US20050136471A1 - Biosensor - Google Patents
Biosensor Download PDFInfo
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- US20050136471A1 US20050136471A1 US11/050,348 US5034805A US2005136471A1 US 20050136471 A1 US20050136471 A1 US 20050136471A1 US 5034805 A US5034805 A US 5034805A US 2005136471 A1 US2005136471 A1 US 2005136471A1
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- support substrate
- biosensor
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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
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; and 5,997,817 the disclosure of each of which is expressly incorporated herein by reference.
- FIG. 13 is a view similar to FIG. 8 of a biosensor in accordance with another aspect of the present invention showing four windows exposing four electrode contacts with one closed window in phantom and showing a diagrammatic view of a corresponding meter including five contacts.
- electrodes 16 , 18 , 20 cooperate with one another to define an electrode array 42 .
- electrodes 16 , 18 , 20 each include a meter-contact portion 44 , a measurement portion positioned in the array 42 , and a lead 46 extending between the contact 44 and the measurement portion.
- Contacts 44 are spaced apart from end 32 . It is appreciated that the contacts 44 can be formed to have many lengths and can extend to end 32 or to edges 34 , 36 , or to any number of locations on substrate 12 . Likewise, the leads 38 that extend from the array 34 can be formed to have many lengths and extend to a variety of locations on the electrode support substrate 12 . It is appreciated that the configuration of the electrode array, the number of electrodes, as well as the spacing between the electrodes may vary in accordance with this disclosure and that greater than one array may be formed as will be appreciated by one of skill in the art.
Abstract
A biosensor is provided in accordance with the present invention. The biosensor includes an electrode support substrate, electrodes positioned on the electrode support, each electrode including a meter-contact portion and a measurement portion, and a sensor support substrate. The sensor support substrate cooperates with the electrode support substrate to define channel in alignment with the measurement portion of the electrodes. Additionally, the sensor support substrate includes opposite ends and at least one window. The at least one window is spaced-apart from the ends and in alignment with the meter-contact portion of at least one of the electrodes.
Description
- The present invention is directed to a biosensor and a method of forming same. More particularly, the present invention is directed to a biosensor with connector windows that expose electrode contacts for engagement with a meter.
- 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; and 5,997,817 the disclosure of each of which is expressly incorporated herein by reference.
- According to the present invention a biosensor is provided. The biosensor comprises an electrode support substrate, electrodes positioned on the electrode support, each electrode including a meter-contact portion and a measurement portion, and a sensor support substrate. The sensor support substrate cooperates with the electrode support substrate to define a channel in alignment with the measurement portion of the electrodes. Additionally, the sensor support substrate includes opposite ends and at least one window. The at least one window is spaced-apart from the ends and in alignment with the meter-contact portion of at least one of the electrodes.
- According to another aspect of the invention a method of forming a biosensor is provided. The method comprises the steps of forming electrodes on a surface of an electrode support substrate, each electrode including a meter-contact portion and a measurement portion, forming a sensor support substrate having opposite ends and at least one window spaced apart from the opposite ends, coupling the sensor support and the electrode support substrate together so that the at least one window is aligned with the meter-contact portion of the electrodes, and applying a reagent to the measurement portion of the electrodes.
- In accordance with another aspect of the invention a biosensor is provided. The biosensor comprises an electrode support substrate, electrodes positioned on the electrode support substrate, each electrode including a meter-contact portion and a measurement portion, a sensor support substrate coupled to the electrode support substrate, the sensor support substrate including opposite ends, an opening in alignment with the measurement portion of the electrodes and at least one window spaced-apart from the ends and in alignment with the meter-contact portion of the electrodes, and a cover coupled to the sensor support substrate.
- Additional features of the invention will become apparent to those skilled in the art upon consideration of the following detailed description of the preferred embodiment exemplifying the best mode of carrying out the invention as presently perceived.
- The detailed description particularly refers to the accompanying figures in which:
-
FIG. 1 is a perspective view of a biosensor in accordance with the present invention. -
FIG. 2A is an exploded view of the biosensor ofFIG. 1 . -
FIG. 2B is an enlarged assembled view of a portion of the biosensor ofFIG. 2 illustrating three discrete windows. -
FIG. 3 is a view taken along lines 3-3 ofFIG. 1 . -
FIG. 4 is a view taken alone lines 4-4 ofFIG. 1 . -
FIG. 5 is a diagrammatic view of the method of manufacturing the biosensor of the present invention. -
FIG. 6 is a perspective view of a biosensor in accordance with another aspect of the present invention. -
FIG. 7 is an exploded view of the biosensor ofFIG. 6 . -
FIG. 8 is an enlarged top diagrammatic view of a biosensor in accordance with another aspect of the present invention showing one window exposing two electrode contacts. -
FIG. 9 is an enlarged top diagrammatic view of a biosensor ofFIG. 8 and a diagrammatic view of a corresponding meter showing the meter including two contacts for engagement with the two exposed electrode contacts of the biosensor. -
FIG. 10 is a view similar toFIG. 8 of a biosensor in accordance with another aspect of the present invention showing five windows exposing five electrode contacts and showing a diagrammatic view of a corresponding meter including five contacts for engagement with the five exposed electrode contacts. -
FIG. 11 is an enlarged cross-sectional view of one window of the biosensor ofFIG. 10 and showing one meter contact sequenced in time in order to illustrate the relative positioning of the electrode contact and the meter contact during insertion of the biosensor in the meter. -
FIG. 12 is an enlarged cross-sectional view of one window of the biosensor ofFIG. 10 and showing a diagrammatic view of a switch in accordance with another aspect of the present invention. -
FIG. 13 is a view similar toFIG. 8 of a biosensor in accordance with another aspect of the present invention showing four windows exposing four electrode contacts with one closed window in phantom and showing a diagrammatic view of a corresponding meter including five contacts. -
FIG. 14 is an enlarged perspective view of a biosensor in accordance with another aspect of the present invention. -
