WO2011092010A1 - Electrode arrangements for biosensors - Google Patents
Electrode arrangements for biosensors Download PDFInfo
- Publication number
- WO2011092010A1 WO2011092010A1 PCT/EP2011/000353 EP2011000353W WO2011092010A1 WO 2011092010 A1 WO2011092010 A1 WO 2011092010A1 EP 2011000353 W EP2011000353 W EP 2011000353W WO 2011092010 A1 WO2011092010 A1 WO 2011092010A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- working electrode
- body portion
- main body
- capillary channel
- biosensor
- Prior art date
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Classifications
-
- 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
-
- 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
-
- 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
Definitions
- Electrochemical biosensors are known. They have been used to determine the concentration of various analytes from biological samples, particularly from blood. Electrochemical biosensors are described in U.S. Pat. Nos. 5,413,690; 5,762,770; 5,798,031 ; 5,997,8171;
- Glucose monitoring is a fact of everyday life for diabetic individuals. Failure to test blood glucose levels properly and on a regular basis can result in serious diabetes-related complications, including cardiovascular disease, kidney disease, nerve damage and blindness.
- a number of biosensors employ electrochemical analysis to determine the blood glucose level by measuring a current related to an analyte concentration.
- Such biosensors may employ a capillary channel with an electrode substrate providing a working electrode area in the capillary channel.
- the current response of the electrochemical cell is directly proportional to the working electrode area.
- variations in the working electrode area are created during the manufacture and assembly of the components of the biosensor that define the capillary channel. Variations in the working electrode area in the capillary channel from one biosensor to another are undesirable since the variation in electrode area introduces imprecision in the measured analyte concentration. Therefore, biosensor arrangements which minimize variations in the working electrode area in the manufacture of the biosensor are desirable.
- the present invention relates to a biosensor.
- the biosensor includes a support substrate, electrodes positioned on the support substrate, a spacer substrate positioned on the support substrate, and a cover positioned on the spacer substrate.
- the cover cooperates with the support substrate to define a capillary channel.
- the electrodes include at least one working electrode defining a working electrode area in the capillary channel.
- the working electrode is configured to minimize variation of the effective working electrode area in the capillary channel due to variations in the spacer substrate placement relative to the working electrode while also maximizing the effective working electrode area within the capillary channel.
- a biosensor comprises a support substrate extending between opposite first and second ends and opposite first and second edges; a spacer substrate positioned on the support substrate that includes an inner edge extending along the support substrate between the first and second ends and the first and second edges; a cover cooperating with the spacer substrate so that the inner edge of the spacer substrate defines a boundary of a capillary channel; and at least one working electrode in the capillary channel.
- the working electrode includes a width and a main body portion extending along a length transversely to the width between opposite ends of the main body portion.
- the main body portion includes at least two working electrode portions positioned along the length of the main body portion in the capillary channel with the at least two working electrode portions connected by at least one connecting portion.
- the working electrode further includes at least one connective neck extending from at least one of the opposite ends of the main body portion and across the inner edge of the spacer substrate.
- the two working electrode portions each define a minimum or least width that is greater than a maximum or greatest width of the connective neck, and the connecting portion defines a maximum or greatest width that is less than a minimum or least width of the connective neck.
- the capillary channel includes an inlet at the first end of the support substrate and the main body portion of the working electrode is located entirely within the capillary channel.
- the working electrode includes a second neck extending from the other of the opposite ends of the main body portion in the capillary channel, the second neck extending across the inner edge of the spacer substrate.
- the working electrode includes first and second connecting portions extending between and connecting the at least two working electrode portions to one another in the capillary channel.
- the first and second connecting portions each include a maximum or greatest width that is less than the minimum or least width of the connective neck, and the first and second connecting portions are separated from one another by a non-conductive space between the connecting portions and working electrode portions.
- the at least one connecting portion of the working electrode includes a plurality of rows of connecting portions extending between the at least two working electrode portions of the working electrode. Adjacent pairs of the rows of connecting portions are separated from one another by a non-conductive space, and each row of the connecting portions includes a maximum or greatest width that is less than the minimum or least width of the at least one connective neck.
- a biosensor comprises a support substrate extending between opposite first and second ends and opposite first and second edges; a spacer substrate positioned on the support substrate that includes an inner edge extending along the support substrate with the inner edge being located between the first and second ends and the first and second edges of the support substrate; a cover cooperating with the spacer substrate so that the inner edge of the spacer substrate defines a boundary of a capillary channel; and at least one working electrode.
- the at least one working electrode includes a main body portion defining a width and a length transverse to the width between opposite ends of the main body portion. The length and width are sized so that the main body portion is located in the capillary channel.
- the working electrode further includes first and second connective necks each extending from a respective one of the opposite ends of the main body portion and across the inner edge of the spacer substrate.
- the main body portion defines a minimum or least width that is greater than a maximum or greatest width of each of the first and second necks.
- Each of the first and second connective necks extends from the main body portion to an electrode lead on the support substrate so that each of the first and second connective necks provides an electrical connection with the working electrode.
- the main body portion of the working electrode includes a maximum width at a center of the main body portion and tapers in width from the center toward each of the first and second connective necks.
- the first connective neck extends to an electrode lead that extends along the support substrate to an electrode contact
- the second connective neck extends to an electrode looping portion located outside the capillary channel.
- the electrode looping portion joins the second connective neck to the electrode lead so that the working electrode forms a continuous loop located within and outside the capillary channel.
- a biosensor comprises a support substrate extending between opposite first and second ends and opposite first and second edges; a spacer substrate positioned on the support substrate that includes an inner edge extending along the support substrate, the inner edge extending from the first edge to the second edge adjacent the first end of the support substrate; a cover cooperating with the spacer substrate so that the inner edge of the spacer substrate defines a boundary of a capillary channel; and at least one working electrode in the capillary channel.
- the working electrode includes a main body portion with a length that extends toward the first and second edges within the capillary channel.
- the working electrode further includes a connective neck extending from an end of the main body portion toward the second end of the support substrate. The inner edge is spaced from the main body portion and extends across the connective neck where the connective neck is oriented to extend toward the second end of the support substrate.
- the main body portion of the working electrode is located entirely within the capillary channel.
- the working electrode includes first and second connective necks extending from opposite ends of the main body portion toward the second end of the support substrate and the inner edge extends across each of the first and second connective necks where the first and second connective necks are oriented toward the second end of the support substrate.
- the main body portion includes a minimum or least width along a substantial portion of the length and the connective neck includes a maximum or greatest width as measured in a direction toward the first and second edges of the support substrate, the minimum width of the main body portion being greater than the maximum width of the connective neck.
