening 128 is formed in theterminal end 116 of thesensor 110 when thecap 127 is folded and welded into place. This capillary opening leads to thereaction zone 124. The width of theopening 128 is approximately the same as the length of thesensing electrodes reaction zone 124. Thesensor 110 of the second embodiment is also a capillary fill device, that is, thereaction zone 124 is small enough to draw a fluid sample into the zone when thecapillary opening 128 is placed in contact with the fluid being tested. Avent 129 provided in thecap 127 is in communication with thereaction zone 124 to release pressure as thereaction zone 124 draws and fills with fluid. Preferably, the bottom or base of the capillary inlet is flush with the top surface ofelectrodes - Mostly encased within the injection molded
body 112 is an electrically conductive plate (stamped or cast) having leads orelectrodes body 112 is molded around the plate and theseleads leads segments segments - The
electrodes body 112 and run from theplug end 114 into thereaction zone 124, just before theterminal end 116. The leads 130,131,132 may be widened if desired in the reaction zone to expose more surface area to the fluid and chemicals contacting one another in the zone. The leads 130,131,132 can be as wide as the sensing parts. These leads 130,131,132 are an electrically conductive material like metal or metal alloy such as platinum, palladium, gold, silver, nickel, nickel-chrome, stainless steel, copper or the like. To enhance their performance and sensitivity, they may also be coated, e.g., made of copper and coated with gold. In the second embodiment, theleads -
Segments 133 of theleads body 112 from theplug end 114 of thesensor 110 and are exposed to providecontact surface areas - As before, the portion of the
leads sensor plug end 114 and the fluidsample receiving end 116 are embedded, or encased, within the plastic injection moldedbody 112; thebody 112 is constructed of an electrically insulating injection moldable plastic. - Apertures are formed in the
top surface 115 andbottom surface 113 of thebody 112 for permitting the ingress and egress of fingers into the mold during the molding process. In particular, a set (3) offirst apertures 146 and a set (3) ofsecond apertures 147 are molded into thetop surface 15 a; athird aperture 148 andfourth aperture 150 and a set (3) offifth apertures bottom surface 113 of thebody 112. Once the molding is completed, each of theseapertures - Within the
reaction zone 124, oneouter lead 130 serves as aprimary working electrode 152, thecenter lead 131 acts as a reference orcounter electrode 153, and the otherouter lead 132 serves as an auxiliary or secondary or second workingelectrode 154. These conductive leads 130,131,132 (orelectrodes sensor 110. Theelectrodes sensor 110 by molded plastic to ensure a signal carried by the leads arises only from that portion exposed to the test sample in theelectrochemical reaction zone 124. - As with the first embodiment, an
enzyme 156 is applied to the outer surface of theprimary working electrode 152 and, if desired, an electron transfer mediator. Anantibody 157 may also be applied to the outer surface of the secondary workingelectrode 154. Anenzyme 156 can also be applied the second workingelectrode 154 and an antibody to the outer surface of the primary workingelectrode 52. - The
enzyme 156 can be applied to the entire exposed surface area of the primary electrode 152 (or secondary electrode 154). Alternatively, the entire exposed area of the electrode may not need to be covered with the enzyme as long as a well defined area of the electrode is covered with the enzyme. Or, an enzyme can be applied to all theelectrodes reaction zone 124 and measurements can be taken by a meter. Preferably, one of the working electrodes (152 or 154) is selectively coated with the enzyme carrying a reagent with the enzyme and the other working electrode (154 or 152) is coated with a reagent lacking the respective enzyme. - The
sensor 110 is used in conjunction with a meter capable of measuring an electrical property of the fluid sample after the addition of the fluid sample into thereaction zone 124. Theplug end 114 of thesensor 110 is inserted and connected to a meter, as before with the first embodiment. - The Molding Process of the Second Embodiment
- The mold has the shape of the
body 112. The conductive 130,131,132 leads/electrodes (in the form of a plate with the joiningextensions apertures jointing extensions - Once the plastic has formed and hardened, the fingers are drawn from the mold through the openings (