FIG. 15 is a view taken along lines 15-15 ofFIG. 14 . - The present invention relates to a biosensor and method of manufacturing said biosensor. This biosensor of the present invention includes opposite ends and is beneficially formed to enable a user to grasp ends without touching electrode contacts, which are themselves formed to electrically connect with a meter. Biosensors of the present invention include at least one discrete window spaced-apart from the end of the biosensor. The at least one window serves as a built-in fiducial for alignment of the biosensor, enabling easy automated process control during assembly. Further, the at least one discrete window is a significant advantage for an integrated strip handling system, since each window creates a detent, providing mechanical feedback for strip mating with meter contacts. Furthermore, when biosensor includes discrete windows, strip alignment problems are eliminated enabling multiple strip configurations to be used with a single meter. That is, the discrete windows of the biosensor prevent problems associated with closely spaced electrode pads touching the wrong meter contact. Aspects of the invention are presented in
FIGS. 1-15 , which are not drawn to scale and wherein like components in the several views are numbered alike. - A
biosensor 10 is shown inFIGS. 1-4 . The term analyte, as used herein, refers to the molecule or compound to be quantitatively determined. Non-limiting examples of analytes include carbohydrates, proteins, such as hormones and other secreted proteins, enzymes, and cell surface proteins; glycoproteins; peptides; small molecules; polysaccharides; antibodies (including monoclonal or polyclonal Ab); nucleic acids; drugs; toxins; viruses of virus particles; portions of a cell wall; and other compounds processing epitopes. The analyte of interest preferably comprises glucose. -
Biosensor 10 is shown inFIG. 1 and includesopposite ends 11, 13, either of which is available to be grasped by a user without contact with electrodes of thebiosensor 10. As shown inFIG. 2A , thebiosensor 10 includes anelectrode support substrate 12 and anelectrical conductor 14 positioned on thesubstrate 12. Theconductor 14 is disrupted to defineelectrodes Biosensor 10 also includes asensor support substrate 22 positioned on thesubstrate 12 and acover substrate 24 positioned on thesensor support substrate 22.Biosensor 10 is in the form of a disposable test strip. It is appreciated however, thatbiosensor 10 can assume any number of forms and shapes in accordance with this disclosure. -
Biosensor 10 is preferably produced from rolls of material. It is understood thatbiosensor 10 also can be constructed from individual sheets in accordance with this disclosure. Whenbiosensors 10 are produced from rolls, the selection of materials necessitates the use of materials that are sufficiently flexible for roll processing, but which are still rigid enough to give a useful stiffness to finishedbiosensor 10. - Referring to
FIG. 2A , theelectrode support substrate 12 includes afirst surface 26 facing thesensor support substrate 22 and asecond surface 28. In addition,substrate 12 has opposite first andsecond ends opposite edges second ends Edge 34 ofsubstrate 12 is formed to include a generally concave-shaped notch 38. It is appreciated thatsubstrate 12 may be formed without a notch, or that the notch may take on any number of shapes and sizes in accordance with the present disclosure. -
Electrode support substrate 12 is generally rectangular in shape, it is appreciated however, thatsupport 12 may be formed in a variety of shapes and sizes in accordance with this disclosure. It is also appreciated that thesubstrate 12 need not necessarily extend the length of thesubstrate 22 as shown inFIGS. 1 and 2 A. In fact, thesubstrate 12 can have a shorter length so long as it is of sufficient length to position the electrodes with a channel and windows as will be described hereafter.Substrate 12 may be constructed from a wide variety of insulative materials. Non-limiting examples of insulative materials that provide desirable electrical and structural properties include glass, ceramics, vinyl polymers, polyimides, polyesters, and styrenics. Preferably,substrate 12 is a flexible polymer, such as a polyester or polyimide. A non-limiting example of a suitable material is 5 mil (125 um) thick KALADEX®, a polyethylene naphthalate film commercially available from E.I. DuPont de Nemours, Wilmington, Del., which is coated with gold by ROWO Coating, Henbolzhelm, Germany. It is appreciated that the thickness of thesupport 12 can be greater or less than 5 mil (125 um) and may be suitable for a number of assembly processes (e.g., lamination, etc.). -
Electrodes conductor 14 onfirst surface 26 ofelectrode support substrate 12. SeeFIGS. 2A and 3 . It is appreciated thatelectrodes electrical conductor 14 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. Preferably,electrical conductor 14 is selected from the following materials: gold, platinum, palladium, iridium, or alloys of these metals, since such noble metals and their alloys are unreactive in biological systems. Most preferably, theelectrical conductor 14 is gold. -
Electrodes electrical conductor 14 by laser ablation. Techniques for forming electrodes on a surface using laser ablation are known. See, for example, U.S. patent application Ser. No. 09/411,940, titled “Laser Defined Features for Patterned Laminates and Electrodes”, the disclosure of which is expressly incorporated herein by reference. Preferably,electrodes electrical conductor 14 from an area extending around the electrodes to form agap 40 of exposedsupport substrate 12. Therefore,electrodes substrate 12. Illustratively, thegap 40 has a width of about 25 μm to about 500 μm, preferably the gap has a width of about 100 μm to about 200 μm. Alternatively, it is appreciated thatelectrodes substrate 12. It is appreciated that while laser ablation is the preferred method for formingelectrodes - As shown in
FIG. 2A ,electrodes electrode array 42. In addition,electrodes contact portion 44, a measurement portion positioned in thearray 42, and a lead 46 extending between thecontact 44 and the measurement portion.Contacts 44 are spaced apart fromend 32. It is appreciated that thecontacts 44 can be formed to have many lengths and can extend to end 32 or toedges substrate 12. Likewise, theleads 38 that extend from thearray 34 can be formed to have many lengths and extend to a variety of locations on theelectrode support substrate 12. It is appreciated that the configuration of the electrode array, the number of electrodes, as well as the spacing between the electrodes may vary in accordance with this disclosure and that greater than one array may be formed as will be appreciated by one of skill in the art. - As described below,
electrodes sensor support substrate 22, electrodes are enabled to be used as an antenna for telemetry, or to signify an expiration date, code number, analyte, etc.). It is also contemplated by the present disclosure to use the electrodes to examine a ratio of currents at one or more time points to determine if thebiosensor 10 has been exposed to inappropriate temperature, humidity, interferences, etc.). - As shown in