- a method for manufacturing a biosensor comprises: providing a support substrate; forming at least one working electrode on the support substrate, the working electrode including a main body portion and at least one connective neck extending from an end of the main body portion, wherein a width of the at least one connective neck is greater than a minimum or least width of part of the main body portion of the working electrode; and positioning a spacer substrate on the support substrate, the spacer substrate including an inner edge that defines a boundary of a capillary channel, the inner edge extending across the at least one connective neck of the working electrode so that the part of the main body portion defining the minimum width is located entirely within the capillary channel.
- a method for manufacturing a biosensor comprises: providing a support substrate; forming at least one working electrode on the support substrate, the working electrode including a main body portion defining a substantially constant width along a substantial portion of a length of the main body portion, the working electrode including a central portion projecting outwardly from the width; and positioning a spacer substrate on the support substrate so that opposite portions of an inner edge of the spacer substrate extend across opposite lateral portions of the main body portion and the central portion of the working electrode is positioned entirely within a capillary channel defined by portions of the inner edge, wherein the central portion occupies less than half of the length of the main body portion between the portions of the inner edge.
- FIG. 1 is a perspective view of one embodiment biosensor.
- FIG. 2 is a plan view with portions shown in partial phantom of the biosensor of FIG. 1.
- FIG. 3 is cross-section view of a portion of the biosensor of FIG. 1 along view line 3— 3.
- FIG. 4 is a plan view of a portion of the biosensor of Fig. 1 showing a sample revising chamber and electrode arrangement.
- FIG. 5 is a plan view of another embodiment capillary channel and electrode arrangement.
- FIG. 6 is a plan view of another embodiment capillary channel and electrode arrangement.
- FIG. 7 is a plan view of another embodiment capillary channel and electrode arrangement.
- FIG. 8 is a plan view of another embodiment capillary channel and electrode arrangement.
- FIG. 9 is a plan view of another embodiment capillary channel and electrode arrangement.
- FIG. 10 is a plan view of another embodiment capillary channel and electrode arrangement.
- FIG. 1 1 is a plan view of another embodiment capillary channel and electrode arrangement.
- FIG. 12 is a plan view of another embodiment capillary channel and electrode arrangement.
- FIG. 13 is a plan view of another embodiment capillary channel and electrode arrangement.
- FIG. 14 is a plan view of another embodiment capillary channel and electrode arrangement.
- FIG. 15 is a plan view of another embodiment capillary channel and electrode arrangement.
- FIG. 16 is a plan view of another embodiment capillary channel and electrode arrangement.
- FIG. 17 is a plan view of another embodiment capillary channel and electrode arrangement. DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
- the present invention relates to a biosensor and a method for manufacturing a biosensor that reduces sensitivity of the effective working electrode area to manufacturing variations.
- the present invention improves precision and accuracy of current measurements in
- FIGS. 1-17 are not drawn to scale and wherein like components in the several views are numbered alike.
- FIGS. 1 -3 illustrate an aspect of the invention in the form of a biosensor 10 having an electrode-support substrate 12, an electrical conductor 13 positioned on the support substrate 12 that defines electrodes 14, 16, 18, a spacer substrate 20 positioned on support substrate 12, and a cover 22 positioned on the spacer substrate 20.
- Spacer substrate 20 defines a capillary channel 25 along support substrate 12.
- Electrodes 14, 16, 18 include at least one working electrode that defines an effective working electrode area in capillary channel.
- the effective working electrode area is the area of the working electrode that contacts a fluid sample in capillary channel 25 when the capillary channel 25 includes sufficient volume of the fluid sample to initiate measurement sequence.
- Biosensor 10 is shown as rectangular in shape, it being understood, however, that biosensor 10 can be provided in any one of a number of shapes in accordance with principles of this disclosure. Furthermore, biosensor 10 can be any one of a substantial quantity of biosensors produced from rolls of material, sheets of material, or other material stock in accordance with the principles of this disclosure. In one embodiment, the selection of materials for the construction of biosensor 10 includes a stock sufficiently flexible for roll processing, but still rigid enough to give a useful stiffness to finished biosensor 10. The biosensor arrangement and method for manufacturing the biosensor described herein minimizes variations in effective working electrode area from one biosensor to the next, improving precision and accuracy of current readings measured by the working electrode during electrochemical analysis of a fluid sample.
- Variation in effective working electrode area can be caused by imprecision in forming the working electrode, or at least the portion of the working electrode exposed within the capillary channel.
- the variation problem attempted to be solved by the present invention is caused by imprecision in forming the capillary channel itself where the effective working area is exposed.
- imprecision may lie in the inner edge or edges formed in the spacer layer to define the capillary channel. This affects effective working electrode area where the working electrode extends across that inner edge, wherein deviation of the inner edge of the spacer at that location directly increases or decreases the exposed portion of the working electrode within the capillary channel, thereby increasing or decreasing the effective working electrode area.
- the present invention relates to working electrode configurations designed to minimize the overall impact of imprecision of the inner edge on the total working electrode area exposed in the capillary channel.
- Support substrate 12 includes a first surface 24 facing the spacer substrate 20 and a second surface 26 opposite first surface 24.
- support substrate 12 has opposite first and second ends 28, 30 and opposite edges 32, 34 extending between the first and second ends 28, 30. While ends 28, 30 and edges 32, 34 of support substrate 12 are illustrated to form a generally rectangular shape, it should be understood that the ends and edges of support substrate 12 may form any one of a variety of shapes and sizes in accordance with the principles of this disclosure.
- support substrate 12 can be formed of a flexible polymer, including, for example, a polyester or polyimide, such as polyethylene naphthalate (PEN). Other suitable materials for support substrate 12 as would occur to one of ordinary skill in the art are also contemplated.
- PEN polyethylene naphthalate
- Electrodes 14, 16, 18 are formed from conductor 13 provided on first surface 24 of support substrate 12.
- material suitable for electrical conductor 13 include aluminum, carbon (such as graphite), cobalt, copper, gallium, gold, indium, iridium, iron, lead, magnesium, mercury (as an amalgam), nickel, niobium, osmium, palladium, platinum, rhenium, rhodium, selenium, silicon (such as highly doped polycrystalline silicon), silver, tantalum, tin, titanium, tungsten, uranium, vanadium, zinc, zirconium, mixtures thereof, and alloys, oxides, or metallic compounds of these elements.
- electrodes 14, 16, 18 are isolated from the rest of the electrical conductor 13 by laser ablation or laser scribing, and electrodes 14, 16, 18 are created by removing the electrical conductor 13 from an area extending around the electrodes either broadly, such as by broad field ablation, or minimally, such as by line scribing.