apertures upper surface openings 170. Once the knives/punches are removed, the cut or skivedextensions leads sensor 112 is then ejected from the mold and any undesirable openings in the sensor can be sealed closed by the same plastic used for the mold. In the preferred alternative, the critical reagents are applied to the sensors in thereaction zone 124 above the leads. A surfactant can be used to treat the capillary inlet to facilitate the capillary function. Any extraneous metal projecting from the sensor can be cut and removed. Then, any desired writings on the sensor (e.g., manufacturing codes, product name, etc.) can then be applied to the sensors by conventional means. - The Third Embodiment
- Shown in FIGS.13-20 is a third embodiment of an electrochemical sensor in accordance with the present invention. These figures use the same reference numbers, but in the 300 series, to identify components that are similar to those in the previous embodiments. FIGS. 13 and 17, respectively, depict the
sensor sensor - In the
third embodiment sensor reaction zone sensor plastic body end sample receiving end plug end bottom surface top surface body housing end cap electrode housing sample receiving end hinge plug end body plug end end cap - FIG. 15 shows a longitudinal sectional side view of
sensor 310. Thetop surface 315 has three sections or surfaces including 315 a,315 b,315 c. The firsttop surface 315 a accounts for a predominate portion of the body, as it extends from theplug end 314 to aledge 415. The secondtop surface 315 b runs from theledge 415 to thehinge 427, on a plane lower than 315 a. The thirdtop surface 315 c extends across one surface of theend cap 327, from thehinge 427 to the outermost edge of the end cap. - The
hinge 427 allows the end cap to be folded onto the body so that the thirdtop surface 315 c abuts the secondtop surface 315 b, face-to-face, and the edge of the end cap rests substantially adjacent theledge 415, as in the second embodiment discussed above. In the finished sensor, thebottom surface 313 a of theend cap 327 becomes part of the top surface of the body and rests adjacent the firsttop surface 315 a, in essentially the same plane, as shown in FIG. 15. - When the end cap is folded onto the second
top surface 315 b of the body, adjacent theterminal end 316 of the body, a channel termed the “electrochemical reaction zone” 324 forms in the body. Thereaction zone 324 is bound on one side by the secondtop surface 315 b and, on the opposite side, by top surface of theend cap 327. The reaction zone has a volume defined by the shape of the body. Alternatively, if desired, the cap may be shaped so that when it is pivoted onto the body, the cap defines the volume of the reaction zone; or the shape of both the cap and the body may form the volume of the reaction zone. - Running throughout the longitudinal axis of the
body 312 are theleads reaction zone 324. FIGS. 17-19 show a sensor in accordance with the invention having twoelectrodes 330′,331′. - In the reaction zone or
cavity 324, the leads are not entirely embedded in the insulative material of the body. In thereaction zone 324, at least a portion of the leads—e.g., the tips, sides, or other portion—is exposed therein as sensingelectrodes body 312. Thereaction zone 324 lies primarily in the bottom lengthwise portion of the detector. Although the reaction lo zone may be formed above or below the electrodes, it is preferably constructed below the electrodes. - The
cap 327 is folded onto the body and securedly affixed to the body to form a substantially tight seal. As result of this configuration, acapillary opening 328 forms in theterminal end 316 of thesensor 310. Thecapillary opening 328 leads to thereaction zone 324 where the edges of thesensing electrodes capillary opening 328 is approximately the same as that of thesensing electrodes -
Body 312 may also have proturberances to ensure correct alignment of the surfaces when folded about the hinge. The protuberances are typically disposed on at least one of (a) the surface of the end cap that folds onto the body and (b) the top third surface of the body onto which the end cap folds that is covered by the end cap when folded onto the body. Although a variety of configurations are possible, in one embodiment, e.g., the protuberances may appear on both the end cap and theupper surface 315 b of the body. - In one embodiment, shown in FIG. 13, the protuberance comprises a