FIG. 2B , thesensor support substrate 22 ofbiosensor 10 extends to theend 32 ofsubstrate 12 to permit a user to grasp the end 11 ofbiosensor 10 without contacting theelectrodes substrate 32 may extendpast end 32 in accordance with this disclosure. Thesensor support substrate 22 is positioned to lie between theelectrode support substrate 12 and thecover substrate 24. Referring now toFIG. 4 , thesensor support substrate 22 cooperates with thesupport substrate 12 and thecover 24 to expose theelectrode array 42 to a liquid sample (not shown) being applied to thebiosensor 10.Sensor support substrate 22 can be formed from any number of commercially available insulative materials. Non-limiting examples of insulative materials that provide desirable electrical and structural properties include vinyl polymers, polyimides, polyesters, and styrenics. Preferably, thesensor support substrate 22 is 10 mil (250 um) thick opaque white MELINEX® 329 plastic, a polyester commercially available from E.I. DuPont de Nemours, Wilmington, Del., which is coated with a thermoplastic resin (Griltex D 1698 E), commercially available from EMS-Chemie (North America) Inc., Sumter, S.C. It is further appreciated thatsensor support substrate 22 may be formed of a double-sided adhesive tape covered by an insulative material in accordance with the disclosure, so long as it is of a sufficient thickness to create a detent about at least onewindow 64, as will be described below. - Referring now to
FIG. 2A , thesensor support substrate 22 includes afirst surface 48 and asecond surface 50 facing theelectrode support substrate 12. When thesensor support substrate 22 is coupled to the substrate 12 afirst end 52 of thesensor support substrate 22 is aligned withend 30, asecond end 54 is aligned withend 32, anedge 56 is aligned withedge 34, and anopposite edge 58 is aligned withedge 36. - Further, the
edge 56 is formed to include anotch 60 that is shaped so as to be aligned withnotch 38 of thesubstrate 12. It is appreciated thatsubstrate 12 may be formed without a notch, or that the notch may take on any number of shapes and sizes in accordance with the present disclosure. Anopening 62 extends from thenotch 60 toward theedge 58. When thesensor support substrate 22 is coupled to thesubstrate 12, as shown inFIGS. 1 and 4 , thesubstrates electrode array 42 are positioned to lie in general alignment with theopening 62 and are thus positioned in thechannel 78 to expose at least a portion of theelectrodes electrode array 42. Aninterior border 80 defines theopening 62. The width of theinterior border 80 can vary in accordance with this disclosure. - The
sensor support substrate 22 extends to theend 32 ofsubstrate 12 and is formed to expose theelectrode contacts 44 for engagement with ameter 124. A non-limiting example of such a meter is shown diagrammatically inFIG. 10 . Referring now toFIG. 1 ,sensor support substrate 22 includeswindows 64 that extend between first andsecond surfaces window 64 creates a detent insensor support substrate 22 and is spaced apart fromend 54. This detent provides mechanical feedback for strip mating with meter contacts and increases the rigidity of thesubstrate 22. Further, the positioning of thewindows 64 enables a user to grasp the end 11 of thebiosensor 10 without touching theelectrode contacts 44. Thus, the inadvertent deposit of skin oils, dirt, skin cells, etc. onto theelectrical contacts 44 through simple handling of thebiosensor 10 is prevented. - In addition, at least one
window 64 may be used to perform alignment of thesubstrates window 64 may be used to perform alignment for other manufacturing processes such as dispensing, labeling, cutting, punching, etc. Moreover, it is appreciated thatwindows 64 can take on a variety of shapes and sizes in accordance with the present disclosure. Illustratively,windows 64 are formed to be slightly larger than therespective contacts 44. A non-limiting example of dimensions ofsuitable windows 64 when contacts have a width of about 1 mm and a length of about 2 mm, is a width of about 1.5 mm and a length of about 2.5 mm. In addition, while threewindows 64 are shown, it is appreciated thatbiosensor 10 can be formed with greater than three windows or as few as one window in accordance with the present disclosure. Non-limiting examples of which include windows illustrated inFIGS. 8-10 , and 13-15. -
Sensor support substrate 22 is coupled to theelectrode support substrate 12 as shown inFIG. 1 . The thermoplastic resin onsurface 48 permits thesubstrate 22 to be heat-sealed to theconductor 14coating substrate 12. It is appreciated thatsubstrates substrate 12 where theconductor 14 has been removed) in accordance with this disclosure. It is also appreciated thatfirst surface 50 ofsubstrate 22 may be printed with, for example, product labeling or instructions for use in accordance with this disclosure. - The
cover substrate 24 is coupled to thespacer support 22 across theopening 62. SeeFIG. 1 . Thecover substrate 24 ofbiosensor 10 includes afirst surface 66 facingsubstrate 12, an oppositesecond surface 68 and avent 69 extending betweensurfaces cover substrate 24 has opposite first and second ends 70, 72 andedges Edge 74 is preferably generally concave shape for alignment withnotches substrates edge 74 may take on any number of shapes and sizes in order to be in general alignment with the shape ofnotches cover substrate 24 is formed of a flexible polymer and preferably from a polymer such as an adhesive coated polyethylene terephthalate (PET)—polyester. A non-limiting example of a suitable PET is 2 mil (50 um) thick clear PET film one side of which is coated with a hydrophilic pressure-sensitive adhesive (Product # ARcare 8877) commercially available from Adhesives Research, Inc. Glen Rock, Pa. - The
cover substrate 24 is formed to cooperate with thesensor support substrate 22 and thesupport substrate 12 to define achannel 78 extending fromedges electrode array 42. Thechannel 78 is preferably a capillary channel that is formed to transport a fluid sample from the user to theelectrode array 42. As shown inFIG. 4 , thechannel 78 extends fromedges interior border 80 of theopening 62. It is appreciated that thechannel 78 can extend from any number of locations ofbiosensor 10 to thearray 42. It is also appreciated thatchannel 78 may also be formed from cooperation between only thesensor support substrate 22 and thesupport substrate 12. - An
electrochemical reagent 82 is positioned on thearray 42. Thereagent 82 provides electrochemical probes for specific analytes. The choice of thespecific reagent 82 depends 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 inbiosensor 10 of the present invention is a reagent for measuring glucose from a whole blood sample. A non-limiting example of a reagent for measurement of glucose in a human blood sample contains 62.2 mg polyethylene oxide (mean molecular weight of 100-900 kilo Daltons), 3.3 mg NATROSOL 244M, 41.5 mg AVICEL RC-591 F, 89.4. mg monobasic potassium phosphate, 157.9 mg dibasic potassium phosphate, 437.3 mg potassium ferricyanide, 46.0 mg sodium succinate, 148.0 mg trehalose, 2.6 mg TRITON X-100 surfactant, and 2,000 to 9,000 units of enzyme activity per gram of reagent. The enzyme is prepared as an enzyme solution from 12.5 mg coenzyme PQQ and 1.21 million units of the apoenzyme of quinoprotein glucose dehydrogenase. This reagent is further described in U.S. Pat. No. 5,997,817, the disclosure of which is expressly incorporated herein by reference. - Non-limiting examples of enzymes and mediators that may be used in measuring particular analytes in