- Other embodiments contemplate other techniques for forming electrodes 14, 16, 18 as would occur to those of ordinary skill in the art, such as lamination, screen-printing, or photolithography.
- Electrodes 14 and 18 define reference or counter electrode 60 and electrode 16 defines working electrode 70, at least a portion of each of which are located in capillary channel 25.
- Leads 62, 64 extend away from the counter electrode 60, and lead 72 extends away from working electrode 70.
- Leads 62, 64, 72 extend from the electrodes 60, 70 to contacts 36, 38, 40, respectively, at the second end 30 of the electrode-support substrate 12.
- Contacts 36, 38, 40 provide an electrical connection with a meter (not shown) or other device when biosensor 10 is positioned therein.
- the leads 62, 64, 72 extending from the electrodes 60, 70 can be formed to have any suitable length and extend to any suitable location on the electrode-support substrate 12.
- the configuration of the electrodes, the number of electrodes, as well as the spacing between the electrodes may vary in accordance with this disclosure and that more than two electrodes may be formed as illustrated and discussed further herein.
- Spacer substrate 20 of biosensor 10 includes a first member 40 extending between the edges 32, 34 of the electrode-support substrate 12. It is contemplated that spacer substrate 20 may be comprised of a single member or a plurality of members.
- First member 40 includes an inner edge 50 facing the capillary channel 25 and defining a boundary of capillary channel 25.
- the inner edge 50 includes multiple portions 50a, 50b, 50c located between ends 28, 30 and edges 32, 34. Edge portions 50a, 50b, 50c extend along at least three sides of the capillary channel 25 in a generally U-shaped pattern to define the boundary of capillary channel 25 having a sample inlet 46 at an end 28 of the biosensor.
- the inlet 46 may also be provided at one of the edges 32, 34 as desired (not shown).
- Other embodiments contemplate an inner edge 50 that is linear, such as shown in FIGS. 15-17.
- Still other embodiments contemplate an inner edge 50 that forms hemi-ovular, semi-circular, or other shaped capillary channels, and the one or more of the portions of inner edge 50 may include linear or non-linear edges along all or part of its length.
- Biosensor 10 is arranged to maximize the effective area of working electrode 70 certain to be exposed when spacer substrate 20 is positioned on support substrate 12 relative to the effective area of working electrode 70 that may be unintentionally exposed or covered by spacer substrate 20.
- Spacer substrate 20 is formed from an insulative material, such as, for example, a flexible polymer including an adhesive coated polyethylene terephthalate (PET)-polyester.
- PET polyethylene terephthalate
- a non- limiting example of a suitable material includes a white PET film, both sides of which are coated with a pressure-sensitive adhesive.
- spacer substrate 20 may be constructed of a variety of materials and includes an inner surface 44 that may be coupled to support substrate 12 and an outer surface 48 coupled to the cover substrate 22 using any one or combination of a wide variety of commercially available adhesives. Additionally, when surface 24 of support substrate 12 is exposed and not covered by electrical conductor 13, spacer substrate 20 may be coupled to support substrate 12 by welding, such as heat or ultrasonic welding.
- first surface 24 of support substrate 12 may be printed with, for example, product labeling or instructions (not shown) for use of biosensor 10.
- Cover substrate 22 is coupled to upper surface 48 of spacer substrate 20.
- Cover substrate 22 includes an inner surface 58 facing spacer substrate 20 and an outer surface 59.
- cover substrate 22 includes opposite first and second ends 61 , 63 and edges 66, 68 extending between the first and second ends 61 , 63.
- cover 22 cooperates with the spacer support substrate 20 and the electrode-support substrate 12 to define a sample receiving chamber or capillary channel 25.
- Cover substrate 22 is generally rectangular in shape; it is appreciated, however, that the cover substrate 22 may be formed in one of a variety of shapes and sizes in accordance with the principles of this disclosure.
- Cover substrate 22 may be formed from a flexible polymer and preferably from a polymer such as a polyester or polyimide.
- a non-limiting example of a suitable polymer is a hydrophilic polyester film.
- capillary channel 25 includes a sample inlet 46 between cover 22 and support substrate 12 adjacent to ends 61 and 28. As shown in FIGS. 1 and 2, capillary channel 25 is located between edges 32, 66 and edges 34, 68 respectively. Capillary channel 25 may also include one or more holes through cover 22 or additional channels extending to edges 32, 66 and/or edges 34, 68 that serve as air outlets. Capillary channel 25 is also defined by inner edge 50 of first member 40 of the spacer substrate 20. Therefore, when biosensor 10 is assembled, capillary channel 25 extends across at least a portion of counter and working electrodes 60, 70. It is further contemplated that electrochemical reagents can be positioned on counter and working electrodes 60, 70.
- the reagents provide electrochemical probes for specific analytes.
- the choice of specific reagents depend on the specific analyte or analytes to be measured, and are well known to those of ordinary skill in the art.
- An example of a reagent that may be used in biosensor 10 is a reagent for measuring glucose from a whole blood sample.
- One arrangement of counter electrode 60 and working electrode 70 in capillary channel 25 is further shown in FIG. 4.
- Working electrode 70 includes a main body portion 74 having length between opposite ends, and a minimum or least width Wl transverse to and along a substantial portion of its length. The length and width are sized so that main body portion 74 is located entirely in capillary channel 25.
- Connective necks 76 extend from opposite ends of main body portion and across inner edge 50. Connective necks 76 each have a maximum or greatest width W2 that is substantially less than minimum width W l . Connective necks 76 include a length sized so that portions 50a, 50c of inner edge 50 are certain to be positioned on connective necks 76 and not main body portion 74. Since the area of the main body portion 74 certain to be in capillary channel 25 is substantially greater than the area of connective necks 76, variation in the effective working electrode area in capillary channel 25 created by variations in the size and shape of inner edge 50 and by the placement of spacer substrate 20 on support substrate 12 is minimized.
- connection accuracy is improved by both connective necks 76 providing connectivity of working electrode 70 to contact 40 through at least lead 72.
- An electrode looping portion 78 extends under spacer substrate 20 from connective neck 76 on one side of working electrode 70 and is joined to lead 72 extending from the other connective neck 76 at a location adjacent to the capillary channel 25.
- the connective necks 76 further enable minimizing the effective area of the looping portion which minimizes the susceptibility of the electrode, particularly the working electrode, to electromagnetic interference.
- FIG. 5 shows a portion of another embodiment of an electrode arrangement for biosensor 100, with features that can be employed in combination with any of the other features of the other biosensor embodiments discussed herein.