ridge 527 and a recessedsurface 528 that mate when the cap is folded onto the body, to form the reaction zone. In this embodiment, theridge 527 may be formed on the secondtop surface 315 b along the periphery of thereaction zone 324, and the recessed surface may be formed on thecap 327, or vice versa. Theridge 527 may also sit in and be substantially aligned with a secondary ridge (not shown), which increases the height ofridge 527. - In the
finished sensor 310, theridge 527 mates with recessedsurface 528 to form a seal, enclosing thereaction zone 324 within the body. Alternatively, theridge 527 and recessedsurface 528 may be further welded together by, e.g., ultrasonic energy, adhesive, or any other suitable techniques. The seal, so formed, prevents thereaction zone 324 from losing fluid or accepting debris. During welding, theridge 527 fuses into the recessedsurface 528 without affecting the performance of the sensor. - In yet another aspect of the third embodiment, shown in FIGS.17-20, the proturberance is an
energy director 529′ formed on at least one of the end cap and theupper surface 315 b′ of the body. A variety of configurations is possible such as one wherein the energy director is disposed entirely on the body for fusing with the cap when pivoting of the cap onto the body. As shown in the embodiment depicted in FIGS. 17-19, theenergy director 529′ typically comprises at least one protruding ridge extending preferably along the periphery of the end cap. Typically, the energy director extends along the three unattached sides of the end cap, although it may extend across portions of the sides. In the embodiment depicted, theenergy director 529′ begins athinge 427′ and extends on theend cap 327′ directionally away from thehinge 427′ and across the end farthest from the hinge. - When the cap is pivoted onto the body, the
energy director 529′ is generally melted by, e.g., ultrasonic energy or other conventional means, to induce formation of a strong, leak-free joint bond between the bottom surface and cap surface. The bond so formed seals the fluid within the chamber, preventing fluid from diffusing out from the reaction zone. Alternatively, a seal may be formed by the application of adhesives. - The sensor of the third embodiment is also a capillary fill device; i.e., when the
capillary opening 328′ is placed in contact with the fluid being tested, thereaction zone 324′ draws the fluid sample into the zone. Included incap 327′ issample fill vent 368′. Whencap 327′ is folded ontobody 312′, at least a portion of thesample fill vent 368′ is in communication with the reaction zone to form adepressurization vent 378′ for releasing air from the reaction zone as the zone fills with fluid. Thedepressurization vent 378′ extends between one edge of thesample fill vent 368′ and theledge 415′ of the reaction zone, which is the back wall of the reaction zone farthest from theterminal end 3 16′. FIGS. 20a,b show a magnified view of the terminal end portion of thesensor 310′ of FIG. 17. FIG. 20a shows thecap 327′ extended away from the body, and FIG. 20b shows thecap 327′ folded onto the body of the sensor. - The
depressurization vent 378′ provides for fill detection in the third embodiment. Fluid drawn through thecapillary opening 328′ travels along the capillary, preferably in the lower portion of thebody 312′, to thereaction zone 324′ where it contacts theelectrodes 331′,332′ ofsensor 310′ (orelectrodes sensor upper surface 315′ of the body is flush with the bottom periphery of thecapillary inlet 328′. As sample fluid enters thereaction zone 324′, it travels toward the end of the reaction zone farthest from the capillary inlet until it reaches thedepressurization vent 378′. As the fluid displaces air present in thedepressurization vent 378′, the fluid contacts at least one of the electrodes in the reaction zone, so as to close an open circuit in thesensor 310′ and cause current to flow through the sensor. The flow of current in the sensor activates the meter, signaling that the capillary chamber or reaction zone is sufficiently filled with fluid. Thedepressurization vent 378′ may also be used to visually detect fluid fill in the reaction zone. - The injection molded
body 312 is constructed of an electrically insulating injection moldable plastic. Thebody 312 is molded around the electrically conductive plate (stamped or cast) with itsleads body 312. The conductive plate is a single piece of material; it includes theleads segments 430 and 431 (reference no. 432 insensor 310′). After the sensor is made, thesegments - The body may have a plurality of guides molded therein with at least one of the guides abutting against at least one of the leads.