biosensor 10 are listed below in Table 1.TABLE 1 Mediator Analyte Enzymes (Oxidized Form) Additional Mediator Glucose Glucose Ferricyanide Dehydrogenase and Diaphorase Glucose Glucose- Ferricyanide Dehydrogenase (Quinoprotein) Cholesterol Cholesterol Ferricyanide 2,6-Dimethyl-1,4- Esterase and Benzoquinone Cholesterol 2,5-Dichloro-1,4- Oxidase Benzoquinone or Phenazine Ethosulfate HDL Cholesterol Ferricyanide 2,6-Dimethyl-1,4- Cholesterol Esterase Benzoquinone and Cholesterol 2,5-Dichloro-1,4- Oxidase Benzoquinone or Phenazine Ethosulfate Triglycerides Lipoprotein Lipase, Ferricyanide or Phenazine Methosulfate Glycerol Kinase, Phenazine and Glycerol-3- Ethosulfate Phosphate Oxidase Lactate Lactate Oxidase Ferricyanide 2,6-Dichloro-1,4- Benzoquinone Lactate Lactate Ferricyanide Dehydrogenase and Phenazine Diaphorase Ethosulfate, or Phenazine Methosulfate Lactate Diaphorase Ferricyanide Phenazine Ethosulfate, or Dehydrogenase Phenazine Methosulfate Pyruvate Pyruvate Oxidase Ferricyanide Alcohol Alcohol Oxidase Phenylenediamine Bilirubin Bilirubin Oxidase 1-Methoxy- Phenazine Methosulfate Uric Acid Uricase Ferricyanide - In some of the examples shown in Table 1, at least one additional enzyme is used as a reaction catalyst. Also, some of the examples shown in Table 1 may utilize an additional mediator, which facilitates electron transfer to the oxidized form of the mediator. The additional mediator may be provided to the reagent in lesser amount than the oxidized form of the mediator. While the above assays are described, it is contemplated that current, charge, impedance, conductance, potential, or other electrochemically indicated property of the sample might be accurately correlated to the concentration of the analyte in the sample with
biosensor 10 in accordance with this disclosure. - A plurality of
biosensors 10 are typically packaged in a vial, usually with a stopper formed to seal the vial. It is appreciated, however, thatbiosensors 10 may be packaged individually, or biosensors can be folded upon one another, rolled in a coil, stacked in a cassette magazine, or packed in blister packaging. -
Biosensor 10 is used in conjunction with the following: -
- 1. a power source in electrical connection with
contacts 44 and capable of supplying an electrical potential difference betweenelectrodes - 2. a meter in electrical connection with
contacts 44 and capable of measuring the diffusion limited current produced by oxidation of the reduced form of the mediator with the above-stated electrical potential difference is applied.
- 1. a power source in electrical connection with
- The meter will normally be adapted to apply an algorithm to the current measurement, whereby an analyte concentration is provided and visually displayed. Improvements in such power source, meter, and biosensor system are the subject of commonly assigned U.S. Pat. No. 4,963,814, issued Oct. 16, 1990; U.S. Pat. No. 4,999,632, issued Mar. 12, 1991; U.S. Pat. No. 4,999,582, issued Mar. 12, 1991; U.S. Pat. No. 5,243,516, issued Sep. 7, 1993; U.S. Pat. No. 5,352,351, issued Oct. 4, 1994; U.S. Pat. No. 5,366,609, issued Nov. 22, 1994; White et al., U.S. Pat. No. 5,405,511, issued Apr. 11, 1995; and White et al., U.S. Pat. No. 5,438,271, issued Aug. 1, 1995, the disclosures of each of which are expressly hereby incorporated by reference.
- Many fluid samples may be analyzed. For example, 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. Preferably, whole blood is assayed with this invention.
- As shown in
FIG. 5 ,biosensor 10 is manufactured using six distinct processes. In process one, a roll of sensorsupport substrate material 84 is fed into a window punch andweb slit station 86. In thestation 86, thewindows 64 and theopening 62 are created through the sensor support substrates in the web and the web is slit to its final dimension in the station. The trim, from the edges of the web of material is removed from the material and wound into aroll 88. Upon leaving thestation 86, the punched sensor support substrates connected to one another via a web are wound into aroll 90. - In process two, a roll of metallized
electrode support material 92 is fed into an ablation/washing and dryingstation 94. A laser system capable of ablatingsupport 12 is known to those of ordinary skill in the art. Non-limiting examples of which include excimer lasers, with the pattern of ablation controlled by mirrors, lenses, and masks. A non-limiting example of such a custom fit system is the LPX-300 or LPX-200 both commercially available from LPKF Laser Electronic GmbH, of Garbsen, Germany. - In the
ablation station 94, the metallic layer of the metallized film is ablated in a pre-determined pattern, to form a ribbon of support material withisolated electrode patterns 96. To ablateelectrodes gaps 40 in 50 nmthick gold conductor ablation station 94, the ribbon is also passed through an optional inspection system where both optical and electrical inspection can be made. The system is used for quality control in order to check for defects. - Next, in process three, the roll of punched
sensor support substrates 90 is fed into a cutting andlamination station 98. At the same time, the ribbon of support material withisolated electrode patterns 96 is fed into thestation 98. The thermoplastic resin coated first surface of thesensor support substrates 90 is applied to the electrode support substrate material so that thewindows 64 are in general alignment with therespective contacts 44 and theopenings 62 are in general alignment with thearrays 42. It is appreciated that thewindows 64 may in fact be used as a built-in fiducial for alignment thesensor support substrates 90 with the ribbon of support material. Once aligned, the web ofsensor support substrates 90 is heat-sealed to the ribbon ofsupport material 96 to formsubassembly 100. - In process four, the
subassembly 100 is fed into areagent dispensing station 102. A reagent that has been compounded is fed, as shown byarrow 104, into the dispensingstation 102 where it is applied in a liquid form in multiple shots to thearray 42. It is appreciated, however, that the reagent can be applied in a single shot by a custom fit precision dispensing station available from Fluilogic Systems Oy, Espoo, Findland. Reagent application techniques are well known to one of ordinary skill in the art as described in U.S. Pat. No. 5,762,770, the disclosure of which is expressly incorporated herein by reference. It is appreciated that reagents may be applied to thearray 42 in a liquid or other form and dried or semi-dried onto thearray 42 in accordance with this disclosure. A reagent-coatedsubassembly 106 then exits thestation 102. - In process five, the reagent-coated
subassembly 106 is fed into a second cutting andlamination station 108. At the same time, a ribbon ofcover material 110 is fed intostation 108. A liner on one side of theribbon 110 is removed in thestation 108 and rewound overguide roll 112 into a roll 114 for discard. The ribbon ofcover material 110 and thesubassembly 106 are aligned so that thecover material 110 lies across theelectrode arrays 42 to form an assembledmaterial 116. - In process six, the assembled
material 116 is fed into a sensor punch/pack station 120 where thematerial 116 is cut to formindividual biosensors 10. Thebiosensors 110 are sorted and packed into vials. Each vial is then closed with a stopper to give packaged biosensor strips as shown byarrow 122. - In use, for example, a user of