- Biosensor 100 includes capillary channel 25 with first counter electrode 60 and a second counter electrode 160.
- a working electrode 170 is positioned in capillary channel 25 between counter electrodes 60, 160.
- a sample sufficiency working electrode (SSWE) 180 is positioned at the end of capillary channel 25 opposite inlet 46 to detect when a sufficient volume of analyte sample is received in capillary channel 25.
- Working electrode 170 is similar to working electrode 70, and includes a main body portion 174 having length between opposite ends and a minimum width Wl located entirely in capillary channel 25.
- Connective necks 176 extend from the opposite ends of main body portion 174 and across inner edge 50. Connective necks 176 have a maximum width W2 that is substantially less than minimum width Wl . Since the area of the main body portion 174 in certain to be located in capillary channel 25 is substantially greater than the area of connective necks 176 that varies in capillary channel 25, variation in the effective working electrode area in capillary channel 25 created by variations in the size of the channel formed by inner edge 50 and the placement of spacer substrate 20 on support substrate 12 is minimized. Furthermore, only one of connective necks 176 provides connectivity of working electrode 170 to contact 40. The other connective neck 176 extends to a sense lead connection 178, which extends along support substrate 12 to another contact (not shown) of biosensor 100.
- FIG. 6 shows a portion of another embodiment of an electrode arrangement for biosensor 200, with features that can be employed in combination with any of the other features of the other biosensor embodiments discussed herein.
- Biosensor 200 includes capillary channel 25 with first counter electrode 60 and a second counter electrode 260.
- Counter electrodes 60, 260 extend across inner edge 50 to leads 62, 262 located along edge 32 of support substrate 12.
- a working electrode 270 is positioned in capillary channel 25 between counter electrodes 60, 260.
- a SSWE 280 and a sample sufficiency counter electrode (SSCE) 290 are positioned at the end of capillary channel 25 opposite inlet 46 to detect when a sufficient volume of analyte sample is received in channel 25.
- SSWE 280 and SSCE 290 extend along leads to contacts (not shown) on support substrate 12.
- Working electrode 270 includes a main body portion with a pair of working electrode portions 274a, 274b spaced along its length.
- Working electrode portion 274a, 274b each have a minimum width Wl transverse to the length, and are sized to be located entirely in capillary channel 25.
- Necks 276 extend from the opposite ends of respective ones of the working electrode portions 274a, 274b and include sufficient lengths to extend across inner edge 50 to a location outside capillary channel 25.
- One of the necks 276 is a terminal neck, meaning generally that it terminates outside the capillary channel and does not extend or lead to another portion of the electrode 16, while the other neck 276 is connected with a lead that extends to at least one contact 40 on support substrate 12.
- Necks 276 each have a maximum width W2 that is substantially less than minimum width W l .
- FIG. 7 shows a portion of another embodiment electrode arrangement for biosensor 200', which can be identical to biosensor 200 except as otherwise noted.
- Biosensor 200' includes a capillary channel 25 with a working electrode 270' positioned in capillary channel 25 between counter electrodes 60, 260.
- Working electrode 270' includes a main body portion with a pair of working electrode portions 274a, 274b each having minimum width W l , and necks 276 extending from opposite ends of respective ones of the working electrode portions 274a, 274b and across inner edge 50. Necks 276 have maximum width W2 that is
- main body portions 274a, 274b are connected to one another by a pair of connecting portions 278a, 278b that each has a maximum width W3 that is less than a minimum width of each of necks 276.
- FIG. 8 shows a portion of another embodiment electrode arrangement for biosensor 200", which can be identical to biosensor 200 except as otherwise discussed herein.
- Biosensor 200" includes a capillary channel 25 with a working electrode 270" positioned in capillary channel 25 between counter electrodes 60, 260.
- Working electrode 270" includes a main body portion with a pair of working electrode portions 274a", 274b" each having a minimum width W l located in capillary channel 25, and necks 276 extending from opposite ends of respective ones of working electrode portions 274a", 274b” and across inner edge 50. Necks 276 have a maximum width W2 that is substantially less than minimum width Wl .
- main body portions 274a", 274b" are connected to one another by a connecting portion 278 that has a maximum width W3 that is less than the minimum width of connective necks 276.
- Working electrode portions 274a", 274b" each include an oval shape that extends between the respective neck 276 and connecting portion 278.
- the increased area of the working electrode portions is formed by adding electrode material to the location between neck 276 and connecting portion 278.
- the increased area of the electrode portion is formed by removing or covering sufficient electrode material between and around main body portions 274a", 274b" to form connecting portion 278 and necks 276.
- insulator material could be printed, or adhesive and/or spacer material placed, in capillary channel 25 to cover sufficient conductor material to form the desired shape and configuration of the main body portion.
- FIG. 9 shows a portion of another embodiment electrode arrangement for biosensor 200"', which can be identical to the other biosensor embodiment 200 except as otherwise noted.
- Biosensor 200"' includes a capillary channel 25 with a working electrode 270"' positioned in capillary channel 25 between counter electrodes 60, 260.
- Working electrode 270"' includes an outwardly projecting central body portion 274a'" that has a minimum width Wl located in capillary channel 25, and lateral portions 276a'", 276b'" extending from opposite ends of the central body portion 274a" 'and across inner edge 50.
- Each of lateral portions 276a'", 276b'" has a maximum width W2 that is substantially less than first width Wl .
- lateral portions 276a'", 276b'" extend along a substantial portion of the length of working electrode 270"' between opposite portions of edge 50 in capillary channel 25.
- lateral portions 276a'", 276b'" extend along at least 50% of the overall length of working electrode 270"' between the opposite sides of inner edge 50. In another embodiment, lateral portions 276a'", 276b'" extend along at least 75% of the overall length of working electrode 270"' between the opposite sides of inner edge 50.
- the outwardly projecting central body portion 274a'" increases the effective area of the working electrode 270"' certain to be located in capillary channel 25, reducing the effect of variability in the effective working electrode area created by inner edge 50.
- Central body portion 274a'" is formed in one embodiment by including additional conductor material to the working electrode between lateral portions 276a'", 276b'" to increase the width at or near the center of working electrode 270"'.
- the spacer may be configured (or insulative material added) so that the exposed width of lateral portions 276"' is reduced, with the unreduced portion of the width forming central body portion 274a'".
- the at least one connective portions of the embodiments of FIGS. 6-8 and the central body portion of the embodiment of FIG. 9 may be used as positive or negative registration patterns for purposes of manufacturing.
- manufacturing equipment can be configured to optically detect the location of the connective portions or central body portion for determining proper placement of adhesive or of the spacer itself.