- The leads330,331,332 extend longitudinally through the
body 312 from theplug end 314 to thereaction zone 324, terminating just before theterminal end 316. The leads 330,331,332 are encased, or embedded, in thebody 312 at a pre-determined distance from each other; they are generally parallel to one another though this is not necessary for operation of the sensor. In the reaction zone, a sufficient portion of the leads are exposed for contacting the fluid sample; the exposed portion includes, e.g., at least the tips, ends, or sides of the electrodes. - The
electrodes leads reaction zone 324 to expose more or less surface area to the fluid and chemicals therein. The leads 330,331,332 extending through the body can be as wide as the exposed portion within the reaction zone, which comprises theelectrodes - Each of the
leads segment 333 a,b,c that may extend outside thebody 312 from theplug end 314 where the leads providesurface areas plug end 314; or the top surface of the leads comes in contact with the meter electrical contact leads. - Apertures molded into the
top surface 315 and thebottom surface 113 of thebody 312 permit fingers to be inserted into and removed from the mold during the molding process. Thetop surface 315 a has two sets of apertures—first apertures 346 andsecond apertures 347—each having three individual openings or apertures. Thebottom surface 313 hasthird aperture 348,fourth aperture 350, and fifth apertures, the latter including threeindividual apertures apertures - Within the
reaction zone 324,conductive electrodes primary working electrode 352, a reference orcounter electrode 353, and asecondary working electrode 354. In the reaction zone, theconductive electrodes sensor 310. The signal carried by the electrodes arises in thereaction zone 324 from contact made by the exposed portion of the electrode with the test sample. In the reaction zone, one electrode, preferably the center electrode is a reference electrode. The reaction zone may also have one or, alternatively, two working electrodes; e.g., primary workingelectrode 352 andsecondary electrode 354. - An enzyme, conjugated to another moiety, such as an antibody or antigen or an analyte, is applied to the outer surface of the
primary working electrode 352, and if desired, an electron transfer mediator may be applied to thesame electrode 352. An antibody may also be applied to the outer surface of the secondary workingelectrode 354 or otherwise present in the reaction zone. As such, thereaction zone 324 can contain antibodies, enzyme-antibody conjugates, enzyme-analyte conjugates, and the like. - The enzyme can be applied to the entire exposed surface of the
primary electrode 352 or thesecondary electrode 354. Alternatively, the enzyme is applied to a particular, defined portion of a working electrode. Or, an enzyme can be applied to all theelectrodes reaction zone 324. Preferably, one of the working electrodes (352 or 354) is selectively coated with the enzyme carrying a reagent with the enzyme, and the other working electrode (354 or 352) is coated with a reagent lacking the respective enzyme. - In yet another aspect of this third embodiment, the reaction zone or
cavity 324 may itself be coated with a substance—such as a reagent, an antibody, or an enzyme—that reacts with certain constituents in the fluid sample to change the electrochemical properties of the sample. The resulting change is readily detected by the electrodes and measured by the meter. - The Molding Process of the Third Embodiment
- The mold has the shape of the
body 312. The conductive 330,331,332 leads (in the form of a composite plate with the joiningextensions - The plate is fed into the mold and placed on or between fingers (not shown) that project into the mold through the openings in the mold, which correspond to the
apertures - Knives or punches (not shown) are inserted through the top surface of the mold (outline of opening formed by the knives/punches370). These knives punch and sever the joining
extensions - After the plastic has formed and hardened sufficiently, the fingers are removed from the mold through the openings; i.e.,
apertures upper surface openings 370, leaving the cut or skivedextensions leads sensor 312 is then ejected from the mold, and any undesirable openings in the sensor can be sealed closed with the same plastic used for the mold. - In a preferred alternative, the critical reagents are applied to the sensor in the
reaction zone 324 above the leads. A surfactant can also be applied to thecapillary opening 328 to facilitate the capillary function. Any extraneous metal projecting from the sensor can be cut and removed. In addition, any desired writings or other designations on the sensor (e.g., manufacturing codes, product name, etc.) Can be applied to the sensors by conventional means. - While the specific embodiments have been illustrated and described, numerous modifications come to mind without significantly departing from the spirit of the invention and the scope of protection is only limited by the scope of the accompanying claims. For instance, in another embodiment of the present invention, a sensor is designed for use with a light reflectance measuring meter for photometric detection of a dye contained within a fluid sample receiving well.
Claims (45)
1. An electrochemical device for cooperating with an electronic meter capable of measuring electrical properties between at least two electrically conductive electrodes, comprising:
at least two spaced apart electrically conductive electrodes;
a body of molded insulative material housing the electrodes and partially embedding at least a portion of each of the electrodes;
means for connecting the meter to the body;
means for receiving a fluid sample; and,
means for detecting when a sufficient amount of the fluid sample has been received by the device selected from the group consisting of an electrical indication and a visual indication;
one or more substances on at least one of the electrodes to change the electrical properties between the electrodes upon reacting with the fluid sample.
2. The electrochemical device of claim 1 wherein the electrodes are substantially molded into the insulative material.
3. The electrochemical device of claim 1 wherein there is 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.
4. The electrochemical device of claim 1 wherein there is an electron mediator on one or more of the electrodes.
5. The electrochemical device of claim 1 wherein the means for receiving the fluid sample is a capillary inlet adapted to draw the fluid sample into the body upon contact with the fluid sample.
6. The electrochemical device of claim 5 wherein the capillary inlet is molded into an end of the body and is in communication with a reaction zone.