biosensor 10 places a finger having a blood collection incision againstrespective notches edge 74adjacent opening 62. Capillary forces pull a liquid sample flowing from the incision into theopening 62 and through thecapillary channel 78 across thereagent 82 and thearray 42. The liquid sample dissolves thereagent 82 and engages thearray 42 where the electrochemical reaction takes place. - The user then inserts the
biosensor 10 into the meter 124 (see, for exampleFIG. 10 ) where an electrical connection is made between theelectrode contacts 44 exposed bywindows 64 and threecorresponding meter contacts 126 of themeter 124. Referring now toFIG. 11 , a non-limiting example of asuitable meter contact 126 is illustrated.Meter contact 126 includes anelectrode engagement portion 128 that is formed of an electrically conductive material and apivot portion 130. Eachmeter contact 126 is spring-loaded so that it pivots over theedge 54 of thespacer support substrate 22 when thebiosensor 10 is moved into themeter 124, as shown for example byarrow 132, and rides across thesurface 50 of said substrate. When, however, theelectrode engagement portion 128 encounters awindow 64, themeter contact 126 pivots on thepivot portion 130 so that theportion 128 engages a corresponding electrode exposed by thewindow 64 and creates an electrically conductive connection between the exposed electrode and the contact. It is appreciated that the illustratedmeter 124 includes greater than threemeter contacts 126, two of which will rest upon thesecond surface 50 of thespacer substrate 22 when thebiosensor 10 is inserted into themeter 124. It is appreciated thatbiosensor 10 may be used with a variety of meters, which may include greater or less than five meter contacts in accordance with this disclosure. - Moreover, it is appreciated that the
biosensor 10 also may be inserted into themeter 124 at a variety of time periods including prior to the sample flowing into theopening 62. Once the electrochemical reaction is complete, a power source (e.g., a battery) applies a potential difference between theelectrodes current measuring meter 124 measures the diffusion-limited current generated by the oxidation of the reduced form of the mediator at the surface of the working electrode as described above. - The measured current may be accurately correlated to the concentration of the analyte in sample when the following requirements are satisfied:
-
- 1. The rate of oxidation of the reduced form of the mediator is governed by the rate of diffusion of the reduced form of the mediator to the surface of the working electrode.
- 2. The current produced is limited by the oxidation of reduced form of the mediator at the surface of the working electrode.
- It is appreciated that the
meter 124 can be designed to be utilized with a number of different biosensors with a variety of different electrodes or contacts. Non-limiting examples of alternative biosensors may require temperature or hematocrit compensation, others might utilize a one, two, four, five or more electrode configuration, others might require coding or expiration information exchange with the meter, etc. Furthermore, themeter 124 may be formed to measure multiple analytes simultaneously on a single strip (e.g., glucose and fructosamine, glucose and ketones, HDL and total cholesterol, etc.). For example, the presence and location of thecontacts 44 exposed through thewindows 64 could readily identify such a biosensor to the meter as a glucose/ketone assay). Thus, by using different combinations of window placement onbiosensor 10, new analytes may easily be added to the meter's applications. - In another aspect of the invention, a
biosensor 210 is provided in accordance with the present invention.Biosensor 210 is shown inFIGS. 6-7 and includes opposite ends 211, 213, either of which is available to be grasped by a user without contact with electrodes of thebiosensor 210.Biosensor 210 includes anelectrode support substrate 212 that supports theelectrical conductor 14 described above with reference tobiosensor 10. Theconductor 14 is disrupted to defineelectrodes Biosensor 210 also includes asensor support substrate 222 positioned on thesubstrate 212 and acover substrate 224 positioned on thesensor support substrate 222.Biosensor 210 is formed in a variety of shapes and sizes and from materials similar tobiosensor 10 as described above. - Referring to
FIG. 7 , theedge 34 of theelectrode support substrate 212 is formed to include anotch 238. It is appreciated thatsubstrate 212 may be formed without a notch, or that the notch may take on any number of shapes and sizes in accordance with the present disclosure.Electrodes conductor 14 similar toelectrodes Electrodes electrode array 242. In addition,electrodes contact 244 and a lead 246 extending between thecontact 244 and thearray 242.Contacts 244 are spaced apart fromend 32. It is appreciated that thecontacts 244 can be formed to have many lengths and can extend to end 32 or toedges substrate 212. Likewise, theleads 246 that extend from thearray 242 can be formed to have many lengths and extend to a variety of locations on theelectrode support substrate 12. It is appreciated that the configuration of the electrode array, the number of electrodes, as well as the spacing between the electrodes may vary in accordance with this disclosure and that a greater than one array may be formed as will be appreciated by one of skill in the art. -
Sensor support substrate 222 ofbiosensor 210 is positioned to lie betweensupport substrate 212 andcover substrate 224.Sensor support substrate 222 extends to theend 32 to permit a user to grasp theend 213 of thebiosensor 210 without touching theelectrodes sensor support substrate 222 cooperates with thesupport substrate 212 and thecover 224 to expose theelectrode array 242 to a liquid sample being applied to thebiosensor 210.Sensor support substrate 222 may have a variety of lengths and is formed from materials similar tosubstrate 22, as described above. - As shown in
FIG. 7 , theedge 56 of thesensor support substrate 22 is formed to include anotch 260. It is appreciated thatsubstrate 212 may be formed without a notch, or that the notch may take on any number of shapes and sizes in accordance with the present disclosure. Anopening 262 extends from thenotch 260 toward theedge 58. When thesensor support substrate 222 is coupled tosubstrate 212, theelectrode array 242 is positioned to lie in general alignment with theopening 262, exposing at least a portion of theelectrode array 242. Aninterior border 280 defines theopening 262. The width of theinterior border 280 can vary in accordance with this disclosure. - The
sensor support substrate 222 extends to theend 32 ofsubstrate 212 and is formed to expose theelectrode contacts 244 for engagement with ameter 282, as shown for example inFIG. 9 . Referring now toFIGS. 7 and 9 , thesensor support substrate 222 includesdiscrete windows 264 that extend between first andsecond surfaces window 264 is spaced apart fromend 54 in order to enable a user to grasp theend 54 of thesensor support substrate 222 without touching theelectrode contacts 244. Thus, the inadvertent deposit of skin oils, dirt, skin cells, etc. onto theelectrical contacts 244 through simple handling of thebiosensor 210 is prevented. In addition, at least onewindow 264 may be used to perform alignment of thesubstrates window 264 may be used to perform alignment for other manufacturing processes such as dispensing, labeling, cutting, punching, etc. Moreover, it is appreciated thatwindows 264 can take on a variety of shapes and sizes as described above with reference towindows 64 in accordance with the present disclosure. - As show in