- FIG. 10 shows another embodiment of biosensor 300 with features that can be employed in combination with any of the other features of the other biosensor embodiments discussed herein.
- Biosensor 300 includes a working electrode 370 with a main body portion 374 defining a minimum width W l and opposite necks 376 extending from the ends of main body portion 374 and across inner edge 50 to a location outside capillary channel 25.
- Main body portion 374 is located within capillary channel 25.
- Necks 376 each define a maximum width W2 that is substantially less than minimum width W l .
- Main body portion 374 is comprised of a series of interconnected rows 378 and columns of working electrode portions 380 to form a grid-shaped pattern.
- Non-conductive areas 382 lie between the rows and columns 378, 380.
- Each of the rows and columns 378, 380 defines a maximum width that is less than a minimum width of necks 376.
- counter electrodes 360, 390 include thickened end portions 362, 392, respectively, that extend into capillary channel 25, and a central section 364, 394, respectively, that extend across capillary channel 25 to the respective end portions 362, 392.
- End portions 362, 392 and central sections 364, 394 frame the grid-shaped main body portion
- FIG. 1 1 embodiment is identical to biosensor 300, except that biosensor 300' includes counter electrodes 360', 390' each including a uniform width extending entirely across capillary channel 25 and through inner edge 50 to a location outside capillary channel 25.
- FIG. 12 shows another embodiment biosensor 300" that is identical to the other biosensor embodiment 300' except that it includes only an SSWE 386" rather than a dual sample sufficiency electrode arrangement, and also includes another configuration of the working electrode 370.
- Working electrode 370" includes a main body portion 374" located within capillary channel 25.
- Main body portion 374" is formed by a plurality of elongated rows 376" of working electrode portions separated by respective ones insulated or non-conductive elongated row portions 378".
- Main body portion 374" also includes opposite working electrode end portions 380" extending across the respective ends of rows 376" to connect rows 376" with respective ones of the necks 382" .
- Each of the rows 376" defines a maximum width Wl and each of the necks 376" defines a minimum width W2 that is greater than width W l .
- main body portion 374" includes a minimum overall width at end portions 380" that is greater than a maximum width of necks 382".
- One useful aspect of certain of these embodiments having the "open" areas or non-conductive portions of the working electrode that are completely or at least partially surrounded by conductive portions of the electrode, such as shown in Figs. 10- 12, is that the working electrode will behave like a planar electrode having an area corresponding to the actual area of the working electrode portions over short durations. Over longer durations, however, the working electrode will behave like a planar electrode having an area that encompasses both the actual area of the working electrode portions and the area of the bounded non-conductive portions. Thus, over time, the working electrode area appears to increase, allowing the biosensor to take advantage of the different time course of the current measured.
- the time constants for this change in current measurement are related to the diffusion coefficient of the electroactive substance in the measured fluid or sample substance.
- FIG. 13 shows another embodiment biosensor 400 with features can be employed in combination with any of the other features of the other biosensor embodiments discussed herein.
- Biosensor 400 includes capillary channel 25 with a first counter electrode 460 and a second counter electrode 490.
- a working electrode 470 is positioned in capillary channel 25 between counter electrodes 460, 490.
- Working electrode 470 includes a main body portion 474 having a maximum first width Wl located in capillary channel 25, and necks 476 extending from opposite ends of main body portion 474 and across inner edge 50. Necks 476 each include a maximum width W2 that is substantially less than maximum width Wl .
- main body portion 474 tapers from maximum width Wl at or near the center of main body portion 474 to a minimum width W3 at the junction with respective ones of necks 476, where the minimum width W3 of main body portion 476 is greater than maximum width W2 of necks 476.
- Counter electrodes 460, 490 are arranged in an opposite manner so that each has a minimum width at or near its center that increases away from the minimum width toward the portions of inner edge 50 on opposite sides of counter electrodes 460, 490. This arrangement maximizes the working electrode area and counter electrode area in capillary channel 25 while also providing a greater effective area of working electrode area 470 certain to be located between the portions of inner edge 50 defining capillary channel 25 relative to the area of necks 476 certain to extend across inner edge 50.
- FIG. 14 shows another embodiment biosensor 500 with features that can be employed in combination with any of the other features of the other biosensor embodiments discussed herein.
- Biosensor 500 includes capillary channel 25 with a first counter electrode 560 and a second counter electrode 590.
- a working electrode 570 is positioned in capillary channel 25 between counter electrodes 560, 590.
- Working electrode 570 includes a main body portion 574 with a plurality of node shaped working electrode portions 578 connected to one another with connecting portions 580.
- Necks 576 extend from opposite sides of main body portion 574 and across inner edge 50.
- Working electrode portions 578 each have a maximum width Wl located in capillary channel 25, and necks 576 each have a maximum width W2 that is substantially less than first width W l .
- Connective portions 578 each include a maximum width W3 that is less than a minimum width of necks 576.
- working electrode portions 578 each include a substantially circular shape.
- other embodiments contemplate other node-like shapes for working electrode portions 578, including oval, square, rectangular, polygonal, and non-circular shapes, for example.
- the plurality of nodes include five node-shaped working electrode portions and the connecting portion includes four connecting portions, and adjacent pairs of the working electrode portions are connected by respective ones of the four connecting portions.
- Other embodiments contemplate two or more node-shaped portions with an appropriate number of connecting portions connecting the node-shaped portions.
- FIG. 15 shows another embodiment biosensor 600 that is a full width end dose biosensor.
- Biosensor 600 includes a capillary channel 625 that extends across the entire width of support substrate 612. The edge 650 of capillary channel is formed by spacer substrate 620. A first counter electrode 660 and a second counter electrode 690 extend across capillary channel 625, and a working electrode 670 is located in capillary channel 625 between counter electrodes 660, 690. SSCE 692 and SSWE 694 are located in capillary channel 625 adjacent the edges of support substrate 612. The portions of biosensor 600 not described can include any of the features of the biosensor embodiments discussed herein.
- Working electrode 660 includes a main body portion 674 extending laterally between toward the side edges of support substrate 612, and opposite connective necks 676 that extend transversely from main body portion 674 toward the end of biosensor 600 opposite capillary channel 625.
- Spacer substrate 612 is positioned so that inner edge 650 extends across connective necks 676 and so that main body portion 674 is located entirely within capillary channel 625. This arrangement maximizes the area of working electrode 670 certain to be located in capillary channel 625 relative to the variation in effective working electrode area that may result due to the placement location of inner edge 650 along connective necks 676 and/or due to any irregularities in the boundaries of capillary channel 625 formed by inner edge 650.