7. The electrochemical device of claim 6 wherein the reaction zone is a channel formed in the body and is adapted for permitting the reaction of the fluid drawn into the body by the capillary force.
8. The electrochemical device of claim 5 wherein the capillary inlet is molded into the body and is in communication with a reaction zone, the reaction zone being a chamber formed in the body, adapted for permitting the reaction of the fluid drawn into the body by the capillary force, and in communication with a vent for relieving pressure.
9. The electrochemical device of claim 1 wherein the means for detecting when a sufficient amount of fluid sample has been received includes a depressurization vent formed in the body, in communication with a reaction zone, and allowing for fill detection to be made visually.
10. The electrochemical device of claim 1 wherein the means for detecting when a sufficient amount of fluid sample has been received includes a reaction zone in communication with a capillary inlet, the reaction zone having an interior surface and at least a portion of the at least two electrodes exposed therein for contacting the fluid sample drawn therein to activate the meter to indicate sufficient fill.
11. The electrochemical device of claim 10 wherein the reaction zone is in communication with a capillary inlet.
12. The electrochemical device of claim 1 wherein the means for detecting when a sufficient amount of fluid sample has been received includes a cavity forming a reaction zone in the body, the reaction zone having at least a portion of the at least two electrodes exposed therein for contacting the fluid sample drawn therein to activate the meter to indicate sufficient fill.
13. The electrochemical device of claim 12 wherein the reaction zone is in communication with a capillary inlet.
14. The electrochemical device of claim 1 wherein the means for detecting when a sufficient amount of fluid sample has been received includes a reaction zone in communication with a capillary inlet, the reaction zone having an interior surface and at least a portion of the at least two electrodes exposed therein for contacting the fluid sample drawn therein to activate the meter to indicate sufficient fill.
15. The electrochemical device of claim 14 wherein the reaction zone is in communication with a capillary inlet.
16. An electrochemical device for cooperating with an electronic meter capable of measuring electrical properties between at least two electrically conductive electrodes, comprising:
at least two spaced apart electrically conductive electrodes;
a body of molded insulative material housing the electrodes, partially embedding at least a portion of each of the electrodes, the body composed of at least two pieces, a body and an end cap, attached to one another;
means for connecting the meter to the body;
means for receiving a fluid sample; and,
means for detecting when a sufficient amount of the fluid sample has been received by the device selected from the group consisting of an electrical indication and a visual indication;
one or more substances on at least one of the electrodes to change the electrical properties between the electrodes upon reacting with the fluid sample.
17. The electrochemical device of claim 16 wherein the electrodes are substantially molded into the insulative material.
18. The electrochemical device of claim 16 wherein there is 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.
19. The electrochemical device of claim 16 wherein there is an electron mediator on one or more of the electrodes.
20. The electrochemical device of claim 16 wherein the means for receiving the fluid sample is a capillary inlet adapted to draw the fluid sample into the body upon contact with the fluid sample.
21. The electrochemical device of claim 20 wherein the capillary inlet is molded into an end of the body and is in communication with a reaction zone.
22. The electrochemical device of claim 21 wherein the reaction zone is a channel formed in the body and is adapted for permitting the reaction of the fluid drawn into the body by the capillary force.
23. The electrochemical device of claim 20 wherein the capillary inlet is molded into the body and is in communication with a reaction zone, the reaction zone being a chamber formed in the body, adapted for permitting the reaction of the fluid drawn into the body by the capillary force, and in communication with a vent for relieving pressure.
24. The electrochemical device of claim 16 wherein the means for detecting when a sufficient amount of fluid sample has been received includes a depressurization vent formed in the body, in communication with a reaction zone, and allowing for fill detection to be made visually.
25. The electrochemical device of claim 16 wherein the means for detecting when a sufficient amount of fluid sample has been received includes a reaction zone in communication with a capillary inlet, the reaction zone having an interior surface and at least a portion of the at least two electrodes exposed therein for contacting the fluid sample drawn therein to activate the meter to indicate sufficient fill.
26. The electrochemical device of claim 25 wherein the reaction zone is in communication with a capillary inlet.
27. The electrochemical device of claim 16 wherein the means for detecting when a sufficient amount of fluid sample has been received includes a cavity forming a reaction zone in the body, the reaction zone having at least a portion of the at least two electrodes exposed therein for contacting the fluid sample drawn therein to activate the meter to indicate sufficient fill.