FIG. 6 , thecover substrate 224 is coupled to thespacer support 222 and extends across theopening 262. Theedge 74 of thecover substrate 224 formed to include anotch 276. It is appreciated thatsubstrate 224 may be formed without a notch, or that the notch may take on any number of shapes and sizes in accordance with the present disclosure. When thecover substrate 224 is coupled to thesensor support substrate 222, aninterior border 282 is aligned with the entrance to theopening 262. The width of theinterior border 282 can vary in accordance with this disclosure. -
Biosensor 210 is manufactured in a similar manner tobiosensor 10, except for the following differences: First, in the window punch andweb slit station 86, twowindows 264 and anopening 262 that has aborder 280 with corners are formed in the web of thesensor support substrate 90. Second, in the ablation/washing and dryingstation 94, twoelectrodes substrate 212.Cover material 110 is then fed into the second cutting andlamination station 108 along with the reagent-coatedsubassembly 106 as discussed above with reference tobiosensor 10. In addition, the ribbon of thecover material 110 and thesubassembly 106 are aligned to form an assembledmaterial 116. The assembledmaterial 116 is then fed into the sensor punch/pack station 120 where thematerial 116 is cut to formindividual biosensors 210 and packed as described above with reference tobiosensors 10. - In use, for example, a user of
biosensor 210 places a finger having a blood collection incision againstarray 242 exposed by opening 262. The liquid sample flowing from the incision dissolves thereagent 82 and engages thearray 42 where the electrochemical reaction takes place. Cooperation between thebiosensor 210 and themeter 282 are similar to that described above with reference tobiosensor 10.Meter 282, however, includes twometer contacts 126. Eachmeter contact 126 is formed to pivot overedge 54 of thesensor support substrate 222 when thebiosensor 210 is inserted into themeter 282. Thesemeter contacts 126 ride across thesurface 50 and pivot into alignedwindows 264 so that theportion 128 engages a corresponding electrode exposed by thewindow 264 and creates an electrically conductive connection between the exposed electrode and the contact. - In accordance with another aspect of the present invention, a
biosensor 310 is provided and is illustrated inFIG. 8 . Thebiosensor 310 is constructed and manufactured identically tobiosensor 210 except itsspacer support substrate 222 is formed to include onewindow 364. Thiswindow 364 exposes bothelectrodes meter 282 illustrated inFIG. 9 .Biosensor 310 is also used in a manner similar tobiosensor 210, except that upon insertion of thebiosensor 310 into themeter 282, themeter contacts 126 each pivot into thesingle window 264 for engagement with an aligned electrode to create an electrically conductive connection between the exposed electrode and the contact. - In accordance with another aspect of the present invention, a
biosensor 410 is provided and is illustrated inFIGS. 10-12 . As shown inFIGS. 11 and 12 ,biosensor 410 includes anelectrode support substrate 412 that supports theelectrical conductor 14 as described above with reference tobiosensor 10. Referring now toFIG. 10 , theconductor 14 is disrupted to defineelectrodes Biosensor 410 also includes asensor support substrate 422 positioned on thesubstrate 412.Biosensor 410 may also include a cover substrate, as shown for example inFIGS. 2 and 7 , positioned on thesensor support substrate 422.Biosensor 410 is formed in a variety of shapes and sizes and from materials similar tobiosensor 10 as described above. -
Electrodes conductor 14 similar toelectrodes electrode contact 444 spaced apart fromend 32 and a lead 446 extending from thecontact 444. It is appreciated that thecontacts 444 can be formed to have many lengths and can extend to any number of locations onsubstrate 212. Likewise, theleads 246 that extend from thecontacts 444 can be formed to have many lengths and extend to a variety of locations on theelectrode support substrate 412. It is appreciated that the configuration of the electrodes may vary as discussed above with reference tobiosensors -
Sensor support substrate 422 ofbiosensor 410 extends to theend 32 of theelectrode support substrate 412.Substrate 422, may however have a variety of lengths and be formed from materials similar tosubstrate 22, as described above. In addition, thesensor support substrate 422 is formed to expose theelectrode contacts 444 for engagement with themeter 124. As shown inFIG. 10 , thesensor support substrate 422 includes fivediscrete windows 464.Windows 464 extend between first andsecond surfaces window 264 is spaced apart fromend 54. Similar towindows window 264 may be used to perform alignment for a variety of manufacturing processes. Moreover, it is appreciated thatwindows 464 can take on a variety of shapes and sizes as described above with reference towindows 64 in accordance with the present disclosure. -
Biosensor 410 is manufactured in a similar manner tobiosensor 210, except for the following differences: First, in the window punch andweb slit station 86, fivewindows 464 are formed in the web of thesensor support substrate 90. Second, in the ablation/washing and dryingstation 94, fiveelectrodes substrate 412. - The
biosensor 410 is used in a manner similar tobiosensors biosensor 410 and themeter 124 are similar to that described above with reference tobiosensor 10. Eachmeter contact 126 is formed to pivot overedge 54 of thesensor support substrate 422 when thebiosensor 410 is inserted into themeter 124. Thesemeter contacts 126 ride across thesurface 50 and pivot into alignedwindows 464 so that theportion 128 engages a corresponding electrode exposed by thewindow 464 and creates an electrically conductive connection between the exposed electrode and the contact. - A non-limiting example of an alternative to
meter contact 126 is illustrated diagrammatically inFIG. 12 . Thealternative meter contact 466 may be a mechanical switch or an optical (LED) switch. Contact 466 may be used for an automatic on/off switch, to signify which type of biosensor has been inserted into the meter, as a fail safe for the meter contact, and/or as a positive mating mechanism. It is appreciated that a variety of commercially available mechanical switches and LED switches may be used in accordance with this disclosure. - In use, the meter is turned on and the biosensor is inserted into the meter. It is appreciated that the user may turn on the meter, or it may turn on automatically upon insertion of the biosensor. The LED emits a light that is directed through a lens towards the biosensor. The light is reflected off of the exposed
conductor 14, through the lens, and toward the photodiode. The photodiode measures the intensity of the light that is reflected back from theconductor 14 and generates a corresponding voltage waveform. A decoder deciphers this waveform and translates it into a reading of the conductor. It is appreciated that many commercially available optical readers may be used in accordance with the present invention. Preferably, the optical reader will be a custom fit reader. - In addition, in accordance with another aspect of the present invention, a