- FIG. 16 shows another embodiment of the biosensor 600 of FIG. 15.
- Biosensor 600' includes a working electrode 670' that includes only one connective neck 676' extending from main body portion 674' across inner edge 650.
- the effective area of the working electrode 670' in capillary channel 625 formed by connective neck 676' is half of that formed by the connective necks 676 of the FIG. 15 embodiment. Therefore, the area of main body portion 674' of working electrode 670' certain to be located in capillary channel 625 is substantially greater than any variation in effective working electrode area that may result due to the placement location of inner edge 650 along connective neck 676' and/or due to any irregularities in the boundaries of capillary channel 625 formed by inner edge 650.
- FIG. 16 further varies from the embodiment of FIG. 15 in the
- Counter electrodes 660', 690' are connected to a single lead 662' along one side of support substrate 612.
- inner edge 650 extends along and partially overlaps counter electrode 690, 690'.
- Biosensor 600 includes a working electrode 670" that includes only one connective neck 676" extending from main body portion 674" across inner edge 650. Furthermore, working electrode 670" includes a minimum width Wl along all or a substantial portion of its length that is substantially greater than a maximum width W2 of the portion of connective neck 676" extending across inner edge 650.
- the area of working electrode 670" certain to be located in capillary channel 625 is maximized and substantially greater than any variation in effective working electrode area that may result due to the placement location of inner edge 650 along the reduced width portion of connective neck 676" and/or due to any irregularities in the boundaries of capillary channel 625 formed by inner edge 650.
- the biosensors are typically packaged in a vial, usually with a stopper or other arrangement formed to seal the vial. It is appreciated, however, that the biosensors may be packaged individually, or biosensors can be folded upon one another, rolled in a coil, stacked in a cassette magazine, packed in blister packaging.
- the packaging is formed as a card with removable individual segments comprised of biosensors, examples of which may be found in U.S. Application No. 12/198, 197 entitled "BIOSENSOR TEST STRIP CARDS,” the contents of which are incorporated herein by reference in its entirety.
- biosensors include the herein described arrangements to maximize the area of the working electrode certain to be located in the capillary channel relative to the area of the portion of the working electrode affected by placement of the inner edge of the spacer substrate, the precision of the analyte measurements taken with the biosensors is improved.
- fluid sample types may be analyzed using the biosensors discussed herein.
- human body fluids such as whole blood, plasma, sera, lymph, bile, urine, semen, cerebrospinal fluid, spinal fluid, lacrimal fluid and stool specimens as well as other biological fluids readily apparent to one skilled in the art may be measured.
- Fluid preparations of tissues can also be assayed, along with foods, fermentation products and environmental substances, which potentially contain environmental contaminants.
- whole blood is assayed with the biosensor.
- a user of the biosensor places a finger having a blood collection incision or puncture against the inlet to the capillary channel.
- the liquid blood sample dissolves the reagents and engages the electrodes in the capillary channel where the electrochemical reaction takes place.
- a power source e.g., a battery
- the potential difference is applied, the amount of oxidized form of the mediator at the reference or counter electrode and the potential difference must be sufficient to cause electro-oxidation of the reduced form of the mediator at the surface of the working electrode.
- a current measuring meter (not shown) measures the current generated by the oxidation of the reduced form of the mediator at the surface of the working electrode.
- biosensors discussed herein minimize the variation in the working electrode area in the capillary channel, improving the accuracy and precision of the measured current from one biosensor to the next.
- An example of a biosensor configured for use with electrochemical techniques is the ACCU- CHE ® Aviva test strip, which is described more fully in U.S. Patent Application
- One illustrative method for manufacturing a biosensor includes providing a support substrate; forming at least one working electrode on the support substrate, the working electrode including a main body portion and at least one connective neck extending from an end of the main body portion, wherein a width of the at least one connective neck is greater than a minimum width of part of the main body portion of the working electrode; and positioning a spacer substrate on the support substrate, the spacer substrate including an inner edge that defines a boundary of a capillary channel, the inner edge extending across the at least one connective neck of the working electrode so that the part of the main body portion defining the minimum width is located entirely within the capillary channel.
- the method may also include positioning a cover on at least the spacer substrate to form the capillary channel between the support substrate and the cover.
- the biosensor is a glucose sensor.
- the main body portion of the working electrode includes first and second working electrode portions and a connecting portion extending between the first and second working electrode portions, the connecting portion defining the part of the main body portion and first and second working electrode portions each define a minimum width in the capillary channel that is greater than the maximum width of the at least one connective neck.
- the connecting portion includes a plurality of connecting portions forming rows extending between the first and second working electrode portions, each of the connecting portions defining a width that corresponds to the minimum width.
- the first and second working electrode portions include a plurality of working electrode portions spaced along the plurality of connecting portions to form a grid-like pattern for the main body portion of the working electrode.
- Another illustrative method for manufacturing a biosensor includes providing a support substrate; forming at least one working electrode on the support substrate, the working electrode including a main body portion defining a substantially constant width along a substantial portion of a length of the main body portion, the working electrode including a central portion projecting outwardly from the width; and positioning a spacer substrate on the support substrate so that opposite portions of an inner edge of the spacer substrate extend across opposite lateral portions of the main body portion and the central portion of the working electrode is positioned entirely within a capillary channel defined by portions of the inner edge, wherein the central portion occupies less than half of the length of the main body portion between the portions of the inner edge.
- the central portion occupies less than one fourth of the length of the main body portion between the portions of the inner edge.