28. The electrochemical device of claim 27 wherein the reaction zone is in communication with a capillary inlet.
29. The electrochemical device of claim 16 wherein the means for detecting when a sufficient amount of fluid sample has been received includes a reaction zone in communication with a capillary inlet, the reaction zone having an interior surface and at least a portion of the at least two electrodes exposed therein for contacting the fluid sample drawn therein to activate the meter to indicate sufficient fill.
30. The electrochemical device of claim 29 wherein the reaction zone is in communication with a capillary inlet.
31. An electrochemical device for cooperating with an electronic meter capable of measuring electrical properties between at least two electrically conductive electrodes, comprising:
at least two spaced apart electrically conductive electrodes;
a body of molded insulative material housing the electrodes, partially embedding at least a portion of each of the electrodes, the body having a hinge constructed therein for permitting the pivoting and connecting of a portion of the body onto itself;
means for connecting the meter to the body;
means for receiving a fluid sample; and,
means for detecting when a sufficient amount of the fluid sample has been received by the device selected from the group consisting of an electrical indication and a visual indication;
one or more substances on at least one of the electrodes to change the electrical properties between the electrodes upon reacting with the fluid sample.
32. The electrochemical device of claim 31 wherein the electrodes are substantially molded into the insulative material.
33. The electrochemical device of claim 31 wherein there is 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.
34. The electrochemical device of claim 31 wherein there is an electron mediator on one or more of the electrodes.
35. The electrochemical device of claim 31 wherein the means for receiving the fluid sample is a capillary inlet adapted to draw the fluid sample into the body upon contact with the fluid sample.
36. The electrochemical device of claim 35 wherein the capillary inlet is molded into an end of the body and is in communication with a reaction zone.
37. The electrochemical device of claim 36 wherein the reaction zone is a channel formed in the body and is adapted for permitting the reaction of the fluid drawn into the body by the capillary force.
38. The electrochemical device of claim 35 wherein the capillary inlet is molded into the body and is in communication with a reaction zone, the reaction zone being a chamber formed in the body, adapted for permitting the reaction of the fluid drawn into the body by the capillary force, and in communication with a vent for relieving pressure.
39. The electrochemical device of claim 31 wherein the means for detecting when a sufficient amount of fluid sample has been received includes a depressurization vent formed in the body, in communication with a reaction zone, and allowing for fill detection to be made visually.
40. The electrochemical device of claim 31 wherein the means for detecting when a sufficient amount of fluid sample has been received includes a reaction zone in communication with a capillary inlet, the reaction zone having an interior surface and at least a portion of the at least two electrodes exposed therein for contacting the fluid sample drawn therein to activate the meter to indicate sufficient fill.
41. The electrochemical device of claim 40 wherein the reaction zone is in communication with a capillary inlet.
42. The electrochemical device of claim 31 wherein the means for detecting when a sufficient amount of fluid sample has been received includes a cavity forming a reaction zone in the body, the reaction zone having at least a portion of the at least two electrodes exposed therein for contacting the fluid sample drawn therein to activate the meter to indicate sufficient fill.
43. The electrochemical device of claim 42 wherein the reaction zone is in communication with a capillary inlet.
44. The electrochemical device of claim 31 wherein the means for detecting when a sufficient amount of fluid sample has been received includes a reaction zone in communication with a capillary inlet, the reaction zone having an interior surface and at least a portion of the at least two electrodes exposed therein for contacting the fluid sample drawn therein to activate the meter to indicate sufficient fill.
45. The electrochemical device of claim 44 wherein the reaction zone is in communication with a capillary inlet.
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Also Published As
Publication number | Publication date |
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CA2442017A1 (en) | 2002-10-03 |
BR0208343A (en) | 2005-05-10 |
CN100380116C (en) | 2008-04-09 |
US20030201176A1 (en) | 2003-10-30 |
WO2002077606A2 (en) | 2002-10-03 |
CN1503905A (en) | 2004-06-09 |
US20050067737A1 (en) | 2005-03-31 |
US6572745B2 (en) | 2003-06-03 |
EP1379861A4 (en) | 2008-06-18 |
JP2005503536A (en) | 2005-02-03 |
EP1379861A2 (en) | 2004-01-14 |
US6849216B2 (en) | 2005-02-01 |
AU2002248674A1 (en) | 2002-10-08 |
US20020157947A1 (en) | 2002-10-31 |
WO2002077606A3 (en) | 2003-02-06 |
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