biosensor 510 is provided and is illustrated inFIG. 13 . Thebiosensor 510 is constructed and manufactured identically tobiosensor 410 except itsspacer support substrate 522 is formed to include four windows 564 instead of five. Thus, one electrode, a non-limiting example of which iselectrode 416, remains covered by thespacer support substrate 522. It is appreciated that greater than one electrode may be covered by thesubstrate 522.Biosensor 510 is used in a manner similar tobiosensor 410, except that upon insertion of thebiosensor 510 into themeter 124, fourmeter contacts 126 pivot into correspondingwindows 464 for engagement with alignedelectrodes meter contact 126 that is aligned withelectrode 416 remains resting upon thesecond surface 50 of thespacer support substrate 522. - In another aspect of the invention, a
biosensor 610 is provided in accordance with the present invention.Biosensor 610 is shown inFIGS. 14 and 15 and includes anelectrode support substrate 612 that includes first andsecond surfaces 626, 628 each of which supports anelectrical conductor 14 formed as described above with reference tobiosensor 10. Theconductor 14 is disrupted to defineelectrodes 616, 618 on thefirst surface 626 and electrodes 620, 622 on the second surface 628.Biosensor 610 also includessensor support substrates substrate 630 extends acrosselectrodes 616, 618 and thesubstrate 632 extends across the electrodes 620, 622.Biosensor 610 may be formed in a variety of shapes and sizes and from materials similar tobiosensor 10 as described above. - Referring to
FIG. 15 , theelectrodes 616, 618 and the electrodes 620, 622 are created or isolated fromconductor 14 similar toelectrodes biosensor 210.Electrodes 616, 618 and electrodes 620, 622 each include acontact 644 and a lead 646 extending from thecontact 644. SeeFIG. 14 .Contacts 644 are spaced apart fromend 32. It is appreciated that thecontacts 644 can be formed to have many lengths and can extend to end 32 or toedges substrates leads 646 can be formed to have many lengths and extend to a variety of locations on theelectrode support substrate 612. It is appreciated that the number of electrodes as well as the spacing between the electrodes may vary in accordance with this disclosure as will be appreciated by one of skill in the art. It is also appreciated that theelectrodes 616, 618 and the electrodes 620, 622 may cooperate to form a variety of electrode arrays in accordance with this disclosure. -
Sensor support substrates biosensor 610 each extend to theend 32 of theelectrode support substrate 612. It is appreciated, however, the relative positioning between thesubstrates electrode support substrate 612 may vary in accordance with this disclosure. Moreover, thesensor support substrates substrate 22, as described above. As shown inFIG. 15 , thesensor support substrate 630 is formed to expose thecontacts 644 of theelectrodes 616, 618 for engagement withmeter contacts 126. Likewise, thesensor support substrate 632 is formed to expose thecontacts 644 of the electrodes 620, 622 for engagement withmeter contacts 126. - The support substrates 630, 632 are formed to include
discrete windows window second surfaces end 54. It is appreciated that at least one of the windows may be used to perform alignment of thesensor support substrate 630 with theelectrode support substrate 612 and thesensor support substrate 632 with theelectrode support substrate 612. It is also appreciated that at least one window may be used to perform alignment for other manufacturing processes such as dispensing, labeling, cutting, punching, etc. Moreover, it is appreciated that thewindows windows 64 in accordance with the present disclosure. -
Biosensor 610 is manufactured in a similar manner tobiosensor 10, except for the following differences: - First, in the window punch and
web slit station 86, twowindows 648 are formed in the web of the sensor support substrate. Likewise, either in thestation 86, or in a second slit station, twowindows 650 are formed in a second web of a sensor support substrate. Second, in process two, a roll of electrode support material that is metallized on first andsecond surfaces 626, 628 is fed into an ablation/washing and dryingstation 94. In theablation station 94, each metallic layer of the metallized film is ablated in a pre-determined pattern, to form a ribbon of support material with isolated electrode patterns onsurfaces 626, 628. The energy required for ablation is similar to that described above with reference tobiosensor 10. - Next, in process three, the first and second rolls of punched sensor support substrates are fed into a cutting and
lamination station 98. At the same time, the ribbon of support material with isolated electrode patterns is fed into thestation 98. The thermoplastic resin coated first surface of the sensor support substrates are each applied to the first andsecond surfaces 626, 628 of the electrode support substrate material so that thewindows contacts 644. It is appreciated that thewindows - In process four, the subassembly is fed into a first
reagent dispensing station 102. A reagent that has been compounded is fed, as shown byarrow 104, into the dispensingstation 102 where it is applied in a liquid form in multiple shots to the array on thefirst surface 626. The subassembly is then fed into a second reagent dispensing station (not shown) where a second reagent that has been compounded is fed into the dispensing station where it is applied in a liquid form in multiple shots to the array on the second surface 628. It is appreciated that the reagent can be applied in a single shot by a custom fit precision dispensing station available from Fluilogic Systems Oy, Espoo, Findland. Reagent application techniques are as described above with reference tobiosensor 10. It is appreciated that reagents may be applied to the arrays in a liquid or other form and dried or semi-dried onto the arrays in accordance with this disclosure. A reagent-coated subassembly then exits the second station. - In process five, the reagent-coated subassembly is fed into a second cutting and
lamination station 108. At the same time, two ribbons of cover material are fed into thestation 108. A liner on one side of each ribbon is removed in thestation 108. The ribbons of cover material and the subassembly are aligned so that one ribbon of cover material lies across a portion of the electrodes 616, 61 8 and that the second ribbon of cover material lies across a portion of the electrodes 620, 622 to form an assembled material. The assembled material is cut to formindividual biosensors 610 as described above with reference tobiosensor 10. -
Biosensor 610 is used in a manner similar tobiosensor 210. Likewise, cooperation between thebiosensor 610 and a meter are similar to that described above with reference tobiosensor 10. A meter suitable for use withbiosensor 610 will include meter contacts that will become aligned withwindows biosensor 610 is inserted into the meter. - The processes and products described above include
disposable biosensors biosensor 10 can be manufactured in a variety of shapes and sizes and be used to perform a variety of assays, non-limiting examples of which include current, charge, impedance conductance, potential or other electrochemical indicative property of the sample applied to biosensor. - Although the invention has been described in detail with reference to a preferred embodiment, variations and modifications exist within the scope and spirit of the invention, on as described and defined in the following claims.