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Abstract
Description
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JP2012550369A JP5663601B2 (en) | 2010-01-29 | 2011-01-27 | Biosensor electrode array |
CN201180007453.1A CN102713610B (en) | 2010-01-29 | 2011-01-27 | Electrode arrangements for biosensors |
MX2012008384A MX2012008384A (en) | 2010-01-29 | 2011-01-27 | Electrode arrangements for biosensors. |
EP11701623A EP2529219A1 (en) | 2010-01-29 | 2011-01-27 | Electrode arrangements for biosensors |
CA2786799A CA2786799A1 (en) | 2010-01-29 | 2011-01-27 | Electrode arrangements for biosensors |
HK13103878.6A HK1176994A1 (en) | 2010-01-29 | 2013-03-27 | Electrode arrangements for biosensors |
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US12/696,316 US20110186428A1 (en) | 2010-01-29 | 2010-01-29 | Electrode arrangements for biosensors |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2014140161A1 (en) * | 2013-03-15 | 2014-09-18 | Roche Diagnostics Gmbh | Electrode configuration for a biosensor |
EP2848928A1 (en) * | 2013-09-12 | 2015-03-18 | Joinsoon Medical Technology Co., Ltd. | Biosensor test strip for biosensor test device |
US10429336B2 (en) | 2014-06-05 | 2019-10-01 | Roche Diabeters Care, Inc. | Electrode arrangements for test element integrity |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102004011648A1 (en) * | 2004-03-10 | 2005-09-29 | Roche Diagnostics Gmbh | Test element analysis system with hard-coated contact surfaces |
EP2602620A1 (en) * | 2011-12-07 | 2013-06-12 | Nxp B.V. | An electronic lateral flow test arrangement and method |
EP3063169B1 (en) | 2013-10-29 | 2018-10-10 | F. Hoffmann-La Roche AG | Nano-enzyme containers for test elements |
EP4033235A1 (en) | 2014-11-03 | 2022-07-27 | Roche Diabetes Care GmbH | Methods of use of electrode arrangements for electrochemical test elements |
US9739774B2 (en) | 2015-09-03 | 2017-08-22 | Nxp B.V. | Substance detection device |
EP3457121A1 (en) * | 2017-09-18 | 2019-03-20 | Roche Diabetes Care GmbH | Electrochemical sensor and sensor system for detecting at least one analyte |
KR20190056820A (en) | 2017-11-17 | 2019-05-27 | 전자부품연구원 | A common electrode probe and diagnostic apparatus using the same |
EP3885761A1 (en) | 2020-03-27 | 2021-09-29 | ARKRAY, Inc. | Biosensor and measurement method using the same |
Citations (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4999482A (en) | 1988-05-24 | 1991-03-12 | Goldstar Co, Ltd. | Optical scanning system for a bar code reader |
US5352351A (en) | 1993-06-08 | 1994-10-04 | Boehringer Mannheim Corporation | Biosensing meter with fail/safe procedures to prevent erroneous indications |
US5413690A (en) | 1993-07-23 | 1995-05-09 | Boehringer Mannheim Corporation | Potentiometric biosensor and the method of its use |
US5424035A (en) | 1993-03-31 | 1995-06-13 | Boehringer Mannheim Gmbh | Test strip analysis system |
US5438271A (en) | 1993-06-08 | 1995-08-01 | Boehringer Mannheim Corporation | Biosensing meter which detects proper electrode engagement and distinguishes sample and check strips |
US5463467A (en) | 1993-06-29 | 1995-10-31 | Boehringer Mannheim Gmbh | Light source pulsed with irregular pulse sequence in analog photometric signal evaluation for a test carrier analysis system |
EP0732406A1 (en) * | 1995-03-17 | 1996-09-18 | Matsushita Electric Industrial Co., Ltd. | A method and a device for quantifying a substrate in a sample liquid using a biosensor |
US5762770A (en) | 1994-02-21 | 1998-06-09 | Boehringer Mannheim Corporation | Electrochemical biosensor test strip |
US5798031A (en) | 1997-05-12 | 1998-08-25 | Bayer Corporation | Electrochemical biosensor |
US5889585A (en) | 1996-09-24 | 1999-03-30 | Lre Technology Partner Gmbh | Method and apparatus for the measurement of blood sugar |
USRE36268E (en) | 1988-03-15 | 1999-08-17 | Boehringer Mannheim Corporation | Method and apparatus for amperometric diagnostic analysis |
US5997817A (en) | 1997-12-05 | 1999-12-07 | Roche Diagnostics Corporation | Electrochemical biosensor test strip |
US6055060A (en) | 1996-07-16 | 2000-04-25 | Boehringer Mannheim Gmbh | Analytical system with means for detecting too small sample volumes |
EP1182451A1 (en) * | 2000-03-08 | 2002-02-27 | Matsushita Electric Industrial Co., Ltd. | Biosensor and method of producing the same |
US6645368B1 (en) | 1997-12-22 | 2003-11-11 | Roche Diagnostics Corporation | Meter and method of using the meter for determining the concentration of a component of a fluid |
US6662439B1 (en) | 1999-10-04 | 2003-12-16 | Roche Diagnostics Corporation | Laser defined features for patterned laminates and electrodes |
US20050016844A1 (en) | 2003-06-20 | 2005-01-27 | Burke David W. | Reagent stripe for test strip |
US6906802B2 (en) | 2000-12-08 | 2005-06-14 | Roche Diagnostic Operations, Inc. | System for analyzing sample liquids containing a position control unit |
US7073246B2 (en) | 1999-10-04 | 2006-07-11 | Roche Diagnostics Operations, Inc. | Method of making a biosensor |
WO2008008298A2 (en) * | 2006-07-11 | 2008-01-17 | Bayer Healthcare Llc | Electrochemical test sensor |
US7473398B2 (en) | 2001-05-25 | 2009-01-06 | Roche Diagnostics Operations, Inc. | Biosensor |
Family Cites Families (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5989409A (en) * | 1995-09-11 | 1999-11-23 | Cygnus, Inc. | Method for glucose sensing |
US6139718A (en) * | 1997-03-25 | 2000-10-31 | Cygnus, Inc. | Electrode with improved signal to noise ratio |
US6071391A (en) * | 1997-09-12 | 2000-06-06 | Nok Corporation | Enzyme electrode structure |
US6616819B1 (en) * | 1999-11-04 | 2003-09-09 | Therasense, Inc. | Small volume in vitro analyte sensor and methods |
US6863800B2 (en) * | 2002-02-01 | 2005-03-08 | Abbott Laboratories | Electrochemical biosensor strip for analysis of liquid samples |
ATE448482T1 (en) * | 2002-07-20 | 2009-11-15 | Acea Biosciences Inc | IMPEDANCE-BASED DEVICES AND METHODS FOR USE IN ASSAY |
US8460523B2 (en) * | 2002-12-02 | 2013-06-11 | Arkray, Inc. | Analysis instrument |
CN100473982C (en) * | 2003-10-31 | 2009-04-01 | 生命扫描苏格兰有限公司 | Method for reducing interferences in an electrochemical sensor using two different applied potentials |
US7294246B2 (en) * | 2003-11-06 | 2007-11-13 | 3M Innovative Properties Company | Electrode for electrochemical sensors |
US7419573B2 (en) * | 2003-11-06 | 2008-09-02 | 3M Innovative Properties Company | Circuit for electrochemical sensor strip |
US7387714B2 (en) * | 2003-11-06 | 2008-06-17 | 3M Innovative Properties Company | Electrochemical sensor strip |
CN1938590B (en) * | 2004-04-19 | 2010-05-05 | 松下电器产业株式会社 | Method for measuring blood components and biosensor and measuring instrument for use therein |
US7601299B2 (en) * | 2004-06-18 | 2009-10-13 | Roche Diagnostics Operations, Inc. | System and method for coding information on a biosensor test strip |
US7887682B2 (en) * | 2006-03-29 | 2011-02-15 | Abbott Diabetes Care Inc. | Analyte sensors and methods of use |
RU2475731C2 (en) * | 2006-05-08 | 2013-02-20 | Байер Хэлткэр Ллк | Low sample volume electrochemical test sensor |
US20080023329A1 (en) * | 2006-07-31 | 2008-01-31 | Thrun Lora B | Exhaust gas sensor having a conductive shield and method for routing mobile ions to a contact pad utilizing the conductive shield |
-
2010
- 2010-01-29 US US12/696,316 patent/US20110186428A1/en not_active Abandoned
-
2011
- 2011-01-27 MX MX2012008384A patent/MX2012008384A/en not_active Application Discontinuation
- 2011-01-27 JP JP2012550369A patent/JP5663601B2/en not_active Expired - Fee Related
- 2011-01-27 CN CN201180007453.1A patent/CN102713610B/en not_active Expired - Fee Related
- 2011-01-27 CA CA2786799A patent/CA2786799A1/en not_active Abandoned
- 2011-01-27 EP EP11701623A patent/EP2529219A1/en not_active Withdrawn
- 2011-01-27 KR KR1020127020036A patent/KR20120102799A/en not_active Application Discontinuation
- 2011-01-27 WO PCT/EP2011/000353 patent/WO2011092010A1/en active Application Filing
-
2013
- 2013-02-01 US US13/756,903 patent/US20130140176A1/en not_active Abandoned
- 2013-03-27 HK HK13103878.6A patent/HK1176994A1/en not_active IP Right Cessation
Patent Citations (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
USRE36268E (en) | 1988-03-15 | 1999-08-17 | Boehringer Mannheim Corporation | Method and apparatus for amperometric diagnostic analysis |
US4999482A (en) | 1988-05-24 | 1991-03-12 | Goldstar Co, Ltd. | Optical scanning system for a bar code reader |
US5424035A (en) | 1993-03-31 | 1995-06-13 | Boehringer Mannheim Gmbh | Test strip analysis system |
US5352351A (en) | 1993-06-08 | 1994-10-04 | Boehringer Mannheim Corporation | Biosensing meter with fail/safe procedures to prevent erroneous indications |
US5438271A (en) | 1993-06-08 | 1995-08-01 | Boehringer Mannheim Corporation | Biosensing meter which detects proper electrode engagement and distinguishes sample and check strips |
US5463467A (en) | 1993-06-29 | 1995-10-31 | Boehringer Mannheim Gmbh | Light source pulsed with irregular pulse sequence in analog photometric signal evaluation for a test carrier analysis system |
US5413690A (en) | 1993-07-23 | 1995-05-09 | Boehringer Mannheim Corporation | Potentiometric biosensor and the method of its use |
US5762770A (en) | 1994-02-21 | 1998-06-09 | Boehringer Mannheim Corporation | Electrochemical biosensor test strip |
EP0732406A1 (en) * | 1995-03-17 | 1996-09-18 | Matsushita Electric Industrial Co., Ltd. | A method and a device for quantifying a substrate in a sample liquid using a biosensor |
US6055060A (en) | 1996-07-16 | 2000-04-25 | Boehringer Mannheim Gmbh | Analytical system with means for detecting too small sample volumes |
US5889585A (en) | 1996-09-24 | 1999-03-30 | Lre Technology Partner Gmbh | Method and apparatus for the measurement of blood sugar |
US5798031A (en) | 1997-05-12 | 1998-08-25 | Bayer Corporation | Electrochemical biosensor |
US5997817A (en) | 1997-12-05 | 1999-12-07 | Roche Diagnostics Corporation | Electrochemical biosensor test strip |
US6645368B1 (en) | 1997-12-22 | 2003-11-11 | Roche Diagnostics Corporation | Meter and method of using the meter for determining the concentration of a component of a fluid |
US6662439B1 (en) | 1999-10-04 | 2003-12-16 | Roche Diagnostics Corporation | Laser defined features for patterned laminates and electrodes |
US7073246B2 (en) | 1999-10-04 | 2006-07-11 | Roche Diagnostics Operations, Inc. | Method of making a biosensor |
EP1182451A1 (en) * | 2000-03-08 | 2002-02-27 | Matsushita Electric Industrial Co., Ltd. | Biosensor and method of producing the same |
US6906802B2 (en) | 2000-12-08 | 2005-06-14 | Roche Diagnostic Operations, Inc. | System for analyzing sample liquids containing a position control unit |
US7473398B2 (en) | 2001-05-25 | 2009-01-06 | Roche Diagnostics Operations, Inc. | Biosensor |
US20050016844A1 (en) | 2003-06-20 | 2005-01-27 | Burke David W. | Reagent stripe for test strip |
WO2008008298A2 (en) * | 2006-07-11 | 2008-01-17 | Bayer Healthcare Llc | Electrochemical test sensor |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2014140161A1 (en) * | 2013-03-15 | 2014-09-18 | Roche Diagnostics Gmbh | Electrode configuration for a biosensor |
JP2016510118A (en) * | 2013-03-15 | 2016-04-04 | エフ.ホフマン−ラ ロシュ アーゲーF. Hoffmann−La Roche Aktiengesellschaft | Biosensor electrode configuration |
KR101749849B1 (en) | 2013-03-15 | 2017-06-21 | 에프. 호프만-라 로슈 아게 | Electrode configuration for a biosensor |
EP2848928A1 (en) * | 2013-09-12 | 2015-03-18 | Joinsoon Medical Technology Co., Ltd. | Biosensor test strip for biosensor test device |
US10429336B2 (en) | 2014-06-05 | 2019-10-01 | Roche Diabeters Care, Inc. | Electrode arrangements for test element integrity |
US11137366B2 (en) | 2014-06-05 | 2021-10-05 | Roche Diabetes Care, Inc. | Electrode arrangements for test element integrity |
Also Published As
Publication number | Publication date |
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KR20120102799A (en) | 2012-09-18 |
CN102713610B (en) | 2015-02-04 |
US20130140176A1 (en) | 2013-06-06 |
EP2529219A1 (en) | 2012-12-05 |
CA2786799A1 (en) | 2011-08-04 |
HK1176994A1 (en) | 2013-08-09 |
MX2012008384A (en) | 2012-08-15 |
CN102713610A (en) | 2012-10-03 |
US20110186428A1 (en) | 2011-08-04 |
JP2013518264A (en) | 2013-05-20 |
JP5663601B2 (en) | 2015-02-04 |
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