Claims (45)
1. A biosensor comprising:
an electrode support substrate,
electrodes positioned on the electrode support, each electrode including a meter-contact portion and a measurement portion, and
a sensor support substrate cooperating with the electrode support substrate to define a channel in alignment with the measurement portion of the electrodes, the sensor support substrate including opposite ends and at least one window, the at least one window being spaced-apart from the ends and in alignment with the meter-contact portion of at least one of the electrodes.
2. The biosensor of claim 1 further comprising a cover substrate coupled to the sensor support substrate.
3. The biosensor of claim 2 wherein the cover substrate cooperates with the electrode support substrate and the sensor support substrate to define the channel.
4. The biosensor of claim 1 further comprising a reagent positioned on the electrode support substrate and spaced-apart from the meter-contact portion of the electrodes.
5. The biosensor of claim 1 wherein the dimensions of at least one of the windows are greater than the dimensions of the meter-contact portion of the respective electrodes.
6. The biosensor of claim 1 wherein the sensor support substrate includes three windows.
7. The biosensor of claim 1 wherein the sensor support substrate includes four windows.
8. The biosensor of claim 1 wherein the sensor support substrate includes five windows.
9. The biosensor of claim 1 wherein the electrode support substrate includes a greater number of electrodes than the sensor support substrate includes windows.
10. The biosensor of claim 1 further comprising a second sensor support substrate coupled to the electrode support substrate, the second sensor support substrate including opposite ends and at least one window, the at least one window being spaced-apart from the ends and in alignment with the meter-contact portion of at least one of the electrodes.
11. A method of forming a biosensor, the method comprising the steps of:
forming electrodes on a first surface of an electrode support substrate, each electrode including a meter-contact portion and a measurement portion,
forming a sensor support substrate having opposite ends and at least one window spaced apart from the opposite ends,
coupling the sensor support and the electrode support substrate together so that the at least one window is aligned with the meter-contact portion of the electrodes, and
applying a reagent to the measurement portion of the electrodes.
12. The method of claim 11 wherein the sensor support substrate includes windows, the windows being used to perform alignment of the sensor support substrate with the sensor support substrate.
13. The method of claim 11 further comprising the step of forming electrodes on a second surface of the electrode support substrate.
14. The method of claim 13 further comprising the steps of forming a second sensor support substrate and coupling the second sensor support substrate to the second surface of the electrode support substrate.
15. (canceled)
16. The method of claim 11 wherein the electrodes are formed on the electrode support substrate with a laser.
17. The method of claim 11 wherein an equal number of electrodes are formed on the electrode support substrate as are windows formed in the sensor support substrate.
18. The method of claim 11 wherein a greater number of electrodes are formed on the electrode support substrate than are windows formed in the sensor support substrate.
19. The method of claim 18 wherein at least one window is formed to expose greater than one electrode.
20. The method of claim 11 wherein an equal number of electrodes are formed on the electrode support substrate as are windows formed in the sensor support substrate.
21. (canceled)
22. The method of claim 11 further comprising forming an opening in the sensor support substrate and the coupling step includes aligning the opening with the measurement portion of the electrodes.
23. The method of claim 22 further comprising coupling a cover substrate to the spacer support substrate so that the cover extends across the opening.
24. A biosensor comprising:
an electrode support substrate,
electrodes positioned on the electrode support substrate, each electrode including a meter-contact portion and a measurement portion,
a sensor support substrate coupled to the electrode support substrate, the sensor support substrate including opposite ends, an opening in alignment with the measurement portion of the electrodes and at least one window spaced-apart from the ends and in alignment with the meter-contact portion of the electrodes, and
a cover coupled to the sensor support substrate.
25. The biosensor of claim 24 wherein the cover extends across the opening.
26. The biosensor of claim 24 wherein the electrode support substrate includes opposite first and second ends and the meter-contact portions are spaced apart from ends.
27. The biosensor of claim 24 wherein the electrode support substrate includes a greater number of electrodes than the sensor support substrate includes windows.
28. The method of claim 24 wherein the electrode support substrate includes an equal number of electrodes as windows formed in the sensor support substrate.
29. The biosensor of claim 22 further comprising a second sensor support substrate coupled to the electrode support substrate, the second sensor support substrate including opposite ends and at least one window, the at least one window being spaced-apart from the ends and in alignment with the meter-contact portion of at least one of the electrodes.
30. A biosensor comprising:
a substrate,
an electrode positioned on the substrate, the electrode including a contact portion and a measurement portion, and a support substrate cooperating with the substrate to define a channel in alignment with the measurement portion, the support substrate including opposite ends and a window, the window being positioned away from the ends and in alignment with the contact portion.
31. The biosensor of claim 30 further comprising a reagent positioned on the substrate and away from the contact portion.
32. The biosensor of claim 30 wherein the dimensions of the window are greater than the dimensions of the contact portion.
33. The biosensor of claim 30 comprising windows.
34. The biosensor of claim 30 comprising electrodes.
35. A method of forming a biosensor, the method comprising the steps of:
forming an electrode on a first surface of a substrate, the electrode including a meter-contact portion and a measurement portion,
forming a support substrate having opposite ends and a window spaced positioned away from the opposite ends,
applying a reagent to the measurement portion, and
coupling the support substrate and the substrate together so that the window is aligned with the meter-contact portion.
36. The method of claim 35 wherein the electrode is formed with a laser.
37. The method of claim 35 wherein electrodes are formed on the substrate.
38. The method of claim 37 wherein the window is formed to expose electrodes.
39. The method of claim 35 wherein the support substrate is formed to include windows.
40. The method of claim 39 wherein an equal number of electrodes are formed on the substrate as are windows formed in the support substrate.
41. The method of claim 39 wherein a greater number of electrodes are formed on the electrode support substrate than are windows formed in the sensor support substrate.
42. A biosensor comprising:
a substrate,
an electrode positioned on the substrate, the electrode including a contact portion and a measurement portion,
a support substrate including opposite ends, an opening in alignment with the measurement portion and a window positioned away from the ends and in alignment with the contact portion, and
a cover coupled to the support substrate.
43. The biosensor of claim 42 wherein the cover extends across the opening.
44. The biosensor of claim 42 comprising windows.
45. The biosensor of claim 42 comprising electrodes.
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EP1347058A3 (en) | 2009-12-30 |
US6866758B2 (en) | 2005-03-15 |
US20030178302A1 (en) | 2003-09-25 |
EP1347058A2 (en) | 2003-09-24 |
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